Personnel Handbook: Educational Training in Human Participants Protection for Investigators

Policy Statement

Educational training in human participants protection is required for all researchers and faculty sponsors involved in human subjects research. Training requirements will adhere to standards and regulations disseminated by the Office of Human Research Protections (OHRP) of the United States Department of Health & Human Services or required under the University's Federal Wide Assurance.

Definitions

Federal Wide Assurance (FWA) -- every institution engaged in human participants research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). The regulations and standards change periodically. Marywood University's FWA covers all research including human subjects sponsored by the University.

Procedures

Evidence of completed training must be submitted with the application to the IRB. Training requirements will adhere to the standards of the Office of Human Research Protections (OHRP). Training resources will be identified by the IRB administrator and made accessible to all investigators.