standard 8.10 reporting research results

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APA Code of Ethics

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8.01 Institutional Approval

When institutional approval is required, psychologists provide accurate information about their research proposals and obtain approval prior to conducting the research. They conduct the research in accordance with the approved research protocol.

8.02 Informed Consent to Research

• When obtaining informed consent as required in Standard 3.10, Informed Consent, psychologists inform participants about (1) the purpose of the research, expected duration, and procedures; (2) their right to decline to participate and to withdraw from the research once participation has begun; (3) the foreseeable consequences of declining or withdrawing; (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort, or adverse effects; (5) any prospective research benefits; (6) limits of confidentiality; (7) incentives for participation; and (8) whom to contact for questions about the research and research participants’ rights. They provide opportunity for the prospective participants to ask questions and receive answers. (See also Standards 8.03, Informed Consent for Recording Voices and Images in Research; 8.05, Dispensing With Informed Consent for Research; and 8.07, Deception in Research.)
• Psychologists conducting intervention research involving the use of experimental treatments clarify to participants at the outset of the research (1) the experimental nature of the treatment; (2) the services that will or will not be available to the control group(s) if appropriate; (3) the means by which assignment to treatment and control groups will be made; (4) available treatment alternatives if an individual does not wish to participate in the research or wishes to withdraw once a study has begun; and (5) compensation for or monetary costs of participating including, if appropriate, whether reimbursement from the participant or a third-party payor will be sought. (See also Standard 8.02a, Informed Consent to Research.)

8.03 Informed Consent for Recording Voices and Images in Research

Psychologists obtain informed consent from research participants prior to recording their voices or images for data collection unless (1) the research consists solely of naturalistic observations in public places, and it is not anticipated that the recording will be used in a manner that could cause personal identification or harm, or (2) the research design includes deception, and consent for the use of the recording is obtained during debriefing. (See also Standard 8.07, Deception in Research.)

8.04 Client/Patient, Student, and Subordinate Research Participants

• When psychologists conduct research with clients/patients, students, or subordinates as participants, psychologists take steps to protect the prospective participants from adverse consequences of declining or withdrawing from participation.
• When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.

8.05 Dispensing With Informed Consent for Research

Psychologists may dispense with informed consent only (1) where research would not reasonably be assumed to create distress or harm and involves (a) the study of normal educational practices, curricula, or classroom management methods conducted in educational settings; (b) only anonymous questionnaires, naturalistic observations, or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation, and confidentiality is protected; or (c) the study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants’ employability, and confidentiality is protected or (2) where otherwise permitted by law or federal or institutional regulations.

8.06 Offering Inducements for Research Participation

• Psychologists make reasonable efforts to avoid offering excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation.
• When offering professional services as an inducement for research participation, psychologists clarify the nature of the services, as well as the risks, obligations, and limitations. (See also Standard 6.05, Barter With Clients/Patients.)

8.07 Deception in Research

• Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.
• Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.
• Psychologists explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data. (See also Standard 8.08, Debriefing.)

8.08 Debriefing

• Psychologists provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and they take reasonable steps to correct any misconceptions that participants may have of which the psychologists are aware.
• If scientific or humane values justify delaying or withholding this information, psychologists take reasonable measures to reduce the risk of harm.
• When psychologists become aware that research procedures have harmed a participant, they take reasonable steps to minimize the harm.

8.09 Humane Care and Use of Animals in Research

• Psychologists acquire, care for, use, and dispose of animals in compliance with current federal, state, and local laws and regulations, and with professional standards.
• Psychologists trained in research methods and experienced in the care of laboratory animals supervise all procedures involving animals and are responsible for ensuring appropriate consideration of their comfort, health, and humane treatment.
• Psychologists ensure that all individuals under their supervision who are using animals have received instruction in research methods and in the care, maintenance, and handling of the species being used, to the extent appropriate to their role. (See also Standard 2.05, Delegation of Work to Others.)
• Psychologists make reasonable efforts to minimize the discomfort, infection, illness, and pain of animal subjects.
• Psychologists use a procedure subjecting animals to pain, stress, or privation only when an alternative procedure is unavailable and the goal is justified by its prospective scientific, educational, or applied value.
• Psychologists perform surgical procedures under appropriate anesthesia and follow techniques to avoid infection and minimize pain during and after surgery.
• When it is appropriate that an animal’s life be terminated, psychologists proceed rapidly, with an effort to minimize pain and in accordance with accepted procedures.

8.10 Reporting Research Results

• Psychologists do not fabricate data. (See also Standard 5.01a, Avoidance of False or Deceptive Statements.)
• If psychologists discover significant errors in their published data, they take reasonable steps to correct such errors in a correction, retraction, erratum, or other appropriate publication means.

8.11 Plagiarism

Psychologists do not present portions of another’s work or data as their own, even if the other work or data source is cited occasionally.

