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...
Guidance Apr 17, 2012 Federal Regulations - ARCHIVED 04/23/2021: This page has been archived.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 20, 2015 eResearch Regulatory Management (eRRM) eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.
Guidance Mar 8, 2013 Electronic Records and Electronic Signatures (21 CFR Part 11) - ARCHIVED 11/8/2021: This page has been archived.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 Oct 27, 2023 Other Reportable Information or Occurrence (ORIO) Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED . Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in...
Guidance Aug 14, 2023 Secondary Use research Secondary Use research is subject to IRB oversight if investigators "obtain identifiable private data or identifiable biospecimens.” This is because the regulatory definition of “human subjects research” is met whenever an investigator obtains, uses... Tags: MiChart Data Use Biorepository Use
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 28, 2022 Updating IRB applications when Researcher(s) Leave U-M When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in... Tags: Regulatory Principal Investigator
Guidance Aug 10, 2023 Reporting Time-Sensitive Modifications NOTE: The following guidance does not apply to studies where IRBMED is relying on an external IRB for regulatory oversight ("ceding" IRB oversight). If your study is ceded, you must reach out to the IRB of Record for guidance and then submit an...
Guidance May 13, 2022 Quality Assurance and Quality Improvement (QA/QI) Projects According to U-M Human Research Protection Program (HRPP) and federal (OHRP) guidance, IRB review and approval is not required for activities that are limited to Quality Assurance and Quality Improvement (QA/QI) activities. However, IRB approval is... Tags: Regulatory Study Teams
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...
Guidance Aug 10, 2020 Decedents Research involving data and/or biospecimens from decedents (deceased i ndividuals) is not regulated under the Common Rule. However, if you or any member of the study team will be accessing Protected Health Information (PHI) of the decedent(s), the...
Guidance Aug 31, 2020 Certification Preparatory to Research Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...
Guidance Sep 9, 2020 De-identified Data Sets NOTE : This page provides HIPAA -related guidance on “ de-identified data sets,” applicable only to data based on Protected Health Information (usually medical records). Other federal regulations enforced by the IRB have different standards and...
Guidance Mar 8, 2021 Children in Research The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow. Children are persons who have not attained the legal age for...
Guidance Sep 21, 2020 Waiver or Alteration of HIPAA Authorization To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...
Guidance Apr 16, 2015 Unanticipated Problems Involving Risks to Subjects or Others For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page. Also see the University of Michigan Human Research Protection Program...
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
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...
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
