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Introduction: Report of the APA's Task Force on Research Ethics
Paul S. Appelbaum, M.D.; Laura Weiss Roberts, M.D., M.A.
Psychiatric Services 2006; doi: 10.1176/appi.ps.57.4.550

Dr. Appelbaum is professor of psychiatry and director of the division of psychiatry, law, and ethics in the department of psychiatry at Columbia University College of Physicians and Surgeons in New York. Dr. Roberts is Charles E. Kubly professor and chairman in the department of psychiatry and behavioral medicine and professor of bioethics at the Medical College of Wisconsin in Milwaukee.

Psychiatrists in our society are entrusted with the professional responsibility of caring for people with mental illnesses, a very large, diverse, and often disadvantaged population. Psychiatric researchers assume the additional responsibility of pursuing new knowledge about the nature of mental illnesses and their effective treatment (1). Taken together, these efforts seek to address and relieve suffering associated with psychiatric diseases, now and in the future.

Important as the goal of alleviating the burden of mental illnesses may be, it is tempered by appreciation that the psychiatrist's role as clinician and human researcher represents a privilege conferred on our profession by our society (2). This privilege is predicated on certain expectations—namely, that as psychiatrists, we will articulate, uphold, and ensure the ethical commitments inherent in the work we do in support of the public good. The report of the American Psychiatric Association's task force on research ethics (3), which appears in this month's issue of Psychiatric Services, reflects recognition by organized psychiatry that the ethical conduct of research with human participants is essential for continued progress in our field. If that recognition can be said to have been implicit among psychiatric researchers in the past, in the contemporary ethical and policy environment such tacit understandings are no longer adequate. Rather, it is critical that we openly discuss and embrace our ethical commitments, as the task force report has done. For this reason, it represents an important milestone for psychiatry.

The task force document is a valuable resource for many different stakeholders in psychiatric research. Psychiatric researchers themselves constitute the first group for whom the formulation of explicit ethical principles of research is crucial. The research community has long been accustomed to implementing the basic requirements of ethical research embodied in the applicable federal regulations (1,4,5,6). These requirements include use of appropriate research designs and methods; careful assessment of risks in light of potential benefits, with minimization of risks whenever possible; and the informed consent of decisionally capable volunteers or their legally authorized surrogates, among others. Even a casual observer could not doubt the centrality of the governing paradigm of research ethics to the current research scene.

Life, however, has a way of giving rise to complexities that make the straightforward application of federal regulations difficult. Similarly, it is often challenging to see how best to translate the elegant principles of the Belmont Report into everyday research activities. Of course risks should be minimized, but does that permit or rule out the use of placebos when partially effective interventions exist (7)? How do the ethical commitments of psychiatry shape the acceptability of certain experimental designs and protocol procedures? And yes, volunteers must be informed of the key elements of the study, risks and benefits, alternatives, and other relevant information. Yet when it seems clear that the more participants are told, the less they comprehend and the more dependent they appear on their physicians' recommendations, how does one decide the correct amount of information to reveal?

Hence there is a sincere need for an ongoing engagement of the research community—not just in terms of reflecting on the principles of ethical research but also with the application of those abstract ideas to the earthy dilemmas that arise in the pursuit of incremental knowledge. That confrontation best occurs in public dialogue, as the research community and others who are concerned with the way research participants are treated—including the participants themselves and their families—deal with the nuances of translating ethical concepts to daily life in the research unit or clinic (8). With the constant development of new research questions, which bring the promise of new benefits but also often pose new or uncertain risks, this process is not one that can be completed and placed aside. The task force report thus should be seen first as a call for the research community to think through and debate these issues in a thoughtful, open, and continuous manner.

A second group for whom this report is material is persons who volunteer for studies that are aimed at expanding our knowledge of psychiatric disorders. Typically, these participants suffer from the illnesses being studied, but not infrequently their family members or members of the general public are recruited as well. Because participants who enter research studies often give up the single-minded fidelity to their treatment interests that marks the best clinical treatment and usually assume additional risks, they are understandably eager to know that researchers are committed to acting in accord with generally agreed-upon ethical norms. The task force report declares psychiatry's vow to abide by those norms and invites research participants to join the discussion about appropriate means and ends.

Without the support of policy makers, funding for research would diminish and advances in knowledge would be neglected. Thus government and private funders of psychiatric research are a third group for which the task force report should be meaningful. Legislators, government administrators, philanthropists, and others who support research endeavors understandably have been concerned at times in the past over allegations of abuses in psychiatric and other medical research. The task force report speaks to the desire of the profession to ensure that any unfortunate behaviors that may have occurred in the past are not repeated. The report also speaks to psychiatry's determination to confront new problems as they arise in a transparent and inclusive fashion. Such a pledge is vital for the continued alliance between our political leaders and our research community.

What about the majority of mental health professionals who are clinicians, not researchers? Why is this report important for them? No one dealing with the consequences of mental illness today can fail to recognize the imperfect nature of so many of our interventions. Advances depend on systematic research, which can only occur when its ethical foundations are firm. Hence clinicians too should find reassurance for the future in psychiatry's recognition of its ethical obligations to the research participants who sacrifice so that others may benefit. The task force report invites all these groups into the discussion, and thus it represents the start of a conversation and not its culmination.

Roberts LW: Ethics and mental illness research. Psychiatric Clinics of North America 25:525-545, 2002
 
Institute of Medicine: Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC, National Academies Press, 2001
 
American Psychiatric Association task force on research ethics: Ethical principles and practices for research involving human participants with mental illness. Psychiatric Services 57:552-557, 2006
 
Levine RJ: Ethics and Regulation of Clinical Research. Baltimore, MD, Urban and Schwartzenburg, 1986
 
Brody B: The Ethics of Biomedical Research: An International Perspective. New York, Oxford University Press, 1998
 
Pinals DA, Appelbaum PS: Ethical aspects of neuropsychiatric research with human subjects, in Neuropsychopharmacology: The 5th Generation of Progress. Edited by Davis KL, Charney D, Coyle JT, et al. Philadelphia, Lippincott Williams and Wilkins, 2002
 
Carpenter W, Appelbaum PS, Levine R: The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia. American Journal of Psychiatry 160:356-362, 2003
 
Appelbaum PS: Rethinking the conduct of psychiatric research. Archives of General Psychiatry 54:117-120, 1997
 
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References

Roberts LW: Ethics and mental illness research. Psychiatric Clinics of North America 25:525-545, 2002
 
Institute of Medicine: Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC, National Academies Press, 2001
 
American Psychiatric Association task force on research ethics: Ethical principles and practices for research involving human participants with mental illness. Psychiatric Services 57:552-557, 2006
 
Levine RJ: Ethics and Regulation of Clinical Research. Baltimore, MD, Urban and Schwartzenburg, 1986
 
Brody B: The Ethics of Biomedical Research: An International Perspective. New York, Oxford University Press, 1998
 
Pinals DA, Appelbaum PS: Ethical aspects of neuropsychiatric research with human subjects, in Neuropsychopharmacology: The 5th Generation of Progress. Edited by Davis KL, Charney D, Coyle JT, et al. Philadelphia, Lippincott Williams and Wilkins, 2002
 
Carpenter W, Appelbaum PS, Levine R: The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia. American Journal of Psychiatry 160:356-362, 2003
 
Appelbaum PS: Rethinking the conduct of psychiatric research. Archives of General Psychiatry 54:117-120, 1997
 
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