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IRB Member Training Verification Form

By Erica Berry,2014-04-20 23:22
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IRB Member Training Verification Form

    Institutional Review Board (IRB) Member Training Verification

    Instructions: ; For new IRB members, please complete Sections A, B and D.

     ; For veteran IRB members completing the Initial CITI Training coursework, please complete Sections B and D

     ; For veteran IRB members completing the Refresher CITI Training coursework, please complete Sections C and D

    A. New IRB Member Orientation Checklist: As a New IRB Member, you are required to complete training in the protection of human subjects in research. The documents listed below are being provided as part of your training for IRB membership. Please check the boxes below

    indicating you have reviewed the following materials: Palmetto Health Institutional Review Board Web Site: www.PalmettoHealth.com, Under “For Health Professionals”,

    Select “Research & Clinical Trials”, Select “Institutional Review Board”, please review the following sections: Processing a Proposal (Section 01) Palmetto Health IRB Policy and Procedures (Section 02) Writing a Protocol (Section 03) Development of Informed Consent (Sections 04) Reporting of Adverse Events (Section 05) Educational Requirements (Section 06) Federalwide Assurance with OHRP (Section 07) The Belmont Report (Section 08) Protection of Human Subjects, 45 CFR 46 (Section 09) Privacy Rule (HIPAA), 45 CFR 160 & 164 (Section 09) Protection of Human Subjects, 21 CFR 50 (Section 10) Institutional Review Boards, 21 CFR 56 (Section 10) Palmetto Health Research Policies (Section 11) Forms (Section 12) IRB Membership Lists (Section 13) Glossary and Helpful Resources (Section 15) Use and Disclosure of PHI for Research Purposes (Section 16)

     “Protecting Study Volunteers in Research” book by Chadwick and Dunn

     Indemnification letter to IRB Members from Corporate Counsel dated September 13, 2006

     Please provide Research Administration with a copy of your current Curriculum Vitae or Resume, signed and dated

    B. IRB Membership Training The Palmetto Health IRB uses the Collaborative IRB Training Initiative (CITI) which is an Internet-based set of educational

    modules on the protection of human subjects in research. Coursework consists of training modules divided into Biomedical Research and Social & Behavioral

    Research. Questions regarding training requirements should be directed to Research Administration. A minimum score of 80% must be obtained. Those not

    reaching a passing score will need to review the content of the modules and re-take the exam until a score of ? 80% is obtained. IRB members who also serve as

    investigators or key study personnel for a particular research project, should complete the CITI training specified for IRB members.

     Initial CITI Training: Complete the online training program entitled “CITI Course in The Protection of Human Research Subjects”. This

    web based online training program is available at www.citiprogram.org. Select “Register for the CITI Course”, under “All Others” select

    “Palmetto Health” then choose your username and password. Once registered you must choose the IRB Member training module and then

    choose “Basic CITI Course”. Completing the required modules will take approximately 4 to 6 hours of your time. You are encouraged to

    complete your training in multiple visits.

    C. Continuing Education: Within two years of initial CITI training, IRB members will need to complete Refresher CITI Training:

     Refresher CITI Training: Complete the online training program entitled “CITI Course in The Protection of Human Research Subjects”.

    This web based online training program is available at www.citiprogram.org. Login using your previously selected username and password.

    Once logged in, choose “Refresher Course”. Completing the required modules will take approximately 1 to 2 hours of your time. You are

    encouraged to complete your refresher training in multiple visits. The Refresher Course must be completed within 2 years from the date of

    your initial CITI training. You cannot complete the Refresher CITI Training without first completing the Initial CITI Training. You are

    encouraged to complete your training in multiple visits. Research Administration will provide and support continuing educational opportunities for IRB Members which encompass many activities such as journals,

    tutorials, educational workshops and conferences. Committee members are encouraged to attend national or regional human subject protection conferences

    as they become available. Monthly educational materials will be provided to Board members at regularly scheduled meetings. An assigned primary

    reviewer will review such materials and provide a summary to the Board on articles of his or her choice. An IRB reference library is available for all IRB Committee members to obtain additional information regarding the history and conduct of research activities. Updates and guidance regarding human

    research protections are provided to IRB members at regular scheduled meetings and will also be provided through www.PalmettoHealth.com under the section

    “Research & Clinical Trials”. Research Administration will provide additional education and training to IRB members as deemed necessary by the

    institution’s IRB Chair and/or Signatory Official.

    D. Contact Information

    Name: (Please print) Title and/or Position: (please list for your name card)

    Work Mailing Address: Telephone Numbers: (please include work, home and mobile)

    Home Mailing Address: E-mail Address:

     _____________________________________________________ __________/___________/___________ __________/___________/___________ Signature of IRB Member Date of Initial CITI Training Completion Date of Refresher CITI Training Completion

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Please return this completed form to Research Administration, Institutional Review Board, Five Richland Medical Park Drive, Columbia, South Carolina, 29203.

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