Human Subjects Research Training Program

As of July 1, 2010, all Key Research Personnel (see definition below) engaged in human subject research must complete the online Collaborative Institutional Training Initiative (CITI) Training Program prior to IRB approval of a new or continuing review application. The prior Drexel University College of Medicine training certification will not be accepted after July 1, 2010. However, the prior training will continue to be valid for any previously submitted applications until a continuing review or new application is submitted. CITI training will not be checked during addenda transactions unless there are changes being made to the research team.

Key Research Personnel are defined as the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved with handling private information (example: patient's medical records and charts) related to study participants during the course of a research project. Key research personnel also include faculty sponsors who provide direct oversight of research with study participants or research using study participant's private information.

The specific type of training required of our key research personnel is dependent upon the predominant or usual areas of research conducted. The four (4) certification training programs offered by CITI below address the areas of Human Subjects Research (HSR), Health Information Privacy and Security (HIPS), Good Clinical Practice (GCP), and Responsible Conduct of Research (RCR).

The training program(s) you are required to complete depend on the nature of your research and which IRB committee to which you normally apply. All key research personnel are required to complete the HSR training program. It may be necessary for you to take more than one of the offered programs depending on which “Learner Group” is most appropriate for you.

The CITI Course Offering links below will take you to course specific guidance regarding your registration, Learner Group, course requirements and frequently asked questions, as well as additional Office of Regulatory Research Compliance (ORRC) resources.

CITI Course Offerings

1. Human Subjects Research
2. Health Information Privacy and Security (HIPS)
3. Good Clinical Practice
4. Responsible Conduct of Research

Additional Training Resources

1. Drexel Core Modules
   1. HIPAA and Medical Research (Part I)
   2. HIPAA Security (Part II)
   3. Infectious Substances Packaging
   4. Substituted (Surrogate) Consent
   5. Recombinant DNA Molecules Training
   6. Select Agent Policies and Procedures
   7. Laboratory Safety and Bloodborne Pathogen Training
2. DUCoM IRB Calendars, Deadlines, and Membership