Clinical Research Rotation for Medicine and Pediatrics Residents

The Clinical Research Rotation is a required two-week program for first-year medicine residents that runs throughout the year; it is also offered twice a year as an elective to pediatrics residents. The goal of this rotation is the development of research protocols in a small-group setting through a critical review of selected clinical research publications, followed by the refinement of an idea to the point of study design and power analysis. Although only some of these protocols will be conducted by the residents during elective time in their residency, the focus is on the process of asking and answering a clinically relevant question. Doris Duke clinical research fellows may also participate in the Clinical Research Rotation.

Each cohort of 4-5 residents is introduced to the program by Daniel S. Donovan, MD, MS, followed by a session devoted to understanding different types of clinical studies through a review and critique of published reports with Rajasekhar Ramakrishnan, Eng ScD, Clinical Research Resource (CRR) biostatistician. Residents then develop an IRB protocol for a study of their choice in a series of meetings with Dr. Ramakrishnan.  In addition, residents observe an Internal Review Board (IRB) meeting, and have an educational session with Karina Davidson, PhD, TRANSFORM Co-Director and Associate Director of the Irving Institute. Pediatrics residents also meet with active investigators in the CRR from Pediatrics. The residents further refine their proposals in a session with Henry N. Ginsberg, MD, Director and PI of the Irving Institute.

At the end of each rotation, the residents present their IRB protocols at a meeting attended by the program faculty and chief residents. The formal presentations include discussions about key issues such as clinical relevance, recruitment, feasibility, ethics, confounders and biostatistics.  This program has been received enthusiastically by both residents and Housestaff Program coordinators. It now stands out as a feature that attracts prospective residents to the Columbia program.

Past Medical Resident Protocols
Power (sample size) Calculation Module

Mentored Medical Student Clinical Research Program

The Irving Institute, in partnership with the Doris Duke Charitable Foundation and other groups in the medical school, introduce medical students to clinical research at a formative stage of their training and development. Third-year medical students from schools throughout the U.S. are invited to apply for slots in a program that provides a full year of research and training between 3rd and 4th year medical studies. Applications consist of a curriculum vita, medical school transcript, two letters of recommendation, and a brief personal statement describing the candidate's interest in one or more research areas of excellence at Columbia. Selection is based on the applicant's potential for a career in clinical research, the extent to which the opportunity offered by the program will enhance the applicant's clinical potential, and the probability of fruitful matches with mentors at Columbia.

In addition to conducting defined research projects, the Fellows participate in a didactic clinical research experience that combines Columbia’s considerable clinical strengths with its existing educational resources. The program includes 2-5 hours per week of formal didactics. Fellows may take up to 12 University course credits as part of the program. Among the most popular courses are offerings in biostatistics and epidemiology. Requirements include attendance at the Irving Institute’s Seminar Series, a lecture series entitled "Responsible Conduct of Research and Related Policy Issues," a passing grade on the competency examination required of all investigators conducting research with human subjects at Columbia (Protection of Human Subjects in Biomedical and Behavioral Research). They also undergo an 18-day Clinical Rotation for 2nd Year Medical Residents; a course on grantsmanship (Funding for Research Activities: Basic Issues in Obtaining Research); and meet regularly with senior and junior mentors assigned each fall. At the end of the year, the Fellows present their clinical research in symposium attended by mentors, other interested faculty, and students.