3
Ethics in Research
Historical Background
Maintain Privacy and Confidentiality
Ethical Principles
Protecting Research Subjects
Avoid Harming Research Participants
Obtain Informed Consent
Avoid Deception in Research,
Except in Limited Circumstances
I
Maintaining
Honesty and Openness
Achieving Valid Results
Encouraging Appropriate Application
Conclusion
magine this: One spring morning as you are drinking coffee and reading the newspaper, you notice a small ad for a psychology experiment at the local university.
Video Link 3.1
Watch excerpts from
Milgram’s experiment.
WE WILL PAY YOU $45 FOR ONE HOUR OF YOUR TIME
Persons Needed for a Study of Memory
“Earn money and learn about yourself,” it continues. Feeling a bit bored, you call and schedule an evening visit to the lab.
You are about to enter one of the most ethically controversial experiments in the history of social science.
You arrive at the assigned room at the university and are immediately impressed by the elegance of the building and the professional appearance of the personnel. In the waiting room, you see a man dressed in a lab technician’s coat talking to another visitor, a middle-aged fellow dressed in casual attire. The man in the lab coat turns, introduces himself, and explains that, as a psychologist, he is interested in whether people learn better when they are punished for making mistakes. He quickly convinces you that this is an important question; he then explains that his experiment on punishment and learning will discover the answer. Then he announces, “I’m going to ask one of you to be the teacher here tonight and the other one to be the learner.”
39
40 Making Sense of the Social World
The experimenter [as we’ll refer to him from now on] says he will write either teacher or learner on small identical slips of paper and then asks both of you to draw one. Yours says teacher.
The experimenter now says, in a matter-of-fact way, “All right. Now the first thing we’ll have to do is to set the learner up so that he can get some type of punishment.”
He leads you both behind a curtain, sits the learner in the chair, straps down both of his arms, and attaches an electric wire to his left wrist (Exhibit 3.1). The wire is connected to a console with 30 switches and a large dial, on the other side of the curtain. When you ask what the wire is for, the experimenter demonstrates. He asks you to take hold of the end of the wire, walks back to the control console, and flips several switches. You hear a clicking noise, see the dial move, and then feel an electric shock in your hand. When the experimenter flips the next switch, the shock increases.
“Ouch!” you say. “So that’s the punishment. Couldn’t it cause injury?” The experimenter explains that the machine is calibrated so that it will not cause permanent injury but admits that when turned up all the way, it is very, very painful.
Exhibit 3.1
Learner Strapped in Chair With Electrodes
Source: From the film Obedience © 1968 by Stanley Milgram, © Renewed 1993 by Alexandra Milgram, and distributed by Penn State,
Media Sales.
Now you walk back to the other side of the room (so that the learner is behind the curtain) and sit before the console (Exhibit 3.2). The experimental procedure has four simple steps:
1. You read aloud a series of word pairs, like blue box, nice day, wild duck, and so on.
2. You read one of the first words from those pairs and a set of four words, one of which is the original paired word. For example, you might say, “blue: sky-ink-box-lamp.”
Chapter 3 Ethics in Research 41
3. The learner states the word that he thinks was paired with the first word you read (“blue”). If he gives a correct response, you compliment him and move on to the next word. If he makes a mistake, you flip a switch on the console. This causes the Learner to feel a shock on his wrist.
Exhibit 3.2
Milgram’s “Shock Generator”
4. After each mistake, you are to flip the next switch on the console, progressing from left to right. You note that a label corresponds to every fifth mark on the dial, with the first mark labeled slight shock, the fifth mark labeled moderate shock, the tenth strong shock, and so on through very strong shock, intense shock, extreme intensity shock, and danger: severe shock.
You begin. The learner at first gives some correct answers, but then he makes a few errors. Soon you are beyond the fifth
Source: From the film Obedience © 1968 by Stanley Milgram, © Renewed mark (slight shock) and are moving in the direction of more and 1993 by Alexandra Milgram, and distributed by Penn State, Media Sales. more severe shocks. As you turn the dial, the learner’s reactions increase in intensity: from a grunt at the fifteenth mark (strong shock) to painful groans at higher levels, to anguished cries of “get me out of here” at the extreme intensity shock levels, to a deathly silence at the highest level. When you protest at administering the stronger shocks, the experimenter tells you, “The experiment requires that you continue.” Occasionally he says, “It is absolutely essential that you continue.”
This is a simplified version of the famous Stanley Milgram’s obedience experiments, begun at Yale University in 1960. Outside the laboratory, Milgram
Obedience experiments surveyed Yale undergraduates and asked them to indicate at what level they would
(Milgram’s): A series of famous terminate their “shocks” if they were in the study. Now, please mark on the console experiments conducted during the 1960s by Stanley Milgram, a below the most severe shock that you would agree to give the learner (Exhibit 3.3). psychologist from Yale University,
The average (mean) maximum shock level predicted by the Yale undergraduates testing subjects’ willingness to was 9.35, corresponding to a strong shock. Only one student predicted that he would cause pain to another person if provide a stimulus above that level, at the very strong level. Responses were similar instructed to do so. from nonstudent groups.
But the actual average level of shock the 40 adults who volunteered for the experiment administered was
Exhibit 3.3 Shock Meter
24.53—higher than extreme intensity shock and just short of danger: severe shock. Of Milgram’s original 40 subjects, 25 complied entirely with the experimenter’s demands, going all the way to the top of the scale (labeled
15
simply as XXX). Judging from the subjects’ visibly high
Very
stress, and from their subsequent reports, they believed
10
20 strong Intense
Strong
shock that the learner was receiving physically painful shocks. shock shock
(In fact, no electric shocks were actually delivered.)
Extreme 25
Moderate
5
We introduce the Milgram experiment not to discuss intensity shock shock obedience to authority but instead to introduce research
Slight shock ethics. We refer to Milgram’s obedience studies throughDanger severe shock 30
0
out this chapter, since they ultimately had as profound an influence on scientists’ thinking about ethics as on how we understand obedience to authority.
42 Making Sense of the Social World
Throughout this book, we discuss ethical problems common to various research methods; in this particular chapter, we present in more detail some of the general ethical principles that professional social scientists use in monitoring their work.
