Before submitting an application to conduct research with human participants, ALL of the researchers and research assistants who will be involved with the project (e.g., principal investigators, faculty, student researchers) must complete one of the following courses:
- the free Good Clinical Practice eCourse created by the National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) and hosted by the Society of Behavioral Medicine (SBM), OR
- the Social-Behavioral-Educational Basic Course in Human Subjects Research offered by the Collaborative Institutional Training Initiative (CITI)
Each researcher’s certificate of completion must be dated within the past 3 years and must be submitted to FXUA’s IRB in PDF form as part of the application, along with the record/tracking number.
Additional information on accessing these courses is provided below.
To take the Good Clinical Practice (GCP) eCourse, you will first need to create a free account with the Society of Behavioral Medicine as a non-member/extramural researcher: https://sbm.execinc.com/edibo/Account
This will allow you to earn a certificate which you can then submit to the IRB as part of your application. The GCP course can be accessed at the following address: https://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course
As explained on the OBSSR website, “Investigators… who are competent in GCP principles will be better able to assure that the rights, safety, and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity; and that data derived from clinical trials are reliable” (Office of Behavioral and Social Sciences Research, n.d., para 2).
The training contains 9 video modules with a variety of interactive quizzes and knowledge tests. You must work through the modules in order. If you have problems with the functionality of the training website, please email email@example.com. If you have questions about the content of the training, please contact firstname.lastname@example.org or email@example.com.
Fairfax University of America does not have institutional access to the CITI Social-Behavioral-Educational (SBE) Basic Course. However, if you have access to this training through another organization, FXUA’s IRB will recognize your completion of those modules as meeting our training requirement.
Information about the CITI SBE course is available at the following address: https://about.citiprogram.org/en/course/human-subjects-research-2. The login page is available here: https://www.citiprogram.org/login. If needed, instructions are available in a “getting started” video and written guide.
CITI Program. (n.d.). Social-Behavioral-Educational (SBE) Basic. Available from https://about.citiprogram.org/en/course/human-subjects-research-2/
Office of Behavioral and Social Sciences Research. (n.d.). Online training resources. National Institutes of Health. Available from https://obssr.od.nih.gov/training/online-training-resources/
Society of Behavioral Medicine. (2020). Good Clinical Practice eCourse. Available from https://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course
Anderson, M. A. (2016). Back to basics: Does my project fall within the scope of the regulations? [Webinar Video]. U.S. Department of Health and Human Services. Available from https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/all-videos/index.html and https://youtu.be/o2fZs_XOMTs
[NOTE: Investigators themselves cannot make a determination as to whether their research can be considered exempt from IRB review. The IRB itself makes that determination.]
Feige, M. (2012). When PI’s come a-knockin: Everything investigators want to know but are afraid to ask. [Webinar Video]. U.S. Department of Health and Human Services. Available from https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/all-videos/index.html and https://youtu.be/FLoHNTuifGQ
Hernandez, J. O. (2016). What you should know about IRB review of research. [Webinar Video]. U.S. Department of Health and Human Services. Available from https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/all-videos/index.html and https://youtu.be/_UK5QatUEKE
Department of Health, Education, and Welfare. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Available from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Office of Behavioral and Social Sciences Research. (2010). eSource: Introductory social and behavioral science training material. National Institutes of Health. Available from https://obssr.od.nih.gov/training/online-training-resources/esource/