In recent years, reports by the Office of the Inspector General (OIG) and enforcement actions taken by the Office for Human Research Protections (OHRP) against a number of prominent universities have called attention to serious problems related to compliance with Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) regulations for the protection of human subjects. Accordingly, national bodies including the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) have called for formal training of personnel involved in the conduct of human subject's research.
To meet the requirements the University of South Dakota has elected to use an Internet-based human subject education program sponsored by the University of Miami. The Collaborative Institutional Training Initiative (CITI) course consists of modules for both the social / behavioral and biomedical researcher. The CITI modules encompass the history of the IRB, regulations governing human subject research and topics specific to areas of particular importance, controversy or complexity.
All personnel who interact with research subjects will be required to turn in a Certificate of Completion with each study/project/protocol submission to the IRB. These personnel include:
The only certificates of training which will be accepted are those from institutions who utilize the same training program as this institution. The University of South Dakota must be assured that all personnel involved in human subject's research have at least equivalent training. USD will also accept the NIH training certificate.
Yes, the application will be reviewed but will not be granted final approval until all research personnel have appropriate training. You may remove untrained personnel from your research team and add them in an amendment after their training is complete.
The Principal Investigator should ensure that all key personnel are certified prior to submission of the IRB Application for Continuing Review.
Yes, research conducted by students or staff must maintain the same high ethical standard as research conducted by faculty.
Yes, the training requirement applies for students doing exempt projects. Students must complete the Social-Behavioral or Biomedical course.
Certification is valid for 3 years.
Go to citiprogram.org
The time required to complete each module varies between 10 minutes and 30 minutes. The total time required is estimated to be 3-6 hours. The course does not have to be completed in one sitting, and personnel can enter the course at any time.
Your individual quiz scores are confidential. The webmaster and staff supporting the distance learning software at the University of Miami where the data are processed and stored have access to individually identifiable quiz scores. However, each of these staff members have signed confidentiality pledges and will not disclose individually identifiable quiz results nor aggregate institutionally identifiable results. Aggregate, anonymous quiz data will be used by course faculty to help improve course content and quiz questions. Absolute confidentiality will be maintained.
The passing score is 70 percent. The score will be based on the overall score from all the required modules. The quizzes are open book.
Once you complete and score a 70 percent passing score (based on the overall score from all required modules), the CITI site will send you an e-mail.
Contact: firstname.lastname@example.org or call the Office of Human Subjects Protection 605-677-6184.