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.
Related Policies
- Educational Training in Human Participants Protection for IRB Members and IRB Administrative Personnel
- Institutional Review of Research Involving Human Participants
Related Committees
History
03/12/04 - Approved by the President of the University as recommended by the Policy Committee of the University
05/18/06 - The word "subjects" was changed to "participants" throughout.
11/14/08 - Change approved by the President of the University as recommended by the Policy Committee of the University, such that all researchers and faculty sponsors must have educational training