University of Delaware

Human Subjects in Research Protection (HSRP)

Training in
Human Subjects Protection (HSP)

Training in the protection of human subjects in research is required for all university members (i.e., faculty, students, researchers, and staff), and collaborators, who will directly interact with research participants or have access to identifiable private information. Training in human subjects protections (HSP) must be completed, and the completion report obtained, prior to seeking review and approval from the IRB to conduct research.

Training in
Good Clinical Practice (GCP)

In addition to the required training in human subjects protections, and as per NIH policy, training in Good Clinical Practice (GCP) must also be completed by all research team members involved in NIH-supported clinical trials. NIH defines a clinical trial as any research study in which one or more human subjects 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.

Training in CITI Program - Every 3 years

All personnel actively engaged in human subjects research must maintain current training by completing the required courses every three (3) years. Training is available, and must be completed, online through the Collaborative Institutional Training Initiative (CITI) Program. Principal Investigators submitting a research proposal for review to the IRB are responsible for ensuring all researchers to be engaged in human subjects research under his/her supervision hold valid and current training certifications. If researchers have not linked their training certification to their user profile in IRBNet, certifications of training completion for all research team members need to be submitted at the time of the application as a single PDF document.


Training in responsible conduct of research (RCR) and/or good clinical practice (GCP) DO NOT fulfill the basic training requirement (HSP) all UD researchers must comply with to carry out human subjects research.

For questions please contact the UD IRB Office by email: or by phone: (302) 831-2137.

How to complete CITI Program Training

To complete online training, users need to register at the CITI Program site and affiliate their profile with the University of Delaware. Several training courses are available under the UD affiliation. Under the ‘Add a Course’ menu researchers must select the appropriate ‘learner group’ for human subjects protections depending on the research they will be involved with; Biomedical Focus; Social-Behavioral-Educational Focus; or Non-UD Researchers (available to non-UD collaborators). There is no cost or fee associated with the completion of required UD training courses.

  • Once a learner group is selected a list of all the required training modules will populate and need to be completed. The program is available online 24/7, users may stop at any time and return to where they left off, at their convenience and as many times as needed, until the training is finished.

  • If a researcher has completed human subjects protections training in CITI Program under a different institution affiliation in the recent past, he or she must log in to CITI program and add their affiliation to UD. Modules previously taken that are still current will be ‘transferred’ to the UD course and only non-completed required modules will need to be done.

  • To successfully complete training a minimum overall passing grade of 85% is a requisite. Once training requirement has been fulfilled, a completion report is generated. A researcher may upload his/her training completion report onto his/her user profile. Doing so will link that training record to the investigator profile and automatically be linked to all his/her submissions to the UD IRB.

  • Completion date will be recorded as the day the last required module(s) was completed and course was finished. In order to maintain training current, the course must be completed before the three years’ expiration window. CITI Program will send an automatic reminder 90 days before the most current completed course will expire.

For questions please contact the UD IRB Office by email: or by phone: (302) 831-2137.

Additional Resources


For questions please contact the or (302) 831-2137

  • UD Research  •   210 Hullihen Hall  •   Newark, DE 19716  •   USA
    Phone: (302) 831-2136  •   Fax: (302) 831-2828  •   © 2015