Course Descriptions
HPA 475 - CONTEXTS FOR CLINICAL RESEARCH
This course will provide an overview of the key institutions and policies within which clinical research takes place. The course includes an overview of the current US healthcare system and policy environment, summarizes epidemiological trends and introduces the ethical and regulatory issues surrounding clinical research.
Learning Objectives:
- Demonstrate mastery of literature reviews
- Critically analyze issues of access, cost and quality
- Compute measures of disease occurrence and association in populations
- Identify the key ethical principles that guide decisions regarding research with human subjects and animals
- Demonstrate an appreciation of the core policy dilemmas of healthcare systems
- Demonstrate an understanding of the theory of insurance as applied to healthcare
- Demonstrate knowledge of major components of the US healthcare system
- Demonstrate an understanding of the factors influencing population health and how these have changed
- Apply the major regulations relevant to clinical research
- Gain certification as a researcher eligible to conduct human research at UIC/NIH
Topics Covered:
1. From Idea to Research
- Research questions
- Mastering the literature/literature review
- Identifying important primary and secondary questions (the role of theory)
- Developing testable hypotheses
2. The Health System/Policy Context
- Healthcare system overview
- Health system size and scope (including international comparisons)
- Healthcare financing/insurance
- Insurance: risk pool/risk spreading
- Economic incentives
- Access vs. cost
- Quality problems and responses (patient safety and guidelines)
- Regional variations
3. The Epidemiological Context
- Factors that influence mortality/morbidity over time (genetics vs. the broader environment (social, economic, etc.) vs. medical care)
- Population measures of health and disease (mortality, morbidity etc)
- The demographic transition
- Transmissible vs. chronic diseases
- Trends in disease incidence and prevalence
- Vulnerable populations
- Behavioral vs. social factors
- Risk factors and relative risks
- Health disparities
4. The Ethical and Regulatory Environment
- The development of Human Subject Protection (Nuremberg Code, Food Drug & Cosmetics Act, Kefauver-Harris Amendment, Privacy Act ’74, National Research Act ’74, Declaration of Helsinki, Ethics laws, Belmont Report)
- Distributive justice
- Beneficence
- Respect for persons
- Research deception
- Ethical dilemmas
- Human subjects
- IRB details (Role of IRB, Expedited status, Exempt status, Informed consent document)
- Research-online
- Research-biologic
- Research-data bank
- Special populations
- HIPPA
- Confidentiality
- IND regulations
Prerequisites:
Graduate or professional standing and approval of the department
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