Guidance
Aug 16, 2012

Forms

The forms below are designed for use with various IRBMED submissions.
SOPs
Jul 14, 2020

IRBMED Standard Operating Procedures

The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM) . The IRBMED Standard Operating Procedures serve as a reference for investigators , IRBs,...
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...
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
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
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...
Templates
May 4, 2018

Data Office Data Request Form

To request data, complete a Data Request Form, which includes IRB information (if applicable), study team information and where you will store your data. Note: You may save your work and submit at a later time
Tags: Data Use
Templates
Apr 17, 2018

Survey Research Informed Consent Template

This template should be used when creating a Survey Research informed consent document. This template may be used only for studies that involve a survey and no other procedures pose minimal risk to subjects
Templates
Mar 13, 2018

Data Office Data Set Specification

To request data, complete a Data Set Specification to define your subject population (inclusion/ exclusion criteria) and the data elements needed in your data set. Note: You may save your work and submit at a later time
Tags: Data Use
Templates
Mar 13, 2018

Data Office Access Request Form

Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at dataoffice@umich.edu .
Tags: Data Use
Guidance
Nov 6, 2015

Certificates of Confidentiality

Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on...
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.
Templates
Jul 9, 2018

CBR Use Proposal Form

Central Biorepository staff will use the information you provide in this form to make contact with the investigator(s) who collected the materials that might be useful to your project, begin to identify candidate samples, and assess and advise on...
Tags: Access
Templates
Jul 8, 2020

Exempt Consent Template

The expectation for all human subject research—whether exempt or not—is for researchers to inform the subjects regarding the research and seek/secure the consent of subjects. Use this consent template for Exempt studies requiring Limited IRB review...
Tags: Study Teams
Templates
Apr 17, 2018

Eligibility Screening Informed Consent Template

This template should be used when creating an Eligibility Screening Informed Consent document. This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects. You may not use this...

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