Research Ethics: Research ethics The Common Rule The Belmont Report

Foundations of Research

1Research ethicsResearch Ethics: The Common Rule The Belmont Report

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© Dr. David J. McKirnan, 2014The University of Illinois [email protected] not use or reproduce without permission Recruitment flyer for Stanly Milgram’s study

of obedience.From Boingboing.net

mailto:[email protected]

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2The “Common Rule” criteria for Human Subjects Protection

The Common Rule

Research institutions are mandated to have boards – Called Institutional Review Boards – that provide ethical review of all Federally funded research.That review follows seven elements, called the Common Rule.Most Universities apply the same standard to all research, whether federally funded or not.


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The Common Rule

Minimize risks Risks must be reasonable Recruit participants equitably Informed consent Document consent Monitor for safety Protect vulnerable participants &

maintain confidentiality

The Common Rule


4The Common Rule

Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring Protect vulnerable

participants, maintain confidentiality

Risks should not exceed those of everyday behavior.

Core issue:

Minimization of risks

Potential harms from research:

Withholding care

Loss of time, money, change in self-perception…

Direct: Tuskegee-likeIndirect: Clinical trials, wait-list designs

Use of deception in experimental manipulation Can people provide informed consent if they are deceived? Possible embarrassment or negative shift in self-perception. Deception erodes trust & confidence in social science.


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Physical harm

Cold War radiation experiments, DirectHarms:

During the 1950s – 60s, in preparation for a potential nuclear war, the U.S. military exposed hundreds of service men and women to varying doses of radiation from nuclear tests.Soldiers (and civilians) were tested for radiation exposure effects, both to assess harms and to convince the public that nuclear war could be “safe” to civilian populations.

The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring Protect vulnerable


The history of behavioral and biomedical research contains many instances of intentional or unintentional physical harm. Wikipedia has a good review here.

Image: imgur.com, public domain

Soldiers being exposed to a nuclear explosion at the Nevada Test Site in 1951. http://www.teoti.com/photography/123738-historical-pictures.html

Click for archival

footage on YouTube

Risk of harm to Participants, cont.

http://www.citywatchla.com/4box-right/5005-humans-used-for-radiation-experiments-a-shameful-chapter-in-us-history

https://en.wikipedia.org/wiki/Unethical_human_experimentation_in_the_United_States%23Fallout_research

https://www.youtube.com/watch?v=ZWSMoE3A5DI

https://www.youtube.com/watch?v=ZWSMoE3A5DI


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Physical harm

Cold War radiation experiments, Army psychoactive drug research

DirectHarms:

The U.S. army performed a variety of harmful drug studies before ethical standards were firmed in during the 1990s. In the 1960s through the 70s service members and, in some cases, prisoners were given varying doses of LSD and other psychotropic drugs to test their possible use as psychoactive chemical weapons.Some these exposures were with fore-knowledge and consent, at other times drugs were slipped into food to test their effects when unanticipated.Click below for an excellent piece in The New Yorker.




http://www.newyorker.com/magazine/2012/12/17/operation-delirium


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Physical harm

Cold War radiation experiments, Army psychoactive drug research, Drug trials in prison populations

DirectHarms:

The great majority of psychoactive drugs used today – for sleep disorder, anxiety or depression, psychotic symptoms… - were initially tested on prisoners. Other testing administered known or potential toxins to gauge their effects.Typically, pharmaceutical companies would work with State officials to gain access to prisoners. Prisoners “volunteered” for the studies, although were rarely fully informed about the agents they were taking.



The shameful history of this testing led to very strict regulations being imposed in the 1990s. Today there is renewed debate about the prospect if prisoner testing were placed on prison testing. Click the image for a NYTimes.com article.


http://www.nytimes.com/2006/08/13/us/13inmates.html

http://www.nytimes.com/2006/08/13/us/13inmates.html?_r=1&


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Physical harm

Cold War radiation experiments, Army psychoactive drug research, Drug trials in prison populations, Some forms of Animal research

DirectHarms:

Animal research has long been contentious for both research and commercial safety. As with prisoner research, animal testing has an ugly history, but has made invaluable contributions to human health.PETA, of course, opposes any animal testing (click image).



NIH and organizations such as Foundation for Biomedical Research argue in Defense of responsible animal testing.Scientific American calls for ban on animal testing for Cosmetics. Many companies advertise their products as animal-testing free, although many use ingredients shown to be safe through prior animal work.The Scientist has an excellent series on animal testing, including the increasing number of alternatives to animals.


http://www.peta.org/issues/animals-used-for-experimentation/animal-testing-101/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3123518/

http://www.scientificamerican.com/article/beauty-and-the-beasts-the-u-s-should-ban-testing-cosmetics-on-animals/

http://www.the-scientist.com/?articles.list/tagNo/384/tags/animal-testing/pageNo/1/

http://fbresearch.org/


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Physical harm

Cold War radiation experiments, Army psychoactive drug research, Drug trials in prison populations, Some forms of Animal research

DirectHarms:



Indirectharms:

Behavior induced by the experiment: Experimental conditions that encourage

risk, alcohol & drug use, smoking…

Many studies on health behavior assess the effects of different conditions – say, modeling by attractive peers – on behaviors such as alcohol or tobacco use.These studies can be ethical if participants are carefully screened (e.g., for no evidence of alcohol abuse…) and monitored during the experiment.Ethical constraints must be very strict in this area, particularly if deception is involved.