22
Historical Background
Formal procedures for the protection of participants in research grew out of some widely publicized abuses.
A defining event occurred in 1946, when the Nuremberg war crime trials exposed horrific medical experiments conducted during World War II by Nazi doctors in the name of “science.”
During the 1950s and 1960s, American military personnel and Pacific Islanders
Nuremberg war crime trials: Trials were sometimes unknowingly exposed to radiation during atomic bomb tests. And held in Nuremberg, Germany, in the 1970s, Americans were shocked to learn that researchers funded by the U.S. in the years following World War
Public Health Service had, for decades, studied 399 low-income African American
II, in which the former leaders of men diagnosed with syphilis in the 1930s to follow the “natural” course of the illness
Nazi Germany were charged with
(Exhibit 3.4). In the Tuskegee syphilis study, many participants were not informed war crimes and crimes against of their illness and were denied treatment until 1972, even though a cure (penicillin) humanity; frequently considered was developed in the 1950s (Jones 1993). the first trials for people accused of genocide.
Such egregious violations of human rights resulted, in the United States, in the creation of a National Commission for the Protection of Human Subjects of
Exhibit 3.4
Audio Link 3.1
Listen to a case of unethical human treatment.
Tuskegee Syphilis Experiment
Chapter 3 Ethics in Research 43
Biomedical and Behavioral Research. The Commission’s 1979
Belmont Report (U.S. Department of Health, Education, and
Welfare 1979) established three basic ethical principles for the protection of human subjects (Exhibit 3.5):
Exhibit 3.5
Belmont Report Principles
Respect for Persons
1. Respect for persons—treating persons as autonomous agents and protecting those with diminished autonomy
2. Beneficence—minimizing possible harms and maximizing benefits
3. Justice—distributing benefits and risks of research fairly Beneficence
The Department of Health and Human Services and the
Food and Drug Administration then translated these principles into specific regulations, which were adopted in 1991 as the Federal Policy for the Protection of Human Subjects. This policy has shaped the course of social science research ever since, and you will have to take it into account as you design your own research investigations. Some professional associations—such as the
American Psychological Association, the American Political Science Association, the American Sociological Association, university review boards, and ethics committees in other organizations—set standards for the treatment of human subjects by their members, employees, and students; these standards are designed to comply with the federal policy.
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. If you do research for a class assignment, you may need to prepare a brief IRB proposal, so they can be sure that your project meets all ethical standards. 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). To promote adequate review of ethical issues, the regulations require that IRBs include members with diverse backgrounds. The
Office for Protection From Research Risks in the National Institutes of Health monitors IRBs, with the exception of research involving drugs (which is the responsibility of the federal Food and Drug Administration).
Justice
Tuskegee syphilis study:
Research study conducted by a branch of the U.S. government, lasting for roughly 50 years
(ending in the 1970s), in which a sample of African American men diagnosed with syphilis were deliberately left untreated, without their knowledge, to learn about the lifetime course of the disease.
Belmont Report: Report in 1979 of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research stipulating three basic ethical principles for the protection of human subjects: respect for persons, beneficence, and justice.
22
Ethical Principles
The American Sociological Association (ASA), like other professional social science organizations, has adopted, for practicing sociologists, ethical guidelines that are more specific than the federal regulations. Professional organizations may also review complaints of unethical practices when asked.
The Code of Ethics of the ASA (1997) is summarized at the ASA website (www
.asanet.org); the complete text of the code is also available at this site.
Respect for persons: In human subjects ethics discussions, treating persons as autonomous agents and protecting those with diminished autonomy.
44 Making Sense of the Social World
Beneficence: Minimizing possible harms and maximizing benefits.
Justice: As used in human research ethics discussions, distributing benefits and risks of research fairly.
Federal Policy for the Protection of Human Subjects: Federal regulations codifying basic principles for conducting research on human subjects; used as the basis for professional organizations’ guidelines.
Mostly, ethical issues in research are covered by four guidelines:
1. To protect research subjects
2. To maintain honesty and openness
3. To achieve valid results
4. To encourage appropriate application
Each of these guidelines became a focus of the debate about Milgram’s experiments, to which we will refer frequently. Did Stanley Milgram respect the spirit expressed in these principles? You will find that there is no simple answer to the question of what is (or isn’t) ethical research practice.
Protecting Research Subjects
This guideline, our most important, can be divided into four specific directions:
Office for Protection From
Research Risks, National
Institutes of Health: Federal agency that monitors institutional review boards (IRBs).
1. Avoid harming research participants.
2. Obtain informed consent.
3. Avoid deception in research, except in limited circumstances.
4. Maintain privacy and confidentiality.
Avoid Harming Research Participants
Encyclopedia Link 3.1
Read about the ethics of the researcher-participant relationship. This standard may seem straightforward, but can be difficult to interpret in specific cases. Does it mean that subjects should not be harmed even mentally or emotionally? That they should feel no anxiety or distress?
The most serious charge leveled against the ethics of Milgram’s study was that he had harmed his subjects.
A verbatim transcript of one session will give you an idea of what participants experienced as the “shock generator,” which made it appear they were delivering increasingly severe shocks to the learner (Milgram 1965:67):
150 volts delivered.
You want me to keep going?
165 volts delivered.
That guy is hollering in there . . . He’s liable to have a heart condition. You want me to go on?
180 volts delivered.
He can’t stand it! I’m not going to kill that man in there! You hear him hollering? He’s hollering. He can’t stand it . . . I mean who is going to take responsibility if anything happens to that gentleman? [The experimenter accepts responsibility.] All right.
195 volts delivered.
You see he’s hollering. Hear that. Gee, I don’t know. [The experimenter says: “The experiment requires that you go on.”] I know it does, sir, but I mean—phew—he don’t know what he’s in for. He’s up to 195 volts.
210 volts delivered.
225 volts delivered. 240 volts delivered.
The experimental manipulation generated “extraordinary tension” (Milgram 1963:377):
Subjects were observed to sweat, tremble, stutter, bite their lips, groan and dig their fingernails into their flesh . . . Full-blown, uncontrollable seizures were observed for 3 subjects. One . . . seizure so violently convulsive that it was necessary to call a halt to the experiment [for that individual]. (p. 375)
Chapter 3 Ethics in Research 45
An observer (behind a one-way mirror) reported, “I observed a mature and initially poised businessman enter the laboratory smiling and confident. Within 20 minutes he was reduced to a twitching, stuttering wreck, who was rapidly approaching a point of nervous collapse” (Milgram 1963:377).
