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...

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...

According to U-M Human Research Protection Program (HRPP) and federal (OHRP) guidance, IRB review and approval is not required for activities that are limited to Quality Assurance and Quality Improvement (QA/QI) activities. However, IRB approval is...

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 Record retention must be consistent with IRB-approved methods for data...