Institutional Review Board

COVID-19 and Human Research Studies at RFUMS

UPDATE AS OF 4/21/2022

The University and Dr. Kaplan's office have agreed that investigators can resume in-person human subjects research.

In an effort to prioritize health and safety during the ongoing spread of COVID-19 in human participant research interactions, all investigators should follow the University’s COVID-19 protocols and safety measures.  
https://dev.rosalindfranklin.edu/covid19/what-you-need-to-know/

The University mask policies are consistent with current guidelines issued by the U.S. Centers for Disease Control and Prevention, along with those of state and local authorities. 

Investigators who submit new IRB applications should state explicitly in their applications how they are adhering to the University’s COVID-19 protocols. If the study or components of the study will not allow for adherence with current COVID-19 protocols, investigators should provide a justification for the inability to adhere to current protocols.

The University will continue to re-evaluate the COVID-19 situation as it evolves.

Please email IRB@rosalindfranklin.edu with any other questions you may have and we will attempt to reply quickly.   

The Institutional Review Board, or IRB, is a committee that is required by federal law to protect the rights and welfare of human subjects participating in research activities. The committee meets this mandate by reviewing proposed and ongoing research activities, ensuring they meet specific criteria for approval.

Federal law governs the IRB’s function, make-up, and authority, but meeting the regulations is done on an institution-specific level. The IRB ensures that valid studies meet the ethical mandates of the Belmont Report, and the legal mandates of federal law.

FEDERAL REGULATIONS

The federal law, commonly referred to as 45 CFR 46, formally, the Code of Federal Regulations at Title 45-Public Welfare, Department of Health and Human Services, Part 46-Protection of Human Subjects, is specific to research conducted or supported by a federal department or agency. However, many institutions, including RFUMS, voluntarily apply some or all subparts of 45 CFR 46 (also referred to as the “Common Rule”) to all research conducted by their investigators, regardless of status or source of funding.