Institute for Christian Teaching

Education Department of Seventh-day Adventists

 

 

 

 

 

 

 

 

 

 

 

 

 

THE USE OF HUMAN SUBJECTS IN RESEARCH AT ADVENTIST COLLEGES

AND UNIVERSITIES: SUGGESTED GUIDELINES

 

 

 

 

 

by

 

Beverly J. Rumble

 

Editor, Journal of Adventist Education

General Conference of Seventh-day Adventists

Silver Spring, Maryland

 

 

 

 

 

 

 

 

 

 

Prepared for the

International Faith and Learning Seminar

held at

Newbold College, Bracknell, Berkshire, England

June 1994

 

 

 

 

 

 

207-94 Institute for Christian Teaching

12501 Old Columbia Pike

Silver Spring, MD 20904 USA


The term "human experimentation" often brings to mind horrifying abuses of human rights, such as experiments in Nazi concentration camps.  Other, less famous examples include the following:

 

•      In the late 1800s E. Franenkel inoculated the eyes of terminally ill infants with gonorrhea cultures.[1]

 

•      Early in the 20th century Richard P. Strong (later professor of tropical medicine at Harvard) injected plague germs into death-row inmates in the Philippines.[2]

 

•      In the Tuskegee (Alabama) syphilis experiment that stretched over 40 years, researchers withheld treatment from 399 poor black men so that they could study the physical effects of untreated venereal disease.[3]

 

•      In 1966, Henry Beecher, a Harvard Medical School professor, exposed more recent abuses in human experimentation.  His "roll of dishonor" included withholding of penicillin from uninformed servicemen with streptococcal infections, a number of whom contracted rheumatic fever; feeding of live hepatitis viruses to residents of a state institution for the retarded to study the disease and attempt to develop a vaccine; the injection of live cancer cells into elderly and senile hospitalized patients without telling them the nature of the cells; and a number of other shocking abuses. Beecher maintained that "unethical or questionably ethical procedures are not uncommon" among researchers, and that the rights of human subjects were widely disregarded.[4]

 

•      In order to investigate whether side effects such as nervousness and depression could be caused by oral contraceptives, Goldzieher gave dummy pills to 76 women who sought treatment in a San Antonio, Texas, clinic to prevent further pregnancies.  None of the women was told that she was participating in research or receiving placebos. Most of the experimental subjects were poor Mexican-Americans with several children.[5]

 

•      In at least 31 separate experiments between the mid-1940s and the 1970s the U.S. Government exposed nearly 700 people to radioactive substances. These included an experiment in which Manhattan Project scientists, the designers of the first atomic bomb, injected 18 people with "relatively massive quantities of bomb-grade plutonium" to see how much of the toxic substance their bodies would retain.[6]

 

        The above examples highlight abuses in medical experiment.  But some investigations by social scientists have been scarcely less questionable.  For example:

 

•      Zillman and Bryant randomly assigned 80 male and female undergraduates to watch various amounts of heterosexual pornography of a six-week period. The students were then asked to estimate the percentage of U.S. adults performing certain sexual acts, and to recommend a prison term for a rapist described in a newspaper article.[7]

 

•      To evaluate a questionnaire that proported to test peoples' comprehension of moral principles, a team of social scientists proposed to administer it to teenagers at a male juvenile delinquency rehabilitation center, and then tempt them to lie or steal.[8]

 

•      Posing as fellow believers, researchers covertly studied a small flying saucer cult whose members were waiting for the end of the world. The ratio of researcher-believers was so high, however, that their participation wronged those studied not only by lying to them but also by providing false "evidence" to reinforce their beliefs (and at the same time, altering the phenomena under investigation).[9]

 

            Other studies have attempted to find a genetic link to criminal behavior or intelligence,[10] or have exposed subjects to psychoactive drugs without their knowledge.

