Education & Training

In addition to research-appropriate experience and qualifications, a working knowledge in the appropriate conduct of research is essential.

�ʹڶ�� HealthCare expects investigators and research staff to understand and comply with federal, state and local laws, regulations and guidance that apply to their research.

This is accomplished through continuous education and training resources offered through a variety of providers and methods.

�ʹڶ�� requires education/training for investigators and staff who will perform study related activities that include:

Intervening with living human beings (e.g., blood draw, manipulation of body or environment, etc.)
Interacting with living human beings (e.g., interview, online questionnaire, etc.)
Conducting informed consent procedures (e.g., discussions with potential participants, obtain signatures or other documentation of consent, etc.)
Obtaining private identifiable information OR identifiable biospecimens about/from living human beings; and/or
Accessing, sharing, analyzing, or otherwise using private identifiable information, including Protected Health Information (PHI), about living human beings.

Humanitarian Use Devices (HUDs) & Education/Training

Federal regulations and �ʹڶ�� distinguish between the use of a HUD "in the practice of medicine” and HUD use "in a clinical trial."

Definition - Practice of Medicine

HUD use in the “practice of medicine” means: treatment/diagnostic use of an HUD according to the FDA approved indication (on-label use); or not according to the FDA-approved indication (off-label use) when the use is for the well-being of a patient and not for research purposes.

Note: �ʹڶ�� does not require compliance with the CITI education policy for use of a HUD in the practice of medicine.

Definition - Clinical Trial

HUD use “in a clinical trial” means: Use in a clinical investigation to evaluate the effect of the intervention on human participants by collecting safety and effectiveness data.

Note: �ʹڶ�� requires compliance with the CITI education policy for use of a HUD in a clinical trial.

Required Training

At a minimum, all investigators and staff participating in the conduct of research for �ʹڶ�� HealthCare are required to complete web-based training through the services of the .

CITI Program is a nationally recognized and well known resource for research education and training.

The CITI Program training courses required by �ʹڶ�� cover four core areas:

Human subjects research (HSR)
Responsible conduct of research (RCR)
Conflicts of interest (COI)
Good Clinical Practice (GCP) - only required for FDA-regulated research OR NIH-funded clinical trials

Training Requirements for FDA-regulated or NIH-funded clinical trials

When conducting FDA regulated research or clinical trials funded by the National Institutes of Health (NIH), investigators and staff must complete Good Clinical Practice (GCP) training in addition to the three core areas mentioned above.

FDA regulated research includes, but is not limited to:

Clinical trials involving an Investigational New Drug (IND) number OR FDA-issued IND exemption
Clinical trials involving an Investigational Device Exemption (IDE) number OR IDE exemption
Research ON FDA-approved drugs, devices, biologics, or Humanitarian Use Device [HUD; an approved HUD will have a Humanitarian Device Exemption (HDE) #]
Studies conducted to generate data for submission to the FDA.

NIH-funded clinical trials are research studies that satisfy ALL of the following criteria:

Receiving funding from the NIH
Involve living human participants
Investigators assign prospectively participants to an intervention
Study design evaluates the effect of intervention on participants, and
The effect under evaluation is health-related biomedical or behavioral outcome

For additional information and details on CITI Program training requirements for �ʹڶ��, please review the and .

Additional Training

training through �ʹڶ�� also offers a number of voluntary supplemental courses in other areas of interest to researchers

The Office for Human Research Protections (OHRP) offers and additional

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