2IntroductionEvery social scientist needs to consider how to practice their discipline ethically.Whenever we interact with other people as social scientists we must give paramount importance to the rational concerns and emotional needs that will shape their responses to our actions.It is here that ethical research practice begins, with the recognition that our research procedures involve people who deserve as much respect for their well-being as we do for ours.
3Historical Background Formal procedures for the protection of participants in research grew out of some widely publicized abuses.The Nuremberg War Crime Trials and Hitler’s experimentsThe Tuskegee syphilis experiments in the 1930’sMilgram’s obedience experiments – Yale 1960Out of these and other experiments that violated human rights, the U.S. created a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
4EthicsThree basic ethical principles for the protection of human subjects were established:Respect for persons: Treating persons as autonomous agents and protecting those with diminished autonomy.Beneficence: Minimizing possible harms and maximizing benefits.Justice: Distributing benefits and risks of research fairly.
5Ethics, cont.Federal regulations require that every institution that seeks federal funding for biomedical or behavioral research on human subjects have an institutional review board (IRB) that reviews research proposals.IRBs at universities and other agencies apply ethics standards that are set by federal regulations but can be expanded or specified by the IRB itself (Sieber 1992:5, 10).
6Ethics, cont.The American Sociological Association (ASA), and The American Psychological Association (APA) like other professional social science organizations, have adopted, for practicing researchers, ethics guidelines that are more specific than the federal regulations.Professional organizations may also review complaints of unethical practices when asked.Problem: most codes apply to standards of practice, not research
7Ethical PrinciplesAchieving Valid Results. Commitment to achieving valid results is the necessary starting point for ethical research practice.Honesty and Openness. The scientific concern with validity requires that scientists be open in disclosing their methods and honest in presenting their findings.
8Ethical Principles, cont. Protecting Research Participants. The Code’s standards concerning the treatment of human subjects include federal regulations and ethics guidelines emphasized by most professional social science organizations:Research should cause no harm to subjects.Participation in research should be voluntary, and therefore subjects must give their informed consent to participate in the research.Researchers should fully disclose their identity.Anonymity and/or confidentiality must be maintained for individual research participants unless it is voluntarily and explicitly waived.Benefits from a research project should outweigh any foreseeable risks.
9Ethical Principles, cont. Avoid harming research participants. Although this standard may seem straightforward, it can be difficult to interpret in specific cases and harder yet to define in a way agreeable to all social scientists.Does it mean that subjects should not be at all harmed psychologically as well as physically?That they should feel no anxiety or distress whatever during the study or only after their involvement ends?
10Ethical Principles, cont. Obtain informed consent. To be informed, consent must be given by persons who are competent to consent, have consented voluntarily, are fully informed about the research, and have comprehended what they have been told (Reynolds 1979).Avoid deception in research, except in limited circumstances. Deception occurs when subjects are misled about research procedures to determine how they would react to the treatment if they were not research subjects.
11Ethical Principles, cont. Maintain privacy and confidentiality. Procedures to protect each subject’s privacy such as locking records and creating special identifying codes must be created to minimize the risk of access by unauthorized persons.The Benefits outweigh the risks – don’t always know the risks
12The Uses of ResearchScientists must also consider the uses to which their research is put.Although many scientists believe that personal values should be left outside the laboratory, some feel that it is proper—even necessary—for scientists to concern themselves with the way their research is used.
13ConclusionsThe extent to which ethical issues are a problem for researchers and their subjects varies dramatically with the type of research design.Survey research, in particular, creates few ethical problems.Some experimental studies have put people in harms way and for some have resulted in death.
14Conclusions, cont.Ultimately, these decisions about ethical procedures are not just up to you, as a researcher, to make.Your university’s IRB sets the human subjects protection standards for your institution and may even require that you submit your research proposal to them for review.So you need to review the human subjects guidelines of professional association in your field, consult your university’s procedures for the conduct of research with human subjects and then proceed accordingly.
15historical uses of unethical research contributed toward present values and ethics in researchunethical Nazi experiment, the Stanley Milgram's experiment, the Tuskegee Syphilis study, the Willowbrook study, and the Laud Humphrey's "Tearoom Sex" study
16led to the creation of the Belmont Report and the Institutional Review Board (IRB) which were formed to protect human subjects involved in research. (more later)
17The National Research Act was enacted by the 93rd United States Congress. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to oversee and regulate the use of human experimentation in medicine.
18It was partly a response to the infamous Tuskegee syphilis study. The act was signed into law on July 12, 1974.
