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Australian Code for the Responsible Conduct of Research, 2018

The  Australian Code for the Responsible Conduct of Research, 2018  (the 2018 Code) establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour.  

Publication Data

The 2018 Code is a principles-based document that articulates the broad principles and responsibilities that underpin the conduct of Australian research.

Developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia, the 2018 Code has broad relevance across all research disciplines.

Adherence to the 2018 Code is a prerequisite for the receipt of funding by the National Health and Medical Research Council.

Guidance to support the Code

The 2018 Code should be read alongside the Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research , 2018 (the Investigation Guide) – see 'Download' below. This guide outlines a model process for institutions to use to manage and investigate potential breaches of the 2018 Code.

The 2018 Code is also supported by guides on specific topics to encourage responsible research conduct. The co-authors have released guides on:

• Managing and investigating potential breaches of the Australian Code for the Responsible Conduct of Research
• Authorship (see download below)
• Management of data and information in research (see download below)
• Peer review (see download below)
• Disclosure of interests and management of conflicts of interest (see download below)
• Supervision (see download below)
• Collaborative research (see download below)
• Publication and dissemination of research (see download below)
• Research Integrity Advisors Guide (see download below)

NHMRC recognises the critical contribution that consumers can make to research, as well as their right to participate in research. The Statement on consumer and community involvement in health and medical research (the Statement) complements the Code, by guiding research institutions, researchers, consumers and community members in the active involvement of consumers and community members in all aspects of health and medical research. The Code, together with the Statement establishes a framework for credibility and community trust in publically funded research.

For further information please refer to the following webpage about the release of the 2018 Code .

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Australian Research Integrity Committee

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National Health and Medical Research Council (NHMRC)

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NHMRC, GPO Box 1421, Canberra, Australian Capital Territory, ACT,2601, Australia Tel: (61) 2 6217 9000 Fax: (61) 2 6217 9100 Email: [email protected] Website: www.nhmrc.gov.au Contact: Executive Director

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The National Health and Medical Research Council (NHMRC) (Australia) consolidates within a single national organization the often independent functions of research funding and development of advice. One of its strengths is that it brings together and draws upon the resources of all components of the health system, including governments, medical practitioners, nurses and allied health professionals, researchers, teaching and research institutions, public and private programme managers, service administrators, community health organizations, social health researchers and consumers.

Biomedical (C J Martin) Fellowships

Subjects: Biomedical sciences.

Purpose: To enable fellows to develop their research skills and work overseas on specific research projects within the biomedical sciences under nominated advisers.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a medical, dental or related field of research, be actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Level of Study: Postdoctorate

Type: Fellowship

Value: An allowance of Australian $5,000 per year is payable for research support, including conference travel, for the 2 year Australian portion of the Fellowship. Please check website for full detail

Length of Study: 4 years, the first 2 of which are to be spent overseas and the final 2 in Australia

Frequency: Annual

Study Establishment: Institutions approved by the NHMRC, such as teaching hospitals, universities and research institutes

Country of Study: Any country

No. of awards offered: Varies

Application Procedure: Application forms available from the website.

Closing Date: July 7th

Funding: Government

No. of awards given last year: 31

No. of applicants last year: 79

Additional Information: Please check website for more details.

Biomedical (Dora Lush) and Public Health Postgraduate Scholarships

Subjects: Biomedical sciences and public health.

Purpose: To encourage science Honours or equivalent graduates of outstanding ability to gain full-time health and medical research experience.

Eligibility: Open to Australian citizens who have already completed a science Honours degree (or equivalent) at the time of submission of the application, science Honours graduates and unregistered medical or dental graduates from overseas, who have permanent resident status and are currently residing in Australia. The scholarship shall be held within Australia.

Level of Study: Postgraduate

Type: Scholarship

Value: Varies

Length of Study: 1 year, renewable for up to 2 further years

Country of Study: Australia

Application Procedure: Applicants should visit the website at https://www.nhmrc.gov.au/grants-funding/apply-funding/postgraduate-scholarships/postgraduate-scholarships-categories-award for details.

Closing Date: Varies

No. of awards given last year: 51

No. of applicants last year: 133

For further information contact:

Centre for Research Management & Policy, NHMRC, GPO Box 9848, Canberra, Australian Capital Territory

Biomedical Australian (Peter Doherty) Fellowship

Purpose: To provide full-time training in basic biomedical sciences research in Australia.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a medical, dental or related field of research or have submitted a thesis for such by December in the year of application, be actively engaged in such research in Australia or overseas and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship salary packages at the Training Support Package level 1 is $62,250. An allowance of $5,000 per year is payable for research support, including conference travel

Length of Study: 4 years

No. of awards given last year: 30

No. of applicants last year: 100

Career Development Fellowship

Subjects: Any human health-related research area.

Purpose: To help researchers to conduct research that is internationally competitive and to develop a capacity for independent research.

Eligibility: Open to Australian citizens or permanent residents, normally between 3 and 9 years postdoctoral experience.

Value: Australian $96,040–106,230 per year

Length of Study: 5 years

Study Establishment: Institutions approved by NHMRC, such as teaching hospitals, universities and research institutes

Application Procedure: Application forms available from the website www.nhmrc.gov.au .

Closing Date: March 19th

No. of awards given last year: 54

No. of applicants last year: 434

Clinical (Neil Hamilton Fairley) Fellowship

Subjects: All health-related fields.

Purpose: To provide training in scientific research methods.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a health-related field of research or have submitted a thesis for such by December of the year of application, be actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship salary packages at the Training Support Package level 1 is currently at $62,250 and if appropriate, clinical loadings will be paid

Application Procedure: Application form available from the website.

No. of awards given last year: 4

No. of applicants last year: 10

Additional Information: For more information check website.

NHMRC Early Career Fellowship

Subjects: Scientific research, including the social and behavioural sciences, that can be applied to any area of clinical or community medicine.

Purpose: To undertake research that is both of major importance in its field and of benefit to Australian health.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status, who are not under bond to any foreign government. Candidates should hold a Doctorate in a health-related field of research or have submitted a thesis for such by December of the year of application, be actively engaged in such research in Australia or overseas and have no more than 2 years postdoctoral experience at the time of application.

Value: Funding is for 4 years at TSP1 Level, which currently is $67,508

Application Procedure: Application forms are available from the website.

Closing Date: May 1st

No. of awards given last year: 9

No. of applicants last year: 21

Additional Information: For more information check website www.nhmrc.gov.au/grants-funding/apply-funding/early-career-fellowships .

NHMRC Medical and Dental and Public Health Postgraduate Research Scholarships

Subjects: Medical, dental and public health research.

Purpose: To encourage medical and dental and public health graduates to gain full-time research experience.

Eligibility: Open to Australian citizens who are medical or dental and public health research graduates registered to practice in Australia, with the proviso that medical graduates can also apply during their intern year and that dental postgraduate research scholarships may be awarded prior to graduation provided that the evidence of high quality work is shown. Also open to medical and dental graduates from overseas who hold a qualification that is registered for practice in Australia, who have permanent resident status and are currently residing in Australia.

Study Establishment: Institutions approved by the NHMRC such as teaching hospitals, universities and research institutes

Application Procedure: Available from the website at www.nhmrc.gov.au/grants-funding/apply-funding/postgraduate-scholarships/postgraduate-scholarships-categories-award .

No. of awards given last year: 6

No. of applicants last year: 12

Additional Information: The award is divided into two categories: Medical and Dental Public Health Postgraduate Research Scholarships and Public HealthPostgraduate Research Scholarships.

NHMRC/INSERM Exchange Fellowships

Purpose: To enable Australian Fellows to work overseas on specific research projects in INSERM laboratories in France and vice versa.

Eligibility: Open to Australian citizens and permanent residents, who are not under bond to any foreign government, who hold a Doctorate in a medical, dental or related field of research or have submitted a thesis for such by December in the year of application, are actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship stipend Australian $62,250. A maintenance allowance for research support of $5,000 per year For more information please check website www.nhmrc.gov.au/_files_nhmrc/file/grants/apply/training/insermfy.pdf

Length of Study: 4 years, the first 2 of which are to be spent in France and the final 2 in Australia

Study Establishment: Institutions approved by the NHMRC, such as teaching hospitals, universities and research institutes, and INSERM laboratories in France

Country of Study: France or Australia

No. of awards offered: 1

Application Procedure: Applications forms available from the website.

No. of awards given last year: 1

Additional Information: This fellowship is awarded in association with I’Institut National de la Santé et de la Recherche Médicale (INSERM), France.

Public Health Australian Fellowship

Subjects: Public health.

Purpose: To provide full-time training in public health research in Australia.

Eligibility: Applicants should hold a Doctorate in a health-related field of research or have submitted a PhD by December in the year of application and have no more than 2 years postdoctoral experience. Applicant must also, for years 1 and 2, nominate a department [preferably institution] and research group other than that where the applicant’s doctoral qualifications were obtained. Open to Australian citizens or permanent residents.

