IRBs and Research Compliance

The primary responsibility of the IRB is to protect the rights and welfare of human subjects in research and to serve as the Privacy Board for the research use and disclosure of Protected Health Information. In doing so, the IRB monitors human subject research to determine that it is conducted ethically and in compliance with federal research regulations, applicable law, HIPAA, each institution’s Assurance, and Trinity Health Michigan policies and procedures.

The IRBs fulfill these responsibilities by conducting prospective review of new studies, the informed consent process, procedures used to enroll participants, review of unanticipated problem and adverse event reporting, determining the need for continuing reviews, as well as other functions.

The IRBs are supported by the Michigan Research Compliance Department through which auditing and education services are provided. Other functions covered by the department include the Michigan Conflict of Interest Committee, research misconduct investigations, Clinical Trial Billing Committee, and the Human Research Protection Program.

In addition to federal regulations, the IRB operates within Trinity Health’s Mission, Values, Organizational Code of Ethics and the Ethical and Religious Directives (ERDs) for Catholic Health Care. All research conducted at Trinity Health Michigan and Georgia sites must comply with the Trinity Health Mission, Core Values, and Catholic moral/ethical principles, as delineated in the "Ethical and Religious Directives for Catholic Health Care Services." In this regard, IRB review and decision making gives special consideration for research participants' cultural, racial, social, religious, and economic circumstances.

IRB review must take place before any research activity starts as it is the role of the IRB to assess the study's potential benefits and risks. Research activities must not start until you receive your IRB approval or exemption letter.

Our IRB Infrastructure

Trinity Health Ann Arbor IRB serving:

• Trinity Health Ann Arbor Hospital, Michigan, including the Michigan Cancer Research Consortium
• Chelsea Hospital, Michigan
• Trinity Health Livingston Hospital, Michigan
• Trinity Health Livonia Hospital, Michigan
• St. Mary’s Georgia
• St. Mary’s Good Samaritan Hospital, Greensboro GA
• St. Mary’s Sacred Heart Hospital, Lavonia GA
• St. Mary’s Medical Group, Athens GA
• IHA multi-specialty group – a wholly owned subsidiary of Trinity Health Ann Arbor Hospital System and a member of Trinity Health. 
• Trinity Health Corporate and projects that meet the definition of system level research

Mercy Health Regional IRB serving:

• Trinity Health Grand Haven Hospital, Michigan
• Trinity Health Grand Rapids Hospital, Michigan
• Trinity Health Muskegon Hospital, Michigan
• Trinity Health Shelby Hospital, Michigan
• Trinity Health Medical Group

Trinity Health Oakland IRB serving:

• Trinity Health Oakland Hospital, Michigan
• Trinity Health Oakland Medical Group and Affiliates

This site houses the templates, forms and contact information regarding questions about the IRB submission process and oversight roles.