Foundations of
Research
1
Research ethics
Research
Ethics:
 The Common Rule
 The Belmont Report
This is a PowerPoint Show

Click “slide show” to start it.

Click through it by pressing any key.

Focus & think about each point; do not
just passively click.

To print:

Click “File” then “Print…”.

Under “print what” click “handouts (6
slides per page)”.
© Dr. David J. McKirnan, 2014
The University of Illinois Chicago
McKirnanUIC@gmail.com
Do not use or reproduce without
permission
Recruitment flyer for Stanly Milgram’s study
of obedience.
From Boingboing.net
Foundations of
Research
The “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.
2
Foundations of
Research
The Common Rule
The Common Rule

Minimize risks

Risks must be reasonable

Recruit participants equitably

Informed consent

Document consent

Monitor for safety

Protect vulnerable participants &
maintain confidentiality
3
Foundations of
Research
Minimization of risks
4


Core issue:
 Risks should not exceed those of
everyday behavior.





The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
Potential harms from research:


Loss of time, money, change in self-perception…
Withholding care
Direct:
Indirect:
Tuskegee-like
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.
Foundations of
Research
5
Risk of harm to Participants, cont.



Physical harm


The history of behavioral and biomedical research contains many
instances of intentional or unintentional physical harm. Wikipedia
has a good review here.
Direct
Harms:



The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
 Cold War radiation experiments,
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.
Click for
archival
footage on
YouTube
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.
Soldiers being exposed to a nuclear explosion at
the Nevada Test Site in 1951.
http://www.teoti.com/photography/123738-historicalpictures.html
Image: imgur.com, public domain
Foundations of
Research
6
Risk of harm to Participants, cont.


Physical harm
The Common Rule
Minimize risks




Direct
Harms:
 Cold War radiation experiments,
 Army psychoactive drug research


Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
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.
Foundations of
Research
7
Risk of harm to Participants, cont.


Physical harm




Direct
Harms:
 Cold War radiation experiments,
 Army psychoactive drug research,
 Drug trials in prison populations


The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
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.
Foundations of
Research
8
Risk of harm to Participants, cont.


Physical harm




Direct
Harms:




Cold War radiation experiments,
Army psychoactive drug research,
Drug trials in prison populations,
Some forms of Animal research


The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
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.
Foundations of
Research
9
Risk of harm to Participants, cont.


Physical harm




Direct
Harms:
Indirect
harms:




Cold War radiation experiments,
Army psychoactive drug research,
Drug trials in prison populations,
Some forms of Animal research


The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
 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.
Foundations of
Research
10
Risk of harm to Participants, cont.



Physical harm




Psychological harm



Discomfort or pain
The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
Experiments that induce anxiety or negative moods.
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…).
Foundations of
Research
11
Risk of harm to Participants, cont.



Physical harm




Psychological harm



Discomfort or pain
 Changed self-perception
The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
Experiments that induce anxiety or negative moods.
E.g., leading participants to believe they were
capable of harming others
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.
Foundations of
Research
Risk of harm to Participants, cont.
Research harms; changes in
self perception.
• 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.
12
Foundations of
Research
Risk of harm to Participants, cont.
Research harms; changes in
self perception.
• 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
13
Foundations of
Research
Risk of harm to Participants, cont.
14
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
Click this box for a cool indy song about the
Psychology.
Milgram experiment and fascism.
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
didextreme.
they? A recent re-re-analysis suggests that
were willing to follow instructions to Or
that
participants were not that disturbed by the study.
Foundations of
Research
15
Risk of harm to Participants, cont.


Physical harm




Psychological harm




Discomfort or pain
 Changed self-perception
The Common Rule
Minimize risks
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
Experiments that induce anxiety or negative moods.
E.g., leading participants to believe they
were
Click for the study web
capable of harming others
site.
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.
Foundations of
Research
16
Risk of harm to Participants, cont.


The Common Rule
Minimize risks

Physical harm




Psychological harm



Discomfort or pain
Reasonable risks
Equitable recruitment
Informed consent
Document consent
Data monitoring
Protect vulnerable
participants, maintain
confidentiality
Experiments that induce anxiety or negative moods.
 Changed self-perception
E.g., leading participants to believe they were
capable of harming others
 Embarrassment
Loss of confidentiality or privacy
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.
Foundations of
Research



17
Risk of harm to Participants, cont.
Physical harm
Psychological harm
Social or political harm
 Portraying social groups in a negative light, e.g.:
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for
safety

Protect vulnerable
participants & maintain
confidentiality
• 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.
Foundations of
Research
Risk of harm to Participants, cont.
18
What makes research vulnerable to research harm?

