production date 2/5/00

Ethics

Guiding Principals

Table of Contents Objectives
Why Ethics Why we study ethics?
Research vs. Ethics Good research and ethics are in opposition
Thou Shalt The single ethical absolute
Ethical Imperatives Research is a social act.
Regulatory History Nuremberg to Tuskegee.
Additional Information Discover interesting Web Links
Questions/Test Take the End of Chapter Test
Report Send a Chapter Report to your Instructor


Before beginning to answer your questions by collecting data and using the statistical skills you have acquired in this course to conduct your inquiry, it is important to understand the guiding principles behind the ethical treatment of subjects in scientific investigations. While this chapter concentrates on the ethical treatment of humans, many of the links to other world wide web sites provide additional material on the ethical treatment of animals in research.

Why Ethics   

Humans believe that all organisms have certain rights. Obviously humans, have more rights than other organisms. However, we have set up, over the years, laws and enforcing bodies to protect both our rights and the rights of other animals. Concern about animal rights is currently a world wide phenomena. The American Psychological Association has published Guidelines for Ethical Conduct in the Care and Use of Animals, as well as ethical standards for the conduct of research with humans. Scientists have long been concerned with the ethical treatment of humans and animals in research. Scientific organizations and more recently the federal government have developed policing bodies to enforce ethical guidelines concerning research with both humans and other animals. Professional organizations like the American Psychological Association have developed ethical standards for professionals.
As a student, about to enter your chosen profession, this course has taught you the beginnings of statistical analysis. You will use your statistical skills to generate new knowledge and progress in your chosen field. However, for your research to be acceptable to your peers, and to be publishable in professional journals, it must conform to the highest ethical standards. This chapter discusses the history of research ethics as it specifically pertains to human research, and introduces you to this important topic. You will certainly want to investigate to see whether your professional organizations have specific guidelines for the ethical conduct of research.

Research vs. Ethics    

In your research classes, you have probably been told that good research concerns itself (indeed may even demand) the use of powerful and significant independent variables. (As you learned earlier, independent variables are usually the variables that are manipulated by the experimenter.) Examples of powerful independent variables might be pain, failure, stress, experimental drugs, excellent learning strategies, etc.. It goes without saying that it is useless to study variables which are not powerful enough to make a difference. However, good ethics would provide that research participants should always be protected from physical and mental discomfort. How can you study stress, and not have your research participants subjected to mental discomfort? In the Milgram study the independent variable was quite powerful. You could see the stress on the subjects. Indeed, Milgram was so concerned about the stress that these teachers endured that the teachers were followed for years to make sure that no harm was done because of participation in the study.

Good research demands that socially important dependent variables be studied. As you remember, the dependent variable in an experiment is usually the variable that is measured by the researcher. The dependent variable values were the ones we used to calculate our statistics (i.e., means, standard deviations, t values etc.). We like to study dependent variables like fear, aggression, cheating, reading achievement, physical strength etc.. In the Milgram study, the last voltage administered by the teacher was measured, but this was a direct indicator of how much a person would harm another when simply told to do so by an authority figure. Understanding the power of authority figures is certainly a socially important dependent variable.

Good ethics requires that each subject be fully informed as to the purpose of the research before they consent to participate. How can a scientist study something like cheating without violating this informed consent provision? In the Milgram study, subjects were deceived in order to study their obedience.

Good research practice mandates that variables be measured, and the data recorded and preserved. Indeed, much of the growth in computer technology has been a direct result of a demand for better machinery to store the vast amount of accumulated data concerning humans. Good ethics provides research participants with protection of their privacy. Anytime that data records are maintained concerning individuals there is a potential that information may be misused and the person's privacy rights violated.

Good research relies on random sampling to make inferences back to a population and random assignment to make sense of the statistical results. Good ethics requires voluntary participation after informed consent. It is difficult, if not impossible, to both be randomly selected to participate and also volunteer to participate in a research project.

Good research is often conducted using controlled experimentation. This means that there are at least two groups formed in the research. The experimental group gets the treatment and the control group gets a placebo. After the research is finished, the two groups are contrasted. Good ethics does not allow researchers to withhold a potentially useful treatment from humans for the sake of research results. If you had a fatal cancer, and there was a new experimental treatment that showed a great deal of promise, and you volunteered to participate in the experiment, how would you feel if you were assigned to the control group and received an inactive drug?

