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.
About AAHRPP Accreditation
The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) is an independent accrediting body that works to protect the rights and welfare of research participants and promotes scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education. WMed Human Research Protection Program (HRPP) is actively seeking accreditation from AAHRPP. AAHRPP will conduct an accreditation site visit at WMed from March 17, 2020 – March 18, 2020. Research community members will be asked to take part in the process. The purpose of the visit is to evaluate the implementation of our policies and procedures. The AAHRPP site visitors will interview organizational officials, IRB members, investigators and research study team members regarding the HRPP here at WMed. In order to ensure everyone is ready for the visit, there will be informational sessions scheduled in the coming weeks.
Research Day Help
The IRB is available to assist those persons that will be submitting projects for Research Day. As you’re preparing to submit your Research Day Abstract Submission and you’re trying to determine if/what IRB oversight is required, please contact the IRB by calling 269-337-4345. If you would like an in-person consultation, please visit us on the 4th floor of the Upjohn Campus. Our office hours are M-F 7 am – 5 pm. If you have questions outside of the office hours, email us at email@example.com or you may also contact Maureen Owens at 269-337-4269. Visit https://imedris.med.wmich.edu to access the electronic IRB application.
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.
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.
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 firstname.lastname@example.org 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.