Certificate Requirements

Students are required to complete 16 credits of coursework.

Required Courses

3 credits
Course Director
: Irene Jillson, PhD

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, PhD

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, RN, 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.

2 credits
Course Director: Nawar Shara, PhD

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.

Electives

3 Credits
Course Directors
: M. Scott Harris, MD & Pravin Chaturvedi, PhD

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 US 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
: Irene Jillson, PhD

This course introduces social science and behavior theory concepts in understanding health disparities and research in this area. It provides students with an introduction to community engagement principles and offers the necessary foundation for translating research into practice. Topics include: defining community engagement and its guiding principles; the role of community engagement in translational; foundations in behavioral science (theory); practice-based research networks; data collection; resources; program evaluation; and ethics in community engagement research.

3 Credits
Course Director
: Kimberly Henderson, PhD

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 the its major challenges the need to eliminate these health disparities within the next decade.

3 Credits
Course Director: Irene Jillson, PhD

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.