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Educational Training in Human Participants Protection for IRB Members and IRB Administrative Personnel

Policy Statement

Educational training in human participants protection is required for members and administrative personnel of the Institutional Review Board for the Protection of Human Participants (IRB). Training will be completed prior to the beginning of the appointment and annually. 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

For purposes of this policy, IRB administrative personnel include the signatory official and IRB administrative and IRB support personnel.

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 participants sponsored by the University.

Procedures

The training curriculum and requirements will be developed collaboratively by the IRB administrator and the Institutional Review Board for the Protection of Human Participants. Materials and resources will be provided in order to complete requirements.


Related Policies



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.