Milgram’s “Behavioral Study of Obedience” was published in 1963 in the Journal of Abnormal and Social
Psychology. In the next year, the American Psychologist published a critique of the experiment’s ethics by psychologist Diana Baumrind (1964:421). From Baumrind’s perspective, the emotional disturbance in subjects was “potentially harmful because it could easily effect an alteration in the subject’s self-image or ability to trust adult authorities in the future” (p. 422). Stanley Milgram (1964) quickly countered that momentary excitement is not the same as harm. As the experiment progressed there was no indication of injurious effects in the subjects; and as the subjects themselves strongly endorsed the experiment, the judgment I made was to continue the experiment. (p. 849)
Milgram (1963) also attempted to minimize harm to subjects with postexperiment procedures “to assure that the subject would leave the laboratory in a state of well being” (p. 374). A friendly reconciliation was arranged between the subject and the victim, and an effort was made to reduce any tensions that arose as a result of the experiment.
In some cases, the “dehoaxing”—or debriefing—discussion was extensive, and all subjects were promised (and later received) a comprehensive report (Milgram, 1964:849). But Baumrind (1964) was unconvinced: “It would be interesting to know what sort of procedures could dissipate the type of emotional disturbance just described” (p. 422).
Debriefing: A researcher’s
When Milgram (1964:849) surveyed subjects in a follow-up, 83.7% endorsed informing subjects after an experiment about the the statement that they were “very glad” or “glad” “to have been in the experiment,” experiment’s purposes and
15.1% were “neither sorry nor glad,” and just 1.3% were “sorry” or “very sorry” to methods and evaluating subjects’ have participated. Interviews by a psychiatrist a year later found no evidence “of any personal reactions to the traumatic reactions” (Milgram, 1974:197). Subsequently, Milgram argued that “the experiment. central moral justification for allowing my experiment is that it was judged acceptable by those who took part in it” (Milgram as cited in Cave & Holm 2003:32).
In a later article, Baumrind (1985:168) dismissed the value of the self-reported “lack of harm” of subjects who had been willing to participate in the experiment and noted that 16% did not endorse the statement that they were “glad” they had participated in the experiment. Many social scientists, ethicists, and others conVideo Link 3.2 cluded that Milgram’s procedures had not harmed subjects and so were justified by the knowledge they proWatch excerpts from duced; others sided with Baumrind’s criticisms (Miller 1986:88–138).
Zimbardo’s Stanford prison experiment. Or, consider the possible harm to subjects in the famous prison simulation study at Stanford University
(Haney, Banks, & Zimbardo 1973). Zimbardo’s prison simulation study was designed to investigate the impact of being either a guard or a prisoner in a prison, a “total institution.” The researchers selected apparently stable and mature young male volunteers and asked
Prison simulation study them to sign a contract to work for 2 weeks as a guard or a prisoner in a simulated
(Zimbardo’s): Famous study prison. Within the first 2 days after the prisoners were incarcerated in a makeshift from the early 1970s, organized basement prison, the prisoners began to be passive and disorganized, while the by Stanford psychologist Philip guards became “sadistic”—verbally and physically aggressive (Exhibit 3.6). Five
Zimbardo, demonstrating the
“prisoners” were soon released for depression, uncontrollable crying, fits of rage, willingness of average college students quickly to become harsh and, in one case, a psychosomatic rash. Instead of letting things continue for 2 weeks disciplinarians when put in the role as planned, Zimbardo and his colleagues terminated the experiment after 6 days to of (simulated) prison guards over avoid harming subjects. other students; usually interpreted
Participants playing the prisoner role certainly felt some stress, but postexperias demonstrating an easy human ment discussion sessions seemed relieve this; follow-up during the next year indireadiness to become cruel. cated no lasting negative effects on the participants and some benefits in the form of
46 Making Sense of the Social World
Exhibit 3.6
Chart of Guard and Prisoner Behavior
Commands
Insults
Deindividuating
reference
Aggression
Threats
Questions
Information
Use of instruments Individuating reference Helping
Resistance
0
10
20
30
40
50
60
70
80
90
100 110
Frequency
Guards
Prisoners
greater insight. And besides, Zimbardo and his colleagues had no way of predicting the bad outcome; indeed, they were themselves surprised (Haney et al. 1973).
Even well-intentioned researchers may fail to foresee potential ethical problems. Milgram (1974:27–31) reported that he and his colleagues were surprised by the subjects’ willingness to administer such severe shocks. In Zimbardo’s prison simulation, all the participants signed consent forms, but even the researchers did not realize that participants would fall apart so quickly, that some prisoners would have to be released within a few days, or that others would soon be begging to be released from the mock prison. Since some risks cannot be foreseen, they cannot be consented to.
Journal Link 3.1
Read about the written consent needed for a youth smoking prevention trial.
Obtain Informed Consent
Just defining informed consent may also be more difficult than it first appears. 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). Yet you probably realize, as did
Chapter 3 Ethics in Research 47
Diana Baumrind (1985), that due to the inability to communicate perfectly, “Full disclosure of everything that could possibly affect a given subject’s decision to participate is not possible, and therefore cannot be ethically required” (p. 165).
Obtaining informed consent creates additional challenges for researchers. For instance, the language of the consent form must be clear and understandable yet sufficiently long and detailed to explain what will actually happen in the research. Examples A (Exhibit 3.7) and B (Exhibit 3.8) illustrate two different approaches to these tradeoffs. Consent form A was approved by a university for a substance abuse survey with undergraduate students. It is brief and to the point but leaves quite a bit to the imagination of the prospective participants.
Consent form B reflects the requirements of an academic hospital’s IRB. Because the hospital is used to reviewing research proposals involving drugs and other treatment interventions with hospital patients, it requires a very detailed and lengthy explanation of procedures and related issues, even for a simple survey.
Requiring prospective participants to sign such lengthy forms can reduce their willingness to participate in research and perhaps influence their responses if they do agree to participate (Larson 1993:114).
