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Policy on Education and Certification of Investigators
Involved in Human Subjects Research

Policy approved: January 21, 2005
Policy effective: March 15, 2005
Replaces policy dated: September 14, 2000
Responsible Office: Vice Chancellor for Research and Economic Development

I. Purpose and Scope of Policy

UNC-Chapel Hill is committed to upholding the highest standards in research involving human subjects. This requires knowledge of ethical and regulatory obligations by all involved in the conduct of such research. The University has adopted this policy to assist its research community in understanding and complying with these shared obligations.

This policy applies to all faculty, staff, students and other personnel who are engaged in the design, conduct or analysis of human subjects research that is conducted under the aegis of UNC-Chapel Hill, regardless of the source of funding, if any. If there are questions about whether a particular activity constitutes human subjects research or is conducted under the aegis of the University, investigators should consult with their Institutional Review Board (IRB).

II. Background and Transition to Revised Requirements

UNC-Chapel Hill has long provided training in this area, as one important part of the preparation necessary to conduct research. In 2000, the National Institutes of Health (NIH) adopted policies requiring recipients of NIH funding for human studies to document education on the protection of human participants. The University concurrently extended this requirement to all persons involved in human subjects research, regardless of funding.

Research involving human subjects is a complex and evolving area. As with any such endeavor, updated and continuing education is critical. Accordingly, UNC-Chapel Hill is now revising these educational requirements to reflect evolving national standards. Enhanced training will increase the level of awareness across the research community and help fulfill these important obligations. This revised policy addresses basic education requirements, annual continuing education requirements, and provisions for alternative training under special circumstances.

Education completed in fulfillment of prior University requirements, including on-campus lectures or computer-based training through NIH, continues to be accepted until March 15, 2005. After March 15, 2005, personnel on new projects submitted for initial IRB review, or on existing projects submitted for renewal, will be required to have completed the upgraded training program described below. Currently active protocols may be suspended if the revised training requirements have not been satisfied by the time approvals are due for renewal.

III. Initial Basic Education

UNC-Chapel Hill has joined the Collaborative Institutional Training Initiative (CITI), and this is now the default for satisfying basic educational requirements. CITI is a web-based program on issues relating to human subjects research. The CITI website is maintained by the University of Miami, with content developed by a national consortium. Over 400 institutions are using CITI for their mandatory training, with over 140,000 individual registrants.

CITI contains modules on topics including ethical principles, IRB regulations, informed consent and vulnerable populations. Each module has a short quiz at the end to assess understanding. The modules have been grouped for (1) Biomedical Research, (2) Social and Behavioral Research, and (3) Research Involving Data and Specimens Only. Users select the grouping that best reflects their area of research, with other modules available as optional. For more detailed information and links to the CITI website, please visit: www.ohre.unc.edu/educ.php.

Unless alternative training has been approved by a UNC-Chapel Hill IRB (see below), all personnel involved with a human research project submitted for IRB review must have completed the CITI Basic Course.

IV. Annual Continuing Education

Following completion of the revised basic education requirement, all personnel who remain engaged in human subjects research are required to complete continuing education on an annual basis, with the schedule determined by the date on which basic training was done. New IRB approvals will not be granted and active protocols may be suspended if the continuing education requirement has not been completed in time. The annual continuing education requirement may be satisfied by one of the following (approx 1 hr to complete):

Completion of the on-line CITI Refresher Course modules. As with the CITI Basic Course, refresher modules are grouped by categories of research activity.
Attendance at one lecture or seminar with a primary focus on human research issues. A list of on- and off-campus offerings that satisfy this continuing education component will be maintained on the education web page: www.ohre.unc.edu/educ.php.

V. Alternative Training for Special Circumstances

Under limited circumstances, the IRBs may approve an alternative human subjects training program to satisfy these requirements. For example, CITI training may be impractical or inappropriate for field workers in remote areas or foreign countries without web access. A modified training package may also be acceptable for support personnel who have a very defined and limited role with respect to their interaction with human participants, such as telephone interviewers or data entry clerks. In these situations, the lead investigator(s) would typically assume responsibility for training their staff.

It is the prerogative of the UNC-Chapel Hill IRB with oversight for a given project to approve an alternative program in fulfillment of this policy. Investigators are encouraged to consult with their IRB early in the application process if one of these circumstances may apply. These situations will be the exception and not the rule.

Annual continuing education remains a requirement for researchers or groups who fulfill their initial requirements through approved alternative training. These researchers (or team leader) should contact their IRB for guidance in fulfilling the continuing education requirement.

VI. Collaborating Investigators or Subcontractors at Other Institutions

Many research projects involve collaborators external to UNC-Chapel Hill. Any collaborators or subcontractors who have contact with human participants or their data are expected to complete training in human research ethics. If the collaborators work in a setting where they are not already subject to institutional training requirements (e.g., private practices, public schools, or community hospitals without an IRB), they should fulfill UNC-Chapel Hill requirements as described above. If, however, the collaborating investigators come from another university or organization where they have already completed training required by their home institution, UNC-Chapel Hill IRBs will recognize that training. It is hoped that this acceptance will be reciprocated when UNC-Chapel Hill investigators collaborate with other organizations.

VII. Certification of Educational Requirements

UNC-Chapel Hill maintains a database that tracks training for all research personnel. The entry of individual training records into that database will vary depending on the vehicle used to obtain that training:

CITI Web-Based Modules: UNC-Chapel Hill is automatically notified once users have completed the selected modules in CITI. It is not necessary for investigators to forward the CITI completion record in order to be entered in the University database. Names should appear in the training database within 48 business hours of completion. Trainees should print a hard copy of the completed CITI Grade Book for their own records.
Alternative Training for Special Circumstances: For those who are approved by their IRB to satisfy requirements via alternative training, paper documentation will need to be provided. Use Documentation of Alternate Training (MS Word) for this purpose. The IRBs will enter that record in the UNC-Chapel Hill training database. In some cases (e.g., a large staff of field workers), only key study personnel will be entered in the training database, and the Principal Investigator will be asked to confirm in IRB correspondence that unlisted staff have been trained via approved alternatives.

Once an individual is entered in the UNC-Chapel Hill training database, reports may be generated for various purposes:

Verifying Required Education for the IRB Application: The Principal Investigator should submit with each IRB application a list certifying that all study personnel have completed required education, generated from the training database.
Verifying Required Education for Project Sponsors:This should be submitted to the Office of Sponsored Research (OSR) for review along with other just-in-time (JIT) information for NIH, or for other sponsors that require certification of human subjects training. The Principal Investigator should submit with the proposal package a list certifying that all key study personnel have completed required education, generated from the training database. Note that the same certification letter may be used for both IRB and Sponsor purposes.

VIII. Resources for Additional Information

For more information, please visit www.ohre.unc.edu/educ.php, consult with the IRBs, or submit questions to irb_training@unc.edu.

Human Research Ethics