Research

Research

researchNHCC has launched a new web-based training course through the Collaborative Institutional Training Initiative (CITI) Program. This program is widely recognized throughout the research industry for providing ethics education to all members of the research community.

The CITI Program is used by NHCC to educate researchers and key personnel involved in research with human subjects. The CITI program will replace our prior NIH online tutorial. Going forward, all new clinical research investigators and staff must complete the CITI program and submit a confirmation of completion of the program to the NHCC IRB in order to participate in research studies at NHCC. This program is offered through our affiliation with the North Shore–LIJ Health System (NSLIJHS).

Clinical research investigators and staff who have already met their education requirements through completion of the current NIH online tutorials must complete the CITI program.

All clinical researchers must complete CITI’s “Basic Human Subjects” program—either for the first time or as a refresher course—by choosing the track that corresponds to their area of research:

  • Biomedical,
  • Social and Behavioral, or
  • Biomedical and Social/Behavioral.

Investigators who want their CITI training to meet requirements for more than one institution will be given the option to affiliate with another institution after logging on to the program. If the affiliated organization requires the same modules as NHCC, the investigator will only have to complete them once to get credit at both institutions.

Requirements

New Clinical Research Investigators and Staff: As of July 1, 2008, will be required to take the CITI program only.

Existing Clinical Research Investigators and Staff who have already completed the NIH Human Subject Protection Tutorials must complete the applicable CITI modules as well.

Procedure: Certification must be secured prior to submitting protocols for review by the Institutional Review Board (IRB).

Go to http://www.citiprogram.org.

Register. (Your participating institution is “North Shore–LIJ Health System.”)
When completing the profile information, “NHCC” should be listed as the Department.
All Clinical Researchers must take the Basic Human Subjects (if they are taking the CITI program for the first time) or the Refresher Course (if they are renewing their CITI training) in the area most appropriate to their research:

  • Biomedical,
  • Behavioral, or
  • Biomedical and Behavioral.

It is highly recommended that Clinical Researchers also take the modules on Good Clinical Practice and ICH and the Responsible Conduct of Research. Both modules are optional for now but may be required in the future.

One of the key benefits of this program is that course completion is transferable between member institutions with brief updates required each year. As a result, if you have transferred to NHCC from another CITI institution and/or you are considering transferring to or collaborating with a CITI institution, you will already have met the majority of your human subject protection educational requirements by completing this course.

In addition, CME/CEU credits are available through the University of Miami for completion of the Human Subjects Protection Basic Course and for the Human Subjects Protection Refresher Course.

Questions regarding your requirements should be addressed to:

Christine Deiker 516-296-2830, cdeiker@numc.edu

Technical issues should be addressed to:
citisupport@med.miami.edu, 305-243-7970

Thank you for your cooperation. We look forward to continuing to work with you in the advancement of human subject research.

The minimum passing aggregate score for the quizzes is 80%. If you want to improve your score on a quiz, you may repeat any quiz in which you did not score 100% correct.

Print or download a Course Completion Report as evidence that you have met your institutional requirements. A copy will be sent to your administrator. You may return to the course site in the future to obtain a copy of the completion report.

CITI Fact Sheet

The CITI program consists of online tutorials with online exams and is offered through the University of Miami. It was developed by experts in the IRB community and focuses on different aspects of bioethics and human subjects research. There is a basic course for the protection of human subjects in either biomedical or social/behavioral research. Choose the basic course that best describes your research. The courses have some content overlap. Students should ask for guidance from their departments about which course to take. The CITI training is designed, updated, and maintained by a number of nationally known IRB professionals. Modules are housed at the University of Miami. The Basic CITI training takes approximately 4 to 6 hours to complete, usually far less if the material is not completely unfamiliar. This training does not need to be completed in one sitting. However, we suggest that you start and finish a quiz without taking a break. The modules are completed in succession. Topic-specific modules are each followed by a short quiz. You may repeat a quiz to improve your score. CITI is user-friendly and available 24 hours a day all year round.

The Collaborative Institutional Training Initiative (CITI) modules include:

  • Biomedical Focus
  • Social and Behavioral Focus
  • Refresher Courses
  • Good Clinical Practice Course
  • Health Information Privacy and Security Course (HIPS)
  • Laboratory Animal Welfare Courses for investigators and IACUC Members
  • Responsible Conduct of Research (RCR)

Registration for CITI

CITI can be accessed at www.citiprogram.org. Closely follow the instructions for registration. Remember your username and password for future access to the CITI program. If you are having problems with the CITI site or course, contact the CITI Office at citisupport@med.miami.edu or at 305-243-7970.

Training

CITI training is required of all faculty, staff, and students who are engaged in the design, conduct, or reporting of research at NUMC that involves human subjects. All personnel listed as investigators on the protocol must submit CITI certification.

Proof of completion of CITI training must be provided at the time of protocol submission.

Renewal of CITI Certification

CITI training must be renewed every two years through a refresher set of modules available through the CITI website at http://www.citiprogram.org.