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107.3 Organization Policy for Training and Evaluation of IRB Members and Chairs

August 2010

The Organization requires completion of the human subject research protection training. The training will include completion of the online compliance training modules: Human Subjects Research, Conflict of Interest, and HIPAA and Research.  In addition, each new primary member, alternate member, or Chair must complete the JHM IRB Orientation program, which will be conducted by  the IRB Training Manager.  The compliance training modules and orientation program must be completed prior to attending a JHM IRB meeting as a voting member.  JHM IRB members and alternate members will be trained in convened and expedited review regulatory criteria and may not serve as a reviewer until the JHM IRB Chair for their committee determines that they have adequate experience and may be added to the designated reviewer list.   JHM IRB members will be provided with copies of Robert Amdur’s Institutional Review Board Member Handbook. for reference and review.  JHM IRB Chairs and members will be provided with funds to allow them to participate in local or national conferences co-sponsored by OHRP and/or the FDA which focus on human subject protection issues.

The Organization will conduct periodically a self-assessment of IRB chairs and members.  JHM IRB chairs will be asked to evaluate members, and the IRB members will be asked to evaluate chairs.  This evaluation will use a form developed by the IO.  The completed forms will be submitted to the Vice Dean for review, and will be considered as part of the IRB committee membership and leadership appointment process.

Continuing education of IRB members shall be conducted periodically by the IRB Counsel for Human Research and the IRB Training and Education Manager.  The continuing education will include updates on regulatory and review process topics.  The IO will convene a retreat annually for IRB members and senior staff as part of the continuing education.