Lecture notesBe sure to take the CITI Research Ethics training this week. The link for instructions is here.
This week we talk about ethics in research. We will address several key issues:
- What researchers mustdo to ensure thier study is ethical
- How the risk of harm get's weighed against the value of scientific data
- How we tell simple research error from fraud
- How can we ensure that research participants give informed consent
- What are / should be the benefits of research to participants & to the larger society
- Who the researcher is responsible to ... how do we separate self-interest & political pressure from science
We will talk about the Tuskegee study, a 40 year study of syphilis in rural Alabama that led to over 400 poor, largely uneducated African-American men being left untreated. Tuskegee is the basis for some of our human subjects protections, and remains the most salient example of unethical research in the United States. Wikipedia has a nice overview of the study here.
We will spend a fair amount of time discussing the Common Rule, eight principles or procedures that underlie ethnical research
I will briefly touch on the Belmont Report and its conclusions; the CITI training will introduce that in more depth. I will also introduce the American Psychological Association rules for informed consent and IRB approval: you will all be including an informed consent document in your paper!
Lecture notes are here.Discussion groups next week: Discussion sections will meet in 1076 BSB during week 5 (2/8/10).
- Your TA will show you how to search online for articles on your paper topic, so narrow down your topic prior to this meeting. E-mail me or your TA if you have questions about appropriate paper topics.
- Bring your laptop / Tablet if you have one ... if not we will ask students to share their laptops.
Ray Chapter 14, Ethics, and four readings. This is a few more pages than most weeks, but each of these is a very interesting and easy read.
The first two, scientific error and politics and an unwelcome discovery address scientific fraud. The first illustrates how difficult it is to understand or control the boundary between "normal" scientific error and fraud, and the highly destructive role politics plays in the process.The second describes real fraud, that managed to go undetected for 10 years.
The second two papers address difficult ethical issues in research design. Ethics of clinical trials addresses the thorny issue of what benefits patients in clinical trials should receive. Patients are often prey to the "therapeutic misconception", that is, the belief that they are in clinical trial to get treatment, not simply as a research subject. When are patients' expectations too high, versus when are they being taken advantage of?
Clinical research in developing countries discusses HIV research in Malawi. When or how can investigators in a developing country use procedures that would be considered unethical in the developed world?
Discussion Group Assignment(Click for a Word copy of Week 4 assignment).
We will discuss your four readings in discussion group this week. To facilitate that discussion, answer the following questions using not more than one typed page.
Readings 1 & 2: how would you prevent the situation that occurred with Dr. Baltimore? How about the frau id committed by Dr. Poehlman? What aspects of the research process make congressional or other government intervention unnecessary (Hint: see editorial by S.J. Gould, lecture notes). What do you think the role of government - or, say, the University - should be in monitoring science to prevent fraud?.
Reading 3: How would you personally balance the scientific versus ethical issues in giving research subjects information about their health status in a blinded, controlled intervention study? Was there a way that the informed consent process might have made this research have been more ethical?
Reading 4: Is using a placebo - control research design in treatment trials in developing countries an example of a Tuskegee-like study? Why or why not? How do you balance the ethnic and scientific issues in this research? Hint: ethics not only concern potential harm to study participants, but the extent to which valid data will answer important questions that directly affect the target population.