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Physical harm



Psychological harmExperiments that induce anxiety or negative moods. Discomfort or pain

Many studies on issues from emotions and alcohol use, coping with stress or change, or adjusting no novel environments can temporarily induce negative reactions or moods.These studies remain ethical given that they have carful: Screening, to eliminate highly vulnerable participants; Monitoring, to assess participants state during the study; Debriefing, to provide information and provide a chance to return to a normal

state. (The same is true when administering alcohol…).



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Physical harm



Psychological harmExperiments that induce anxiety or negative moods. Discomfort or painE.g., leading participants to believe they were

capable of harming others Changed self-perception

One of the most famous research programs crossing this ethical line were the obedience studies conducted by Stanley Milgram in the 1960s.

Images: Simplypsychology.org/

Click image for an excellent overview from SimplyPsychology.


http://www.simplypsychology.org/milgram.html


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• In 1962, in the wake of the Nuremberg Trials of Nazi war crimes, Stanley Milgram wanted to discover how common citizens could be led to commit clearly evil acts.

• He recruited participants for a “Memory study”, where they would serve as instructors.

• Milgram hired actors to portray the ostensible “Learners”.

• Milgram thus used deception in his recruitment materials and study instructions.• Any deception study is ethically problematic because participants are not providing

accurate informed consent.• Studies that use deception to hide hypotheses from participants typically have no

other potential study harms.• Milgrams’ use of deception was unethical; Participants consented not knowing they

would be subjected to substantial stress.

Research harms; changes in self perception.


http://www.history.com/topics/world-war-ii/nuremberg-trials



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• The “learner” was attached to (phony) electrodes, in a separate room from the “teacher”, who sat with the experimenter.

• Each time the “student” (the actor…) missed an item on a memory task, the “teacher” was told to administer increasingly intense shocks.

• The study assessed how high a shock participants would administer as the “learner” consistently gave wrong answers…

• …how many were obedient enough to administer shock levels they thought were lethal, while the “student” screamed in the other room.

• Bottom line: many ordinary people will harm others when commanded to by an authority.

• Of course, participants then had to live with the knowledge that they were willing to follow

Research harms; changes in self perception.




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In 1962, in the wake of the Nuremberg Trials of Nazi war crimes, Stanley Milgram wanted to discover how common citizens could be led to commit clearly evil acts. Click for an excellent overview from Simply Psychology.

Study participants were deceived into thinking they were in the role of teachers for a memory task. Each time the “student” (actually an actor) missed an item on a memory task, the “teacher” was told to administer increasingly intense shocks.

Many participants were obedient enough to take the shock to levels they thought were lethal, while the “student” showed increasingly extreme discomfort.

Bottom line: many ordinary people will harm others when commanded to by an authority.

Of course, participants then had to live with the knowledge that they were willing to follow instructions to that extreme.Or did they? A recent re-re-analysis suggests that

participants were not that disturbed by the study.

Click this box for a cool indy song about the Milgram experiment and fascism.


http://www.history.com/topics/world-war-ii/nuremberg-trials


https://publichealthwatch.wordpress.com/2014/09/06/psychologists-say-milgrams-famous-experiment-on-obedience-to-authority-has-been-misunderstood/

http://www.indyweek.com/indyweek/dar-williams-buzzer/Content?oid=1217279


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Physical harm




In 1971 the U.S. had been subject to several tragic prison riots. Political debate focused on whether criminals – the great majority Black and poor – were cognitively or psychologically “impaired” to the extent that they could not function in society.Sociological research at the time described the effects of “total institutions” such as prisons or psychiatric hospitals, that actually created deviant behavior.Phillip Zimbardo set out to test this experimentally, by constructing a realistic prison in the Stanford Psychology Dept. basement, and randomly assigning male undergraduates to the roles of prisoners or guards.Consistent with the hypothesis, the students – all affluent, white, well educated and screened for psychological health – acted little different than those at Attica State Prison, where riots had taken place.As with the Milgram experiment, participants were left with the knowledge that, whether prisoner or guard, they were capable arbitrary brutality.

E.g., leading participants to believe they were capable of harming others Changed self-perception Click for the study web

site.


http://www.prisonexp.org/

http://www.prisonexp.org/


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Physical harm




Many studies address coping or risk behavior in populations that may be stigmatized. For example, the author conducted AIDS research among gay and bisexual men from the 1980’s forward. During much of that time being “outed” as gay/bisexual could lead to job loss to actual violence. As more men (and women) became infected with HIV, that status became a second important source of stigma.Loss of confidentiality through sloppy record keeping, or even recognizing a research participant on the street, could have real adverse consequences. Research with potentially stigmatized people – whether due to poverty, criminal background, abuse history, or otherwise – requires very careful protections to ensure that vulnerable participants are not socially harmed just by being a research participant.

E.g., leading participants to believe they were capable of harming others Changed self-perception

Loss of confidentiality or privacy Embarrassment



17The Common Rule

Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for

safety Protect vulnerable

participants & maintain confidentiality

Physical harm Psychological harm Social or political harm

Portraying social groups in a negative light, e.g.:• Interpretations of research results that suggest lower

intelligence among lower socio-economic status or minority participants;

• “Pathologizing” minority groups by problem – focused research and reporting: Research funding addressing poor, GLBTQ, minority and

other populations typically focuses on problems: drug abuse, domestic problems, criminality…;

Although these are important topics, the consistent portrayal of a community in ‘problem’ terms can enhance negative stereotypes.

