Foundations of
Research
Research ethics
Research Ethics:
 The Tuskegee Study
 The Common Rule
 The Belmont Report
Dr. David J. McKirnan, University of Illinois at
Chicago, Psychology; mckirnanuic@gmail.com
1
Foundations of
Research
Research questions, hypotheses & designs

 The Tuskegee Study
 The Common Rule
 The Belmont Report
Certificate of 25 years completion in
the Tuskegee Study.
Image: U.S. Public Health Service.
Dr. David J McKirnan, McKirnanUIC@gmail.com
2
Foundations of
Research
3
Tuskegee & the Natural History of Syphilis
Tuskegee study of the “Natural history” of untreated
syphilis.
 Led to many ethical
standards in place today.
 Began Institutional Review
Board structure
Eunice Rivers, Tuskegee Study Coordinator, with study
investigators
Image: U.S. Public Health Service
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research
Tuskegee & the Natural History of Syphilis
4
Tuskegee began as a treatment trial.
Became a “Natural history” of untreated
syphilis
Natural History studies…

Monitor disease progression, viz:
 Natural progression in morbidity & mortality
 Individual differences in progression
 Variables that confer vulnerability / resistance to disease progression.
Data on African-American syphilis progression were limited
Systematic Northern European data
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research
Tuskegee & the Natural History of Syphilis
5
Tuskegee addressed a serious public health problem:


1920s – 30s Syphilis prevalence in poor, rural Black men was
extremely high;

25% of African-American employees at a private Alabama
company tested positive for syphilis

Prevalence in 5 Alabama counties ranged from 35% to 40%.

For context, today an Incidence of 5% = “syphilis outbreak”.
At study outset treatments were only marginally effective

Mercury was one of the earliest treatments, used extensively
in Europe from the Renaissance to the 1940s



"A night in the arms of Venus leads to a lifetime on Mercury”.
The arsenic-derived drug Salvarsan was the treatment of
choice in 1930.
One “folk” treatment actually consisted of drinking kerosene (!).
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1928 – 1930: Tuskegee is begun as a prevalence and
treatment study

Funding:

The Public Health Service (PHS, predecessor to the CDC)

The Rosenwald Fund (An African-American development fund).

Participants: primarily poor, uneducated, African-Americans.

Stage 1: Prevalence study



7,000 – 10,000 people tested;

Syphilis prevalence = 36%
Stage 2: Treatment trial

Salvarson & Mercury; Penicillin not yet used in general medicine.

1,200 treated by 1930.
Thus, the eventual observational study was not even a true
natural history: treatment was provided in the early stages.
6
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1931: The Depression slashes funding


The treatment arm of the study is defunded.

Rosenwald fund pulls out of the study

Neither the PHS nor the State of Alabama have funds to
continue the study.
Men still followed by the Tuskegee Institute
 European data showed most
syphilis symptoms to be physical
rather than neurological.
 Tuskegee Investigators
hypothesized that symptoms
among African-Americans would
be predominantly neurological.
 Since no coherent theory would
predict this, it is a classic example
of “scientific racism”.
7
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1932: PHS funds the continuation of the Natural History
study.

Participants: 600 poor, African-American sharecroppers

399 participants had syphilis at study outset.

Participants told they are simply receiving medical treatment,
not that they are in a research study

Incentives for participation: medical care, meals, burial
insurance.

Infected men not told they had syphilis.

Cohort is recruited and
maintained by local AfricanAmerican Nurse, “Miss Evers”

Nurse Evers cultivates personal
relationships with participants,
and drives them to their
medical visits.
8
Foundations of
Research
9
Tuskegee & the Natural History of Syphilis
1945: Penicillin becomes generally available.


Alexander Fleming identified Penicillin in 1929.

The treatment potential recognized in 1939.

Large scale production begun by the U.S. War Production Board
(WPB) in 1943, to treat “venereal disease”.
Tuskegee participants not informed that treatment is available

One rationalization was that
penicillin may not be effective for
longer-standing syphilis.