Value: Australian $67,508 and $5,000

No. of awards given last year: 17

No. of applicants last year: 61

Public Health Overseas (Sidney Sax) Fellowships

Purpose: To provide full-time training overseas and in Australia in public health research.

Eligibility: Applicants should hold a Doctorate in a health-related field of research or have submitted a PhD by December in the year of application and have no more than 2 years postdoctoral experience. Open to Australian citizens or permanent residents.

Value: Fellowship salary support packages at the Training Support Package level 1, that is $62,250, will be paid. Minimum cost airfares for the Fellow and dependants will be provided for direct travel to, and return from, the overseas centre. Additional overseas and Australian allowances are also payable

No. of awards given last year: 3

No. of applicants last year: 11

Training Scholarship for Indigenous Health Research

Subjects: Indigenous Australian Health Research.

Purpose: To provide support for research training or training leading to research areas of particular relevance to Indigenous Australians.

Eligibility: Applicant must be an Australian citizen or Australian permanent resident, have made prior arrangements with the Head of Department or Institution in which they propose to study, provide a specific study plan within a clearly defined area and conduct research of potential benefit to Australia.

Value: Depends on the qualification and current registration. Please check website

Length of Study: 1 year, renewable up to further 2 years

Application Procedure: Available from the website at www.nhmrc.gov.au/grants-funding/directory-previous-nhmrc-grants/training-scholarships-indigenous-health-research .

Closing Date: August 4th

No. of applicants last year: 6

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© 2018 Macmillan Publishers Ltd.

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(2018). National Health and Medical Research Council (NHMRC). In: The Grants Register 2018. Palgrave Macmillan, London. https://doi.org/10.1007/978-1-349-94186-5_833

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DOI : https://doi.org/10.1007/978-1-349-94186-5_833

Published : 10 January 2018

Publisher Name : Palgrave Macmillan, London

Print ISBN : 978-1-137-59209-5

Online ISBN : 978-1-349-94186-5

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The ARC is committed to the highest standards of integrity in all aspects of research it supports. This includes ensuring that ARC-funded research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards; as well as the development and support of a research environment that is underpinned by a culture of integrity. To encourage responsible research practices, all Proposals and ARC-funded research Projects are either recommended or required to conform to the principles outlined in the following and their successor documents, as stipulated within the scheme-specific funding rules:

• The Australian Code for the Responsible Conduct of Research (2018) 

Supplementary Guides supporting implementation of the Code

Arc research integrity policy, national principles of intellectual property management for publicly funded research, the national statement on ethical conduct in human research (2007)—updated 2018, the national statement on ethical conduct in human research (2023)—effective 1 january 2024, ethical conduct in research with aboriginal and torres strait islander peoples and communities: guidelines for researchers and stakeholders.

• AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (the AIATSIS Code)

The Australia Council for the Arts, Indigenous Cultural Protocols for Producing Indigenous Australian Music, Writing, Visual Arts, Media Arts and Performing Arts (2007)

• The Australian Code For The Care And Use Of Animals For Scientific Purposes 8th edition ( 2013)

Other guidelines relating to the use of animals for scientific purposes, as promulgated by the NHMRC

The australian code for the responsible conduct of research (2018)  .

In June 2018, the ARC, National Health and Medical Research Council (NHMRC) and Universities Australia (the co-authors) issued the  Australian Code for the Responsible Conduct of Research 2018  (the Code) and the  Guide to Managing and Investigating Potential Breaches of the Code  (the Investigation Guide).

• Message from the co-authors about the release of the revised Australian Code for the Responsible Conduct of Research 

The Code articulates the broad principles that characterise an honest, ethical and conscientious research culture. It outlines the expectations for the conduct of research in Australia or research conducted under the auspices of Australian institutions. The new Investigation Guide will assist institutions to manage, investigate and resolve complaints about potential breaches of the Code.

The 2018 Code and Investigation Guide replace the 2007 version of the Code. NHMRC, ARC and Universities Australia expect institutions to meet the requirements of the 2018 Code and Investigation Guide by no later than 1 July 2019.

• Further information relevant to the implementation of the 2018 Code and Investigation Guide is available on the NHMRC website.  

The ARC, NHMRC and Universities Australia are developing a series of supplementary guides designed to support institutions and researchers to implement and comply with the Australian Code for the Responsible Conduct of Research (the Code).

The following guides have been released and can be downloaded from the  NHMRC’s website :

• Authorship 
• Management of Data and Information in Research 
• Peer Review 
• Disclosure of Interests and Management of Conflicts of Interest
• Research Supervision
• Collaborative Research
• Publication and Dissemination of Research
• Research Integrity Advisors

The policy outlines requirements for institutions, and individuals engaged in ARC business, to report to the ARC research integrity matters, and the action the ARC may take in response to reported breaches of the Code. It also describes how the ARC can refer concerns or complaints to research institutions, who, in accordance with the Code, are responsible for managing and investigating potential breaches of the Code.  

The National Principles of Intellectual Property (IP) Management for Publicly Funded Research (the National Principles) were developed by a working party of the Australian Government’s Coordinating Committee on Innovation .

The National Principles were developed to assist researchers, research managers and research institutions develop best practice in identifying, protecting and managing IP, thus ensuring appropriate commercial outcomes from publicly funded research.

The intention of the National Principles is simply to improve the commercial outcomes from publicly funded research where a commercial outcome is appropriate. The National Health and Medical Research Council (NHMRC) publicly announced the adoption of these National Principles in April 2013.  

Jointly developed by the ARC, the NHMRC and UA, the  National Statement on Ethical Conduct in Human Research  consists of a series of guidelines on ethical conduct in human research and is intended for use by:

• any researcher conducting research with human participants;
• any member of an ethical review body reviewing that research;
• those involved in research governance; and
• potential research participants.  

The National Statement on Ethical Conduct in Human Research 2023 was issued on 29 June 2023. The 2023 National Statement will take effect, and replace, the 2007 National Statement from 1 January 2024. Co-authored by NHMRC, the Australian Research Council (ARC) and Universities Australia (UA), the National Statement is Australia’s principal human research guideline setting out the requirements for the ethical design, review and conduct of human research in Australia.

The 2023 National Statement and a summary of amendments can be found on NHMRC's website. The major changes in this update are to Chapter 2.1 and Section 5.  

Developed by NHMRC, Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders provides a set of principles to ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islanders people and communities.  

AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

The  Guidelines for Ethical Research in Australian Indigenous Studies  embody the best standards of ethical research and human rights. It is essential that Indigenous people are full participants in research projects that concern them, share an understanding of the aims and methods of the research, and share the results of this work. At every stage, research with and about Indigenous peoples must be founded on a process of meaningful engagement and reciprocity between the researcher and Indigenous people.  

• Music: Protocols for Producing Indigenous Australian Music
• Writing: Protocols for Producing Indigenous Australian Writing
• Visual Arts: Protocols for producing Indigenous Australian Visual Arts
• Media Arts: Protocols for Producing Indigenous Australian Media Arts  
• Performing Arts: Protocols for Producing Indigenous Australian Performing Arts

The ARC recognises that the Protocols may also have much broader application, and, as applicable, advises that any researchers accessing, using or reproducing music, literature, arts, images or ceremonies of Indigenous peoples, or Indigenous cultural materials conduct their research in accordance with these protocols.  

The Australian Code For The Care And Use Of Animals For Scientific Purposes 8 th edition ( 2013)

Endorsed by the NHMRC, the ARC, the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and UA the purpose of the  Australian code for the care and use of animals for scientific purposes  is to promote the ethical, humane and responsible care and use of animals used for scientific purposes. The ethical framework and governing principles set out in the Code provide guidance for investigators, teachers, institutions, animal ethics committees and all people involved in the care and use of animals for scientific purposes. The Code encompasses all aspects of the care and use of animals for scientific purposes where the aim is to acquire, develop or demonstrate knowledge or techniques in any area of science.  

NHMRC provides additional guidelines and information for Animal Ethics Committees and researchers, relating to particular fields of research or types of animals. These guidelines should be read in conjunction with the  Australian code for the care and use of animals for scientific purposes  8th edition (2013) . They are available on NHMRC’s website and include, but are not limited to:

• Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals (2008) ; and
• A Guide to the care and use of Australian native mammals in research and teaching (2014) . 

ACN - 101321555 | ABN - 39101321555

Australasian human research ethics consultancy services pty ltd (ahrecs).

Research Ethics Monthly | ISSN 2206-2483

Release of the national statement on ethical conduct in human research 2007 (updated 2018) – with interview.

The revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018) was released on 9 July 2018.

. Content of the updated National Statement

The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 and is subject to rolling review. This means that parts of the National Statement are updated as needed, in accordance with strategic planning, or in response to user feedback or national or international developments in research or ethics.

