Effective January 1, 2020 New Training Requirements for the Human Research Protection Program

Our commitment to training and education programs is one of the many strengths of CHOP’s human research protection program (HRPP). Initial and continuing education help to ensure that principal investigators and their research teams have the foundational knowledge they need to conduct human subjects research safely and with integrity to facilitate breakthroughs for pediatric diseases.

The Research Compliance & Risk Subcommittee (consisting of faculty and Principal Investigators) and Research Institute leadership reviewed and approved the following updated training requirements for the HRPP.

Initial training requirements

The updated initial training requirements effective January 1, 2020 are:

• Required for everyone conducting human subjects research – CITI’s Human Subjects Research (HSR) course: Biomedical Research OR Social & Behavioral Research OR Administration Supporting Research course, whichever is most relevant to the study team member’s portfolio of studies.
• Required for everyone conducting a clinical trial/interventional study — CITI’s GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) OR GCP for Social & Behavioral Research Best Practices for Clinical Research, whichever is most relevant to the study team member’s portfolio of studies. This requirement is in addition to #1.
  • Effective January 1, 2020, CITI’s Good Clinical Practice (GCP) course will be required for allresearch team members who are conducting clinical trials/interventional studies; this requirement applies to all funding sources and is consistent with the NIH’s requirements. A clinical trial/interventional study involves one or more human subjects who are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. If you are a research team member on a clinical trial/interventional study that is active as of January 1, 2020 you will need to complete the GCP course prior to January 1, 2020.
• Required for the CHOP sponsor or sponsor-investigator of an FDA-issued IND or IDE and any person(s) to whom responsibility to manage the IND/IDE has been delegated (see Policy for details)— IND/IDE Support Program’s sponsor training. This requirement is in addition to #1 and #2.

Ongoing training requirements / three-year recertification

Continuing education is an integral component of our HRPP, so CHOP requires all research team members to demonstrate ongoing education that is relevant to the protection of human subjects.  You will have several options to satisfy your ongoing training/three-year recertification requirement. Completion of any oneof these options will complete your ongoing training requirement.  These revised requirements become effective January 1, 2020.

• Completion of any CITI Human Subjects Research (HSR) course: Biomedical OR Social & Behavioral Refresher OR Administration Supporting Research course, whichever is most relevant to the study team member’s portfolio of studies.
• Completion of any CITI GCP Refresher course.
  • Note: The NIH requires research teams involved in conduct, oversight, or management of clinical trials to complete GCP training at least every three years.
• IND/IDE Support Program’s sponsor training.
• Completion of two hours of continuing education which can be met through completion of any HRPP training opportunity provided by CHOP (e.g., PROSPER, IRB), professional organizations (e.g., SOCRA, ACRP), or other training provider. More information about this option will be distributed later this year.

We appreciate the research community’s commitment to ensuring the protection of human subjects and the time involved in meeting the education requirements.

If you have questions about these updated requirements, please contact Matthew Hodgson at 267-426-8723 or at hodgsonm@email.chop.edu