There was no clear theoretical
rationale for this assumption


The assumption – later proved
false – was not tested by giving the
Tuskegee men treatment.
Treatment was given only when the
study was stopped.
Image: U.S. Public Health Service
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1950s - 1960s; Multiple papers published in Medical
Journals describe the study.
Few or no ethical questions posed to PHS or the journals
1963
1956
1935
Dr. David J McKirnan, McKirnanUIC@gmail.com
10
Foundations of
Research
11
Tuskegee & the Natural History of Syphilis
1965: Dr. Irwin Schatz sends a letter to PHS (Then CDC)
“I am utterly astounded by the fact that physicians allow patients with a potentially
fatal disease to remain untreated when effective therapy is available.”
 CDC files the letter, noting it was the first such letter received.
 No reply was written.
1966: Dr. Peter Buxtun writes CDC after reviewing
published articles on Tuskegee
 Buxtun invited to CDC to discuss the study.
 CDC does not change its policy or stop the study.
1968: Buxtun again writes CDC
 Committee formed to investigate the study.
 CDC again does not change policy or stop the study.
Peter Buxton
Image: U.S. Public Health Service
Foundations of
Research
Tuskegee & the Natural History of Syphilis
12
1972: Buxtun discusses the study with a reporter from the
Associate Press.
 Jean Heller writes an explosive columns for the Washington
Star (now Washington Post) and New York Times.
1972: Secretary of Health & Human Welfare
(now Health & Human Services) convenes a panel
 … in response to the Washington Star
report, not from communication from CDC.
 Describes himself as “shocked” and
“horrified”.
1972: Sen. Ted Kennedy begins congressional hearings.
 Congress hears about the study for the first time, despite 40
years of government funding for it.
 The study ends and remaining participants given penicillin.
Foundations of
Research
Tuskegee & the Natural History of Syphilis
1975; Class action suit brought by surviving members
of the cohort.
1980s; HIV / AIDS re-invokes prospect of unethical
research or treatment
 Incidence of HIV infections skewed toward AfricanAmericans & other minorities
 Search for vaccines & treatments
raises the prospects of racist or
unequal treatment.
1997; Presidential apology
 Bill Clinton apologizes to the 8
remaining cohort members.
Dr. David J McKirnan, McKirnanUIC@gmail.com
13
Foundations of
Research

Core ethical issues in Tuskegee
No informed consent
 Key issue: Research was presented as Clinical care

Refusal of treatment
 …not informed when Penicillin became available

Coercive enrollment & retention
 Deception: Patients unaware they were in a research study
 Exploitation: • personal relationships with Nurse Evers
• vulnerability of uneducated, poor men with a
disease
 Primary incentive was burial $, which would require lifetime
participation

Co-opted population members:

Local African-American Medical Personnel were key players
on the research and study team.
Dr. David J McKirnan, McKirnanUIC@gmail.com
14
Foundations of
Research

Include participants of all races & both
genders in study cohorts


Barring a compelling reason to exclude groups.
Members of the target population included
on research team & design boards


Ethical Principles stemming from Tuskegee aftermath:
Note: African-Americans were on the research
and outreach teams in Tuskegee
Facilitate access to an intervention to the
entire population
 Cannot withhold “Standard of Care”.
 Standard of Care shifted during the Tuskegee study – from
Salvarson to penicillin – but study procedures did not.
 Research must contribute to population being studied
 Communicate research results
 Develop applied programs or interventions
Dr. David J McKirnan, McKirnanUIC@gmail.com
15
Foundations of
Research
Ethics procedures stemming from Tuskegee

Informed consent

Non-coercive enrollment & retention

Led to the 1979 Belmont Report


16
Indirectly to core elements of the “Common Rule”.
Ethical review & monitoring

Led to establishment of the Federal Office for Human
Research Protections (OHRP)

Led to laws requiring Institutional Review Boards (IRBs)
 All Federally funded research must be reviewed and monitored
by a local IRB
 Most institutions (e.g., UIC) require IRB approval of all
research, federally funded or not.
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research
Click
 European data showed most syphilis symptoms to be
physical rather than neurological.
 Tuskegee Investigators hypothesized that symptoms among
African-Americans would be predominantly neurological.
This is an example of:
A = Expanding a hypothesis to a new study
B = A change in theory
C = Scientific racism
D = Tailoring a hypothesis to a specific culture
Psychology 242, Dr. McKirnan
17
Foundations of
Research
Click
The Belmont Report mandates that in field or clinical research
members of the study population be included in the investigative
team.
This is to ensure that the procedures are sensitive to participants’
concerns.
What happened with this in the Tuskegee study?
A = The study did not employ African-American personnel, so
the study was insensitive to that group.
B = There were African-American personnel, but they had no
real role in the research.
C = The study employed two key African-American personnel;
an investigator and the outreach worker, and that
prevented the worse of the ethical problems.
D = The study employed two key African-American personnel,
but they actually facilitated the unethical study.
Dr. David J McKirnan, McKirnanUIC@gmail.com
18
Foundations of
Research
Click
Which of these was not an unethical feature of the study:
A = Syphilis was not that important a health threat
to the population under study.
B = A lack of informed consent
C = Coercive enrollment and retention practices
D = Refusal of effective treatment
Psychology 242, Dr. McKirnan
19
Foundations of
Research
Click
Which of these was not an unethical feature of the study:
A = Participants were not given their diagnosis.
B = There was no institutional ethical review.
C = The study did not contribute to the population
being studied.
D = Members of the target population were not
included in the research team.
Psychology 242, Dr. McKirnan
20
Foundations of
REsearch