Ignoring or relying too strongly on some groups: e.g., women or minorities in clinical research.



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What makes research vulnerable to research harm? Strong financial pressure for study results:

The ability to market clinical interventions – new drugs, medical devices, behavioral programs – depends upon positive results of efficacy trials.

Publication & grant pressure: Advancement in the research industry- promotions, recognition, getting

grants or contracts – requires that investigators consistently publish positive results.

Simple bias or prejudice: Most researchers are Caucasian, with middle or upper-middle class

backgrounds; The “Ivory Tower” syndrome; it is common for researchers have little direct

experience with the populations they are studying. Lack of institutional controls

Active Institutional Review Board Study monitors

Up-front ethical reviews & ongoing monitoring for ethical compliance can prevent potential harms.



19Risk of harm to Participants, cont.

Prevention of research harms: Independent & rigorous Institutional Review Board

[IRB]:• An IRB is a set of active researchers, who review and

monitor proposals for their adherence to the common rule.

Diversity among investigators, research centers. Study monitoring:

• We will see examples of good and poor monitoring below.

The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for

safety Protect vulnerable


NIH.gov, public domain

Careful pilot testing & monitoring of study manipulations Informed consent and debriefing to:

a) fully inform participants about the study

b) eliminate any imposed state, e.g. temporary stress, negative affect…


20Reasonableness of risks

Whether a risk to participants is reasonable rests on a Cost – benefit analysis

Does the study present risks greater than every-day life?

• How much greater, for how long?

Core issue:The Common Rule

Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable


Potentially harmful research may be justified if it provides invaluable data, e.g.:

Milgram obedience studies; Zimbardo prison experiment; Intrusive animal studies; Studies that pay people to take medical or behavioral risks.

Are the potential harms – ‘costs’ – justified by the likely knowledge to be gained, i.e., potential benefits?


21Reasonableness of risks

The Zimbardo Prison Study subjected college students to real stress…

…but provided valuable data about how social roles and the physical setting affect behavior.

Click the image for an overview of the study.© 1999-2015, Philip G. Zimbardo, http://www.prisonexp.org/the-story/

Weighing risks against potential benefits is difficult and complex… We lack a scientific metric for evaluating

degrees of potential harm. The benefits of research are rarely guaranteed.

Research with little harm may still be unjustified if it will not provide useful data:

Research always requires time, effort, potential embarrassment…;

Research that is trivial or incompetent may be inherently unethical for those reasons.

Even research with scientific or applied benefit often has no direct benefit for the study participants themselves.

http://www.prisonexp.org/the-story/

http://www.prisonexp.org/the-story/


22Reasonableness of risk

Causes of unreasonable research risk: The “Costs” of participation may not be fully understood by investigator;

Benefits may be overstated or not framed in terms of target population;

Publication & grant pressure to recruit participants at any cost.

Prevention: Independent & rigorous Institutional Review Board [IRB];

The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable


Community Advisory Board [CAB]; A board of people from the target population;

Pilot testing to assess the actual risks of the research.

ShutterStock


23Participant Recruitment

People potentially affected by research must: Have the opportunity to join the study; Have the opportunity to withdraw once enrolled; Not be coerced or deceived into enrollment.

Equitable recruitment:

How do we ensure that all social groups are represented? Some groups are less likely to enlist than are others;

How much should Investigators try to overcome peoples’ reluctance to join a study?

At what point does that become coercive? Some groups – drug abusers, those in poverty – will respond to

even a small monetary incentive to join even high risk studies. Is offering a monetary incentive to those individuals coercive? Are they treated inequitably by not being offered money?




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Coercive payments or incentives; Culturally or socio-economically coercive. Potential loss of benefits, such as recruitment in a medical setting.

Deceptive descriptions of experiment Ability to comprehend protocol & provide informed consent;

Children, elderly, developmentally delayed, mentally ill… Highly complex or long-term research protocols

Prevention: Local IRB & Funder’s requirements for equitable representation.

Participant Recruitment The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Data monitoring for safety Protect vulnerable


Potential problems in recruitment: Arbitrary bias in sampling

Excluding – or only including – groups for reasons unrelated to the research protocol (I,e, convenience, or ease of recruitment).

Using highly unrepresentative samples (e.g., reliance on college students in social / behavioral research).


25Informed consent Key elements of the Informed Consent document:

Purpose & procedures of the study. Why the participant was recruited. Study requirements and duration. Possible risks or harms, The study is voluntary & the participant can withdraw at any time. Any potential benefits or costs of participation. Who to contact for information / concerns, including the IRB. Written signature.

How do we know the participant understood? Administer consent quiz, or personal interview.

How to document consent? For studies where participants are anonymous the IRB can waive

written consent.




26Informed consent

Deception in experiments: How do we provide informed consent if the

participant cannot know the hypothesis? The study must present no risks of harm; The participant must be thoroughly debriefed

after the study. Deception can erode trust & confidence in

social science.

The consent document is one of the most closely examined issued in IRB ethical reviews.




27Data and clinical trial monitoringTwo key elements of Research Monitoring:

Monitoring of clinical trials;Studies of a new drug or treatment.

Behavioral intervention studies.

