Human Subjects Research Training Requirements

Adventist HealthCare (AHC) requires that all individuals involved in the conduct of human subjects research and individuals who review human subjects research or possess human subjects research oversight responsibilities complete certification of human subjects research training through the Collaborative Institutional Training Initiative (CITI) at https://www.citiprogram.org/.

Duration of training completion is user dependent, but typically requires approximately 5 hours to complete. Satisfactory completion of the assigned modules requires a composite passing score of 85% or higher in the respective Learner Group (1-5) course and the separate Research Conflict of Interest course. AHC also recommends that individuals on both FDA-regulated and non-regulated clinical studies complete the Good Clinical Practice (GCP) course.

Who is required to complete this training?

  • Individuals who intervene or interact with subjects or have access to subjects’ identifiable information (including those involved with Humanitarian Use Devices)
  • Individuals who review human subjects research or possess human subjects research oversight responsibilities (including Institutional Review Board (IRB) members, IRB Office Staff, Institutional Officials, and Human Research Protection Quality Committee Members).

Who is not required to complete this training?

  • Individuals involved with projects deemed not to be human subjects research
  • Individuals who are found to not be engaged in human subjects research

Timeframe for Completion of Training

New research personnel who are doing clinical studies involving human subjects at AHC, personnel who are working on the research, or those involved with the oversight of human research activities are required to successfully complete the CITI training modules for their appropriate Learner Groups prior to active participation in any human research protocol. This education includes the basic CITI course modules on research involved with human subjects specified for your Learner Group and the three required CITI course modules in Conflicts of Interest in Research Involving Human Subjects.

The Principal Investigator, co- and sub- investigator, and other research personnel listed on IRB submissions and the Delegation of Authority form must satisfactorily complete or be current with all required modules before receiving IRB approval on initial or continuing review of a submission, or prior to a submission being declared exempt. Satisfactory completion of all required modules is also required as part of the “just-in-time” (JIT) information required for federal agents.

Noncompliance with Required Training

Individuals who have not completed their assigned required training by the designated completion date may be removed from their research or oversight role. Reinstatement will occur only once the required training is complete.

Acceptable Alternatives

Research personnel must complete all AHC required CITI modules and may affiliate on the CITI website to incorporate modules completed for other institutions. Research personnel not affiliated with AHC may contact the IRB Office to determine if their documentation of human research protection training at another institution may satisfy AHC requirements.

Renewal of Training

Renewal of CITI Basic training is required every three years in order to continue research activities that involve human subjects. CITI Refresher modules must be completed every three years. The CITI system will send a reminder notice 30 days prior to expiration.

Please see the Registration Instructions for more information.

 

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Learner Group Descriptions

Learner Group 1: Biomedical Investigator/Research Personnel

The individuals who belong to this group are involved with human subjects research that relates most directly to the biomedical sciences.

Learner Group 2: Social and Behavioral Investigators/Research Personnel  

The individuals who belong to this group are involved with human subjects research that relates most directly to the social or behavioral sciences. 

Learner Group 3: Data or Specimen Research/Research Personnel

The individuals who belong to this learner group are involved only with data analysis or specimen processing given to them by others who are directly involved with human subjects research.

Learner Group 4: IRB members/IRB Office staff/Human Research Protection Quality Committee (HRPQC) members

These individuals are members of the IRB, the IRB Office and members of the HRPQC who are involved with actions such as oversight of the AHC IRB and IRB management issues. 

Learner Group 5: Institutional Officials

These are individuals at AHC who oversee the programmatic aspects of the human research.

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