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 Jun 18, 2020 Use and Distribution of Biospecimens and Data Policy This policy operates subject to the Medical School Governing UMMS Research Biorepositories Policy ("Research Biorepositories Policy") and applies to all Central Biorepository (CBR) resources. This policy establishes a framework for appropriate... Tags: Data Use Biorepository Use
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 Feb 12, 2020 Statement of Practice: IRBMED Finalization of Study Documents This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version. Tags: IRBMED Statement of Practice
Policies Feb 3, 2020 Statement of Practice: Flexibility Initiatives The University of Michigan's federalwide assurance with the Department of Health and Human Services (HHS) allows the IRB flexibility in its application of federal regulations to studies not federally funded or FDA-regulated. Click here for PDF...
Policies Aug 28, 2018 Statement of Practice: Interpretation of Expedited Category (8) - ARCHIVE 04/23/2021: This page has been archived, as it no longer fully reflects IRBMED practice. Expedited Category (8) pertains to the continuing review of research, regardless of its previously determined risk level. The IRB member performing expedited...
Policies Aug 28, 2018 Statement of Practice: Interpretation of Expedited Category (5) Expedited Category (5) pertains to research involving data/materials that have been collected previously for research or non-research purposes and/or will be collected solely for non-research purposes, provided that certain criteria are met. Click...
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.
Policies May 26, 2017 Statement of Practice: Sections 15 and 16 of IRB Application Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...
Policies May 1, 2015 Statement of Practice: Flexibility Initiative: Two-Year Approvals - ARCHIVED This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted a two-year approval may not be used to support proposals or future awards involving federal funding. Click here...
Policies May 1, 2015 Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...
Policies May 1, 2015 Statement of Practice: Flexibility Initiative: Exemption 2A - ARCHIVED This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Click here for PDF version.
Policies Feb 18, 2015 Statement of Practice: External Adverse Event Reports & Unanticipated Problems Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...
