Ethical design

You’ve learned from the notes and readings that experimental studies have tremendous value in the epidemiologic community, but also that they might not always be feasible or otherwise have some important limitations. We will now engage in a discussion to practice developing an experimental study to address a particular research question. To do this, it is useful to think in terms of limitations: whether a study will take too long or cost too much, whether it is ethical, whether blinding can sufficiently be maintained, and so on. The goal is to use a variety of novel examples (generated by each of you!) to better understand when and how experimental studies should be conducted. Participate in the discussion by developing a response to the questions below in an articulate and thorough way. • Propose a research question you think can be addressed by an experimental study (use your imagination, it does not have to be a drug trial), and present your question articulately. Be sure that your treatment assignment and health outcomes of interest are clearly stated. • Identify the population you would recruit to answer the question (i.e., the group of people you would invite to participate) and what groups of people you would exclude. • Address aspects of blinding, randomization, compliance, and loss to follow-up in YOUR study (please do not provide generic language from the notes and readings – apply it to your study). This means you should think practically about how you might recruit, enroll, assign treatment, ascertain your health outcome of interest, etc.