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Institutional Review Board - Health Sciences & Behavioral Sciences
- Continuing Review Process
- Data Security Guidelines
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including system generated determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Incident Reporting (AE/ORIO)
- Informed Consent Guidelines & Templates
- Introduction to Human Subjects Research Protection: A Guide for Student Investigators Last Updated: March 2019
- IRB Amendment Process
- IRB Application Process
- IRB Health Sciences and Behavioral Sciences (HSBS)
- IRB Repository Application Supplement Template that outlines the information necessary for IRB review of a U-M data/biospecimen repository. Complete and upload to the IRB Repository Application within the eResearch Regulatory Management System (eRRM).
- IRB Repository Application: eResearch Job Aids Webpage with links to step-by-step instructions to create and submit an REP, amend an REP, file a continuing review, and terminate an REP. Provided by ITS.
- IRB Review Process
- IRB-HSBS Education
- IRB-HSBS Exempt Protocol Template A suggested brief template for exempt protocols.
- IRB-HSBS: Key Changes to the Common Rule IRB-HSBS general session presentation (updated 10/12/2017) explaining key changes in the 2018 Common Rule (Regulations for the Protection of Human Subjects ~ 45 CFR 46)
- OHRP Repository Guidance Issues to Consider in the Research Use of Stored Data or Tissues (1997)
- Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.