Human Subjects Research Resources

This page contains quick links to U-M IRBs, U-M policies, and external websites related to human subjects research that ORCR frequently references when working with investigators and U-M units.

References and Resources

IRBMED U-M Medical School Institutional Review Board (IRBMED)
IRB-HSBS U-M Health Science and Behavioral Science Intitutional Review Board
U-M Policy on Misconduct SPG 303.-03 - Policy Statement on the Integrity of Scholarship and Procedures for Investigating Allegations of Misconduct in the Pursuit of Scholarship and Research
U-M Policy on Research with Human Subjects SPG 303.05 Policy on Research with Human Participants
U-M Policy on Information Security Incident Reporting SPG 601.25 Information Security Incident Reporting Policy
U-M Policy on Information Security SPG 601.27 Information Security Policy
U-M Policy on Personally Owned Devices SPG 601.33 Security of Personally Owned Devices That Access or Maintain Sensitive Institutional Data
U-M IT Information on Safe Computing IT Information on Safe Computing
U-M Ethics, Integrity & Compliance
Data Sharing Resource Center For questions on data sharing agreement, data management plans, data use agreements, etc.
Office of Research and Sponsored Projects (ORSP)
HRPP Operations Manual (OM)
eResearch eResearch is the University of Michigan's site for electronic research administration.
Food and Drug Administration (FDA)
FDA Guidance Documents and Notices Links to the FDA's webpage to search for FDA guidance documents.
FDA Forms
FDA Warning Letters
Health Insurance Portability and Accountability Act (HIPAA)
ICH E6(R2) Good Clinical Practice
Office of Human Research Protections (OHRP) OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research.
OHRP Guidance Documents
OHRP Determination Letters
Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
MICHR Education and Mentoring Educational sessions for study coordinators.
IRBMED Collaborative U-MIC Online educational materials for IRB members and researchers.

Questions?

If you have any questions about how these policies relate to U-M ORCR or HRPP processes, please send a message to orcr-deptemail@umich.edu.

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