HS-IRBs News January 2017
Health Sciences and Minimal Risk IRBs, IRB News / Volume 9, Number 1, January 2017
Upcoming Beginners WorkshopThe Health Sciences IRBs for Beginners Workshop provides training on the HS IRB's processes, regulatory approval process, resources, and ARROW online application system. The two-hour workshop is held several times each year in the HSLC computer lab (room 2121), and is meant for individuals new to the HS IRBs processes or for those looking for help on how to effectively submit an IRB application. The workshop consists of two sections meant to provide the regulatory framework and technical skills to submit an application. Upcoming dates and registration links, when available, can be found below.
- Monday, January 30th - 1PM to 3PM, HSLC 2121 - Registration available here.
Reminder: Upcoming Changes to Informed Consent Document StampAfter the February 11 update to ARROW, the IRB approval stamp for consent forms, information sheets, and assent forms will no longer include an expiration date or the UW's federalwide (FWA) number. Consent and assent documents will no longer expire and, following a transition period, study teams will no longer need to request reapproval of their consent documents at continuing review. Additional guidance is available here.
- New Studies: For studies approved after February 11th, consent documents will receive the new stamp. The only time the consent documents will be stamped again is when revisions are made to the consent documents via a change in protocol.
- Ongoing Studies: For studies approved before February 11th, consent documents will receive the new stamp with either the next continuing review or change of protocol if the change includes revisions to any consent document. If a study has multiple consent documents and a change revises any consent documents, all of the consent documents will receive the new stamp at that time for consistency's sake.
Improving IRB Processes for ResearchersAs part of an ongoing effort to improve informed consent-related guidance for the UW research community, the HS IRBs Informed Consent Working Group has developed new templates to help research teams create informed consent documents. We are seeking volunteers to try out these new consent form templates before we roll them out to the wider research community. We are excited for the templates to be used, and we hope they will bring more clarity to the consent form preparation process. The templates would be usable in any UW investigator-initiated study. If you are interested in trying out the new templates and providing us with feedback after doing so, please email ICWGquestions@medicine.wisc.edu. If you have any questions, please contact that same email address.
Routine FDA Audit for HS-IRBs OfficeIn December, the HS-IRBs underwent a routine FDA audit. These inspections typically occur every five years, and the last inspection occurred in 2011. The FDA inspector reviewed policies, guidance, procedures, and IRB records. Overall, the audit was a success, with the FDA making only a few recommendations for improvements. These changes have started to be implemented, and any impacts to study teams will be announced in future newsletters.
AAHRPP ReaccreditationThe UW-Madison Human Research Protection Program (HRPP), which includes the HS IRBs Office, had its 3rd re-accreditation visit from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in August 2016. The site visit included interviews with researchers, IRB members, and administrators across campus. In December, AAHRPP awarded our HRPP program full accreditation for five years until December 2020. The final report highlighted the strong leadership provided by senior leaders on campus, the Office of Research Policy's role in promoting consistency and compliance, and the benefits of the substantive and informative pre-review process. Thank you once more to all those involved in this process!
- 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.