8.12 Publication Credit

• Psychologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have substantially contributed. (See also Standard 8.12b, Publication Credit.)
• Principal authorship and other publication credits accurately reflect the relative scientific or professional contributions of the individuals involved, regardless of their relative status. Mere possession of an institutional position, such as department chair, does not justify authorship credit. Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement.
• Except under exceptional circumstances, a student is listed as principal author on any multiple-authored article that is substantially based on the student’s doctoral dissertation. Faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate. (See also Standard 8.12b, Publication Credit.)

8.13 Duplicate Publication of Data

Psychologists do not publish, as original data, data that have been previously published. This does not preclude republishing data when they are accompanied by proper acknowledgment.

8.14 Sharing Research Data for Verification

• After research results are published, psychologists do not withhold the data on which their conclusions are based from other competent professionals who seek to verify the substantive claims through reanalysis and who intend to use such data only for that purpose, provided that the confidentiality of the participants can be protected and unless legal rights concerning proprietary data preclude their release. This does not preclude psychologists from requiring that such individuals or groups be responsible for costs associated with the provision of such information.
• Psychologists who request data from other psychologists to verify the substantive claims through reanalysis may use shared data only for the declared purpose. Requesting psychologists obtain prior written agreement for all other uses of the data.

8.15 Reviewers

Psychologists who review material submitted for presentation, publication, grant, or research proposal review respect the confidentiality of and the proprietary rights in such information of those who submitted it.

Source: You can read the full APA Ethics Code at http://www.apa.org/ethics/code/index.aspx .

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Chapter 3: Research Ethics

From Moral Principles to Ethics Codes

Learning Objectives

• Describe the history of ethics codes for scientific research with human participants.
• Summarize the Tri-Council Policy Statement on Ethical Conduct—especially as it relates to informed consent, deception, debriefing, research with nonhuman animals, and scholarly integrity.

The general core principles of respect for persons, concern for welfare, and justice provide a useful starting point for thinking about the ethics of psychological research because essentially everyone agrees on them. As we have seen, however, even people who agree on these general principles can disagree about specific ethical issues that arise in the course of conducting research. This discrepancy is why there also exist more detailed and enforceable ethics codes that provide guidance on important issues that arise frequently. In this section, we begin with a brief historical overview of such ethics codes and then look closely at the one that is most relevant to psychological research in Canada—the Tri-Council Policy Statement (TCPS).

Historical Overview

One of the earliest ethics codes was the  Nuremberg Code —a set of 10 principles written in 1947 in conjunction with the trials of Nazi physicians accused of shockingly cruel research on concentration camp prisoners during World War II. It provided a standard against which to compare the behaviour of the men on trial—many of whom were eventually convicted and either imprisoned or sentenced to death. The Nuremberg Code was particularly clear about the importance of carefully weighing risks against benefits and the need for informed consent. The  Declaration of Helsinki  is a similar ethics code that was created by the World Medical Council in 1964. Among the standards that it added to the Nuremberg Code was that research with human participants should be based on a written  protocol —a detailed description of the research—that is reviewed by an independent committee. The Declaration of Helsinki has been revised several times, most recently in 2013.

In the United States, concerns about the Tuskegee study and others led to the publication in 1978 of a set of federal guidelines called the  Belmont Report . The Belmont Report explicitly recognized the principle of seeking justice, including the importance of conducting research in a way that distributes risks and benefits fairly across different groups at the societal level. The Belmont Report was influential in the formation of national ethical guidelines for research in both the US and Canada.

In Canada, researchers and research institutions must follow the code of ethics formally laid out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans . The term “Tri-Council” is commonly used to collectively describe the three research granting agencies that are funded by the Canadian federal government: the Social Sciences and Humanities Research Council of Canada (SSHRC), the Canadian Institutes of Health Research (CIHR), and the Natural Sciences and Engineering Research Council of Canada (NSERC). The first edition of the Tri-Council Policy Statement (TCPS) was published in 1998, when it replaced all previous guidelines that had been developed by individual agencies and institutions. In 2010 a second edition (TCPS 2) was published that consolidated the core principles, clarified and updated the guidelines, updated terminology, and clarified the scope and responsibilities of institutional research ethics boards (REBs). The guidelines in the TCPS 2 are based on the three core principles already discussed: respect for persons, concern for welfare, and justice.

A detailed online tutorial of the specific guidelines contained within the TCPS 2 is available on the following website: TCPS 2

Successful completion of the tutorial takes up to 3 hours and provides the user with a certificate that is now required by many universities and other research institutions before a research proposal will be evaluated by the institution’s research ethics board (REB)  – a committee that is responsible for reviewing research protocols for potential ethical problems. An REB must consist of at least five people with varying backgrounds, including at least two members with expertise in relevant research disciplines, at least one member knowledgeable in ethics, and at least one community member who has no affiliation with the institution. The REB helps to make sure that the risks of the proposed research are minimized, the benefits outweigh the risks, the research is carried out in a fair manner, and the informed consent procedure is adequate.

