At WMed, we believe that research is at the forefront of the advancement of knowledge through innovation and discovery. The Human Research Protection Program (HRPP) is a key component of WMed’s research strategy. The HRPP, in collaboration with the local research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted at, under the auspices of, or using the services or resources of the medical school.
New Case Report Guidance
Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes. Although the use of protected health information to prepare the paper and/or poster does not require IRB review, the author(s) of a case report must comply with HIPAA. The purpose of the new guidance is to provide support for clinicians in the review of case reports.
New Guidance - Navigating the Institutional Approval Process
A new guidance document has been creating to help researchers navigate the WMed required institutional assurance process. This guidance provides a quick reference guide for researchers as they prepare for IRB submission. You can access the guide at http://med.wmich.edu/hrppguidance.
Request for CVs
In an effort to utilize the full functionality of the iMedRIS system, we’re asking researchers to complete their user profiles in the electronic system. Next time you’re in iMedRIS please upload your CV utilizing this brief video.
New Guidance - Researcher Guidebook
The Researcher Guidebook is a resource designed to guide investigators and study staff through policies and procedures related to the conduct of human research that are specific to WMed. Additionally, it serves as a guide for the research community when preparing and submitting materials to the WMed IRB. General information regarding human research protections as well as relevant federal regulations and guidance has been incorporated throughout this manual where applicable.
Electronic IRB Application
The electronic IRB application is available at https://imedris.med.wmich.edu. Users can also visit the IRB E-Submission webpage for more information. For assistance with accessing or using the electronic system, please contact the IRB at email@example.com or 269-337-4345. We're located on the fourth floor of the W.E. Upjohn M.D. Campus. Feel free to drop in with questions. If you would like to schedule a time for one-on-one training, please call 269-337-4345.
Revised Common Rule Changes Now in Effect
The Department of Health and Human Services (DHHS) has incorporated changes to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”), effective January 21, 2019. The WMed IRB has fully implemented the 2018 Common Rule requirements. You may receive a re-determination that your research now meets the criteria for exempt status or, because of the relaxation of the continuing review requirement, the WMed IRB may no longer require annual continuing review for your study. If these changes apply, you will receive a formal letter from the WMed IRB outlining the status of your study and if the continuing review requirement is still applicable to your study.