Human Subjects Protection Training – Certification / Recertification
- List of Investigators with Human Subjects Protection Training Certificates
- Research Certification
- Research Recertification
- Q&As about Human Subjects Protection Training Recertification
- Contact Us
Boston University Medical Center requires that all researchers involved in human subjects research must receive formal training in the protection of human subjects. Further, we require that researchers be recertified every two 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 BUMC, whether here at BUMC 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: 1) a certificate of completion of human subjects protection training from CITI; and 2) a certificate of completion of the BUMC HIPAA Module. Each researcher named on an IRB application must have certificates for both human subjects protection training and the HIPAA Module on file in the IRB office.
1) HUMAN SUBJECTS PROTECTION TRAINING CERTIFICATES:
All new initial human subjects protection training must be done through CITI.
- BUMC no longer offers on-site training for human subjects protection training certification.
- BUMC no longer accepts the NIH/NCI on-line training to meet the requirements of human subjects protection training.
- BUMC still accepts some certificates from other institutions for human subjects protection training (see “From Another Institution” below).
From CITI: All BUMC investigators who currently do not have human subjects protection training certificates, 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 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, you will be presented with several curriculum options. As part of initial certification, you should select either the curriculum for Medical Campus Biomedical researchers or Medical Campus Social-Behavioral researchers, whichever is better aligned with your usual research (see image).
After you complete the modules in whichever curriculum you selected, CITI automatically notifies the IRB office that you have been successfully certified.
From Another Institution: We will only accept CITI training from other institutions. If investigators are from other institutions and they only have NIH training, then they must do the BUMC CITI training. For investigators from other institutions and BUMC investigators who already have CITI Human Subjects Protection Training certificates from other institutions (this includes certificates from VA facilities), their CITI certificates from other institutions are accepted as documentation of human subjects protection training certification. These certificates should be emailed to email@example.com 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 is done through CITI. Whether your Human Subjects Protection Training certificate is from BUMC CITI or from another institution (including the VA), everyone must complete the CITI BUMC HIPAA Module before they can be approved to perform human research at BUMC.
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 human researchers must be recertified every two years. The deadline for the current recertification cycle is June 30, 2015. Investigators who have not met the institution’s recertification requirements by this deadline 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 who obtained their initial research certification before July 1, 2014 must be recertified before June 30, 2015. Trainees (students, house officers, post-docs) who are named on BUMC IRB protocols must also be recertified. In addition, because the BUMC 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 required Recertification curriculum section below for descriptions).
Who does not need to be recertified?
There are four groups who do not need to be recertified:
- Researchers who received their initial research certification on or after July 1, 2014.
- Researchers who became BUMC/BMC employees on or after July 1, 2014, whose CITI human subjects protection training certification had been obtained at their previous institution and accepted by our BUMC IRB.
- BUMC 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 IRB do not need to complete our 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 firstname.lastname@example.org with an explanatory email.
- Clinical researchers whose primary affiliation is at another institution but who are named on a BUMC 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 institution.
The required Recertification curriculum:
To be recertified, you must correctly answer at least 48 of the multiple choice quiz questions found at the end of the Clinical Research Times Feature Articles dating from September 2013 through March 2015 (Clinical Research Times).
Taking the quizzes:
You can easily scan past Articles and review which quizzes you have not yet taken by clicking the My Account/Login tab at the top left corner of the Clinical Research Times web page to log in. You will see the options shown below. Click on the second option, Review “My Account” (my scores on past quizzes).
A list of the Feature Articles will be displayed; look for the Articles in which the Status column indicates “Incomplete”. Click on the Article’s title to read it. At the end of the article, click on the link, Click here to login to My Account if you are a BUMC researcher and would like to take the quiz now, to take the corresponding quiz.
Upon correctly completing at least 48 total quiz questions, your certification will then be renewed until June 30, 2017.
What if you don’t remember when you were certified? Check out our List of Investigators with Human Subjects Protection Training Certificates. If your name is not on this list, then we have no record that you are currently certified to do human research at BUMC. If you do not find your name but you do have a CITI human subjects protection training certificate either from BUMC or another institution, then please send that CITI certificate to email@example.com with your contact information. If you completed CITI human subjects protection training at another institution prior to being employed at BUMC, then please be sure to indicate your BUMC date of hire in your cover email when you send in your CITI certificate to firstname.lastname@example.org.