When an experimental design requires subject deception, researchers may withhold information before the experiment but then debrief subjects after the experiment ends (Milgram did this). In the debriefing, the researcher explains what really happened in the experiment, and why, and responds to subjects’ questions. A carefully designed debriefing procedure can often help research participants deal with their anger or embarrassment at having been deceived (Sieber 1992:39–41), thus substituting for fully informed consent prior to the experiment.
Finally, some participants can’t truly give informed consent. College students, for instance, may feel unable to refuse if their professor asks them to be in an experiment. Legally speaking, children cannot give consent to participate in research; a child’s legal guardian must give written informed consent to have the
Exhibit 3.7
Consent Form A
University of Massachusetts at Boston
Department of Sociology
October 28, 1996
Dear ____________________________:
The health of students and their use of alcohol and drugs are important concerns for every college and university. The enclosed survey is about these issues at UMass/Boston. It is sponsored by University
Health Services and the PRIDE Program (Prevention, Resources, Information, and Drug Education). The questionnaire was developed by graduate students in Applied Sociology, Nursing, and Gerontology.
You were selected for the survey with a scientific, random procedure. Now it is important that you return the questionnaire so that we can obtain an unbiased description of the undergraduate student body. Health
Services can then use the results to guide campus education and prevention programs.
The survey requires only about 20 minutes to complete. Participation is completely voluntary and anonymous. No one will be able to link your survey responses to you. In any case, your standing at the University will not be affected whether or not you choose to participate. Just be sure to return the enclosed postcard after you mail the questionnaire so that we know we do not have to contact you again.
Please return the survey by November 15th. If you have any questions or comments, call the PRIDE program at 287–5680 or Professor Schutt at 287–6250. Also call the PRIDE program if you would like a summary of our final report.
Thank you in advance for your assistance.
Russell K. Schutt, PhD
Professor and Chair
Research|Social Impact
Link 3.1
Read about research ethics.
48 Making Sense of the Social World
Exhibit 3.8
Consent Form B
Research Consent Form for Social and Behavioral Research
Dana-Farber/Harvard Cancer Center
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates
OPRS 11-05
Protocol Title: ASSESSING COMMUNITY HEALTH WORKERS’ ATTITUDES AND KNOWLEDGE ABOUT
EDUCATING COMMUNITIES ABOUT CANCER CLINICAL TRIALS
DF/HCC Principal Research Investigator / Institution: Dr. Russell Schutt, PhD/ Beth Israel Deaconess
Medical Center and Univ. of Massachusetts, Boston
DF/HCC Site-Responsible Research Investigator(s) / Institution(s): Lidia Schapira, MD/ Massachusetts
General Hospital
Interview Consent Form
A. INTRODUCTION
We are inviting you to take part in a research study. Research is a way of gaining new knowledge. A person who participates in a research study is called a “subject.” This research study is evaluating whether community health workers might be willing and able to educate communities about the pros and cons of participating in research studies.
It is expected that about 10 people will take part in this research study.
An institution that is supporting a research study either by giving money or supplying something that is important for the research is called the “sponsor.” The sponsor of this protocol is National Cancer Institute and is providing money for the research study.
This research consent form explains why this research study is being done, what is involved in participating in the research study, the possible risks and benefits of the research study, alternatives to participation, and your rights as a research subject. The decision to participate is yours. If you decide to participate, please sign and date at the end of the form. We will give you a copy so that you can refer to it while you are involved in this research study.
If you decide to participate in this research study, certain questions will be asked of you to see if you are eligible to be in the research study. The research study has certain requirements that must be met. If the questions show that you can be in the research study, you will be able to answer the interview questions.
If the questions show that you cannot be in the research study, you will not be able to participate in this research study.
Page 1 of 6
DFCI Protocol Number: 06-085
Date DFCI IRB Approved This Consent Form: January 16, 2007
Date Posted for Use: January 16, 2007
Date DFCI IRB Approval Expires: August 13, 2007
Chapter 3 Ethics in Research 49
Exhibit 3.8
(Continued)
Research Consent Form for Social and
Behavioral Research
Dana-Farber/Harvard Cancer Center
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates
OPRS 11-05
We encourage you to take some time to think this over and to discuss it with other people and to ask questions now and at any time in the future.
B. WHY IS THIS RESEARCH STUDY BEING DONE?
Deaths from cancer in general and for some specific cancers are higher for black people compared to white people, for poor persons compared to nonpoor persons, and for rural residents compared to nonrural residents. There are many reasons for higher death rates between different subpopulations. One important area for changing this is to have more persons from minority groups participate in research about cancer.
The process of enrolling minority populations into clinical trials is difficult and does not generally address the needs of their communities. One potential way to increase participation in research is to use community health workers to help educate communities about research and about how to make sure that researchers are ethical. We want to know whether community health workers think this is a good strategy and how to best carry it out.
C. WHAT OTHER OPTIONS ARE THERE?
Taking part in this research study is voluntary. Instead of being in this research study, you have the following option: • Decide not to participate in this research study.
D. WHAT IS INVOLVED IN THE RESEARCH STUDY?
Before the research starts (screening): After signing this consent form, you will be asked to answer some questions about where you work and the type of community health work you do to find out if you can be in the research study.
If the answers show that you are eligible to participate in the research study, you will be eligible to participate in the research study. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
After the screening procedures confirm that you are eligible to participate in the research study:
You will participate in an interview by answering questions from a questionnaire. The interview will take about
90 minutes. If there are questions you prefer not to answer we can skip those questions. The questions are about the type of work you do and your opinions about participating in research. If you agree, the interview will be taped and then transcribed.Your name and no other information about you will be associated:
. . .
Page 2 of 6
DFCI Protocol Number: 06-085
Date DFCI IRB Approved this Consent Form: January 16, 2007
Date Posted for Use: January 16, 2007
Date DFCI IRB Approval Expires: August 13, 2007
(Continued)
50 Making Sense of the Social World
Exhibit 3.8
(Continued)
Research Consent Form for Social and
Behavioral Research
Dana-Farber/Harvard Cancer Center
BIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates
OPRS 11-05
with the tape or the transcript. Only the research team will be able to listen to the tapes. Immediately following the interview, you will have the opportunity to have the tape erased if you wish to withdraw your consent to taping or participation in this study. You will receive $30.00 for completing this interview.
