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Guidance
Sep 13, 2021

Protocol Resources

The study protocol should comprise all the key information about study conduct, including but not limited to rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study...
Tags: Protocol Regulatory Study Coordinator Study Teams U-M resource
Guidance
Nov 14, 2011

Protocol Deviations, Exceptions, Violations

This table summarizes types of protocol deviations , exceptions, and violations that should be reported to IRBMED as ORIOs.
Guidance
Jun 1, 2018

Emergency Research (Planned and Approved) with Exception from Informed Consent

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency...
Policies
Feb 27, 2020

Privacy and Confidentiality Protections for Individual-Level Data Policy

This policy operates subject to all applicable laws, regulations, and U-M policies regarding protection of clinical and research data. It sets standards specific to Central Biorepository (CBR) operations in accordance with sound ethical principles...
Tags: Data Use Biorepository Use
Guidance
Mar 8, 2021

Record Keeping Guidelines

Research records include, but may not be limited to, consent forms case report forms (CRFs) subject-specific forms for adverse events, notes to file, and protocol deviations Records may be kept in hard-copy or electronically. Record retention must...
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12/15/2021: This page has been archived.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
Jun 7, 2021

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
Feb 16, 2022

Research Involving Genetic, Genomic, and/or DNA Collection or Analysis

This guidance document outlines IRB expectations for research involving genetic analysis which generates or uses human genetic information through analysis of human biospecimens and/or data. For this guidance, the relevant human genetic information...
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
Dec 15, 2020

Reporting Time-Sensitive Modifications

PDF Version Revised 12/14/2020 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...
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...
Policies
Mar 23, 2018

Indirect Cost Recovery

The Medical School's expectations regarding the recovery of indirect costs from Federal, Industry/For-Profit, and Non-Profit sponsor s.
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
Jul 23, 2021

Multi-Site and Performance Site applications: Reporting to IRBMED

This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M is a coordinating center is not the single IRB (sIRB)/IRB of record/reviewing IRB for sites other than U-M...
Tags: Study Coordinator CTSO Work Guide
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
Nov 14, 2011

Complaints from Subject or Others about a Research Study

The table below presents instructions and guidance on reporting complaints from subjects or others.
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
Aug 14, 2015

External Adverse Event (AE) Reporting

This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non -UM investigators and non -UM IRBs , events about which the UM investigator receives a report, usually from the study sponsor...
Policies
Feb 18, 2015

Statement of Practice: External Adverse Event Reports & Unanticipated Problems

Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...
Guidance
Apr 10, 2018

Clinical Research Billing Guidance (CRB)

The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at...

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Office of Research
University of Michigan Medical School
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Ann Arbor, MI 48109

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Phone: 734-615-1332
Fax: 734-615-9458
Email: ummsresearch@umich.edu

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