The core curriculum includes coursework in the following disciplines: epidemiology, biostatistics, research methods, ethics, communication, and grant writing. These courses are part of the Indiana University Clinical Investigator Training Enhancement (CITE) Program, funded through a National Institute of Health K-30 grant. Fellows may also pursue advanced training in medical informatics at the Regenstrief Institute for Health Care.
Fellows will supplement these courses with further study in a variety of areas that may include: health policy, information technology, decision support, medical economics, organizational behavior and management, quality improvement and qualitative and quantitative research methods. Fellows will have the opportunity to obtain a two-year masters degree in their field of interest.
Fellows will receive a stipend commensurate with their PGY rank. In addition, fellows may also apply for a supplemental $12,500 per year through the Morris Green Research fellowship.
In addition to salary support, each fellow will be provided appropriate office space, administrative support, and a computer.
Each fellow will also have available up to $20,000 in research support over the two years, and will receive funds to attend two professional meetings a year. One of these meetings will be the Annual Pediatric Academic Society meeting. The other meeting will be chosen by the fellow and his or her mentor.
The coursework that is required of trainees who participate in our training program is based upon the existing CITE program at Indiana University, funded by a K-30 grant from the National Institutes of Health. The CITE program prepares health care professionals for careers in clinical research. The courses that comprise the CITE program focus on core competencies recommended by the NIH, as well as a review of relevant literature and other K-30 programs. A total of 30 credit hours are required in the following areas: Clinical Research (16- 17 credits); Mentored Research (7-9 credits); Implementation Research (3 credits); and Electives (4-6 credits).
Based on the electives chosen by the trainee, they will be eligible to receive a master's degree in public health, clinical research, informatics, or health administration.
|Course Title||Course Number|
|2002||M.D., Michigan State University|
|Course Title||Course Number|
|Clinical Research Methods||G660|
|Electives in consultation with mentor|
Clinical Research Methods (G660). This course covers the major types of study design (other than clinical trials) used in clinical research, including cohort, case-control, cross-sectional, survey, and secondary database studies. Fundamental themes in clinical research - and how to appropriately investigate them –are also addressed, such as diagnostic tests, therapy, etiology, and prognosis. Other topics include questionnaire design, meta-analysis, economic analysis, health status measurement, qualitative research, computerized searching, and health services and outcomes research.
Clinical Trials (G661). This course covers core topics in conducting clinical trials, including design, recruitment, informed consent, randomization, blinding, data collection and analysis, safety monitoring, study closeout, and alternative designs such as cross-over and nonrandomized trials. Also, regulatory and special topics are covered including drug trials phase I through IV, patenting and other legal issues, institutional review boards, cancer trials, cells and human tissue, and trials involving special populations.
Biostatistics (G651). This course covers the use of computers and statistical software for data analyses, fundamental statistical concepts including probability and distributions, and application of parametric and nonparametric statistics on continuous and categorical data.
Research Ethics (G504). This course provides an introduction to both the theory and practice of research ethics and covers the key ethical principles and concepts. Topics covered include the history of science and misconduct, mentoring and laboratory supervision, data management and ownership, human subjects research (including safety compliance), animal rights and welfare, research writing, authorship and mentorship, conflict of interest and industry relationships, intellectual property and copyright, and genetic technology.
Research Communication (G655). This course combines a core didactic set of classes on the key elements of scientific writing along with the requirement for completion of a paper to be submitted for publication in a peer-reviewed journal. Two secondary skills are also covered. Manuscript review is addressed, including coreview of a manuscript with a mentor or other faculty scientist. The principles of presenting research at scientific meetings are also covered, including preparing an abstract, an oral presentation, and a poster.
Grant Writing (N802). This course combines a core didactic set of classes along with the requirement for completion of a grant to be submitted for intramural or external funding. Topics covered include specific aims and hypotheses, background section and previous work, study design and methods, statistical analysis and sample size determination, budget preparation, and other special issues. Identifying federal and nonfederal funding sources will be addressed. Elements of a successful grant are reinforced through mock study sections.
Mentored Research (G664). This is a formal research project in the form of an organized scientific contribution or comprehensive analysis conducted under the mentorship of a faculty scientist. The capstone experience is submission of an abstract to a scientific meeting, defense of one's research before an Advisory Committee, and completion of a first-authored paper deemed suitable for publication in a scientific journal.
Implementation Research (G610). This course taught by IU-CHSOR faculty covers key aspects of this field and is organized into six themes: implementation theory and tools; health care quality; evidence-based medicine; study design methods; management systems; and individual behavior change.
Electives. Trainees can take 4-6 credits of electives, selected from the entire offering of graduate courses at both Indiana University and Purdue University at Indianapolis as well as IU at Bloomington. Trainees wishing to matriculate with a degree in public health, informatics, or health administration will utilize these electives to adjust their curricula to accommodate the requirements for these degrees.
Additions to the CITE curricula. All I-HSR Trainees will complete the courses required by the CITE program. However, I-HSR trainees will be required to complete five additional courses in order to supplement trainee preparation in health services research. These requirements include:
Biostatistics and Visualization of Data. At least two additional courses in biostatistics or visualization of data will be required. Course options include graduate level statistical courses offered through the Department of Mathematical Sciences at IUPUI and Biostatistics II (G652) offered through the IU SOM which provides a more in-depth coverage of multiple regression and ANOVA and introduces more advanced statistical topics such as logistic regression and survival analysis. Courses in visualization of data, mining, learning, and massive data are available through the Purdue Departments of Statistics and Computer Science, including Statistical Machine Learning Reading Seminar (STAT 598N), Statistical Data Mining (STAT 598M), Learning from Data (STAT 695A), Data Visualization (STAT 695V), or Introduction to Scientific Visualization (CS 530).
Epidemiology. At least one course in epidemiology will be required. Options include:
- Fundamentals of Epidemiology (H517) which introduces trainees to basic epidemiologic concepts including determinants of health and patterns of disease in populations and implications of disease processes on prevention strategies and policy development.
- Epidemiologic Research Methods (P600) which provides an in-depth presentation of the major research designs, analytical methods and practical issues specifically related to conducting research in the field of Epidemiology.
- Advanced Epidemiology (P601) which will include topics that represent cutting edge techniques, and philosophical issues to conduct and interpret the findings of epidemiological studies.
- Implementation Science and HSR. At least one course in implementation science will be required. Options include the Health Services Research lecture series (see below) and:
- Patient Safety (SPEA-H 615, PBHL-H 615, and School of Nursing J 692). This is a new course taught by CHSOR and campus faculty, including topics such as observing and creating a culture of safety, communication and complexity, reliability and design, methods and tools to reduce harm, leadership for patient safety, and health policy perspective.
Public Health. At least one course in public health will be strongly recommended. Options available to trainees include:
- Human Disease and Prevention (H617) helps trainees to develop knowledge of selected diseases and social pathologies important in public health and helps them turn this knowledge into educational materials for public health presentations and interventions.
- Health Education in Clinical Settings (C515) examines health education and promotion within health service delivery organizations; the sociocultural construction of health and illness; the patient-provider relationship; a review of models of behavior change and maintenance program planning, implementation and evaluation of health education interventions in clinical settings; review selected model programs.
- Policy Design, Implementation and Management (P611) explores health policy topics from economic, financial, sociological, political and psychological perspectives. Analytical paradigms are applied to organizational or macro policy making issues.