Office of Clinical Research
The mission of the Office of Clinical Research (OCR) is to support our investigators as they design and conduct human research studies. In addition, the OCR works with the Institutional Review Board to provide the Human Research Protection Program (HRPP) for the Boston University Medical Campus and Boston Medical Center. The goal of the HRPP is to protect the rights and welfare of our research subjects by providing education to our research teams and by assuring that studies are conducted as approved by the IRB and in compliance with human research regulations. The services of the HRPP are outlined briefly below.
All of our services are available to investigators on the Boston University Medical Campus and at Boston Medical Center. Our formal education programs (courses and seminars) are also available to investigators on the Charles River Campus.
Specific services include:
- Initial Human Subjects Protection training and Human Subjects Training Re-certification (conducted every 2 years): Regulations require that everyone involved in human research must have received appropriate Human Subjects Protection training. The OCR manages this process for BUMC. We require both initial training as well as re-certification every two years. The re-certification process is managed through quizzes delivered in the Clinical Research Times.
- Clinical Research Monthly Seminars covering an array of topics that are important for faculty and staff who perform human research.
- Investigator consultations (individuals and groups), providing advice on study design, on ethical and regulatory issues, and on questions about submissions to the IRB.
- Training sessions for groups (half-day and full-day instructional seminars) are offered on a variety of topics for both new and experienced researchers.
- Early-stage Quality Assurance Assessments. We perform these assessments early in the course of studies to assure that the study is being conducted as approved by the IRB.
- For-cause audits are conducted when there is a concern that a study may have deviated from the approved protocol or is not in compliance with regulations.
- Clinical Research Times (monthly online newsletter) provides information on topics of interest for our human research community.
- The IRB internship is an 8-week program designed to give trainees an in-depth experience in the function of the IRB. “Interns” serve as IRB members and participate in presenting and reviewing protocols submitted to the IRB.
More information about the investigator consultations, group trainings, QA assessments and for-cause audits can be found on the Clinical Research Resources Office (CRRO) website.
To support investigators who have obtained IRB approval and who need data from existing clinical records at Boston Medical Center for their research, we provide a data management specialist who can access and compile all of the necessary clinical data. For more information, see the link to the Clinical Data Warehouse elsewhere on this website.
The OCR also sends out announcements about research funding opportunities when those opportunities allow only a limited number of applicants from Boston University. In these situations, we issue a call for pre-proposals and have an internal selection committee review the candidates and select the strongest applications for submission.
Thomas J. Moore, MD
Director, Office of Clinical Research