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Section 3.3: Data Ethics. Question…. To test the effectiveness of a new medication, should some patients be subjected to a placebo? To test the effectiveness of a surgery, should some patients be subjected to false surgeries (placebos)?
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Question… • To test the effectiveness of a new medication, should some patients be subjected to a placebo? • To test the effectiveness of a surgery, should some patients be subjected to false surgeries (placebos)? • To test the effectiveness of a treatment for a human’s disease, should the procedure be tested on rats, even if it meant their death? • Should you test it on cats or dogs if it meant their death?
Basic Ethics of an Experiment • The organization which carries out the study must have an INSTITUTIONAL REVIEW BOARD • Reviews all planned studies in advance • Protects subjects from potential harm • All subjects must give their INFORMED CONSENT before data is collected. • All data must be kept CONFIDENTIAL. • Only statistical summaries for groups of subjects may be made public.
Institutional Review Board • Purpose is “to protect the rights and welfare of human subjects (including patients) recruited to participate in research activities”, not to decide if it is a good idea. • IRB reviews the plan, may require changes. • Comprised of members of organization, at least one person outside of organization, one scientist, and one nonscientist (minimum of 5 on board).
Institutional Review Board (cont’d) • Reviews the consent form to be sure subjects are informed about nature of study and any potential risks. • IRB monitors progress at least once a year. • Studies with “minimal risk to subjects” will have a shorter review process (ex., sample surveys).
Institutional Review Board • Workloads of IRB’s are very large…so what can happen as a result? • IRB’s may not be thorough in their review of the plan and may miss critical information as a result. • IRB’s may be tempted to label study as “minimal risk” to speed up the process. • (Example, at Duke University Medical Center in 1999, the government shut down their human subject research due to inadequate protection of the subjects…there were more than 2000 studies going on).
Informed Consent • Subjects must be informed in advance about… • Nature and purpose of the study • Possible risks • If a survey, what kinds of questions which will be asked • How much time will be required • Then they must give their consent in writing.
Informed Consent • Who can’t give their informed consent? • Children under the age of 18 • Prison inmates • Those with mental disorders • Unconscious patients in an emergency room with no one to speak for them gives their “implied” consent for treatment • Problems encountered… • Full disclosure of better treatments or potential hazards could be withheld in order to gain subjects. • Mentioning every hazard could lead to very long consent forms…could scare off subjects.
Confidentiality • Need to keep the identities of the subjects separate from the rest of the data. • Can only give general summaries about data. • Different than ANONYMITY (the subjects’ names are not known even to the director of the study)… this is rarely done.
Back to the question… • Remember, placebos often work. Placebo medications may still benefit the subject. • Placebo surgeries have more controversy: • Yes: Doctors need to be able to make comparisons, so “sham surgeries” must be used. • No: All surgeries carry some risk. Patients could be put at risk without receiving any possible benefits of surgery. • Many people are opposed to animal testing when it is an animal they see as “cute” or a “pet”, and not as opposed when it is an animal more often referred to as a “pest” or “rodent”. • The controversy continues…
Homework • Pg. 180-181, #3.44, 3.45, 3.47 • Pg. 187, #3.53 • Pg. 191-192, #3.61, 3.64, 3.65