medical research ethics ppt

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Chapter 4: Research Ethics

2014, Doing Research in the Real World, 3rd edn

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Ethics in research involving humans were first codified in 1946 as Nuremberg code. Subsequently other ethical declarations and guide lines were developed to protect the research participants as well as the researchers. The basic research bioethics includes three principles-respects for person, beneficence, and justice. To make a research with human subjects ethically sound the research protocol should have social and scientific values, fair subject selection, favorable risk benefit ratio, independent review, and informed consent of and respect for the participants. Above all the researcher should be honest and responsible enough to safeguard the rights and welfare of the research subjects. DOI: 10.3329/bjpp.v24i1.5734Bangladesh J Physiol Pharmacol 2008; 24(1&2) : 24-26

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Research involving human subjects are important to develop new therapeutics for the betterment of the human race. To take part in such research as volunteers is moral duty of any human. But such experiments should be justifiable and minimal risky for the participants. History of unethical research involving humans led to the development of many guidelines to make such research ethical as well as to gain maximum possible output. Several guidelines have been formulated to ensure research with human participants ethical. All the guidelines emphasize on one thing in particular- informed consent of the human subjects. Other considerations include rational benefit-harm ration, beneficence, justice, adequate research design and approval from proper authorities. All these guidelines aim to prevent any unethical research involving humans against their will.

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The twentieth century witnessed a succession of heinous experiments on human subjects in the name of science. The deplorable nature of these experiments led to the development of several guidelines that laid down the principles of research ethics. Respect, bene cence, and justice are the principles that form the foundation of research ethics today. These principles should be implemented through the channels of the informed consent process, privacy and con dentiality, risk bene t analysis, and fair recruitment. Proper implementation of research ethics ensures the protection of the rights and well-being of the participants. Some individuals are considered to be “vulnerable” in the research context because their autonomy is either diminished or lacking. Examples include children, some elderly persons, those with temporary or permanent cognitive impairment, prisoners, and refugees. Vulnerable groups require additional protection measures if they are involved in research. Public health research differs from general health research that necessitates additional ethical considerations. Research involving public health interventions or research conducted during public emergencies, such as natural disasters and disease outbreaks, has unique ethical challenges. Furthermore, in public health research, an understanding or familiarity with the community in which the research will be done is essential to ethical conduct of research. research ethics committees [otherwise known as institutional review boards (IRB)] play a central role in research involving human participants. The proposed research must be reviewed and approved prior to initiation and monitored thereafter with ongoing reviews of safety reports, progress reports, and emerging information or circumstances that may impact the study. A substantial number of conditions need to be met to ensure research starts and then remains ethical. Researchers should be quali ed by education, training, and experience to take on the role of investigators. The scienti c aspects of the research should be robust and valid and the research itself should be purposeful. It is important that ethical considerations be a constant, integrated into the research undertaking, from inception right through to the dissemination and or sharing of the results.

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Ethical abuse of human subjects is still prevalent in researches. Biomedical research as the use of modern day medical technology to test hypothesis so as to deduce conclusions that are generalisable as theories and principles involve human subjects. If such research is not morally guided, it runs the danger of abusing the sacredness of human life and dehumanising the human person. Therefore, ethics as the philosophical science, which establishes the moral order of human acts would necessarily be required to check and balance the procedural systems of such research. It is within this context that this paper interrogates the role of ethics in biomedical research. This paper carefully and critically analyses how and why researchers abuse the human subject. Appealing to the Kantian moral imperatives, it opines that human subjects should never be treated as means to an end but as end in themselves. It succinctly points out the relevance of ethics in researches involving human subjects, particularly, biomedical research.

udo schuklenk

ABSTRACT This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.

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Ethics in Medical Research

Published by Herman Lesmono Modified over 5 years ago

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Presentation on theme: "Ethics in Medical Research"— Presentation transcript:

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Ethics in medical research

Ethics in medical research professor ayo ojuawo deparment of paediatrics university of ilorin ayojuawo_at_yahoo.com – powerpoint ppt presentation.

