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Informed Consent

National and International Principles and Regulations Governing Human Research Participants

National and International Principles and Regulations Governing Human Research Participants

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

 

Published in 1979, the Belmont Report lays out the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects in the U.S.

 

Declaration of Helsinki

 

Developed by the World Medical Association, this statement has largely replaced the Nuremberg Code as the current international standard for experimentation using human subjects.

 

Federal Policy for the Protection of Human Subjects (Common Rule)

 

Legislation adopted by the United States governing all research involving human subjects done by or funded by federal departments or agencies.

 

International Ethical Guidelines for Biomedical Research Involving Human Subjects

 

Developed by the Council for International Organizations of Medical Sciences, these guidelines lay out internationally-accepted standards for research involving human subjects.

 
 

This statement arose from the Nuremberg Military Tribunal after WWII. It states that human experimentation is only justifiable if its results benefit society, and if it is carried out in accord with basic ethical and legal principles.

 
 
Web Sites
 

Protecting Human Subject Research Partcipants

 

This online training program has been put together by the U.S. National Institutes of Health to introduce research teams to the basic guidelines and regulations governing research involving human subjects. Must register to view.

 
 

Put together by the National Institutes of Health Bioethics Library, this is a listing of guidelines, opinions, and regulations on the use of human tissue samples in research.

 

The Ethics of Research on Vulnerable Populations

 

This online resource includes a number of good case studies on research involving vulnerable populations, such as children, the mentally ill, and prisoners.

 
 

The U.S. OHRP is charged with interpreting and overseeing the implementation of all regulations regarding the protection of human subjects. Includes links to ethical guidelines and regulations, fact sheets, and policy statements of the NIH.

Books

Berg, Jessica W, Paul S. Appelbaum, Charles W. Lidz, and Lisa S. Parker. 2001. Informed Consent: Legal Theory and Clinical Practice New York: Oxford University Press, 2001.

This volume, co-written by a lawyer, a physician, and a social scientist, takes an in-depth look at the concept of informed consent. It looks at the legal requirements for professionals in obtaining informed consent, the history of informed consent, and ethical issues that arise around informed consent in the doctor-patient relationship.

Darby, Mary and Gerry McGlynn. Informed Consent for Human Subjects: A Primer. Boston: Management Decision and Research Center, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs, 2002.

This publication provides an overview of informed consent, pertinent regulations, and the process of obtaining consent from potential research participants for research done under the jurisdiction of the U.S. Department of Veterans Affairs.

Emanuel, Ezekiel J. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore: Johns Hopkins University Press, 2003.

This well-written volume includes a large number of essays looking at all different ethical aspects of clinical research involving human participants.

Federman, D.D. et al. 2002. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, D.C. , National Academies Press.

This book outlines a three-pronged approach to ensure the protection of research participants through the establishment of effective Human Research Participant Programs. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards.

Gostin, Lawrence O. and Cori Vanchieri. Ethical Considerations for Research Involving Prisoners. Washington D.C.: National Academies Press, 2007

This report looks at the ethical considerations related to research involving prisoners, and the special protections needed for prisoner participants in research because of the restrictions placed on their liberty and autonomy.

Kahn, J.P., A.C. Mastroianni, and J. Sugarman, eds. 1998. Beyond Consent: Seeking Justice in Research. New York: Oxford University Press.

Surveying the history of the use of human participants in research, this book examines aspects of justice in research. The author looks at the need to expand access to potentially beneficial research to all members of society, concerns about the exploitation of research participants, and the need for research ethics and institutional review boards to be more sensitive to the needs of marginalized persons. While this book focuses on medical research, many of the issues dealt with apply es to almost all research involving human participants.

Manson, Neil C. and Onora O’Neill. 2007. Rethinking Informed Consent in Bioethics. New York: Cambridge University Press.

The authors of this volume look at the issue of trying to set defensible and feasible standards for informed consent in research. They look at the reasons why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethical better. Instead, the authors argue for a more flexible idea of informed consent that is negotiated through accurate, honest communication between the doctor/researcher and the patient.

National Bioethics Advisory Commission (NBAC). Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. 2 vols. Rockville, MD: U.S. Government Printing Office, 1999. To view full text click here and scroll down to find full text of report

This report discusses ethical issues raised in the use of human biological materials (cells collected through biopsies, organs and tissues removed during surgeries) for research purposes. It talks about issues related to notifying individuals about the use of their specimens, as well as privacy, and intellectual property issues related with the use of these specimens for biomedical research purposes.

---. Ethical and Policy Issues in Research Involving Human Participants. Volume I: Report and Recommendations of the National Bioethics Advisory Commission, Full Report. [Ch. 4: “Assessing Risks and Potential Benefits and Evaluating Vulnerability”]. Volume II: Commissioned Papers. Bethesda, MA: NBAC, 2001.

 

This is the final report and related papers from the U.S. National Bioethics Advisory Commission laying out best practices for the use of human participants in research. Discusses issues of informed consent, working with vulnerable populations, the role of Institutional Review Boards and issues surrounding the ongoing monitoring of research involving human participants.