The TCPS 2 includes provisions for two levels of research ethics review. Full REB review  is the default requirement for research involving humans. However, for research   in which “the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research,” the REB may deem it to be a case of minimal risk research [1] . In such cases (as is sometimes the case with surveys, questionnaire-based studies, and naturalistic observation studies), the REB may delegate the research ethics review to one or more members of the REB. A further exception is made in the case of student course-based research, in which case the REB may delegate the review to the relevant department or faculty.

Although researchers and research institutions in Canada formally follow the guidelines detailed within the TCPS 2, students of psychology should also be aware of the ethics code of the American Psychological Association (APA), which shares many principles and procedures with the TCPS 2.

The APA’s  Ethical Principles of Psychologists and Code of Conduct  (also known as the  APA Ethics Code ) was first published in 1953 and has been revised several times since then, most recently in 2002. It includes about 150 specific ethical standards that psychologists and their students are expected to follow. Much of the APA Ethics Code concerns the clinical practice of psychology—advertising one’s services, setting and collecting fees, having personal relationships with clients, and so on. For our purposes, the most relevant part is Standard 8: Research and Publication . The APA also oversees research on nonhuman animal participants, but the TCPS 2 does not. In Canada, research on animals is overseen by the Canadian Council on Animal Care. We should consider some of the most important aspects that are common to both TCPS 2 and the APA—informed consent, deception, debriefing, and scholarly integrity—in more detail .

APA Ethics Code

Standard 8: Research and Publication 8.01 Institutional Approval

When institutional approval is required, psychologists provide accurate information about their research proposals and obtain approval prior to conducting the research. They conduct the research in accordance with the approved research protocol.

8.02 Informed Consent to Research

When obtaining informed consent as required in Standard 3.10, Informed Consent, psychologists inform participants about (1) the purpose of the research, expected duration, and procedures; (2) their right to decline to participate and to withdraw from the research once participation has begun; (3) the foreseeable consequences of declining or withdrawing; (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort, or adverse effects; (5) any prospective research benefits; (6) limits of confidentiality; (7) incentives for participation; and (8) whom to contact for questions about the research and research participants’ rights. They provide opportunity for the prospective participants to ask questions and receive answers. (See also Standards 8.03, Informed Consent for Recording Voices and Images in Research; 8.05, Dispensing With Informed Consent for Research; and 8.07, Deception in Research.)

Psychologists conducting intervention research involving the use of experimental treatments clarify to participants at the outset of the research (1) the experimental nature of the treatment; (2) the services that will or will not be available to the control group(s) if appropriate; (3) the means by which assignment to treatment and control groups will be made; (4) available treatment alternatives if an individual does not wish to participate in the research or wishes to withdraw once a study has begun; and (5) compensation for or monetary costs of participating including, if appropriate, whether reimbursement from the participant or a third-party payor will be sought. (See also Standard 8.02a, Informed Consent to Research.)

8.03 Informed Consent for Recording Voices and Images in Research

Psychologists obtain informed consent from research participants prior to recording their voices or images for data collection unless (1) the research consists solely of naturalistic observations in public places, and it is not anticipated that the recording will be used in a manner that could cause personal identification or harm, or (2) the research design includes deception, and consent for the use of the recording is obtained during debriefing. (See also Standard 8.07, Deception in Research.)

8.04 Client/Patient, Student, and Subordinate Research Participants

When psychologists conduct research with clients/patients, students, or subordinates as participants, psychologists take steps to protect the prospective participants from adverse consequences of declining or withdrawing from participation.

When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.

8.05 Dispensing With Informed Consent for Research

Psychologists may dispense with informed consent only (1) where research would not reasonably be assumed to create distress or harm and involves (a) the study of normal educational practices, curricula, or classroom management methods conducted in educational settings; (b) only anonymous questionnaires, naturalistic observations, or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation, and confidentiality is protected; or (c) the study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants’ employability, and confidentiality is protected or (2) where otherwise permitted by law or federal or institutional regulations.

8.06 Offering Inducements for Research Participation

Psychologists make reasonable efforts to avoid offering excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation.

When offering professional services as an inducement for research participation, psychologists clarify the nature of the services, as well as the risks, obligations, and limitations. (See also Standard 6.05, Barter With Clients/Patients.)

8.07 Deception in Research

Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified by the study’s significant prospective scientific, educational, or applied value and that effective nondeceptive alternative procedures are not feasible.

Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress.

Psychologists explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data. (See also Standard 8.08, Debriefing.)

8.08 Debriefing

Psychologists provide a prompt opportunity for participants to obtain appropriate information about the nature, results, and conclusions of the research, and they take reasonable steps to correct any misconceptions that participants may have of which the psychologists are aware.

If scientific or humane values justify delaying or withholding this information, psychologists take reasonable measures to reduce the risk of harm.