Since 2007, Section 3 of the National Statement has addressed ethical considerations specific to research methods or fields. The 2018 revision provides a new structure for Section 3, based on the elements of a research project (from conception to post-completion). The revised Section 3 begins with a chapter that addresses ethical issues in all research, followed by specialised guidance for research involving human biospecimens, genomics and xenotransplantation.

While significant changes have been made to all aspects of the guidance provided in Section 3, we note, in particular, the additional guidance that has been provided in relation to collection, use and management of data and information and to management of the findings or results arising from genomic research.

As part of this update, changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of the revisions to Section 3.

Revisions to the National Statement were informed by working committees and through public consultation in accordance with requirements of the National Health and Medical Research Council Act 1992.

Currency and effective date

All users of the National Statement, including HRECs, research offices and researchers are expected to ensure that the current version of the National Statement is being used in developing research proposals, making submissions for ethics review and undertaking ethics review. However, as a consequence of the scope of the revisions to Section 3, we expect that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019.

This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated, most recently, in 2015. To facilitate this transition, both the current version of the National Statement and the updated version are available on the NHMRC website at http://nhmrc.gov.au/guidelines/publications/e72 .

Use of the National Statement is also linked to the Human Research Ethics Application (HREA), released in December 2016 to replace the National Ethics Application Form.

To coincide with the release of the revised National Statement, questions in the HREA will require revision and users of the HREA will be advised when the revised HREA is online.

Institutions and HRECs are encouraged to allow a transition period for researchers while the revisions to the HREA take effect. The provision of a transition period, how it will be managed and its timeframe are at the discretion of individual Institutions/HRECs.

Australia’s research integrity framework is underpinned by three national standards developed by NHMRC and its co-authors, the Australian Research Council (ARC) and Universities Australia (UA). Together these three standards provide guidance on responsible and ethical research conduct for both humans and animals.

The overarching document is the Australian Code for the Responsible Conduct of Research, 2018. The Code is the leading reference for researchers and institutions across all disciplines about the expectations for responsible research conduct and the handling of investigations into research misconduct. After 10 years in operation, the Code has been reviewed and the 2018 edition was released in June 2018. The other two documents are the National Statement and the Australian code for the care and use of animals for scientific purposes (also endorsed by CSIRO).

AHRECS (While we know it predated the recent work on s3) What drove the decision to conduct a rolling review, rather than a review of the entire document?

NHMRC During the revision of the National Statement that was completed in 2007, it was determined that a more flexible, more efficient approach to revising the document would be a good innovation. We wanted to be able to both respond to the needs of users for more limited changes – from a word, to a paragraph, to a single chapter – without having to review the whole document and to be able to integrate or modify the content in response to changes nationally or internationally in research, research ethics or government regulation. Review of the 1999 National Statement took three years from start to finish and we thought we could improve on that timeline! We have found that this approach has, in practice, enabled us to make both minor changes and significant changes to single chapters of the document, as well as to review one of the five sections of the document, as we have just done.

AHRECS Are there downsides to that approach?

NHMRC Yes, there are. The major downside is that the document is ‘of a piece’ and changes to any one part of the document invariably require consideration of changes to the other parts, not just in terms of cross-referencing, but in terms of the content itself. This issue of ‘consequential effect’ manifests itself in the need to ensure consistency in our guidance and to consider the impact on the whole document of more philosophical or conceptual changes that have been introduced by the changes. An example in the most recent revision of Section 3 is that our approach to interventional research in Section 3 had a ‘flow on’ effect to Section 5 in terms of where certain guidance belonged, how that guidance should reflect changes in the clinical research sector since 2007 and how it should reflect other guidance documents (e.g. related to safety reporting) that NHMRC has published in the last 12 months.

AHRECS What were you hoping to accomplish with the changes to section 3 (and Section 5 + the Glossary)? Was it achieved?

NHMRC Principally, we were hoping to facilitate a re-thinking on the part of users (researchers and HRECs, primarily) regarding how they conceptualise and address ethical issues in the design, review and conduct of the research. We began with a decision to abandon the idea of ‘categories’ or ‘types’ of research as the main way to package this guidance and to focus on the reality that most ethics guidance applies to ALL research, thereby requiring ALL researchers to consider it, rather than just going to their specialised chapter of the document and, potentially, ignoring the broader issues. We then settled on the ‘life cycle’ of a research project as the best structure – that is, from conception to post-completion stages of a research project. This also enabled us to see more clearly what was not general guidance and encapsulate that extra guidance in separate, specialised chapters that each required consideration of the general guidance as a prerequisite to fully understanding and implementing the specialised guidance content.

The changes that we made to Section 5 and the Glossary were a direct consequence of the revision of Section 3 and we purposefully did not introduce changes to those parts of the document that were independent of the Section 3 revision, even though it was pretty tempting to do so sometimes.

We do think that we achieved our objectives and we are very satisfied with the results of the review process.

AHRECS If you could say just one thing about the work to date what it be?

NHMRC Review of the National Statement, while challenging, involves very stimulating and satisfying dialogue with lots of researchers, reviewers and other users of the document. We are so committed to it that we are almost immediately taking on the review of Section 4 and Section 5 – so, watch this space!

AHRECS When someone says they would have liked examples to better illustrate the new concepts in the update how do you respond?

NHMRC A weaselly response would be: it depends on which new concepts you are talking about; but, to use one example, a good look at Chapter 3.3: Genomic research and the Decision tree for the management of findings in genomic research and health care that we included (on page 52) to address this complex issue provides just such an attempt to illustrate by example. The main impediment to using examples or case studies to illustrate concepts is the difficulty of deciding which concepts to illustrate and with how many examples, as well as potentially expanding the size of the document exponentially in order to do the examples justice.

AHRECS When will a html version be available online?

At present, the 2007 version of the National Statement (updated May 2015) is available in both PDF and HTML format; whereas the version updated 2018 is only available in PDF. We are not 100% sure when the HTML version of the National Statement (updated 2018) will be available, but we anticipate within the next two to three months. Please also note that the current address ( https:// beta .nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1 ) is only temporary, which means that you’ll need to update your bookmarks/links again when the final version of the new NHMRC website is released in late August or early September.

This post may be cited as: NHMRC (31 July 2018) Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Research Ethics Monthly . Retrieved from: https://ahrecs.com/human-research-ethics/release-of-the-national-statement-on-ethical-conduct-in-human-research-2007-updated-2018-with-interview

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Nih research matters.

December 18, 2018

2018 Research Highlights — Clinical Advances

Prevention, diagnosis, and treatment of human disease.

With NIH support, scientists across the United States and around the world conduct wide-ranging research to discover ways to enhance health, lengthen life, and reduce illness and disability. Groundbreaking NIH-funded research often receives top scientific honors. In 2018, these honors included two NIH-supported scientists who earned Nobel Prizes and three NIH-funded researchers who earned prestigious Lasker Awards . Here’s just a small sample of the NIH-supported research accomplishments in 2018. For more health and medical research findings from NIH, visit NIH Research Matters .

Full 2018 NIH Research Highlights List

Preventing opioid overdoses

Every day, more than 100 people nationwide die from an overdose of opioids, including prescription opioids such as oxycodone and fentanyl. Two recent studies highlighted very different strategies to help prevent overdose. One showed that certain medications reduced the risk of death by about half for people who’d previously had a non-fatal opioid overdose . But less than a third who’d had a non-fatal opioid overdose received them. A separate study showed that notifying a clinician that one of their patients had died of an opioid overdose reduced the number and doses of opioid medications later prescribed .

Physical clot removal can help more people after stroke

An ischemic stroke occurs when blood vessels that supply the brain become blocked. Doctors can try to protect the brain from permanent damage by physically removing the blockage with a procedure called a thrombectomy. This approach was previously approved for use up to six hours after a stroke. A multi-site clinical trial showed that brain imaging was able to identify certain people who could benefit from a thrombectomy for up to 16 hours after a stroke. Based in part on this finding, experts issued new treatment guidelines so that more lives could be saved.

Antibody combination suppresses HIV

Since the 1990s, people with HIV, the virus that causes AIDS, have taken combinations of drugs called antiretroviral therapy (ART) to prevent the virus from multiplying. However, researchers have been looking for treatments that can last longer and cause fewer side effects. In an early phase clinical trial, a combination of two antibodies suppressed blood levels of HIV for months after treatment in some people. With further improvement and testing, long-acting antibody combinations may become an alternative to daily drugs.

Bystanders save lives using defibrillator for cardiac arrest

Experts estimate that each year more than 18,000 Americans have a cardiac arrest in public near witnesses who could potentially administer immediate treatment. A study found that people are more likely to survive a cardiac arrest if a bystander uses an automated external defibrillator while waiting for emergency medical services. The analysis suggests that each year bystanders saved about 1,700 additional lives by using these devices.

Fecal transplants restore gut microbes after antibiotics

Antibiotics can kill both harmful and helpful bacteria in the digestive tract. That can make people more vulnerable to infections after treatment. Researchers found that they could use a fecal transplant to return beneficial bacteria to people with cancer who received antibiotics for stem cell transplant procedures. The study showed that a person’s own gut bacteria can be used to quickly restore a healthy microbiome following intensive antibiotic treatment.

