IRBpolicies

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

Policy for Investigators & Sponsors || Policy for Members & Administrative Personnel || Policy for Responsible Conduct of Research

Basic training through the Collaborative Institutional Training Initiative (CITI) is required as of September 1, 2008. Training for Responsible Conduct of Research is required as of December 1, 2009. For detailed information, see our CITI FAQs page.

All researchers, co-investigators and sponsors working with human participants need to complete:

    A basic course in either :

            Social / Behavioral Research Researcher, Student or Sponsor;
            Biomedical Researcher, Student or Sponsor; OR
            Clinical Trial Researcher or Student

AND

A basic course in Responsible Conduct of Research (RCR)

Link to CITI Training Site

For CITI training questions, please contact Kristie Congdon at 570-961-4778 or Ann Loyek at 570-340-6031.

EDUCATIONAL TRAINING IN RESPONSIBLE CONDUCT OF RESEARCH

Policy Statement
Educational training in the Responsible Conduct of Research (RCR) is required for all Marywood researchers (faculty, staff, and students). RCR Training will meet the standards of the Public Health Service, National Science Foundation, National Institutes of Health and other regulatory agencies. Required training is identified by the Assistant Vice President for Research and made accessible through the Office of Research and Community Collaboration website.

Definitions

All researchers refers to those who are making application for any internal or external funding, even those who have no committee reporting requirements.
In these cases, evidence of RCR training must be submitted to the Office of Research and Community Collaboration before an internally or externally funded project can begin.
Responsible Conduct of Research training includes instruction in the following core areas: data acquisition, management, sharing and ownership, mentor and trainee responsibilities, peer review, collaborative research, publication practices and responsible authorship, conflict of interest and commitment, protection of human subjects, animal welfare, and research misconduct.

Procedures
Evidence of completed Responsible Conduct of Research training must be submitted with research protocol applications to the Institutional Review Board (IRB), Exempt Review Board (ERB), Departmental Review Board (DRB), and Institutional Animal Care and Use Committee (IACUC). If the proposal does not require committee approval as above, then evidence of RCR training must be submitted to the Office of Research and Community Collaboration before an externally or internally funded project can begin.

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@maryu.marywood.edu