19The Belmont Report attempts to summarize the basic ethical principles identified by the Commission* in the course of its deliberations. ( )
20The Belmont Report is one of the leading works concerning ethics and health care research. It allows for the protection of participants in clinical trials and research studies .
21Unethical Historical studies research abuse by Nazi doctors during World War IIsixteen German physicians practiced unethical medical experiments on Jews, gypsies, and political prisoners.In 1947, out of this horror, came the Nuremberg Code
22Under this code, the physicians were convicted for crimes against humanity. Stanley Milgram's experimentMilgram was a psychologist from Yale University. He conducted a study on the conflict between obedience toward authority and ones personal conscience.
23those accused at the World War II, Nuremberg War Criminal trials Their defense was based on "obedience" and that they were just following their supervisor's orders.how people reacted toward an authority figure while giving an apparent electrical shock
24so called "teachers" (who were unknown subjects of the experiment) were recruited by Milgram. Asked to administer an electrical shock of increased intensity to a "learner" for each mistake he made during the experiment.
25fictitious story given to these "teachers" was that the experiment was exploring effects of punishment (for incorrect responses) on learning behavior."teacher" was not aware that the "learner" in the study was an actor
26When the "learner" gave an incorrect response, the volt would increase by 15 volts intervals. Some teachers went to the maximum of 450 voltsAt times the "teacher" questioned the experiment but continued
27study raised many questions about how the subjects could bring themselves to administer such high shocksMore important to our interests are the ethical issues it raised about research
281. What right does a researcher have to expose subjects to such stress? 2. What activities should be or not be allowed in marketing research?3. Does the search for knowledge always justify such "costs" to subjects?4. Who should decide such issues?
291932, the Tuskegee Syphilis Study 40-year project administered by the US Public Health Service in Macon County, Alabama.American Government promised 400 men free treatment for ‘bad blood’
30The treatment was never given to the men and was in fact withheld. The sample was made up of poor African American men who were told that they had "bad blood” that had syphilisdid not receive standard treatment for syphilis
31The men in the study were not informed of the research design and it's risks to them. symbolized the medical misconduct and blatant disregard for human rights that takes place in the name of science
32They were not mad scientists; rather they were government physicians, respected men of science The study's unethical features did not come to light until 1972over one hundred of the infected men died and others suffered from serious syphilis related conditions
33a class action civil suit of $1 a class action civil suit of $1.8 billion was filed against those who were involved in the study. The case never came to trial. Each participant only received $37,500 in damages, and the* heirs of the deceased received $15,000.
341963 to 1966, the Willowbrook Study involved a group of children diagnosed with mental retardation, who lived at the Willowbrook State Hospital in Staten Island, New Yorkchildren were deliberately infected with the hepatitis virus
35Investigators defended the injections by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and it would be better for them to be infected under carefully controlled research conditions.
36study's purpose was to study the history of the disease when left untreated and later to assess the effects of gamma globulin as a therapeutic intervention
37study generated a variety of concerns, such as the deliberate infection of the children and the attempts to convince the* parents to enroll them in the study in exchange for admission to the hospital (which was deliberately short of space).
38the mid-1960s, Laud Humphreys – Tea Room Trade a sociologist, he recognized that the public and the law enforcement held stereotypical beliefs about men who committed impersonal sexual acts with one another in public restrooms
39"Tearoom sex", as fellatio in public restrooms is called, accounted for the majority of homosexual arrests in the USFor his PhD dissertation at Washington University, Humphreys decided that is was important for
40society to gain a better understanding of who these men were and what motivated them to seek quick, impersonal sexual gratification.answer this question by means of participant observation and structured interviews
41Humphreys stationed himself in "tearooms" and offered to serve as a "watchqueen“ He observed hundreds of acts and gained the confidence of some of the men he observed
42Humphreys secretly followed some men and recorded the license numbers on their vehicles
43Humphreys showed up at their private homes and claimed to be a health service interviewer. He asked them questions about their marital status, race, job, and other personal questions.
44Humphreys' findings destroyed many stereotypes Humphreys' findings destroyed many stereotypes. He found that 54% of the men were married, and 38% were neither bisexual nor homosexual. Most of the men were successful, well educated, economically stable, and highly praised in the community.
45Only 14% of the men he observed were homosexual and part of the gay community (http://web.missouri.edu).Humphreys' research was administered in the mid 's before the IRB was in existence
46So what became of all this in regards to ethical research? In 1979, the federal government developed regulations of ethical principals underlying the current regulations and standards that are contained in the Belmont Report.
