About the IRB
What is the IRB?
IRB stands for "Institutional Review Board." The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
What is a human subject?
A human subject is a living individual about whom an investigator conducting research obtains data through intervention/interaction with the individual or identifiable private information.
What does the IRB consider research?
Research means a systematic investigation (including research development, testing, and evaluation) designed to contribute to generalized knowledge.
When does the WMed IRB meet?
The WMed Institutional Review Board meets the first Thursday of each month at 7:30 a.m. Full Board proposals submitted 3 weeks prior to the scheduled meeting are assigned an IRB primary reviewer. Researchers and primary reviewers work together to prepare the proposal for the meeting agenda. Research proposals submitted after the three-week deadline will be reviewed the following month. Click here for the 2017 Full Board Meeting Calendar.
IRB Application Process
The WMed IRB currently oversees research projects conducted at Ascension-Borgess, Bronson Healthcare, and WMU Homer Stryker M.D. School of Medicine. For submissions to the WMed IRB please follow the guidelines here. These step-by-step guidelines cover the application process for new submissions and any supplemental forms that may be necessary for your particular research project (ex: Research involving the Internet or children).
Research Protocol Guidelines
The following guidelines are to be used when preparing research protocols for submission to the Western Michigan University Homer Stryker MD School of Medicine (WMed) Institutional Review Board (IRB). These guidelines are to be followed for studies that are both experimental in nature (i.e. clinical or non-clinical interventions, randomized controlled trial, etc.) or non-experimental (no randomization, retrospective chart reviews, surveys, interviews, focus groups, observations, etc.). Not all sections will be relevant for every study protocol. Please obtain assistance from Patrice Mason if you are conducting investigator initiated work at 269.337.6471 or Patrice.Mason@med.wmich.edu
All study applications must contain one form from each of the two categories listed below (Institutional Research Approval Forms and IRB Study Application Forms) to be reviewed by the WMed IRB. If either form is missing in the submission process, review of the application will be delayed until both have been received.
Institutional Research Approval Forms (must submit one):
Institutional Proposed Study Assurance and Approval: WMed Sites
Institutional Proposed Study Assurance and Approval: WMed Affiliated Institutions
IRB Study Application Forms (must submit one):
Request for Exempt Determination (Use this application if you believe your study qualifies as EXEMPT according to the definitions in the SOP Handbook.)
Initial Application - HUD
Initial Submission Application (Use this application for all other studies.)
All additional forms that may be needed for the submission process can be found listed below. While filling out the application(s), if you have any issues or questions, please call or email us at the contact information located above.
Research Training Requirements (CITI)
For any new IRB applications submitted for review, all investigators and study team members will be required to complete applicable Collaborative Institutional Training Initiative (CITI Program) training modules. CITI Program is a leading provider of research education content. All applicable online training modules must be completed and documentation of completion submitted prior to IRB approval.
You can access the required modules on the CITI Program website. Instructions for both new and returning CITI users can be found here.
PLEASE NOTE: Good Clinical Practice (GCP) training certification is not the same as Human Subjects Protections (HSP) training certification, so completion of additional CITI HSP modules may be required. Additional training from outside sources may be requested at intervals differing from WMed's institutional requirements. Investigators and study staff must comply with the applicable requests. If you are an existing or current CITI user with another institution, when you affiliate with Western Michigan University Homer Stryker M.D. School of Medicine, the CITI program will compare your previously completed modules to the WMed required modules. The program will automatically identify any additional modules that may need to be completed.
Researcher Forms and Documents
For those already conducting IRB approved research at Bronson Healthcare and WMU Homer Stryker M.D. School of Medicine, forms needed to continue conducting those research projects can be found listed below. If you are unsure what form you need, please call or email us at the contact information located above.
WMed's Standard Operating Procedure (SOP) Handbook for guidelines on the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) can be found here as well. The SOP Handbook guides the HRPP and IRB in making sound decisions for conducting research. It is the responsibility of the researcher to understand the proper conduct in regards to the SOP Handbook, GCP and HSP.