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Human Subjects

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Relevant IRB Policies and Procedures

Human subjects training is required for all Fred Hutch personnel involved in the design, conduct or reporting of human subjects research conducted at Fred Hutch or through the Fred Hutch/University of Washington Cancer Consortium. Training must be completed every three years. For additional information, refer to the training policy above.

Human Subjects Training Requirements

Human Subjects training is required for Fred Hutch personnel involved in one or more of these activities:

  • Design: developing the research concept, scientific method, or objectives for a study that involves intervention or interactions with a human subject or the use of identifiable data or tissue derived from a human subject.
  • Conduct: implementation and management of research involving human subjects. Staff conducting research include principal investigators, research staff working on a research study, and others engaged in research activity supporting the research study (e.g., conducting interviews, surveys, data collection).
  • Reporting: analyzing, summarizing, or preparing manuscripts involving data derived from a research study involving human subjects.

Training is mandatory for all personnel involved in design OR conduct OR reporting of research. In practice, this will include not only investigators, but also nurses, data managers, lab technicians, and others.

Course Options

Basic Human Subjects Training

You need a basic course if you have not had training in human research protection before. Accepted courses include:

  • In-person lecture at Fred Hutch (basic lecture only);
  • CITI web-based course (Biomedical or Social Behavioral basic course only):
    • Group 1. Biomedical Research, or
    • Group 2. Social Behavioral Research;                    
  • OHRP Human Research Protection Training (for individuals with research subject to HHS regulations only);
  • PRIM&R Investigator 101;
  • University of Washington Clinical Certificate Program - Introduction to Clinical Trials.

Refresher Human Subjects Training

You need a refresher course within 3 years after completing the basic course. Accepted courses include:

  • In-person lecture at Fred Hutch (basic or refresher);
  • CITI web-based course (Biomedical or Social Behavioral basic or refresher):
    • Group 1. Biomedical Research, or
    • Group 2. Social Behavioral Research;
  • OHRP Human Research Protection Training (for individuals with research subject to HHS regulations only);
  • PRIM&R Investigator 101;
  • University of Washington Clinical Certificate Program - Introduction to Clinical Trials;
  • Attendance at conferences on human subjects protection or clinical trial management;
  • Fred Hutch lectures on research ethics for trainees;
  • Testing through a book on human subjects protection;
  • Case studies conducted by investigators;
  • At least 1 year's IRB membership and participation in 6 IRB meetings in the last 2 years
Go to Hutch Learning to access Human Subjects curricula.
 
Hutch Learning

Documentation

Documentation of attendance at Fred Hutch lectures and completion of CITI training are entered automatically in Hutch Learning. There may be up to a week delay for Hutch Learning to reflect your completion status. (Note, you have to associate to Fred Hutch when enrolling in CITI courses for completion to be accurately recorded.) If you have taken other training that meets the Human Subjects training requirements, please send documentation to iro@fredhutch.org.

If you need to send a certification letter verifying a research member's training, use the template letter below.

* Sample Letter of NIH for Human Subjects Training Completion


Questions?

If you have questions about registration, training status, course content or requirements, contact the IRO department at iro@fredhutch.org.