Factors contributing to higher incidence of diabetes for black Americans

Black adults in the United States are nearly twice as likely as white adults to develop type 2 diabetes. A study found that biological risk factors—including excess weight and too much belly fat—are primarily responsible for higher rates of diabetes for black Americans. The results suggest that making positive changes in known risk factors, like losing excess weight, can help reduce this racial health disparity.

Daily aspirin shows no benefit for healthy older adults

Studies have found that aspirin can help some people prevent a second heart attack or stroke. Aspirin may also help prevent a first heart attack or stroke in people who are at high risk for these conditions. For healthy older adults, however, a large clinical trial found that a daily low-dose aspirin doesn’t prolong life or help prevent heart disease, physical disability, dementia, or stroke.

Spinal cord stimulation improves hand grip after spinal injury

Spinal cord damage can lead to serious disabilities, including paralysis. More than a quarter of a million Americans are now living with spinal cord injuries. A noninvasive treatment helped six people with spinal cord injuries in the neck to improve their hand strength and dexterity. The approach could help expand treatment options for people with these serious injuries.

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole . Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus. [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

[1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[2] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[3] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk ; Kimmelman, J., Hyun, I., Benvenisty, N.  et al.  Policy: Global standards for stem-cell research.  Nature   533 , 311–313 (2016). https://doi.org/10.1038/533311a

[4] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk

[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

Sandel M. J. (2004). Embryo ethics--the moral logic of stem-cell research.  The New England journal of medicine ,  351 (3), 207–209. https://doi.org/10.1056/NEJMp048145 ; George, R. P., & Lee, P. (2020, September 26). Acorns and Embryos . The New Atlantis. https://www.thenewatlantis.com/publications/acorns-and-embryos ; Sagan, A., & Singer, P. (2007). The moral status of stem cells. Metaphilosophy , 38 (2/3), 264–284. http://www.jstor.org/stable/24439776 ; McHugh P. R. (2004). Zygote and "clonote"--the ethical use of embryonic stem cells.  The New England journal of medicine ,  351 (3), 209–211. https://doi.org/10.1056/NEJMp048147 ; Kurjak, A., & Tripalo, A. (2004). The facts and doubts about beginning of the human life and personality.  Bosnian journal of basic medical sciences ,  4 (1), 5–14. https://doi.org/10.17305/bjbms.2004.3453

[6] Vazin, T., & Freed, W. J. (2010). Human embryonic stem cells: derivation, culture, and differentiation: a review.  Restorative neurology and neuroscience ,  28 (4), 589–603. https://doi.org/10.3233/RNN-2010-0543

[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

[11] Hurlbut, W. B. (2006). Science, Religion, and the Politics of Stem Cells.  Social Research ,  73 (3), 819–834. http://www.jstor.org/stable/40971854

[12] Akpa-Inyang, Francis & Chima, Sylvester. (2021). South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study. BMC Medical Ethics . 22. 10.1186/s12910-021-00678-4.

[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

[15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

[16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa.  Stem Cell Res Ther   4 , 54 (2013). https://doi.org/10.1186/scrt204 ; Pew Research Center. (2014, May 1). Public health a major priority in African nations . Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/

[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024 . National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction.  Frontiers in pharmacology ,  13 , 1013740. https://doi.org/10.3389/fphar.2022.1013740

[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

[26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

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[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

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Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

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Sue Haupt is an honorary senior research fellow at Peter MacCallum Cancer Centre in Melbourne, Australia, and a research associate at The George Institute for Global Health, Women’s Health Program, Centre for Sex and Gender Equity in Health and Medicine, University of New South Wales (UNSW) Sydney, Australia.

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Cheryl Carcel is the head of the brain health programme at The George Institute for Global Health UNSW Sydney, Australia.

Robyn Norton is a founding director of The George Institute for Global Health, a professor of public health at UNSW Sydney and chair of global health at Imperial College London, UK.

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In 2022, clinical trials indicated that a drug called lecanemab could slow cognitive decline in people with Alzheimer’s disease; soon after the results were published, the global Alzheimer’s community heralded lecanemab as a momentous discovery. However, closer inspection of the data by independent investigators revealed that the drug might significantly help men, but not women 1 .

The finding is a reminder that, even though tremendous advances are being made in the clinical application of cutting-edge technologies, such as gene editing and artificial intelligence (AI), there is a remarkable lack of understanding about how many aspects of human health are affected by variables as seemingly basic as sex and gender.

Sex and gender in science

Over the past decade or so, funders and publishers have made extensive efforts to encourage researchers to address the effects of sex and, in human studies, gender where appropriate. Thanks in part to these efforts, more insights are beginning to emerge. For Alzheimer’s and many other diseases that are common causes of death, including cardiovascular diseases, cancer, chronic respiratory conditions and diabetes, a person’s sex and gender can influence their risk of developing the disease, how quickly and accurately they are diagnosed, what treatment they receive and how they fare.

But even for the most-studied conditions, many questions remain. Few investigators have begun to probe the interrelationships between sex and gender , for example. And in cases in which researchers are managing to unpick the multifaceted effects of sex, this knowledge is not being sufficiently incorporated into the design of clinical trials or adequately changing the practice of medicine.

The consideration of sex and, where appropriate, gender in biological research must become routine — especially as molecular genetics, biomedical engineering and AI open up possibilities for treatments that are better tailored to the needs of individuals. Likewise, the culture of medicine must be transformed so that approaches to treatment evolve in response to the data. This will require further engagement from funders and publishers, but action from many other players, too. Pharmaceutical companies and intergovernmental organizations, among others, must acknowledge three things: how sex and gender can have huge effects on health outcomes; how these effects are often disregarded in basic research and clinical trials; and that change can come only through increasing awareness among all stakeholders of the importance of shifting the dial.

Health outcomes affected

In most human clinical records so far, sex is reported by physicians or participants in studies ticking one of two boxes: ‘female’ or ‘male’. In those clinical studies in which data are collected on chromosomes, hormone levels, reproductive anatomy or other sex characteristics, these features will frequently reflect a person’s sex assigned at birth. But this is not always the case. Added to this, sex and gender have often been used interchangeably, but they are not the same and they do not always align. Current definitions of gender include the social, psychological, cultural and behavioural aspects of being a man or woman (whether cisgender or transgender), non-binary or identifying with one or more other evolving terms 2 .

In several countries, new recommendations about how researchers should obtain data on people’s sex and gender should mean that, in the future, investigators will be able to more-accurately probe the roles of both in human health. But in general, there has been incomplete capture of information for sex and gender so far, including for individuals whose sex characteristics and/or gender identities don’t fall into a binary categorization scheme.

Women are more likely to die after a severe heart attack than are men. Credit: Simon Dawson/Reuters

In this article, consistent with much of the published population-wide data, we refer to a woman as someone who identifies with that gender and was assigned female sex at birth (a cis woman), and a man as someone who identifies with that gender and was assigned male sex at birth (a cis man). But we recognize that participants in the studies we describe might not have been asked about both their gender and their sex.

For all sorts of non-communicable diseases, there are differences between men and women in the average age at which they are diagnosed, the average age at which they die and even in their rates of death.

We need more-nuanced approaches to exploring sex and gender in research

Such variations, from the earlier onset of cardiovascular diseases in men to the more frequent occurrence of Alzheimer’s disease in women, might stem from differences in biology, which can affect people’s likelihood of developing a disease and how they respond to treatment. Or these discrepancies might stem from variation in people’s exposure to the environmental factors that trigger the disease, how they manage their condition, how they are treated by carers and so on, all of which can be influenced by a person’s gender. Often, a combination of factors will be at work.

Take heart attacks. Studies conducted over the past decade have revealed extensive sex differences in the expression of certain genes in heart tissue, which in turn affect the type and function of the cells that make up the heart.

Such variation could help to explain why men are likely to have a heart attack for the first time around six years earlier than women — in the United States, at 65.6 years old in men compared with 72 years old in women 3 — and why (in Australia, at least) heart attacks are at least twice as common in men relative to women of comparable ages (see go.nature.com/3qbvrxq ). Likewise, although mechanisms are yet to be fully understood, it is plausible that differences in people’s biology help to explain why women are more likely to experience pain between their shoulder blades, nausea or vomiting and shortness of breath during a heart attack; why men are more likely to experience chest pain and increased sweating; and why women are nearly twice as likely as are men to die after a severe heart attack.

Yet, when it comes to the risk of dying, social and environmental factors — shaped by gender — also seem to be important.

