The University of Minnesota (UM) recently found itself in the news because of concerns related to human subject protections in its research program. (See the recent IRB Members Blog item on this issue for a refresher.) As a result, UM has undertaken a reorganization of its human research protection program. The workplan guiding the reorganization is 75 pages long; the executive summary alone exceeds 7 pages.
Highlights of the proposed reorganization, as reported by the Post-Bulletin of Rochester, MN, and in the executive summary included increasing IRB staffing; streamlining the review process, including creating a prereview process; studying and learning from IRBs at other institutions; establishing IRB service as valued activity for promotion and pay raises; compensating IRB members; and reducing workload and increasing meetings to enable more thorough review of projects. Specific expectations related to the education and training of investigators and the management of conflicts of interest (COI) were also included in the report, as was a recommendation to create a Community Oversight Board, separate from the IRB, to advise the institution on best practices for research participant protection. The inclusion of vulnerable populations in research also merited special attention in the remediation plan.
These measures are not without significant cost, the report points out. The UM human research protection program’s current annual budget is $2.2 million. The estimated cost to implement the action plan is a $5.5 million one-time cost, with the subsequent annual budget of $4.4 million.
Please take a minute to click on the links above to learn more about this situation. We realize the linked documents are long. However, we encourage you to read at least the Post-Bulletin news article and the workplan’s executive summary.
Regarding UM, UAMS, and AAHRPP — UM has been accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2004, making it one of the first HRPPs to earn that accreditation. UAMS earned its initial AAHRPP accreditation in 2005 and will submit an application for reaccreditation this fall. Many of the items in UM’s workplan will sound similar to processes in place at UAMS, some of which were developed here as a direct result of previous accreditation applications. We expect that AAHRPP, when it evaluates UAMS’ reaccreditation and does its expected site visit, will look closely at the same sorts of things mentioned in UMs workplan. Some IRB reviewers will meet with AAHRPP staff as part of the reaccreditation site visit, so it may be helpful to use the workplan to learn more about the issues important to AAHRPP.