One of the essential conflicts addressed by ethics is between the values of science to benefit all mankind and the values that dictate concern for individual research participants. As noted before, almost all good research has ethical concerns. Ethics boards are usually not presented with research proposals where there are no ethical considerations. The study of research ethics is concerned with conflict resolution and not with ethical absolutes. Indeed, I believe there is really only one unbreakable rule in research ethics - this is the one thou shalt.

Thou Shalt   

Thou shalt allow research participants to emerge from their research experience unharmed - or assured and accepted that the risks are minimal and reasonable when compared to the new knowledge gained.

Ethical Imperatives   

Research and statistical training emphasizes technical competence. Struggling to grasp descriptive statistics, the analysis of variance, the technique of just noticeable differences, the use of the research design processes, and similar concepts absorbs the attention of students. And, perhaps it should, for research productivity requires mastery over content and method.

In spite of its technical nature, though, research is still a human act. The history of knowledge production is not a desiccated and linear tale of discoveries by hollow, stuffed, nameless researchers. Rather, we have our Galileo's our Copernicus's and our Milgram's who proved that research, even the most seemingly obscure research on inanimate objects, occurs within an ideological context.

When humans conduct research on other humans, the research act becomes a social act involving an exchange between two parties. One party, the researcher, hopes to obtain information from the other, the subject. The researcher offers the subject the opportunity to contribute to the production of new knowledge. At times, this opportunity directly benefits the subject, but, primarily, the subject's participation is altruistic. The ethical glue that binds subjects to researchers is the belief that the researcher will protect the subject from harm.

As in all social acts, questions arise about righteous and noble conduct between participants in the research act. Textbooks and simple formulas do not deliver answers to these ethical and moral questions. Instead, answers evolve from sound reasoning and valid argumentation from first principles, from study of written opinion, and, ultimately, from collective judgment about applicable principles and practices. Few students in social science and educational research have opportunities to grapple with these ethical issues -- but, these issues often become among the most difficult, problematic issues you will face as working professionals.

Regulatory History   

Although the development of new knowledge and innovative action has occurred through research on human subjects probably since the dawn of civilization, several recent trends led to increases in the number and sophistication of formal research efforts. First, large amounts of federal funds for research in medicine and related fields became available after World War II. Funding for social science and educational research, although not as extensive as for medical research, also increased. Second, improved research methodologies and technologies made more sophisticated research designs conceivable and possible.

Warning: Links in the next section may contain disturbing material



As methodologies and technologies of research advanced, so did some troubling concerns about the ethics of research on human beings. After World War II an international military tribunal was established to prosecute the German war criminals. This series of trials came to be known as the Nuremberg Trials. In the first trial, the following persons were prosecuted Hermann Wilhelm Goring, Rudolf Hess, Joachim von Ribbentrop, Robert Ley, Wilhelm Keitel, Ernst Kaltenbrunner, Alfred Rosenberg, Hans Frank, Wilhelm Frick, Julius Streicher, Walter Funk, Hjalmar Schacht, Gustav Krupp von Bohlen und Halbach, Karl Doenitz, Erich Raeder, Baldur von Schirach, Fritz Sauckel, Alfred Jodl, Martin Bormann, Franz von Papen, Arthur Seyss-Inquart, Albert Speer, Constantin von Neurath, and Hans Fritzsche. The details of that trial are well documented at the Yale Law School's Avalon Project. In a subsequent Nuremberg trial beginning on December 9, 1946, an American Military Tribunal prosecuted Karl Brandt and 22 other Nazi physicians or administrators for "experiments" conducted on unconsenting inmates (including children) of concentration camps. This trial, known as the The Doctors Trail, has been extremely well documented by the United "States Holocaust Memorial Museum.

