University of Delaware
Toolbox

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.

IMPORTANT

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.

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.

Additional Resources

Questions?

For questions please contact the hsrb-research@udel.edu or (302) 831-2137

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