When psychologists become aware that research procedures have harmed a participant, they take reasonable steps to minimize the harm.

8.09 Humane Care and Use of Animals in Research

Psychologists acquire, care for, use, and dispose of animals in compliance with current federal, state, and local laws and regulations, and with professional standards.

Psychologists trained in research methods and experienced in the care of laboratory animals supervise all procedures involving animals and are responsible for ensuring appropriate consideration of their comfort, health, and humane treatment.

Psychologists ensure that all individuals under their supervision who are using animals have received instruction in research methods and in the care, maintenance, and handling of the species being used, to the extent appropriate to their role. (See also Standard 2.05, Delegation of Work to Others.)

Psychologists make reasonable efforts to minimize the discomfort, infection, illness, and pain of animal subjects.

Psychologists use a procedure subjecting animals to pain, stress, or privation only when an alternative procedure is unavailable and the goal is justified by its prospective scientific, educational, or applied value.

Psychologists perform surgical procedures under appropriate anesthesia and follow techniques to avoid infection and minimize pain during and after surgery.

When it is appropriate that an animal’s life be terminated, psychologists proceed rapidly, with an effort to minimize pain and in accordance with accepted procedures.

8.10 Reporting Research Results

Psychologists do not fabricate data. (See also Standard 5.01a, Avoidance of False or Deceptive Statements.)

If psychologists discover significant errors in their published data, they take reasonable steps to correct such errors in a correction, retraction, erratum, or other appropriate publication means.

8.11 Plagiarism

Psychologists do not present portions of another’s work or data as their own, even if the other work or data source is cited occasionally.

8.12 Publication Credit

Psychologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have substantially contributed. (See also Standard 8.12b, Publication Credit.)

Principal authorship and other publication credits accurately reflect the relative scientific or professional contributions of the individuals involved, regardless of their relative status. Mere possession of an institutional position, such as department chair, does not justify authorship credit. Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement.

Except under exceptional circumstances, a student is listed as principal author on any multiple-authored article that is substantially based on the student’s doctoral dissertation. Faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate. (See also Standard 8.12b, Publication Credit.)

8.13 Duplicate Publication of Data

Psychologists do not publish, as original data, data that have been previously published. This does not preclude republishing data when they are accompanied by proper acknowledgment.

8.14 Sharing Research Data for Verification

After research results are published, psychologists do not withhold the data on which their conclusions are based from other competent professionals who seek to verify the substantive claims through reanalysis and who intend to use such data only for that purpose, provided that the confidentiality of the participants can be protected and unless legal rights concerning proprietary data preclude their release. This does not preclude psychologists from requiring that such individuals or groups be responsible for costs associated with the provision of such information.

Psychologists who request data from other psychologists to verify the substantive claims through reanalysis may use shared data only for the declared purpose. Requesting psychologists obtain prior written agreement for all other uses of the data.

8.15 Reviewers

Psychologists who review material submitted for presentation, publication, grant, or research proposal review respect the confidentiality of and the proprietary rights in such information of those who submitted it.

Source: You can read the full APA Ethics Code here: Ethical Principles of Psychologists and Code of Conduct

Informed Consent

I nformed consent means obtaining and documenting people’s agreement to participate in a study, having informed them of everything that might reasonably be expected to affect their decision. Properly informing participants  includes details of the procedure, the risks and benefits of the research, the fact that they have the right to decline to participate or to withdraw from the study, the consequences of doing so, and any legal limits to confidentiality. For example, some places  require researchers who learn of child abuse or other crimes to report this information to authorities.

Although the process of obtaining informed consent often involves having participants read and sign a  consent form , it is important to understand that this written agreement is not all it is. Although having participants read and sign a consent form might be enough when they are competent adults with the necessary ability and motivation, many participants do not actually read consent forms or read them but do not understand them. For example, participants often mistake consent forms for legal documents and mistakenly believe that by signing them they give up their right to sue the researcher (Mann, 1994) [2] . Even with competent adults, therefore, it is good practice to tell participants about the risks and benefits, demonstrate the procedure, ask them if they have questions, and remind them of their right to withdraw at any time—in addition to having them read and sign a consent form.

Note also that there are situations in which informed consent is not necessary. These include situations in which the research is not expected to cause any harm and the procedure is straightforward or the study is conducted in the context of people’s ordinary activities. For example, if you wanted to sit outside a public building and observe whether people hold the door open for people behind them, you would not need to obtain their informed consent. Similarly, if a professor wanted to compare two legitimate teaching methods across two sections of her research methods course, she would not need to obtain informed consent from her students unless she planned to publish the results in a scientific journal about learning.

Deception  of participants in psychological research can take a variety of forms: misinforming participants about the purpose of a study, using confederates, using phony equipment like Milgram’s shock generator, and presenting participants with false feedback about their performance (e.g., telling them they did poorly on a test when they actually did well). Deception also includes not informing participants of the full design or true purpose of the research even if they are not actively misinformed (Sieber, Iannuzzo, & Rodriguez, 1995) [3] . For example, a study on incidental learning—learning without conscious effort—might involve having participants read through a list of words in preparation for a “memory test” later. Although participants are likely to assume that the memory test will require them to recall the words, it might instead require them to recall the contents of the room or the appearance of the research assistant.

Some researchers have argued that deception of research participants is rarely if ever ethically justified. Among their arguments are that it prevents participants from giving truly informed consent, fails to respect their dignity as human beings, has the potential to upset them, makes them distrustful and therefore less honest in their responding, and damages the reputation of researchers in the field (Baumrind, 1985) [4] .

Note, however, that the TCPS 2 and the APA Ethics Code takes a more moderate approach—allowing deception when the benefits of the study outweigh the risks, participants cannot reasonably be expected to be harmed, the research question cannot be answered without the use of deception, and participants are informed about the deception as soon as possible. This approach acknowledges that not all forms of deception are equally bad. Compare, for example, Milgram’s study in which he deceived his participants in several significant ways that resulted in their experiencing severe psychological stress with an incidental learning study in which a “memory test” turns out to be slightly different from what participants were expecting. It also acknowledges that some scientifically and socially important research questions can be difficult or impossible to answer without deceiving participants. Knowing that a study concerns the extent to which they obey authority, act aggressively toward a peer, or help a stranger is likely to change the way people behave so that the results no longer generalize to the real world.

Debriefing  is the process of informing research participants as soon as possible of the purpose of the study, revealing any deception, and correcting any other misconceptions they might have as a result of participating. Debriefing also involves minimizing harm that might have occurred. For example, an experiment on the effects of being in a sad mood on memory might involve inducing a sad mood in participants by having them think sad thoughts, watch a sad video, or listen to sad music. Debriefing would be the time to return participants’ moods to normal by having them think happy thoughts, watch a happy video, or listen to happy music.

Scholarly Integrity

Scholarly integrity includes the obvious points that researchers must not fabricate data or plagiarize. Plagiarism means using others’ words or ideas without proper acknowledgement. Proper acknowledgement generally means indicating direct quotations with quotation marks  and  providing a citation to the source of any quotation or idea used.

The remaining standards make some less obvious but equally important points. Researchers should not publish the same data a second time as though it were new, they should share their data with other researchers, and as peer reviewers they should keep the unpublished research they review confidential. Note that the authors’ names on published research—and the order in which those names appear—should reflect the importance of each person’s contribution to the research. It would be unethical, for example, to include as an author someone who had made only minor contributions to the research (e.g., analyzing some of the data) or for a faculty member to make himself or herself the first author on research that was largely conducted by a student.

Key Takeaways

• There are several written ethics codes for research with human participants that provide specific guidance on the ethical issues that arise most frequently. These codes include the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.
• The Tri-Council Policy Statement is the ethics code followed by researchers and research institutions in Canada.
• The APA Ethics Code is also an important ethics code for researchers in psychology. It includes many standards that are relevant mainly to clinical practice, but  Standard 8  concerns informed consent, deception, debriefing, the use of nonhuman animal subjects, and scholarly integrity in research.
• Research conducted at universities, hospitals, and other institutions that receive support from the federal government must be reviewed by an research ethics board (REB)—a committee at the institution that reviews research protocols to make sure they conform to ethical standards.
• Informed consent is the process of obtaining and documenting people’s agreement to participate in a study, having informed them of everything that might reasonably be expected to affect their decision. Although it often involves having them read and sign a consent form, it is not equivalent to reading and signing a consent form.
• Although some researchers argue that deception of research participants is never ethically justified, the TCPS 2 and the APA Ethics Code allow for its use when the benefits of using it outweigh the risks, participants cannot reasonably be expected to be harmed, there is no way to conduct the study without deception, and participants are informed of the deception as soon as possible.
• Practice: Read the Nuremberg Code, the Belmont Report, and  Standard 8  of the APA Ethics Code. List five specific similarities and five specific differences among them.
• Practice: Complete the online tutorial for the TCPS 2.
• Discussion: In a study on the effects of disgust on moral judgment, participants were asked to judge the morality of disgusting acts, including people eating a dead pet and passionate kissing between a brother and sister (Haidt, Koller, & Dias, 1993) [5] . If you were on the REB that reviewed this protocol, what concerns would you have with it? Refer to the appropriate core principles in support of your argument.
• Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada. (2010). Tri-council policy statement: Ethical conduct for research involving humans . Ottawa: Interagency Secretariat on Research Ethics. ↵
• Mann, T. (1994). Informed consent for psychological research: Do subjects comprehend consent forms and understand their legal rights? Psychological Science, 5 , 140–143. ↵
• Sieber, J. E., Iannuzzo, R., & Rodriguez, B. (1995). Deception methods in psychology: Have they changed in 23 years? Ethics & Behaviour, 5 , 67–85. ↵
• Baumrind, D. (1985). Research using intentional deception: Ethical issues revisited. American Psychologist, 40 , 165–174. ↵
• Haidt, J., Koller, S. H., & Dias, M. (1993). Affect, culture, and morality, or is it wrong to eat your dog?  Journal of Personality and Social Psychology, 65 , 613–628. ↵

A set of ten principles written in 1947 in conjunction with the trials of Nazi physicians that provided a standard by which to compare the behaviour of the men on trial.

