ALSO IN THIS ISSUE
Human Research Protection Programs Accreditation and Oversight – Can it Help With Your IRB?
Editor's comment: As we talk with our colleagues and listen about research issues, one of the most frequent concerns is IRB regulation and oversight. Psychologists - whose research comprises the vast majority of behavioral and social science research that comes under IRB purview - have varied experiences with their IRBs. Over the last several years there has been a move to accredit institutional oversight processes, analogous to the current accreditation of animal research laboratories. We asked Marjorie Speers, the Director of one of the organizations chartered to develop accreditation services, to discuss how accreditation might benefit behavioral and social sciences research.
Many of you may have heard of AAHRPP ("ay-harp") - the Association for the Accreditation of Human Research Protections. But you may not know just what AAHRPP does, nor why its activities are likely to benefit psychologists whose research comes under IRB review.
AAHRPP is an organization, founded in 2001, whose mission is to offer a voluntary accreditation program for institutions responsible for overseeing research involving human participants. Since May 2003, ten organizations have been accredited, including universities, hospitals, and independent review boards.
AAHRPP was founded by seven national organizations committed to the ethical conduct of human research, including the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), the Federation of American Societies of Experimental Biology (FASEB), National Association of State Universities and Land Grant Colleges, National Health Council, Public Responsibility in Medicine and Research (PRIM&R), and the Consortium of Social Science Associations (COSSA) of which APA is a member. COSSA's involvement helps ensure that AAHRPP's philosophy and program are friendly toward psychology and other behavioral and social sciences and that its accreditation standards cover the range of non-biomedical human participants research. In addition, every effort is made to ensure that the behavioral and social sciences are represented in AAHRPP's administration, Board of Directors, Council on Accreditation, and in the site visit teams.
Why are AAHRPP and its programs good for psychological science? Many of you may wonder how another level of oversight could be a good thing, or how accreditation and its accompanying institutional self-study and evaluation could benefit the behavioral sciences.
There is a widely held belief that the federal regulations for protecting human subjects are not readily applicable to psychological research because they were developed largely in response to highly publicized clinical research abuses and are used and interpreted under a biomedical framework. Of course, the basic ethical principles that govern the conduct and review of research are the same regardless of the type of research - i.e., the principles of respect for persons, beneficence, and justice do not change with research design. Whether conducting a psychological experiment involving students, interviews with adults, or a secondary analysis of existing identifiable data, investigators must respect individuals as human beings and protect their rights and welfare.
However, the standards for achieving these ethical principles do differ according to research design and the level and nature of risk associated with the study. And this is where the problem lies. The federal regulations, which are taken to reflect the ethical principles and standards, must be interpreted appropriately for different types of research. And, here is where AAHRPP's unique position can benefit behavioral research.
As both Director of AAHRPP and as a psychologist I am well aware of the psychology community's concerns about research oversight issues broadly, and how they relate to voluntary accreditation in particular. Behavioral scientists have understandable concerns about research review and the IRB process. However, these concerns can be addressed with positive outcomes through the AAHRPP accreditation process.
The accreditation process involves a lengthy period of information gathering and self-assessment, for which AAHRPP provides guidance that promotes high-quality practices. Institutions can thus improve their practices on the way to accreditation. Each accreditation involves at least one site visit by a team that always includes a behavioral or social scientist when there is behavioral/social science research at the institution. When examining a broad research portfolio at a university, the site visit team considers a number of issues, including whether the local IRB interprets the accreditation standards according to the different types of research being conducted. The site visit team will look at the way the IRB reviews the informed consent process, handles consent documentation requirements for behavioral and social science research, and the use of the expedited review process for research involving no more than minimal risk.
In all research, there can be both over and under-interpretation of the regulatory requirements. In addition to looking for instances of over-interpretation, the site team also looks at areas where regulations might be under-utilized, such as in providing privacy protections or in maintaining confidentiality of data. In reviewing an organization that conducts behavioral research, the site visit team's goal is to ensure that the organization appropriately interprets its obligations to protect participants.
Why is voluntary accreditation beneficial to behavioral/social sciences? By ensuring that behavioral and social scientists play a part in the review and accreditation process, another valuable aspect of voluntary accreditation is that it offers a set of national standards that organizations can strive to meet, and that can be consistently interpreted. In addition, voluntary accreditation will leave the oversight process in the hands of institutions and scientists - AAHRPP was founded during a period of intense scrutiny of research programs, and lawmakers' interest in further regulating in this arena has not yet abated. If the research community can demonstrate a commitment to self-regulation, the less likely it is that members of Congress will respond in ways we fear may be truly restrictive and burdensome. The research community's willingness to meet a set of national standards is likely to convince those responsible for regulation and guidance that more is not needed.
Although accreditation is yet another layer of oversight, and does require an investment of material and human resources, its benefits may make it a worthy return on investment. In addition to improved protection programs, assurance that accredited organizations are in full regulatory compliance, and ultimately, increased public trust in research, the accreditation process allows the research community to define and aspire to its own best practices.
I welcome your queries about the AAHRPP accreditation program, and encourage you to visit the AAHRPP web site, where complete information about the program is available.