Policies Mar 2, 2022 Statement of Practice: HIPAA and U-M study team members outside Michigan Medicine in eResearch applications Consult guidance from Michigan Medicine Corporate Compliance Office (level-2 login or VPN required) and IRBMED for general definitions (PHI, HIPAA, Covered Entity, etc.) and concepts. The vast majority of studies subject to IRBMED oversight involve... Tags: Study Coordinator Principal Investigator Study Teams IRBMED Statement of Practice
Policies Feb 27, 2020 Privacy and Confidentiality Protections for Individual-Level Data Policy This policy operates subject to all applicable laws, regulations, and U-M policies regarding protection of clinical and research data. It sets standards specific to Central Biorepository (CBR) operations in accordance with sound ethical principles... Tags: Data Use Biorepository Use
Policies Mar 19, 2018 Consent and HIPAA Privacy Rule Authorization Policy This policy aims to ensure that donor preferences are given due respect in the conduct of research projects that are facilitated by the Central Biorepository (CBR). It operates subject to the UMMS Policy Governing Tissue Sample Collection, Ownership... Tags: Data Use Biorepository Use
Policies Jun 15, 2017 Institutional Review Board Oversight Policy This policy is to ensure that Central Biorepository (“CBR”) operations, and research projects facilitated by the CBR, undergo appropriate ethics committee review to protect human research subjects.