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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...
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

Limited Data Sets

Research on coded private information , or on non-identifiable information, is not regulated under the Common Rule . However, HIPAA Privacy Rule protections apply if a coded or non-identifiable data set contains Protected Health Information (PHI) in...
Guidance
Jul 29, 2020

Seeking Reconsent from Research Participants

Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...
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...
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,...
Policies
Jul 10, 2020

Statement of Practice: eResearch Cross-Reference Table

IRBMED has developed the eResearch Cross-Reference Table and Guide to guide study team members, IRB staff, and IRB board members in achieving complete and consistent resolution of all IRB review contingencies. Click here for PDF version.
Tags: IRBMED Statement of Practice
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
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
May 11, 2020

Humanitarian Use Device Requirements for U-M Physicians & Investigators

The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals...
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...
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
Policies
Feb 12, 2020

Statement of Practice: IRBMED Finalization of Study Documents

This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.
Tags: IRBMED Statement of Practice
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
Nov 21, 2019

University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...
Tags: MICHR
Guidance
Nov 11, 2019

External (non-UM) Study Team Members

Policies
Aug 5, 2019

Statement of Practice: Ancillary Approval & Final IRBMED Approval

Click here for PDF version .
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
Feb 15, 2019

FAQ: Repository application (REP)

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Office of Research
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Ann Arbor, MI 48109

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Ann Arbor, MI 48109-2800

Phone: 734-615-1332
Fax: 734-615-9458
Email: ummsresearch@umich.edu

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