HS-IRBs News December 2016

Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 12, December 2016

HS-IRBs Office Closures

The HS IRBs Office will be closed the following days in December and early January:

New and Updated Guidance Documents

The Guidance and SOP Working Group (GSWG) has two new documents:

If you have any questions or suggestions for GSWG, please contact Tesha Zimmerman at tmzimmer@medicine.wisc.edu.

Implementation Date Change for NIH Single IRB Requirement

Per NOT-OD-17-027, the NIH requirement for single IRB review for multisite research funded by NIH will be effective September 25, 2017. This is a change from the previous May 25, 2017 implementation date.

This policy will apply only to studies where the same research protocol is conducted at all study sites. Multisite studies currently ongoing will not need to comply with this policy until a competing renewal application is submitted. Guidance from NIH regarding key questions such as costs for single IRB review and what information about single IRB review needs to be included in grant applications and proposals is pending. The HS IRBs Office is very involved in the national discussions about implementation of this new policy, and we will provide further information when available. In the meantime, researchers are encouraged to contact the HS IRBs Reliance Team with any questions regarding IRB oversight for collaborative and multisite projects.

Improving IRB Processes for Researchers

As part of our continuing efforts to improve processes within the HS IRBs Office, IRB staff will be part of a new Noncompliance/Corrective and Preventive Action Plan working group on campus. The group will also consist of members of ICTR and the Office of the Vice Chancellor for Research and Graduate Education (VCRGE). Goals will include developing resources for study teams that need to develop a corrective action plan since there is currently little guidance to conduct root cause analyses, etc. The group has drafted several documents as a starting direction for study teams that are struggling.

CT.gov Update

The final NIH Policy requires studies that receive NIH funding in whole or in part and that meet the definition of a clinical trial need clinicaltrials.gov language included in the consent form as well as registration on the clinicaltrials.gov website. NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” If you have questions about this requirement, please contact CT.gov Support, Office of Research Policy at 608-890-1241 or ClinicalTrials.gov_Support@research.wisc.edu.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.