IRB Member Newsletter--Volume 5 (Spring/Summer 2012)
Updates for IRB Members
- New IRB Members
- IRB Member Evaluations and Survey Update
- OHRP Audit Update
- Reminder: Help Documents available for ARROW
Welcome to New Health Sciences (HS) and Minimal Risk (MR) IRB Members!
February 2012 marked the start of a new group of HS-IRB members. We are happy to welcome the following new members to the Board and look forward to their contributions:
- Mark Juckett, MD, Hematology-Oncology
- Rasmus Birn, PhD, Psychiatry
- Jennifer Laffin, PhD, FACMG, Director, UW Cytogenetic Services Laboratory, WSLH
- Catherine (Casey) Reiser, MS, CGC Pediatrics, Genetic Counseling Program Director
- Elizabeth Petty, MD, Pediatrics, Senior Associate Dean for Academic Affairs at SMPH
Welcome to you all, and we look forward to working with you over the coming year!
IRB Member Evaluations and Survey Update
Due in part to recommendations made during the Association for the Accreditation of Human Research Protection Programs (AAHRPP) site visit in 2011, the IRB Office in conjunction with the IRB Chairs began formal evaluations of IRB members during the early part of 2012. The initiative included a survey on IRB Office and Board functioning sent to all current IRB members. Over 66% of HS-IRB members and 77% of MR-IRB members completed the survey--thank you to all who took the time to provide input and feedback! Overall, IRB members felt that meetings are run efficiently, staff reviews are helpful, and materials are available sufficiently ahead of time to adequately prepare. See future newsletters for responses to comments and questions from IRB members provided in the survey.
Office for Human Research Protections Audit Update
As you are undoubtedly aware, IRBs do not escape audits and the UW HS-IRBs have been no exception. Over the last several years, we have undergone not-for-cause audits by the VA, Food and Drug Administration (FDA), AAHRPP, and most recently, the Office for Human Research Protections (OHRP). The last OHRP audit of the UW occurred in 2000. This OHRP audit included review of meeting minutes, and policies for all campus IRBs as well as over 130 consent forms from studies approved by the HS and MR-IRBs. An initial response from OHRP regarding the review of these documents was received, which the UW is in the process of responding to. The questions from OHRP related to the Health Sciences IRBs focused primarily on consent form content, particularly the inclusion of the required and additional elements of consent that are described within the Common Rule. In 2008, the Health Sciences IRBs implemented a Consent Form Checklist which helps the IRB to confirm inclusion of required language and documents why revisions may (or may not) be necessary. The use of the Consent Form Checklist appears to have minimized noncompliance with federal consent form requirements. If you ever wonder why the IRB application asks so many questions and why we ask IRB members to complete primary reviewer forms, it is to help the IRB comply with complex federal requirements. A non-compliant IRB can adversely affect the entire UW-Madison research community.
Reminder: Help Documents available for ARROW
If you have not recently visited the For IRB Members page of the HS-IRBs website (or the website in general) - please do! There is a tremendous amount of guidance available for IRB members and many include notated screen shots. Guidance includes: Brief Responsibilities of an HS-IRB Member /Brief Responsibilities of an MR-IRB Member , Primary Reviewer Guidance for Initial Reviews , IRB Member Fact Sheets (which include short summaries of key regulatory issues), and extensive guidance on how to use ARROW. Most recent additions to this page include Reviewing IRB Meeting Minutes in ARROW and Guidance for UW Madison Health Sciences IRB & Minimal Risk IRB Primary Reviewers for Summarizing Initial Review Applications . Coming soon is a link within the IRB Member page specifically for New IRB Members.
Get to Know Your Guidance Documents: Incidental Findings Guidance (Health Sciences IRBs Guidelines for Handling Incidental Findings in Research Protocols Involving Brain Imaging)
In April 2010, the Health Sciences IRBs adopted guidelines to assist the committee and research teams on incidental findings (aka adventitious findings) that can occur in studies that involve imaging the brain. These guidelines were developed by a subcommittee that included expertise from neuroradiology, UW and UWHC legal, the IRB, and bioethics. These guidelines provide researchers with options for the review and disclosure of incidental findings teams, clarifies who the IRB views as responsible for the review of brain images obtained for a research study when information about incidental findings will be disclosed to subjects, provides template consent form language based on whether disclosure to subjects is planned, and describes procedures that should be followed if incidental findings will be disclosed.