An ethics code that was created by the World Medical Council in 1964, adding that research with human participants should be based on a written protocol.

A detailed description of the research that is reviewed by an independent committee.

Published in 1978 in the United states, this explicitly recognized the principle of seeking justice including the importance of conducting research in a way that distributes risks and benefits fairly across different groups at the societal level.

Ethical Conduct for Research Involving Humans: Canadian code of ethics that must be followed by researchers and research institutions.

A committee that is responsible for reviewing research protocols for potential ethical problems.

The default requirement for research involving humans.

When the likelihood and magnitude of possible harms faced by the participants is no greater than those encountered in in everyday life.

A code first published in 1953 which includes approximately 150 specific ethical standards that psychologists and their students are expected to follow.

A document informing participants of procedure, risks, and benefits of the research that is signed during the process of informed consent.

Includes misinforming participants of the purpose of the study, using confederates, using fake equipment, or presenting false performance feedback.

The process of informing research participants as soon as possible of the purpose of the study, revealing deception, and correcting misconceptions they may have as a result of participating in the study.

Research Methods in Psychology - 2nd Canadian Edition Copyright © 2015 by Paul C. Price, Rajiv Jhangiani, & I-Chant A. Chiang is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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• Study selection:   Give numbers of studies screened, assessed for eligibility, & included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.
• Study characteristics:   For each study, present characteristics for which data were extracted (e.g., study size, PICOs, follow-up period) & provide the citations.
• Risk of bias within studies:   Present data on risk of bias of each study &, if available, any outcome level assessment.
• Results of individual studies:   For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group  (b) effect estimates & confidence intervals, ideally with a forest plot. 
• Synthesis of results:   Present results of each meta-analysis done, including confidence intervals & measures of consistency.
• Risk of bias across studies:   Present results of any assessment of risk of bias across studies.
• Additional analysis:   Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression).

References:

• Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009 Aug 18;151(4):264-9, W64. doi: 10.7326/0003-4819-151-4-200908180-00135. Epub 2009 Jul 20. PMID: 19622511.  https://pubmed.ncbi.nlm.nih.gov/19622511/
• Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009 Aug 18;151(4):W65-94. doi: 10.7326/0003-4819-151-4-200908180-00136. Epub 2009 Jul 20. PMID: 19622512. https://pubmed.ncbi.nlm.nih.gov/1962251 2
• Tricco AC, Lillie E, Zarin W,  et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018 Oct 2;169(7):467-473. doi: 10.7326/M18-0850. Epub 2018 Sep 4. PMID: 30178033.  https://www.acpjournals.org/doi/epdf/10.7326/M18-0850
• Flow Diagram Generator This is an updated version of the original PRISMA flow generator. Includes a downloadable PDF version.
• Flow Diagram (PRISMA) Contains both PDF & Word versions. From PRISMA.

See the EQUATOR network for more guidelines for reporting health research.

As a collaborator on your research team, an informationist can write the methods section of your publication. With an informationist as a co-author you can be confident that the methods section of your paper will meet the relevant PRISMA reporting standards and be replicable by other groups.

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• Indian J Anaesth
• v.60(9); 2016 Sep

Legal and ethical issues in research

Camille yip.

1 Department of Women's Anaesthesia, KK Women's and Children's Hospital, Bukit Timah, Singapore

Nian-Lin Reena Han

2 Division of Clinical Support Services, KK Women's and Children's Hospital, Bukit Timah, Singapore

Ban Leong Sng

3 Anesthesiology and Perioperative Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

INTRODUCTION

The ethical and legal issues relating to the conduct of clinical research involving human participants had raised the concerns of policy makers, lawyers, scientists and clinicians for many years. The Declaration of Helsinki established ethical principles applied to clinical research involving human participants. The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future. Therefore, it is important to be familiar with Good Clinical Practice (GCP), an international quality standard that is provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),[ 1 ] or the local version, GCP of the Central Drugs Standard Control Organization (India's equivalent of US Food and Drug Administration)[ 2 ] and local regulatory policy to ensure that the research is conducted both ethically and legally. In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications. Some of the core principles of GCP in research include defining responsibilities of sponsors, investigators, consent process monitoring and auditing procedures and protection of human subjects.[ 3 ]

ISSUES RELATED TO THE RESEARCH PARTICIPANTS

The main role of human participants in research is to serve as sources of data. Researchers have a duty to ‘protect the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects’.[ 4 ] The Belmont Report also provides an analytical framework for evaluating research using three ethical principles:[ 5 ]

• Respect for persons – the requirement to acknowledge autonomy and protect those with diminished autonomy
• Beneficence – first do no harm, maximise possible benefits and minimise possible harms
• Justice – on individual and societal level.

