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: Researchers must document that they have received human subjects training through one of the following three program. Each of these trainings provides a certificate of completion. Each researcher named on an IRB application must have a certificate from one of these three sources on file in the IRB office.
- NIH online course: The NIH Office of Extramural Research offers an online course (http://phrp.nihtraining.com/users/login.php) in English and Spanish. These certificates should be emailed to firstname.lastname@example.org
- CITI course: 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 (be careful because there is also a “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 screen shot below). After you complete the modules in whichever curriculum you selected, CITI automatically notifies the IRB office that you have been successfully certified.
- Human Subjects Training certificates from other institutions (this includes certificates from VA facilities) are also accepted as documentation of research 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.
You can check your current Certification/Recertification status by clicking on the “List of Investigators with Human Subjects Training Certificates” link at the top of this page.
Research Recertification (deadline approaching)
All BUMC human researchers must be recertified every two years. The deadline for the current recertification cycle is June 30, 2013. There are two components to the required recertification curriculum this year: a general component and a HIPAA/Privacy component. Each component is described below. Most of us will require both, but some may require only the HIPAA/Privacy component.
Who needs to be recertified?
Full recertification required: 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, 2012 must be recertified. 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 or at any of the Boston Health Net Community Health Centers must also be recertified. If you fall into one of these groups, you will need to complete both the general and the HIPAA/Privacy components of recertification (see The required recertification curriculum section below for descriptions).
Only the HIPAA/Privacy component required: There are three groups who need to only complete the HIPAA/Privacy component.
- Researchers who received their initial research certification after July 1, 2012.
- Researchers who became BUMC/BMC employees after July 1, 2012 whose research certification had been obtained at their previous institution and accepted by our IRB.
- BUMC faculty, staff, and trainees who are primarily based at a VA facility do not need to complete the general component of the recertification curriculum. The VA system requires its own recertification every two years via CITI’s VA recertification program. BUMC will accept this VA recertification. (However, they must email a copy of their less-than-two-years-old CITI VA recertification form to firstname.lastname@example.org or fax it to the IRB office (617-638-7234) with an explanatory cover letter.)
If you are in one of these three groups, you only need to complete the HIPAA/Privacy component to be recertified.
No recertification needed: 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:
General Component: To get credit for this component of the curriculum, you must correctly answer at least 36 of the multiple choice quiz questions that correspond to the Clinical Research Times monthly Feature Articles dating from September 2011 through February, 2013 (Clinical Research Times).
HIPAA/Privacy Component: The March, 2013 issue of the Clinical Research Times had a special Feature Article on the HIPAA and data privacy requirements for human researchers. There are 10 multiple choice quiz questions that correspond to that article. To get credit for this component of the curriculum, you must correctly answer at least 7 of these 10 questions correctly.
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 top of the Clinical Research Times web page and logging in. You will see the options shown below. Click on “Review ‘My Account’ (my scores on past quizzes).”
A list of the articles will be displayed, click on an article’s title to read it, and on “Quiz” to take the corresponding quiz.
Upon completing these required recertification components, your certification will be renewed until June 30, 2015.
The certificates of recertification will be posted on the on-line List of Investigators with Human Subjects Protection Training Certificates the next day after successful completion of the Privacy and Confidentiality Module, and the CR TIMES quizzes for recertification. The recertification certificates do not need to be submitted to the IRB Office.
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, we have no record that you are currently certified to do human research at BUMC. If you do not find your name but you have a training certificate either from here or another institution, please fax that certificate to the IRB at FAX 617-638-7234 with your contact information. If you completed human subjects protection training at another institution prior to being employed at BUMC, then please be sure to indicate your BUMC date of hire on your fax cover sheet when you fax in your certificate.