The Human Research Protection Program (HRPP) is a service and compliance unit within the Office of Research at Western Michigan University Homer Stryker M.D. School of Medicine (WMed). It manages the Institutional Review Board (IRB) that reviews and oversees human subjects research. Please check back regularly for IRB-related news and updates.
New Electronic IRB Application is Now Live
The electronic IRB application is now 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 new 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
The Scoop on Case Reports
We’ve had a lot of questions on case reports being submitted to research day for presentation. If you are writing a case report involving one or two subjects, no IRB review is required. When writing up a case report, keep in mind that you cannot use identifiable information (includes living and deceased individuals). This includes name, initials, dates of service, medical record number, or even age if older than 89 years of age. The full list of 18 identifiers which can’t be used are described here.
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 new regulations do not impact IRB studies approved prior to January 21, 2019.
For IRB studies approved after January 20, 2019, notable regulation changes include:
- Expanded exempt categories of review. Some studies that previously required expedited review may be eligible for exempt review under the new regulations.
- Relaxation of continuing review requirement. Certain expedited studies approved under the new regulations will no longer require annual continuing review.
- Informed consent changes. A new “Key Elements” section and a rearrangement of content is required for non-exempt studies.