Strong financial pressure for study results:


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:



The ability to market clinical interventions – new drugs, medical devices,
behavioral programs – depends upon positive results of efficacy trials.
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.
Foundations of
Research
Risk 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:
•
19
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for
safety

Protect vulnerable
participants & maintain
confidentiality
We will see examples of good and poor monitoring below.

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…
NIH.gov, public domain
Foundations of
Research
Reasonableness of risks
Core issue:

Whether a risk to participants is reasonable
rests on a Cost – benefit analysis

20
Does the study present risks greater than everyday life?
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
• How much greater, for how long?

Are the potential harms – ‘costs’ – justified by the likely knowledge
to be gained, i.e., potential benefits?
 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.
Foundations of
Research
21
Reasonableness of risks
 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.
 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.
 Even research with scientific or applied
benefit often has no direct benefit for the
study participants themselves.
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/
Foundations of
Research
Causes of unreasonable research risk:



22
Reasonableness of risk
The “Costs” of participation may not be fully
understood by investigator;
Benefits may be overstated or not framed in terms of
target population;
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
Publication & grant pressure to recruit participants at
any cost.
Prevention:

Independent & rigorous Institutional Review Board [IRB];

Community Advisory Board [CAB]; A
board of people from the target
population;

Pilot testing to assess the actual risks of
the research.
ShutterStock
Foundations of
Research
Participant Recruitment
Equitable recruitment:

23
People potentially affected by research must:
 Have the opportunity to join the study;
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
 Have the opportunity to withdraw once enrolled;
 Not be coerced or deceived into enrollment.
 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?
Foundations of
Research
Arbitrary bias in sampling


The Common Rule
Participant Recruitment
Potential problems in recruitment:

24
Excluding – or only including – groups for reasons
unrelated to the research protocol (I,e, convenience,
or ease of recruitment).

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
Using highly unrepresentative samples (e.g., reliance
on college students in social / behavioral research).
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.
Foundations of
Research
25
Informed consent
 Key elements of the Informed Consent document:
 Purpose & procedures of the study.
 Why the participant was recruited.
 Study requirements and duration.
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
 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.
Foundations of
Research
26
Informed 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 Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
 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.
Foundations of
Research

Monitoring of clinical trials;

Studies of a new drug or treatment.

Behavioral intervention studies.


The Common Rule
Data and clinical trial monitoring
Two key elements of Research Monitoring:

27

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants & maintain
confidentiality
Participants are followed over time with multiple study visits.
Data Safety Monitoring Boards;

Independent bodies that oversee data collection and analyses.
Foundations of
Research
28
Data and clinical trial monitoring
Monitoring for safety:
 Trial monitoring
 Data Safety Monitoring Board
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety


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.
Protect vulnerable
participants & maintain
confidentiality
Foundations of
Research


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.



Fen-Phen; a case study of failed trial
Monitoring
The manufacturer reported 4 cases of severe cardiac effects during
trial monitoring, despite 41 having actually occurred.
29
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants & maintain
confidentiality
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 FenPhen 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
Foundations of
Research


Fen-Phen; a case study of failed trial
Monitoring
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
Here
a large
company
hadoccurred.
a strong motive


30
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants & maintain
confidentiality
for
The
Food and Drug monitoring;
Administration bypassed
whoare
had a multiinadequate
diet staff
pills
concerns, and approved the drug without a “black box” warning.
billion
dollar a year
industry.
Large Pharmaceutical
Companies
can have substantial influence in FDA

decisions

Administration [FDA] was monitoring the trial,
the
company
intentionally
data that
1997; 30
year-old
woman dies
of cardiac eventwithheld
after taking Fen-Phen
for a month.
would have
1998 ;stopped
Mayo clinic approval.
finds multiple cases of cardiac problems in women


Wyeth
Even
though the Food and Drug
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.

