Templates
May 11, 2020

Humanitarian Use Device (HUD) Informed Consent Template

This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...
Guidance
Mar 13, 2020

Urgent Amendment Procedures

Update March 16, 2020: The process outlined below for urgent Amendments is being temporarily suspended until further notice. IRBMED has published new procedures and a workflow diagram for time-sensitive and urgent modifications to active research...
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
Jul 1, 2019

Grants Processing Deadline

The Medical School Grant Services & Analysis (GS&A) Office requests that all proposals be submitted to the office ten (10) business days prior to the sponsor's proposal deadline. This includes the cumulative time needed for both the Medical...
Guidance
Jun 25, 2019

SINGLE IRB AND MULTI-SITE RESEARCH (MSR)

Multi-site research (MSR) means that multiple participating sites are involved in supporting the conduct of the same research protocol. However, not all participating sites may perform the same functions to support the conduct of the research...
Tags: Regulatory
Guidance
Apr 17, 2019

De-identified Data Sets

NOTE : This page provides HIPAA -related guidance on “ de-identified data sets,”applicable only to data based on Protected Health Information (usually medical records). Other federal regulations enforced by the IRB have different standards and...
Guidance
Apr 17, 2019

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...
Guidance
Apr 9, 2019

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...
Policies
Mar 11, 2019

Statement of Practice: PEERRS Certification Requirements

This document replaces the August 22, 2018 "PEERRS Certification Requirements" document. Click here for PDF version. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where...
Guidance
Jan 18, 2019

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...
Guidance
Jan 16, 2019

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
Jan 16, 2019

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 ]. The federal exemption categories are revised and expanded as part of Revised Common Rule (...
Guidance
Jan 16, 2019

Transition to 2018 Regulations

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...

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