Participants are followed over time with multiple study visits.

Data Safety Monitoring Boards;Independent bodies that oversee data collection and analyses.

The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable



28Data and clinical trial monitoring

Investigators in clinical trials are required to monitor and report any health or safety “adverse events”.

Trial related – due to a feature of the trial protocol:

E.g., heart complications during trials of weight loss drugs;Can be deemphasized or ignored in trials testing products;Often ignored in behavioral intervention studies.

Non-Trial related; e.g., deaths during longitudinal study of

injection drug users Trial-related Serious Adverse Events may

require a protocol change or may stop the study.



Monitoring for safety: Trial monitoring Data Safety Monitoring Board


29Fen-Phen; a case study of failed trial Monitoring The Common Rule

Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable


1992; Physicians begin prescribing a combination of Fenflouramine and Phentermine (“Fen-Phen”) for obesity, with no FDA approval.

1996; After clinical trials by the manufacturer the FDA approves Redux, a Fen-Phen drug.

The manufacturer reported 4 cases of severe cardiac effects during trial monitoring, despite 41 having actually occurred.

The Food and Drug Administration bypassed staff who had concerns, and approved the drug without a “black box” warning. Large Pharmaceutical Companies can have substantial influence in FDA

decisions Wyeth spends $52 million promoting the drug, garnering $300 million in annual sales. Time Magazine notes Fen-Phen as the hot new diet drug, but raises safety questions.

1997; 30 year-old woman dies of cardiac event after taking Fen-Phen for a month. 1998 ; Mayo clinic finds multiple cases of cardiac problems in women

taking Fen-Phen FDA receives 144 Adverse Event reports; 30% of patients taking Fen-

Phen show cardiac abnormalities. Fen-Phen pulled from market. 2003; Forbes Magazine reports 153,000 law suits against Wyeth, who

pays out $13 billion in settlements.

Click the image for the PBS Frontline documentary Fen Phen Nation

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html



30Fen-Phen; a case study of failed trial Monitoring The Common Rule



1992; Physicians begin prescribing a combination of Fenflouramine and Phentermine (“Fen-Phen”) for obesity, with no FDA approval.

1996; After clinical trials by the manufacturer the FDA approves Redux, a Fen-Phen drug.

The manufacturer reported 4 cases of severe cardiac effects during trial monitoring, despite 41 having actually occurred.

The Food and Drug Administration bypassed staff who had concerns, and approved the drug without a “black box” warning. Large Pharmaceutical Companies can have substantial influence in FDA

decisions Wyeth spends $52 million promoting the drug, garnering $300 million in annual sales. Time Magazine notes Fen-Phen as the hot new diet drug, but raises safety questions.

1997; 30 year-old woman dies of cardiac event after taking Fen-Phen for a month. 1998 ; Mayo clinic finds multiple cases of cardiac problems in women

taking Fen-Phen FDA receives 144 Adverse Event reports; 30% of patients taking Fen-

Phen show cardiac abnormalities. Fen-Phen pulled from market. 2003; Forbes Magazine reports 153,000 law suits against Wyeth, who

pays out $13 billion in settlements.

Click the image for the PBS Frontline documentary Fen Phen Nation

Here a large company had a strong motive for inadequate monitoring; diet pills are a multi-billion dollar a year industry.

Even though the Food and Drug Administration [FDA] was monitoring the trial, the company intentionally withheld data that would have stopped approval.

This is also example of industry research having a corrupting effect on FDA decisions.




31Data and clinical trial monitoring

The DSMB monitors:Trial integrity; is the research protocol being followed correctly.“Stopping rules” for research risks or positive findings Data integrity:

Ensures that data are collected in a valid fashionGuards the data against “unblinding” of participants or investigators;

The DSMB is entrusted with all the codes for experimental groups and “unblinds” participants and investigators only when the trial is over.



Monitoring for safety: Trial monitoring Data Safety Monitoring Board


32The Women’s Health Initiative; a case study of “stopping rules” for a clinical trial. The Common Rule



1980s-90s: Millions of women use Hormone Replacement Therapy of estrogen plus progestin (E+P) to relive menopausal symptoms.

1991: NIH begins a study after observational data suggest that women using hormones have lower rates of heart disease.

2002: The E+P part of the Initiative is stopped early after women show higher rates of heart attack, stroke and breast cancer.

Millions of women abandon hormones overnight.

2004: The study of estrogen only is stopped one year early: women taking estrogen show fewer breast cancers and only small increased risk of stroke.

Here is an example of stopping rules working both ways: The estrogen & progestin arm was stopped because

the DSMB detected adverse effects from the therapy.

The estrogen only arm was stopped because it showed such strong positive results that all participants were all put on the therapy.


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How sensitive should scientists be to political or social pressures around their research, e.g., sexual behavior stem cells gun risks

Thought questions: Monitoring for safety

How do we separate self-interest & political pressure from science?



How much does military or corporate (pharmaceuticals, tobacco..) funding for research distort scientific findings?

climate change evolution economics & social policy

Are scientists responsible for the social impact of their findings? E.g., negative portrayal of social “out-groups” The use of empirically validated techniques for unethical practices


34Vulnerability to coercion in research

Cognitive: The capacity to think about and provide informed consent for participation:

Children, older adults;Dementia or cognitive limitations, mentally ill, drug users.


participants & confidentiality

What makes someone vulnerable to coercion in research?

