Courses

3 Credits
Course Director: Sarah Vittone, Ph.D.

This interactive case-based course explores ethical considerations and issues pertaining to scientific research, especially biomedical research with human subjects. Issues regarding scientific integrity, ethical research design and implementation, and research involving special populations are analyzed. Certification of training in the protection of human subjects is accomplished during progression through the material. The foundational principles of the Belmont Report underlying the responsible conduct of research are explored fully in the core content areas of human subjects, conflicts of interest and commitment, collaborative science, data acquisition, management, sharing, and ownership, publication practices and responsible authorship, mentor/trainee responsibilities, peer review, and research misconduct. The course is designed to help participants become comfortable with the language and literature of research ethics through the analysis stakeholder interests and perceptions using case studies presenting moral dilemmas in research ethics. This course is especially helpful to clinical investigators and members of Institutional Review Boards (IRB) as the application of federal regulations to particular cases is probed in depth.

3 Credits
Course Director: Nawar Shara, Ph.D.

This course provides a foundation for current and future thinking in terms of practical aspects of the importance of biostatistics in conducting clinical research and thereafter translating its findings. One purpose of this course is to make the student aware of the complexities of the relationships between biostatistics and clinical research, particularly as they pertain to decision making. This course provides students a scientifically oriented perspective on the types of information that is integral for the proper design and conduct of clinical research. The goal is to improve students’ conceptual understanding of the differences and similarities among the different inferential tests, and the appropriate use of statistical tests. Assessments target articulation of arguments and decisions involving, or based on, fundamental aspects of biostatistics in the context of medical research.

3 Credits
Course Director: Shaunagh Browning, DNP, R.N., FNP

This course prepares students to implement successful clinical investigations. Specifically, this course teaches how to establish a clinical research practice, understand and apply the federal and local regulations governing clinical research, develop, implement and financially manage a protocol. As well, it addresses assurance of study quality, private and reliable data systems, intellectual property, and the identification and resolution of problems and risks. Student performance is evaluated by periodic quizzes covering content from several lectures, class participation, and a final examination.

1 Credit
Course Director: Jason G. Umans, M.D., Ph.D.

This monthly CCRS anchors the entire CTR curriculum and supplements both coursework and mentored research by bringing together all students along with CTR Scholars in GHUCCTS faculty and research development programs to:

• Share issues and challenges in design and execution of CTR;
• Host monthly presentations by outstanding clinical investigators;
• Host monthly presentations by outstanding translational investigators; and
• Provide the forum for a monthly interdisciplinary CTR journal club and stimulate cross-disciplinary approaches and collaborations.

1 Credit
Course Director: Jason G. Umans, M.D., Ph.D.

This interactive course focuses on applying knowledge experimental design, biostatistics, and research ethics to trainee specific proposal. Students will work in groups to identify a researchable question and study hypothesis, and consider alternative approaches to study design, participant recruitment, and data collection. Following the introduction session, the students will submit a draft project title. Students should work with their mentors to produce a first rough draft of a grant for submission to NIH as well as industry sponsors.

3 Credits
Course Director: Chamberlain Diala, Ph.D.

Aspects of the social and behavioral sciences (e.g., psychology, sociology, and anthropology) that are applicable to public health will be reviewed and their applications defined through case studies and presentations by public health leaders. The objective of this course is to develop the capacity to understand and apply principles of health behavior theory in the context of health research. The primary questions to be explored in the course include:

• What are the theories that underlie health behaviors?
• How are theories applied in health care?
• How are behavioral theories incorporated into research?
• How can behavioral intervention strategies be improved?

2 Credits
Course Director: Nawar Shara, Ph.D.

This course builds upon the introductory statistics concepts and skills developed in the first term, extending them to practical application in study and clinical trial design and interpretation. Topics include structural aspects of clinical trials, protocol design, randomization and blinding, issues of error, bias and hypothesis testing, selecting and working with trial outcome variables, issues in safety versus efficacy trials, power and sample size calculations, secondary subgroup and exploratory analysis.

