All | Research A to Z

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

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...

Guidance

Feb 19, 2016

International Research

In order for UM researchers to conduct a research project outside of the U.S., the foreign host hospital/research center must negotiate an International Assurance Agreement with the Office of International Activities (OIA) in the Office of Human...

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...

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 18, 2015

Statement of Practice: External Adverse Event Reports & Unanticipated Problems

Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...

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 19, 2021

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

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...

Guidance

Jun 5, 2017

Telephonic Consent - ARCHIVED

12/15/2021: This page has been archived. See Electronic Informed Consent and Waivers under OHRP, FDA and HIPAA pages for up-to-date information on similar topics. In most cases, a potential research subject (or subject's representative) must be...

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...

Guidance

Dec 6, 2016

Evaluation, Screening and Diagnostic Testing for Determination of Clinical Trial Eligibility

Many investigators have expressed uncertainty concerning when consent should be obtained from a subject who is being evaluated for possible eligibility to participate in one or more clinical trials. The following guidance has been developed to...

Guidance

Nov 14, 2011

Protocol Deviations, Exceptions, Violations

This table summarizes types of protocol deviations , exceptions, and violations that should be reported to IRBMED as ORIOs.

Guidance

Jan 3, 2022

Blood Draw Guidance

Blood draws for research purposes should be limited to the smallest necessary volume. Maximum blood draw volumes for research should also take into account blood drawn for clinical care. Investigators should coordinate with clinical teams regarding...

Tags: Study Coordinator

Guidance

May 11, 2012

Recruitment Advertising

Advertisements for recruiting potential research subjects can take many shapes. Examples include: flyers in a hospital hallway or on a student union bulletin board; newspaper, radio or television ads; direct mailings; electronic mail announcements;...

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