Training

Training Required for All Research Team Members

Training: Human Subject Protection (HSP) Training

 

Who does this apply to?

All members of a research team that meet the definition of “engaged in research” are required to complete human subject protection (HSP) training.

 

Engaged Study Team Members: An individual is "engaged" in human subjects research when the individual, (i) intervenes or interacts with living individuals for research purposes; or (ii) obtains individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].

 

Recertification and Renewal

Human Subject Protection training must be renewed every three years.

 

Where can I complete this training?

Training may be completed through Collaborative IRB Training Initiative (CITI) or through the Clinical Research Training Course (NIH).

 

Which CITI modules fulfill the HSP training requirement?

The modules are grouped by categories of research.  There are two modules for HSP training.  Choose the module/group that best fits the type of research you normally conduct.  Below are the two modules for HSP training: 
 

  • Group 1. Biomedical research investigators and key personnel: Biomedical research is patient-oriented and involves the study of the mechanisms of human disease, therapies or interventions for disease, clinical trials, and development of new technology.   Biomedical research includes oncology research. 

  • Group 2. Social and behavioral research investigators and key personnel: Social and Behavioral research applies the behavioral and social sciences to the study of humans.  This research is conducted by many academic disciplines to include but not limited to education, sociology, anthropology, economics, political science, and history.

 

For more information regarding HSP training and registering for the course in CITI click here.

 

Training Required for Research Involving Private Health Information (PHI)

Training: HIPAA Training

 

Who does this apply to?

HIPAA Training and certification is mandatory for all investigators and research personnel who will access, use or disclose Private Health Information (PHI).

 

Recertification and Renewal

HIPAA training must be renewed every three years.

 

Where can I complete this training?

Training may be completed through Collaborative IRB Training Initiative (CITI).

 

Which CITI modules fulfill the HIPAA training requirement?

The following module in CITI fulfills the HIPAA training requirement:
 

  • Group 4: HIPAA and Human Subjects

 

For more information regarding HIPAA training and registering for the course in CITI click here.
 

 

Training Required for NIH Funded Investigators and Research Team Members

Training: Good Clinical Practice (GCP) Training

 

Who does this apply to?

All National Institute of Health (NIH) funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials.  The policy applies to all active grants and contracts, at any point in the life cycle of the clinical trial.

 

Definitions:
 

NIH Clinical Trial – A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions [defined below], on health-related biomedical or behavioral outcomes.

 

Interventions – A process or action that is the focus of a clinical study.  Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available.  Interventions can also include noninvasive approaches, such as surveys, education, and interviews.

 

Recertification and Renewal

Good Clinical Practice training must be renewed every three years.

 

Where can I complete this training?

Biomedical Research: Training may be completed through Collaborative IRB Training Initiative (CITI).

Social and Behavioral Research: Training may be completed through the Society of Behavioral Medicine (SBM).

 

Which CITI modules fulfill the GCP training requirement?

There are three courses that are available for the training.  The first course (Good Clinical Practice, US FDA Focus) should be completed by all research personnel involved in NIH supported clinical trials.  This course incorporates relevant ICH principles.  The remaining courses should be completed if relevant to your particular international research.  

 

  • Good Clinical Practice Course, US FDA Focus [also called:  GCP for Clinical Trials with Investigational Drugs and Medical Devices (US FDA Focus)] (Includes ICH)
  • Good Clinical Practice Course for Clinical Trials Involving Medical Devices (international focus).
  • Good Clinical Practice Course for Clinical Trials Involving Investigational Drugs (ICH / international focus)

 

For more information regarding GCP training see the GU Memorandum and Policy or visit the NIH website on FAQs regarding the NIH Policy on GCP.

 

Training Required for Public Health Service (PHS) Investigators

Training: Financial Conflict of Interest (FCOI) Training

 

Who does this apply to?

Investigators who receive PHS funding (NIH, FDA, etc.) or cooperative group funding must also undergo conflict of interest (COI) training before engaging in the funded research.

 

For more information, click here.