 

            Professors and students at Seventh-day Adventist healthcare training institutions, as well as at our other colleges and universities sometimes conduct medical and social science experiments and studies using human subjects.  In the United States, the federal government closely regulates medical experimentation on humans; therefore, that area will not be the primary focus of this paper, though some of the policies established for healthcare institutions provide the basis of its suggestions for social science research. Administrators would be well advised to use these guidelines in developing policies for their institutions.  A list of helpful sources is included at the end of the paper.

 

Reasons of Experimenting on Human Subjects

 

As abhorrent as the above experiments seem to us today, they appeared perfectly defensible and even urgently necessary to the people who performed them. So we are forced to look more closely at the reasons for using human beings in research.

 

In general, researchers argue that hey are contributing to and extending human knowledge through research, and that their studies advance health, science, and human welfare (perhaps also providing the researchers with some renown in the annals of science).  An ethicist cementing on such research said that these scientists seek to avoid the "menace of avoidable ignorance."[11] In times of national emergency, such as wartime, research seems a patriotic imperative, for it provides knowledge that may help subdue enemy aggression or save the lives of military personnel.

 

Researchers claim that they need to use human subjects in their studies because they cannot achieve the same results with simulations or animals. This is especially true in social science research.  In resisting external controls on their research, they argue that freedom of inquiry is essential for healthy research.[12]

 

Despite researchers' commitment to the general good and to extending human knowledge, their "omnivorous appetite"[13] for scientific research, as ethicist Paul Ramsey puts it, can cause them to lose sight of the importance of each individual subject. As Henry Beecher pointed out.

 

"Any classification of human experimentation as 'for the good of society' is to be viewed with distaste, even alarm. Undoubtedly all sound work has this as its ultimate aim, but such high-flown expressions. . . have been used within recent memory as cover for outrageous acts. . . There is no justification. . .for risking an injury for the benefit of other people. . .such a rule would open the door wide to perversions of practice, even such as were inflicted by Nazi doctors on concentration camp prisoners. . .The individual must not be subordinated to the community."[14]

 

Although progress depends heavily on science and technology, we no longer naively assume that this is the way to the good life.  Nuclear weapon, widespread pollution and abuses of human beings in research like that cited above have sensitized us to the potential for evil–as well as good–that science and technology can achieve.  Previously undreamed-of capabilities for human beings to control birth and death, to transplant human organs, even to manipulate genetic material, have highlighted the need for external controls over researchers and medical personnel.

 

Exposes in scientific journals and the popular press have revealed a stark conflict of interest between researchers' ambitions and subjects' well being.  As a result, in the U.S. federal regulations have been passed requiring oversight and collective decision making.[15]

 

The areas that have generated the most serious ethical problems are the design of the experiment, choice of subjects, obtaining informed consent, balancing risk to the subject with benefits to the researcher and society, and maintaining the participant's dignity and privacy. These topics will be dealt with in greater detail later in this paper.

 


Moral Implications

 

As Christians, we view the scientific method differently from those who hold a naturalistic philosophy about the origins of human beings. We believe that God designed the universe to operate in an orderly way, although He may occasionally step outside of natural processes to perform miracles.  Therefore, since the universe is orderly, and God made human beings capable of rational thought, we can design experiments to explore the mechanisms of the physical universe and even to study human behavior through the social sciences. We can thereby discover some of the marvelous aspects of God's creation, extend the boundaries of knowledge, and alleviate human suffering.

 

However, our beliefs will put certain constraints on the kinds of scientific research that we do. For example, if we believe that human beings are created in the image of God, we will treat humanity at every stage of life with respect–even miscarried fetuses, human tissue, and frozen embryos–in contrast to how we would act if we believed that homo-sapiens are essentially no different from other creatures in the natural world.

 

Human experimentation raises a number of religious and ethical dilemmas.  Traditionally, such research occurred in the field of medicine, where the physician was expected to be committed to the good of the individual patient. The primary rule of medical morality was to do no harm–based on the Hippocratic Oath and guidelines for medical ethics drawn up by the General Assembly of the World Medical Association in 1949.[16] The timing of the latter guidelines was doubtless inspired in part by the Nuremberb trials, which revealed the flagrant abuses of Nazi researchers.

