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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
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
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...
Policies
Feb 3, 2020

Statement of Practice: Flexibility Initiatives

The University of Michigan's federalwide assurance with the Department of Health and Human Services (HHS) allows the IRB flexibility in its application of federal regulations to studies not federally funded or FDA-regulated. Click here for PDF...
Policies
Aug 28, 2018

Statement of Practice: Interpretation of Expedited Category (8)

Expedited Category (8) pertains to the continuing review of research, regardless of its previously determined risk level. The IRB member performing expedited review under category 8 must determine that the ongoing and future research activity...
Policies
Aug 28, 2018

Statement of Practice: Interpretation of Expedited Category (5)

Expedited Category (5) pertains to research involving data/materials that have been collected previously for research or non-research purposes and/or will be collected solely for non-research purposes, provided that certain criteria are met. Click...
Templates
Apr 17, 2018

One-Time Blood or Tissue Sample (Minimal Risk) Informed Consent Template

This template should be used when creating a One-Time Blood or Specimen Sample ( Minimal Risk ) informed consent document. You may not use this template if you plan to conduct genetic analysis on subjects’ samples you plan to submit subjects’...
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...
Policies
May 1, 2015

Statement of Practice: Flexibility Initiative: Two-Year Approvals - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted a two-year approval may not be used to support proposals or future awards involving federal funding. Click here...
Policies
May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...
Policies
May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 2A - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Click here for PDF version.
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
Nov 21, 2012

Guidance for Blinded Studies

Guidance
May 11, 2012

Recruitment Advertising

Advertisements for recruiting potential research subjects can take many shapes. Examples include: flyers in a hospital hallway or on a student union bulletin board; newspaper, radio or television ads; direct mailings; electronic mail announcements;...
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
Jul 24, 2007

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

The probability* and magnitude of harm or discomfort anticipated in the research and not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or...
Guidance
Sep 5, 2005

Research and Non-English Speaking or Reading Subjects

Many patients at the University of Michigan Health System do not speak English or lack the fluency to understand medical and scientific information presented in English. In order for such a patient to participate in a research study, steps must be...
Guidance
May 5, 2002

IRBMED Guidance for IRB Reviewers and Medical School Investigators Regarding Genetic/DNA Research Studies

January 2015: This 2007 guidance is under revision. Certain passages may not reflect current IRBMED views and recommendations. The following is a list of issues that should be considered when reviewing protocols and informed consent documents...

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