IRBs and the Review of Psychological Research

Relevant Internet Sites

Federal Office for
Human Research Protections
Department of Health and Human Services

http://ohrp.osophs.dhhs.gov/

Federal Regulations
http://ohrp.osophs.dhhs.gov/
humansubjects/guidance/45cfr46.htm

FAQ’s on the Requirement for Education on the Protection of Human Subjects in Research
http://grants.nih.gov/grants/
policy/hs_educ_faq.htm

National Bioethics
Advisory Commission

http://bioethics.gov/cgi-bin/bioeth_counter.pl

IRB … Mention these three little letters at any gathering of researchers, then stand back – you’re in for an intense discussion about a complex, convoluted, and confusing system that often doesn’t seem very systematic.

For the uninitiated, they’re not talking about the International Rugby Board, the Institute of Radiation Breeding, the Irish Republican Brotherhood, or the Insitut Ruder Boskovik. IRB stands for Institutional Review Board – the committee at your university that reviews research proposals in order to ensure adequate protections for the people who will be the participants in the research.

The dissatisfaction around IRBs doesn’t involve the need to ensure the well-being of people who are participating in scientific studies per se – scientists support the principles of protection for research subjects. What bugs researchers is the way IRBs operate.

IRBs are on the front line of federal regulation of science, but they are not federal entities. IRBs are established and maintained by individual universities and other entities that receive research support from any federal agency.

IRBs are charged with carrying out the requirements set forth in Title 45 of the Code of Federal Regulations Part 46 (45 CFR 46). It is the local application of these regulations that seems to generate the most heat around IRBs. As noted by the National Bioethics Advisory Committee (NBAC) in its draft report on ethical and policy issues in human subjects research: “Although IRBs are broadly charged with ethical review, in practice they must fulfill many procedural requirements.”

Many of the frustrations about IRBs are universal, cutting across all scientific disciplines. Among the usual list of concerns are: A lack of standard procedures and requirements among IRBs, differences in the scope of authority exerted by different IRBs, delays in review, and even the qualifications of IRB members. Researchers also fear that institutional and disciplinary politics come into play in IRB review of their proposals. On this last point, for example, some researchers believe that institutions use IRBs more to protect the institution from litigation than to enforce ethics or regulatory requirements.

According to a draft report by the American Association of University Professors, “The government’s system for regulating research involving human subjects was born out of fear that researchers might, whether wittingly or not, physically or mentally injure the human beings that they study. The government’s system is meant, therefore, to limit professional choice insofar as it might otherwise result in harm to human subjects.”

“In pursuit of this aim,” notes the draft report, which is posted on the AAUP website (www.aaup.org), “the government imposes a regulatory burden on research institutions and their individual researchers. Whether the burden is reasonable depends upon several considerations, not the least of which is the application of the government’s rules to disparate academic fields of study, each with its own concepts and methods of research and standards of professional responsibility.”

The AAUP report was developed jointly by representatives of several social science organizations and focuses primarily on the experience of scientists from those disciplines in dealing with IRB review of their research. It reflects many of the widely held views in the behavioral and social sciences that IRBs are not geared toward the methods and topics addressed in their research.

THE BIOMEDICAL MODEL
Psychologists and others who conduct behavioral and social science research face a number of unique concerns in IRB review. Most of these are related to the fact that IRBs and the regulations that govern them generally are based on a biomedical model of research. For example, IRBs are charged with determining risk to participants in a particular study. But what the regulators had in mind when they developed this mandate was physical risk. Determining whether there might be psychological or other non-physical risks from behavioral and social science research is comparatively difficult, and that difficulty is exacerbated both when the review is conducted by people who are unfamiliar with the sciences or if the behaviors being studied are sensitive or are considered to be in the realm of moral or value-laden topics.

Another difficult area is informed consent: how do you get consent from children, or from people whose judgement may be impaired due to mental illness? Again, these questions are made more difficult when addressed by people who are not familiar with the field of research.

Many scientists also have voiced the concern that in addressing behavioral and social science research, IRBs sometimes go beyond the scope of their mission; that they look at protocols, methodology or research design. This can delay review or possibly even result in rejection of a proposal based not on issues of protecting human subjects but rather on unrelated aspects of the study.

A PLETHORA OF HOME PAGES
One thing is certain: There’s no lack of information or discussion about IRBs or the ethics and other aspects of research involving human subjects. A random look on the Internet (just type IRB on the address line) reveals a plethora of IRB home pages, here and abroad. Institutions have their own policies, their own review and submissions requirements, and often have multiple IRBs with jurisdiction over a research proposal, which poses problems for studies that involve multiple sites even if all the site are within the same institution.

At the national level, there is movement on several fronts to address many of the general concerns voiced by the research community regarding the system of protections for human subjects in research. The most notable effort is the NBAC report mentioned above, although a complementary study by the Institute of Medicine is looking at human subjects protections in research, including issues around the accreditation of human research review programs.

NBAC’s upcoming report is likely to be the most comprehensive in scope of any current initiative. It will contain recommendations for sweeping changes in the system of protections for humans in research, and at least in the drafting stages, includes ethical requirements to research conducted in other countries.

In the public draft of its report, NBAC acknowledges some of the difficulties facing some kinds of behavioral and social science research:

As the behavioral and social determinants of more diseases are known (e.g., AIDS, lung cancer, heart attack, stroke), the focus of intervention strategies has broadened from the individual to the population, and the research setting has in some cases moved into the community…. For example, research on cigarette smoking once focused on cessation efforts, and interventions were targeted at individuals…. Now, with the emphasis on prevention of smoking behavior, research interventions are often targeted at particular populations and carried out at the community level…. With such community-oriented research interventions, defining the research participants and identifying the appropriate participant protections can be challenging.

The immediate future of the NBAC report is somewhat indefinite, only because the panel was convened under the Clinton Administration, and is set to go out of business in the Fall. NBAC will transmit its recommendations to the National Science and Technology Council, which also may or may not continue to exist under the Bush Administration.

But the issues addressed by NBAC, and the debate and discussion on IRBs more generally, will continue regardless of any changes in the policy making processes. It is critical that the concerns of psychological researchers be articulated in any administrative and legislative deliberations on IRBs.

As a first step, APS wants to encourage discussion within the field. With this in mind, we invite your comments and observations about your IRB experiences, whether it is serving on a review committee, having your research reviewed by an IRB, or any other aspect of your experience. Issues that are unique or particularly relevant to psychological science are especially important.

Please write to us at apsobserver@aps.washington.dc.us. And look for more information on behavioral science and IRBs in upcoming issues of the Observer.

Observer Vol.14, No.3 March, 2001

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