After the interview is completed: Once you finish the interview there are no additional interventions.
…
N. DOCUMENTATION OF CONSENT
My signature below indicates my willingness to participate in this research study and my understanding that
I can withdraw at any time.
__________________________________________ ____________________________________
Signature of Subject
Date
or Legally Authorized Representative
__________________________________________ ____________________________________
Person obtaining consent
Date
To be completed by person obtaining consent:
The consent discussion was initiated on __________________ (date) at ______________ (time).
A copy of this signed consent form was given to the subject or legally authorized representative.
For Adult Subjects
The subject is an adult and provided consent to participate.
The subject is an adult who lacks capacity to provide consent, and his/her legally authorized representative: gave permission for the adult subject to participate
did not give permission for the adult subject to participate
Page 6 of 6
DFCI Protocol Number: 06-085
Date DFCI IRB Approved this Consent Form: January 16, 2007
Date Posted for Use: January 16, 2007
Date DFCI IRB Approval Expires: August 13, 2007
Chapter 3 Ethics in Research 51
child participate in research (Sieber 1992). Then, the child must in most circumstances be given the opportunity to give or withhold assent to participate in research, usually by a verbal response to an explanation of the research. Special protections exist for other vulnerable populations—prisoners, pregnant women, mentally disabled persons, and educationally or economically disadvantaged persons. And in a sense, anyone deliberately deceived in an experiment cannot be said to really have given “informed” consent, since the person wasn’t honestly told what would happen.
Social media and digital technologies have in recent years opened the doors to new kinds of ethical problems in research, by blurring the lines between public and private behavior. If you have a Facebook or MySpace page with 600 “friends,” is that your private page, or a public document? In Chapter 4, we’ll see how social researchers are eagerly mining such data for information on people’s social networks; “Employers are looking at people’s online postings and Googling information about them, and I think researchers are right behind them,” said Professor Nicholas Christakis (as cited in Rosenbloom 2007:2), a Harvard sociologist in a New
York Times article in 2007. But the federal guidelines under which Institutional Review Boards are set up didn’t anticipate the Internet. “The [human subject] rules were made for a different world, a pre-Facebook world,” said Samuel D. Gosling, a psychology professor at the University of Texas who uses Facebook as a data source.
“There is a rule that you are allowed to observe public behavior, but it’s not clear if online behavior is public or not” (as cited in Rosenbloom 2007:2).
In truth, though, the public vs. private debate is a long-standing issue in social science. Laud Humphreys
(1970) decided that truly informed consent would be impossible to obtain for his study of the social background of men who engage in homosexual behavior in public facilities. Humphreys served as a lookout—a
Research|Social Impact
“watch queen”—for men who were entering a public bathroom in a city park with the intention of having sex.
Link 3.2
In a number of cases, he then left the bathroom and copied the license plate numbers of the cars driven by the
Read more about informed consent. men. One year later, he visited the homes of the men and interviewed them as part of a larger study of social issues. Humphreys changed his appearance so that the men did not recognize him. In his book Tearoom
Trade, Humphreys concluded that the men who engaged in what were widely viewed as deviant acts were, for the most part, married, suburban men whose families were unaware of their sexual practices. But debate has continued ever since about Humphreys’s failure to tell the men what he was really doing in the bathroom or why he had come to their homes for the interview.
Tearoom Trade: Book by Laud
He was criticized by many, including some faculty members at the University of
Humphreys investigating the
Washington who urged that his doctoral degree be withheld. However, many other social background of men who professors and some members of the gay community praised Humphreys for helpengage in homosexual behavior in ing to normalize conceptions of homosexuality (Miller 1986:135). public facilities; controversially, he did not obtain informed consent
If you served on your university’s IRB, would you allow research such as from his subjects.
Humphreys’s to be conducted?
Avoid Deception in Research, Except in Limited Circumstances
Deception occurs when subjects are misled about research procedures. Frequently, this is done to simulate realworld conditions in the lab. The goal is to get subjects “to accept as true what is false or to give a false impression”
(Korn 1997:4). In Milgram’s (1964) experiment, for example, deception seemed necessary because actually giving electric shocks to the “stooge” would be cruel. Yet to test obedience, the task had to be troubling for the subjects. Milgram (1974:187–188) insisted that the deception was absolutely essential. Many other psychological and social psychological experiments would be worthless if subjects understood what was really happening to them while the experiment was in progress. But is this sufficient justification to allow the use of deception?
Some important topics have been cleverly studied using deception. Gary Marshall and Philip Zimbardo (of prison study fame), in a 1979 study, told the student volunteers that they were being injected with a vitamin supplement to test its effect on visual acuity (Korn 1997:2–3). But to determine the physiological basis of
52 Making Sense of the Social World
Researcher Interview
Link 3.1
Watch a researcher describe how an
IRB works.
Journal Link 3.2
Read a qualitative study that protects subjects’ identities by using pseudonyms. emotion, they actually injected them with adrenaline, so that their heart rate and sweating would increase, and then placed them in a room with a student stooge who acted silly. Piliavin and Piliavin, in a 1972 study, staged fake seizures on subway trains to study helpfulness (Korn:3–4). Again, would you allow such deceptive practices if you were a member of your university’s IRB? Giving people stimulating drugs, apart from the physical dangers, is using their very bodies for research without their knowledge. Faking an emergency may lessen one’s willingness to help in the future or may, in effect, punish the research subjects—through embarrassment—for their reaction to what is really “just an experiment.”
But perhaps risk, not deception per se, is the real problem. Aronson and Mills’s (1959) study of severity of initiation to groups is a good example of experimental research that does not pose greater-than-everyday risks to subjects but still uses deception. This study was conducted at an all-women’s college in the 1950s. The student volunteers who were randomly assigned to the “severe initiation” experimental condition had to read a list of embarrassing words. Even in the 1950s, reading a list of potentially embarrassing words in a laboratory setting, then listening to a taped discussion, was unlikely to increase the risks to which students were exposed in their everyday lives. Moreover, the researchers informed subjects that they would be expected to talk about sex and could decline to participate in the experiment if this requirement would bother them. None dropped out. To further ensure that no psychological harm was caused, Aronson and Mills explained the true nature of the experiment to subjects after the experiment. The subjects did not seem perturbed: “None of the
Ss expressed any resentment or annoyance at having been misled. In fact, the majority were intrigued by the experiment, and several returned at the end of the academic quarter to ascertain the result” (p. 179).
