Human Subject Research Review

Welcome to the Detroit Medical Center (DMC) Research Review Process. Through this website, clinical investigators may apply for authorization to perform research, including clinical trials (studies), at DMC sites. Research Review is not an Institutional Review Board (IRB); instead, it conducts a screening process that allows the DMC to review proposed studies, budgets and performance site agreements in order to ensure that they are appropriately structured to comply with State and Federal regulations and DMC Policy.

The identification and review of research studies, their protocols and budgets allows the DMC to monitor regulatory compliance, including research-related billing and consent practices. The process is intended to assist both the investigator and the DMC in remaining in compliance with respect to regulations governing research and clinical trials.

All clinical research involving human subjects at a DMC site must also obtain IRB approval. The DMC IRB of record is the Wayne State University (WSU) Human Investigation Committee (HIC). Investigators may apply to the WSU-HIC prior to receiving DMC Research Review authorization. The WSU-HIC will review an investigator's protocol, but will not grant final approval of it until the proposed study is authorized by the DMC.

The DMC developed the Research Review website and online application process to expedite the review process. Research Review will complete its review of studies promptly upon the submission of the application and associated required materials. The DMC expects to complete all reviews within thirty (30) days. In most cases, the review process will be completed in five (5) to seven (7) days. Only the most complicated contracts may exhaust the thirty (30) day period. Upon DMC authorization, attainment of WSU-HIC approval and notification to relevant clinical service coordinators, the investigator may commence the study.

Investigators may visit the DMC Medical Investigators page to learn more about the review process, view the DMC Research Review Application and/or register to complete a Research Review Application.

Thomas Malone, M.D., Chief Medical Officer
Stanton Beatty, Esq., Chief Compliance & Governance Officer