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Who Me? Unethical?Who Me? Unethical?
oror
History & Ethical PrinciplesHistory & Ethical Principles
of Human Subjects Resea...
Course ObjectivesCourse Objectives
Understand the role of morals and ethics
in human attitudes and behavior.
Understand th...
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 recurr...
We will ...We will ...
Consider some dynamics of human
attitudes about morals and ethics.
Define ethics & morals in relati...
As an example of humanAs an example of human
attitudes: Is deception wrong?attitudes: Is deception wrong?
If its harmless?...
Some will make an absoluteSome will make an absolute
moral judgment. Others willmoral judgment. Others will
consider vario...
Defining our TermsDefining our Terms
Morality - our belief about right and wrong (usually subjective and
unexamined).
Ethi...
Morality is our personal,Morality is our personal,
subjective sense of right &subjective sense of right &
wrong. Its sourc...
Ethical theories somewhatEthical theories somewhat
discourage such sliding around.discourage such sliding around.
They for...
Why Study History?Why Study History?
History Places Ethics & Morals inHistory Places Ethics & Morals in
Perspective.Perspe...
Some Historical BackgroundSome Historical Background
In 1300, Pope Boniface VIII issued his
famous bull against cutting up...
Beliefs and Morals EvolveBeliefs and Morals Evolve
The prohibition against dissection
became a firmly held moral position....
The EnlightenmentThe Enlightenment
1628 - William Harvey’s theory
that the blood circulates through
the body pumped by the...
Could Research on HumansCould Research on Humans
Do Any Wrong?Do Any Wrong?
Research on humans
seemed to hold the keys
to ...
With theWith the ExceptionException of...of...
Nazi war crimes against unconsenting
human subjects by scientists.
Some of ...
During the NurembergDuring the Nuremberg
War Crimes Trials,War Crimes Trials,
23 German doctors were charged with23 German...
The Nuremberg Code (1947)The Nuremberg Code (1947)
As part of the verdict, the CourtAs part of the verdict, the Court
enum...
Did the Nuremberg Code Impact theDid the Nuremberg Code Impact the
behavior of American scientists whobehavior of American...
The 18th World MedicalThe 18th World Medical
Assembly (1964), in theAssembly (1964), in the
Declaration of HelsinkiDeclara...
Declaration of HelsinkiDeclaration of Helsinki
Differentiated Therapeutic Research
from Non-Therapeutic Research
Therapeut...
But, in AmericaBut, in America
Willowbrook (1950s)
Mentally retarded children were deliberately injected
with hepatitis vi...
Beecher ArticleBeecher Article
“Ethics and Clinical Research”
Henry K. Beecher, New Engl J Med 274 (1966): 1354:66
22 publ...
Tuskegee Syphilis StudyTuskegee Syphilis Study
American medical research project
conducted by the U.S. Public Health
Servi...
Tuskegee Study in ContextTuskegee Study in Context
1932: 300 black syphilitic males recruited
1933: 300 controls added
194...
National ActionNational Action
1973 - Kennedy Hearings. Tuskegee, etc., and
then a search for ethical issues in social/beh...
Belmont ReportBelmont Report
Basic Ethical Principles
Respect for Persons
– Respect for autonomy
– Protection of persons w...
Using these Principles willUsing these Principles will
Help us Apply the RegulationsHelp us Apply the Regulations
They giv...
But first, let’s discoverBut first, let’s discover
what all is meant bywhat all is meant by
Respect
Beneficence
& Justice
Please refer to your handoutPlease refer to your handout
entitledentitled
“The Meanings of“The Meanings of
Respect, Benefi...
Respecting autonomy,Respecting autonomy,
protecting the non-autonomousprotecting the non-autonomous
How can the consent pr...
Beneficence - maximizing benefit,Beneficence - maximizing benefit,
minimizing harm or wrongminimizing harm or wrong
Is the...
Kinds of Benefit to SubjectsKinds of Benefit to Subjects
Relationships
Knowledge/education/experience
Material resources
T...
Who Else Might Benefit?Who Else Might Benefit?
The subject’s institution
The subject’s family
The community
The researcher...
Kinds of RiskKinds of Risk
Just plain inconvenience & hassle
Emotional or psychological risk
Social risk
Physical risk
Eco...
Risk to Whom?Risk to Whom?
The subject
The subject’s institution
The family
The community
The researcher & his institution...
Evaluation of Risks/BenefitsEvaluation of Risks/Benefits
Estimate the kinds of risks &
benefits likely to occur.
Estimate ...
Justice IssuesJustice Issues
How can you ensure that recruitment
targets the population that will benefit
from the researc...
Let’s Try Out these PrinciplesLet’s Try Out these Principles
on Real Caseson Real Cases
Review the 2 page summary of
meani...
Please examine “Feeling Good &
Helping” with respect to respect,
beneficence & justice? Compare your
findings to those on ...
Special Problems inSpecial Problems in
Juvenile HallJuvenile Hall
Youths (ages 12 - 17) entering Juvenile Hall for
minor c...
Some More Exploration ofSome More Exploration of
Use of Principles (Belmont)Use of Principles (Belmont)
A Ph.D. Candidate ...
IRBs’ Role & Scientists’ RoleIRBs’ Role & Scientists’ Role
Identify bad science; it is always unethical.
Recognize good sc...
So… Who me? Unethical?So… Who me? Unethical?
No, just a case of normal:
– Failure to learn approaches to ethical/
methodol...
You’ve Come Full CircleYou’ve Come Full Circle
You’ve looked at ethics & moralsYou’ve looked at ethics & morals
in histori...
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ETHICS AT WORK

