IRB Member Newsletter--Volume 7 (Spring 2013)
Updates for IRB Members
- New and Departing IRB Members
- Website Redesign
- Revised Reportable Event Guidance
- Reminder: New Point-Of-Contacts for IRB Member Questions
- Updates to 2013 MR IRB Meeting Dates
- Spotlight on HRPP Policy
IRB Member Changes
We are happy to welcome Irene Hamrick, MD, Family Medicine to the MR IRB.
We look forward to working with you over the coming year!
Thank you to the following IRB members who are leaving the committees. We appreciate your service to the IRBs.
- Tara LaRowe, PhD, Family Medicine
- Pilar Ossorio, PhD, JD, Law School, Law and Bioethics
Congratulations to Pilar on her recent appointment to the HHS Advisory Committee on Human Research Protections. As a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), she is charged with look for improvements to the current system of human research protection programs, with particular emphasis on vulnerable participants. Additional details can be found here: http://law.wisc.edu/news/Articles/Pilar_Ossorio_appointed_to_Healt_2012-09-27
The HS IRBs website has been redesigned and many documents updated, "Special Topics" are now linked from the main page and include FAQs, Multi-Site Research, and VA Research, among others. Additionally, the IRB Member page may now be accessed through the large "For IRB Members" icon under the left hand menu. Also updated for IRB Members are the IRB Member FAQs . Please review for answers to the following frequently asked questions:
- How do I know if I have been assigned as a reviewer for an upcoming meeting?
- What if I am assigned to review meeting minutes?
- Who is the IRB Member Point-Of-Contact (Liaison) for my board?
Revised Reportable Event Guidance
In addition to the general site redesign, the Reportable Events page on the HS IRBs website has been revised to help make the guidance about reportable events more accessible. Several new documents have been posted to assist study teams with understanding what to report and when. Some current guidance documents have been revised to reflect changes in reporting time frames. A summary of the new and revised reportable events documents has been posted.
The following IRB Member Fact Sheets have also been updated to reflect current reportable event guidance:
Reminder: New Point-Of-Contacts (Liaisons) for IRB Member Questions
IRB members are encouraged to contact the IRB office with any questions they have. In order to better serve you, the HS IRBs Office has instituted a point of contact system for IRB members. Please contact the following people with any questions or concerns, including help with ARROW, IRB meeting logistics, and guidance on conducting reviews:
HS IRB Members POC
Gemma Gliori, firstname.lastname@example.org, 261-1157
Brooke Mechelke, email@example.com, 263-8880
MR IRB Members POC
Chelsea Dahmen, firstname.lastname@example.org, 265-4389
For specific questions about a protocol you have been assigned, please contact the staff reviewer assigned to that study.
If you will miss or be late for a meeting, please continue to alert the IRB main office at 263-2363 or email email@example.com
Revised: 2013 MR IRB Meeting Dates
The 2013 schedule for MR IRB meetings has been revised to remove the last meeting in December (12/23/13). This meeting has been canceled due to conflicts with holiday scheduling. The IRB Meeting Dates have been updated to reflect the revised meeting schedule.
Spotlight on HRPP Policy: IRB Member Conflict of Interest
The UW-Madison has a policy in place to identify, evaluate and manage conflicts of interest (COI) for IRB members and IRB consultants that may affect decision-making by the IRB member or consultant in the review of research protocols. This policy places restrictions on participation in the review process by those who have a conflict of interest. An IRB member or IRB consultant has a conflict of interest with respect to a protocol when:
- An IRB member or IRB consultant, or an immediate family member of the IRB member or IRB consultant, has a professional interest as a principal investigator or co-investigator in the protocol, or
- An IRB member or IRB consultant, or an immediate family member of an IRB member or IRB consultant, has a financial interest in a business entity that (a) sponsors the study or (b) owns or licenses a technology tested in the study, and the IRB member’s or IRB consultant’s financial interest meets or exceeds one of the following thresholds:
- Compensation of $20,000 or more in a calendar year from a business entity.
- An ownership interest in a publicly traded business entity valued at $20,000 or more or a 5% or greater equity interest.
- An ownership interest in a privately held business entity.
- A leadership position in a business entity (e.g. service as an officer, member of the board of directors, or in any other position of trust, confidence, and responsibility for a business entity, whether or not the investigator receives compensation for such service).