The IRB monitors compliance with federal and state laws, hospital policies and ethical principles outlined in the Belmont Report.
As regulated by the United States Department of Health & Human Services, it comprises at least five members of varying backgrounds (Assurance of Compliance). The IRB membership includes community members with non-scientific backgrounds, as well as healthcare professionals with the competency to review research.
The UM Health-West IRB is charged with protecting the rights and welfare of participants in clinical trials and other human subjects research studies conducted at University of Michigan Health-West. The UM Health-West IRB follows the Belmont Report, which has 3 main principles guiding the members, which are:
Respect of Persons – the participant should be given the information in a format they can understand and given the option to participate or decline the trial voluntarily
Beneficence – protect the patient by doing more good than harm
Justice – individuals should have the same opportunity to join a trial regardless of financial, racial, or demographic status
UM Health-West IRB meets month, if necessary, to review proposals for research studies.
Electronic Submission System
IRBManager is the electronic submission system used by UM Health-West for research involving human subjects.
For questions related to IRB process, including submission, review and approval, contact the Clinical Research Department at 616.252.5020 or email@example.com.
All prospective investigators should note that all IRB submissions must be made through IRBManager. Paper submissions will not be accepted.
IRBManager is a web-based tool and can be accessed from any internet browser. It is available at https://metrohealth.my.irbmanager.com.
You will need a username and password to access the system for the first time. Your password should be kept confidential and not shared with anyone. See the IRBManager User Guide for instructions on how to set up an account or contact the office of the IRB as noted above.
The IRBManager User Guide will also familiarize you with navigating the electronic system.
IRBManager is Title 21 CFR Part 11 compliant.