Human Subjects Protection Training – Certification / Recertification
Boston University Medical Campus (BUMC)/Boston Medical Center (BMC) require that all researchers involved in human subjects research must receive formal training in the protection of human subjects. After initial certification, researchers need to be recertified every three years.
Who must be certified/recertified: The training requirement applies to all faculty, staff, students, visitors or any other individuals who work with human subjects in research or their data. Some examples include: individuals who obtain informed consent, administer study interventions such as surveys, or collect/analyze private or personal information from individuals. This policy applies to all individuals working with human subjects under the auspices of Boston University Medical Campus (BUMC) and/or Boston Medical Center (BMC), whether here at BUMC/BMC or at another location, and regardless of their institutional affiliation or source of funding.
How to obtain your initial certification: Two types of certification are required for anyone who wants to do human research here at BUMC/BMC: 1) a certificate of completion of human subjects protection training from the Collaborative Institutional Training Initiative (CITI); and 2) a certificate of completion of the BUMC/BMC Research HIPAA Module. Each researcher named on an IRB application must have certificates for both human subjects protection training and the BUMC/BMC Research HIPAA Module on file in the IRB office. (Note that the HIPAA module appears in CITI in two places, as a separate module and within the Basic courses. Take either one, and it will be reflected that you have completed this requirement.)
BUMC/BMC will accept CITI training that was completed at another institution. See below for instructions on how to transfer CITI certification to BUMC/BMC.
1) HUMAN SUBJECTS PROTECTION TRAINING CERTIFICATES:
Individuals who are getting human subjects protection training certification through CITI for the first time
All BUMC/BMC investigators who currently do not have human subjects protection training certification, should use the CITI program to get one. Instructions for registering yourself in the CITI program can be found here. During registration, be sure to select “Boston University Medical Campus/Boston Medical Center” as your institutional affiliation (do not pick the “Boston University” option). Also, be sure to list your “@bu.edu” email address (if you have one) as the preferred email address.
After entering other information about yourself within CITI, you will be presented with several curriculum options. As part of initial certification, you should select in Question 1 either the curriculum for Medical Campus Biomedical researchers or Medical Campus Social-Behavioral researchers, whichever is better aligned with your usual research (see image).
[Note: For Question 2, choose “No.” , Please DO NOT select any of the refresher courses.]
After you complete the Basic CITI modules in whichever curriculum you selected, CITI automatically notifies the IRB office that you have been successfully certified.
Individuals who come to BUMC/BMC from other institutions
We will accept CITI training from other institutions. If investigators are from other institutions and they only have NIH training, then they must do the BUMC/BMC CITI training (see How to Obtain Your Initial Certification, above).
BUMC/BMC investigators who already have CITI Human Subjects Protection Training certificates from other institutions, need to affiliate themselves with “Boston University Medical Campus/Boston Medical Center” as their institutional affiliation in CITI (do not pick the “Boston University” option); this will transfer completed courses and individuals will then only be required to complete any additional courses exclusive for the BUMC/BMC institution. Instructions can be found here.
For VA investigators, their VA CITI certificates are accepted as documentation of human subjects protection training certification. These certificates should be emailed to firstname.lastname@example.org or faxed to the IRB office (617-638-7234) with a cover letter requesting that this training be accepted as initial certification. **Please do NOT attach training certificates to INSPIR applications.
2) BUMC HIPAA MODULE:
Initial certification also requires completion of the BUMC HIPAA module. This training and certification is done through CITI. Whether your Human Subjects Protection Training certificate is from BUMC/BMC CITI or from another institution (including the VA), everyone must complete the CITI BUMC/BMC Research HIPAA Module before they can be approved to perform human research at BUMC/BMC.
Go to the CITI website (as described here). From the list of available courses (see image below), select “BUMC HIPAA Module.” When you have completed the module, CITI automatically sends a notice of completion to the BUMC IRB office.
All BUMC/BMC human researchers must be recertified every three years. Individuals with expired training will not be permitted to submit new protocols to the IRB, nor be named on any new protocols, nor added to existing protocols until the recertification requirements have been met.
Who needs to be recertified?
All faculty and staff who are engaged in human research, who are employed by BUSM, BUSPH, BUGSDM, or Boston Medical Center, and whose initial training has expired or is about to expire. Trainees (students, house officers, post-docs) who are named on BUMC/BMC IRB protocols must also be recertified. In addition, because the BUMC/BMC IRB is their IRB of record, human researchers at the Boston Public Health Commission and at any of the Boston HealthNet Community Health Centers must also be recertified. If you fall into one of these groups, you will need to complete recertification (see the Recertification Process section below for instructions).
Who does not need to be recertified?
There are two groups who do not need to be recertified:
- BUMC/BMC faculty, staff, and trainees who are primarily based at a VA facility who wish to be named on a protocol being reviewed by the BUMC/BMC IRB do not need to complete the BUMC/BMC recertification process. We will accept documentation that they have completed the VA’s CITI certification/recertification program. These VA-based investigators must email a copy of their up-to-date VA CITI recertification form to email@example.com with an explanatory email.
- Clinical researchers whose primary affiliation is at another institution but who are named on a BUMC/BMC IRB protocol (for example, a collaborator at Brigham and Women’s Hospital) do not need to complete our BUMC recertification. They would, however, be expected to meet any recertification requirements of their home institutions.
To be recertified, you must take the “Boston University Medical Campus/Boston Medical Center” CITI Refresher course through CITI. You would either select “Yes, please enroll me in the Biomedical Refresher Course” or “Yes, please enroll me in the Social & Behavioral Refresher Course.”, whichever is better aligned with your type of research. Instructions for taking the refresher course through the CITI program can be found here.
After you complete the modules in whichever curriculum you selected, CITI automatically notifies the IRB office that you have been successfully recertified.