 

Penslar, R. L. and the U.S. National Institutes of Health, Office for the Protection of Human Subjects in Research. 1993. Protecting Human Subjects: Institutional Review Board Guidebook. Washington, D.C.: Gocernment Printing Office.

 

This is the official guidebook for institutional review boards (IRB)in charge of reviewing federally-funded projects involving human research subjects. The guidebook covers regulations and policies, the duties of an IRB, scientific research design and ethical considerations raised by these designs and techniques, and special classes of research subjects that merit an enhanced level of protection.

Shamoo, Adil E. and Felix A. Khin-Maung-Gyi. 2002. Ethics of the Use of Human Subjects in Research. New York, Garland Science.

Provides a practical introduction to ethical issues of human participants in research.

Vanderpool H.Y. 1996 The Ethics of Research Involving Human Subjects: Facing the 21st Century. Frederick, Maryland, University Publishing Group.

A collection of essays discussing the complex issues of research involving human participants, including research ethics and regulations, conflicts of interest, cross-cultural research, and critical issues in specialized areas of research, such pediatric and genome research.

Journal Articles

Appelbaum, Paul S, Charles W. Lidz, and Robert Klitzman. 2009. Hastings Center Report 39(1):30-39.

Discusses the concept of informed consent in research, especially in terms of voluntariness and questions of impairment in giving consent. The authors look at the legal model of informed consent to try and define these elusive terms.

Bok, S. 1995. Shading the truth in seeking informed consent for research purposes. Kennedy Institute of Ethics Journal, 5(1): 386-388.

The author argues that what some researchers take to be a simple trade-off between minor violations of the truth in recruiting research participants, represents a profound miscalculations with far-reaching and cumulative ethical issues raised. Truth-telling in research projects is important not only to the integrity of that individual’s project but also for the fragile research environment in its own right.

Dickert, Neal W. 2009. Re-examining respect for human research participants. Kennedy Institute of Ethics Journal. 19(4): 311-338.

The author re-examines the concept of respect for persons when conducting clinical research and discusses that this cannot just be reduced to autonomy, there are many was to show respect for a person. He argues that along with autonomous agency, respect demands attention to important subjective experiences, a person’s existence as a part of a community, and considerations of comportment.

Erikkson, Stefan, Anna T. Hoglund, and Gert Helgesson. 2008. Do ethical guidelines give guidance? A critical examination of eight ethics regulations. Cambridge Quarterly of Healthcare Ethics. 17(1) 15-29.

As an example of how biomedical legislations and guidelines are not very useful tools for the development of ethical competence, the author looks at eight ethical guidelines on obtaining informed consent and shows how complications can arise when these kinds of guidelines are used by themselves to guide ethical behavior and develop ethical competence.

Eckenwiler, Lisa. 2001. Moral Reasoning and the Review of Research Involving Human Subjects. Kennedy Institute of Ethics Journal. 11(1): 37-69.

 

The author argues that the model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants as it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The author looks at instances where the current review model falls short, and suggests a number of solutions, including the need for effective consultation with the various communities affected by research and greater reliance on subject representatives.

Edwards, Sarah J. L. 2005. Research Participation and the Right to Withdraw. Bioethics 19(2): 112-30.

This author discusses the right of human participants in research have to withdraw from a study at any time, and why this right to withdraw should not be unconditional. It instead, the author suggests, should be an ongoing set of negotiations between the patient and researcher.

Gerlach, Julie Waltz. 2002. What should IRBs consider when applying the privacy rule to research? Kennedy Institute of Ethics. 12(3): 299-303.

 

Discusses relevant regulation involving the protection of information about human participants in research, and participants’ rights regarding the use of that information.

 

Gostin, Lawrence O. 2007. Biomedical Research Involving Prisoners. JAMA: Journal of the American Medical Association 297(7): 737-740.

 

Discusses the history , ethics and regulatory issues involved when using prisoners in biomedical research. Suggests safeguards that should be put in place to promote responsible research and to reduce risks to participating prisoners.

Grady, Christine. 2001. Money for Research Participation: Does it Jeopardize Informed Consent? The American Journal of Bioethics. 1(2): 40-44.

This article explores the idea that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent.

Huntington, Ian and Walter Robinson. 2007. The Many Ways of Saying Yes and No: Reflections on the Research Coordinator’s Role in Recruiting Research Participants and Obtaining Informed Consent. IRB: Ethics and Human Research 29(3): 6-10.

This article contains a qualitative report and reflections of a research coordinator working on recruiting research participants for two minimal risk studies involving children and adults with cystic fibrosis. She discusses the challenges of obtaining informed consent, and some strategies to overcome these challenges without pressuring someone into participating in the study.

Iltis, Ana. 2006. Lay Concepts in Informed Consent to Biomedical Research: The Capacity to Understand and Appreciate Risk. Bioethics 20(4): 180-90.

This paper examines the relationship between the obligation to disclose information regarding risks in informed consent, and the requirement that persons have the capacity to understand and appreciate the information. As a normal person often has a limited capacity to comprehend the risk involved in research, some research projects should require human participants to have a higher than normal ability to appreciate risk in order to give consent to participate.