SUMMARY

Begun – and should have remained – a natural history of
participants’ response to treatment.
Had the virtue of being conducted by a local institution –
Tuskegee Institute – with African-American Investigators & staff.
Became a wholly unethical no-treatment history.


21
Tuskegee study begin as a potentially valuable trial
of treatment outcomes


Tuskegee Study: Overview
Based on spurious – and racist – scientific reasoning about
differences between Africans and Caucasians

Investigators took advantage of participants economic and
social vulnerability to exploit and harm them.

Note: Tuskegee participants were not actually given syphilis;
they were not given treatment.
Tuskegee led to many of our research norms and
institutional controls.
Foundations of
Research
Research questions, hypotheses & designs


 The Common
 The Tuskegee Study
Rule: Core
criteria for ethical
research
 The Belmont Report
and the Informed
Consent document
Still from the Milgram Study on obedience
Dr. David J McKirnan, McKirnanUIC@gmail.com
22
Foundations of
Research
The “Common Rule” criteria for Human Subjects Protection
The Common Rule

Minimize risks

Risks must be reasonable

Recruit participants equitably

Informed consent

Document consent

Monitor for safety

Protect vulnerable participants &
maintain confidentiality
Dr. David J McKirnan
23
Foundations of
Research
24
Minimization of risks
The Common Rule
Core issue:
 Risks should not exceed those of
everyday behavior.

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

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
 Is the informed consent valid?
 Possible embarrassment or negative self-perception
 Erode trust & confidence in social science
Dr. David J McKirnan
Foundations of
Research

Physical harm
Direct:
25
Potential harms, cont.




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 for safety

Protect vulnerable
participants & maintain
confidentiality
Indirect:  Behavior induced by the experiment:
 Experimental conditions that encourage
risk, alcohol & drug use, smoking…

Psychological harm

Discomfort or pain
Experiments that induce anxiety or other
negative moods
 Changed self-perception
The Zimbardo or Milgram studies led
participants to believe they were capable of
harming others
 Embarrassment
Loss of confidentiality or privacy
Dr. David J McKirnan
Foundations of
Research

26
Potential harms, cont.
Social or political harm
 Portraying social groups in a negative light, e.g.:
 IQ among lower socio-economic status or minority
participants
 “Pathologizing” GLBT or other populations
 Ignoring or discounting some groups: e.g., women or
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
minorities in clinical research…
Factors that make researchers vulnerable to research harm:

Financial pressure for study results

Publication & grant pressure

Simple bias or prejudice

Lack of institutional controls

Active Institutional Review Board

Study monitors
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research
27
Harm to Participants, cont.
Prevention of research harms:
 Independent & rigorous Institutional Review
Board [IRB]
 Diversity among investigators, research centers
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Data monitoring for safety

Protect vulnerable
participants & maintain
confidentiality
 Study monitoring
 Careful pilot testing & monitoring of study manipulations
 Informed consent and debriefing to:
a) fully inform participants about the study
b) eliminate any imposed state
Foundations of
Research
Core issue:

Whether a risk to participants is reasonable
rests on a Cost – benefit analysis

Does the study present risks greater than
every-day life?


28
Reasonableness of risks
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 they justified by the likely knowledge to
be gained?
 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
Dr. David J McKirnan
Foundations of
Research
29
Reasonableness of risks
 Research that presents little harm
may 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
The Zimbardo Prison Study
subjected college students
to real stress…
…but provided invaluable
data about how social roles
and the physical setting
affects behavior.
guaranteed.
 Often research that has great scientific or applied benefit has no
direct benefit for the study participants.
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research
Causes of unreasonable research risk:



30
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].
 An advisory board of people from the
target population (CAB or Community Advisory
Board).
 Pilot testing to assess the actual risks of
the research.
Dr. David J McKirnan
Foundations of
Research
Equitable recruitment:

31
Participant Recruitment
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?
Dr. David J McKirnan
Foundations of
Research
Arbitrary bias in sampling


The Common Rule
Participant Recruitment
Potential problems in recruitment:

32
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
33
Informed consent
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent
 Why the participant was recruited.

