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1.24 HRPP Training Requirements for IRB Members and IRB Analysts

Last Revised: 7/14/20223/4/2026

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for training for IRB members and alternates.alternates, and IRB Analysts.

2.0 Policy

It is the policy of the Organization that IRB members and alternatesalternates, and IRB Analysts will be qualified through initial and continuing education in order to fulfill their responsibility to protect the rights and welfare of human subjects.

3.0 Definitions

  • 3.1. CITI (Collaborative Institutional Training Initiative) available through www.citiprogram.org or through the IRB website.

4.0 Initial Training and Orientation

  • 3.1. 4.IRB Members and Alternates
    • 3.1.1. New IRB members, including alternate members, will meet with the IRB Executive Chair or designee, and appropriate IRB AdministratorsAnalysts for orientation to cover the following items:
      • 4.3.1.1.1. Ethical principles underlying human subject research
      • 3.1.1.2. Overview of HHSHHS, FDA and FDAother applicable regulations
      • 3.1.1.3. 4.1.2.Structure and components of the HRPP overview
      • 3.1.1.4. 4.1.3. StructureProcesses of ORA and IRB meetingsreview
      • 4.3.1.4.1.5. Responsibilities of IRB members
      • 3.1.1.6. 4.1.5. OverviewUse of theRSS (Research Support SystemSystem) (RSS).application
    • 4.3.1.2. New IRB members and alternates who also act as investigators or research personnel will be required to complete CITI (Collaborative Institutional Training Initiative; www.citiprogram.org) training (including GCP as appropriate) as per HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel). For new IRB members and alternates who do not act as investigators or research personnel, orientation (as described above) will be considered the equivalent of initial CITI training.
    • 4.3.1.3. New IRB members are invited to attend an IRB meeting as a guest during the orientation period.
    • 3.1.4.4. Full orientation must be completed before the new IRB members may serve as a reviewer or count as a voting member. Prior to completion of orientation, agenda will record new IRB members as “non-voting”.
    • 4.3.1.5. New IRB members aremay be assigned an experienced IRB member as a mentor, to provide assistance as necessary.
  • 3.2. IRB Analysts
    • 3.2.1. IRB Analysts will undergo training supervised by the Assistant Director of the ORA (or designee) and the Education Coordinator, and conducted by members of the IRB/ORA staff as per Standard Procedures
      • 3.2.1.1. Content of the training will be reviewed by the Asst Director and Education Coordinator on a regular basis and adjusted as needed
    • 3.2.2. Training (as described above) will be considered the equivalent of initial CITI training; completion of CITI is encouraged but not required.
      • 3.2.2.1. New IRB Analysts who also act as investigators or research personnel must complete CITI Training as described in HRPP 1.23 (HRPP Training Requirements),

5.4.0 Continuing Education

  • 4.1. 5.IRB Members
    • 4.1.1. Continuing education for IRB members is required throughout service on the IRB in order to ensure ethical oversight of human subject research and compliance with current regulatory and policy requirements.
    • 5.4.1.2. IRB members are expected to participate in continuing education which may be obtained through any or all of the following mechanisms:
      • 5.4.1.2.1. In-service training at IRB meetings.
      • 5.4.1.2.2. Training workshops/webinars.
      • 5.4.1.2.3. Regional IRB conferences.
      • 5.4.1.2.4. Review of publications distributed by the ORA at IRB meetings or via email.
      • 5.4.1.2.5. Review of new informationor affecting the HRPP such as newrevised laws and regulations, new OHRP/FDA guidance documents, and new or revised HRPP policies distributed by the ORA via email or at IRB meetings.
    • 5.4.1.3. Completion of required continuing education will be assessed at the time of the annual evaluation of IRB members (seeper HRPP policy 1.22 [Assessment of the Effectiveness and Efficiency of the HRPP]) in terms of general regulatory and HRPP policy knowledge. Members who remain deficient after this review may have their appointment terminated.
  • 4.2. IRB Analysts
    • 4.2.1. IRB Analysts are expected to engage in on-going continuing education (for example, attending IRB conferences and/or webinars, and by reviewing articles or other published works related to human subject protection).

DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 2/1/2018 - revision not documented

 Revised: 7/14/2022 - Deleted list of specific documents to be supplied to new IRB members; added requirement that full orientation of new members must be completed before the new member may serve as a reviewer or count as a voting member; clarified that completion of required continuing education will be assessed at the time of the annual evaluation of IRB members in terms of general regulatory knowledge; deleted requirement that ORA maintain initial and continuing education training records.

 Revised 3/4/2026 - Revised to title of policy to reflect additional information regarding training of IRB analysts; Clarified contents of orientation for IRB members (section 3.1.1); describe training of and continuing education for IRB analysts; stylistic changes.

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