Skip to main content
← U-M RESEARCH COMPLIANCE PROGRAMS ← Research A-Z Gateway ← Medical School Office of Research Homepage
University of Michigan Medical School Logo Medical School Office of Research A-Z Logo Logo
Research A to Z
  • Menu
  • Templates
  • SOPs
  • Guidance
  • Policies
  • Informational
  • Glossary
  • About
  • Login
Search Logo
Content Type
Topic
Unit

Can't find what you're looking for? You may need to login to see more documents.

Policies
Feb 27, 2014

Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study Documents . Click here for PDF version of the current document . When watermarking consent documents and recruitment...
Guidance
May 7, 2018

Expedited Review

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS...
Templates
Jul 20, 2018

Foreign Language Short Forms

Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a...
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
Jun 11, 2018

Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting

Investigators and research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and...
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
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...
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
Feb 17, 2017

Responsibility for REP Oversight and Compliance

REP application and Application Supplement Form capture several different levels and types of information about a repository's processes and intents, including: information characterizing a repository to identify useful relationships for researchers...
Guidance
Jun 11, 2018

Adverse Event Reporting

Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...
Guidance
Nov 2, 2020

FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...
Guidance
Nov 14, 2011

Complaints from Subject or Others about a Research Study

The table below presents instructions and guidance on reporting complaints from subjects or others.
Policies
Jun 15, 2017

Institutional Review Board Oversight Policy

This policy is to ensure that Central Biorepository (“CBR”) operations, and research projects facilitated by the CBR, undergo appropriate ethics committee review to protect human research subjects.
Guidance
Mar 2, 2022

Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments

Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance, limited English proficiency (LEP): insufficient understanding of English; Illiteracy or low literacy: a reading...
Templates
Jun 14, 2021

Standard Informed Consent Template

New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage. Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.
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...
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...
Guidance
Feb 17, 2017

Tips on the REP Application and Supplement Form

An REP application must include an Application Supplement Form, uploaded in Section 08 . The Application Supplement Form, in combination with the eResearch Repository application (REP), to provides a comprehensive overview of the repository's...
Guidance
Jun 17, 2011

AHRQ: Mandatory Use of Data Safety and Monitoring Plans

The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...
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...

Pages

  • « first
  • ‹ previous
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • next ›
  • last »

Office of Research
University of Michigan Medical School
1301 Catherine Street SPC 5624
Ann Arbor, MI 48109

North Campus Research Complex (NCRC)
2800 Plymouth Road Building 520, 3rd Floor
Ann Arbor, MI 48109-2800

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

US News Best Grad Schools 2018
University of Michigan
Michigan Medicine
U-M Medical School Learn more about U-M compliance »
© 2023The Regents of the University of Michigan -- U-M Gateway Non-Discrimination Policy -- Michigan Web Design by Boxcar Studio