Tobacco consumption increases a person’s risk of having a heart attack, and smoking is much more common among men globally. Worldwide, around 37% of men smoke compared with around 8% of women . Also, in part because health-care professionals and others are more familiar with the heart attack symptoms commonly seen in men, when women have a heart attack, they are more likely to delay seeking help, and carers are often slower to intervene 4 . In fact, in a study of more than 500,000 people who experienced a heart attack and were admitted to hospital in the United Kingdom between 2004 and 2013, women were 37% more likely to receive an incorrect initial diagnosis after a severe heart attack than were men 5 . Even when women tell their physicians that they have chest pain, they are two to three times less likely to be referred to a cardiologist than are men 6 .

A similarly complicated picture has been emerging in relation to strokes 7 — another cardiovascular disease — and, in the past few years, in relation to cancer.

Smoking is more common among men than women globally. Credit: Behrouz Mehri/AFP/Getty

Most cancers that occur in non-reproductive organs develop earlier in men than they do in women. In the United States, oesophageal cancer is 4.5 times more likely to occur and cause death in men than in women, for example, and lung cancers, the most common drivers of cancer-associated deaths worldwide, kill around 40% more men than women 8 .

Just as with heart disease and stroke, some of this variation seems to stem from behavioural differences. Tobacco consumption increases a person’s risk of developing several cancers 7 . For thyroid cancers, however, women are more likely to develop the disease than are men — three times more likely in some places — which suggests that other factors might drive the different rates of this particular cancer in women and men 9 . But tumours typically arise because of problems with cells’ genetic-repair systems, together with inadequate damage clearance, and genetic differences between men and women that affect cancers are beginning to emerge.

Male–female comparisons are powerful in biomedical research — don’t abandon them

Much more research is needed to understand how sex affects the rate at which genes mutate, cells’ capacities to repair and clear damaged DNA, and when genetic damage starts causing disease. Yet research led by one of us (S.H.) on lung adenocarcinoma, the most common type of lung cancer, suggests that women can survive for longer than men after they are diagnosed, in part thanks to cancer-defence genes in women driving more-robust immune responses 10 . X chromosomes encode many genes that are linked to immunity, and women with two X chromosomes might express these genes at higher levels than men with XY chromosomes.

Responses to cancer treatments also differ between men and women. Chemotherapies tend to work better in women than in men. This could be because it can take longer for women’s bodies to clear certain drugs, which could partly explain why women are also 34% more likely than men to experience harmful side effects 11 . Moreover, women with lung cancer typically have better outcomes after surgery, which they undergo more often than men 8 . This is probably due, at least in part, to women having less advanced disease when they are diagnosed than men do 12 . But the generally stronger immune responses in women might also help their recovery 8 .

Too often ignored

Despite these compelling indications that sex and gender matter, when it comes to many diseases that are leading causes of death, many researchers and health practitioners still fail to adequately take sex and gender into account. They might also be influenced by conscious or unconscious bias.

In the case of heart disease, the differences in gene expression and cellular make-up and activity found in men and women’s hearts highlight the need for sex-specific cardiac tissue models, sustained by sex-appropriate vasculature 13 . (Women on average have smaller hearts with narrower vessels compared with men.) Currently, researchers tend to construct heart models using either animal or human cells, but without necessarily ensuring that cells are sourced from individuals of only one sex per model. In fact, identifying sex disparities in basic heart biology is crucial to engineering relevant heart models with stem cells, for example, which investigators are now developing to aid the study of heart disease 13 .

For both heart disease and stroke, because of decades of under-representation of women in clinical trials, many of today’s standard treatments are based on studies of what happens in men who weigh around 70 kilograms. In clinical trials conducted for stroke and heart conditions between 2010 and 2017, women worldwide were under-enrolled relative to the prevalence of these diseases in the general population — by around 20% 14 . There is also significant underfunding of research for many conditions that are more prevalent in women compared with those that are more common in men (see ‘Disparities in health and disease’).

Source: A. A. Mirin J. Womens Health 30 , 956–963 (2021).

Basic research on cancer is similarly riddled with problems. Take the sex of the cell lines that are stored in commercial cell banks, which have been studied for decades and are the source of much of today’s textbook knowledge. For lung cancers, male lines outnumber female lines by two to one. For liver cancers, the ratio is seven to one. Until a few years ago, few researchers studying cancer in cultured cells in the lab even considered the sex of the cells they were studying. Also, the standard media in which cells are grown is frequently supplemented with fetal calf serum from a mixture of male and female calves, and so contains both male and female sex hormones. And phenol red, a dye commonly used to monitor the pH of tissue culture media mimics the hormone oestrogen 8 .

To add to the difficulties, research findings that emerge from the use of these cell lines are often tested in mice of only one sex. The results of these studies are then used to guide human trials that include both men and women participants. And in oncological clinical trials, just as with stroke and heart disease, women are still under-enrolled relative to the burden of disease they experience 7 .

Inclusivity in human trials will ensure the best possible outcomes for all participants, including cis and trans women and men, gender-diverse and intersex people (see ‘Inclusivity in practice’). Studies are showing, for example, that circadian rhythms — which can affect heart function and might impact how drugs are metabolized — differ between men and women 15 . So how might they compare in non-binary or transgender people? Likewise, knowledge about the immune responses of people with atypical numbers of sex chromosomes is likely to be crucial when it comes to the use of immune checkpoint inhibitors and other immune therapies for treating cancer. Those with Klinefelter syndrome, for example, who, similar to cis women, are at a higher risk of developing breast cancer than are cis men, have multiple X chromosomes that are rich in genes involved in the immune response.

Inclusivity in practice

How researchers include diverse groups of people in clinical trials with enough participants to be able to uncover between-group differences is a challenge.

Women represent nearly half of the population, but they are still under-represented in many clinical trials for numerous diseases, even in cases in which disease prevalence for women has been measured. For smaller population groups, such as transgender people, there are not enough data to even know what representative inclusion looks like. In fact, even if participation does reflect the prevalence of disease in the broader population in any one trial, teasing out effects might require combining the results of multiple studies in meta-analyses.

Advisory governing boards for pharmaceutical companies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, funders and regulatory agencies could help with this by ensuring that terminology is adequately and consistently defined, and that populations are properly profiled.

Heightened awareness

Routinely taking sex and gender into account in research and using that knowledge to change health care could benefit billions of people. So what’s needed to make this happen?

Policy changes — such as the US National Institutes of Health’s 2016 call for the inclusion of male and female sexes in studies involving cells, tissues and animals — are crucial. But for many researchers, such calls seem burdensome, especially because studying more than one sex can increase costs. ( Sample sizes might need to be increased to achieve sufficient statistical power when comparing groups.)

Alongside initiatives from funders and publishers, awareness must be built — among students, researchers, clinicians, medical ethics committees, research governance bodies and community groups — of the ramifications of failing to consider sex and gender, and how to correct the problem.

Accounting for sex and gender makes for better science

Efforts led by the Canadian Institutes of Health Research (CIHR) are encouraging. Even though the permeation of knowledge from research to health care has been glacial, between 2011 and 2019, the proportion of all research grant applications submitted to the CIHR that took sex into consideration increased from around 22% to 83%. Gender as a variable is now also included in many of the human studies funded by the CIHR .

Several initiatives have contributed to this. As an example, as well as asking grant applicants to include a section in their research proposals on whether they are considering sex and gender and how they will do so, or why this is not considered applicable, the CIHR has provided training for scientists and organized workshops involving researchers and specialists in sex and gender. Applicants are more likely to receive funding if they provide a satisfactory rationale for their choices.

Convincing people in leadership roles — in governments, laboratories, medical ethics boards, education and so on — of the importance of including sex and gender in research is especially crucial. More studies demonstrating the financial costs of not doing so could help. Between 1997 and 2000, for instance, eight prescription drugs were retracted from the US market because inadequate clinical testing in women had failed to identify that the drugs put women at greater risk of developing health problems than men. This error cost pharmaceutical companies and taxpayers an estimated US$1.6 billion per drug 16 .

The scale of transformation needed will also require more engagement from global players.

Even as far back as 2007, the 60th World Health Assembly — the decision-making body of the World Health Organization (WHO) — passed a resolution to urge researchers to split their data according to sex and to include gender analyses where appropriate. Steps to improve care for transgender people or those with diverse genders are also starting to be taken; in December last year, the WHO established a Guideline Development Group, to provide recommendations on how to address the health of transgender and gender-diverse people . But more extensive efforts, comparable to all United Nations member states committing to target 5.b of the 2015 Sustainable Development Goals by 2030, will be crucial. (This target is to “enhance the use of enabling technology, in particular information and communications technology, to promote the empowerment of women”.)

Lastly, under the guidance of regulatory bodies such as the European Medicines Agency and the scientific entrepreneur community, the pharmaceutical industry must do more to ensure that preclinical work is robust, and that products are tested on enough people of different sexes and genders. Many leading pharmaceutical companies acknowledge on their websites the importance of including diverse groups in clinical trials , but evidence of actions to address the issue is only just emerging.

Awareness of the problems around sex and gender is growing fast. And although many are concerned that medical applications of AI will perpetuate already existing biases 17 , promising developments are emerging in the use of machine learning to make diagnoses that are appropriate for people’s sex and gender.