• Professor Ayo Ojuawo
• Deparment of Paediatrics
• University of Ilorin
• ayojuawo_at_yahoo.com
• Ethics in research is very critical and must be addressed in proposals. Ethics is about what is morally right and proper in research.
• Ethics are vital because of past atrocities in research work. Examples are the experiments conducted by the Nazi doctors on Jews, the Tuskegee experiments in the United States etc.
• While researchers in biological sciences and medicine have always taken ethics seriously, those in the social have not been inclined to do so.
• Every one is required to address ethics and comply with, and do research in ethically proper way today
• Ethics is a philosophical consideration of morals- right or wrong
• It is a process of thinking, of morals, of behaviour and intentions
• Ethics evolves out of a collective responsibility to humanity
• The term bio-medical ethics was coined in the early 1970s to refer to the application of moral reasoning to vexing questions at the frontiers of biology and medicine
• Sometimes it can be difficult to distinguish research from program evaluation, health care or public health interventions
• If the goal is generalizeable knowledge, then the activity is research
• If the goal is generate knowledge relevant only to a particular individual or program, then it is not
• All healthy research must be scientifically sound to be ethical
• The scientific merit of any research must be matched with the ethical process
• Unsound research on human subjects may expose research subjects to risks or inconvenience.
• Ethical review and bio-medical ethics evolved in response to a history of medical abuses
• Medical abuses by Nazi doctors (Nuremburg Trial and code of 1947)
• Publication of article on medical abuses in the New England Journal of Medicine
• Public revelation of the Tuskegee syphilis study in 1974
• The various abuses of the dignity and rights of human beings led to the set-up of different commissions to set international standards in Research involving human beings
• The Nuremberg Code outlines permissible medical experimentation on human beings. The first provision of the code requires that the voluntary informed consent of the human subject is absolutely essential. The Code also requires that
• the risks to patients be minimized
• research be conducted by qualified investigators using appropriate designs
• participants always be free to withdraw from participation at any time and
• Any research pursued, have a favorable risk/benefit ratio
• The World Medical Association created the Declaration of Helsinki, to guide physicians who become involved in medical research.
• Three Basic Ethical Principles
• AUTONOMY -Respect for persons, community etc
• BENEFICENCE / MALFICENCE ensuring that no harm is done
• JUSTICE- Distributive justice, equality of individuals and that the benefits and risks should be distributed fairly
• Informed consent of individuals participating will be obtained orally, through tapes, or in written form (international funding bodies require WRITTEN CONSENT which is a challenge for Nigerian researchers)
• Provision of consent form
• Respect for persons/community
• Respect for persons/community etc
• Description of entry into homes of respondents and how informed consent will be obtained
• Same with entry into community
• Same as the handling of under-aged in studies and how informed consent will be obtained
• Sharing of outcomes with targeted individuals etc.
• CONFIDENTIALITY
• Describing how harm to respondents or targeted community will be avoided at all cost
• Ensuring full disclosure of the nature of the research with particular reference to harm/ risks and benefits
• Dimension of beneficence
• Dimensions of distributive justice
• Giving every person or community equal chance of participating in the work.
• Distributing benefits fairly
• Describing how the conditions of the individuals and community will be ameliorated in the course and after the research
• UITH ERC is well established and functional since 1991, current Provost was the 1st Chairman, yours truly, Current Chairman
• Thirteen member committee including Laymen and Lawyers
• Registered with NHREC and has Federal Wide Assurance FWA certification
• Meet bi-monthly
• Reviews proposals from Lecturers, Consultants, Residents, Postgraduate students, Undergraduate students etc
• Review process submit 5 copies, takes about 2 weeks for review, Researcher meets with the committee to discuss the proposal, corrections are pointed out to researcher, final paper is reviewed and approval given.
• The committee MONITORS the project
• Areas of concentration
• Relevant Literature review citing relevant lite
• Aims and objectives
• METHODOLOGY
• Study population
• Sampling technique
• Sample size
• Inclusion and Exclusion criteria
• Description of procedures
• Data Analysis
• INFORMED UNDERSTOOD CONSENT
• Information sheet / Consent form
• Information provided in different languages
• States the procedure, risk, benefit, confidentiality of information, voluntary withdrawal without penalty
• Consent form must be signed / thumb print
• Consent by proxy (minors, incompetent etc)
• Please note that your proposal will be reviewed by your institutions review board and the NATIONALHEALTH RESEARCH ETHICS COMMITTEE which is based in the Federal Ministry of Health if project involves 3 collaborating centres or more, is a national and/or funded by international agencies
• Download the document on NHREC from the Internet. It describes process etc for review
• Check details for the international funding agencies from their web site.
• Note that there could be long turn around for the review of your proposal
• Ethics are not just about the review of your proposal but transcend the entire work. Funding can be terminated if the funding bodies finds ethics are being breached in the course of research
• Adherence to extant research code and ensuring integrity in research work (e.g., selection of sample/respondents, reporting and analysis of data)

