IRB Member Newsletter--Volume 3 (Summer 2011)
Updates for IRB Members
- New IRB Members
- AAHRPP Reaccreditation Site Visit
- FDA Audit
- Reviewing Minutes in ARROW
- New IRB Member Web Page
- Proposed Revisions to the Common Rule
Welcome to New HS and MR IRB Members!
5 new HS and 2 new MR IRB members have recently come on board and have either already started attending meetings or will be shortly. We appreciate their willingness to serve on the IRB and look forward to working with them.
New HS Members: Scott Nagle, MD, PhD, Radiology; Karen Oliver, PhD, VA Representative; Lee Wilke, MD, Surgery; Dia Yamanouchi, MD, PhD, Surgery; Maha Mohamen, MD, Department of Medicine -Nephrology.
New MR Members: Tara LaRowe, PhD, Department of Family Medicine; Sue Riesch, PhD, RN, FAAN, School of Nursing.
AAHRPP Reaccreditation Site Visit
From September 27 to 30, 2011, UW-Madison will host a reaccreditation site visit by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). AAHRPP is a private organization that accredits Human Research Protection Programs (HRPPs). The University of Wisconsin-Madison has a complex HRPP, first accredited in 2008, that involves the campus IRBs, scientific review committees, research teams, and other oversight bodies. The site visit involves interviews of UW-Madison, UW Hospital and Clinics, and Madison VA personnel as well as a review of IRB records. Several current MR and HS IRB members have been informed that they were selected as interviewees. The IRB offices along with the Office of Research Policy within the Graduate School will be contacting selected IRB members over the next several weeks to set up group sessions to help interviewees prepare for the site visit interview.
The final agenda and all prep session materials will be posted on the HRPP website.
HS IRBs Recently Audited By FDA
The week of August 1st, the HS IRBs Office underwent a routine audit by the FDA. Our last audit was approximately 5 years ago, so this visit was not unexpected. The auditors reviewed the files of FDA-regulated studies, both in paper and in ARROW, and also reviewed IRB policies and procedures. The auditors found the IRB’s application of FDA regulations to be satisfactory.
Reviewing Minutes in ARROW
VA regulations require minutes of committee meetings to be ratified by the convened IRB. Two IRB members are assigned as primary reviewers who are responsible for reviewing the set of meeting minutes they have been assigned to ensure they are accurate and complete as well as recommending to the IRB regarding whether the minutes can be accepted as proposed or accepted with revisions they outline.
As of July 2011, the process for reviewing minutes occurs entirely in ARROW. IRB Members now have a Meeting Minutes tab in their inbox, and this is where assigned minutes can be found. The process for reviewing minutes in ARROW can be found here: Reviewing IRB Meeting Minutes in ARROW
Website Updates: New IRB Member Page
The HS-IRBs website moved to a new platform that includes a robust search engine and allows visitors to leave feedback on posted documents. As part of this transition, we have revamped our IRB Members Page. This page can be found by clicking on the For IRB Members link in the menu bar. Here you will find upcoming IRB meeting dates and locations, documents that outline your responsibilities as an IRB member, guidance on reviewing submissions, important news and announcements, training materials, and ARROW guidance.
Proposed Revisions to the Common Rule
The Office of the Secretary of the Department of Health and Human Services is proposing revisions to the federal regulations governing human subjects research (i.e. The Common Rule). They have requested comments on how current regulations might be modernized and revised to be more effective.
A summary of the proposed revisions can be found here: http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html.
The full description can be found here:http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm