U of M Receives Human Research Protection Status: Reaccreditation-Pending

Following a reaccreditation site visit in June, the University of Minnesota has received notice from the Council on Accreditation of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) that the status of its Human Research Protection Program is “Reaccreditation Pending.”

Under the status, the University of Minnesota remains an AAHRPP accredited organization. However, it must implement several changes that address standards not met as identified in AAHRPP’s final site visit report and provide additional updates to AAHRPP to meet all criteria for full accreditation.

Many of the areas identified for improvement are already being addressed through the University’s work plan to strengthen its human research protection program, which will be fully implemented June 2016.

University of Minnesota Vice President for Research Brian Herman had the following statement:

We are pleased the University of Minnesota remains accredited by AAHRPP, the foremost relevant accreditation body for human research participant protection. We are committed to the improvements outlined by the Council on Accreditation and to ensuring that the well-being of research participants remains at the center of all University research activities. Many of AAHRPP’s suggestions have already been addressed and implemented at the U of M, and we are on our way to an “above and beyond” human participant research program that will be a model for universities and hospitals across the nation.

As AAHRPP is aware, over the past year, the University has undergone a rigorous review and assessment of its human research policies and practices and is now undertaking a major initiative to enhance its human research protection program. Some key areas of enhancement include: more education and training for investigators and staff, changes to some IRB processes and policies, new approaches for managing conflicts of interest, and increased community participation and oversight.

As the AAHRPP Final Site Visit Report commended, the leadership of the University is committed “[t]o providing additional resources and improving the protections of human participants,” and we are confident our work plan and other improvements will meet and often times exceed what AAHRPP has requested for reaccreditation.

According to AAHRPP, “The Council on Accreditation may place an Organization in the Reaccreditation-Pending category when the Organization does not meet the criteria for Full Accreditation, and the Council believes the Organization is able and willing to commit to take corrective actions to meet the criteria for accreditation within a reasonable time period.”

In order to move the University to full reaccreditation status, AAHRPP has asked for four quarterly improvement plans between now and the Council’s September 2016 meeting, two status reports, and a limited site visit by AAHRPP expected in May or June 2016.

The quarterly improvement plans are to cover four of the AAHRPP standards not yet met as outlined in the attached letter and Final Site Visit Report. The four standards pertain to: resources for research participant protection (Standard I-2); responding to research participant concerns (Standard I-4); the structure and composition of the Institutional Review Board (IRB) (Standard II-1); and strengthening processes to evaluate research protocols and plans that protect research participants (Standard II-2).

A full list of accreditation standards, which are grouped under three domains and contain 60 individual elements, can be found on the AAHRPP website.

Learn more about the University’s work plan at z.umn.edu/human

Accreditation Status Letter

Final Site Visit Report

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