There are several reasons why I’ve entitled this presentation: “Who me? Unethical?” My basic purpose is to provide insight into differences in moral and ethical perspectives I hope you will be pondering the 6 questions you have in hand, as we discuss the history and principles of ethics of human research: 1. Is “unethical” as commonly used, the opposite of “ethical.” What do we mean by these words? 2. Are “morality” and “ethics” necessarily synonymous? 3. Do society’s views on ethics and morals change over history. If so, why? Are they changing now? 4. Is it necessarily ethical to treat the regulations as simple rules to be followed unquestioningly? 5. Are the regulations intended to be followed unquestioningly or should ethical theory and ethical principles enlighten our interpretation of the regulations? 6. Why do moral, upstanding people have difficulty perceiving ethical issues in their own research?
1. You perhaps know the basic regulations, but do you know how ethical principles are supposed to be used to interpret those regulations? 2. The historical context of the ethics of human research helps explain why they are as they are and how they evolve. 3. We will actually get to apply ethical principles to real cases and see how to use them to interpret the regs. 4. I hope this more flexible and powerful approach to research ethics will help you to constructively discuss issues ethics and regulations with those whose perspective is different from yours. E.g., a distraught mother whose daughter came home with a parental permission form for innocuous survey research at school… research victim. What is her perspective? How to respond?
First, we will see that a few simple rules don’t produce good ethical decision making about human research. True, we start with simple rules, but those rules often conflict with one another and more complex judgment is needed. We also will see that human attitudes, morals and ethics about research and science evolve over time. We turn to the history of ethics and human research to see where our current thinking and our current regs come from. Out of that we will see what ethical principles we now use to interpret the federal regs intelligently and flexibly.
1. Is Candid Camera harmless? Or have attitudes in our society changed about that? What attitudes has changed? 2. Is debriefing always appropriate? When studying effects of authoritarianism and low SEC on child rearing, should you say we were studying how poorly educated and authoritarian parents discipline their children? 3. Most potential subjects know about deception and concealment. So could you get consent to waive informing with the understanding that there would be full informing afterward? 4. Would you permit a competent and famous scientist to do research you wouldn’t allow a student to do? 5. Could one study an important topic such as conformity without deception?
Does our morality tell us something different from what ethics would tell us?
The dictionary gives many definitions, reflecting the many usages of the words “morality” and “ethics.” Here, I’ll stick to the definitions that differentiate the two since we will find that differentiation useful as IRB members and researchers.. Morality is our seemingly instinctive sense of right and wrong. But as we will see, morality is hardly instinctive but is a product of our learning or socialization. Immoral is usually used to mean deliberately doing something obviously wrong. Ethics is the reflective study of good, and of how one makes right choices. It is a learned process that even immoral people can use to their own evil ends, but that can help moral people in their pursuit of good. Unethical is often used to mean immoral.
We get our sense of morality from many sources. Its no wonder people’s sense of morality changes as they develop, and often becomes highly inconsistent so that what we consider right in one circumstance becomes wrong in another. E.g., my upbringing and religion made me certain I would not want to deceive people, tho I thought Candid Camera was a wonderful show (not real deception). By the time I got to graduate school in psychology in 1961, I was sure deception was essential to most research in social psychology. But that was science, and hence it was good deception.
I have spent the last 20 years, off and on, examining kinds of deception and the wrongs they may incur. My efforts have been guided by ethical theory. Consequently, my views on deception in research are now much more refined and clear, and much easier to communicate, than before. However, you may still disagree with them. That’s what makes all this so interesting. I now regard the term “deception” as a bit of a red herring when discussing ethics. Some of the things that fall under that rubric are highly unacceptable. Other activities that fall under that rubric are not at all objectionable or unacceptable.
Believe it or not, all of this preamble about ethics and morals is leading up to a brief discussion of history. Remember “Who me? Unethical?” And our five questions: 1. Is “unethical” as commonly used, the opposite of “ethical.” What do we mean by these words? 2. Are “morality” and “ethics” necessarily synonymous? 3. Do society’s views on ethics and morals change over history. If so, why? Are they changing now? 4. Is it necessarily ethical to treat the regulations as simple rules to be followed unquestioningly? 5. Are the regulations intended to be followed unquestioningly or can ethical theory and ethical principles enlighten our interpretation of the regulations?