To lay a basis for decisions about the guilt of Nuremberg defendants, basic moral, ethical, and legal principles were introduced to the Tribunal. These principles, known collectively as the "Nuremberg Code," introduced a basis for judging the ethical use of human subjects in research that was accepted and refined in subsequent pronouncements such as the American Hospital Association's 1952 statement on the use of investigational drugs in hospitals, the 1964 Declaration of Helsinki (revised in 1975) by the World Medical Association, and the 1966 Ethical Guidelines for Clinical Investigation by the Judicial Council of the American Medical Association. Papers addressing the interpretation of the Nuremberg Principles are still important today. Professional organizations, such as the American Psychological Association and the American Anthropological Association, have developed their own statements of ethical principles in the conduct of research with human subjects.

When the Milgram study was conducted, the Nuremberg defendants had previously stated that they did what they were accused of doing because they were told to do so. Few people actually believed that this was a reason. The impact of the Milgram study resulted from the conclusions that indicated human beings will harm another if told to do so by someone believed to be in authority. Milgram's teachers learned that their behavior was fundamentally no different than that of the Nazi defendants.

In 1953, the National Institutes of Health required that research at its Clinical Center in Bethesda, Maryland, first be reviewed and approved by a committee responsible for protecting any humans under study. In 1966, the Surgeon General extended this requirement to all extra mural research or research training grants supported by the US Public Health Service. In 1971, The Institutional Guide to Department of Health, Education, and Welfare Policy on the Protection of Human Subjects was published. While these human subjects protections were becoming institutionalized, several highly publicized studies generated intense official and public scrutiny of research on human beings.

Jewish Chronic Disease Hospital --

In 1965, a member of the board of directors of the Jewish Chronic Disease Hospital in Brooklyn brought a lawsuit against the hospital to have access to records of 22 patients who received injections of suspensions of cultures from human cancer tissue. The licenses of two physicians to practice medicine ultimately were revoked because the subjects were not informed that the injected material contained live cancer cells. The physicians involved explained that they wanted to avoid emotional reactions from the patients and refusals of participation.

This event also illustrates how the breaking of ethical codes can have dramatic effects outside of the event itself. Gary Null, discussed this event on a broadcast by Pacifica Radio station,WBAI-FM (99.5), 505 Eighth Ave., 19th Fl.,New York, NY 10018 (212) 279-0707. John DiNardo thought it important enough to transcribe the broadcast. I have provided this transcript (it can be freely reproduced) for you to read. I believe it provides additional information about this unethical event, and illustrates how a wrong can be used to support ideas and beliefs that are far removed from the event itself. If you read the transcript, not only consider this event, but how it was used in this broadcast.

Milledgeville State Hospital --

In 1969, Milledgeville State Hospital, a large institution for patients with mental disorders in Georgia, was charged with administration of investigational drugs to patients without the consent of the patient, legal guardian, or attending physician, and without any institutional review of the research.

Tuskegee Syphilis Study --

In 1930, a study was initiated by the US Public Health Service of the natural history of syphilis among African American males now known as the Tuskegee Syphilis Study. One group of men had untreated syphilis, the other contained men judged free of the disease. The participants were examined periodically. No treatment was provided, even after penicillin therapy became widely available in the 1950's. Steps were taken to keep subjects from obtaining therapy from other sources. This study continued until 1973 (!) well past the time when laws, regulations, and codes were developed and institutionalized to protect human subjects. As you are probably aware, President Clinton formally apologized to the surviving Tuskegee subjects and their families in May, 1997.

End of Links that may be disturbing.


These and other prominent violations of standards established in the Nuremberg Code led to increased pressure to regulate research ethics. Formal regulations appeared in the Federal Register during May 1974, and became effective during July 1974. These regulatory activities were prompted by establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research by Title II of the National Research Act of 1974 (PL 93-348). The National Commission was charged to investigate, develop guidelines, and make recommendations for the use of human subjects in research. (You can look at several statements pertaining to the protection of human subjects from different universities Here.) The National Commission's report widely known as The Belmont Report, formulated three principles and corresponding practices essential to protect human research subjects. Title 45, Part-46, of the Code of Federal Regulations outlines federal legal requirements for the protection of human research subjects. Some states have their own laws and regulations for research with humans. Penn State has filed a written assurance of compliance with the US Department of Health and Human Services regulations for protection of human subjects. Many Penn State policies, statements, and forms can be found Here. You will want to search your institution's web pages for material related to research ethics.