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ETHICS AT WORK

  1. 1. Who Me? Unethical?Who Me? Unethical? oror 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
  2. 2. 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 principles”). Understand how to use ethical principles to interpret the Federal Regulations.
  3. 3. This is a tall order!This is a tall order! How are we going to do this?How are we going to do this?
  4. 4. 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 form. The “Who Me? Unethical” syndrome. Ethics is often thought to be about bad things others do, not about one’s own judgment. 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.
  5. 5. We will ...We will ... Consider some dynamics of human attitudes about morals and ethics. Define ethics & morals in relation to human research. Review the historical background of ethics and morals in human research. Introduce the “Belmont ethical principles.” Do some ethical problem solving using the Belmont principles. Let’s begin with a look at human attitudes...
  6. 6. 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 or conceal? If the study is very important and well designed? If deception is the only way important knowledge can be gained? There is probably not much agreement on answers to these questions. Different people come from different prior experiences and values.
  7. 7. 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 morality?morality?
  8. 8. Defining our TermsDefining our Terms Morality - our belief about right and wrong (usually subjective and unexamined). 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.
  9. 9. Morality is our personal,Morality is our personal, subjective sense of right &subjective sense of right & wrong. Its sources include:wrong. Its sources include: Up-Bringing Religion Peer Pressures Experience Local Rules The Media Self Interest Values Laws Loyalty Public Opinion Sense of Responsibility Attitudes, for example, Toward Science
  10. 10. 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.
  11. 11. Why Study History?Why Study History? History Places Ethics & Morals inHistory Places Ethics & Morals in Perspective.Perspective. 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...
  12. 12. 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 human dissection.
  13. 13. 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 of science. … except that anatomists performed clandestine autopsies all along in universities.
  14. 14. 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,...
  15. 15. 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.
  16. 16. 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.
  17. 17. 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.”
  18. 18. 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: voluntary consent benefits outweigh the risks ability of the subject to terminate participation.
  19. 19. 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? No
  20. 20. 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).
  21. 21. 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 beneficial results. Non-therapeutic research is conducted to generate knowledge for a discipline, and might have positive results in future patients.
  22. 22. But, in AmericaBut, in America 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.
  23. 23. 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 approval. Published in some of the most prestigious journals and conducted at some of the most prestigious institutions.
  24. 24. 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.
  25. 25. 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.)
  26. 26. National ActionNational Action 1973 - Kennedy Hearings. Tuskegee, etc., and then a 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.
  27. 27. Belmont ReportBelmont Report Basic Ethical Principles Respect for Persons – Respect for autonomy – Protection of persons with reduced autonomy Beneficence – Maximize benefits and minimize harms or risks Justice – Equitable distribution of research costs and benefits
  28. 28. Using these Principles willUsing these Principles will Help us Apply the RegulationsHelp us Apply the Regulations They give us other dimensions to consider. They enable us to include needed subtlety in our ethical decision making, as appropriate. If we make a controversial decision, documentation in the IRB minutes will show that the decision was reasonable.
  29. 29. But first, let’s discoverBut first, let’s discover what all is meant bywhat all is meant by Respect Beneficence & Justice
  30. 30. Please refer to your handoutPlease refer to your handout entitledentitled “The Meanings of“The Meanings of Respect, BeneficenceRespect, Beneficence & Justice”& Justice”
  31. 31. 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 vulnerable subjects? How can the study maximally protect subject privacy?
  32. 32. 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?
  33. 33. Kinds of Benefit to SubjectsKinds of Benefit to Subjects Relationships Knowledge/education/experience Material resources Training opportunity Opportunity to earn esteem of others Empowerment Effective treatment
  34. 34. Who Else Might Benefit?Who Else Might Benefit? The subject’s institution The subject’s family The community The researcher & her institution The funder Science Society
  35. 35. Kinds of RiskKinds of Risk Just plain inconvenience & hassle Emotional or psychological risk Social risk Physical risk Economic risk Legal risk
  36. 36. Risk to Whom?Risk to Whom? The subject The subject’s institution The family The community The researcher & his institution Science Society
  37. 37. 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 society.
  38. 38. 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?
  39. 39. 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 & Justice Take out cases: – Read “Obedience” – Evaluate it in relation to the meanings of respect, beneficence & justice
  40. 40. 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 on “Obedience.”
  41. 41. 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.
  42. 42. 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.”
  43. 43. 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 improve research. Recognize the value of multiple perspectives in ethical problem solving.
  44. 44. 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?
  45. 45. 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!

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