Policies May 18, 2022 Statement of Practice: PEERRS Certification Requirements This document replaces the March 11, 2019 "PEERRS Certification Requirements" document. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where certification is not otherwise...
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 Oct 15, 2021 Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices... Tags: Study Coordinator Study Teams IRBMED Statement of Practice
Policies Jul 10, 2020 Statement of Practice: eResearch Cross-Reference Table IRBMED has developed the eResearch Cross-Reference Table and Guide to guide study team members, IRB staff, and IRB board members in achieving complete and consistent resolution of all IRB review contingencies. Click here for PDF version. Tags: IRBMED Statement of Practice
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 Aug 5, 2019 Statement of Practice: Ancillary Approval & Final IRBMED Approval Click here for PDF version .
Policies Aug 28, 2018 Statement of Practice: IRBMED Communication Methods for Study Teams The IRBMED office prefers eResearch correspondence as a means of communication between IRBMED and study teams. Other communication options include phone, email, and in-person consultations. Click here for PDF version.
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...