During the Crusades, the knights of old felt a duty to god to return their fallen comrades to halloed soil -- not to bury them in heathen soil. But carrying dead bodies back home in those days was a difficult and smelly operation, for both man and horse. Being resourceful, the knights would cut up the bodies, strip off the flesh, boil the bones, then carry the bones back home for burial, presuming, I suppose, that the soul resides in one’s bones. Pope Boniface VIII disapproved of this gruesome procedure and forbade dissection of human bodies. This papal proclamation was then interpreted to apply to anatomists and others who had a scientific interest in the functioning of the human body.
Attitudes evolved during the middle ages to hold that the body was the repository of the soul and was not to be dissected. Presumably this would somehow impact someone’s ticket to heaven and eternal bliss. However, medical historians tell us that many famous academicians in Europe clandestinely provided anatomy lessons for their students by dissecting human cadavers.
The enlightenment brought with it new, scientific ideas about what was good and what was bad. Science and rational analysis of known facts, rather than religious dogma or faith, began to dominate philosophers’ thinking about the nature of good and of right action. With this came public attitudes that were very favorable to human research and to its potential for human happiness and progress.
In fact, human research came to be the new religion for many scientists. Certain conclusions were taken on blind faith: Research on living humans holds the keys to a better future. Research and knowledge are unequivocally good. Values and ethics pertain to philosophy and religion, not to science. Research is objective and value free..
With the exception of: Nazi war crimes against un-consenting human subjects by scientists. Some of the research questions were scientifically interesting, but the findings could never justify the cruelty and murder of human subjects.
At the Nuremberg War Crimes Trials,23 German doctors were charged with crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed the murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.”
The Nuremberg Code, outlining some rules for permissible medical experiments on humans: voluntary consent benefits outweigh the risks ability of the subject to terminate participation.
Did the Nuremberg Code impact the behavior of American scientists who did research on humans? In a word. NO
The 18th World Medical Assembly (1964), in the Declaration of Helsinki. Set forth additional recommendations to guide medical doctors in biomedical research involving human subjects. Were slightly revised in 1978 (Tokyo), 1983 (Venice), and 1989 (Hong Kong).
Declaration of Helsinki Differentiated Therapeutic Research from Non-Therapeutic Research Therapeutic research gives patients the opportunity to receive an experimental treatment that might have beneficial results. Non-therapeutic research is conducted to generate knowledge for a discipline, and might have positive results in future patients.
Willowbrook (1950s) Mentally retarded children were deliberately injected with hepatitis virus to study its effects. Jewish Chronic Disease Hospital (1960s) Live cancer cells were injected into 22 senile patients. With no benefit to patients, and no consent of kin.
Finally enlightened American researchers, politicians and the media began to understand that “Who Me? Unethical?” applied to us Ethics and Clinical Research” Henry K. Beecher, New Engl J Med 274 (1966): 1354:66 22 published medical studies presenting risk to subjects without their knowledge or approval. Published in some of the most prestigious journals and conducted at some of the most prestigious institutions.
American medical research project conducted by the U.S. Public health Service from 1932 to 1972 examined the natural course of untreated syphilis in black men. The subjects, impoverished sharecroppers from Macon county, Alabama, were unknowing participants in the study; they were not told that they had syphilis, nor were they offered effective treatment after a cure was found.
Historical Context of the Tuskegee study: 1932: 300 black syphilitic males recruited 1933: 300 controls added 1943: Penicillin for military 1949 Nuremberg Code 1951 Penicillin widely available 1966 Local ethics committee review Study widely reported in medical journals 1966: Peter Buxton (SF PHS) & & NYT publicity. 1972 PHS Tuskeege Panel (Broadus Butler & Jay Katz had major role in calling for regulation.)
