Guidance
Aug 26, 2022

Radiation Exposure Guide

Ionizing radiation includes x-rays, beta-rays, gamma-rays, neutrons, and other high-speed particles. When subjects are exposed to ionizing radiation as part of their study activity, the risks incurred from radiation exposure must be assessed by the...
Tags: Regulatory Study Teams
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12/15/2021: This page has been archived.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
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
Feb 26, 2021

Elements and Uses of a Repository

A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...
Templates
Jan 13, 2014

Assent Template

(Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.
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 (...
Templates
Jun 14, 2021

Standard Informed Consent Template

New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage. Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.
Guidance
Aug 10, 2020

HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule governs the use and release of a patient's personal health information, also known as Protected Health Information (PHI) , by a covered entity . To use and/or disclose PHI...
Guidance
Apr 18, 2012

Who May Consent for Participation in Research Studies (Michigan)

Participant = Minor Participant = Incapacitated / Incompetent Adult Outpatient Psychotherapy Minor age 14 or over if seeking limited confidential outpatient psychotherapy services under M.C.L. §330.1707 Parent(s)* with legal custody or guardian† See...
Guidance
May 3, 2021

Single IRB (sIRB) and Cooperative Multi-Site Research

sIRB Timing, Fees and Budgeting When requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date. See section “IRBMED as the sIRB (accepting oversight)” of this guidance...
Tags: Regulatory Sponsor
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...
Guidance
Aug 10, 2020

Uses & Disclosures of Protected Health Information (PHI)

Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...

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