IRBpolicies

Mandatory Training for Investigators, Faculty Sponsors, IRB Members and IRB Administrative Personnel

TRAINING through Collaborative Institutional Training Initiative (CITI) - Required as of September 1, 2008
CITI FAQs - Please read FAQs prior to proceeding to the CITI training site! Most researchers need to complete the Social and Behavior learner group modules, unless they are conducting Biomedical research. Good Clinical Practice only needs to be completed by those working on clinical trials. Link to CITI Training Site

After reading the FAQs, if you have any further questions about the new training/educational
requirement through the CITI program, please contact Tonya Renae McNair at (570) 348-6211, x. 6088.

Policy for Investigators || Policy for Members & Administrative Personnel

Please submit a copy of your completion certificate, and that of your sponsor/advisor (if applicable), with your IRB application. Please also submit training certificates for any co-investigators or research assistants. If your sponsor has previously submitted a certificate, he/she needs only supply the completion date on your application form.

EDUCATIONAL TRAINING IN HUMAN SUBJECTS
PROTECTION FOR INVESTIGATORS

Policy Statement

Educational training in human subjects protection is required for all researchers and faculty sponsors and anyone else engaged in research and submitted to the Institutional Review Board for the Protection of Human Participants (IRB). 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 subjects 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.

EDUCATIONAL TRAINING IN HUMAN SUBJECTS PROTECTION
FOR IRB MEMBERS AND IRB ADMINISTRATIVE PERSONNEL

Policy Statement

Educational training in human subject 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.

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.

Marywood Home Page

Direct comments to the IRB staff here: IRB@marywood.edu