Title
Office of Human Research Ethics SOP 0301: Education & Training
1. Purpose
Recognizing that a vital component of a comprehensive human research protection program is an education program for all individuals involved with research subjects, the University of North Carolina at Chapel Hill (UNC‐Chapel Hill) is committed to providing training and an ongoing educational process for Institutional Review Board (IRB) members, the staff of the IRB and Human Research Protection Program (HRPP) Office, investigators, and members of their research team related to ethical concerns and regulatory and organizational requirements for the protection of human subjects.
2. Procedures
2.1 Training/Ongoing Education of IRB Chair, Members, and Staff
2.1.1 Orientation
New IRB members, including alternate members must undergo an IRB orientation program. New members will first meet with the OHRE Education & Training Manager or designee for an orientation session and also with Office of Human Research Ethics (OHRE) staff for training on the IRB electronic system. Prior to this orientation meeting, new members are sent a set of PowerPoint Modules that provide an overview of IRB function, ethics, regulations, HIPAA, IRB 111 Review Criteria and operations. At orientation, the new member will be given the link to IRB Handbook, Amdur & Bankert 4 and a review of resources, information, checklists and education presentations on the IRB Member webpage, some of the information included are:
- Belmont Report;
- Nuremberg Code
- Helsinki Declaration
- TriCouncil Ethical Conduct
- CIOMS International Ethical
- WHO Standards & Operational Guide
- E6 Guideline
- OHRP International Compilation of Human Research Standards
- OHRP Informed Consent Checklist
- Past IRB Meeting Educational Presentations
- 1963 Milgram Behavioral Study
- 1966 Beecher "Ethics & Clinical Research"
- 1972 Heller Syphillis Victims
- 1986 Krugman Willowbrook
- 1966 Faden Advisory Committee
- 2001 Gelsinger, "Jesse’s Intent"
- 2010 Physicians Experiments in Torture
- 2011 Reverby Normal Exposure
- Consent templates
- Social Security Number Disclosure, use for research and use as an identifier
- The UNC‐Chapel Hill Policies and Procedures for the Protection of Human Subjects;
- Federal regulations relevant to the IRB; and
- Tools used by IRB reviewers (checklists etc.).
New members are required to complete the same Collaborative Institutional Training Initiative (CITI) training required of all researchers at UNC-Chapel Hill. Prior to orientation with the OHRE representatives, members may attend the first IRB meeting as an observer. Prior to attending a second IRB meeting, at which new members will be a voting member, new members are encouraged to prepare a practice primary reviewer checklist for a study on the agenda. A Q&A session with the Education & Training Manager or their designee, as applicable, is scheduled to discuss any questions the new member has about the process, checklist, or study. This offers an opportunity for them to become familiar with the role of primary reviewer preparation and then to hear the presentation of the assigned primary reviewer in the IRB meeting, discussion, and vote. New members may serve as primary reviewer beginning with the third IRB meeting attended.
2.1.2 Initial CITI Education
IRB members and HRPP and IRB administrators and staff will complete the required modules in the CITI Course in the Protection of Human Research Subjects; renewal is required every three (3) years. The modules are grouped by categories of research. Researchers, IRB Members, and Staff are only required to complete one group of modules that best fits the type of research they normally conductor review.
- Group 1: Biomedical Research: Medical, physiological, or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices, or other interventions.
- Group 2: Social and Behavioral Research: Studies on sociological, psychological, anthropological, or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.
- Group 3: Data and Specimens ONLY: No direct contact with human subjects. Research limited to use of records, data (including secondary data sets), or biological samples.
Optional modules should be completed to the extent they are applicable to the role. Good Clinical Practice (GCP) training is required of any UNC-Chapel Hill investigators, research staff, or IRB member who are involved in the design, conduct, reporting, or review of clinical trials. A GCP refresher course is required every three (3) years.
2.1.3 Continuing Education for IRB Members
To ensure that oversight of human research is ethically grounded and the decisions made by the IRB is consistent with current regulatory and policy requirements, training is continuous for IRB members throughout their service on the IRB.
In addition to initial training requirements, continuing education is delivered to IRB members and regularly. UNC‐Chapel Hill uses the following activities as a means for offering continuing education to IRB members, and to HRPP and IRB administrators and staff:
- Annual IRB Member Retreat.
- IRB Meeting 10‐minute educational presentations which are also mailed to every IRB Member and senior staff each month and are also posted on a members' webpage.
- Monthly email to all IRB Members & Analysts of the meeting in‐service materials and additional regulatory updates, recent publications, and guidance.
