Human Subjects Protection Training – Certification / Recertification

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.

Research Certification

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.
  • 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 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.

Select Biomed-SBER curriculum

Research Recertification

All BUMC clinical researchers must be recertified every two years. This includes all faculty and staff who are engaged in research and who are employed by BUSM, BUSPH, BUGSDM, or Boston Medical Center. 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, clinical researchers at the Boston Public Health Commission or at any of the Boston Health Net Community Health Centers must also be recertified.

Clinical researchers who are named on a BUMC IRB protocol but who are formally affiliated with another institution (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.

BU faculty, staff, and trainees who are based at a VA facility do not need to complete BUMC recertification. The VA system requires recertification every two years via CITI’s VA recertification program. BUMC will accept this VA recertification. VA investigators who are named on BUMC protocols are not required to complete the BUMC recertification. However, they must fax a copy of their CITI VA recertification form to the IRB office (617-638-7234) with an explanatory cover letter. To meet the requirements for the current recertification deadline, each VA investigator must send a CITI certificate that is less than two years old to the IRB office. In addition to your VA recertification, you will still need to complete the Privacy and Confidentiality module from the March 2013 CR TIMES Feature Article titled, “Privacy and Confidentiality Requirements in the Use and Disclosure of Health Information for Research.” and correctly answer 7 out of its 10 quiz questions in order to be up-to-date with your recertification.

To be recertified through BUMC recertification, you must have read the Feature Articles in our online newsletter (the Clinical Research Times) and must have correctly answered 75% of the total quiz questions that accompany those articles during each two-year period. If your original certification is dated before 7/1/2012, you must complete this recertification by correctly answering 75% of the total quiz questions from the Clinical Research Times issues 9/2011 through 3/2013. The current recertification effective date is 7/1/2013 and will be in effect until 6/30/2015.

All the past issues of the CR Times are available in the CR Times’ MY Account. Each article takes about 10-15 minutes to read and complete the questions. For this recertification period, there are 16 articles, with 4 questions each, for a total of 64 questions, and an additional article with 10 questions. You must accumulate 36 correct quiz answers from the CR TIMES Feature Articles published between September 2011 and February 2013, PLUS 7 correct quiz answers for the March 2013 Feature Article’s privacy and confidentiality module in your “My Account” to be recertified.

You can easily review which quizzes you have not yet answered by clicking the “My Account/Login” tab at top of the Clinical Research Times web page, logging in, and then clicking “Review My Account.” 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.

You do not need to be recertified by June 30, 2013, if your hire date was after 7/01/12, or if your original certification was obtained after 7/01/12. However, you will still need to complete the Privacy and Confidentiality module from the March 2013 CR TIMES Feature Article titled, “Privacy and Confidentiality Requirements in the Use and Disclosure of Health Information for Research.” and correctly answer 7 out of its 10 quiz questions in order to be up-to-date with your training.

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, please fax that certificate to the IRB at FAX 617-638-7234. 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.

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