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
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
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,...
Guidance
Mar 13, 2020

Urgent Amendment Procedures

Update March 16, 2020: The process outlined below for urgent Amendments is being temporarily suspended until further notice. IRBMED has published new procedures and a workflow diagram for time-sensitive and urgent modifications to active research...
Guidance
Apr 9, 2019

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...
Policies
Mar 11, 2019

Statement of Practice: PEERRS Certification Requirements

This document replaces the August 22, 2018 "PEERRS Certification Requirements" document. Click here for PDF version. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where...
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
Jun 11, 2018

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
May 30, 2018

Blood Draw Guidelines

The whole blood volume is used as a general guide in estimating reasonable volumes of blood that can be removed safely. The table below shows values for mean blood volume in children , men and women (Geigy Scientific Tables, 7th Ed; 1971): Whole...
Guidance
May 9, 2018

Payment to Research Subjects

The IRBMED reviewers look at each project individually in order to assess the risks and benefits involved. There is no set guideline regarding the total amount of payment investigators may give to study participants. Payments to subjects are not...
Guidance
May 7, 2018

Deception and Concealment

Deception in human subjects research means deliberately misleading subjects about the nature of a study. Concealment means deliberately withholding certain information. Studies involving deception or concealment must meet all criteria for a waiver...
Guidance
May 7, 2018

FDA Expanded Access Program at the University of Michigan

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...

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