Didactic Clinical Research Curriculum
The Didactic Research Curriculum consists of five elements:
- The CREST Seminar
- Completion of a Master’s Degree
- Participation in the CREST mentoring program
- Completion of the Vascular Medicine Training “Internships”
- IRB Internship
- Circulation Editorial Board Internship
- Grant Review Committee Internship
- CREST Grant writing workshop
The first three elements, the IRB internship, and the Grant writing workshop are already established as part of the CREST program. The two remaining internships have been designed to particularly enhance the research training experience for the Vascular Medicine fellows. All five elements take advantage of unique resources available on the Boston University Campus. The curriculum will be individualized depending on the level of experience of the candidate. The CREST Program recently entered its 6th year of funding, and since inception, 53 fellows have completed the two-year program including completion of the mentored research project, manuscript submission, grant application, and the Masters degree, clearly establishing the feasibility of the proposed research training curriculum.
The CREST seminar is held every other Tuesday from noon to 1 PM and includes lunch. All CREST fellows and faculty are required to attend. The seminars are one of two basic types. First, faculty present didactic lectures relevant to the conduct of clinical research including how to choose a mentor, ethical aspects of research, designing consent forms, conflict of interest, how to design survey questions, planning data analysis, how to write a paper, clinical trials, outcomes research, translational research, studies with industry, etc. These lectures expose the trainees to a broad array research methodologies and topics of general interest.
In the second type of seminar, the trainees present their own research projects. In the first year, fellows present background and hypothesis and plans for study design and analysis. In the second year, fellows present a completed study with original data and interpretation. The fellows are required to prepare and practice the presentation with their research mentor, and the presentations are evaluated by the other fellows and faculty.
The CREST seminar includes specific lectures on the responsible conduct of research. In addition, the Boston University Medical Campus has several other required programs to ensure that the fellows will receive adequate training on this topic. First, the Boston University Office of Clinical Research provides a required program each September on this topic for all new trainees. This orientation covers institutional policies regarding scientific conduct, authorship guidelines, and maintaining research data. The Office also sponsors additional lectures during the academic year that match the National Institutes of Health, Public Responsibility in Medicine and Research (PRIM&R), and the Association of American Medical Colleges. Finally, all clinical investigators on the Boston University Medical Campus are required to complete an ongoing training program that consists of a monthly article followed by an on-line quiz.
Master’s Degree: As participants in the CREST Program, the Vascular Medicine Fellows are required to complete a Master’s degree through Boston University School of Public Health or the Division of Graduate Medical Sciences at the School of Medicine. There are three Master’s degree choices:
- Master of Science in Epidemiology, School of Public Health
- Master in Public Health, School of Public Health
- Master of Arts in Clinical Investigation, School of Medicine
The Master’s degree programs provide formal training in research methodology and biostatistics and greatly enhance the fellow’s ability to gain independent research support and conduct research that will advance the field of Vascular Medicine. The Master’s of Public Health (MPH) is generally geared toward individuals planning a career in public health and not necessarily clinical research. Fellows with an interest in the public health aspects of vascular medicine may enroll in the MPH program. However, we particularly encourage the Vascular Medicine Fellows to enter into the Master of Science (MSc) program because it is more focused on research methodology. In addition, the MSc degree requires 32 credits rather than the 48 credits required for the MPH, thus providing more time for completion of the research project. The Masters of Arts in Clinical Investigation is designed for individuals interested in clinical trials, and provides greater emphasis on regulatory issues and the actual conduct of such studies. All degree programs have several common course requirements including basic epidemiology and training in biostatistics, including training in SAS. All of the programs offer courses in the design, conduct and analysis of clinical trials. All require the completion of an original research project and preparation of a thesis, which must be defended before a committee of experts in the field.
While most fellows enter a Master’s degree program, some Vascular Medicine Fellows may already have Master’s degree. While these fellows are able to “opt out” of the degree requirement, we expect that the fellows will take additional courses or pursue a more advanced degree work to broaden and deepen their methodological expertise. The Boston University Medical Center Leadership Program in Vascular Medicine covers tuition costs.
CREST Mentoring Program
This an essential component of the CREST program serves to enhance our mentoring experience. The mentoring program has a dual structure:
The Primary (or Research) Mentor: This mentor supervises the fellow’s clinical research project and will interact on a daily to weekly basis with the fellow.
The Secondary (or Career) Mentor: In addition to the Research Mentor, there is a Secondary Mentor to focus on career development and networking
Vascular Medicine Training “Internships”:
To further enhance the training of the Vascular Medicine Fellows, they complete two practical “internships” that help prepare them for an independent research career.
Early in the first year of the program, fellows complete a four-week internship as an ex officio member of the Boston Medical Center Institutional Review Board (IRB). The internship consists of an initial two-hour didactic session taught by the chair of the IRB that includes an orientation to the IRB, fellow responsibilities, and what happens when an IRB receives an application or adverse event report. The fellows then attend four IRB meetings. They are assigned protocols to review and present at the meeting. The fellows participate in the general discussion and critique of the protocol, but do not have an official vote. Feedback from fellows who have completed the internship as part of CREST suggests that it is an extremely valuable experience that clarifies the rationale for many IRB procedures and has helped them to prepare IRB protocols.
Circulation Editorial Board Internship
The editorial offices of the journal Circulation are located at Boston University School of Medicine. Dr. Vita is the Deputy Editor of the journal. Several research mentors or advisory committee members are Associate Editors, including Drs. Freedman, Benjamin, and Keaney. The journal publishes high impact research in the field of Vascular Medicine. We take advantage of this unique resource and have each Vascular Medicine Fellow complete a four-week internship and attend the weekly editorial board meeting.
Grant Writing Workshops
A requirement of the Boston University Medical Center Leadership Program in Vascular Medicine is participation in a grant-writing workshop with completion of a grant that is ready for submission. This activity was initiated as part of the CREST Program and has the following components:
- A review of types of grants available to a graduating fellow, including NIH KO8, K23, R03, R01, R21 grants and private foundation grants.
- Fellows then work with their mentor to draft the specific aims sections of their application. The submission is reviewed and critiqued by the workshop group. Based on this discussion of their proposal, the fellow revises the specific aims until they are judged to be acceptable.
- The fellows then develops the full-length grant. • The faculty provide a didactic session that reviews strategies for writing the background, preliminary data, and method sections. Another session covers the structural elements of the grant including the biosketch, abstract, key personnel, other support, resources and environment, etc. We also review the sections on protection of human studies and inclusion of women, minorities, and children. Finally, there is a session on grant budgeting and consultants, collaborators and subcontracts.
- The fellows complete their application for an internal review session one month prior to the submission date of the grant. The fellows’ grants are reviewed by the faculty. The fellow receives this feedback in a timely manner to allow for revision of the grant for actual submission.