Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program - IRB PRO100

Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program - IRB PRO100

Abstract:
This procedure describes mandatory training for individuals who supervise or are involved in research with human subjects. Links to corresponding policies and other documents are included.
Effective Date:
10/26/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

 

HRPP Document:     PRO100
Effective Date:   3/30/07
Revision Date:  11/2/09, 1/27/10, 10/26/2010
Subject:  Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program

Definition

Collaborative IRB Training Initiative (CITI): This internet-based course in human research protection and bioethics is designed specifically for all personnel that have a significant involvement in the planning, conduct, and analysis of any scientific activity that employs human research participants. It is sponsored by a consortium of IRB professionals and researchers from universities and medical schools across the country and is administered by the University of Miami. The course consists of training modules that are divided into two tracks: Biomedical Research and Social/Behavioral Research. The learning objectives of the CITI course are:

  • To provide an understanding of the historical perspectives, ethical principles, and federal regulations associated with the conduct of research with human participants;
  • To provide a clear understanding of what constitutes informed consent process and how it must be applied in research involving humans;
  • To provide basic information on the regulations and policies governing research with investigational drugs, biologics, and devices; and
  • To provide a clear understanding of the ethical issues and federal regulations in force during the conduct of Social/Behavioral research, records based research and genetics research with human participants.

Procedure

Investigator Responsibilities

Prior to participating in human subjects research, the investigator and key personnel conducting the research under the jurisdiction of the UAB IRB:

  • Completes “initial training” requirement by one of the following methods (see GUI 314):
    • Collaborative IRB Training Initiative CITI "Basic" Course;
    • National Institutes of Health NIH Human Participant Protections Education for Research Teams;
    • Office for Human Research Protections Investigator 101 CD and WebCT Course;
    • UAB Graduate Course or School of Medicine/Public Health administered program GRD 717 or Clinical Research Training Program (UAB); or
    • Provides documentation upon arriving at UAB of completing:
      • The CITI biomedical or behavioral course; or
      • A training course intended to meet the federal IRB training requirements that are offered by another institution that holds a Federalwide Assurance (FWA). Persons submitting certification of a training course other than the CITI course should also submit a description of the course (e.g., syllabus, course objectives, and outline). Depending on the date when the "transferred" training was completed, continuing IRB training may also be required.
  • Completes “continuing education” requirements at least biennially (once every two years) of a course approved by the IRB, IRB Chair and IO (see GUI314):
    • Approved Alternatives
      • Seminars or conferences at regional or national meetings containing presentations with ethics and/or human subjects research are eligible for IRB credit. Attendees should contact the OIRB before attending, submit a synopsis of the event and, afterward, provide proper documentation of attendance.

If the required training is not completed, the investigator or key personnel will not be allowed to participate in the research activities.

OIRB Responsibilities

Senior Staff:

  • Maintains the agreement with the Miami CITI for web-based training;
  • Arranges and provides live local initial and continuing education and training programs as listed above;
  • Verifies investigators and key personnel involved in research have completed the necessary training requirements;
  • Completes initial or continuing education, as appropriate after joining the OIRB staff or provides documentation of satisfactory completion;
  • Completes continuing education at least biennially – failure to do so will be documented in employee evaluation;
  • Completes DoD required training, as applicable;
  • Recommends, identifies, and maintains educational resources for inclusion in OIRB in-house library (see GUI315).

Administrative and Clerical Staff:

  • Completes initial or continuing education as appropriate after joining the OIRB staff or provides documentation of satisfactory completion;
  • Completes continuing education at least biennially – failure to do so will be documented in employee evaluation;
  • Accounts for and maintains IRB human subjects protections training database;
  • Verifies investigators and key personnel involved in research have completed the necessary training requirements;
  • Orders reference materials and maintains in-house library of resources for staff, IRB member, and investigator use.

IRB Responsibilities

IRB Member:

  • Completes an orientation before being allowed to serve on the IRB, which includes the following (See PRO104 Procedure for Qualifications and Composition of IRBs and OIRB Staff):
    • Educational session with senior staff member;
    • Attending as an observer at two or more IRB meetings;
    • Reviewing materials pertaining to human subjects protections:
      • UAB IRB policies and procedures on CD
      • Investigator’s Guidebook and all IRB forms on CD
      • The Belmont Report,
      • The Clinical Research Resources Training and Guidance for Regulatory Compliance Handbook which includes:
        • 45 CFR 46 and 164;
        • 21 CFR 11, 50, 54, and 56;
        • FDA Information Sheets for IRBs and Clinical Investigators;
        • Additional Guidance on the FDA Compliance Manual on Investigators and IRBs;
        • DHHS OCR Guidance on HIPAA Privacy in Research;
        • DoD Guidance Document (GUI339);
        • DOE Guidance Document (GUI338);
  • Completes initial training in human subjects protections and biennial continuing education by completing a course approved by the IRB – failure to do so will result in not being allowed to serve on the IRB;
  • Completes DoD required training, as applicable;
  • Understands and is knowledgeable about strategies to maintain confidentiality of identifiable data, including storage, handling and sharing;
  • Receives training through scheduled sessions through lectures incorporated into convened IRB meetings;
  • May exercise the option to attend regional or national human subjects protection conferences or workshops;
  • Completes a self-evaluation tool assessing their knowledge, and identifying educational needs for the coming year (see SUP413 UAB IRB Member Self-Evaluation Form);
  • Recommends and has access to resources from the IRB in-house reference library to obtain additional information regarding the history and conduct of research activities;
  • Receives written feedback yearly based on self-evaluations and written reports presented to the IO biannually.

Institutional Responsibilities

Institutional Officials:

  • Completes the OHRP Assurance training module;
  • Completes other applicable training modules, such as DoD required training.

Approved on October 29, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director