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.

Guidance
Jun 7, 2021

Other Reportable Information or Occurrence (ORIO)

Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED . Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in...
Guidance
Jun 4, 2021

Information Blocking in a Blinded Study

Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes...
Tags: MiChart OnCore Support Participant Management
Guidance
May 3, 2021

Single IRB (sIRB) and Cooperative Multi-Site Research

sIRB Timing, Fees and Budgeting When requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date. See section “IRBMED as the sIRB (accepting oversight)” of this guidance...
Tags: Regulatory Sponsor
Guidance
Mar 19, 2021

Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity

Guidance
Mar 18, 2021

Assent of Children in Research

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. Links to additional information are...
Guidance
Mar 8, 2021

Children in Research

The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow. Children are persons who have not attained the legal age for...
Guidance
Mar 8, 2021

Record Keeping Guidelines

Research records include, but may not be limited to, consent forms case report forms (CRFs) subject-specific forms for adverse events, notes to file, and protocol deviations Record retention must be consistent with IRB-approved methods for data...
Tags: Regulatory Study Coordinator Study Teams
Guidance
Feb 26, 2021

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...
Guidance
Feb 22, 2021

International Council for Harmonisation: Good Clinical Practice (ICH-GCP)

The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6(R2) Guidelines. International Council for Harmonisation (ICH) Good Clinical Practice ( GCP ) standards (ICH-GCP) standards are fully...
Guidance
Dec 18, 2020

Investigational In Vitro Diagnostics (IVDs) utilized in Clinical Investigations of Therapeutic Products

Human subjects research applications received by IRBMED include clinical investigations of therapeutic products that propose to utilize in vitro diagnostic (IVD) tests or assays. PDF version
Informational
Dec 17, 2020

Guidance for Writing HUM Applications for Creating a Biorepository 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 creating a biospecimen collection. IRBMED may require more information...
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...
Guidance
Dec 15, 2020

Reporting Time-Sensitive Modifications

PDF Version Revised 12/14/2020 NOTE: The following guidance does not apply to studies where IRBMED is relying on an external IRB for regulatory oversight ("ceding" IRB oversight). If your study is ceded, you must reach out to the IRB of Record for...
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
Oct 21, 2020

Prisoners in Research

Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...
Guidance
Sep 21, 2020

Waiver or Alteration of HIPAA Authorization

To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...
Guidance
Sep 9, 2020

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
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

HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule governs the use and release of a patient's personal health information, also known as Protected Health Information (PHI) , by a covered entity . To use and/or disclose PHI...
Guidance
Aug 10, 2020

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...

Pages

  • « first
  • ‹ previous
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 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