- A Member & Staff website that includes:
- copies of education handouts;
- dates of upcoming educational offerings of interest to members & staff;
- links to other training resources;
- references from governmental sites (OHRP, FDA, NIH, DOE, EPA);
- educational offerings from OHRP and other IRBs;
- a membership directory;
- a link to CITI; and
- Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and topical informational sites (FDA Drugs, Medline Plus tutorials, and Certificates of Confidentiality).
- Periodic webinar offerings.
- Periodic sessions with the IRB Analysts and IRB members to include HRPP Informational Sessions as well as training topics.
- Identification and dissemination by the Director of new information that might affect the human research protection program, including laws, regulations, policies, procedures, and emerging ethical and scientific issues to IRB members via email, mail, or during IRB meetings.
- Unlimited access to the IRB Office resource library.
The UNC-Chapel Hill library has available electronic copies of IRB Management & Function of IRB Member Handbook, resources for IRB Members, Staff, and researchers.
The activities for continuing education vary on a yearly basis depending on operating budget and areas of need, as determined by the Education & Training Manager in consultation with the OHRE Director and Associate Director for Operations & Education. IRB members who have not fulfilled their continuing education requirements will not be assigned as primary or secondary reviewer until they are fulfilled. Continuing failure to complete training may result in the individual being removed or not renewed as an IRB member. Fulfillment of training requirements is included as part of the evaluation of the performance of IRB members/alternates. The Institutional Official (IO) will provide support to send as many members of the IRB as possible to attend the annual Public Responsibility in Medicine and Research (PRIM&R) conference or regional OHRP conferences on human research protections.
2.2 Training / Ongoing Education of Investigators and Research Team
As stated previously, a vital component of a comprehensive human research protection program is an education program for all individuals involved with research subjects. UNC‐Chapel Hill is committed to providing training and an ongoing educational process for investigators and members of their research team related to ethical concerns and regulatory and organizational requirements for the protection of human subjects.
2.2.1 Education and Training Requirements
Investigators, key personnel, and other members of the research team must complete the UNC‐Chapel Hill required core modules in the CITI Course in the Protection of Human Research Subjects, including the module on Conflicts of Interest, at least every three years.
Optional modules should be completed to the extent they are applicable to the research team member's role and study. GCP training is required of any UNC-Chapel Hill investigator or research staff who are involved in the design, conduct, or reporting of clinical trials.
Final UNC-Chapel Hill IRB approval will not be granted for i) initial applications and ii) personnel modifications adding new study personnel to the study until education requirement(s) have been completed for the new personnel.
2.2.1.1 Documentation of Equivalent Education for Spanish Speakers
UNC-Chapel Hill provides a Spanish language equivalent CITI course for study staff that are non-English speakers. Completion of the course is tracked in the CITI database and reported to UNC-Chapel Hill the same as other CITI training courses.
2.2.1.2 Ongoing Research Education and Training Requirements
Continuing education requirements in the Protection of Human Research Subjects (as described above) must be completed for all individuals engaged in human subjects research at least every three (3) years by completing a CITI Refresher Course, or if all Refresher Courses have been previously completed, researchers should complete the Initial CITI training modules again. Continuing education is tracked through CITI and will be imported in IRBIS, the electronic IRB system.
2.2.1.3 OHRE/IRB Monitoring of CITI Training
Final approval of initial study submissions will not be granted until all appropriate members of the research team have completed the designated applicable CITI course(s).
Modifications adding new team members will not be approved until the new member(s) of the research team has completed the designated applicable CITI course(s).
Renewal of applicable CITI training is required for every team member every three (3) years. While research plans and applications for continuing review will be reviewed and approved if CITI training has expired for team members, conducting research without up-to-date training is considered to be noncompliance with institutional policy. Ongoing failure of research team members to complete applicable CITI training and failure by the Principal Investigator to ensure study team member have completed applicable CITI training per the requirements may be considered to be serious and continuing noncompliance, which may result in restriction of research privileges.
2.2.2 Additional Educational Opportunities
The Education & Training Manger and other IRB Staff make a number of presentations throughout the UNC-Chapel Hill campus. These presentations include:
- Requests from study teams for additional training,
- Requests for class presentations on IRB Overview as part of an undergraduate or graduate level class,
- Requests to lead research ethics seminars for residents, and
- Twice a year an IRB Overview is presented by IRB staff in the orientation series of lectures for new study coordinators.
Contact Information
Policy Contact
Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097
Ph: 919-966-3113
Fax: 919-966-7879