Mistreatment of research subjects is considered research misconduct (no ethical review approval, failure to follow approved protocol, absent or inadequate informed consent, exposure of subjects to physical or psychological harm, exposure of subjects to harm due to unacceptable research practices or failure to maintain confidentiality).[ 6 ] There is also scientific misconduct involving fraud and deception.

Consent, possibility of causing harm

Based on ICH definition, ‘informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate’. As for a standard (therapeutic) intervention that carries certain risks, informed consent – that is voluntary, given freely and adequately informed – must be sought from participants. However, due to the research-centred, rather than patient-centred primary purpose, additional relevant information must be provided in clinical trials or research studies in informed consent form. The essential components of informed consent are listed in Table 1 [Adapted from ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6(R1)].[ 1 ] This information should be delivered in the language and method that individual potential subjects can understand,[ 4 ] commonly in the form of a printed Participant Information Sheet. Informed consent is documented by means of written, signed and dated informed consent form.[ 1 ] The potential subjects must be informed of the right to refuse to participate or withdraw consent to participate at any time without reprisal and without affecting the patient–physician relationship. There are also general principles regarding risk assessment, scientific requirements, research protocols and registration, function of ethics committees, use of placebo, post-trial provisions and research publication.[ 4 ]

Essential components of an informed consent

Special populations

Informed consent may be sought from a legally authorised representative if a potential research subject is incapable of giving informed consent[ 4 ] (children, intellectual impairment). The involvement of such populations must fulfil the requirement that they stand to benefit from the research outcome.[ 4 ] The ‘legally authorised representative’ may be a spouse, close relative, parent, power of attorney or legally appointed guardian. The hierarchy of priority of the representative may be different between different countries and different regions within the same country; hence, local guidelines should be consulted.

Special case: Emergency research

Emergency research studies occur where potential subjects are incapacitated and unable to give informed consent (acute head trauma, cardiac arrest). The Council for International Organisations of Medical Sciences/World Health Organisation guidelines and Declaration of Helsinki make exceptions to the requirement for informed consent in these situations.[ 4 , 7 ] There are minor variations in laws governing the extent to which the exceptions apply.[ 8 ]

Reasonable efforts should have been made to find a legal authority to consent. If there is not enough time, an ‘exception to informed consent’ may allow the subject to be enrolled with prior approval of an ethical committee.[ 7 ] Researchers must obtain deferred informed consent as soon as possible from the subject (when regains capacity), or their legally authorised representative, for continued participation.[ 4 , 7 ]

Collecting patient information and sensitive personal information, confidentiality maintenance

The Health Insurance Portability and Accountability Act has requirements for informed consent disclosure and standards for electronic exchange, privacy and information security. In the UK, generic legislation is found in the Data Protection Act.[ 9 ]

The International Committee of Medical Journal Editors (ICMJE) recommendations suggest that authors must ensure that non-essential identifying information (names, initials, hospital record numbers) are omitted during data collection and storage wherever possible. Where identifying information is essential for scientific purposes (clinical photographs), written informed consent must be obtained and the patient must be shown the manuscript before publication. Subjects should also be informed if any potential identifiable material might be available through media access.

Providing incentives

Cash or other benefits ‘in-kind’ (financial, medical, educational, community benefits) should be made known to subjects when obtaining informed consent without emphasising too much on it.[ 7 ] Benefits may serve as appreciation or compensation for time and effort but should not result in the inducement to participation.[ 10 ] The amount and nature of remuneration should be compared to norms, cultural traditions and are subjected to the Ethical Committee Review.[ 7 ]

ISSUES RELATED TO THE RESEARCHER

Legal issues pertaining to regulatory bodies.

Various regulatory bodies have been constituted to uphold the safety of subjects involved in research. It is imperative to obtain approval from the appropriate regulatory authorities before proceeding to any research. The constitution and the types of these bodies vary nation-wise. The researchers are expected to be aware of these authorities and the list of various bodies pertinent to India are listed in the article “Research methodology II” of this issue.

