All | Research A to Z

Guidance

May 7, 2018

FDA Expanded Access Program at the University of Michigan

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...

Templates

Mar 29, 2017

FDA Expanded Access Informed Consent Template

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...

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...

Guidance

Mar 6, 2012

Accessing Medical Records

When requesting records the requestor must be listed on the approved IRB, provide the IRB# and approval letter. Medical record requests for research /review will be imaged and viewable in CareWeb . Health Information Management will generally image...

Guidance

Apr 17, 2012

Federal Regulations - ARCHIVED

04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...

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

Informational

Dec 17, 2020

Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR

This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for secondary use of biospecimens. IRBMED may require more information from...

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

Policies

Feb 27, 2020

Privacy and Confidentiality Protections for Individual-Level Data Policy

This policy operates subject to all applicable laws, regulations, and U-M policies regarding protection of clinical and research data. It sets standards specific to Central Biorepository (CBR) operations in accordance with sound ethical principles...

Tags: Data Use Biorepository Use

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 (...

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 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...

Policies

Jun 18, 2020

Use and Distribution of Biospecimens and Data Policy

This policy operates subject to the Medical School Governing UMMS Research Biorepositories Policy ("Research Biorepositories Policy") and applies to all Central Biorepository (CBR) resources. This policy establishes a framework for appropriate...

Tags: Data Use Biorepository Use

Guidance

Feb 17, 2017

Repository Overview

Data and biospecimen repositories (sometimes called registries, banks , or libraries) are used to store data, with or without biospecimens, for future research use. Federal regulations and U-M policies that protect the privacy of patients and...

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...

Guidance

Aug 10, 2020

Protected Health Information (PHI)

Policies

Oct 15, 2021

Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...

Tags: Study Coordinator Study Teams IRBMED Statement of Practice

Guidance

Mar 8, 2013

Electronic Records and Electronic Signatures (21 CFR Part 11) - ARCHIVED

11/8/2021: This page has been archived. UMMS Regulatory Affairs maintains documentation regarding FDA Part 11 compliance at Data Integrity and Sharing (level-2 login required). The regulations in 21 CFR Part 11 set forth the criteria under which FDA...

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

Apr 10, 2018

Clinical Research Billing Guidance (CRB)

The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at...

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