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Human Subjects Research Training

Drexel is part of the Collaborative Institutional Training Initiative (CITI) along with over 1130 other organizations throughout the world. Drexel chose CITI training because the content is extensively reviewed and critiqued by multiple institutions and updated regularly. If key research personnel have taken CITI training elsewhere, the previously completed training will be accepted at Drexel, with the caveat that key research personnel must complete any CITI courses required by Drexel that have not already been completed.

Training Requirements

All key research personnel at Drexel or affiliated sites for whom the Drexel IRB has provided approval must complete the online CITI program as well as any other necessary courses. IRB approval of any individual application is contingent upon the fulfillment of this requirement. IRB members, HRPP administrative officials and staff are also required to complete this training.

CITI Required Training by Learner Groups

During CITI registration you will be prompted to select one of three Learner Groups. Select the Learner Group that most closely reflects the main emphasis of your work and IRB committee to which you usually apply. Training requirements are based on the Learner Group with which you identify.

Learner Group 1

  • Medical (Healthcare Providers, residents, fellows, medical students)
  • Biomedical Engineering
  • Nursing
  • Public Health
  • Nutrition
  • Psychology
  • Investigators/staff submitting to Medical IRB #1, #4, or to Western IRB (WIRB).
Minimum training modules requirement:
  1. Human Subjects Research
  2. Health Information Privacy & Security (HIPS)

Learner Group 2

  • Social, Behavioral and Educational Research Investigators (Education, Creative Arts Therapists, IST, Business, Law, Library science)
  • Investigators/staff submitting to the Social and Behavioral IRB #3.
Minimum training requirement:
  1. Human Subjects Research
  2. Health Information Privacy & Security (HIPS)* (Only required for Learner Group 2 if you plan to collect or access PHI)

Learner Group 3

  • IRB Members
  • ORRC Staff
  • Research Administration
Minimum training requirement
  1. Human Subjects Research
  2. Health Information Privacy & Security (HIPS)
  3. Good Clinical Practice (GCP)
  4. Responsible Conduct of Research (RCR) for Administrators

Additional Training Requirements

Requirements to complete any supplemental training modules are based upon your specific research protocol design and activities to be conducted on behalf of the protocol. Descriptions and examples of when additional training may be required are listed below.

When Protocol Design Involves: Additional Training Required:
Evaluation of drugs, devices, biologics or interventional/behavioral treatments Good Clinical Practice (GCP)
National Science Foundation (NSF) funding Responsible Conduct of Research (RCR)
Access and review of Protected Health Information (PHI) Health Information Privacy & Security (HIPS)
Access and review of Protected Health Information (PHI) Drexel Core Module HIPAA I
Access and review of Protected Health Information (PHI) Drexel Core Module HIPAA II
Shipping biologic samples off DU campus Infectious Substances Packaging
Enrollment of subjects unable to provide consent Substituted (Surrogate) Consent
Use of recombinant materials, manipulation/alteration/modification Recombinant DNA Molecules Training
Use or processing of high risk controlled chemical/biologic agents Select Agent Policies and Procedures
Collection and analysis of biologic specimens in a “non” CAP/CLIA certified laboratory Laboratory Safety and Bloodborne Pathogen Training
Prisoners are engaged in the research protocol CITI course: ID 506 Research with Prisoners in Social/Behavioral protocols
OR
CITI course: ID 8 Research with Prisoners in Medical/biomedical protocols