3 Credits
Course Director: Jon Fryzek, Ph.D.

This course provides an overview and introduction to epidemiology, particularly as it relates to the design, interpretation, and importance of clinical (experimental) research. Topics include understanding association and causality; cross-sectional studies and surveys. The design, analysis, and interpretation of case-control and cohort studies are emphasized together with sources of bias in both contexts. Other topics include population attributable risk; confounding factors; effect modification (interaction); analysis for confounding and interaction. This course builds on the multivariate analysis techniques and analyses for sensitivity, specificity, and screening that were introduced in the introductory biostatistics course.

3-6 Credits
Course Director: Jason Umans, M.D., Ph.D.

Individuals pursuing the MSCTR will be required to complete a final project in which they will design and develop a clinical or translational research proposal or in which they will conduct and report the results of a clinical or translational research project, including the option of a secondary analysis of existing data. Students should demonstrate and apply skills and knowledge gained in the in the MSCTR coursework to their approved final project.

The capstone project must be designed and approved by a research mentor and by the student’s faculty advisor (a member of the program faculty) and program director. To obtain approval, the trainee must submit a one-two page concept paper in the first or second term of his or her course of study. The Final Project Approval form must provide a brief description of the intended project and must be approved by the trainee’s advisor and the program director.

3 Credits
Course Directors: M. Scott Harris, M.D., and Pravin Chaturvedi, Ph.D.

In a blending of online and live learning, this course will provide an overview of the process and issues common to all drug development projects, with particular attention to the new chemical entity (NCE). The course will focus on the decisions that need to be made throughout the drug development process and the criteria influencing these decisions. The faculty for this flagship course are experts in their fields. The curriculum will review how molecular targets are identified and how compounds (both small molecules and biologics) are optimized for specificity and pharmacokinetics, minimizing drug-drug interactions and off-target effects. The course will cover the Investigational New Drug (IND) applications, including the preclinical safety and toxicology studies required to enable these applications; first-in-human trials; pharmacokinetics in humans; drug-drug interactions; proof-of- concept studies; confirmatory trials leading to the filing of a New Drug Application (NDA) or Biologics Licensing Application (BLA) in the United States and Marketing Authorization Application (MAA) in Europe; and post-marketing pharmacovigilance. Manufacturing issues and standards unique to small molecules and biologics will also be addressed. The course will review federal and international regulations governing clinical research.

3 Credits
Course Director: Florencia Gonzalez, MPH

This course introduces concepts and best practices of community engagement (CE) and patient engagement (PE) in research as approaches to help address health disparities and promote health equity. Mastery of the course content should result in the student’s capacity to effectively engage diverse communities and patients in the research development process (from grant writing to dissemination of study findings). Topics include an introduction to CE and PE guiding principles and best practices; the role of PE and CE in translational research; approaches for PE and CE in research; building community-academic partnerships; grant writing and budgeting for CE and PE; ethics in of PE and CE.

3 Credits
Course Director: Chamberlain Diala, Ph.D.

There is convincing evidence that most racial and ethnic minorities in the United States experience health disparities as compared with the majority of the population. These disparities differ in the several minority groups but they all result in limiting the length and quality of life of many members of this group. The public health profession has taken as one of its major challenges the need to eliminate these health disparities within the next decade.

3 Credits
Course Director: TBA

This course is designed to introduce students to the practice of global health research, with a focus on but not limited to the conduct of research in developing countries. This is both a principles course, in which mastery is obtained through class lectures, readings, discussions, and research groups regarding health research, and a skills course in which mastery is obtained through the development of research proposals, the structured review of peer-reviewed health research articles, and the completion of the online CITI course for the protection of human subjects. The course emphasizes the scientific method as a mode of inquiry applied to quantitative, qualitative and mixed method research. It considers particular issues related to global health research, including: the use and interpretation of secondary data; cultural, linguistic, socioeconomic and other considerations in study design, data collection instruments, study methods, and analysis and interpretation of data; involvement of donors in funding and conduct of health research; opportunities for and considerations in collaborative global health research; and ethical issues and related to global health research.