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Human Research Accreditation Relevant to Anthropology Marjorie A Speers As the executive director of the Association for the Accreditation of Human Research Pro-tection Programs (AAHRPP), I was pleased to see the recent adoption of the AAA Statement on Ethnography and Institutional Review Boards, for which I provided input. Many questions arise when it comes to research review in anthropology, and the statement will be a useful tool for anthropologists and ethnographers to interpret their obligations for review and oversight by IRBs. AAHRPP offers voluntary accreditation to all organizations that conduct or review research involving human participants, and was founded in 2001 by seven national organizations that share a deep commitment to ethical research: Association of American Medical Colleges, Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimen-tal Biology, National Association of State Universities and Land-Grant Colleges, National Health Council and Public Responsibility in Medicine and Research. As of mid-July, AAHRPP had accredited ten organizations, including universities, hospitals and independent review boards. Relevance
to Anthropology The basic ethical principles that govern the conduct and review of research are the same regardless of research type: respect for persons, beneficence and justice. In anthropology, it is often believed that federal regulations for protecting human subjects do not readily apply. But, as AAA has so eloquently reinforced in its recent statement, anthropologists need to be mindful of the principles governing ethical research, as well as the need for certain anthropological research to be reviewed by an IRB. What is important is that the federal regulations—which are taken to reflect ethical principles and standards—be interpreted appropriately for different types of research. The standards for achieving these ethical principles differ according to re-search design and the level and nature of risk associated with a research study. This is where problems with interpretation lie, and is where AAHRPP’s unique position can benefit anthropological research. Self-Assessment Once the self-assessment is submitted to AAHRPP and reviewed, a site visit is scheduled. The site visitors are selected based on the type of organization under review and the breadth of its research portfolio. In the case of a university that conducts a broad array of research, a social scientist would serve on the team. The site visit team will consider several issues: the way the IRB reviews the informed consent process, how it handles consent documentation requirements, and the use of the expedited review process for research involving no more than minimal risk. In social science research, there is both over- and under-interpretation of the regulatory requirements. While the site visit team will look for evidence of over-interpretation, it will also be looking for cases where regulations might be under-utilized, such as in providing privacy protections or in maintaining confidentiality of data. This is the particular value of the accreditation process for anthropological res-earch: the site visit team will look to ensure that the organization appropriately interprets its obligations to protect participants. Value of
Accreditation Moreover, the threat of Congres-sional action could produce an executive branch response, either from the NSF or the Office for Human Research Protections. 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. If your organization is planning to seek AAHRPP accreditation, I encourage you to become involved in the self-assessment process. Many organizations set up teams that cross-cut disciplines to complete the self-assessment. This is an opportunity for social science researchers to have a “seat at the table,” and for their interests and concerns to be clearly heard. Finally, I am aware of organizations’ concerns that accreditation is yet another layer of oversight. Accreditation does require an investment of material and human resources, but I believe the benefits will ultimately make it a worthy return on investment: improved protection programs, an assurance that accredited organizations are in full regulatory compliance, and ultimately, increased public trust in research. I welcome your queries about the AAHRPP accreditation program and encourage you to visit our website, www.aahrpp.org, where complete information is available. Marjorie Speers is executive director of the Association for the Accreditation of Human Research Protection Programs. She served as acting executive director of the National Bioethics Advisory Commission, where she oversaw the development of Ethical and Policy Issues in Research Involving Human Participants, a comprehensive report on the oversight system of protection. Previously, Speers was deputy associate director for science at the Centers for Disease Control and Prevention, where she oversaw all domestic and international research. She has also held faculty positions at the University of Texas Medical Branch at Galveston and the University of Connecticut. |
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