Principles and Practices   

The principles and practices delineated in The Belmont Report have their roots both in duty-based and rights-based moral theory. Duty-based moral theory judges actions based on conformance to principles of rectitude. Such an approach sees deception of human subjects in research, for example, as a violation of the general obligation to be truthful. Rights-based theory judges actions based upon their contribution to self-determination. Rights, then, exist something like "moral furniture" to allow individuals to stand at the same height. Such an approach sees the deception of human subjects in research as an affront to autonomy and privacy. Note, however, that duty-based and rights-based approaches represent only two of many moral codes that could frame the ethics of research with human subjects. For instance, it is conceivable that ethical principles could emphasize self-sacrifice, rather than self-centeredness, for voluntary participation in research to produce social good rather than individual benefit.

Three fundamental principles define the ethics of use of human subjects in research: respect for persons; beneficence; and justice. Three corresponding practices -- informed consent, assessment of benefits and risks, fair selection of subjects -- implement these principles. Any institution that receives federal funds for research must constitute an Institutional Review Board (IRB) composed of peers of researchers, people with training in law and ethics as these fields relate to research, and representatives of vulnerable groups and the lay community with whom research is conducted. IRB's review, approve, and monitor use of human subjects in research. Penn State's IRB is divided into two committees so that research dealing with social and behavioral research can be reviewed separately from biomedical research. Penn State's Hershey Medical Center has a separate IRB and legal assurance of compliance with the US Department of Health and Human Services.

Principle of respect for persons applied to informed consent

The first principle of the Nuremberg Code states:

The voluntary consent of human subjects is absolutely essential. This means that the person involved should have the legal capacity to give consent; should be so situated as to be able to exercise free choice without the intervention of any element of force, fraud, deceit, duress, over reaching, or other ulterior form of constraint or coercion and should have sufficient knowledge and comprehension of elements of the subject matter involved as to enable him or her to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to the subject the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon health or person which may possible come from the subject's participation in the experiment.

The principle of respect for persons involves two basic convictions. First, individuals are autonomous, independent, self-governing agents who are allowed to decide for themselves whether to participate in research. Autonomy involves capability to deliberate about personal goals and to act from this deliberation. Second, individuals with diminished autonomy need special protection. People with diminished autonomy cannot make their own decisions due to, for instance, immaturity, illness, incarceration, mental disability, or dependency. Obviously, the extent to which autonomy is diminished depends upon the nature and complexity of the research protocol as it interacts with the subject. In some cases, third parties need to provide consent. Where it is possible, subjects with diminished autonomy should assent to participate, even though full consent cannot be obtained. The principle of respect for persons is implemented by obtaining the informed consent of subjects prior to their participation in research.

Informed consent has at least four features:
1. Potential subjects receive information.
Subjects must receive information about the research procedure, its purposes, the risks and anticipated benefits of participating in the research and any alternatives to the research protocol (when therapy or services are provided). Also, the subject needs to have the opportunity to ask questions and to withdraw from the research at any time, for any reason (even if the reason is unclear or troubling to the researcher).

2. The potential subject comprehends this information.
Comprehension involves understanding the research protocol, which is predicated on the capacity of the subject to understand. In some cases, lack of comprehension is due to a poor explanation by the researcher; in other cases, the potential subject may not be able to understand the protocol. The burden of proof of comprehension is on the researcher.

3. The consent to participate is voluntary -- that is, free of coercion and not obtained through undue influence.
Coercion involves overt threat of harm to obtain compliance (e.g., a threat to withdraw health services to which an individual would be otherwise entitled). Undue influence occurs through excessive, inappropriate, or improper reward or overture to obtain compliance, especially when the potential subject is vulnerable (e.g., large monetary reward for participation of poor subject to become involved in risky research; a higher grade for student participation in research).

4. A clear decision is made to participate.
The subject must make an affirmative statement to participate. Failure to refuse to participate does not imply consent. The need for a clear decision often motivates the researcher to obtain the subject's signature on an informed consent form. Informed consent, though, is a process, not a product. Subjects may sign a form, but, at the same time, may not met criteria for informed consent.

The principle of beneficence applied to the assessment of risks and benefits.

