Ethics in Experimental Research

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Presentation transcript:

Ethics in Experimental Research Showing concern for the welfare of human subjects

Horror Stories Tuskegee syphilis study of 1932 Stanley Milgram’s conformity research of 1963 commercially funded, “for profit” research (2001): conflicts of interest and the “file drawer” problem Pharmaceutical manufacturers “outsourcing” drug trials to poor countries with lax standards (2004) U.S. energy Dept. and radiation tests on civilians (1970’s) LSD and the CIA’s MK Ultra program (1973)

Radioactive oatmeal! More than 100 boys living in an orphanage were fed Quaker Oats with radioactive iron and calcium in the 1950's. The diet was part of an experiment to prove that the nutrients in Quaker oatmeal travel throughout the body. A class action settlement for $1.85 million was reached in 1998

The atomic veterans During and after WWII, American soldiers were forced to observe nuclear blasts within 50 miles of ground zero. Thousands of these soldiers later died of leukemia and other rare forms of cancer. Their families were barred from suing the federal government

Wendell Johnson’s diagnosogenic theory of stuttering “The Monster Study” In 1938, Wendell Johnson and Mary Tudor trained orphans to be more conscious of small speech errors. Johnson’s theory was that punishing fluency errors made them worse. All five stutterers in the test group showed increased stuttering; five out of six of the normal children exhibited worse fluency. The experiment, referred to by some as the “Monster Experiment” turned some of the children into lifelong stutterers despite later efforts to reverse the damage.

Cloning Fraud 2005: South Korean researcher, Woo Suk Hwang, fabricated evidence that he had successfully cloned human embryos. The journal Science, retracted two studies he had published.

Outsourcing clinical trials The price of bringing a new drug to market is about $1 million per day Much of that cost is devoted to human clinical trials western drug makers are outsourcing safety and efficacy studies to developing countries, a large proportion of them to India and Russia. There are currently some 400 clinical trials underway in India

Ethical matrix for social science research Good ends Bad ends Good means Ethical research Subjective ethic (backfires) Bad means Machiavellian research Unethical research

Belmont report Autonomy: Beneficence: Justice: Free-choice, no pressure to participate, consideration of “at risk” groups or individuals persons with diminished autonomy Beneficence: “do no harm,” ensure the well-being of participants Justice: fair distribution of risks and benefits of research subject recruitment, selection subject compensation

How common is research misconduct? “More than 1 percent of scientists report direct knowledge of an instance of misconduct.” Elliot (2000). How prevalent is fraud? That’s a multi-million dollar question. Science, 290, pp. 1662-1663 Motivations include tenure and promotion pressure to “publish or perish” lucrative grants, patents fame, notoriety, prestige

Fraud in scientific research Intentional fraud Cyril Burt’s research on monozygotic twins—fudging the results of IQ tests William Summerlin’s cancer research—faked results of tumor shrinkage Unintentional fraud Weitzman’s research on women's and men's incomes following divorce—blamed “computer error” for erroneous results Pons and Fleischmann's research on “cold” fusion—couldn’t be replicated by other researchers

No harm to the participants minimizing psychological risks Example: simulations that accentuate racist, sexist, or homophobic attitudes minimizing physical risks Example: behavioral psychologists’ penchant for shocking subjects in the 60’s and 70’s showing concern for the welfare of participants Example: Stanley Milgram’s conformity research

Voluntary informed consent Before conducting any research using human participants, a participant’s voluntary informed consent must first be obtained: Voluntary: the subject willingly agrees to participate in the study, and is free to withdraw at any time without penalty Informed: the subject is aware of any risks (physical or psychological) associated with participating Consent: the subject’s consent is unambiguous, e.g., a signed permission form (no such things as “implied consent”)

Exceptions to the consent requirement Low-risk anonymous surve Observations gathered in public places Information in the public domain

Failure to obtain informed consent Kinch’s study on the “Pygmalion effect” Problems associated with using freshman in experimental research Can students under 18 legally give their consent? Should participation in experiments be a course requirement? Ethics of participant-observation Going “under cover” to study groups may violate their rate to privacy

Deception and the use of cover stories Elms (1982) recommends the following strictures for the use of deception in experimental research: As a last resort: When there is no other feasible way to obtain the desired information example: studies on student cheating When the benefits substantially outweigh the risks example: controlled double-blind studies on drug efficacy When subjects are given the option to withdraw at any time, without penalty When any physical or psychological harm is temporary When subjects are debriefed and the research procedures are made available for public review

Privacy concerns Humphrey’s (1970) “tea room” trade research Personnel action—failure to ensure anonymity Incest case—failure to remove identifying information

Privacy concerns Anonymity: no one including the experimenter can match the data to specific individuals Confidentiality: the experimenter knows participants’ identities but takes steps to protect participant’s privacy.

Standards governing social science research at the department level Human Subjects Committees at the university level: Institutional Review Boards (IRBs) professional associations American Psychological Association’s “Ethical Guidelines” Code of Ethics” of the American Speech Hearing and Language Association

Debriefing participants Dehoaxing: undoing the cover story and revealing the true purpose of the investigation Desensitizing: addressing any lingering psychological or emotional concerns associated with participating in the investigation Explaining the benefits of participation to subjects Thanking subjects and providing for future contact if necessary

Treating participants with respect and dignity the “subjects” versus “participants” controversy avoiding “isms” in research; sexism, racism, ethnocentrism, ageism, etc. ethics of withholding treatment from control groups