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Biorepository Informed Consent Informational Sheet (editable PDF)

This illustrated biorepository informational sheet is designed to accompany the biorepository informed consent template . Click the button below to download the editable PDF document to your computer. Then edit and save the PDF to reflect the...

Tags: Regulatory

Guidance

Aug 29, 2018

Transition to 2018 Regulations

Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the " Common Rule ") were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The majority of changes are scheduled to go into effect on...

Policies

Aug 28, 2018

Statement of Practice: IRBMED Communication Methods for Study Teams

The IRBMED office prefers eResearch correspondence as a means of communication between IRBMED and study teams. Other communication options include phone, email, and in-person consultations. Click here for PDF version.

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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

Aug 14, 2015

External Adverse Event (AE) Reporting

This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non -UM investigators and non -UM IRBs , events about which the UM investigator receives a report, usually from the study sponsor...

Guidance

Oct 17, 2011

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications

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Biorepository Informed Consent Informational Sheet (editable PDF)

Transition to 2018 Regulations

Statement of Practice: IRBMED Communication Methods for Study Teams

Most Viewed

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

External Adverse Event (AE) Reporting

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications

Medical School Office of Research