We had long been aware that scientists elsewhere did unethical research. Finally, the other shoe dropped … in America 1973 - Kennedy Hearings. Tuskeegee, etc., & the search for ethical issues in social/behavioral research: Stanley Milgram’s Obedience Study Laud Humphreys’ Study of “tearoom trade” 1974 - National Research Act established the National Commission for Protection of Human Subjects of Biomedical & Behavioral Research: Required IRBs at institutions receiving HEW support for human subjects research.
Respect - protecting the autonomy of (autonomous) persons, with courtesy and respect for all individuals, and protection for those who are not autonomous. Beneficence - maximizing good outcomes for science, humanity, and the individual research participants while avoiding or minimizing unnecessary risk, harm, or wrong. Justice - ensuring reasonable, non-exploitative and carefully considered procedures and their fair administration: fair distribution f costs and benefits among persons and groups (I.e., those who bear the risks should be those who will benefit from the research.
Using these principles helps us to apply the regulations in various ways. They give us other dimensions to consider. They enable us to include needed subtlety into our ethical decision making, as appropriate. If we make a controversial decision, documentation in the IRB minutes will show that the decision was reasonable.
How do cultural differences in influence the way the consent process should be conducted? Does autonomy have different meanings in different cultures? What should the researcher do to learn how to make the research procedures culturally appropriate? What are some creative ways in which the informed consent process can be carried out?
Let’s grade Milgram on respect for autonomy: 1. Can you find ways in which Milgram respects the autonomy of his subjects? 2. Is privacy protected? Is confidentiality assured? 3. Is the study a waste of subjects’ time or is it worthwhile? Now let’s grade Milgram on Beneficence: 1. Can you find ways in which the research is beneficent? In what ways does it benefit sibkects? Soceity? 2. How are risks minimized? 3. How are benefits maximized? Let’s grade Milgram on justice: 1. Could the procedure be made more fair? 2. Is the population that is studied representative of the population that will benefit?
Who will be willing to report their findings with respect to “Feeling Good & Helping”? Who will be willing to report their findings with respect to “A Proposition”?
1. Rate this study in relation to respect, beneficence, and justice 2. Can you think of ways to improve it on any of the relevant dimensions?
Does this researcher have the needed competencies or special qualities? Is the research worth doing? What are the risks? Benefits? This was a highly competent, specialized researcher who could contribute to the world’s knowledge. But the IRB argued that reporting names in a book that might become famous is different from having neighbors who know who committed what atrocity. Might become the basis of war crimes trials or a negative decision by IMS for persons wanting to immigrate. The important point of the research was to illustrate the principle of how ethnic hatreds can be whipped up by opportunistic politicians. Disguising identities would not reduce the value of the research, and revealing identities could do great harm.
What have we been doing, using the Belmont principles? I think we have been fulfilling the role of IRBs and scientists’ role in ethical and scientific decision making.
But no one is immune to failing to plan or to defensiveness about our prior decisions. Are we unethical? Let’s return to some of our initial questions.
ETHICS AT WORK
Who Me? Unethical?Who Me? Unethical?
History & Ethical PrinciplesHistory & Ethical Principles
of Human Subjects Researchof Human Subjects Research
Presented by Joan E. SieberPresented by Joan E. Sieber
Professor of PsychologyProfessor of Psychology
California State University, HaywardCalifornia State University, Hayward
Hayward, CAHayward, CA
Course ObjectivesCourse Objectives
Understand the role of morals and ethics
in human attitudes and behavior.
Understand the historical context in which
the ethical principles of research evolved.
Know the ethical principles governing
human research (the “Belmont
Understand how to use ethical principles
to interpret the Federal Regulations.
This is a tall order!This is a tall order!
How are we going to do this?How are we going to do this?
You will gain important insights byYou will gain important insights by
noticing four recurring themes:noticing four recurring themes:
Ethics as morality or etiquette. Many fail to understand
that ethics is a problem solving strategy. They treat ethics
as an intuitive knowing of what is right, or as something
“nice” that is added after research design, e.g., a consent
The “Who Me? Unethical” syndrome. Ethics is often
thought to be about bad things others do, not about one’s
Misapplication of good ideas. Principles that evolved in
one context may be applied to new contexts where they do
not make much sense.