Avoiding bias, inappropriate research methodology, incorrect reporting and inappropriate use of information

Good, well-designed studies advance medical science development. Poorly conducted studies violate the principle of justice, as there are time and resources wastage for research sponsors, researchers and subjects, and undermine the societal trust on scientific enquiry.[ 11 ] The Guidelines for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials.[ 1 ]

Fraud in research and publication

De novo data invention (fabrication) and manipulation of data (falsification)[ 6 ] constitute serious scientific misconduct. The true prevalence of scientific fraud is difficult to measure (2%–14%).[ 12 ]

Plagiarism and its checking

Plagiarism is the use of others' published and unpublished ideas or intellectual property without attribution or permission and presenting them as new and original rather than derived from an existing source.[ 13 ] Tools such as similarity check[ 14 ] are available to aid researchers detect similarities between manuscripts, and such checks should be done before submission.[ 15 ]

Overlapping publications

Duplicate publications violate international copyright laws and waste valuable resources.[ 16 , 17 ] Such publications can distort evidence-based medicine by double-counting of data when inadvertently included in meta-analyses.[ 16 ] This practice could artificially enlarge one's scientific work, distorting apparent productivity and may give an undue advantage when competing for research funding or career advancement.[ 17 ] Examples of these practices include:

Duplicate publication, redundant publication

Publication of a paper that overlaps substantially with one already published, without reference to the previous publication.[ 11 ]

Salami publication

Slicing of data from a single research process into different pieces creating individual manuscripts from each piece to artificially increase the publication volume.[ 16 ]

Such misconduct may lead to retraction of articles. Transparent disclosure is important when submitting papers to journals to declare if the manuscript or related material has been published or submitted elsewhere, so that the editor can decide how to handle the submission or to seek further clarification. Further information on acceptable secondary publication can be found in the ICMJE ‘Recommendations for the Conduct, Reporting, Editing, and Publishing of Scholarly Work in Medical Journals’.

Usually, sponsors and authors are required to sign over certain publication rights to the journal through copyright transfer or a licensing agreement; thereafter, authors should obtain written permission from the journal/publisher if they wish to reuse the published material elsewhere.[ 6 ]

Authorship and its various associations

The ICMJE recommendation lists four criteria of authorship:

• Substantial contributions to the conception of design of the work, or the acquisition, analysis or interpretation of data for the work
• Drafting the work or revising it critically for important intellectual content
• Final approval of the version to be published
• Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Authors and researchers have an ethical obligation to ensure the accuracy, publication and dissemination of the result of research,[ 4 ] as well as disclosing to publishers relevant corrections, retractions and errata, to protect scientific integrity of published evidence. Every research study involving human subjects must be registered in a publicly accessible database (e.g., ANZCTR [Australia and NZ], ClinicalTrials.gov [US and non-US], CTRI [India]) and the results made publicly available.[ 4 ] Sponsors of clinical trials must allow all study investigators and manuscript authors access to the full study data set and the right to use all study data for publication.[ 5 ] Source documents (containing trial data) and clinical study report (results and interpretation of trial) form part of the essential documentation that must be retained for a length of time prescribed by the applicable local legislation.[ 1 ] The ICMJE is currently proposing a requirement of authors to share with others de-identified individual patient data underlying the results presented in articles published in member journals.[ 18 ]

Those who have contributed to the work but do not meet all four criteria should be acknowledged; some of these activities include provision of administrative support, writing assistance and proofreading. They should have their written permission sought for their names to be published and disclose any potential conflicts of interest.[ 6 ] The Council of Scientific Editors has identified several inappropriate types of authorship, such as guest authorship, honorary or gift authorship and ghost authorship.[ 6 ] Various interventions should be put in place to prevent such fraudulent practices in research.[ 19 ] The list of essential documents for the conduct of a clinical trial is included in other articles of the same issue.

The recent increase in research activities has led to concerns regarding ethical and legal issues. Various guidelines have been formulated by organisations and authorities, which serve as a guide to promote integrity, compliance and ethical standards in the conduct of research. Fraud in research undermines the quality of establishing evidence-based medicine, and interventions should be put in place to prevent such practices. A general overview of ethical and legal principles will enable research to be conducted in accordance with the best practices.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

ICH E6 (R2) Good clinical practice - Scientific guideline

This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Keywords:  Good clinical practice (GCP), Ethics Committee, investigator, sponsor, protocol, investigator's brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report, clinical trials, innovation, design, ICH E6(R3)

Current version

ICH guideline for good clinical practice E6(R2) - Step 5

Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b

Overview of comments on ICH E6 (R3) guideline

Draft ICH guideline E6 on good clinical practice

ICH guideline for good clinical practice E6(R2) 4 - Step 2b

ICH E6 (R1) guideline for Good Clinical Practice

External links

• ICH E6 (R2) Training on Interpretation and Application developed by Multi-Regional Clinical Trials (MRCT) Centre (see  See ICH E6 (R2) Training on Interpretation and Application under Online Training Programme   - providing link to https://cpd.partners.org/mrct  where registration is required)
• ICH E6 Step 4 presentation (see  ICH E6 Step 4 pr esentation under E6(R2) Good Clinical Practice: WG Presentations / Trainings)
• Overview on ICH E3, E6(R2), E8(R2), E9(R1), E17

Related content

• Clinical efficacy and safety: general
• ICH: efficacy
• Scientific guidelines

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