Required Research Training
Seattle Children's offers Human Subject Protections Training (HSPT), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) courses through the Collaborative Institutional Training Initiative (CITI) Program.
Human Subjects Protections Training (HSPT)
- Human Subjects Protection Training (HSPT) provides fundamental training regarding human subjects research, human subjects protections and associated guidances and regulations.
- Who should complete this course? The National Institutes of Health (NIH) requires this training for all key personnel on NIH grants and contracts. It is the goal of Seattle Children's that all researchers and their staff who do human subjects research receive training in human subjects protection.
- Multiple HSPT courses are available on CITI. Choose the course that is most applicable to your area of research. You may also take this training in person by enrolling via Seattle Children’s Learning Center. Seattle Children's also accepts human subjects protection training provided by the University of Washington or Fred Hutchinson Cancer Center.
- This training is currently required once and does not need to be renewed.
Good Clinical Practice (GCP) Training
- Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical research studies.
- Who should complete this course? As of January 1, 2017, NIH requires all investigators and research staff involved in the conduct, oversight or management of a new or ongoing clinical trial to complete GCP training. It is Seattle Children's goal that all investigators and their staff who do human subjects research receive GCP training.
- Multiple GCP courses are available on CITI. Choose the course that is most applicable to your area of research.
- Regardless of the GCP course you complete, all GCP courses (including refresher courses) are required every three years. Investigators and research staff are responsible for retaining a copy of their training certificate.
Good Laboratory Practice (GLP) Training
- This training program describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported and archived as set forth by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and U.S. Department of Agriculture (USDA), as well as the Organization for Economic Co-operation and Development (OECD) international guidelines. It provides a working knowledge of GLP that supports and reinforces technical education and training.
- Who should complete this course? This course is designed for individuals involved in nonclinical laboratory studies within industry, academia, government or other testing facilities.
- Consult with your Seattle Children’s supervisor whether or not you are required to complete this course.
- Good Clinical Practice (GLP) training is required every three years. There is no refresher course for GLP at this time. Investigators and research staff are responsible for retaining documentation of their completed training.
Responsible Conduct of Research (RCR) Training
- Seattle Children’s Research Institute strives for excellence in the responsible conduct of research (RCR).
- Who should complete this course? Although recommended for all Children’s researchers, all undergraduates, graduate students and postdoctoral researchers who will be supported by National Science Foundation (NSF) funded research, or are receiving support through any NIH training, career development award (individual or institutional), research education grant or dissertation research grant must complete this course.
- The preferred RCR training program is the University of Washington’s Biomedical Research Integrity Program. The trainee must complete eight hours of training, including five lectures and three discussion groups. Proof of completion must be provided to the Seattle Children’s Research Institute’s Office of Research Compliance (ORC) at email@example.com. Another in-person RCR training with equal contact hours may be substituted with approval from ORC.
- If the trainee cannot attend the UW’s Biomedical Research Integrity Program or another in-person RCR training program, they may request permission from ORC to substitute a Collaborative Institutional Training Initiative (CITI) RCR course.
- RCR training must occur at least once at each career stage (e.g., early in graduate studies, at postdoctoral status, etc.), and no less than once every four years. Investigators and research staff are responsible for retaining documentation of their completed training.