The Ethical Underground. There is always a countervailing
group that ignores nonsensical “ethical” pronouncements.
We will ...We will ...
Consider some dynamics of human
attitudes about morals and ethics.
Define ethics & morals in relation to human
Review the historical background of ethics
and morals in human research.
Introduce the “Belmont ethical principles.”
Do some ethical problem solving using the
Let’s begin with a look at human attitudes...
As an example of humanAs an example of human
attitudes: Is deception wrong?attitudes: Is deception wrong?
If its harmless? Like candid camera?
If subjects are debriefed?
If the researcher obtains subjects’ consent to deceive
If the study is very important and well designed?
If deception is the only way important knowledge can
There is probably not much agreement on answers to
these questions. Different people come from
different prior experiences and values.
Some will make an absoluteSome will make an absolute
moral judgment. Others willmoral judgment. Others will
consider various ethicalconsider various ethical
perspectives or theories.perspectives or theories.
Perhaps no two people will havePerhaps no two people will have
exactly the same answer afterexactly the same answer after
considering the matter.considering the matter.
What is ethical theory? What isWhat is ethical theory? What is
Defining our TermsDefining our Terms
Morality - our belief about right and wrong (usually subjective and
Ethics - (a) the study of principles for choosing right action when
doing right may also involve doing harm or wrong; (b) the use of
ethical theory to choose the best course of action; (c ) the study of
what is good and bad in human character and conduct. (Note: these
are disciplined, rational and reasoned thought processes).
Normative ethical theory - the theories that set forth different sets
of principles for choosing right action (e.g., act utilitarianism, rule
utilitarianism, deontology, contractarianism).
NB. Some define ethics as synonymous with morality.
Morality is our personal,Morality is our personal,
subjective sense of right &subjective sense of right &
wrong. Its sources include:wrong. Its sources include:
Sense of Responsibility
Attitudes, for example,
Ethical theories somewhatEthical theories somewhat
discourage such sliding around.discourage such sliding around.
They force us to moreThey force us to more
systematically definesystematically define
the assumptionsthe assumptions
that underlie our decisionsthat underlie our decisions
about of what is the right actionabout of what is the right action
to take in a given situation.to take in a given situation.
Why Study History?Why Study History?
History Places Ethics & Morals inHistory Places Ethics & Morals in
History helps us understand theHistory helps us understand the
problems people were trying to solve.problems people were trying to solve.
Let’s see how...Let’s see how...
Some Historical BackgroundSome Historical Background
In 1300, Pope Boniface VIII issued his
famous bull against cutting up of dead
bodies, to stop crusading knights from
boiling the bones of dead comrades
and shipping the bones home to avoid
burial on heathen ground.
This ban was then interpreted to include all
Beliefs and Morals EvolveBeliefs and Morals Evolve
The prohibition against dissection
became a firmly held moral position.
Until about three centuries ago the
human body and mind were not
considered an appropriate domain
… except that anatomists performed
clandestine autopsies all along in
The EnlightenmentThe Enlightenment
1628 - William Harvey’s theory
that the blood circulates through
the body pumped by the heart.
1796 - Jenner vaccinated with cowpox liquid to
protect others from smallpox.
1860’s Lister develops antiseptic surgery.
1885 Pasteur develops rabies vaccine.
Koch discovered the microbial
basis of anthrax, tuberculosis, typhoid,
gangrene, gonorrhea, diphtheria,...
Could Research on HumansCould Research on Humans
Do Any Wrong?Do Any Wrong?
Research on humans
seemed to hold the keys
to a better future.
Research and knowledge
seemed unequivocally good.
Values and ethics were regarded as the
realm of philosophy and religion.
Research was objective and value free.
With theWith the ExceptionException of...of...
Nazi war crimes against unconsenting
human subjects by scientists.
Some of the research questions were
scientifically interesting, but the findings
could never justify the cruelty and
murder of human subjects.