Joffe, Steven. 2006. Altruistic Discourse and Therapeutic Misconception in Research Informed Consent. American Journal of Bioethics 6(5): 53-54.

Discusses misconceptions patients involved in research can have about the benefits of the research they are participating in.

Kishore, R.R. 2006. Biomedical Research and the Mining of the Poor: The Need for their Exclusion. Science and Engineering Ethics. 12(1): 175-183.

This article looks at the adequacy of international guidelines on the use of human subjects in research, and their adequacy in protecting the poor against exploitation. The author concludes that given failure of ethical guidelines in protecting the extreme vulnerability of this population, they should be excluded from being enrolled as research subjects.

Kottow, M. 2004. The Battering of Informed Consent. Journal of Medical Ethics 30(6): 565-569.

The author argues that thought autonomy has been hailed as the foremost principle of bioethics, the voluntary participation of research participants is being subject to frequent restrictions, often in the form of paternalism by doctors. The author discusses why this is a major problem in clinical research, and why bioethics should insist on reinforcing autonomy in these settings.

Kristinsson, S. 2007. Autonomy and Informed Consent: A Mistaken Association? Medicine, Healthcare and Philosophy 10(3): 253-264.

This essay explores the importance of informed consent in efforts to improve regulatory frameworks for research ethics, and explores reasons why informed consent is so important in the responsible conduct of research involving human subjects. The author uses ethical theory to explore informed consent, and concludes that the justification for informed consent should be along the lines of Kantian autonomy and not individual autonomy.

Levine, Carol. Ruth Faden and Christine Grady. 2004. The Limitations of ‘Vulnerability’ as a Protection for Human Research Subjects. American Journal of Bioethics 4(3): 44-86.

This article examines the concept of vulnerability in research ethics, and discusses how different regulations and policy documents have dealt with the concept of vulnerability, either as an inability to give informed consent or emphasizing unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. Because so many groups are now considered to be vulnerable, the term has lost its force, and it may not adequately protect certain subjects from harm. The author calls for the use of regulation to protect these groups, but also for researchers to pay attention to characteristics of the research protocol and environment that present ethical challenges.

Miller, Franklin F., John P. Gluck and David Wendler. 2008. Debriefing and Accountability in Deceptive Research. Kennedy Institute of Ethics Journai18(3):235-251.

This article discusses the importance of the debriefing requirement for human research involving the use of deception.

Newton, Sam K. and John Appiah-Poku. 2007. The Perspectives of Researchers on Obtaining Informed Consent in Developing Countries. Developing World Bioethics 7(1): 19-24.

This study focuses on a series of interviews done with 12 lecturers and doctoral students who had carried out research in developing countries at a leading school of public health in the UK. The researchers found that though the concept and application of the doctrine of informed consent should have been the same regardless of place, the researchers had needed to take into consideration the setting the research was to be conducted in, the autonomy of the patient, and the need to develop innovative ways to carry out the study taking into consideration the circumstances of the environment.

Sharpe, Richard R. and Morris W. Foster. 2007. Grappling with groups: protecting collective interests in biomedical research. Journal of Medicine and Philosophy 32(4):321-337.

This article looks at strategies for protecting historically disadvantaged groups in the context of genetic research, and discusses the benefits and drawbacks of these strategies.

Weijer, Charles M. 2001. The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation . Ethical and Policy Issues in Research Involving Human Participants. Volume II: Commissioned Papers. P1 – P29. Washington, D.C.: National Bioethics Advisory Commission.

Weijer, Charles M. 1999. Research Involving the Vulnerable Sick. Accountability in Research 7: 21–36.

Discusses challenges associated with research involving the vulnerable sick, including deciding who among the ill count as vulnerable, and the need to include protections, including enrolling subjects in a study only with a strong justification, ensuring that consent is free and comprehending, and setting limits on the risk to which they may be asked to endure.

Weijer, Charles and Ezekiel J. Emanuel. 2000. Protecting Communities in Biomedical Research. Science 289 142-44.

Authors discuss the need to establish standards for the protection of communities involved in biomedical and genetics research, and lays out a five-step plan for designing these sorts of protections.

Wendler, Dave. 1998. When Should ‘Riskier’ Subjects Be Excluded from Research Participation? Kennedy Institute of Ethics Journal 8(3): 307-327.

The exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This article seeks to fill this gap by giving a a specific account of a "condition on inclusion risks" (CIR), a condition under which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.

Wendler, David and Jonathan E. Rackoff. 2001. Informed Consent and Respecting Autonomy: What’s a Signature Got to Do with It? IRB: Ethics and Human Research 23(3): 1-4.

Wilkinson, T.M. 2001 Research, Informed Consent, and the Limits of Disclosure. Bioethics 15(4): 341-363.

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. This includes informing research participants about researchers' personal characteristics and views, whenever they are relevant to the research being done, as well as always being informed about who is sponsoring the research.

Developed for the National Academy of Engineering, Online Ethics Center. Last updated 5/4/2010