Monday, February 14, 2011

Delivering a Better Product to Improve Protections for Research Participants

Helping organizations provide protections for research participants through accreditation is AAHRPP’s main goal. As we enter into our tenth year of accreditation, we are taking steps that directly support this goal. We are making the Advance accessible to all online. This transition will leverage the Advance’s ability to provide reliable and relevant information to a much larger community of those involved in protecting research participants and promoting ethically sound research. We hope that by closing the print editions we will open an avenue to listening, where we will be able to turn your feedback into actionable change that matters most to research participants and organizations.

In addition to changes with the Advance, we have released an updated Evaluation Instrument for Accreditation. While the Accreditation Standards and Elements remain unchanged, the requirements to meet certain Elements have been updated, primarily in response to changes in guidance from federal agencies. Most notably, the stipulations in VHA Handbook 1200.05, “Requirements for the Protection of Human Subjects in Research,” released on May 21, 2010, from the Department of Veterans Affairs, have been added.

These VHA Handbook requirements must be implemented by March 31, 2011.

Other updates to the Evaluation Instrument were minor, reflecting the addition and removal of guidance documents issued by the Office for Human Research Protections.

The AAHRPP Accreditation Procedures were updated on December 14, 2010, with two changes. First, when organizations submit a Step 1 application, they will have one year to respond to the review provided by AAHRPP staff and move to the next step – submission of the Step 2 application. While most organizations have responded quickly, some have not. The one-year period is intended to motivate organizations to respond promptly and keep the goal of achieving accreditation as a top priority of the organization.

Second, when organizations earn reaccreditation, the five-year period will be set to the expiration date of the last accreditation. This means that organizations placed in Reaccreditation-Pending will earn accreditation for five years minus the time they were in the pending category. Accreditation assures the public that organizations are achieving high standards for protecting research participants only if organizations put into place and maintain policies, procedures, and practices that meet the accreditation standards. Sometimes, circumstances such as loss of staff or funds will have negative consequences on a human research protection program. Nonetheless, it is important for organizations to maintain the quality of their protection programs, especially as the public is beginning to rely more and more on the AAHRPP accreditation seal as a sign of excellence.

The Evaluation Instrument for Accreditation and AAHRPP Accreditation Procedures are available at

-Marjorie A. Speers, Ph.D.

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