Tuesday, September 6, 2011

AAHRPP Accreditation Benefits Researchers

Researchers sometimes harbor misperceptions that AAHRPP accreditation leads to more requirements and to increased work for them. In reality, accreditation has benefited researchers by making human research protection programs more efficient, flexible, standardized, and responsive.

AAHRPP accredits organizations according to the regulations and guidance they follow, and it looks for flexibility within those regulations. A common site visit finding is that research involving no human participants, such as analysis of anonymized data sets, is categorized as exempt, and yet in some organizations the IRB initially and continually reviews the research. Such research does not need to be reviewed by an IRB. Flexibility comes into play as well with waivers of the consent process or waivers of the requirement to document consent. When U.S. federal regulations (e.g., 45CFR46) do not apply, AAHRPP organizations provide equivalent protections that may be more appropriate for the type of research being conducted. For example, pregnant woman participating in social science research might be better protected by equivalent standards than by the regulatory requirements found in Subpart B.

AAHRPP encourages organizations to monitor and analyze their review times, and it publishes standard metrics for comparison. This approach fosters efficiency, starting with the resources necessary to be efficient. Site visitors explore review times by listening to comments from researchers and prescribing corrective actions when needed. In addition, AAHRPP requires the HRPP to draw up a quality improvement plan to monitor compliance as well as quality, efficiency, and effectiveness. This creates an evolution of efficiency and quality.

Because accredited organizations must have complete policies and procedures and follow them in practice, accreditation results in more standardized and consistent reviews within the regulations as well as across organizations. Policies and procedures are required to be available to researchers, and organizations must inform researchers of educational programs and of policy changes or updates. AAHRPP also reviews template letters to investigators and recommends complete language so that researchers will have clear explanations of IRB decisions. Additionally, AAHRPP Standards require organizations to set up a mechanism for researchers to provide feedback, complaints, questions, or input to the HRPP and IRB, as well as a process to respond in a timely fashion. Overall, accreditation enhances communication with researchers.

AAHRPP endeavors to keep up with developments in research and be responsive to changing methodologies, research requirements, and researchers’ needs. For example, AAHRPP Standards encourage organizations to include community members in the design and conduct of research that relies on the methodologies used in community-based participatory research. In this regard, AAHRPP requires IRBs that review community-based participatory research to be prepared to deal with ethical challenges involved in such research and to seek education or consultation when appropriate.

Researchers often ask organizations that conduct clinical trials to apply for AAHRPP accreditation to accommodate trial sponsors that prefer accredited performance sites. But social scientists are also finding that once an organization is accredited, the HRPP and IRB become more efficient and standardized: They continually strive to improve, and they develop a working relationship of communication with researchers. Accreditation not only enhances protection for human participants, but it also benefits researchers and makes research programs more attractive to sponsors. AAHRPP accreditation goes hand in hand with a quality research program.

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