For decades, for instance, physicians worldwide have been determining whether a person has had a heart attack by using the Global Registry of Acute Coronary Events (GRACE) score, which was derived from trials mainly involving men. In 2022, the application of machine learning to data that had been split for men and women refined the predictors for women. And these revised predictors did a better job of matching individuals to appropriate interventions 18 .

Greater awareness, the wealth of data now emerging and the possibilities presented by new tools, from AI to gene editing, could mean a new era for research and medicine.

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Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome

Collaborators.

• International PCOS Network : Marianne Andersen ,  Ricardo Azziz ,  Adam Balen ,  Estifanos Baye ,  Jacqueline Boyle ,  Leah Brennan ,  Frank Broekmans ,  Preeti Dabadghao ,  Luigi Devoto ,  Didier Dewailly ,  Linda Downes ,  Bart Fauser ,  Stephen Franks ,  Rhonda M Garad ,  Melanie Gibson-Helm ,  Cheryce Harrison ,  Roger Hart ,  Rachel Hawkes ,  Angelica Hirschberg ,  Kathleen Hoeger ,  Femke Hohmann ,  Samantha Hutchison ,  Anju Joham ,  Louise Johnson ,  Cailin Jordan ,  Jayashri Kulkarni ,  Richard S Legro ,  Rong Li ,  Marla Lujan ,  Jaideep Malhotra ,  Darren Mansfield ,  Kate Marsh ,  Veryan McAllister ,  Edgar Mocanu ,  Ben W Mol ,  Ernest Ng ,  Sharon Oberfield ,  Sasha Ottey ,  Alexia Peña ,  Jie Qiao ,  Leanne Redman ,  Raymond Rodgers ,  Luk Rombauts ,  Daniela Romualdi ,  Duru Shah ,  Jane Speight ,  Poli Mara Spritzer ,  Elisabet Stener-Victorin ,  Nigel Stepto ,  Juha S Tapanainen ,  Eliza C Tassone ,  Shakila Thangaratinam ,  Mala Thondan ,  Chii-Ruey Tzeng ,  Zephne van der Spuy ,  Eszter Vanky ,  Maria Vogiatzi ,  Angela Wan ,  Chandrika Wijeyaratne ,  Selma Witchel ,  Jane Woolcock ,  Bulent O Yildiz

Affiliations

• 1 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia; National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia; Monash Centre for Health Research and Implementation, Monash Public Health and Preventive Medicine, Monash University and Monash Health, Melbourne, Victoria, Australia. Electronic address: [email protected].
• 2 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia; National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia; Monash Centre for Health Research and Implementation, Monash Public Health and Preventive Medicine, Monash University and Monash Health, Melbourne, Victoria, Australia.
• 3 University of New South Wales, Sydney, New South Wales, Australia.
• 4 Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.
• 5 Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, The Netherlands.
• 6 Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Centre, Oulu University Hospital, Oulu, Finland.
• 7 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia; National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia; Robinson Research Institute, University of Adelaide and Fertility SA, Adelaide, South Australia, Australia.
• PMID: 30033227
• PMCID: PMC6939856
• DOI: 10.1016/j.fertnstert.2018.05.004

Study question: What is the recommended assessment and management of women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference?

Summary answer: International evidence-based guidelines including 166 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of women with PCOS.

What is known already: Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. Diagnosis of PCOS remains controversial and assessment and management are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist.

Study design, size, duration: International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Appraisal of Guidelines for Research and Evaluation (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength.

Participants/materials, setting, methods: Governance included a six continent international advisory and a project board, five guideline development groups, and consumer and translation committees. Extensive health professional and consumer engagement informed guideline scope and priorities. Engaged international society-nominated panels included pediatrics, endocrinology, gynecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, public health and other experts, alongside consumers, project management, evidence synthesis, and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Twenty face-to-face meetings over 15 months addressed 60 prioritized clinical questions involving 40 systematic and 20 narrative reviews. Evidence-based recommendations were developed and approved via consensus voting within the five guideline panels, modified based on international feedback and peer review, with final recommendations approved across all panels.

Main results and the role of chance: The evidence in the assessment and management of PCOS is generally of low to moderate quality. The guideline provides 31 evidence based recommendations, 59 clinical consensus recommendations and 76 clinical practice points all related to assessment and management of PCOS. Key changes in this guideline include: i) considerable refinement of individual diagnostic criteria with a focus on improving accuracy of diagnosis; ii) reducing unnecessary testing; iii) increasing focus on education, lifestyle modification, emotional wellbeing and quality of life; and iv) emphasizing evidence based medical therapy and cheaper and safer fertility management.

Limitations, reasons for caution: Overall evidence is generally low to moderate quality, requiring significantly greater research in this neglected, yet common condition, especially around refining specific diagnostic features in PCOS. Regional health system variation is acknowledged and a process for guideline and translation resource adaptation is provided.

Wider implications of the findings: The international guideline for the assessment and management of PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program.

Study funding/competing interest(s): The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine. Guideline development group members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Full details of conflicts declared across the guideline development groups are available at https://www.monash.edu/medicine/sphpm/mchri/pcos/guideline in the Register of disclosures of interest. Of named authors, Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring, Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder interest in an IVF unit. The remaining authors have no conflicts of interest to declare. The guideline was peer reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREEII criteria and underwent methodological review. This guideline was approved by all members of the guideline development groups and was submitted for final approval by the NHMRC.

Keywords: GRADE; Polycystic ovary syndrome; assessment; evidence-based; guideline; management.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Publication types

• Research Support, Non-U.S. Gov't
• Australia / epidemiology
• Disease Management*
• Evidence-Based Medicine / methods
• Evidence-Based Medicine / standards*
• Internationality*
• Polycystic Ovary Syndrome / diagnostic imaging
• Polycystic Ovary Syndrome / epidemiology
• Polycystic Ovary Syndrome / therapy*
• Practice Guidelines as Topic / standards*
• Reproductive Medicine / methods
• Reproductive Medicine / standards*
• Young Adult

Grants and funding

• K99 HD060762/HD/NICHD NIH HHS/United States
• R00 HD060762/HD/NICHD NIH HHS/United States

Extreme temperatures may increase risk of stroke mortality, especially in low-income countries

For immediate release: May 22, 2024

Boston, MA—Extreme heat and extreme cold are both associated with increased risks of death from ischemic and hemorrhagic stroke, according to a new study led by Harvard T.H. Chan School of Public Health. The researchers found that the link between extreme temperatures and stroke mortality was stronger in low-income countries than in high-income countries.

The study was published on May 22, 2024, in Stroke.

“Our findings are another step toward understanding the effects of climate change on stroke,” said lead author Barrak Alahmad , research fellow in the Department of Environmental Health . “As temperatures become more extreme, we foresee an increase in fatal strokes and a widening disparity in stroke mortality between high- and low-income countries, as the latter are likely to bear the brunt of climate change.”

Previous research on the relationship between extreme temperatures and stroke mortality has yielded mixed or inconclusive results. Most studies have been limited to single cities or countries, mostly high-income, and few have differentiated between stroke subtypes. To address these gaps, the researchers leveraged the Multi-Country Multi-City Network, a global environmental health consortium, to build a multinational, multiregional database of ischemic and hemorrhagic stroke mortality. The database was composed of more than 3.4 million ischemic stroke deaths and more than 2.4 million hemorrhagic stroke deaths, reported between 1979 and 2019 across 522 cities in 25 countries.

The study found that for every 1,000 ischemic or hemorrhagic stroke deaths, about 11 were attributable to extreme cold or hot days. Of those 11 deaths, the coldest and hottest 2.5% of days contributed to 9.1 and 2.2 excess deaths, respectively. Out of every 1,000 hemorrhagic strokes, the coldest and hottest 2.5% of days contributed to 11.2 and 0.7 excess deaths. The study also found that low-income countries bore a higher burden of heat-related hemorrhagic stroke mortality than high-income countries and may bear a higher burden of cold-related hemorrhagic stroke mortality as well (though evidence was suggestive, not conclusive). It did not find a relationship between countries’ gross domestic product and risk of temperature-related ischemic stroke mortality.

The researchers hypothesized that better indoor temperature control systems and lower rates of outdoor work in high-income countries, as well as worse-quality health care in low-income countries, might explain the disparities. They noted that further study is necessary to uncover the drivers of low-income countries’ higher burden of temperature-related hemorrhagic stroke mortality and identify helpful interventions.

Limitations of the study included that it was limited in its geographic scope—rural settings and countries in South Asia, Africa, and the Middle East were underrepresented—and that individual-level demographics were not collected or examined. Additionally, the study only focused on stroke deaths; additional research into the incidence of non-fatal strokes would provide further understanding of the actual burden of temperature and strokes.

“We call on professional stroke societies to invest in more of this research, especially as climate change continues to escalate, and to shine a brighter light onto emerging environmental risk factors that will make strokes—already a significant driver of mortality worldwide—even deadlier,” Alahmad said.