Fen-Phen
 This is taking
also example of industry research

FDA receives 144 Adverse Event reports; 30% of patients taking Fen-

2003; Forbes Magazine reports 153,000 law suits against Wyeth, who
pays out $13 billion in settlements.
having Phen
a corrupting
on FDA
decisions.
show cardiac effect
abnormalities.
Fen-Phen
pulled from market.
Click the image for the PBS Frontline
documentary Fen Phen Nation
Foundations of
Research
31
Data and clinical trial monitoring
Monitoring for safety:
 Trial monitoring
 Data Safety Monitoring Board
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety


Protect vulnerable
participants & maintain
confidentiality
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 fashion

Guards 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.
Foundations of
Research




32
The Women’s Health Initiative; a case study of
“stopping rules” for a clinical trial.
1980s-90s: Millions of women use Hormone
Replacement Therapy of estrogen plus progestin
(E+P) to relive menopausal symptoms.
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety
1991: NIH
begins
after of
observational
data working
Protect vulnerable
Here
is ana study
example
stopping rules
participants & maintain
suggestboth
that women
using
hormones
have
lower
rates
confidentiality
ways:
of heart disease.

 The estrogen & progestin arm was stopped because
2002: Thethe
E+P
part of the Initiative is stopped early after women
DSMB detected adverse effects from the
show higher
rates of heart attack, stroke and breast cancer.
therapy.
Millionsof
women
abandon
hormones
overnight.
The
estrogen
only arm
was stopped
because it showed
such strong positive results that all participants
were all put on the therapy.
 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.
Foundations of
Research
How do we separate self-interest & political
pressure from science?



33
Thought questions: Monitoring for safety
How much does military or corporate
(pharmaceuticals, tobacco..) funding for research
distort scientific findings?
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants & maintain
confidentiality
How sensitive should scientists be to political or social
pressures around their research, e.g.,
 climate change
 sexual behavior

stem cells

evolution

gun risks

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
Foundations of
Research
34
Vulnerability 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:
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants &
confidentiality
 Not recognizing harm or exploitation that emerges once
the research begins;
 Recognizing harms but not having the psychological or
physical capacity to withdraw.
What makes someone vulnerable 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.
Foundations of
Research
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:


35
Vulnerability to coercion in research
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants &
confidentiality
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.
Foundations of
Research
The Common Rule
The Common Rule

Minimize risks

Risks must be reasonable

Recruit participants equitably

Informed consent

Document consent

Monitor for safety

Protect vulnerable participants &
maintain confidentiality
36
Foundations of
Research
The Common Rule
The Common Rule
 The common rule protects
participants during the process
of research.

Minimize risks

Risks must be reasonable
 Researchers also have
Recruit participants
equitably for the use of their
responsibility


Informed consent results.

 We discussed the problems with a
Document consent


negative portrayal of research
Monitor for safetypopulations when results are published.
 The
next case study shows the
Protect vulnerable
participants
extreme of irresponsible use of research
& maintain confidentiality
results.
37
Foundations of
Research
A case study of the unethical use of
scientifically validated techniques.
38
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.
Foundations of
Research
39
Case study of unethical use of scientifically validated techniques.

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.
Mark Wilson/Getty Images
More
than a decade after George J. Tenet, then
From the New Yorks Times article.
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.
 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.”
Foundations of
Research

Case study of unethical use of scientifically validated techniques.
40
The American Psychiatric Association & American
Medical Associations refused to endorse their
members’ involvement in interrogations:


The CIA
were linked
to torture & theory
unlawful
 interrogations
The misuse
of scientific
detention;
and data can have very serious
As helping professions, the Psychiatric and Medical
consequences.
communities refused to sanction or participate in torture.
From the New Yorks
Times article.
 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.
Foundations of
Research

Case 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 ˆ
Dr. Jennifer A. Doudna. Three years
ago, she helped make one of the
most monumental discoveries in
biology.
41
Foundations of
Research

42
Case study 2: Researchers’ larger ethical responsibility
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.
Matt Edge for The New York Times ˆ
Dr. Jennifer A. Doudna. Three years
ago, she helped make one of the
most monumental discoveries in
biology.
 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.
 Click here for a discussion of attempts to ban or limit this research.
Foundations of
Research

43
Case study 2: Researchers’ larger ethical responsibility
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 –
Dissemination
of a technique
to change
or insert
new - DNA sequences
in the genome.
something as fundamental as the human
These alterations would then be passed down to
genome
is potentially dangerous.
successive
generations.
At manipulation
this stage the
is able
preliminary,
so its
This
gene
mayresearch
someday be
to
cure genetic
diseases.would be particularly irresponsible.
application
It may
lead
“custom”
genetic
tampering of
 also
Even
astothe
research
develops,
errors mayMattlead
Edge for The New York Times ˆ
embryos, to create physical – and psychological –
Dr. Jennifer A. Doudna. Three years
to dire results.
ago, she helped make one of the
characteristics parents want in their children.
most monumental discoveries in
biology.
 However, any new technology – physical,
electronic,
or biological
– seems
to always
find
 The Chinese
have already
begun research
in primate
embryos.
a
market. troubling, given the early stage of the research and the
 This is particularly
potential
consequences
for a commercial
use of gene
to modify
 So,
should researchers
“go there”
andsplicing
work on
embryos.
topics such as gene tampering at all?
 Click here for a discussion of attempts to ban or limit this research.
Foundations of
Research
44
Misleading, biased or fraudulent results.
The Common Rule
 Beyond potential harm to

participants, social groups or
society at large, a key form of
Risks must be reasonable
research ethics is honesty in
gathering
and reporting results.
Recruit participants
equitably

