Guidance Jul 29, 2020 Seeking Reconsent from Research Participants Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...
Guidance Jul 22, 2020 Study-Specific Adverse Event (AE) Reporting Plans The IRBMED Standard Adverse Event (AE) Reporting Timetable is designed to accommodate a wide range of study designs and risk levels. These standard guidelines apply only to IRBMED reporting; they do not apply to reporting that may be required by...
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...
Guidance Jan 16, 2019 Transition to 2018 Regulations - ARCHIVED 04/23/2021: This page has been archived.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 Jun 11, 2018 Adverse Event Reporting Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...
Guidance Jun 11, 2018 Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting Investigators and research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and...
Guidance May 22, 2018 UMMS Biorepository Registration Decision Tree This decision tree represents UMMS policy for registration of biorepositories funded by a UMMS Department , and/or operating in UMMS space, and/or directed by faculty with an appointment in the Medical School. For more information, see Medical...
Guidance May 7, 2018 Expedited Review The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS...
Guidance May 7, 2018 Deception and Concealment Deception in human subjects research means deliberately misleading subjects about the nature of a study. Concealment means deliberately withholding certain information. Studies involving deception or concealment must meet all criteria for a waiver...
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 Feb 1, 2018 Exempt Under OHRP/FDA, but Regulated by HIPAA Applications - ARCHIVED 04/23/2021: This page has been archived. Please refer to the more comprehensive Exempt human subjects research and Federal Exemption Categories pages.
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...
Guidance Jun 5, 2017 Telephonic Consent - ARCHIVED 12/15/2021: This page has been archived. See Electronic Informed Consent and Waivers under OHRP, FDA and HIPAA pages for up-to-date information on similar topics. In most cases, a potential research subject (or subject's representative) must be...
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 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 Feb 17, 2017 Repository Overview Data and biospecimen repositories (sometimes called registries, banks , or libraries) are used to store data, with or without biospecimens, for future research use. Federal regulations and U-M policies that protect the privacy of patients and...
Guidance Dec 6, 2016 Evaluation, Screening and Diagnostic Testing for Determination of Clinical Trial Eligibility Many investigators have expressed uncertainty concerning when consent should be obtained from a subject who is being evaluated for possible eligibility to participate in one or more clinical trials. The following guidance has been developed to...
Guidance Jul 14, 2016 Resources - ARCHIVED 07/12/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant internal and external resource websites. The lists below provide direct links to resources both within the University of Michigan and outside the...
