Section 3.3: Data Ethics

1. Section 3.3: Data Ethics

2. 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?

3. 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.

4. 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).

5. 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).

6. 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).

7. 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.

8. 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.

9. 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.

10. 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…

11. Homework • Pg. 180-181, #3.44, 3.45, 3.47 • Pg. 187, #3.53 • Pg. 191-192, #3.61, 3.64, 3.65