During the NurembergDuring the Nuremberg
War Crimes Trials,War Crimes Trials,
23 German doctors were charged with23 German doctors were charged with
crimes against humanity for “performingcrimes against humanity for “performing
medical experiments upon concentrationmedical experiments upon concentration
camp inmates and other living humancamp inmates and other living human
subjects, without their consent, in thesubjects, without their consent, in the
course of which experiments thecourse of which experiments the
defendants committed the murders,defendants committed the murders,
brutalities, cruelties, tortures, atrocities, andbrutalities, cruelties, tortures, atrocities, and
other inhuman acts.”other inhuman acts.”
The Nuremberg Code (1947)The Nuremberg Code (1947)
As part of the verdict, the CourtAs part of the verdict, the Court
enumerated some rules for Permissibleenumerated some rules for Permissible
Medical Experiments, now known as theMedical Experiments, now known as the
Nuremberg Code. These rules include:Nuremberg Code. These rules include:
benefits outweigh the risks
ability of the subject to terminate
Did the Nuremberg Code Impact theDid the Nuremberg Code Impact the
behavior of American scientists whobehavior of American scientists who
did research on humans?did research on humans?
The 18th World MedicalThe 18th World Medical
Assembly (1964), in theAssembly (1964), in the
Declaration of HelsinkiDeclaration of Helsinki
Set forth additional recommendations to
guide medical doctors in biomedical
research involving human subjects.
Were slightly revised in 1978 (Tokyo),
1983 (Venice), and 1989 (Hong Kong).
Declaration of HelsinkiDeclaration of Helsinki
Differentiated Therapeutic Research
from Non-Therapeutic Research
Therapeutic research gives patients the opportunity
to receive an experimental treatment that might have
Non-therapeutic research is conducted to generate
knowledge for a discipline, and might have positive
results in future patients.
But, in AmericaBut, in America
Mentally retarded children were deliberately injected
with hepatitis virus to study its effects.
Jewish Chronic Disease Hospital (1960s)
Live cancer cells were injected into 22 senile patients.
… with no benefit to patients,
and no consent of kin.
Beecher ArticleBeecher Article
“Ethics and Clinical Research”
Henry K. Beecher, New Engl J Med 274 (1966): 1354:66
22 published medical studies presenting
risk to subjects without their knowledge or
Published in some of the most prestigious
journals and conducted at some of the
most prestigious institutions.
Tuskegee Syphilis StudyTuskegee Syphilis Study
American medical research project
conducted by the U.S. Public Health
Service from 1932 to 1972 examined the
natural course of untreated syphilis in black
men. The subjects, impoverished
sharecroppers from Macon County,
Alabama, were unknowing participants in
the study; they were not told that they had
syphilis, nor were they offered effective
treatment after a cure was found.
Tuskegee Study in ContextTuskegee Study in Context
1932: 300 black syphilitic males recruited
1933: 300 controls added
1943: Penicillin for military
1949: Nuremberg Code
1951: Penicillin widely available
1966: Local ethics committee review
Study widely reported in medical journals
Peter Buxton (SF PHS) & & NYT publicity.
1972: PHS Tuskegee Panel (Broadus Butler &
Jay Katz had major role in calling for regulation.)
National ActionNational Action
1973 - Kennedy Hearings. Tuskegee, etc., and
then a search for ethical issues in social/behavioral
Stanley Milgram’s Obedience Study
Laud Humphreys’ Study of “tearoom trade”
1974 - National Research Act established the
National Commission for Protection of Human
Subjects of Biomedical & Behavioral Research
Required IRBs at institutions receiving HEW
support for human subjects research.
Belmont ReportBelmont Report
Basic Ethical Principles
Respect for Persons
– Respect for autonomy
– Protection of persons with reduced autonomy
– Maximize benefits and minimize harms or risks
– Equitable distribution of research costs and
Using these Principles willUsing these Principles will
Help us Apply the RegulationsHelp us Apply the Regulations
They give us other dimensions to
They enable us to include needed
subtlety in our ethical decision making,
If we make a controversial decision,
documentation in the IRB minutes will
show that the decision was reasonable.
