1. 6.3 Ethics in Statistics

2. Minimizing Risk vs. Maximizing Info To test a new surgical practice, should you account for the placebo effect by performing some sham surgeries where you cut the person open, but don’t do anything? This is why we test on animals before we test on people To avoid a negative placebo effect, is it ok to not tell the subjects of possible negative side-effects?

3. Informed Consent Before you can begin a study, each subject must give informed consent. – You must inform people of all potential risks – To account for a negative placebo: both groups are told the risks of the drug that they may or may not get Even for a survey, no physical harm is possible but the possibility for emotional harm remain – You might ask a question related to a traumatic event. – It’s best to inform the subject the topic of the survey before asking the specific questions. Minors can’t legally give consent, so you must ask their parent/guardian

4. Informed Consent: What is Informed? Inform subjects about ALL potential risks Inform subjects of alternative treatments to their disease/ailment Is it really informed if the subject signs without reading the 6+ pages?

5. Institutional Review Board (IRB) Every company, university, institution that conducts research involving human subjects has an IRB. They must give approval before any clinical trial may begin no matter what – Even if you’re just surveying students on how they feel about a type of lecture aid, that data can’t be published if the IRB didn’t give approval. Exist solely to protect the rights and welfare of human subjects – Not concerned with the purpose or validity of the study

6. Confidential vs. Anonymity It is important you are ethical in your treatment of private information Confidential: Personal information is kept secret and not released – Example: I tell you the average test score, but not the scores of individual students Anonymity: Even the person conducting the survey doesn’t know who said what – Example: The survey in the beginning of the year was anonymous because I had you not write your names on the survey

7. Current vs. Future Risks In the pharmaceutical industry, nothing is worse than putting a drug on the market that has to get recalled because its too dangerous Experimental drugs are tested on animals first, but there is still a lot more risks because there is much of the drug that we don’t know Sample Size: more data vs. more people at risk The control group. Is it ethical to have a group with a real disease receive no medical treatment for the period of the trial?

8. Clinical Trials There is an established procedure for bringing new drugs onto the market. 1) Cell Cultures & Computer Models: work with nothing living. 2) Animal Testing 3) Phase I Clinical Trials: Test the drug on a small number of healthy people who don’t have the drug… why? – Testing for side effects. Something that harms a healthy person could be fatal to someone who already has a compromised immune system. – Figure out appropriate dosage

9. Clinical Trials 4) Phase II Clinical: Test the drug on a small number of people who have the disease (100) – Is it more effective than current treatments? The control group takes the current treatment… compare new vs. current NOT new vs. nothing – Are the side effects too harmful? 5) Phase III Clinical Trials: Test the drug on a large number of people who have the disease (1,000’s) to collect a wealth of data and lower the error from variance on our experimental data

10. Clinical Trials 21% of drugs in Phase I fail to reach Phase II 30% of drugs in Phase II fail to reach Phase III 32% of drugs in Phase III fail to make it to the Market Counting all the failed attempts, it costs about $800 million over 12 to 15 years to develop one new drug and bring it to the market.

11. Ethical Violations After prosecuting those who violate ethics, is it ethical for us to use the data or should we throw it out? – Almost all of our knowledge about how the human body reacts to freezing is based off of Nazi experiments from the concentration camps. Page 298 – Example 6.19: An example of racism and ethical violations in the US from 1930 to 1970 – Story in margin, dishonesty in Russia