To request data, complete a Data Request Form, which includes IRB information (if applicable), study team information and where you will store your data. Note: You may save your work and submit at a later time

This document replaces the March 11, 2019 "PEERRS Certification Requirements" document. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where certification is not otherwise...

Researchers may incentivize study subjects by entering their names in a lottery operated by the study team. If a study’s incentive budget is small, a lottery allows one subject, drawn at random from the pool, to receive the full amount of the...

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...

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...

Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...

To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if...