Human Subjects Protection

Relevant IRB Policies and Procedures

• IRB Training (Policy 2.20)

Human subjects protection (HSP) 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/Seattle Children's 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). 
  • performance of routine clinical or non-clinical tasks associated with specific roles and/or service areas in the outpatient clinical setting, as described by ADM503 Clinical Research Training Requirements for Fred Hutchinson Cancer Center Clinic Staff, when those tasks provide direct or indirect support for the conduct of research.
• 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 Protection Training

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

• CITI online course:
  • Group 1. Human Subjects Protection (HSP) - Basic Course
    • Appropriate course for staff working on treatment interventional trials
  • Group 2. Social Behavioral Human Subjects Protection - Basic Course
    • Appropriate course for staff working on non-treatment interventional trials   
• OHRP Human Research Protection Training (for individuals with research subject to HHS regulations only)
  
• PRIM&R (Public Responsibility in Medicine and Research) Investigator 101
  
• University of Washington Clinical Certificate Program - Introduction to Clinical Trials
• Other equivalent training (e.g., human subjects lectures at another institution) may fulfill the initial training requirement. Email iro@fredhutch.org to determine if the training’s content satisfies the requirement. Note, GCP training does not fulfill the human subjects training requirement.

Refresher Human Subjects Protection Training

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

• CITI online course:
  
  • Group 1. Human Subjects Protection (HSP) - Refresher Course
    • Appropriate course for staff working on treatment interventional trials
  • Group 2. Social Behavioral Human Subjects Protection - Refresher Course
    • Appropriate course for staff working on non-treatment interventional trials
• 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
• At least 1 year's IRB membership and participation in 6 IRB meetings in the last 2 years
• Other equivalent training (e.g., human subjects lectures at another institution) may fulfill the initial training requirement. Email iro@fredhutch.org to determine if the training’s content satisfies the requirement. Note, GCP training does not fulfill the human subjects training requirement.

Documentation

CITI training completions are entered automatically in Hutch Learning. There may be up to a week delay for Hutch Learning to reflect your completion status. (Note, learner must affiliate with 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.