Patient Oriented Research II: Allen McCutchan, M.D., M.Sc.

Objectives: This course will review the ethics and basic regulatory issues for research involving human subjects; the principles of data management for clinical research, including architecture, access and confidentiality, and integrity of databases; and skills in graphic and verbal presentation of research data. Scholars will prepare a mock submission to the IRB for peer review and practice presenting graphic and tabular data.

Course Content:

Topic Content

Foundations of Research Regulation
Introduction to the IRB:

Overview of the regulation of human experimentation; Structure and Function of IRBs

Writing and reviewing an IRB Proposal
(monitoring boards)

Principles of IRB review
Preparation and review of applications to the IRB

Monitoring of Research Composition and functions of Data and Safety Monitoring Boards (DSMB)
Ethical Basis of protection of research subjects Ethical principles for protection of human research subjects
Research Ethics - Responsible conduct Conflict of interest and commitment, scientific integrity, misconduct, ethics of publishing
Business ethics, research budgeting, and contracts Preparing and managing a research budget
Selected topics in the ethics of patient oriented research Discussion by students of their personal case studies in ethics
Peer Critique of Student IRB submissions I
(Simulated IRB review panel)
Discussion of student IRB proposals by peer reviewers
Legal Aspects of informed Consent Introduction to legal issues related to informed consent
Peer Critique of Student IRB submissions II (Simulated IRB review panel) Discussion of student IRB proposals by peer reviewers

Syllabus/Schedule