Showing concern for the welfare of human subjects.

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Presentation transcript:

Showing concern for the welfare of human subjects

 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)

 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

 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

 “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.

 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.

 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

Good endsBad ends Good meansEthical research Subjective ethic (backfires) Bad meansMachiavellian research Unethical research

 Autonomy:  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

 “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  Motivations include  tenure and promotion  pressure to “publish or perish”  lucrative grants, patents  fame, notoriety, prestige

 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

 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

 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”)

Low-risk anonymous surve Observations gathered in public places Information in the public domain

 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

 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

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

 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.

 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

 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

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