Other Harvard Chan co-authors included Antonella Zanobetti , Joel Schwartz , and Petros Koutrakis .

The study was supported by the Kuwait Foundation for the Advancement of Science (grant CB21-63BO-01), the Medical Research Council-UK (grant MR/V034162/1), the European Union’s Horizon 2020 Project Exhaustion (grant 820655), the Swiss National Science Foundation (grant TMSGI3_211626), and the National Institutes of Health (grant R01ES034038).

“Extreme Temperatures and Stroke Mortality: Evidence from A Multi-Country Analysis,” Barrak Alahmad, Haitham Khraishah, Meghana Kamineni, Dominic Royé, Stefania I. Papatheodorou, Ana Maria Vicedo-Cabrera, Yuming Guo, Eric Lavigne, Ben Armstrong, Francesco Sera, Aaron S. Bernstein, Antonella Zanobetti, Eric Garshick, Joel Schwartz, Multi-Country Multi-City (MCC) Network, Michelle L. Bell, Fahd Al-Mulla, Petros Koutrakis, Antonio Gasparrini, Stroke , May 22, 2024, doi: 10.1161/STROKEAHA.123.045751

Visit the Harvard Chan School website for the  latest news ,  press releases , and  multimedia offerings .

image: iStock/Dmitry Kovalchuk

For more information:

Maya Brownstein [email protected]

Harvard T.H. Chan School of Public Health  brings together dedicated experts from many disciplines to educate new generations of global health leaders and produce powerful ideas that improve the lives and health of people everywhere. As a community of leading scientists, educators, and students, we work together to take innovative ideas from the laboratory to people’s lives—not only making scientific breakthroughs, but also working to change individual behaviors, public policies, and health care practices. Each year, more than 400 faculty members at Harvard Chan School teach 1,000-plus full-time students from around the world and train thousands more through online and executive education courses. Founded in 1913 as the Harvard-MIT School of Health Officers, the School is recognized as America’s oldest professional training program in public health.

• MyU : For Students, Faculty, and Staff

News Roundup Spring 2024

CEGE Spring Graduation Celebration and Order of the Engineer

Forty-seven graduates of the undergraduate and grad student programs (pictured above) in the Department of Civil, Environmental, and Geo- Engineering took part in the Order of the Engineer on graduation day. Distinguished Speakers at this departmental event included Katrina Kessler (MS EnvE 2021), Commissioner of the Minnesota Pollution Control Agency, and student Brian Balquist. Following this event, students participated in the college-wide Commencement Ceremony at 3M Arena at Mariucci. 

UNIVERSITY & DEPARTMENT

The University of Minnesota’s Crookston, Duluth, and Rochester campuses have been awarded the Carnegie Elective Classification for Community Engagement, joining the Twin Cities (2006, 2015) and Morris campuses (2015), and making the U of M the country’s first and only university system at which every individual campus has received this selective designation. Only 368 from nearly 4,000 qualifying U.S. universities and colleges have been granted this designation.

CEGE contributed strongly to the College of Science and Engineering’s efforts toward sustainability research. CEGE researchers are bringing in over $35 million in funded research to study carbon mineralization, nature and urban areas, circularity of water resources, and global snowfall patterns. This news was highlighted in the Fall 2023 issue of  Inventing Tomorrow  (pages 10-11). https://issuu.com/inventingtomorrow/docs/fall_2023_inventing_tomorrow-web

CEGE’s new program for a one-year master’s degree in structural engineering is now accepting applicants for Fall 2024. We owe a big thanks to DAN MURPHY and LAURA AMUNDSON for their volunteer work to help curate the program with Professor JIA-LIANG LE and EBRAHIM SHEMSHADIAN, the program director. Potential students and companies interested in hosting a summer intern can contact Ebrahim Shemshadian ( [email protected] ).

BERNIE BULLERT , CEGE benefactor and MN Water Research Fund founder, was profiled on the website of the University of Minnesota Foundation (UMF). There you can read more about his mission to share clean water technologies with smaller communities in Minnesota. Many have joined Bullert in this mission. MWRF Recognizes their Generous 2024 Partners. Gold Partners: Bernie Bullert, Hawkins, Inc., Minnesota Department of Health, Minnesota Pollution Control Agency, and SL-serco. Silver Partners: ISG, Karl and Pam Streed, Kasco, Kelly Lange-Haider and Mark Haider, ME Simpson, Naeem Qureshi, Dr. Paul H. Boening, TKDA, and Waterous. Bronze Partners: Bruce R. Bullert; Brenda Lenz, Ph.D., APRN FNP-C, CNE; CDM Smith; Central States Water Environment Association (CSWEA MN); Heidi and Steve Hamilton; Jim “Bulldog” Sadler; Lisa and Del Cerney; Magney Construction; Sambatek; Shannon and John Wolkerstorfer; Stantec; and Tenon Systems.

After retiring from Baker-Tilly,  NICK DRAGISICH  (BCE 1977) has taken on a new role: City Council member in Lake Elmo, Minnesota. After earning his BCE from the University of Minnesota, Dragisich earned a master’s degree in business administration from the University of St. Thomas. Dragisich retired in May from his position as managing director at Baker Tilly, where he had previously served as firm director. Prior to that, he served as assistant city manager in Spokane, Washington, was the city administrator and city engineer in Virginia, Minnesota, and was mayor of Chisholm, Minnesota—all adding up to more than 40 years of experience in local government. Dragisich was selected by a unanimous vote. His current term expires in December 2024.

PAUL F. GNIRK  (Ph.D. 1966) passed away January 29, 2024, at the age of 86. A memorial service was held Saturday, February 24, at the South Dakota School of Mines and Technology (SDSM&T), where he started and ended his teaching career, though he had many other positions, professional and voluntary. In 2018 Paul was inducted into the SDSM&T Hardrocker Hall of Fame, and in 2022, he was inducted into the South Dakota Hall of Fame, joining his mother Adeline S. Gnirk, who had been inducted in 1987 for her work authoring nine books on the history of south central South Dakota.

ROGER M. HILL  (BCE 1957) passed away on January 13, 2024, at the age of 90. His daughter, Kelly Robinson, wrote to CEGE that Roger was “a dedicated Gopher fan until the end, and we enjoyed many football games together in recent years. Thank you for everything.”

KAUSER JAHAN  (Ph.D. 1993, advised by Walter Maier), PE, is now a civil and environmental engineering professor and department head at Henry M. Rowan College of Engineering. Jahan was awarded a 3-year (2022- 2025), $500,000 grant from the U.S. Department of Environmental Protection Agency (USEPA). The grant supports her project, “WaterWorks: Developing the New Generation of Workforce for Water/Wastewater Utilities,” for the development of educational tools that will expose and prepare today’s students for careers in water and wastewater utilities.

SAURA JOST  (BCE 2010, advised by Timothy LaPara) was elected to the St. Paul City Council for Ward 3. She is part of the historic group of women that make up the nation’s first all-female city council in a large city.

The 2024 ASCE Western Great Lakes Student Symposium combines several competitions for students involved in ASCE. CEGE sent a large contingent of competitors to Chicago. Each of the competition groups won awards: Ethics Paper 1st place Hans Lagerquist; Sustainable Solutions team 1st place overall in (qualifying them for the National competition in Utah in June); GeoWall 2nd place overall; Men’s Sprint for Concrete Canoe with rowers Sakthi Sundaram Saravanan and Owen McDonald 2nd place; Product Prototype for Concrete Canoe 2nd place; Steel Bridge (200 lb bridge weight) 2nd place in lightness; Scavenger Hunt 3rd place; and Aesthetics and Structural Efficiency for Steel Bridge 4th place.

Students competing on the Minnesota Environmental Engineers, Scientists, and Enthusiasts (MEESE) team earned second place in the Conference on the Environment undergraduate student design competition in November 2023. Erin Surdo is the MEESE Faculty Adviser. Pictured are NIKO DESHPANDE, ANNA RETTLER, and SYDNEY OLSON.

The CEGE CLASS OF 2023 raised money to help reduce the financial barrier for fellow students taking the Fundamentals of Engineering exam, a cost of $175 per test taker. As a result of this gift, they were able to make the exam more affordable for 15 current CEGE seniors. CEGE students who take the FE exam pass the first time at a rate well above national averages, demonstrating that CEGE does a great job of teaching engineering fundamentals. In 2023, 46 of 50 students passed the challenging exam on the first try.

This winter break, four CEGE students joined 10 other students from the College of Science and Engineering for the global seminar, Design for Life: Water in Tanzania. The students visited numerous sites in Tanzania, collected water source samples, designed rural water systems, and went on safari. Read the trip blog: http://globalblogs.cse.umn.edu/search/label/Tanzania%202024

Undergraduate Honor Student  MALIK KHADAR  (advised by Dr. Paul Capel) received honorable mention for the Computing Research Association (CRA) Outstanding Undergraduate Research Award for undergraduate students who show outstanding research potential in an area of computing research.

