Guidance Feb 15, 2023 Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements This document provides guidance on the monitoring requirements for non-significant risk (NSR) device studies that are initiated by UM investigators and under IRBMED oversight . It also provides instructions on completing the IRB application for the... Tags: Regulatory Study Coordinator Principal Investigator MICHR Study Teams Investigator Initiated
Guidance Aug 31, 2022 Emergency Research (Planned and Approved) with Exception from Informed Consent Overview The Food and Drug Administration (FDA) regulation at 21 CFR 50.24 , and Office for Human Research Protections (OHRP) Secretary's Waiver , allows a narrow exception to the requirement to prospectively obtain and document informed consent... Tags: Regulatory
Guidance Aug 22, 2022 Emergency Use of a Test Article in Life-Threatening Circumstances This guidance describes the circumstances regarding Emergency Use of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product. Emergency... Tags: Regulatory MICHR Investigator Initiated
Guidance Dec 15, 2021 Waivers and Alterations under OHRP, FDA and HIPAA Common Rule regulations and FDA guidance , and HIPAA regulations each allow for an IRB to approve research that departs from the usual requirements regarding the participant’s free and informed decision to participate in the study, or regarding the...
Guidance Dec 15, 2021 Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. This guidance is intended for research studies that...
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 May 11, 2020 Humanitarian Use Device Requirements for U-M Physicians & Investigators The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals...
Templates May 11, 2020 Humanitarian Use Device (HUD) Informed Consent Template This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...
Policies Nov 21, 2019 University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-... Tags: MICHR
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 UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...
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...
Templates Mar 29, 2017 FDA Expanded Access Informed Consent Template This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...
Guidance Mar 8, 2013 Electronic Records and Electronic Signatures (21 CFR Part 11) - ARCHIVED 11/8/2021: This page has been archived. UMMS Regulatory Affairs maintains documentation regarding FDA Part 11 compliance at Data Integrity and Sharing (level-2 login required). The regulations in 21 CFR Part 11 set forth the criteria under which FDA...
Guidance Apr 17, 2012 Federal Regulations - ARCHIVED 04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...
Guidance Jul 10, 2020 eResearch Cross-Reference Table These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...
