Frequently Asked Questions

Why is training necessary?

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.

What type of training is offered?

To meet the requirements the LECOM has elected to use an Internet-based human subject education program sponsored by the University of Miami. The Collaborative IRB 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.

Who must be trained?

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 LECOM IRB. These personnel include:

• Institutional Review Board members
• Principal investigators
• Co-investigators
• Project directors
• Faculty and instructors
• Students
• All research staff, including study coordinators, study nurses, residents, and individuals who obtain informed consent, administer surveys, or collect identifiable private information
• All other employees listed on protocols that involve the use of human subjects in research
• All research staff who do not work directly with human subjects, but analyze data and/or biological specimens obtained from subjects or patients

Will this institution accept certification of training from other institutions for new LECOM employees or students?

The only certificates of training which will be accepted are those from institutions who utilize the same training program as this institution. LECOM must be assured that all personnel involved in human subject's research have at least equivalent training. LECOM will also accept the NIH training certificate.

Will the IRB review an initial application if all key personnel are not trained and certified?

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.

Are training and certification of all key personnel required for continuing review?

The Principal Investigator should ensure that all key personnel are certified prior to submission of the IRB Application for Continuing Review.

Does the training requirement apply to expedited and full board research conducted by students or staff?

Yes, research conducted by students or staff must maintain the same high ethical standard as research conducted by faculty.

Does the training requirement apply to students doing exempt research?

Yes, the training requirement applies for students doing exempt projects.

How long will certification be valid?

Certification is valid for 3 years.

How do I access the required CITI training program?

Go to the CITI Training website.

How long will it take to complete the training?

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.

Where are the test data maintained and what about confidentiality?

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.

Is there a minimum passing score required in order to be certified?

The passing score is 70%. The score will be based on the overall score from all the required modules. The quizzes are open book.

How do I receive a certificate of completion?

Once you complete and score a 70% passing score (based on the overall score from all required modules), the CITI Training website will send you an e-mail.

If I encounter a problem or have a question, whom do I contact?

Call the LECOM Office of Research at (814) 866-8142.