Course Objectives

Who Me? Unethical?orHistory & Ethical Principles of Human Subjects ResearchPresented by Joan E. SieberProfessor of PsychologyCalifornia State University, HaywardHayward, CA

Course 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.

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

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.

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...

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.

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.What is ethical theory? What is morality?

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.

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 Morality is our personal, subjective sense of right & wrong. Its sources include:

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.

Why Study History?History Places Ethics & Morals in Perspective.History helps us understand the problems people were trying to solve. Let’s see how...

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.

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.

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,...

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.

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.

During 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 (1947) As part of the verdict, the Courtenumerated some rules for PermissibleMedical Experiments, now known as theNuremberg Code. These rules include: • 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? 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.

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.

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.

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.

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.)

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.

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

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.

But first, let’s discover what all is meant by Respect Beneficence & Justice

Please refer to your handout entitled “The Meanings of Respect, Beneficence & Justice”

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?

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?

Kinds of Benefit to Subjects • Relationships • Knowledge/education/experience • Material resources • Training opportunity • Opportunity to earn esteem of others • Empowerment • Effective treatment

Who Else Might Benefit? • The subject’s institution • The subject’s family • The community • The researcher & her institution • The funder • Science • Society

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

Risk to Whom? • The subject • The subject’s institution • The family • The community • The researcher & his institution • Science • Society

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.

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?

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

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.”

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.

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.”

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.

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 looked at ethics & morals in historical perspective, and used that perspective in ethical problem solving.Good Work! Thank you!

Course Objectives