What is coercion in research?Enrollment: Joining a study that a reasonable person would see as

harmful or exploitive.Continued participation: Not recognizing harm or exploitation that emerges once

the research begins; Recognizing harms but not having the psychological or

physical capacity to withdraw.


35Vulnerability to coercion in research The Common Rule Minimize risks Reasonable risks Equitable recruitment Informed consent Document consent Monitor for safety Protect vulnerable

participants & confidentiality

What makes someone vulnerable to coercion in research?

Authority: liable to authorities who have a vested interest in your participation.

Prisoners, Medical patients, students and others with a Dual Role:

Patients / students may feel obligated to participate in a study conducted by their physician / Professor.

Deferential: participation due to deferential attitudes or cultural pressure rather than actual willingness.

Medical: selected due to serious health-related condition for which there are no satisfactory remedies.

Poor / disadvantaged: lacking important social goods – money or health care – provided via research participation.


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The Common Rule

Minimize risks Risks must be reasonable Recruit participants equitably Informed consent Document consent Monitor for safety Protect vulnerable participants &

maintain confidentiality

The Common Rule


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The Common Rule Minimize risks Risks must be reasonable Recruit participants equitably Informed consent Document consent Monitor for safety Protect vulnerable participants

& maintain confidentiality

The Common Rule

The common rule protects participants during the process of research.

Researchers also have responsibility for the use of their results.

We discussed the problems with a negative portrayal of research populations when results are published.

The next case study shows the extreme of irresponsible use of research results.


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The American Psychological Association [APA] actively contributed to the CIA program of “enhanced interrogation” (torture) until 2008.

In 2014 the Senate released a report describing CIA “enhanced interrogations” during the Iraq war.

They concluded that the CIA engaged in torture, and that the program was unsuccessful.

It had been widely known that APA-sanctioned Psychologists had helped design and administer the interrogation program.

In 2015 an ethics panel of Psychologists and human rights activists issued a report on the show deep involvement of the APA in the Bush era torture program.

Click for NYTimes.com overview.An American soldier patrolling outside Abu Ghraib prison in 2005. The public disclosure of images of prisoners being abused there prompted debate about the way the United States was treating detainees. Credit John Moore/Getty Images, New York Times.

A case study of the unethical use of scientifically validated techniques.

http://www.nytimes.com/2014/12/10/world/senate-torture-report-shows-cia-infighting-over-interrogation-program.html

http://www.nytimes.com/interactive/2015/05/01/us/document-report.html

http://www.nytimes.com/2015/05/01/us/report-says-american-psychological-association-collaborated-on-torture-justification.html



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Beginning in 2003, the APA worked closely with CIA Psychologists James Mitchell and Bruce Jessen to develop “enhanced interrogation” (I.e. physical and psychological torture) used at Guantanamo Bay and other “Black sites” around the world.

APA worked with the Bush White House, State Department and CIA to tailor it’s ethical standards to allow Mitchell and other Psychologists to develop and conduct the CIA interrogation program.

The White House actually help write a 2005 APA policy statement allowing Psychologists’ assistance in “enhanced interrogation”. The secretive committee that prepared the document was comprised primarily of Military Psychologists.

Dr. Martin Seligman, past president of APA, contributed to the CIA effort by presenting his theory of Learned Helplessness as a method of extracting information.

From a 2004 CIA memo : "The goal of [harsh] interrogation is to create a state of learned helplessness and dependence conducive to the collection of intelligence.”

From the New Yorks Times article.

Case study of unethical use of scientifically validated techniques.

Mark Wilson/Getty Images

More than a decade after George J. Tenet, then the C.I.A. director, signed a secret order suspending the agency’s use of enhanced interrogation techniques, the American Psychological Association’s actions are coming under scrutiny.

http://psychology.about.com/od/lindex/f/earned-helplessness.htm

http://psychology.about.com/od/lindex/f/earned-helplessness.htm

http://www.reuters.com/article/2009/08/26/idUSSP478656


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From the New Yorks Times article.

Case study of unethical use of scientifically validated techniques.

The American Psychiatric Association & American Medical Associations refused to endorse their members’ involvement in interrogations:

The CIA interrogations were linked to torture & unlawful detention;

As helping professions, the Psychiatric and Medical communities refused to sanction or participate in torture.

In it’s 2005 report, the APA ethics committee declared that, as a research organization, it was exempt from the ethical standards of “helpers”.

(This resembles the Bush Administration's declaration that those held at Guantanamo, Abu Graib and elsewhere were “detainees” in a battle zone, rather than “prisoners of war”, so the Geneva Convention guidelines for the ethical treatment of prisoners did not apply.)

After years of boycotts and protests, in 2008 APA finally altered its stance and accepted the “do no harm” ethical stance of helping professions.

See a chilling documentary of the APA’s adoption of torture policy here.

The misuse of scientific theory and data can have very serious consequences.

http://focusreframed.com/?p=99



41Case study 2: Researchers’ larger ethical responsibility

What responsibility does a researcher have for the eventual use of a discovery?

What if a finding that may do great good may also do great harm?

How does the scientific community – and should the scientific community – control that?

Matt Edge for The New York Times ˆDr. Jennifer A. Doudna. Three years ago, she helped make one of the most monumental discoveries in biology.

http://www.nytimes.com/2015/05/12/science/jennifer-doudna-crispr-cas9-genetic-engineering.html?hp=


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Click the image for an NYT piece about Dr. Jennifer Doudna, who discovered an easy method to alter DNA.

