SOPs Sep 22, 2022 IRBMED Standard Operating Procedures The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM) . The IRBMED Standard Operating Procedures serve as a reference for investigators , IRBs,...
Informational Dec 17, 2020 Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for secondary use of biospecimens. IRBMED may require more information from...
Guidance Feb 19, 2016 International Research In order for UM researchers to conduct a research project outside of the U.S., the foreign host hospital/research center must negotiate an International Assurance Agreement with the Office of International Activities (OIA) in the Office of Human...
Policies Dec 14, 2023 Required Use of Clinical Research Coordinator Career Ladder This policy outlines the required use of the Clinical Research Coordinator (CRC) career ladder. Tags: Study Coordinator
Guidance Dec 18, 2020 Investigational In Vitro Diagnostics (IVDs) utilized in Clinical Investigations of Therapeutic Products Human subjects research applications received by IRBMED include clinical investigations of therapeutic products that propose to utilize in vitro diagnostic (IVD) tests or assays. PDF version
Guidance Feb 17, 2017 Responsibility for REP Oversight and Compliance REP application and Application Supplement Form capture several different levels and types of information about a repository's processes and intents, including: information characterizing a repository to identify useful relationships for researchers...
Guidance Nov 6, 2015 Certificates of Confidentiality Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on...
Guidance May 7, 2018 FDA Expanded Access Program at the University of Michigan For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing [email protected] The FDA Expanded Access program allows a...
Policies Dec 9, 2016 Institutional Cost Sharing This policy describes the process and conditions for obtaining a research cost share commitment from the Medical School Dean’s Office, Hospital and Health Center, or EVPMA . It also addresses the process for Medical School units seeking a cost share...
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 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...
Guidance Aug 14, 2023 Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance, limited English proficiency (LEP): insufficient understanding of English; Illiteracy or low literacy: a reading...
Guidance Feb 26, 2021 Elements and Uses of a Repository A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...
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 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...
Guidance Feb 17, 2017 Tips on the REP Application and Supplement Form An REP application must include an Application Supplement Form, uploaded in Section 08 . The Application Supplement Form, in combination with the eResearch Repository application (REP), to provides a comprehensive overview of the repository's...
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 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.
Guidance Sep 13, 2023 Research Involving Genetic, Genomic, and/or DNA Collection or Analysis This guidance document outlines IRB expectations for research involving genetic analysis which generates human genetic information through analysis of human biospecimens. For this guidance, the relevant human genetic information includes heritable...