who me unethical or history ethical principles of human subjects research presented by joan e. sieber professor of

1. Who Me? Unethical? orHistory & Ethical Principles of Human Subjects Research 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? 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?

2. 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?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?

3. This is a tall order!How are we going to do this? 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. 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.

4. You will gain important insights by 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. 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. As an example of human 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. 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?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?

7. Some will make an absolute moral judgment. Others will consider various ethical perspectives or theories. Perhaps no two people will have exactly the same answer after considering the matter. Does our morality tell us something different from what ethics would tell us?Does our morality tell us something different from what ethics would tell us?

8. Defining 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. 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. 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.

9. Morality is our personal, subjective sense of right & 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 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. 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.

10. Ethical theories somewhatdiscourage such sliding around. They force us to moresystematically define the assumptions that underlie our decisions about of what is the right action to take in a given situation. 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. 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.

11. Why Study History? 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? 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?

12. Some 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. 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.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.

13. Beliefs 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. 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.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.

14. The 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,... 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.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.

15. Could Research on Humans 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. 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..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..

16. With the Exception 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. 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.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.

17. 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.�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.�

18. The Nuremberg Code (1947) voluntary consent benefits outweigh the risks ability of the subject to terminate participation. 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. 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.

19. Did the Nuremberg Code Impact the behavior of American scientists who did research on humans? No Did the Nuremberg Code impact the behavior of American scientists who did research on humans? In a word. NODid the Nuremberg Code impact the behavior of American scientists who did research on humans? In a word. NO

20. 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). 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).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).

21. 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. 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.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.

22. But, 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. 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. 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. Beecher 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. 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.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.

24. Tuskegee 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. 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.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. Tuskegee 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.) 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.)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.)

26. National 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. 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.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.

27. Belmont 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 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.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.

28. Using these Principles will Help 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. 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. 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.

29. But first, let�s discover what all is meant by Respect Beneficence & Justice

30. Please refer to your handout entitled �The Meanings of Respect, Beneficence & Justice�

31. Respecting autonomy, protecting 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? 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?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?

32. Beneficence - maximizing benefit, minimizing 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. Kinds of Benefit to Subjects Relationships Knowledge/education/experience Material resources Training opportunity Opportunity to earn esteem of others Empowerment Effective treatment

34. Who Else Might Benefit? The subject�s institution The subject�s family The community The researcher & her institution The funder Science Society

35. Kinds of Risk Just plain inconvenience & hassle Emotional or psychological risk Social risk Physical risk Economic risk Legal risk

36. Risk to Whom? The subject The subject�s institution The family The community The researcher & his institution Science Society

37. Evaluation 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. Justice 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. Let�s Try Out these Principleson 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 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?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?

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.� 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�?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�?

41. Special Problems in Juvenile 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. 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?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?

42. Some More Exploration of 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.� 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.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.

43. IRBs� 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. 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.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.

44. 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? 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. 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.

45. You�ve Come Full Circle Thank you! Thank you!