But first, let’s discoverBut first, let’s discover
what all is meant bywhat all is meant by
Please refer to your handoutPlease refer to your handout
“The Meanings of“The Meanings of
Respect, BeneficenceRespect, Beneficence
& Justice”& Justice”
Respecting autonomy,Respecting autonomy,
protecting the non-autonomousprotecting the non-autonomous
How can the consent process maximize
autonomy and respect?
What else can be done to maximize
autonomy and respect in general?
What protections can be in place for
How can the study maximally protect
Beneficence - maximizing benefit,Beneficence - maximizing benefit,
minimizing harm or wrongminimizing harm or wrong
Is the research kind to subjects?
Is the design acceptable?
How can the risks be minimized?
How can the benefits be maximized
Are there special qualifications you
would want in a PI who conducts a
given study? If so, what qualifications?
Kinds of Benefit to SubjectsKinds of Benefit to Subjects
Opportunity to earn esteem of others
Who Else Might Benefit?Who Else Might Benefit?
The subject’s institution
The subject’s family
The researcher & her institution
Kinds of RiskKinds of Risk
Just plain inconvenience & hassle
Emotional or psychological risk
Risk to Whom?Risk to Whom?
The subject’s institution
The researcher & his institution
Evaluation of Risks/BenefitsEvaluation of Risks/Benefits
Estimate the kinds of risks &
benefits likely to occur.
Estimate their probability.
Estimate their magnitude.
These risks and benefit may be to
subjects, their community, or to
Justice IssuesJustice Issues
How can you ensure that recruitment
targets the population that will benefit
from the research?
How can you ensure that recruitment
will not unfairly target a population?
How can the inclusion/exclusion criteria
be made fair?
Let’s Try Out these PrinciplesLet’s Try Out these Principles
on Real Caseson Real Cases
Review the 2 page summary of
meanings of Respect, Beneficence &
Take out cases:
– Read “Obedience”
– Evaluate it in relation to the meanings of
respect, beneficence & justice
Please examine “Feeling Good &
Helping” with respect to respect,
beneficence & justice? Compare your
findings to those on “Obedience.”
Next, examine “A Proposition” with
respect to respect, beneficence &
justice. Compare your findings to those
Special Problems inSpecial Problems in
Juvenile HallJuvenile Hall
Youths (ages 12 - 17) entering Juvenile Hall for
minor crimes will be interviewed concerning their
diet, to test the hypothesis that high-sugar foods
produce impulsive, ill-considered behavior. The
nature of the crime will be examined in relation to
the nature of the diet in the 12 hours preceding the
crime. Parents are rarely available, or are too
angry to act in their delinquent child’s interest, at
this time. The interview will be conducted after
obtaining the youth’s assent.
Some More Exploration ofSome More Exploration of
Use of Principles (Belmont)Use of Principles (Belmont)
A Ph.D. Candidate in Political Science, and native
of Kosovo, wanted to interview old neighbors who
had committed atrocities against one another to
document sources of the animosity (which he
believed were different from what the news media
was reporting). He wanted to name names as this
is a form of oral history, and argued that
“everybody already knew who did what.”
IRBs’ Role & Scientists’ RoleIRBs’ Role & Scientists’ Role
Identify bad science; it is always unethical.
Recognize good science, and, when
possible, make it better.
Encourage brainstorming about how to
Recognize the value of multiple
perspectives in ethical problem solving.
So… Who me? Unethical?So… Who me? Unethical?
No, just a case of normal:
– Failure to learn approaches to ethical/
methodological problem solving.
– Failure to plan and consult with others qualified
to help with ethical problem solving.
– Defensiveness about one’s own research skills
& unwillingness to learn.
– Putting ethics and preparation of a sound
protocol at the end of the process with about
1/2 hour to do the job. After all, its only paper
work and bureaucracy, isn’t it?
You’ve Come Full CircleYou’ve Come Full Circle
You’ve looked at ethics & moralsYou’ve looked at ethics & morals
in historical perspective, andin historical perspective, and
used that perspective inused that perspective in
ethical problem solving.ethical problem solving.
Good Work! Thank you!Good Work! Thank you!