 

How do we balance the needs of the individual with those of society? Should researchers be allowed to induce or coerce individuals to subject themselves to certain risks for the good of others? To clarify this, let us look at two extreme positions: The first would subordinate the individual to the good of society. This would allow medical and psychological experimentation on human beings without their consent if the studies would benefit society. This represents the classical utilitarian theory of choosing the greatest good for the greatest number. Thus, anytime a researcher could claim that a procedure or experiment would benefit society, he or she could justify overriding the rights of the individuals involved for each person counts for only one.

 

At the opposite extreme, absolute individualism acknowledges no significant relationship between the individual and society, and asserts the primacy of the individual over the group. Most ethicist acknowledge that at times the individual must be limited by the needs of society, and that each person has an obligation, as part of a community, to act in ways that benefit others.

 

Human beings do not exist as isolated atoms. They are actually constituted by their relationships–to the world, to their family, to their fellow human beings, to the Church, and to God. It is important to stress that these relationships are not extrinsic or spatial but intrinsic; they belong to the very fabric of each person's being.[17]

 

Jesus' admonition to "love your neighbor as yourself" ties together both respect for persons and one's obligation to the larger community.


It may be helpful at this point to divide moral obligations into two categories–those that are required of all human beings, and others that are heroic–above and beyond the call of duty. Some people would want to volunteer for experiments to help others, despite the risk to themselves. But no one should be coerced into participating in such studies. In every case, we must evaluate the balance between the risks and potential benefits and give potential subjects enough information to allow them to make an informed choice.

 

In recent times, Western society has become more concerned about protecting the individual against possible invasions of dignity, privacy, and freedom. Christian ethics has always asserted that every person possesses certain inalienable rights, that individuals are ends in themselves. They are never to be used merely as a means to something else–no matter what their race or color, how well or poorly endowed with talents, or how primitive or developed. Therefore, the individual takes primacy over society. However much the good of the whole exceeds that of any of its parts, and whatever duties each person owes to society, individuals constitute the supreme value, and society exists only to promote the good of its members.

 

"In view of people's tendency to exploit their fellow human beings, the scriptural revelation of the innate, inalienable dignity and value of the individual provides an indispensable bulwark of freedom and growth."[18] Christ's example and teachings and the admonitions of Old Testament prophets provide a basis ethical framework for making decisions about how to treat people, both in daily life and in experimentation.

 

Our Lord has taught us that the Decalogue is centrally a statement of what love demands. But since justice is one of the things that love enjoins, it is possible to distill from the Ten Commandments a list, even though it be a partial list, of the rights and liberties men can claim. . . This. . is only a partial list of the rights we tend to claim. . . We can go to the Old Testament prophets and learn from, say, Hosea, that the powerless have a right to be protected against the strong.[19]

 

Each human being is unique, created in the image of God and redeemed at an infinite price. He or she possesses the power to think and to do, according to Ellen White.[20] This means that God places a high value on allowing each person to choose freely what actions he or she will take. This principle should influence researchers' choice of subjects and topics for investigation.  They too are free to choose, but should keep in mind Paul's admonition: "Brethren, ye have been called unto liberty; only use not liberty for an occasion to the flesh, but by love serve one another" (Galatians 5:13).

 

Research, optimally, should consist of a "truly joint venture between two human beings working together for the increase of human knowledge and the ability of human beings to serve one another. From this perspective, the subject is a coparticipant in the human quest for progress."[21] This gives the subject a more active role, and requires the researcher to respect his or her humanity and rights as a freewill agent. Therefore, as Hans Jonas points out, the most highly motivated, the most highly educated, and the least captive members of our communities would make the best research subjects. Subjects with poorer knowledge, motivation, and decision-making freedoms (who are consequently more readily available in terms of number and possible manipulation) should be used more sparingly and reluctantly.[22] Curran suggests as a criterion whether one would subject his or her own children to the proposed experiments.[23]

 


Unfortunately, this has not been the usual method of choosing subjects for experimentation. Those from lower socioeconomic classes, minorities, prisoners, the gullible, and the mentally incompetent have borne an undue share of the burden as subjects of experimentation.