She discovered an easy easy way to alter existing – or insert new - DNA sequences in the genome.

These alterations would then be passed down to successive generations.

This gene manipulation may someday be able to cure genetic diseases.

It may also lead to “custom” genetic tampering of embryos, to create physical – and psychological – characteristics parents want in their children.

Case study 2: Researchers’ larger ethical responsibility


Click here for a discussion of attempts to ban or limit this research.

The Chinese have already begun research in primate embryos.

This is particularly troubling, given the early stage of the research and the potential consequences for a commercial use of gene splicing to modify embryos.

http://www.nytimes.com/2015/03/20/science/biologists-call-for-halt-to-gene-editing-technique-in-humans.html



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Click the image for an NYT piece about Dr. Jennifer Doudna, who discovered an easy method to alter DNA.

She discovered an easy easy way to alter existing – or insert new - DNA sequences in the genome.

These alterations would then be passed down to successive generations.

This gene manipulation may someday be able to cure genetic diseases.

It may also lead to “custom” genetic tampering of embryos, to create physical – and psychological – characteristics parents want in their children.

Case study 2: Researchers’ larger ethical responsibility


Click here for a discussion of attempts to ban or limit this research.

The Chinese have already begun research in primate embryos.

This is particularly troubling, given the early stage of the research and the potential consequences for a commercial use of gene splicing to modify embryos.

Dissemination of a technique to change something as fundamental as the human genome is potentially dangerous. At this stage the research is preliminary, so its

application would be particularly irresponsible. Even as the research develops, errors may lead

to dire results. However, any new technology – physical,

electronic, or biological – seems to always find a market.

So, should researchers “go there” and work on topics such as gene tampering at all?

http://www.nytimes.com/2015/03/20/science/biologists-call-for-halt-to-gene-editing-technique-in-humans.html



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The Common Rule Minimize risks Risks must be reasonable Recruit participants equitably Informed consent Document consent Monitor for safety Protect vulnerable participants

& maintain confidentiality

Misleading, biased or fraudulent results.

Beyond potential harm to participants, social groups or society at large, a key form of research ethics is honesty in gathering and reporting results.

Behavioral research has been plagued by… Questionable or tenuous results,

that cannot be repeated (replicated) by others,

Intentional (if thoughtless) biases, More rarely, outright fraud.


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Quick note:Any research study begins assuming the Null Hypothesis.(Negative finding: any ‘results’ are by chance alone; there in nothing going on…)

If the results are strong enough, the investigator can Reject the Null Hypothesis. (Positive finding: the results are not just due to chance or a confound;

the hypothesis is confirmed,the theory is supported)

For obvious reasons positive results are the bread and butter of science,A false positive is a positive result due to to error, biases, or subtle (…not so subtle…) fraud.It appears that science generally, and the behavioral sciences in particular, are rife with false positives

negative Results are considered to have little value.

Negative finding

Positive finding

False Positives: questionable, tenuous, non-reproducible results.


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Inaccurate or non-reproducible (false positive) results often stem from confirmatory bias among investigators, sloppy work, or inappropriate statistics. Replication is a process where a study is repeated exactly, to

ensure the results were not due to a fluke or the specific conditions in one lab (i.e., an artifact).

Converging studies address a topic using different methods or measures, to ensure the results are not simply due to the general method used.

Research journals (and grant awards) strongly favor new, exciting or innovative results. So, few replicating or converging studies are performed; it can be difficult to get them published.

A lot of work then goes ‘unchecked’ – and replicating studies that are conducted often fail to reproduce the original result. The Reproducibility Project attempted to rigorously replicate

100 Ψ studies from 2008. Over 60% showed far weaker (or no) results when reexamined.

False Positives

http://www.nytimes.com/2015/08/28/science/many-social-science-findings-not-as-strong-as-claimed-study-says.html


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Data from: Fanelli D (2010) “Positive” Results Increase Down the Hierarchy of the Sciences. PLoS ONE 5(4): e10068. doi:10.1371/journal.pone.0010068

Positive Results Bias A 2010 study in PloS ONE

showed over 70% of published articles in all science disciplines to have positive results.

Psychiatry and Psychology articles show > 90% positive results!

It is not remotely plausible that > 90% of our hypotheses are “true” and actually supported by objective research.

Our positive results bias can lead tenuous or simply false “findings” to be published, making our empirical base generally suspect.

False Positives

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0010068


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False Positives in Science Dr. Megan Head and colleagues examined 100,000 research papers spanning

scientific disciplines including medicine, biology and psychology. Click here for a summary. Dr Head said the study found a high number of p-values that were only just over

the traditional threshold that most scientists call statistically significant. “This suggests that some scientists adjust their experimental design, datasets or

statistical methods until they get a result that crosses the significance threshold,” she said.

“They might look at their results before an experiment is finished, or explore their data with lots of different statistical methods, without realising that this can lead to bias.”

many publications we have and the quality of the scientific journals they go in. “Journals, especially the top journals, are more likely to publish experiments with

new, interesting results, creating incentive to produce results on demand.” Works against longer research time frames, and almost rules out studies that

attempt to replicate previous studies to test whether their results are actually robust.

tiny effect size can have very low p-values with a large enough sample size. Similarly, a low p-value does not mean that a finding is of major clinical or biological interest.

studies presented in the American Psychiatric Assn. annual meetings in 2009 and 2010. They found 97.4% of those that were supported by the pharmaceutical industry reported positive findings. Only 68.7% of those that weren't supported by drug manufacturers were as encouraging.

