Data Ethics in Statistics: Understanding Ethical Dilemmas in Descriptive Statistics - Prof, Study notes of Statistics

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Chapter 7

Data Ethics

Obvious Ethics Violations Using deception in order to obtain responses Publishing fake data Leaving subjects out of the analysis because their results don’t say what you want them to say Doing several analyses and reporting only the ones that support your hypothesis Law requires federally funded studies to have an Institutional Review Board , follow Informed Consent guidelines, and to keep individual data Confidential

The organization that carries out a study must have an Institutional Review Board (IRB) review all planned studies in advance to protect the subjects from possible harm.

• (^) Don’t decide whether the study will produce valuable information
• (^) Must have at least five members
• (^) At least one scientist, one non-scientist, at least one unaffiliated with the organization
• (^) Members should be diverse (race, gender, and culture)
• (^) Check out our university’s IRB http://www.orc.research.sc.edu/irb.html

All individuals who are subjects in a study must give their informed consent before data are collected.

• (^) Informed in advance about any risk of harm
• (^) Consent is usually in writing All individual data must be kept confidential.
• (^) Only statistical summaries for groups of subjects may be made public
• (^) Anonymity – subjects’ names are not known, even to the director of the study
• (^) no follow-up or results for the patient
• (^) Anonymity is not common is statistical studies

Example A 72-yr old man with M.S. is hospitalized. His doc feels he may need to be placed on a feeding tube to ensure adequate nourishment. He asks the patient about this in the morning and the patient agrees. However, in the evening (before the tube has been placed), the patient becomes disoriented and seems confused about his decision to have the feeding tube placed. He tells the doc he doesn’t want it in.

The doc revisits the question in the morning, when the patient is again lucid. Unable to recall his state of mind from the previous evening, the patient again agrees to the procedure. Do you believe the patient has given informed consent to this procedure? A. Yes B. No

An IRB for a university approved to offer free HIV screening. A flyer says that for persons who come for testing, a code is used instead of your own name. You receive a copy of the report for your information, but only the code identifies the report as yours. You can learn the results of the test by coming in person to pick up the report, still w/o giving your name. This practice offers A. Anonymity B. Confidentiality C. Both anonymity and confidentiality

• (^) Recall: Clinical trials are experiments that study the effectiveness of medical treatments on actual patients.
• (^) Randomized comparative experiments are the only way to see the true effects of new treatments.
• (^) Clinical trials produce great benefits, but most of these benefits go to future patients.
• (^) Trials pose risks that are borne by the subjects of the trial.
• (^) Balance future benefits against present risks.

World Medical Association (1948) Most respected international standard Developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. “the interests of the subject must always prevail over the interests of science and society”

Because “the interests of the subject must always prevail,” medical treatments can be tested in clinical trials ONLY when there is reason to hope that they will help the patients who are the subjects in the trials. Future benefits alone are not enough to justify any experiment with human subjects.

Unethical - Tuskegee Syphilis Study In the 1930s syphilis was common among black men in the rural South. Public Health Service recruited 399 poor black sharecroppers w/ syphilis and 201 others w/o the disease in order to observe how syphilis progressed when no treatment was given. The study subjects were not treated, even after penicillin became a standard treatment for syphilis. PHS tried to prevent any treatment until word leaked out and forced an end to the study in

A 1996 review said, “It has come to symbolize racism in medicine, ethical misconduct in human research, paternalism by physicians, and government abuse of vulnerable people.” In 1997, President Clinton formally apologized to the surviving participants in a White House ceremony The Tuskegee study helps explain the lack of trust that lies behind the reluctance of many blacks to take part in clinical trials

Are Placebo Controls Ethical? Placebo controls have long been debated in terms of ethics. There are arguments for and against the ethicality of placebo controls Let’s here some arguments for each side

Placebo Controls Ethical? Yes… Placebo gives a true baseline for the effectiveness of a new drug. Consider 3 groups: new drug, best existing drug, placebo

• (^) Placebo control group helps us see if the study is flawed so that even the best existing drug does not beat the placebo.
• (^) Sometimes the placebo wins, so the doubt about the efficacy of the new and existing drugs is justified. Ethical except in life-threatening conditions.

Placebo Controls Ethical? No… It isn’t ethical to deliberately give patients an inferior treatment. If past trials showed that the existing drug is better than a placebo, it is no longer ethical to give patients a placebo. Existing drug includes the placebo effect, so just compare existing drug to new. Placebo group is only ethical if the existing drug is an older one that did not undergo proper clinical trials, doesn’t work well, or is dangerous.

National Institute of Health (clinicaltrials.gov) Phases of Clinical Trials In Phase I trials , researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II trials , the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In Phase III trials , the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. In Phase IV trials , post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

There is a push to require more stringent Phase IV testing Vioxx was a drug approved for treatment of arthritis Vioxx's Phase III study involved 8,076 patients Nevertheless, it was not powerful enough to reliably detect rare adverse events with a prevalence of 1%–2% compared with placebo Phase IV trials allowed detection of these rare adverse effects and Vioxx was pulled from the market in 2004

Behavioral and Social Science Experiments Direct risks are less acute, in general “Ethical Principles” of the American Psychological Association require consent

• (^) Unless a behavior merely observes a behavior in a public place APA allows deception
• (^) only when it is necessary to the study
• (^) Does not hide info that may influence a subject’s willingness to participate
• (^) Is explained to subjects ASAP

Researchers conducting a “personal space” experiment set up shop in a public men’s restroom. Urinals were blocked off to force men to use

• (^) a urinal next to an experimenter (treatment)
• (^) A urinal away from the experimenter (control) Another experimenter used a periscope from a stall to record
• (^) Time it took to start urinating
• (^) Length of time urination occurred

Would this experiment be considered ethical according to the current standards of the APA? A. Yes B. No