Are you satisfied that this procedure caused no harm? The minimal deception in the Aronson and Mills experiment, coupled with the lack of any ascertainable risk to subjects and a debriefing, satisfies the ethical standards for research of most psychologists and IRBs, even today.
Maintain Privacy and Confidentiality
Maintaining privacy and confidentiality after a study is completed is another way to protect subjects, and the researcher’s commitment to that standard should be included in the informed consent agreement (Sieber
1992). 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. For the protection of health care data, the Health Insurance Portability and Accountability Act (HIPAA), passed by Congress in 1996, created much more stringent regulations. As implemented by
Health Insurance Portability and the U.S. Department of Health and Human Services in 2000 (and revised in 2002),
Accountability Act (HIPAA): A
U.S. federal law passed in 1996 the HIPAA Final Privacy Rule applies to oral, written, and electronic information that guarantees, among other that “relates to the past, present, or future physical or mental health or condition of things, specified privacy rights an individual” (Legal Information Institute, 2006. § 1320d[6][B]). The HIPAA Rule for medical patients, in particular requires that researchers have valid authorization for any use or disclosure of “prothose in research settings. tected health information” (PHI) from a health care provider. Waivers of authorization can be granted in special circumstances (Cava, Cushman, & Goodman 2007).
However, statements about confidentiality also need to be realistic. The law allows even confidential research records to be subpoenaed and may require reporting child abuse. A researcher may feel compelled to release information if a health- or life-threatening situation arises and participants need to be alerted. The
National Institutes of Health can issue a Certificate of Confidentiality to protect researchers from being legally required to disclose confidential information.
Certificate of Confidentiality:
Researchers who focus on high-risk populations or behaviors or sensitive topics,
Document issued by the National
Institutes of Health to protect such as crime, substance abuse, sexual activity, or genetic information, can request researchers from being legally such a certificate. Suspicions of child abuse or neglect must still be reported, and in required to disclose confidential some states, researchers may still be required to report such crimes as elder abuse information. (Arwood & Panicker 2007).
Chapter 3 Ethics in Research 53
Maintaining Honesty and Openness
Protecting subjects, then, is the primary focus of research ethics. But researchers have obligations to other groups, including the scientific community, whose concern with validity requires that scientists be open in disclosing their methods and honest in presenting their findings. To assess the validity of a researcher’s conclusions and the ethics of this researcher’s procedures, you need to know how the research was conducted. This means that articles or other reports must include a detailed methodology section, perhaps supplemented by appendixes containing the research instruments or websites or other contact information where more information can be obtained. Biases or political motives should be acknowledged, since research distorted by political or personal pressures to find particular outcomes is unlikely to be carried out in an honest and open fashion.
Stanley Milgram’s research exemplifies adherence to the goal of honesty and openness. His initial 1963 article included a description of study procedures, including details about the procedures involved in the learning task, administration of the “sample shock,” the shock instructions and the preliminary practice run, the standardized feedback from the “victim” and from the experimenter, and the measures used. Many more details, including pictures, were provided in Milgram’s (1974) subsequent book.
The act of publication itself is a vital element in maintaining openness and honesty, since then others can review procedures and debate with the researcher. Although Milgram disagreed sharply with Diana
Baumrind’s criticisms of his experiments, their mutual commitment to public discourse in journals widely available to psychologists resulted in more comprehensive presentation of study procedures and more thoughtful conversation about research ethics. Almost 50 years later, this commentary continues to inform debates about research ethics (Cave & Holm 2003).
In spite of this need for openness, researchers may hesitate to disclose their procedures or results to prevent others from “stealing” their ideas and taking the credit. However, failure to be open about procedures can result in difficult disputes. In the 1980s, for instance, as mentioned in Chapter 2, there was a long legal battle between a U.S. researcher, Robert Gallo, and a French researcher, Luc Montagnier, both of whom claimed credit for discovering the AIDS virus. Eventually the dispute was settled at the highest levels of government, through an agreement announced by American president Ronald Reagan and French prime minister Jacques Chirac (Altman 1987). Gallo and Montagnier jointly developed a chronology of discovery as part of the agreement. Enforcing standards of honesty and encouraging openness about research are often the best solutions to such problems.
Encyclopedia Link 3.2
Read about how to retain ethical communication with research participants.
Journal Link 3.3
Read about a study where only a portion of participants received a beneficial treatment. Research in the News
HONESTY IN RESEARCH
In the
News
The number of scientific articles increased by 44% between 2001 and 2010, but during that same period, the number of articles that were retracted due to the exposure of fraudulent or otherwise misleading findings multiplied more than 15 times, to a total of 339. Misleading findings have led to retractions in psychological research about animals, in biological research about cloning, and in immunological research about vaccines and autism. In response, researchers have been fired, funding has been terminated, and scientific journals have become more diligent.
Source: Cook, Gareth. 2011. Fraud in a lab coat: Science is finally getting serious about misconduct. The Boston
Sunday Globe, August 21: K9.
54 Making Sense of the Social World
Achieving Valid Results
Audio Link 3.2
Listen to more about
Milgram’s experiment.
It is the pursuit of objective knowledge—the goal of validity—that justifies our investigations and our claims to the use of human subjects. We have no business asking people to answer questions, submit to observations, or participate in experiments if we are simply trying to trumpet our own prejudices or pursue our personal interests. If, on the other hand, we approach our research projects objectively, setting aside our predilections in the service of learning a bit more about human behavior, we can honestly represent our actions as potentially contributing to the advancement of knowledge.
