Wayne State University

Wayne State Human Research Protection Program (HRPP) preparing for sweeping changes to federal regulations

The Wayne State HRPP and IRB Administration Office have been busy gearing up for major changes to federal regulations that protect the rights and welfare of human participant (subject) research which will go into effect on January 21, 2019. Information and guidance specific to the Common Rule changes are available on our webpage designated to educating our researchers on these Federal policy changes. We encourage you to visit this page, to become familiar with the new regulations, and how they may impact your future research.

The revised Common Rule will be in effect for all studies that have been APPROVED on or after January 21, 2019. The IRB administration office will post our modified consent templates on our website in December 2018 to allow researchers to begin preparing the consent form prior to any January 21, 2019 submissions. All of the updated policies, applications, templates and guidance documents will be posted to the WSU IRB website on the eve of January 21, 2019.

We recognize that this may create new challenges for those of you who are planning to submit your study for review during January 2019. We are doing everything possible to prepare our research community, IRB members, and staff for these changes. We ask for your patience as we transition to the updated regulations, and learn from one another along the way.

Please visit the IRB Education page for additional guidance about the changes to the regulations and more. Any questions can be directed to irbquestions@wayne.edu.

If you wish to receive additional news and updates from the IRB, you can send a request to join our listserv by emailing wsuirbinfo@wayne.edu .

Electronic Submission System: E-Protocol

The IRB Administration Office has been actively implementing the Electronic Protocol (eProtocol) submission review system since December 2017. The PH1 IRB is currently accepting new full board submissions using eProtocol. The B3 IRB and M1 IRB will begin accepting new full board initial submissions December 2018 and the medical pediatric (MP) boards with follow in early 2019. Principal investigators, research key personnel, and dean/chairs/authorized signatories will need to use eProtocol for IRB FULL BOARD NEW/INITIAL submissions. All eProtocol users will need to update their CITI Training profiles to include their WSU Access ID. For more information regarding all IRBs implementation dates, submission instructions (i.e. updating CITI Profile), and training opportunities please visit the IRB's Education Website. If you wish to receive more information regarding eProtocol please send an e-mail to wsuirbinfo@wayne.edu. Please also visit the Division of Research eProtocol website for videos and manuals about eProtocol.

Housed within the  Division of Research, the Wayne State University HRPP is responsible for the Institutional Review Board (IRB) review and approval of research involving Human Subjects, ensuring that all human subject research at Wayne State be conducted in accordance with all Federal, institutional and ethical guidelines.