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...

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 Records may be kept in hard-copy or electronically. Record retention must...

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...

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...

Updated February 8, 2021 Note: If 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...

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...

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...

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)...

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...