The details in Milgram’s 1963 article and 1974 book on the obedience experiments make a compelling case for his commitment to achieving valid results—to learning how obedience influences behavior. In Milgram’s
(1963) own words,
It has been reliably established that from 1933–45 millions of innocent persons were systematically slaughtered on command . . . Obedience is the psychological mechanism that links individual action to political purpose. It is the dispositional cement that binds men to systems of authority . . . for many persons obedience may be a deeply ingrained behavior tendency . . . Obedience may [also] be ennobling and educative and refer to acts of charity and kindness, as well as to destruction. (p. 371)
Video Link 3.3
Watch an interview about naturally occurring data.
Milgram (1963) then explains how he devised experiments to study the process of obedience in a way that would seem realistic to the subjects and still allow “important variables to be manipulated at several points in the experiment” (p. 372). Every step in the experiment was carefully designed to ensure that subjects received identical stimuli and that their responses were measured carefully.
Milgram’s (1963) attention to validity is also apparent in his reflections on “the particular conditions” of his experiment, for, he notes, “Understanding of the phenomenon of obedience must rest on an analysis of [these conditions]” (p. 377). These particular conditions included the setting for the experiment at Yale
University, its purported “worthy purpose” to advance knowledge about learning and memory, and the voluntary participation of the subject as well as of the learner—as far as the subject knew. The importance of some of these “particular conditions” (such as the location at Yale) was then tested in subsequent replications of the basic experiment (Milgram 1965).
However, not all psychologists agreed that Milgram’s approach could achieve valid results. Baumrind’s
(1964) critique begins with a rejection of the external validity—the generalizability—of the experiment.
“The laboratory is unfamiliar as a setting and the rules of behavior ambiguous . . . Therefore, the laboratory is not the place to study degree of obedience or suggestibility, as a function of a particular experimental condition” (p. 423). And so, “the parallel between authority-subordinate relationships in Hitler’s Germany and in
Milgram’s laboratory is unclear” (p. 423).
Stanley Milgram (1964) quickly published a rejoinder in which he disagreed with (among other things) the notion that it is inappropriate to study obedience in a laboratory setting: “A subject’s obedience is no less problematical because it occurs within a social institution called the psychological experiment” (p. 850).
Milgram (1974:169–178) also pointed out that his experiment had been replicated in other places and settings with the same results, that there was considerable evidence that subjects had believed that they actually were administering shocks, and that the “essence” of his experimental manipulation—the request that subjects comply with a legitimate authority—was shared with the dilemma faced by people in Nazi Germany and soldiers at the My Lai massacre in Vietnam (Miller 1986:182–183).
But Baumrind (1985) was still not convinced. In a follow-up article in the American Psychologist, she argued that “far from illuminating real life, as he claimed, Milgram in fact appeared to have constructed a set of conditions so internally inconsistent that they could not occur in real life” (p. 171).
Milgram assumed that obedience could fruitfully be studied in the laboratory; Baumrind disagreed.
Both, however, buttressed their ethical arguments with assertions about the external validity (or invalidity)
Chapter 3 Ethics in Research 55
of the experimental results. They agreed, in other words, that a research study is in part justified by its valid findings—the knowledge to be gained. If the findings aren’t valid, they can’t justify the research at all. It is hard to justify any risk for human subjects, or even any expenditure of time and resources, if our findings tell us nothing about human behavior.
Encouraging Appropriate Application
Finally, scientists must 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.
Stanley Milgram made it clear that he was concerned about the phenomenon of obedience precisely because of its implications for people’s welfare. As you have already learned, his first article (1963) highlighted the atrocities committed under the Nazis by citizens and soldiers who were “just following orders.” In his more comprehensive book on the obedience experiments (1974), he also used his findings to shed light on the atrocities committed in the Vietnam War at My Lai, slavery, the destruction of the American Indian population, and the internment of Japanese Americans during World War II. Milgram makes no explicit attempt to “tell us what to do” about this problem. In fact, as a dispassionate psychological researcher, Milgram (1974) tells us,
“What the present study [did was] to give the dilemma [of obedience to authority] contemporary format by treating it as subject matter for experimental inquiry, and with the aim of understanding rather than judging it from a moral standpoint” (p. xi).
Yet it is impossible to ignore the very practical implications of Milgram’s investigations. His research highlighted the extent of obedience to authority and identified multiple factors that could be manipulated to lessen blind obedience (such as encouraging dissent by just one group member, removing the subject from direct contact with the authority figure, and increasing the contact between the subject and the victim).
A widely publicized experiment on the police response to domestic violence, mentioned earlier, provides an interesting cautionary tale about the uses of science. Lawrence Sherman and Richard Berk (1984) arranged with the Minneapolis police department for the random assignment of persons accused of domestic violence to be either arrested or simply given a warning. The results of this field experiment indicated that those who were arrested were less likely subsequently to commit violent acts against their partners. Sherman (1993) explicitly cautioned police departments not to adopt mandatory arrest policies based solely on the results of the Minneapolis experiment, but the results were publicized in the mass media and encouraged many jurisdictions to change their policies (Binder & Meeker 1993; Lempert 1989). Although we now know that the original finding of a deterrent effect of arrest did not hold up in many other cities where the experiment was repeated, Sherman (1992:150–153) later suggested that implementing mandatory arrest policies might have prevented some subsequent cases of spouse abuse. In particular, in a follow-up study in Omaha, arrest warrants reduced repeat offenses among spouse abusers who had already left the scene when police arrived.
However, this Omaha finding was not publicized, so it could not be used to improve police policies. So how much publicity is warranted, and at what point in the research should it occur?
Social scientists who conduct research on behalf of specific organizations may face additional difficulties when the organization, instead of the researcher, controls the final report and the publicity it receives. If organizational leaders decide that particular research results are unwelcome, the researcher’s desire to have findings used appropriately and reported fully can conflict with contractual obligations. Researchers can anticipate such dilemmas and resolve them when the contract is negotiated—or simply decline a particular research opportunity altogether. But often such problems arise only after a report has been drafted, or a researcher who needs the job or to maintain a personal relationship ignores the problems. These possibilities cannot be avoided entirely, but because of them, it is always important to acknowledge the source of research funding in reports and to consider carefully the sources of funding for research reports written by others.
Encyclopedia Link 3.3
Read a brief overview about research ethics.