 Behavioral research has been
Informed consent

Document consent

Monitor for safety

Protect vulnerable participants
 Intentional (if thoughtless) biases,
& maintain confidentiality


Minimize risks
plagued by…
 Questionable or tenuous results,
that cannot be repeated (replicated)
by others,
 More rarely, outright fraud.
Foundations of
Research
False Positives: questionable, tenuous,
non-reproducible results.
Quick note:
Any research study begins assuming the Null Hypothesis.
Negative finding:
finding any ‘results’ are by chance alone; there in nothing going on…)
(Negative
If the results are strong enough, the investigator can Reject the Null
Hypothesis.
finding the results are not just due to chance or a confound;
(Positive finding:
the hypothesis is confirmed, the theory is supported)
For obvious reasons positive results are the bread and butter of
science, negative Results are considered to have little value.
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
45
Foundations of
Research
46
False Positives
 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.
Foundations of
Research
47
False Positives
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.
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
 Our positive results bias can lead tenuous or simply false “findings” to
be published, making our empirical base generally suspect.
Foundations of
Research
48
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
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.
Foundations of
Research
Misleading, biased or fraudulent results.
49
 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.
Foundations of
Research
Tweaking
Stage managing
Cherry picking
P-hacking
Simple faking
50
Foundations of
Research
Misleading, biased or fraudulent results.
51
 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) – but to find
procedures that will empirically confirm it.
Foundations of
Research
Misleading, biased or fraudulent results.
 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 choices
Making the stimulus all s/he can respond
to; Implicit Attitude Test, stereotype
research, very minimal stimuli and moral
judgments
52
Foundations of
Research
Misleading, biased or fraudulent results.
53
 “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
Foundations of
Research
 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.
54
Foundations of
Research
 Multiple studies
 Pharmaceutical 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.
55
56
Foundations of
Research
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:
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.”
From: PHYS.org, Social Sciences, March 18, 2015;
http://phys.org/news/2015-03-scientists-unknowingly-tweak.html.
Downloaded 9/20/15.
Foundations of
Research
Misleading, biased or fraudulent results.
57
 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.
Foundations of
Research
58
Misleading, biased or fraudulent results.
 There is substantial pressure –
and temptation – for actual
fraud.
 Career advancement – and funding
– requires finding positive results;
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.
Koos Breukel for The New York Times
 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.
 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.
Foundations of
Research
The consequences of biased research studies
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”:
59
Foundations of
Research
Behavioral scientists are responding to the
replication crisis by being more transparent
about all their data; NYT paper here.
60
Foundations of
Research
Quiz; Think about each possible answer, then
choose the one you would have clicked in class.
How do we determine whether a research risk is
“reasonable”?
A = A cost – benefit analysis
B = No risk is acceptable
C = The Research Investigator decides if the study
is too risky
D = Risk cannot exceed what riskier people in
society face anyway
61
Foundations of
Research
Quiz
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 people
B = Financial and professional pressure for positive
research results
C = A lack of clear methods for many research
areas
D = It is not possible to monitor a study once it is
underway
62
Foundations of
Research
Click
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.
63
Foundations of
Research
Click
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.
64
Foundations of
Research
SUMMARY


Overview
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.
65
66
Foundations of
Research

The Common Rule: Core
criteria for ethical research
 The Belmont Report

and the Informed
Consent document
Respect
for
persons
Beneficence
Justice
Foundations of
Research
Belmont Report
67
(CITI training)
1. Respect For Persons
 Right to exercise autonomy & make informed choices.
2. Beneficence
 Minimization of risk & maximization of social / individual benefit
How 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
Foundations of
Research
Optional
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.
68
Foundations of
Research

Why am I being asked to participate in this research?



The informed consent document
..who is being recruited or selected?
Why is this research being done?
Overview Box:
Brief descriptions..




procedures,
purposes,
potential risks & benefits,
potential outcomes.

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?
69
Foundations of
Research
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
70