Document consent

Data monitoring for safety
 Study requirements and duration.

Protect vulnerable
participants & maintain
confidentiality
 Key elements of the Informed Consent document:
 Purpose & procedures of the study.
 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.
Dr. David J McKirnan
Foundations of
Research
34
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.
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research

Two key elements of Research Monitoring:

Monitoring of clinical trials

Studies of a new drug or treatment

Behavioral intervention studies


35
Data and clinical trial monitoring
The Common Rule

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
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research
36
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.
Dr. David J McKirnan, McKirnanUIC@gmail.com
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.



37
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.
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.
Dr. David J McKirnan, McKirnanUIC@gmail.com
Click for a PBS Frontline
documentary on Fen-Phen
Foundations of
Research
38
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.
Dr. David J McKirnan, McKirnanUIC@gmail.com
Foundations of
Research


39
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.
1991: NIH begins a study after observational data suggest that
women using hormones have lower rates of heart disease.
The Common Rule

Minimize risks

Reasonable risks

Equitable recruitment

Informed consent

Document consent

Monitor for safety

Protect vulnerable
participants & maintain
confidentiality

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.
Both arms of the study were stopped early:
 The first trial because the DSMB detected adverse effects of E+P therapy
 The second because estrogen showed strong enough positive results that the
“control” women were all put on therapy.
Foundations of
Research
How do we separate self-interest & political
pressure from science?



40
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
Dr. David J McKirnan
Foundations of
Research
41
Vulnerability to coercion in research
The Common Rule

Minimize risks
What is coercion in research?

Reasonable risks

Equitable recruitment
Enrollment:

Informed consent

Document consent

Monitor for safety
 Joining a study that a reasonable person would see as
harmful or exploitive
Continued participation:

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.
Dr. David J McKirnan
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 via Dual Role


42
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.
Dr. David J McKirnan
Foundations of
Research
Case study of unethical use of scientifically based techniques.
The American Psychological Assn. endorsed Psychologists serving
as interrogators at Guantánamo Bay until September 15, 2008.

American Psychiatric & Medical Associations
refused to endorse interrogations

Interrogations linked to torture & unlawful detention

As “helping professions” they are prohibited from this

As a research organization APA declared itself
exempt from ethical standards of “helpers”

If research-based techniques are used, does APA
as a research organization have an ethical
responsibility?

After years of boycotts and protests, APA finally altered its stance
and accepted the “do no harm” ethical stance of helping
professions.
Dr. David J McKirnan
43
Foundations of
Research
Bonus section: Ethics and the research “industry”
There is substantial pressure – and
temptation – for data faking
 Career advancement – and funding – requires
finding positive results
 Experiments must “work” to be published
 Drug licensing, marketing diagnostic devices or behavioral interventions
all require positive findings.
 The varieties of research fraud
 Simple faking of data; Deitrik Stapel successfully faked 20 years of data
(click image & below for the story)
 He was aided by trust and lack of strong oversight in the research industry.
 “Cherry Picking” results; publishing only those that “work”.
 Drug companies would selectively submit only successful trials to the FDA
 FDA now requires submission and access to all drug trials
 Selective choice of variables:
 Large data sets contain multiple variables,
 Investigators can “cheat” by analyzing those that show positive results.
Dr. David J McKirnan
44
Foundations of
Research
Click
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
Psychology 242, Dr. McKirnan
45
Foundations of
Research
Click
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
Psychology 242, Dr. McKirnan
46
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.
Psychology 242, Dr. McKirnan
47
Foundations of
Research
Click
Are experiments using deception ethical?
A = Yes, as long as the investigator things 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.
Psychology 242, Dr. McKirnan
48
Foundations of
REsearch
SUMMARY


Tuskegee Study: 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.
49
Foundations of
Research
Research questions, hypotheses & designs
 The Tuskegee Study
 The Common Rule:
Core criteria for ethical
research
 The Belmont Report

and the Informed
Consent document
Dr. David J McKirnan
50
Foundations of
Research
Belmont Report
(CITI training)
51
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
Dr. David J McKirnan
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?
Dr. David J McKirnan
52
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
Dr. David J McKirnan
53