 

To treat individuals ethically means not only to respect their decisions and protect them from harm, but also to actively attempt to ensure their well-being. This is encompassed in the term beneficence,  which implies the following principles for research on human beings: "(1) do not harm, and (2) maximize possible benefits and minimize possible harms."[24]

 

Although discovering what will in fact benefit people may require exposing them to risk, forethought and oversight are needed to assess when it is justified to seek certain benefits despite the risks involved, and when the experiment should be forgone because of the possible risks.  Such risks may involve psychological, physical, legal, social, or economic harm.

 

For the Christian researcher, the principle of stewardship is also a relevant concern. "We do not possess anything in the world, absolutely, not even our own [or other people's] bodies; we hold things in trust for God, who created them, and are bound, therefore, to use them only as He intends that they should be used."[25]

 

Montemorelos University's "Philosophy and Role of Research" statement expresses well the concept of stewardship:

 

A consciousness of our stewardship of God's creation prohibits the investment of time, ability, or economics resources in the search of knowledge that may result in adverse effects for human life, or that involve immoral elements or consequences. By the same token, this consciousness motivates us to the diligent research of all practical possibilities toward the common well-being of mankind.[26]

 

Christian principles should be applied at every stage of research–planning the study, choosing subjects, informing participants of the risks and benefits, performing the experiment, debriefing subjects, and guarding the privacy of subjects–as well as careful analysis of the data, reporting of the study, and ethical use of the data after the study has been completed.

 

Design of the Experiment of Study

 

David Rutstein points out that "Attention must be given to the ways an experiment can be designed to maintain its scientific validity, meet ethical requirements, and yet yield the necessary new knowledge."[27] The experiment's design goes straight to the basis questions asked by the investigator. What problem does he or she seek to solve? What information does he desire to obtain? Are the proposed methods and techniques consistent with Christian ethics?

 

In the medical area, a standard question is whether the experimentation is therapeutic, or conducted only for its research value. Research is clearly non-therapeutic when it is carried out solely to gain information that will benefit others, but which is of no use to the patient.


An analysis of the design of social science experiments should address the following questions:

 

•      Is it ethical to ask people to perform the actions specified by the researcher?

•      Will the procedures cause psychological injury or humiliation to the subjects?

•      Could any part of the research cause irreversible changes in the subjects' personality or moral values?

•      Do the researcher's actions mislead subjects by lending support to false ideas or prejudices?

 

Application of the principles underlying these questions would clearly eliminate any proposals that require participants to perform illegal or immoral acts, that expose them to pornography or depictions of violence, or ask them to participate in psychological experiments that would be demeaning to themselves or to others.

 

Potential conflicts of interest and threats to researcher integrity also present ethical dilemmas.  Research sponsored by an organization that expects a particular result (a tobacco company, for example), whether or not it uses human subjects, should raise a red flag for researchers who seek to do pure science and arrive at truth, unencumbered by any type of coercion. Christian researchers will doubtless also want to engage in serious reflection and prayer, perhaps seeking pastoral and ethical guidance, before participating in research that may contribute to military weaponry or be used to destroy or harm human beings or the natural world.

 

Choosing Subjects for Research

 

Methods for choosing subjects may not be as obvious or ethically neutral as some researchers would have us believe. Participant selection raises ethical issues on two levels: social and individual. Researchers should not offer potentially beneficial research only to certain categories of persons, or select only "undesirable" persons for risky research.  Social justice requires that distinctions be drawn between classes of subjects. Those who cannot give consent or who ought not to be further burdened, such as the indigent, children, the institutionalized or mentally infirm, and prisoners should be used only under certain carefully controlled conditions.