Rene Descartes: “I think; therefore I am.”

3.3: Data Ethics Statistics Chap 3: Designing Experiments

Are sham surgeries ethical? New England Journal of Medicine: “Randomized, double-blind, placebo-controlled trials are the gold standard for evaluating new interventions and are routinely used to assess new medical therapies.” The law requires well-designed experiments to show that new drugs work and are safe. No so for surgery Only about 7% of studies of surgery use randomized comparisons.

Are sham surgeries ethical? For surgery, placebo = sham surgery Is this ethical?

Basic Standards of Data Ethics The organization that carries out the study must have an institutional review board that reviews all planned studies in advance in order to protect the subjects from possible harm. All individuals who are subjects in a study must give their informed consent before data are collected. All individual data must be kept confidential. Only statistical summaries for groups of subjects may be made public.

Institutional Review Boards Purpose: protect the rights and welfare of human subjects

Confidentiality Purpose: protect the subjects’ privacy Different from Anonymity Anonymity prevents any follow-up

Clinical Trials Experiments that study the effectiveness of medical treatments on actual patients Need to balance future benefits against present risks 1964 Helsinki Declaration of the World Medical Association: “the interests of the subject must always prevail over the interests of science and society.”

Behavioral and Social Science Experiments Milgram Experiment Simply Psychology article ABC Report