02. Training

02. Training

02. Training

In 2000, the NIH enacted a policy (NOT-OD-00-039) requiring that study or "key" personnel involved in human subjects research complete education in the protection of those subjects. At UAB, study personnel are required to complete an approved “initial’ training option and to complete an approved "continuing" option once during every 3-year period.

The training requirement applies to all key personnel, including

  • all investigators—principal, co-principal, or other investigators;
  • all persons involved in the consent process—discussing participation or obtaining consent;
  • all persons engaged in the design, conduct, analysis, or reporting of the research.

The IRB will not approve a protocol unless all study personnel have completed the required training. Although some human subjects research is exempt from IRB review, NIH requires investigators conducting such research to complete training in the protection of human subjects.

Training is available in languages other than English for non-UAB staff and community workers on protocols conducted outside the United States. Before using non-English training, investigators should contact the OIRB for guidance and then clearly describe the training plan in the HSP.

Initial IRB Training

The initial training requirement may be met in several ways. The most popular options are listed below:

  • CITI Basic Course in Human Research Protections
  • NIH Protecting Human Research Participants
  • Investigator 101 WebCT Course

Instructions for course registration and IRB certification are posted on the Initial IRB Training web page.

New faculty members or researchers may begin or continue their research if they provide certification of completing (a) the CITI biomedical or behavioral course or (b) a training course intended to meet the federal IRB training requirements that is 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.

Continuing IRB Training

Continuing IRB training is required once every 3 years. The Continuing IRB Training web page lists approved options. Individuals who plan to attend events not in that list but related to human subjects research may submit an agenda or synopsis of the event before attending so the IRB may determine if training credit can be given for that event.

Certification and Record-Keeping

Depending upon the event, the person completing the training may have to complete and send the UAB Verification of Training Completion to the OIRB. Currently, the OIRB is automatically notified of courses completed through CITI or through UAB WebCT. All other online options require filing the verification, as described on the IRB Training web site.

Individuals are required to keep accurate and up-to-date records of their IRB training. The OIRB maintains records of individuals´ IRB training for protocols reviewed by the IRB. These records can be viewed online from any on-campus computer through the IRB e-reports system.

To certify IRB training to sponsors, investigators use the information in IRB e-reports to complete a form that is available from the Office of Sponsored Programs. That form and instructions can be found at the OSP Forms web page.

Please direct any questions about IRB training to the OIRB (934-3789, irb@uab.edu).

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