IRB Member Newsletter--Volume 11 (Spring 2018)
Change in IRB Member Liaison Support As you may be aware, the Health Sciences IRBs identify personnel to support IRB members with questions about meeting schedules, review processes (including help navigating ARROW), and any other member-related issues. Our current IRB Member Liaisons are: IRBReview@medicine.wisc.edu or our main phone number 263-2362. IRB Member Survey We will be conducting a survey of all IRB Members in Qualtrics to provide the HS IRBs Office and Chairs with feedback. The questions are meant to elicit your thoughts about the IRB Chairs (and their management of meetings), the HS IRBs Office Staff (and their communication with you, as well as the materials they prepare for meetings), educational materials and experiences, and IRB Member experience. Please keep an eye out for an email asking you to take the survey, which will be sent April 30, 2018. Delayed Implementation of Revised Common Rule The Department of Health and Human Services (HHS) issued its final proposal for changes to the Federal Policy for the Protection of Human Subjects (what we know as the "Common Rule") on January 18, 2017. Although the effective date of the revised Common Rule was originally January 19, 2018, HHS postponed implementation until at least July 19, 2018 with the possibility of a further 6-month delay. In the meantime, many of the provisions of the revised Common Rule have been incorporated into campus policy as outlined below. Campus leadership adopted these policies because they allow more studies to qualify for quicker review processes. Changes to Campus Policies As of February 19, 2018, several changes to campus policy were made to reduce burdens on study teams while ensuring adequate protection of human subjects. Most of these updates only can apply to research that is NOT federally supported, FDA-regulated, or fall under VA purview. These include:
- Exempt human subjects research: New categories of research will qualify for exemption from IRB review. The HS IRBs Office developed a tool to help research teams identify which studies qualify for these new exemption categories and can be found here. This change means that some projects that used to be reviewed by the full Minimal Risk IRB will now reviewed in-house instead, usually by Monica Esquibel.
- Continuing review: In October 2017, campus policy was changed to excuse many non-exempt minimal risk research studies from continuing review. In February 2018, campus policy was revised again so that additional types of minimal risk research no longer require continuing review. You will notice that staff reviews for new initial applications now include a space for staff reviewers to recommend foregoing the Continuing Review requirement if applicable for that study.
- 5 pages or fewer OR
- 10 pages or fewer AND based on current UW-Madison Health Sciences IRBs templates or similar template