Head ML, Holman L, Lanfear R, Kahn AT, Jennions MD (2015) The Extent and Consequences of P-Hacking in Science. PLoS Biol 13(3): e1002106. doi:10.1371/journal.pbio.1002106 Click for original article

http://www.anu.edu.au/news/all-news/scientists-unknowingly-tweak-experiments

http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1002106




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There is substantial pressure – and temptation – to cut corners, introduce subtle biases, or engage in simple fraud to produce positive results.

“Tweaking” study designs to ensure positive results; Ideally, a study is designed to test the hypothesis:

The null hypothesis and the alternate hypothesis (négative & positive results) each have a fair chance of emerging.

Unfortunately, many studies are conceived less to test a hypotheses than to prove or confirm one.

A strong confirmatory bias can induce both intentional and unintentional biases in favor of positive results.


Researchers may repeat experiments, tweaking one element or another – the setting, the measurements, statistical analyses, participants – until they get the expected result. This powerful confirmatory bias is often not seen as a problem.


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TweakingStage managingCherry pickingP-hackingSimple faking


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but to find procedures that will empirically confirm it.

There is substantial pressure – and temptation – to cut corners, introduce subtle biases, or engage in simple fraud to produce positive results.

1. “Tweaking” study designs to ensure positive results; Ideally, a study is designed to test the hypothesis:. Unfortunately, many studies are conceived less to test a hypotheses than to

prove or confirm one. A strong confirmatory bias can induce both intentional and unintentional

biases in favor of positive results. This can be a consequence of a strong theory:

The researcher is convinced (based on previous studies, with or without clear evidence) that the theory is correct.

The point of the study is then not to test whether the theory is correct– we already “know” it is (or want it to be) –



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2. Behavioral researchers typically stage manage the experimental setting, instructions, available information and the like.• This is a virtue if the stage management simply enhances external

validity, by making the setting more “real world” –like.• This is a serious problem if it pushes the participant toward

confirming the hypothesis. • “Stage managing”


…limiting participants’ behavioral choicesMaking the stimulus all s/he can respond to; Implicit Attitude Test, stereotype research, very minimal stimuli and moral judgments


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“Tweaking” study designs to ensure positive results, Stage managing

3. “Cherry Picking” results; publishing only those that “work”. Multiple statistical tests at p<.05. (1 / 20 by chance…) Multiple variables /selective choice of variable(s) and post-writing

the hypothesis. (not necessarily consious fraud; making sense of the findings, but inadvertantly making them sound like they had been predicted.

Multiple complete studies File drawer phenomenon



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Selective choice of variables (A variation on Cherry picking): Large data sets contain multiple variables. Investigators can cheat by re-writing their hypothesis to address the

variables that they already know to “work” in the study.o For example, Bohannon’s fake chocolate study assessed multiple

possible outcomes of a diet program.o His showed results only for the one variable that happened to change.o Given how many variables he tested, there was over 90% chance that at

least one of them would look a little different at the end of the study. This form of fraud is not always intentional or malicious; with

complex data our bias toward positive results will draw attention to only some outcomes.

As we saw in the Fen Phen scandal, however, company-sponsored researchers occasionally simply ignore negative outcome variables.

http://io9.com/i-fooled-millions-into-thinking-chocolate-helps-weight-1707251800


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Multiple studiesPharmaceutical companies have been particularly implicated in this:

o Companies would run multiple trials of a new drug, and submit only the successful outcomes to the FDA for approval.

o The FDA now requires submission and access to all drug trials.This has been called “the file drawer problem”; journals have little

interest in negative results, so only positive outcomes get submitted for publication.

Researchers rarely attempt to publish negative results Although this is changing as researchers become aware of the

positive results bias, and journals become more accepting of negative results.


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Dr Head said the study found a high number of p-values that were only just over the traditional threshold that most scientists call statistically significant.“This suggests that some scientists adjust their experimental design, datasets or statistical methods until they get a result that crosses the significance threshold,” she said.“They might look at their results before an experiment is finished, or explore their data with lots of different statistical methods, without realizing that this can lead to bias.”

4 P-hacking

Dr Megan Head of Australian National University recently published a study of 100,000 research papers published around the world, spanning medicine, biology and psychology. (Click for an overview).

Her data suggest “p-hacking” as an important source of false positive research results:

From: PHYS.org, Social Sciences, March 18, 2015; http://phys.org/news/2015-03-scientists-unknowingly-tweak.html.

Downloaded 9/20/15.


http://phys.org/news/2015-03-scientists-unknowingly-tweak.html




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Simple faking; Unfortunately, it is not that difficult to fake a study and garner substantial

media attention of a phony (even silly) “finding”. How to create a fake study and get world-wide attention: John

Bohannon’s fake chocolate weight loss study.


http://io9.com/i-fooled-millions-into-thinking-chocolate-helps-weight-1707251800


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Koos Breukel for The New York Times

Diederik Stapel, a Dutch social psychologist, perpetrated an audacious academic fraud by making up studies that told the world what it wanted to hear about human nature.

