Conference Programme, Abstracts & Papers

Session 5B - Health Services and Research: Interdisciplinary Perspectives
Chair: Leeat Granek

Placebo Controls: Epistemic Virtue or Vice?
Jeremy Howick
Department of Philosophy, Logic, and Scientific Method, London School of Economics and Political Science, London, United Kingdom

Randomized, placebo-controlled trials are often considered the gold standard for medical research. However, placebo controls have been challenged on ethical and practical grounds. I argue that, in addition to cases where placebo controls may be unethical or impractical, there are cases where placebo controls are impossible to construct. In particular, treatments whose characteristic effects are not readily distinguished from their incidental effects do not lend themselves to being imitated by placebos.
Comparing the effectiveness of these treatments to placebos leads to misguided accusations of methodological errors such as unblinding, and false negative results. If I am correct, then for at least a certain class of treatments, requiring placebo controls is an epistemological vice. Treatments that are impossible to test in conventional placebo-controlled trials include surgery, psychotherapy, acupuncture, and exercise.
I critically evaluate attempts to solve the problem with placebo controls in studies of complex treatments (Kirsch 2005; Paterson and Dieppe 2005), and conclude that they are all lacking. I then argue for a method that takes the strengths of the attempted methods into account while avoiding their problems. I suggest replacing placebo-controlled trials of certain treatments with comparative trials. A comparative trial compares one treatment against another treatment instead of a placebo.

Is Informed Consent an Adequate and Necessary Protection for Research Subjects?
Gloria Likupe
Faculty of Health and Social Care, University of Hull, Cottingham Road, HU6 7RXUnited Kingdom

The principle of informed consent was born out outrage at the atrocities committed by German physicians and scientists under the Hitler regime After the Second World War, the war crimes tribunal convicted several of the Nazi Doctors and produced what has since become to be known as the Nuremberg Code, widely regarded as the first international code of human experimentation ethics.
Later the international codes of ethics such as the Declaration of Helsinki and the International Ethical guidelines adopted by the Council for International Organizations of Medical Sciences outline and reassert the primacy of informed consent. The declaration of Helsinki makes it clear that medical progress is based on research which ultimately must rest on experimentation on the patient. The declaration also makes it clear that informed consent is central to research on human subjects. While the situation is clear in non therapeutic research, it is not so in therapeutic research where clearly there are some populations such as in emergency  situations from which it will not be possible to obtain informed consent.  Some have argued that even in situations where researchers are dealing with competent adults, research subjects systematically misinterpret the risk/benefit ratio of participating in research because they fail to understand the underlying scientific methodology. In such cases what the participant is actually consenting to is substantially different to what they think they are consenting to and therefore informed consent is frustrated.
This paper will discuss whether informed consent is an adequate protection for research subjects and whether it is necessary.

Download Conference Paper -