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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
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...
Guidance
Jun 4, 2021

Information Blocking in a Blinded Study

Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes...
Tags: MiChart OnCore Support Participant Management
Policies
Mar 2, 2022

Statement of Practice: HIPAA and U-M study team members outside Michigan Medicine in eResearch applications

Consult guidance from Michigan Medicine Corporate Compliance Office (level-2 login or VPN required) and IRBMED for general definitions (PHI, HIPAA, Covered Entity, etc.) and concepts. The vast majority of studies subject to IRBMED oversight involve...
Tags: Study Coordinator Principal Investigator Study Teams IRBMED Statement of Practice
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
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
Policies
Nov 17, 2022

Statement of Practice: IRBMED Communication Methods for Study Teams

The IRBMED office prefers eResearch correspondence as a means of communication between IRBMED and study teams. Other communication options include phone, email, and in-person consultations. Click here for PDF version.
Guidance
Mar 6, 2012

Accessing Medical Records

When requesting records the requestor must be listed on the approved IRB, provide the IRB# and approval letter. Medical record requests for research /review will be imaged and viewable in CareWeb . Health Information Management will generally image...
Guidance
Mar 12, 2012

Study-Specific AE Reporting

Click to review previous steps Step 1 Step 2 Refer to the IRB - approved documents for the specific study that includes a detailed plan for AE reporting . Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB , sponsor, IRB...
Policies
Oct 15, 2021

Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...
Tags: Study Coordinator Study Teams IRBMED Statement of Practice
Guidance
Nov 11, 2019

External (non-UM) Study Team Members

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
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
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
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
Mar 2, 2022

Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments

Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance, limited English proficiency (LEP): insufficient understanding of English; Illiteracy or low literacy: a reading...
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
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
Apr 8, 2013

Lotteries as Incentives for Research Participation

Researchers may incentivize study subjects by entering their names in a lottery operated by the study team. If a study’s incentive budget is small, a lottery allows one subject, drawn at random from the pool, to receive the full amount of the...
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...

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