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.
Our Accredited Program Promotes High Quality Research
WMed achieved full accreditation by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) in June of 2020.
As the "gold seal," AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is committed to scientifically and ethically sound research and continuous improvement.
IRB News
Ascension Borgess Policy Change
For research studies where employees or agents of the medical school are not conducting human subjects research at Ascension Borgess, the WMed IRB will no longer be the IRB of record. When WMed employees or agents are involved with the conduct of human research at any Ascension Borgess facility, the WMed Human Research Protection Program will maintain oversight. Employees or agents of the medical school refers to individuals who: (1) act on behalf of the organization; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. If you have questions, please contact Maureen Owens at maureen.owens@wmed.edu or 269.337.4269.
HRPP Emergency Preparedness Response Plan
New guidance documents are now available regarding the HRPP Emergency Preparedness Response Plan.
Getting Started
Before preparing your application for research utilizing EHR data sets please read through the following steps to complete the IRB application.
Process to Assist with Research Development
A process has been implemented to improve communication during research protocol development. The process begins with the completion of a Project Request & Triage Form. Once the form is submitted, you will be contacted to set up the appropriate meeting(s) and/or connect you with the appropriate resources. If you have any questions about the form, please contact Theresa McGoff at theresa.mcgoff@wmed.edu or Maureen Owens at maureen.owens@wmed.edu.
Notice of Important Changes to Requests for Data
As of February 16, 2022, the Virtual Data Warehouse (VDW) will now be responsible for data management for all electronic health record (EHR) data for quality improvement and research projects. This includes data pull requests from our affiliates at Ascension Borgess, Bronson, and Grace Health. Requests for data projects will now begin by using the Project Request and Triage Form and will be followed by a consultation with the VDW Data Manager. Please note, after February 16, the data request piece will no longer be a part of the IRB application process in the electronic submission system (iMedris). If you have a project that will be impacted by this change, please email datawarehouse@wmed.edu.
Updated Researcher Guidebook Now Available
The latest and most up-to-date version of the HRPP and IRB Researcher Guidebook is now available on the WMed website. For more information, go to the Researcher Guidebook webpage.
New Protocol Templates Available
There is now a protocol template specifically for secondary use of identifiable private health information; A cross-sectional study design template for survey studies or taking physical or biochemical measures at a single point in time. And lastly, educational studies trying to determine the effectiveness of a particular type of instruction, or trying to assess the educational needs or backgrounds of students. They are available on the Forms & Templates webpage under Protocol Templates.
Working with the IRB Remotely
IRB review of submitted applications will continue as usual. The IRB is available to assist by calling 269-337-4345. Our remote office hours are M-F 7 am – 6 pm. If you have questions outside of the office hours, email us at irb@wmed.edu. Visit https://imedris.wmed.edu to access the electronic IRB application.