HS-IRBs News July 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 7, July 2012
The HS-IRBs office is mourning the loss of our dear friend and colleague, Carla Phillips, who died July 7th. Carla has been an IRB staff reviewer since 2003 and was an invaluable part of the office. Carla primarily supported the MR IRB and was an expert in several areas including tissue banks, research databases, and exempt projects. Carla was the “go-to” person for many study teams, in part because of her unique ability to smooth the way to IRB approval for even the most complicated studies.Carla’s kindness, intelligence, and humor were deeply appreciated by her colleagues in the office. She was a generous and supportive colleague, always willing to help out when needed. We very much enjoyed Carla’s wit and regularly relied on her wisdom and advice. We will always miss her presence in the office and will keep her close in our memories. Carla’s family welcomes donations in her memory to the Leukemia and Lymphoma Society and Agrace Hospice.
Note to Study Teams: Submissions that Carla was working on have been reassigned to other HS-IRBs staff. If you have questions about your submission, please check ARROW to see who is currently handling the submission and contact that person directly.
Important Reminder Regarding Requests to Defer IRB Oversight
In addition to reviewing Guidelines for Ceding IRB Review to an External IRB , study teams who wish to request that IRB oversight for their study be deferred to a non-UW-Madison IRB that is not part of WIC or Meriter must check with the proposed IRB of record to confirm whether it is willing to assume IRB oversight for UW-Madison. Not all IRBs will agree to assume IRB oversight for another institution and we have had several requests for deferral that have been declined by the proposed IRB of record. Failure to contact the proposed IRB of record to confirm it is willing to assume oversight can cause significant delays in obtaining IRB approval for a study. If you have questions about the deferral process, please contact Carol Pech (firstname.lastname@example.org).
Update on the Community-Based Research (CBR) Working Group
As mentioned in the January newsletter, the HS IRBs Office formed a working group with the goal of
improving the HS IRBs review processes for community-based research (CBR). With the assistance of the UW Survey Center and ICTR, the working group conducted two
focus groups in February to solicit feedback about the IRB review process from researchers who conduct
community-based research through UW-Madison. About 20 people participated in the focus groups.
Some of the main concerns raised by the focus group participants were challenges posed by differences in terminology between the IRB and CBR investigators, the time it takes to get an application approved by the IRB, perceived inconsistencies in the review process, and challenges working with ARROW and the campus human subjects research training module. These concerns and others were discussed during a follow-up meeting with focus group participants in June, which was lead by Staci Lowe, the HS-IRBs community research specialist. The group discussed the importance of contacting the IRB office early and often when planning CBR studies, understanding which projects actually require IRB review as well as the regulatory requirements for multisite or collaborative research, and learning about the resources that are available to CBR investigators.
We want to thank everyone who participated in this important project. We look forward to working with researchers and their collaborating partners on strategies to facilitate community-engaged research.
OHRP Audit Successfully Concluded
The Office of Human Research Protections (OHRP) has concluded its not-for-cause audit of the University's human research subjects protection system. Two fairly minor findings are noted in the close out report, both of which have been addressed via a revision to an existing reporting policy and the implementation of an informed consent checklist for the IRB in 2008. We appreciate the thorough review conducted by OHRP and are pleased that our program continues to meet the high standards set by OHRP and other agencies.
Tip for Using the Record Human Subjects Training Snapshot Activity
When using the Record Human Subjects Training Snapshot activity in ARROW, please remember to both click the link for the activity and then click OK in the window that pops up. The OK button is located in the lower right corner of the list of training dates generated by the snapshot activity. Clicking OK will update the submission's history tab to show that the snapshot activity has been used and also will display whether all study teams members have completed the required training.
- Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email email@example.com. These are the quickest ways to get help with general questions.
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.