12.4 Training/ Ongoing Education of Investigators and Research Team

12.4   Training / Ongoing Education of Investigators and Research Team

As stated above, one component of a comprehensive human research protection program is an education program for all individuals involved with research subjects. SBU is committed to providing training and an on-going educational process for investigators and members of their research team related to ethical concerns and regulatory and institutional requirements for the protection of human subjects. As an example, initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support, or manage human subjects research sponsored by the Department of Defense.

Approval of new and continuing review submissions will be withheld unless all individuals listed on the project registration form as part of the study team are current in their certification to conduct human subjects research, as defined in this document. ORC maintains the database of training certifications.

12.4.1  Initial Education

  • All Principal Investigators and members of their research team must: review core training documentation including the “SBU Standard Operating Policies and Procedures for Human Research Protection,” and the “Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,
  • be familiar with the SBU HRPP website, and the availability of links and other information contained within, and
  • complete either:
    • the SBU-required Core Modules in CITI Course in the Protection of Human Research Subjects, and pass the required quizzes with a score of 80 or better OR
    • A course in human research protections offered by the Office of Research Compliance (available for groups of twenty or more trainees). This option also requires completion of a CITI refresher course for the purposes of assessing competency with the course material, via a score of 80 or better on the required quizzes.  

    12.4.1.1 The Collaborative Institutional Training Initiative (CITI)

    SBU offers access to the CITI program to all SBU faculty, staff, or students. Non-SBU investigators can use the CITI program if they are on file with CORIHS as an investigator on an IRB application (approved or pending). Unauthorized use of the CITI program is prohibited.

    The CITI web-based program is available at http://www.citiprogram.org, Investigators register under SUNY University at Stony Brook.  After login, questions will be asked to assess what type of training you require based on certain criteria; it is the investigator’s responsibility to choose the answers that most accurately addresses:

    • Your level of SBU training (initial, first renewal, second renewal etc.)
    • Your type of research (biomedical, social behavioral, FDA etc.)
    • Your role in the research activities (data/tissues only, interaction with subjects, etc.)

    Completion of the initial training through CITI will take approximately 4-6 hours, although the trainee can go back over multiple sessions to complete training.

    The University of Miami (which provides the IT, administrative support, and home to the CITI program) issues CME/CEU credits for a fee. In order to qualify for CME/CEU credits, you must take and pass all required modules for the group you choose. Click the link for CME/CEU credits on the Learner's Menu for detailed information.

    12.4.2  Waiver of Initial Education

    If investigators or members of their research team are new to SBU, and can verify that they have successfully completed the CITI Course at their former institution (involving equivalent modules to that required by the University), they may request a waiver of that aspect of Initial Education.  However, they still must confirm review of SBU SOPs and website materials.

    12.4.3  Continuing Education and Recertification

    All investigators and members of their research teams must meet SBU continuing education requirement every three years after certification of Initial Education for as long as they are involved in human subject research. There is no exception to this requirement. Acceptable training includes:

    • the SBU-required CITI Refresher Modules (chosen in accordance with the criteria referenced above in Section 12.4.1.1, with a passing score on the required quizzes with a score of 80 or better.

    or

    • A refresher course in human research protections offered by the Office of Research Compliance (available for groups of twenty or more trainees). This option also requires completion of modified CITI refresher course for the purposes of assessing competency with the course material, via a score of 80 or better on the required quizzes. 

    And

    • Thorough review of all CORIHS Updates sent regularly from the Office of Research Compliance on guidance and hot topics pertinent to human subject protections
    • Attendance at PRIMR or OHRP seminars, conferences and webinars, and/or attendance at an ORC-sponsored workshop is strongly recommended.
    • Investigators who are also CORIHS Chair, CORIHS members, or ORC staff will satisfy the training requirements for CORIHS members and staff described in this policy under Section 2.13.

    12.4.4  Additional Resources

    Human research protection information will be made available on the ORC website, and via the CORIHS updates referenced above, on an ongoing basis to ensure that the University research community is apprised of current regulatory and policy requirements and training opportunities.

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