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AAHRPP Is Taking Accreditation Seriously

by Johanna Ebner, Public Information Office

With its ethical standards and principles now established and its institutional accreditation process finalized, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) held its first Council of Accreditation in April of this year and accredited its first institutions in May. AAHRPP, incorporated in April 2001, is a nonprofit organization that provides the means for research institutions voluntarily to become accredited in human research protections.

AAHRPP was spawned by the consequences for universities and research institutions, including for social and behavioral scientists, of increased public and political pressure for scrutiny of basic research that uses humans in research. AAHRPP seeks to do more than ensure compliance. Its plan is to help institutions reach performance standards that surpass the stated goals of state and federal requirements, but by using approaches that are “user friendly” to social and behavioral scientists.

AAHRPP ensures that the interests and needs of the social sciences are reflected in efforts to set or change standards. The Consortium of Social Science Associations (COSSA) is a founding member, and its involvement helps ensure AAHRPP’s representation of the social sciences in standards setting. Three members of the Board of Directors were nominated by COSSA. In addition, the organization incorporates the social sciences through its cadre of site visitors.

Commitment to All Fields

AAHRPP has maintained a commitment to all fields of research. This accreditation principle goes beyond the clinical sciences, according to AAHRPP Executive Director Marjorie Speers. “What I believe is the difference in the principles and standards used in human research accreditation is how one interprets them,” said Speers. “The ethical principles for conducting research remain the same.”

Speers, who has experience in the behavioral and social sciences and a PhD in psychology and epidemiology, believes that it is important for social scientists to constantly be aware of the need for accreditation. There needs to be more discussion within the social sciences she noted, as she pointed out that there are about 3,000 institutions across the United States in need of accreditation.

First Step

The first part of the process towards accreditation involves a thorough self-assessment. The university or research institution is given support and guidance in conducting its own examination of how its current processes work (and fail to) from the bottom up. This self-assessment includes an examination of when and how universities and their Institutional Review Boards (IRB) use available mechanisms to efficiently process minimal risk studies that characterize social science research. The Association then uses a site-visit model employing a rigorous set of performance standards and outcome measures. A team of site visitors chosen by AAHRPP initially evaluates each organization. A site visit team submits a report of its findings to the Council on Accreditation. Many of the site visitors are researchers; half of the researchers are clinical and half are behavioral and social scientists. They review applications and reports, and make determinations regarding accreditation. The Council is chosen by the Board of Directors and consists of experienced site visitors.

AAHRPP is the creation of seven nonprofit founding member organizations representing the leadership of universities; medical schools; teaching hospitals; biomedical, behavioral, and social scientists; and patient and disease advocacy organizations. The founding organizations developed the principles and standards behind AAHRPP, put together the finances, formed the board of directors, and developed the organization’s mission and philosophy.

Human Subjects Are Essential

“Human research participants are critical to the research performed by scientists and scholars in the diverse range of the social and behavioral science,” said Howard Silver, COSSA Executive Officer, in COSSA’s Statement on AHRPP. “Protecting participants’ welfare and dignity should be the primary concern of scientists and scholars. More importantly, protections must be appropriate for risks associated with different types of research…AAHRPP’s accreditation will help to serve the interests of all research participants because AAHRPP has sought the input and views of scientists and scholars from all disciplines in setting its standards.”

In a recent interview with Footnotes, Speers said, “The standards and principles used by AAHRPP were designed to be applicable to research universities, medical schools, government agencies, contract agencies, or anyone doing research involving human participants. The standards are applicable to any and all types of research—behavioral, law, history, business, medical.”

Milestone

AAHRPP reached a milestone in its development when it announced on May 1, that it awarded its first Full AAHRPP Accreditation to the following organizations: The University of Iowa-Iowa City and the Western Institutional Review Board in Olympia, Washington. In June Speers announced in a meeting at ASA headquarters that AAHRPP had just awarded full accreditation to the New England Institutional Review Board.

“We congratulate these organizations in reaching this important milestone,” said Speers. “They sought AAHRPP accreditation because it is the right thing to do. These organizations demonstrated, both through the self-assessment and site visit processes, that that they take their ethical commitments very seriously, and that participant protection is one of their top priorities.”

Because AAHRPP was formed at the initiative of the research community, this community demonstrated its willingness to take human research seriously, said Speers. “What makes it superior is that it is a voluntary accreditation and not government run. Being voluntary shows a commitment to self-regulation by research institutions to maintain as high standards as possible.”

Being non-governmental ensures the highest confidentiality permitted on discussing human research practices, which builds public trust. In addition to improving research quality, the dedication and high standards applied to the research institutions by AAHRPP reassures research participants of their well-being. The accreditation process is peer-driven and includes an internal and external assessment in order to identify deficiencies.

“We help organizations interpret the federal regulations and give them recommendations. For example, if an organization does not use ‘exemption’ we encourage them to do so,” said Speers. “We have done a lot with informed consent. We help institutions know when to waive the right to informed consent.”

AAHRPP’s vision is to be recognized nationally and internationally as an organization that improves the protections of research participants and facilitates all types of research. They strive to be the program of choice for all organizations seeking accreditation of their human research protection programs. Through its unbiased and confidential accreditation process, AAHRPP is committed to continual improvement of its own programs and the programs of accredited organizations. AAHRPP accreditation is valid for three years. Accredited organizations submit annual reports to the Association on the status of their human research protection programs. To become accredited through AAHRPP or to become a site visitor, visit www.aahrpp.org.