New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage. Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.

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...

This guidance document outlines IRB expectations for research involving genetic analysis which generates human genetic information through analysis of human biospecimens. For this guidance, the relevant human genetic information includes heritable...

Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance, limited English proficiency (LEP): insufficient understanding of English; Illiteracy or low literacy: a reading...

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...

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies .

This document provides guidance on completing the IRB application and the informed consent document(s) for IRBMED applications (under IRBMED oversight) that are planning to collect data/biospecimens directly from research participants with an...