47It was the capstone of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It outlines the ethical principals upon which the ethics of a research study are evaluated in the United States.
48The Belmont Report embodies the moral consensus upon which stand our present US Federal regulations governing the ethics of human subjects research conduct with Federal funds from the majority of Federal agencies.
49Belmont Report's requirements matured into the Institutional Review Board (IRB) system that we have today.This goals is accomplished by having the IRB assure that the following requirements are satisfied:
501. risk to subjects are minimized 2. risk to subjects are reasonable in relation to anticipated benefits,3. selection of subjects is equitable, i.e. fair. informed consent is sought form each subject or his/her legally authorized representative,
514. informed consent is sought form each subject or his/her legally authorized representative, 5. informed consent is appropriately documented,
526. when appropriate, the research plan makes provisions for monitoring data collection,7. privacy and confidentiality of research subjects is appropriately protected, and
538. when some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included.The IRB has to approve that these requirements are followed before they approve a research study and must
54review these documents on, at the least, an annual basis. However, IRB’s are made up of human beings who are not perfect and research has been conducted unethically due to irresponsible IRB’s
55The Nuremburg Code was established in Germany in 1949: “The voluntary consent of the human subject is absolutely essential.” Children were excluded from all research.From , the Nuremburg Code was not considered pertinent to Harvard University researchers.
56Harvard researchers felt that they had a moral sense that differentiated them from previous generations and prevented the need for codes, rules, and regulations. Many research studies were conducted in the United States, including Human Radiation Experiments
57The Fernald School was the site of the 1946–53 joint experiments by Harvard University and MIT that exposed young male children to tracer doses of radioactive isotopes
58at the Fernald School in Waltham, MA at the Fernald School in Waltham, MA. There, seventy-four “mentally retarded” children were fed radioactive calcium and iron in oatmeal to determine the absorption of those nutrients.
59A 1995 class-action suit resulted in a 1998 District court decision awarding the victims a $1.85 million settlement from MIT and Quaker.
60Diminished autonomy debate Of the many conflicting views regarding children as research subjects, the core issues are whether children need to be protected as vulnerable persons or whether they should be viewed as humans who are social beings and ought to contribute to the good of others.
61Research in children prior to 1966 has a history of using convenient populations, including children of researchers and poor or orphaned children. There were no research policies passed before 1966 that directly addressed children.
62We now recognize that research inherently carries risk and is not always beneficial. The question today is: How is it possible to ensure equitable access to benefits while protecting the interests of patient-subjects?
63New “scandals” are emerging New “scandals” are emerging. The Office of Human Research Protections (OHRP) has shut down programs at some major research institutions and there have been a number of Congressional inquiries and reports. There is also increased legal attention focused on research.
64Ethical considerations: Informed consent in pediatrics is a misnomer. Informed consent in pediatrics equals parental permission and assent of the child.
65Assent means that the child is aware of the condition or disorder, understands what to expect, understands the procedure or treatment, and expresses support for participation in the study.
66There is likely a lower age at which dissent (or assent) is not possible. Should the age of assent be set at when a child understands when something is being done against his or her wishes? Or when a child can appreciate being used for another’s purpose?
67Data shows that children over the age of eleven have the ability to comprehend important aspects of research. Younger children can only reason in terms of tangible objects (e.g., blood draw).
68These findings only demonstrate that younger children struggle with the customary approach to consent. Assent and consent are not the same thing.
69Differences Between Research and Innovative Therapy The traditional view is that we need a reason for distinguishing “experimentation” from “treatment.” The critical ethical distinction is that the physician serves as a double agent.
70In innovative therapy, the physician’s primary concern is the interest of the patient. In research, the physician’s primary concern is to benefit society.History (abuses and unethical research) justified the creation of regulations and rules and, eventually, a common rule was created.
71Regulations, protocols, and policies have changed over time and should continue to do so but the debate about use of children (elderly and mentally diminished subjects) in research and innovative therapy continues
72How old does a child need to be to distinguish the difference between clinical care and research? 14?Today, information must be provided to parents with general information about the purpose of the clinical research.
73The researchers must use specific measures to distinguish research from clinical care.
74Pediatric ethics must consider what is in the best interests of the children, whenever and wherever research is considered or conducted. Whether commercial or privately funded, the IRB should be weighing risk and benefit. But best interest is abstract.
75New IssueToday IRBs should be looking at payment to physicians as well as to subjects as issue of ethical concernHow is this influencing research, why it’s done and who participates?