Guidance Nov 2, 2020 FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...
Guidance Oct 21, 2020 Prisoners in Research Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...
Guidance Aug 10, 2020 Uses & Disclosures of Protected Health Information (PHI) Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...
Guidance Jul 8, 2020 Federal Exemption Categories Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [ 45 CFR 46.104 ]. See also OHRP's Human Subject Regulations Decision Charts: 2018 Requirements The federal...
Guidance Jul 8, 2020 Exempt Human Subjects Research This page contains information regarding human subjects research that falls within the federal exemption categories or U-M exemption categories . Exempt human subjects research does require an application and determination in the eResearch system...
Policies Jun 18, 2020 Use and Distribution of Biospecimens and Data Policy The University of Michigan Medical School (“UMMS”) Central Biorepository (“CBR”) is a repository of human biospecimens that serves as central storage facility, point of research access, and administrative hub for research using these biospecimens... 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...
Guidance Jan 16, 2019 Transition to 2018 Regulations - ARCHIVED 04/23/2021: This page has been archived. This transition is largely complete. All new applications are evaluated according to 2018 Revised Common Rule. With questions, contact your IRB staff. On January 21, 2019 most provisions of the Revised Common...
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...
Templates Jul 20, 2018 Foreign Language Short Forms Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a...
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...
Templates Apr 17, 2018 One-Time Blood or Tissue Sample (Minimal Risk) Informed Consent Template This template should be used when creating a One-Time Blood or Specimen Sample ( Minimal Risk ) informed consent document. You may not use this template if you plan to conduct genetic analysis on subjects’ samples you plan to submit subjects’...
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). This policy operates subject to the University of Michigan Medical School Policy for... Tags: Data Use Biorepository Use
Guidance Jan 3, 2018 NIH Genomic Data Sharing Policy All U-M IRBs ( IRBMED , IRB-HSBS , IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing. Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance...
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...
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...
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...