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Medical Ethics

Apr 25, 2011

4.07k likes | 10.12k Views

Medical Ethics. Introduction. What is Ethics?. What is medical science?. How are medical science and ethics related?. Why Ethics Become Important?.

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• ancient times
• ethical dilemmas
• medical science
• high technology medicine

Presentation Transcript

Medical Ethics Introduction

What is Ethics? What is medical science? How are medical science and ethics related?

Why Ethics Become Important? • Nowadays, conflicts of interests between the government and medical institutions, between medical institutions and medical personnel, between physicians and patients are getting more and more serious and complex.

High technologies not only brought us hopes of cure but have also created a heavy economic burden. • The ethical dilemmas of high technology medicine-brain death, organ transplantation, and concerns about quality of life-have become increasingly prominent.

A new and more specific code of ethics must be developed to meet the demands of social development and medical service. • This new code integrates the traditional medical ethics with modern principles and values.

Section 1: Morality, Ethics • Section 2: Professional ethics, medical ethics, bioethics, clinical ethics • Section 3: The History of Medical Ethics

Section 1: Morality, Ethics 1.What is Morality 2.What is Ethics? 3.Ethics and Morality 4.to distinguish between Ethics and Law 5.to distinguish between Ethics and Policy

1.What is Morality The science of human duty; the rules of human conduct. The function of morality is "to combat the deleterious consequences of human sympathies" (Beauchamp). Its aim is "to contribute to betterment -- or at least non-deterioration -- of the human predicament" (Warnock). "Ethics aims at discovering what are those other properties belonging to all things which are good" (Moore).

2.What is Ethics? • Ethicsare standards of conduct (or social norms) that prescribe behavior. • Ethics as a field of study is a normative discipline whose main goals are prescriptive and evaluative rather than descriptive and explanatory. So Ethicists are different from social scientists. • Ethicists (or moral philosophers) study standards of conduct.

But standards of conduct do not describe our actual behavior, since people often violate widely accepted standards. • For Example, most people accept the idea that one ought to tell the truth, yet many people lie all of the time. Even though people lie all of the time, we indicate our endorsement of honesty as a standard of conduct by defending honesty in public, by teaching our children/students to be honesty, and by expressing our disapproval of lying.

In thinking about standards of conduct, it will be useful to distinguish between “ethics” and “morality”. • Morality consists of a society’s most general standards. These standards apply to all people in society regardless of their professional or institutional roles. • Moral standards include those rules that most people learn in childhood, e.g. “don’t lie, cheat, steal, harm other people, etc.” • Many ethicists maintain that moral duties and obligations override other ones: so, “if I have a moral duty not to lie, then I should not lie even if my employment requires me to lie.”

3.Ethics and Morality • So that we can see, moral standards distinguish between right and wrong, good and bad, virtue and vice, justice and injustice. • Ethics are not general standards of conduct but the standards of a particular profession, occupation, institution, or group within society. The word “ethics”, when used in this way, usually serves as a modifier for another word, e.g. business ethics, medical ethics, sports ethics, military ethics, etc. • They are all professional ethics.