Click for New York Times overview.

There is substantial pressure – and temptation – for actual fraud. Career advancement – and funding

– requires finding positive results;

The varieties of research fraud Simple faking; Deitrik Stapel successfully faked 20 years of data (click image).

Stapel perpetrated the largest fraud in modern behavioral science. He made up results that were plausible and interesting (“sexy”, in his word),

but close enough to real results to not be questioned He was aided by trust and lack of strong oversight in the research industry. Over a 20-year fake research program he published 55 research papers,

11+ Doctoral dissertations, and secured substantial research funding.

Experiments must “work” to be published, to get drugs licensed, to apply for further funding…

As a consequence, U.S. Behavioral research shows a strong bias toward positive results.


http://www.nytimes.com/2011/11/03/health/research/noted-dutch-psychologist-stapel-accused-of-research-fraud.html?_r=0

http://www.nature.com/news/us-behavioural-research-studies-skew-positive-1.13599

http://www.nytimes.com/2013/04/28/magazine/diederik-stapels-audacious-academic-fraud.html

http://www.nytimes.com/2013/04/28/magazine/diederik-stapels-audacious-academic-fraud.html


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What are the consequences of subtle (or not so subtle) cheating in research? Compromised or poorly conducted research…

“Tweaking” study designs to ensure positive results, Cherry picking only positive results, Statistical “errors” favoring the hypothesis, Simple faking, Lax standards for evaluating results,

… can lead to the appearance (or gross overstatement) of positive results in data that actually do not support the hypothesis.

Evidence from journal publications shows Psychiatry / Psychology to have a very strong “positive results bias”:

The consequences of biased research studies


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Behavioral scientists are responding to the replication crisis by being more transparent about all their data; NYT paper here.

http://www.nytimes.com/2015/08/29/science/psychologists-welcome-analysis-casting-doubt-on-their-work.html


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How do we determine whether a research risk is “reasonable”?

A = A cost – benefit analysisB = No risk is acceptableC = The Research Investigator decides if the study

is too riskyD = Risk cannot exceed what riskier people in

society face anyway

Quiz; Think about each possible answer, then choose the one you would have clicked in class.


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Which of these is most important as a cause of research harms, or data that are inaccurate or actually fraudulent?

A = Science attracts ethically questionable peopleB = Financial and professional pressure for positive

research resultsC = A lack of clear methods for many research

areasD = It is not possible to monitor a study once it is

underway

Quiz


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I want to recruit poor people for a study of an experimental vaccine. To ensure I get enough people to take the vaccine I offer $200 dollars for each of five study visits.Is this ethical?

A = Yes, taking an experimental drug is risky and people should be paid well.

B = No, the researchers do not know if the vaccine works yet.

C = Yes, as long as they are told whether they are getting the real drug or the placebo.

D = No, that rate of compensation for poor people is coercive.

Click


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Are experiments that use deception ethical?

A = Yes, as long as the investigator thinks the results may be important.

B = No, participants cannot give informed consent if they do not know what the experiment is about.

C = Yes, as long as there is IRB review and systematic debriefing after the study.

D = No, IRBs will not sanction deception in research.

Click


65OverviewSU

MM

ARY

The “Common Rule”: core guidelines Minimize risks Risks must be reasonable Recruit participants equitably Informed / Document consent Monitor for safety Protect vulnerable participants & maintain confidentiality

Larger institutions have key roles in maintaining ethical behavior

Institutional Review Boards (IRBs) Organizations such as the APA can behave in clearly unethical

fashion The “research industry” directly presses for questionable,

mediocre or fraudulent research.


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The Common Rule: Core criteria for ethical research

The Belmont Report and the Informed Consent document

Respect for

persons

JusticeBeneficence


67Belmont Report (CITI training)

1. Respect For Persons Right to exercise autonomy & make informed choices.

2. Beneficence Minimization of risk & maximization of social / individual benefitHow much information should participants get from a blinded, randomized trial?

See ethics of clinical trials

3. Justice Research should not unduly involve groups unlikely to benefit

from subsequent applications. Include participants of all races & both genders Members of target population on design & research team Research & researchers contribute to study population studied Communicate research results & develop programs/ interventions

http://www.uic.edu/classes/psych/psych242/Articles/NYT,%20Clinical%20trial%20ethics,%201-5-99.doc


68Optional

Optional section:Click to go to a detailed description of the sections used in a complete informed consent document.I will not ask you to list these in the exam.Several key items you should know:• The research is completely voluntary• Participant must understand each element

of the study.• Participant must willingly sign the informed

consent document.


69The informed consent document

Why am I being asked to participate in this research? ..who is being recruited or selected?

Why is this research being done? Overview Box:

What is the purpose of this research? What procedures are involved? What are the potential risks and discomforts?Are there benefits to taking part in this research? What other options are there? ...What happens if I decline participation?

procedures, purposes, potential risks & benefits, potential outcomes.

Brief descriptions..


70 Informed consent elements, 2

Will I be told about new information that may affect my decision to participate? What about privacy and confidentiality? What if I am injured as a result of my participation? What are the costs for participating in this research?

...e.g., for services, etc.

Will I be reimbursed for any of my expenses for participation in this research? Can I withdraw or be removed from the study? Who should I contact if I have questions? Signature of participant or legally authorized representative

Documents

Research Ethics: Research ethics The Common Rule The Belmont Report