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ORS assists faculty and staff in proposal development, review and endorsement of proposals, submission of electronic proposals, negotiation and execution of contracts, reporting, receipt and processing of the Notice of Awards (NOA), interpretation of sponsor guidelines, and ensuring compliance with both agency and University policies.
The Centers for Disease Control and Prevention provide information on human participant protection in clinical investigations involving human subjects and the use of drugs, biologics or devices.
The Office for the Protection of Research Subjects (OPRS) provides administrative support for the review and approval of research protocols (experiments) involving humans and human embryonic stem cells (hES).
FDA regulations and guidance documents are accessible from this site as well as international GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance.
The Partners.org virtual Regulatory Binder assists research sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research.
The purpose of the NIH Clinical Research Toolbox is to provide a Web-based information repository for investigators and staff involved in clinical research.
Investigators who need to translate a research protocol into lay language for informed consent documents and/or IRB submission may benefit from the University of Michigan’s "Simplification Guide to Medical Terms."
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Investigators can learn more about national clinical studies, including relevant history, policies, and laws.