4.to distinguish between Ethics and Law • (1) some actions that are illegal may not be unethical. (kill) • (2) some actions that are unethical may not be illegal. (secret) • (3) laws can be unethical or immoral. (Nazi’s) • (4) we use different kinds of mechanisms to express, teach, inculcate, and enforce laws and ethics.

Laws are often expressed in highly technical and complex jargon, and we often need specially trained people---lawyers and judges---to interpret them. Ethics and morals tend to be less technical and complex. • (5) we use the coercive power of government to enforce laws. People who break certain laws can be fined, imprisoned, or executed. People who violate ethical or moral standards do not face these kind of punishments unless their action also violate laws. We often “punish” people who disobey moral or ethical obligations by simply expressing our disapproval or by condemning the behavior.

5.to distinguish between Ethics and Policy • Political standards focus on the conduct of groups or social institutions, whereas ethical and moral standards focus on the conduct of individuals. • Political standards take a macro-perspective on human affairs; ethical and moral standards adopt a micro-perspective. • However, the distinction between ethics and politics is not absolute since many actions, institutions, and situations can be evaluated from an ethical or political point of view.

Section 2: Professional ethics, medical ethics, bioethics, clinical ethics

1.Professional Ethics • Professional ethics are standards of conduct that apply to people who occupy a professional occupation or role. • A person who enters a profession acquires ethical obligations because society trusts them to provide valuable goods and services that cannot be provided unless their conduct conforms to certain standards. • Professionals who fail to live up to their ethical obligations betray this trust. • Professional ethics studied by ethicists include medical ethics.

2.Medical ethics • The expressions “professional ethics” and “medical ethics” were coined by Thomas Percival. • Medical ethics is a special kind of ethics only as it relates to a particular realm of facts and concerns and not because it embodies or appeals to some special moral principles or methodology.

It is applied ethics. It consists of the same moral principles and rules that we would appeal to ,and argue for, in ordinary circumstances. • It is just that in medical ethics these familiar moral rules are being applied to situations peculiar to the medical world.

3.Bioethics • Bioethics could be defined as the study of ethical issues and decision-making associated with the use of living organisms • Bioethics includes both medical ethics and environmental ethics. Bioethics is learning how to balance different benefits, risks and duties.

4.Clinical ethics Clinical ethics is a practical discipline that provides a structured approach for identifying ,analyzing, and resolving ethical issues in clinical medicine.

Clinical medical ethics is a practical and applied discipline that aims to improve patient care and patient outcomes by focusing on reaching a right and good decision in individual cases. • It focuses on the doctor-patient relationship and takes account of the ethical and legal issues that patients, doctors, and hospitals must address to reach good decisions for individual patients.

Clinical ethics emphasizes that in practicing good clinical medicine, physicians must combine scientific and technical abilities with ethical concerns for the personal values of the patients who seek their help.

The content of clinical ethics includes • specific issues such as truth-telling, informed consent, end of life care, palliative care, allocation of clinical resources, and the ethics of medical research. • the study of the doctor-patient relationship, including such issues as honesty, competence, integrity, and respect for persons.

Section 3: The History of Medical Ethics

A brief history of medical ethics in China As in ancient Greek medicine, the professional values of ancient Chinese medicine arose with the development of medical professionalism itself. In ancient China, “profession” meant one’s duties. The value system of medical ethics in China has a long tradition that can be traced back to ancient times.

Zhou Dynasty (from 1065-771 B.C.E.) an independent medical profession and medical system took shape , built around four aspects: dietetic, internal, surgery, and veterinary. Spring and Autumn Period (770-476 B.C.E.) and the Warring States (475-221 B.C.E.) medicine began to divorce itself from witchcraft (magic) and became an experience-based knowledge and a professional skill .

In ancient China, folk physicians didn’t have fixed clinics or hospitals but went from one place to another practicing medicine freely. • They hadn’t formal training and weren’t licensed, but performed their work by their own skills and consciences.

