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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When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications.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

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

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

Policies

May 18, 2022

Statement of Practice: PEERRS Certification Requirements

This document replaces the March 11, 2019 "PEERRS Certification Requirements" document. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where certification is not otherwise...

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

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

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

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

Jan 3, 2022

Blood Draw Guidance

Blood draws for research purposes should be limited to the smallest necessary volume. Maximum blood draw volumes for research should also take into account blood drawn for clinical care. Investigators should coordinate with clinical teams regarding...

Tags: Study Coordinator

Templates

Nov 25, 2021

Specialty Informed Consent Templates

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if...

Tags: Regulatory Study Coordinator Principal Investigator Participant Management Study Teams

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

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

Jul 23, 2021

Payment to Research Participants

The IRBMED reviews the amount of payment, the proposed method, and timing of disbursement of payments investigators give to study participants to assure that they do not present undue influence [ 45 CFR 46 .116, 21 CFR 50 .20]. There is no set...

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

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

Guidance

Mar 19, 2021

Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity

Guidance

Mar 18, 2021

Assent of Children in Research

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. Links to additional information are...

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

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 Record retention must be consistent with IRB-approved methods for data...

Tags: Regulatory Study Coordinator Study Teams

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