CORE COURSES OF THE MSCI

Research Project (Program Directors, 4 credits):  Design, implementation and analysis of a mentored clinical research project led by the trainee.  CRECD/MSCI trainees are required to conduct a mentored clinical research project. Mentors are recruited from the faculty of MMC and VU representing a substantial and diverse portfolio of research activities.  Program directors assisted the scholar to identify a mentor after expressing a theme of research interest. Trainees and mentors developed the project hypotheses and thereafter designed and implemented the research project.  Projects could be complementary to but were required to be independent of ongoing work by the mentor.   

Research Involving Human Beings (MSCI 723, Murray, Wolff, 3 credits; previously called “Clinical Trials” ):  An overview of human subject research methods remains unchanged, except for the addition of Dr. Murray as Director includes practical topics and insight for human subject research and an in-depth review of the science of clinical trials with an emphasis on statistical methodology. Topics covered in this course now include: (1) Introduction and Historical Perspectives; (2) Choosing Research Question(s) and Objective(s); (3) Design of Patient Oriented Study Designs; (4) Design of Epidemiological Studies; (5) Hypothesis Testing & Statistical Methods I; (6) Statistical Methods II; (7) Sample Size and Power Determination; (8) Survival analysis/Cox Proportionate Hazard Models; (9) Interim Analysis and Meta analysis; (10) Randomization and Blinding Methods; (11) Phase II Studies; (12) Phase III and Multi-Center trials; (13) Protocol writing; (14) Phase I and Pharmacologic Studies; (15) Case Report Forms/Budget/Personnel; (16) Questionnaires; (17) Databases for clinical trials; (18) Drug and Biologic Development – the FDA Processes; (19) Recruitment and trial monitoring; (20) Data Safety Monitoring Boards; (21) Evidence Based Medicine; (22) Quality of Life Issues and Assessment; (23) Economic and Health Outcome Analysis; (24) Research from the Patient’s Perspective; (25) Ethical and Legal Principals in Clinical Research; (26) Investigator Responsibilities in Clinical Research; (27) Institution Trial Oversight and the IRB; (28) HIPAA and Data Integrity; (29) Minority and Protected Research Participants; (30) Research in the Community; (31) Writing a Consent Form; (32) Mock IRB; (33) Statistical and Graphic Software; and (34) Writing a Paper Describing Clinical Research.

Research Ethics MSCI 703, (Freund, Szetela, 2 credits) Topics include: (1) Research Ethics:  Where Did It Come From, What Does It Mean?; (2) Ethical Theory: From Abstraction to Action; (3) “The Codes:”  Nuremberg, Helsinki, Common Rule and Others; (4) Would *You* Become a Research Subject?; (5) Concepts of Race and Ethnicity:  Historical and Current; (6) A Historical Perspective:  American Eugenics; (7) Consequences:  Redress of Disparities in Health and Research; (8) What Makes Clinical Research Ethical?; (9) “Research” or “Treatment”?  The Therapeutic Misconception; (10) Current Controversies:  FDA, Conflict of Interest, Evolving Data; (11) IRB Regulations, I ♥ My IRB and policies regarding the use of human and animal subjects; (12) Ethics in Protocol Design; (13) Issues of Negative Results; (14) “Informed Consent” and Understanding Risks and Benefits; (15) Vulnerable and Special Populations; (16) Seeking Informed Consent; (17) Recruitment and Retention:  the Subjects’ Perspective and the Investigator’s Perspective; (18) Genetics Research and Stored Tissues; (19) Mock IRB; (20) International Research; (21) Responsible authorship.

Minority Communities, Minority Health and Health Disparities (Bruce, 2 credits):  The overall goal of this course directed by Dr. Bruce Marino is to provide students with a critical understanding of the historical, political, economic, social, cultural, and environmental factors associated with the inequitable health status of racial and ethnic minorities.  Students in this course will examine how individual and community-level factors contribute to the creation and perpetuation of health disparities.  Students will also be exposed to current literature and have the opportunity to discuss issues such as the intersection of race/ethnicity with other social determinants (e. g. gender, socioeconomic status); the measurement of discrimination and racism; and the effectiveness of current health and social policies designed to improve minority health and eliminate health disparities.  By the end of the course, students will have a familiarity with the issues, challenges, barriers, and proposed solutions associated with the health of minority communities.

Molecular Medicine (Murray, Wolff, 3 credits):  The molecular medicine course links introductions to current and emerging molecular techniques in clinical discovery and diagnosis, to their application in clinical research. Examples include the use of qRT-PCR and SNPs in the identification of genetic risk factors for disease and disease prognosis; pharmacogenomics; the advancing use of biologics, including but not limited to therapeutic antibodies) in a variety of therapeutic areas; the impact of HLA antigen subtypes in tissue matching and in disease outcomes; the use of genomics and proteomics in discovery, diagnosis, and therapeutic monitoring; advances in stem cell biology for therapy and for tissue engineering, as examples    (Given in July, August at Meharry each Year)

Scientific Communication (Dolce, Limbird, Rucker, 2 credits) This course is composed of a scientific communications module taught by Drs Dolce and Limbird, and a Grant Writing Module, taught by Dr Rucker. In scientific communications, trainees learn how to read and understand a scientific paper; how to describe a data figure; how to present a 10 minute talk; how to present a poster, with talk and poster presentations as part of the coursework. The grant writing module is composed of 8 hours of didactic introductions to grant writing during the June Scientific Communication module, with the involvement of Dr Rucker on the grant writing teams for the K Awards that are written subsequently by all MSCI participants. Given in June of each year, with meetings 6 hours each week.

Biostatistics I (MCSI 524-5009, Byrne, 4 credits): The course provides the  basic concepts of biostatistics, including probability, sampling distributions (discrete/continuous), hypothesis testing, parameter estimation, and confidence intervals.  Classical data analyses for cohort and case-control studies.  Incidence density rate definition, estimation, rate-, risk-, and odds-ratios, analysis of cohort and case-control data, and stratified analysis. Dr Aramandla Ramesh will participate in the teaching of this course in 2008 for the Meharry Medical College MSCI participants.

Epidemiology I (MPH 514-5501, Griffin, 4 credits):  This course provides an introduction to epidemiology, with an emphasis on clinical research and includes measures to describe the frequency of disease occurrence and observational designs for study of disease etiology, prognosis and treatment.

Health Behavioral Methods: Measurement and Motivation (MPH 514-5514, Elasy, 3 credits).  This course provides an overview of qualitative methods for clinical research.  This addresses two core areas in health behavior research: 1) the measurement of knowledge, attributes, attitudes and behaviors that are relevant to health behavior research, with a focus on scale development and 2) the dispositional and situational variables that underlie current theories of behavior and behavior change, with current application.  Topics covered include: Item Generation, Health Belief Model, The Trans-theoretical Model, Guidelines for Response Options, Social Cognitive Theory, Reliability, Motivational Study Example, Group, Organization and Community Interventions, Validity, Precede-Proceed Planning Model, Challenges in Measurement, Social Marketing Theory, Survey Presentations, Modifying Physician Behavior, Factor Analysis, Application of Behavioral Methods to Public Health Investigations, Application of Behavioral Methods to CME, Market Research, Scale Development Example, and Evaluation of Theory based Interventions.  Issues pertinent to the minority and underserved patient are included in these discussions.