56 Making Sense of the Social World
22
Conclusion
Different kinds of research produce different kinds of ethical problems. Most survey research, for instance, creates few if any ethical problems and can even be enjoyable for participants. In fact, researchers from
Michigan’s Institute for Survey Research interviewed a representative national sample of adults and found that
68% of those who had participated in a survey were somewhat or very interested in participating in another; the more times respondents had been interviewed, the more willing they were to participate again (Reynolds
1979:56–57). On the other hand, some experimental studies in the social sciences that have put people in uncomfortable or embarrassing situations have generated vociferous complaints and years of debate about ethics (Reynolds 1979; Sjoberg 1967).
Research ethics should be based on a realistic assessment of the overall potential for harm and benefit to research subjects. In this chapter, we have presented some basic guidelines, and examples in other chapters suggest applications, but answers aren’t always obvious. For example, full disclosure of “what is really going on” in an experimental study is unnecessary if subjects are unlikely to be harmed. In one student observation study on cafeteria workers, for instance, the IRB didn’t require consent forms to be signed. The legalistic forms and signatures, they felt, would be more intrusive or upsetting to workers than the very benign and confidential research itself. The committee put the feelings of subjects above the strict requirement for consent.
Ultimately, then, 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 will require that researchers—even, in most cases, students—submit their research proposal to the IRB for review. So an institutional committee, following professional codes and guidelines, will guard the ethical propriety of your research; but still, that is an uncertain substitute for your own conscience.
Key Terms
Belmont Report 43
Beneficence 43
Certificate of Confidentiality 52
Debriefing 45
Federal Policy for the Protection of
Human Subjects 44
Health Insurance Portability and
Accountability Act (HIPAA) 52
Justice 43
Nuremberg war crime trials 42
Obedience experiments
(Milgram’s) 41
Office for Protection from Research Risks,
National Institutes of Health 43
Prison simulation study (Zimbardo’s) 45
Respect for persons 43
Tearoom Trade 51
Tuskegee syphilis study 42
Highlights
• Stanley Milgram’s obedience experiments led to intensive debate about the extent to which deception could be tolerated in psychological research and how harm to subjects should be evaluated.
• Egregious violations of human rights by researchers, including scientists in Nazi Germany and researchers in the Tuskegee
syphilis study, led to the adoption of federal ethical standards for research on human subjects.
• The 1979 Belmont Report developed by a national commission established three basic ethical standards for the protection of human subjects: (1) respect for persons, (2) beneficence, and
Chapter 3 Ethics in Research 57
(3) justice. The Department of Health and Human Services adopted in 1991 the Federal Policy for the Protection of Human
Subjects. The policy requires that every institution seeking federal funding for biomedical or behavioral research on human subjects have an institutional review board to exercise oversight.
• Standards for the protection of human subjects require avoiding harm, obtaining informed consent, avoiding deception
except in limited circumstances, and maintaining privacy and confidentiality. Scientific research should maintain high standards for validity and be conducted and reported in an honest and open fashion.
• Effective debriefing of subjects after an experiment can help to reduce the risk of harm due to the use of deception in the experiment. S T UDEN T S T UDY SI T E
The Student Study Site, available at www.sagepub.com/chambliss4e, includes useful study materials including web exercises with accompanying links, eFlashcards, videos, audio resources, journal articles, and encyclopedia articles, many of which are represented by the media links throughout the text. The site also features Interactive
Exercises—represented by the green icon here—to help you understand the concepts in this book.
IE
Exercises
Discussing Research
1. Should social scientists be permitted to conduct replications of Milgram’s obedience experiments? Zimbardo’s prison simulation? Can you justify such research as permissible within the current ASA ethical standards? If not, do you believe that these standards should be altered so as to permit Milgramtype research?
2. Why does unethical research occur? Is it inherent in science?
Does it reflect “human nature”? What makes ethical research more or less likely?
3. Does debriefing solve the problem of subject deception? How much must researchers reveal after the experiment is over, as well as before it begins?
Finding Research
1. The Collaborative Institutional Training Initiative (CITI) offers an extensive online training course in the basics of human subjects protections issues. Go to the public access CITI site (www
.citiprogram.org/rcrpage.asp?affiliation=100) and complete the course in social and behavioral research. Write a short summary of what you have learned.
2. The U.S. Department of Health and Human Services maintains extensive resources concerning the protection of human subjects in research. Read several documents that you find on its website (www.hhs.gov/ohrp/) and share your findings in a short report.
Critiquing Research
1. Pair up with one other student and select one of the research articles you have reviewed for other exercises. Criticize the research in terms of its adherence to each of the ethical principles for research on human subjects, as well as for the authors’ apparent honesty, openness, and consideration of social consequences. Try to be critical but fair. The student with whom you are working should critique the article in the
same way but from a generally positive standpoint, defending its adherence to the four guidelines but without ignoring the study’s weak points. Together, write a summary of the study’s strong and weak points or conduct a debate in class.
2. How do you evaluate the current American Sociological
Association ethical code? Is it too strict, too lenient, or just
58 Making Sense of the Social World
about right? Are the enforcement provisions adequate? What provisions could be strengthened?
Follow the instructions for entering your answers and responding to the program’s comments.
3. IRB members and the researchers who submit proposals to them must be familiar with a number of key concepts about ethical principles. The interactive exercises “Ethics” lesson at the text’s study site will help you learn how to do this.
To use these lessons, choose one of the four “Ethics” exercises from the opening menu for the Interactive Exercises.
4. Now go to the book ’s Study Site (www.sagepub.com/ chambliss4e) and choose the Learning from Journal Articles option. Read one article based on research involving human subjects. What ethical issues did the research pose, and how were they resolved? Does it seem that subjects were appropriately protected? Doing Research
1. List elements in a research plan for the project you envisioned for the “Doing Research” section in Chapter 2 that an IRB might consider to be relevant to the protection of human subjects. Rate each element from 1 to 5, where 1 indicates no more than a minor ethical issue and 5 indicates a major ethical problem that probably cannot be resolved.
2. Write one page for the application to the IRB that explains how you will ensure that your research adheres to each relevant standard. Ethics Questions
1. Read the entire American Sociological Association Code of
Ethics at the ASA website (www.asanet.org/about/ethics.cfm).
2. Discuss the potential challenges in adhering to the ASA’s ethical standards in research.
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