GRADUATE STUDENTS

AKASH BHAT  (advised by William Arnold) presented his Ph.D. defense on Friday, October 27, 2023. Bhat’s thesis is “Photolysis of fluorochemicals: Tracking fluorine, use of UV-LEDs, and computational insights.” Bhat’s work investigating the degradation of fluorinated compounds will assist in the future design of fluorinated chemicals such that persistent and/or toxic byproducts are not formed in the environment.

ETHAN BOTMEN  (advised by Bill Arnold) completed his Master of Science Final Exam February 28, 2024. His research topic was Degradation of Fluorinated Compounds by Nucleophilic Attack of Organo-fluorine Functional Groups.

XIATING CHEN , Ph.D. Candidate in Water Resources Engineering at the Saint Anthony Falls Laboratory is the recipient of the 2023 Nels Nelson Memorial Fellowship Award. Chen (advised by Xue Feng) is researching eco-hydrological functions of urban trees and other green infrastructure at both the local and watershed scale, through combined field observations and modeling approaches.

ALICE PRATES BISSO DAMBROZ  has been a Visiting Student Researcher at the University of Minnesota since last August, on a Doctoral Dissertation Research Award from Fulbright. Her CEGE advisor is Dr. Paul Capel. Dambroz is a fourth year Ph.D. student in Soil Science at Universidade Federal de Santa Maria in Brazil, where she studies with her adviser Jean Minella. Her research focuses on the hydrological monitoring of a small agricultural watershed in Southern Brazil, which is located on a transition area between volcanic and sedimentary rocks. Its topography, shallow soils, and land use make it prone to runoff and erosion processes.

Yielding to people in crosswalks should be a very pedestrian topic. Yet graduate student researchers  TIANYI LI, JOSHUA KLAVINS, TE XU, NIAZ MAHMUD ZAFRI  (Dept.of Urban and Regional Planning at Bangladesh University of Engineering and Technology), and Professor Raphael Stern found that drivers often do not yield to pedestrians, but they are influenced by the markings around a crosswalk. Their work was picked up by the  Minnesota Reformer.

TIANYI LI  (Ph.D. student advised by Raphael Stern) also won the Dwight David Eisenhower Transportation (DDET) Fellowship for the third time! Li (center) and Stern (right) are pictured at the Federal Highway Administration with Latoya Jones, the program manager for the DDET Fellowship.

The Three Minute Thesis Contest and the Minnesota Nice trophy has become an annual tradition in CEGE. 2023’s winner was  EHSANUR RAHMAN , a Ph.D. student advised by Boya Xiong.

GUANJU (WILLIAM) WEI , a Ph.D. student advised by Judy Yang, is the recipient of the 2023 Heinz G. Stefan Fellowship. He presented his research entitled Microfluidic Investigation of the Biofilm Growth under Dynamic Fluid Environments and received his award at the St. Anthony Falls Research Laboratory April 9. The results of Wei's research can be used in industrial, medical, and scientific fields to control biofilm growth.

BILL ARNOLD  stars in an award-winning video about prairie potholes. The Prairie Potholes Project film was made with the University of Delaware and highlights Arnold’s NSF research. The official winners of the 2024 Environmental Communications Awards Competition Grand Prize are Jon Cox and Ben Hemmings who produced and directed the film. Graduate student Marcia Pacheco (CFANS/LAAS) and Bill Arnold are the on-screen stars.

Four faculty from CEGE join the Center for Transportation Studies Faculty and Research Scholars for FY24–25:  SEONGJIN CHOI, KETSON ROBERTO MAXIMIANO DOS SANTOS, PEDRAM MORTAZAVI,  and  BENJAMIN WORSFOLD . CTS Scholars are drawn from diverse fields including engineering, planning, computer science, environmental studies, and public policy.

XUE FENG  is coauthor on an article in  Nature Reviews Earth and Environment . The authors evaluate global plant responses to changing rainfall regimes that are now characterized by fewer and larger rainfall events. A news release written at Univ. of Maryland can be found here: https://webhost.essic. umd.edu/april-showers-bring-mayflowers- but-with-drizzles-or-downpours/ A long-running series of U of M research projects aimed at improving stormwater quality are beginning to see practical application by stormwater specialists from the Twin Cities metro area and beyond. JOHN GULLIVER has been studying best practices for stormwater management for about 16 years. Lately, he has focused specifically on mitigating phosphorous contamination. His research was highlighted by the Center for Transportation Studies.

JIAQI LI, BILL ARNOLD,  and  RAYMOND HOZALSKI  published a paper on N-nitrosodimethylamine (NDMA) precursors in Minnesota rivers. “Animal Feedlots and Domestic Wastewater Discharges are Likely Sources of N-Nitrosodimethylamine (NDMA) Precursors in Midwestern Watersheds,” Environmental Science and Technology (January 2024) doi: 10.1021/acs. est.3c09251

ALIREZA KHANI  contributed to MnDOT research on Optimizing Charging Infrastructure for Electric Trucks. Electric options for medium- and heavy-duty electric trucks (e-trucks) are still largely in development. These trucks account for a substantial percentage of transportation greenhouse gas emissions. They have greater power needs and different charging needs than personal EVs. Proactively planning for e-truck charging stations will support MnDOT in helping to achieve the state’s greenhouse gas reduction goals. This research was featured in the webinar “Electrification of the Freight System in Minnesota,” hosted by the University of Minnesota’s Center for Transportation Studies. A recording of the event is now available online.

MICHAEL LEVIN  has developed a unique course for CEGE students on Air Transportation Systems. It is the only class at UMN studying air transportation systems from an infrastructure design and management perspective. Spring 2024 saw the third offering of this course, which is offered for juniors, seniors, and graduate students.

Research Professor  SOFIA (SONIA) MOGILEVSKAYA  has been developing international connections. She visited the University of Seville, Spain, November 13–26, 2023, where she taught a short course titled “Fundamentals of Homogenization in Composites.” She also met with the graduate students to discuss collaborative research with Prof. Vladislav Mantic, from the Group of Continuum Mechanics and Structural Analysis at the University of Seville. Her visit was a part of planned activities within the DIAGONAL Consortium funded by the European Commission. CEGE UMN is a partner organization within DIAGONAL, represented by CEGE professors Mogilevskaya and Joseph Labuz. Mantic will visit CEGE summer 2024 to follow up on research developments and discuss plans for future collaboration and organization of short-term exchange visits for the graduate students from each institution. 

DAVID NEWCOMB  passed away in March. He was a professor in CEGE from 1989–99 in the area of pavement engineering. Newcomb led the research program on asphalt materials characterization. He was the technical director of Mn/ROAD pavement research facility, and he started an enduring collaboration with MnDOT that continues today. In 2000, he moved from Minnesota to become vice-president for Research and Technology at the National Asphalt Pavement Association. Later he moved to his native Texas, where he was appointed to the division head of Materials and Pavement at the Texas A&M Transportation Institute, a position from which he recently retired. He will be greatly missed.

PAIGE NOVAK  won Minnesota ASCE’s 2023 Distinguished Engineer of the Year Award for her contributions to society through her engineering achievements and professional experiences.

The National Science Foundation (NSF) announced ten inaugural (NSF) Regional Innovation Engines awards, with a potential $1.6 billion investment nationally over the next decade. Great Lakes ReNEW is led by the Chicago-based water innovation hub,  Current,  and includes a team from the University of Minnesota, including PAIGE NOVAK. Current will receive $15 mil for the first two years, and up to $160 million over ten years to develop and grow a water-focused innovation engine in the Great Lakes region. The project’s ambitious plan is to create a decarbonized circular “blue economy” to leverage the region’s extraordinary water resources to transform the upper Midwest—Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin. Brewing one pint of beer generates seven pints of wastewater, on average. So what can you do with that wastewater?  PAIGE NOVAK  and her team are exploring the possibilities of capturing pollutants in wastewater and using bacteria to transform them into energy.

BOYA XIONG  has been selected as a recipient of the 2024 40 Under 40 Recognition Program by the American Academy of Environmental Engineers and Scientists. The award was presented at the 2024 AAEES Awards Ceremony, April 11, 2024, at the historic Howard University in Washington, D.C. 

JUDY Q. YANG  received a McKnight Land-Grant Professorship Award. This two-year award recognizes promising assistant professors and is intended to advance the careers of individuals who have the potential to make significant contributions to their departments and their scholarly fields. 

Professor Emeritus CHARLES FAIRHURST , his son CHARLES EDWARD FAIRHURST , and his daughter MARGARET FAIRHURST DURENBERGER were on campus recently to present Department Head Paige Novak with a check for $25,000 for the Charles Fairhurst Fellowship in Earth Resources Engineering in support of graduate students studying geomechanics. The life of Charles Fairhurst through a discussion with his children is featured on the Engineering and Technology History Wiki at https://ethw.org/Oral-History:Charles_Fairhurst#00:00:14_INTRODUCTION

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