The principle of beneficence requires the researcher to do good for the subject. The term "beneficence" means "to do good" and covers acts of kindness and charity that go beyond strict obligation. This principle is embedded in the Hippocratic Oath, which states, "I will use treatment to help the sick ... but never with a view to injury or wrong doing." Extended to research, this principle requires the researcher to never injure a subject regardless of the benefits that might accrue to others. Of course, physical harm comes to mind with the term "injury," but research may result in psychological, social, and economic harm to the subject.

The principle of beneficence has two aspects. First, the researcher should not design studies that harm subjects. Some of the so-called Nazi "experiments" involved harming, even killing, subjects. Brutal or inhumane treatment of subjects never is morally justified. However, the dilemma is that avoiding harm requires knowing what is harmful, and, in the process of obtaining this information, the researcher may, indeed, expose subjects to harm. Therefore, the second aspect of the principle of beneficence requires researchers to maximize the potential benefits from research, while minimizing its possible harm.

The principle of beneficence is implemented by assessing the risks and benefits of proposed research. At times, this assessment clearly reveals that human subjects actually are not necessary at all to attain research objectives. However, the assessment of risks and benefits frequently is not clear; rather, it often involves controvertible judgments of whether the risks to subjects are reasonable in relation to the anticipated benefits. Assessment of risk involves identifying all possible harms that may occur, estimating the probability of the occurrence of harm, and considering the severity of the harm that will occur if the risk is realized.

Benefits from participation in research may flow to the participants themselves. For instance, subjects may have access to an innovative treatment that, although not proven efficacious, may represent a last hope for remission of a disease. Benefits may flow to society in terms of increased knowledge, better practice, improved safety, technological advances, or better health. If no benefits from proposed research are anticipated, then research should not be conducted. It should be clear that establishment of a simple and precise benefit/risk calculus for evaluating research protocols is an unreachable as a philosopher's stone. Judgments are involved in delineating risks, their probability, and their severity, if realized. This is also true for specifications of the anticipated benefits of research. It is precisely because judgments are involved that IRBs are established to help researchers weigh the risks and benefits of proposed research. Two perspectives often are better, or at least more cautious, than one.

Risk/benefit information is provided to the subject when informed consent is obtained. The risks and benefits surrounding a research protocol often are quite technical. As indicated in the previous section of this chapter, subjects must comprehend this information. Therefore, researchers are required to carefully and accurately translate statements of risks and benefits into language that is tailored to the subjects.

For researchers, one controversial aspect in the assessment of risks and benefits is the role of research design. Researchers often feel that the technical aspects of their research should not come under review. However, poorly designed research does not yield benefits. For instance, a study with too few subjects may not be statistically powerful enough to be able to reject a null hypothesis. (We will discuss issues of power in statistical analysis in later chapters.) In such cases, individual subjects are exposed to risks without any potential for social benefit.

Assessment of the adequacy of research designs presents difficulty for IRBs because they are composed of members who are lay people as well as researchers. Even the researchers serving on an IRB may not hold the competence necessary to evaluate another researcher's work. The danger is that the IRB process may allow researchers to rise only to the level of competence of the IRB.

The principle of justice applied to fair selection of subjects.

Justice in use of human research subjects requires fair distribution of the burdens and benefits of research. During the early years of scientific research involving human subjects, the burden of risk for serving as a subject fell on poor ward patients, while the benefits of research flowed to private care patients. Subjects should not be selected for research merely because their participation can be manipulated or coerced as a result of, for example, their illness, socioeconomic status, institutionalization, or infirmity. On the other hand, inclusion of underrepresented groups in research is also important. For instance, under representation of women in research protocols concerned with the prevention and reduction of hypertension has led to a lack of information about the efficacy of hypertension therapies for women.

National Research Act   

Money

The federal government holds a big stick (money) over the heads of researchers in order to enforce proper ethical treatment of research subjects. For example, in 1973 regulations from the US Department of Health, Education and Welfare stated:

No grant involving human subjects at risk will be made to an individual unless he is affiliated with or sponsored by an institution which can and does assume responsibility for the protection of the subjects involved.

The Act

This statement was turned into the National Research Act of 1974. Several points need to be made. According to this Act, federal grant money is not available to researchers conducting research on humans unless they are sponsored by an institution. Individual researchers are precluded from receiving federal grant money. Second, that institution must assume some responsibility for the protection of the humans involved in research.