Ancient physicians paid great attention to prognosis and accumulated rich experience, codified in ancient medical books such as the Canon of Medicine and Classic on Medical Problems. • By judging whether a patient was curable or incurable, a physician decided whether to accept the case for treatment.

Medicine should not be offered in six circumstances, namely, to (1) people who have unreasonable arrogance and indulgence, (2) people who appreciate riches more than life, (3) people who cannot even keep body and soul together, (4) people who suffer from interlocking Yin and Yang, (5) people who are too weak to take medicines, and (6) people who don’t believe in medicine but in sorcery. —Bianque

the Han Dynasty (206 B.C.E.-220 C.E.) Confucianism shaped the core values of Chinese culture. medicine is a humane art it emphasizes on caring about patients and on physicians’ self-cultivation in virtue. Benevolence is the core of Confucian ethics. In Confucianism “benevolence” means, “to love the people.”

Confucianism required doctors to be very cautious and responsible in the course of diagnosis and prescription in order to avoid mistakes that would harm patients.

The Confucian principle also calls for respect for patients. The principle calls for “universal love,” that is, to treat every patient equally, regardless of social status, family background, appearances, age, etc.

“Whoever comes to seek cure must be treated like your own relatives regardless of their social status, family economic conditions, appearances, ages, races, and mental abilities. — Simiao Sun

For Confucians, morality is grounded in human nature, which is expressed by Confucius as ren or humaneness, sometime simply as benevolence. • From this origin of morality, some more concrete moral principles spurt out, such as the principles of ren, yi, li and zhi, or principles of benevolence, of justice, of propriety , and of moral consciousness. • These are major guiding principles for our common lives.

The leading principle is the moral mind and our concern about the sufferings of others. • “one must understand Confucianism before one really understand what medicine is all about.”

With the introduction of Western medicine beginning in the nineteenth century, China’s medical system has changed tremendously. • A new type of medical system has emerged and a new perspective on professional ethics has gained people’s attention. • This change has also brought new requirements for doctors, who now are responsible not only for their patients, but also for their hospitals and the whole society.

Meanwhile, Western theories of medical ethics and professional standards of medicine were introduced into China.

never being selfish but always ready to help others” have become the principal values of medical ethics.

History of Medical Ethics in the West

1．Ancient Egypt: Ancient Egyptian Medicine • The people of Ancient Egypt made several major medical discoveries and began treating diseases in a physical manner alongside older spiritual cures.

2．Ancient Greek Medicine • Medical practice in Ancient Greece, like Egypt, was based largely upon religious beliefs. • The works of Hippocrates and his followers led to several scientific facts being recorded for the first time • Hippocrates theory of the Four Humours was, for a long time, the basis upon which to develop medical reasoning.

Ancient Roman Medicine • Roman medicine was a mixture of new theories and developments of Greek practices. Medicine was improved through the studies of Galen, through a desire to maintain a fit and healthy army and through empirical observation. • Medicine in Ancient Rome also brought about some great developments of Public Health facilities.

Oriental and Islamic Medicine • The Islamic Authorities placed a lot of value in medicine. • Baghdad had a hospital by AD 850 and doctors had to pass medical examinations by AD 931 in order to practice. • Hospitals were later developed throughout the Islamic world, with the most famous being those in Damascus and Cairo.

Developments of Galen and Hippocrates theories • Rhazes said that it was vitally important to observe patients and make notes of all minor details. He was the first man to observe and record the differences between smallpox and measles. • Avicenna wrote the Canon of medicine . This developed some of Galen’s ideas and was used with aspiring doctors in both Arabia and later in the West.

Medicine in Medieval and Early Modern Europe • Medicine during the Medieval period changed in a number of ways, often for the worse. • Medieval Europe was a place that placed less importance on the value of Public Health facilities

As the church taught that God sent illness, and that repenting would cure all evils, many people at the time believed that pilgrimage would cure them. Other theories were based upon astrology, the movement of the sun and stars.

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