Policy VIII.A

Policy

DEPARTMENT:	INSTITUTIONAL REVIEW BOARD
POLICY NUMBER:	VIII.A
SECTION:	IRB Education and Training
REVIEW RESPONSIBILITIES:	IRB Policy and Procedure Committee
ORIGINAL CREATION DATE:	September 15, 2000
REVISION DATES:	March 19, 2004; May 28, 2004

Subject: Investigator and Key Study Personnel Training

Definition:
Collaborative IRB Training Initiative (CITI): An internet-based set of educational modules on the protection of human participants in research. 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.

Policy:
It is the policy of the Vanderbilt University (VU) Institutional Review Board (IRB) that all Investigators and key study personnel conducting human subjects research under the jurisdiction of the VU IRB complete initial and annual human research protections training.

I. The June 5th, 2000 NIH Guide Notice mandated all key study personnel involved in NIH funded human subjects research must have formal instruction in human research protections. This has been embraced by many of the Federal agencies; therefore, all VU human research Investigators and key study personnel must complete the following initial and continuing education requirements and provide certification of completion to the VU IRB:

Initial Training.

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. 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:

1. To provide an understanding of the historical perspectives, ethical principles, and Federal regulations associated with the conduct of research with human participants;

2. To provide a clear understanding of what constitutes informed consent and how it must be applied in research involving humans;

3. To provide basic information on the regulations and policies governing research with investigational drugs, biologics, and devices;

4. 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; and

5. To provide Investigators conducting research at VA facilities a clear understanding of the special procedural and regulatory policies for human research at VA research facilities.

Annual Training.

There are several annual training options for the Principal Investigator and key study personnel. The Principal Investigator and key study personnel have an open invitation to attend or complete as many of the IRB educational sessions as available. The appropriate documentation of attendance will need to be provided to the IRB to demonstrate compliance with the annual training requirements.

II. An Investigator’s Handbook has been created as a resource manual for researchers in Behavioral/Social and Health Sciences. These manuals will assist the Investigators in smoothly navigating the IRB process and adhering to the Federal regulations and IRB policies related to human research protections. The manuals are located on the IRB website.

III. All Investigators and key study personnel conducting research involving humans at VU are encouraged to review the core training materials including the VU Federalwide Assurance, the VU IRB policies and procedures, The Belmont Report, the Federal regulations including 45 CFR 46, 21 CFR 50 and 56, links to Federal agencies governing human subjects research, and links to other various agencies and resources (e.g., National Institutes of Health, Food and Drug Administration, Office of Human Research Protections, National Bioethics Committee, etc.). These links are available on the IRB website at http://www.mc.vanderbilt.edu/irb/.

IV. All IRB forms and related information with applicable instructions are also available on the IRB website for downloading in various formats (i.e. Word, Mac, or PDF). Electronically available “Help” files will assist Investigators precisely at the time of proposal development of human research by teaching the important protections mandated in accordance to regulatory mandate and ethical guidance.

V. The IRB will send mass e-mail notifications, limited to a mailing list of all Investigators and key study personnel that have active studies, to alert them of pertinent IRB issues or decisions that may impact their research.

VI. All new Investigators, key study personnel, and graduate students are encouraged to attend an IRB 101 session in preparation for the ethical conduct of human subjects research and an overview of the Federal regulations governing IRB operations and research involving human participants. Copies of the OHRP “Investigator 101” training module are also available upon request from the IRB Education and Compliance Team.

VII. The IRB Reference Library houses information on assorted topics regarding the history and conduct of research activities. These resources will be available for checkout upon request.

References:
Collaborative IRB Training Initiative (CITI) Training: http://www.citiprogram.org
Vanderbilt University Institutional Review Board Website: http://ww.mc.vanderbilt.edu/irb/