ethics in experimental research
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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 - PowerPoint PPT PresentationTRANSCRIPT
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 (2004)
U.S. energy Dept. and radiation tests on civilians (1970’s)
LSD and the CIA’s MK Ultra program (1973)
Why is my colon Why is my colon glowing?glowing?
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 Brush OffThe Brush Off 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 StudyThe 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.
My Bad…My Bad… 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.
Hard to swallowHard to swallow 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 ends Bad ends
Good means Ethical research
Subjective ethic (backfires)
Bad means Machiavellian research
Unethical research
Autonomy:Autonomy: Free-choice, no pressure to participate, consideration of “at risk” groups or individuals
persons with diminished autonomy Beneficence:Beneficence:
“do no harm,” ensure the well-being of participants
Justice: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. 1662-1663
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 minimizing psychological riskspsychological risks Example: simulations
that accentuate racist, sexist, or homophobic attitudes
minimizing physical minimizing physical risksrisks Example: behavioral
psychologists’ penchant for shocking subjects in the 60’s and 70’s
showing concern for showing concern for the welfare of the welfare of participantsparticipants Example: Stanley
Milgram’s conformity research
VoluntaryVoluntary: : the subject willingly agrees to participate in the study, and is free to withdraw at any time without penalty
Usually requires written consent
Age: Age: 18 or older, with parent or 18 or older, with parent or legal guardian’s permissionlegal guardian’s permission
Capacity: Capacity: participants must participants must have the mental ability to make a have the mental ability to make a reasoned choicereasoned choice
Special Populations: Special Populations: children, children, elderly, at risk groups, etc.elderly, at risk groups, etc.
Before conducting any research using human participants, a participant’s informed consent must first be obtained: Informed:Informed: the subject is aware of any risks
(physical or psychological) associated with participating
ConsentConsent: the subject’s consent is unambiguous, e.g., a signed permission form
no such things as “implied consent” opting out must be easy
Low-risk anonymous surveys 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: Anonymity: no one including the experimenter can match the data to specific individuals
Confidentiality: 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:Dehoaxing: undoing the cover story and revealing the true
purpose of the investigation Desensitizing:Desensitizing:
addressing any lingering psychological or emotional concerns associated with participating in the investigation
Explaining the benefits Explaining the benefits of participation to subjects
Thanking subjects Thanking subjects and providing for future contact or referral if necessary
the “subjects” versus “participants” controversy
avoiding “isms” in research; sexism, racism, ethnocentrism, ageism, etc.
ethics of withholding treatment from control groups