IRB:Protecting the Rights and Welfare of Human Research Subjects              
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IRB:Protecting the Rights and Welfare of Human Research Subjects
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Guidelines & Procedures


     393 E. Walnut St.
     Pasadena, California 91188
     E-Mail: kpsc.irb@kp.org

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Continuing education of individuals involved in human subjects research is essential to assure that Kaiser Permanente complies with its obligation to the Federal Government and protects the safety and welfare of members participating in research at Kaiser Permanente.  Human Research Subject protection law and regulation is constantly evolving, and so in addition to these required researcher trainings, KPSC-HI IRB provides continuous training and education to the research community across several modalities including custom cohort presentations, individual consultations, and our newsletter. 

PROGRAMS

Ø     CITI Human Subjects Research (HSR) Training [SCAL Investigators / HI Investigators] 
HSR: Effective September 25, 2018, investigators, who do not have an NIH training on file with the IRB and plan to conduct and/or participate in non-clinical trial research, must complete this one-time CITI "Biomedical (Biomed) Comprehensive" Human Subjects Research (HSR) training. The IRB may be able to accept an equivalent HSR certification from an outside institution.

Ø     For investigators in Southern California, click here for instructions   (updated 7/11/2025)

Ø     For investigators in Hawaii, click here for instructions   (updated 7/30/2025)

Ø     CITI Good Clinical Practice (GCP) Training [SCAL Investigators / HI Investigators] 
GCP: Clinical trial investigators must complete CITI Good Clinical Practice (GCP) training and re-certify every three years

Investigators should choose the GCP course most relevant to their research from three available options:

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus),
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), or
  • GCP - Social and Behavioral Research Best Practices for Clinical Research.

Ø     For investigators in Southern California, click here for instructions   (updated 6/26/2025)

Ø     For investigators in Hawaii, click here for instructions   (updated 7/30/2025)

Ø     HIPAA Researcher Training [SCAL Investigators / HI Investigators] (updated 8/5/2025) - All researchers must complete this one-time mandated HIPAA training. Submit as instructed on the Documentation of Completion on page 23.

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