1. Lesson #11: Ethics

2. What are ethics as they pertain to experiments??? O Is it ethical to conduct animal testing? O Is it ethical to distribute placebo medication? O Is it ethical to perform placebo surgeries?

3. In order for someone to participate in an experiment, 3 items must be satisfied so that ethics are addressed…

4. Institutional Review Board O Purpose is “to protect the rights and welfare of human subjects (including patients) recruited to participate in research activities”. Their purpose is not to decide if it is a good idea.

5. IRB’s O They will review the paperwork to make sure the subjects know exactly what will be expected of them. O They keep track of the experiments and check in on them from time to time.

6. Informed Consent O Subjects must be informed in advance about… O Nature and purpose of the study O Possible risks O If it’s a survey, what kinds of questions which will be asked O How much time will be required O Then they must give their consent in writing.

7. Who can’t give their informed consent ? 1. Children under age 18 2. Prison inmates 3. Those with mental disorders 4. Unconscious patients in an emergency room with no one to speak for them gives their “implied” consent for treatment

8. Confidentiality O Need to keep the identities of the subjects separate from the rest of the data (i.e., in a file not with the data). O Can only give general summaries about data.

9. Confidentiality Different than ANONYMITY (the subjects’ names are not known even to the director of the study)… someone sends in a questionnaire and it has no identifying information as to its sender. This is rarely done.

10. So…. O Since placebo medications may actually have medicinal value (placebo effect), using placebos may actually benefit the patient. O But what about placebo surgeries? Even a real surgery carries with it risk…if someone is having a surgery without any possible result, is that ethical?

11. Group Work #17 O In your groups, take a stand for or against the use of animals in medical research. Write at least one paragraph stating your group’s opinion after discussing your side of the controversy.

12. Clinical Trials O Clinical Trials are experiments which now have human subjects. If you have a clinical trial, these were 3 of the rules you must follow in order to conduct one.

13. Go onto the Internet. CLINICALTR IALS. gov has the most resources my classes have found so far. Find a study which interests you and print it. Don ’ t print an extremely long one. O If you can find one from this year, you will earn extra credit points. O Bring your print outs to class on Friday. You will share them and examine them with your groups. FOR FRIDAY