Boston University Medical Campus
Clinical Research

Human Subjects Protection Training – Certification / Recertification

• List of Investigators with Human Subjects Protection Training Certificates
• Research Certification
• Research Recertification
• FAQs about Human Subjects Protection Training Certification
• FAQs about Human Subjects Protection Training Recertification
• On-Site Training Schedule

Research Certification

To assure that all clinical researchers understand their responsibility to protect the welfare of their research subjects, the NIH requires that researchers be “certified” in human subjects protection before releasing research funds. This requirement has been in place since October, 2000. The Executive Committee of the BUMC Institutional Review Board (IRB) feels that all clinical researchers should receive this training, not just those with NIH funding, so they extended this certification requirement to all clinical researchers regardless of their funding sources.

All clinical researchers must be certified in order to do clinical research at BUMC. Everyone who is involved in designing a clinical study, has contact with research subjects or their data, or is responsible for analyzing data and developing study results should be certified: as examples, investigators, research coordinators and other research staff, study biostatisticians, and study data managers.

There are two (2) ways to become certified. First, we offer face-to-face seminars here at BUMC. The speakers at the seminars are our IRB chairpersons or other experienced IRB members. At the end of the seminar, attendees are given a certificate documenting that they have met the certification requirements.

Alternatively, researchers can complete the online human subjects protection curriculum offered by the National Institutes of Health (NIH). The “course” takes about 90-120 minutes to complete. It includes material for reading and a number of quiz questions. Successfully completing the quiz questions allows the student to print off a certificate documenting completion of the curriculum. The course can be found at:
http://phrp.nihtraining.com.

The certificates provided either by the face–to-face seminars or the NIH website should be attached to grant applications or IRB submissions that require proof of human subject protection certification.

We also accept proof of certification from other institutions that have acceptable training programs. If you have received training at another institution, please submit a cover letter or memo requesting a review, along with the proof of training and the training curriculum, to the Office of Clinical Research (Email: irbtemp@bu.edu, Fax: 617-638-7234).

Research Recertification

All BUMC clinical researchers must be recertified every two years to do human research. To be recertified, 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. (No, you may not be recertified by taking the NIH on-line course again!)

The next recertification is due 6/30/09. If your original certification is dated before 7/1/08, you must complete this recertification by correctly answering 75% of the total quiz questions from the Clinical Research Times issues 9/07 through 3/09.

To summarize, for all BUMC clinical researchers:

All the past issues of the CR Times are available in its Archives. Each article takes about 10-15 minutes to read and complete the questions. For the upcoming recertification period, there are 17 articles, with 4 questions each, for a total of 68 questions. Therefore you must have 51 correct answers in your “Account” to be recertified.

You can easily review which quizzes you have not yet answered by clicking the “My Account/Login” button 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 now, if your hire date was after 7/01/08, or if your original certification was obtained after 7/01/08. You will, however, need to be recertified in the next 2-year cycle

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 the “certified” 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 Office of Clinical Research 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..

Only BUMC investigators must do recertification, including BUMC-affiliated organizations who are covered under the Federalwide Assurance Number. If you are not a BUMC researcher, you are only required to have initial certification training, not recertification. All Principal Investigators (PI) that submit to the BUMC IRB in INSPIR must do recertification.