This Act made a profound impact on colleges and universities across the nation. It has certainly changed the lives of university professors. I find that many undergraduate students don't realize that the major function of university faculty at many institutions is to conduct research. At many research universities (as opposed to teaching universities), faculty are hired, promoted, and receive salary increases based primarily on their research productivity. Indeed with the recent financial problems facing most universities, even the word research has changed its meaning. Talking to many of my colleagues they tell me that just conducting research is not enough to progress up the promotion and tenure ladder, they must conduct funded research that financially supports their university. This is not to say that research universities ignore teaching. At many universities a professor's teaching ability is highly valued. However, many faculty members at research universities believe that a recent trend across this nation is to regard the attainment of large research grants by faculty as more important than their ability to teach. Of course, you are in the best position to evaluate this trend at your school. If most of your classes are taught by graduate students instead of professors, if it is exceedingly difficult to get an appointment with a professor because they have most of their time devoted to research and writing, if graduate education is valued far more than undergraduate education, then you are probably enrolled in an institution that overvalues funded research.

The National Research Act of 1974 has greatly impacted the lives of university students. When I was finishing my degree at the University of Nebraska in 1970, my research plan was evaluated exclusively by my dissertation committee. Now, of course, any research that is affiliated in almost any way with a university and uses human subjects, or the data collected from humans must be evaluated and approved by ethical review boards. At Penn State, where I am currently on faculty, we have the protection of human subjects through the Behavioral and Social Sciences and Biomedical Review Committees. If you plan to conduct a research project as part of a class assignment, or if a research project involving human subjects is affiliated with you and your school, through your position as a student at this institution, you may need permission to conduct the research by an established ethics board at your institution.

Why Ethical Review Boards?   

Ethical rules and policing bodies sprang out of the fact that in most research ethical considerations are present. It is only a slight exaggeration to say that if your research doesn't break some ethical considerations it is probably not worth doing. Usually these ethical rules are broken for scientific purposes and not because of some evil intent on the part of the scientist. To properly use the scientific method, one usually has to do some damage to one or more of your human subject's fundamental rights.

For many professionals even the decision to conduct, or not to conduct, research is an ethical consideration. For example, if you are studying to become a psychologist, then you know that it is one of a psychologist's obligations to use their research skills to extend knowledge for the sake of ultimate human betterment. Much of the academic work required to become a college educated professional (psychologist, doctor, engineer, chemist, teacher etc.) is devoted to teaching you how to conduct research to extend the knowledge base in your area. The techniques you learn in your research courses often directly conflict with ideas promulgated in an ethics course.

Additional Information   

You are encouraged to use the web to further your research ethics understanding. The following resources are highly recommended:
On Being a Scientist: Responsible Conduct in Research published by the National Academy of Sciences.
Many links can be found on the Applied Ethics Resources on the WWW page. Particularly important is the link at this site to the search results using the words "Applied Ethics" using the major search engines.
Many interesting links to Internet resources concerning research ethics are provided by the Center for Research Ethics.
Steven Hale (no relation to this author) maintains an interesting web site of information on nonconsensual experimentation with humans.
You might be interested in Indiana University's policy about faculty using students in research.

In 1995, Time magazine published a story reporting research done at Carnegie Mellon University by Marty Rimm. Rimm's report Marketing Pornography on the Superhighway, was published in the Georgetown Law Journal. The original article, and the Time cover story have both been shown to have serious research flaws, but were used by conservative special interest groups to attempt to limit access to the Internet. You may want go gain a general understanding of this report and the issues around it by viewing the relevant material at the Carnegie Mellon web site. Note particularly the information at Vanderbilt University's Project 2000 web site. Finally, an interesting discussion of The Belmont Report and other ethical principles and how they were ignored by Carneigie Mellon University in relation to an investigation on Cyberporn is available on the internet.

Questions/Test    

This link allows you to take a computer scored end-of-chapter test. If your instructor requests to see the results of this examination, you can either copy and e-mail or print the feedback you will receive immediately after taking the test.

Report    

Please send a report indicating your understanding of this chapter to your instructor. You will need to know both your and your instructor's e-mail addresses.