Thursday, December 15, 2011

For decades, the responsibility for protecting human research participants rested squarely with the IRB. Today, while it still plays a pivotal role, the IRB is part of a comprehensive human research protection program (HRPP) designed to spread responsibility and accountability across the research enterprise.

Some have expressed concerns that the rise and acceptance of HRPPs have ushered in a more rigorous review process. But that was the intent: to hold researchers and IRBs, among others, to high standards and, in the process, improve the quality of research and strengthen research protections.

The concept of an HRPP was officially introduced in 2001 by the Institute of Medicine (IOM) and its Committee on Assessing the System for Protecting Human Research Subjects. Yet it is AAHRPP that is widely credited with moving HRPPs from concept to reality.

“AAHRPP’s contributions have been substantial,” says James A. Weyhenmeyer, Ph.D., Vice President for Research and Economic Development at Georgia State University and Chair of AAHRPP’s Board of Directors. Because of AAHRPP and its accreditation standards, “now there’s an infrastructure in place and agreement on the ground rules. The research is better, and so are the protections,” he says.

Gaining worldwide acceptance

In its April 17, 2001, report, Preserving Public Trust: Accreditation and Human Research Participant Programs, the IOM argued for a more systematic approach toward human research protections. Specifically, the report called for “a broader human research participant protection system than just the IRB, with multiple functional elements that in total are referred to as human research participant protection programs, or HRPPPs.” The report also recommended accreditation as a way to improve protections and to confer a mark of excellence.

AAHRPP was incorporated the month that the IOM report was published. AAHRPP opened for business in October 2001 and, by February 2002, had released its initial set of accreditation standards. The first accreditations followed 14 months later.

Since then, 241 organizations have earned accreditation, including institutions in 45 states, the District of Columbia, India, Puerto Rico, Canada, China, Korea, and Singapore. Together, these accreditations present perhaps the strongest affirmation that the concept of an HRPP has taken hold in the United States and is on its way to becoming the standard worldwide.

The advantages of an integrated approach

AAHRPP’s accreditation standards don’t require organizations to label their protection programs as HRPPs. But the standards do call for a comprehensive system that protects all research participants. Furthermore, the standards acknowledge the responsibilities of all those involved in research, including IRB members and IRB staff, researchers and research staff, sponsors, and others across the research enterprise.

“In the past, we took a more IRB-centric view, and people would point to the IRB staff, IRB chair, or members as the persons responsible,” explains Moira Keane, M.A., C.I.P., Executive Director, HRPP, University of Minnesota, and Chair of AAHRPP’s Council on Accreditation. “AAHRPP’s emphasis on the HRPP recognizes that we’re all stakeholders and we’re all accountable.”

The benefits of this holistic, integrated approach are considerable:
  • Stronger research protections because the responsibility is shared and is supported by a comprehensive system, including oversight, education, evaluation, auditing, and quality improvement.
  • Enhanced communications among stakeholders within individual institutions and across the research enterprise.
  • Common, higher standards as more organizations become accredited and expect their research partners to follow suit.
  • Greater understanding of the importance of research and protections, which leads to increased respect and visibility for researchers, IRB members, and other HRPP members.
  • More competent HRPP and IRB members who know the regulations, know their organization’s policies and procedures, make better decisions and determinations, and are confident to use the flexibility in the regulations appropriately.
  • Improved data collection as institutions adopt common standards and systems.

“The impact is significant because AAHRPP’s standards apply not just to the IRB but to the entire research program,” Dr. Weyhenmeyer says.

Ms. Keane agrees, citing the progress she’s identified in the eight years since she began conducting AAHRPP site visits.

“AAHRPP’s approach requires that all components of the HRPP work well and work together,” she says. “We’re seeing less miscommunication, more connection among HRPP components, and stronger programs in general. I would argue that stronger programs result in better protections and better results.”

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