the irb, ethics, and the objective study of religion in health

The IRB, Ethics, and the Objective Study of Religion in HealthAuthor(s): Stephen G. PostSource: IRB: Ethics and Human Research, Vol. 17, No. 5/6 (Sep. - Dec., 1995), pp. 8-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564567 .

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IRB

legitimate claim to partial ownership of the stored biological materials, as well as to some of the commercial profits resulting from patenting an immortalized cell line in the unlikely event that profits are to be made from the research. Participants in genetic research projects do not have as large a claim on control, ownership, and profits as the scientists do who create transformed cell lines that would not otherwise exist, but, like John Moore, the persons who contribute the original tissue samples that are the biological foundation for the resulting cell lines also have a role in this achievement. We do not think that the contributors of the original DNA samples should be excluded from consid- erations about ownership and profit. Rather, we propose that participants in genetic studies (i.e., the sample sources) be regarded as the original "owners" in a sequential ownership of biological materials, a sequence that sometimes results in the creation of an immortalized cell line and, on rare occasions, patents and commercial profit. Our suggestion is that the original owners in this sequential ownership be promised in consent documents they sign that they will receive 10-25% of any profits gained from a cell line created from their DNA sample (including profits made by subsequent investigators at other institutions), if that should happen. This arrangement of ownership and profit should seem fair, we believe, to reasonable persons inside and out- side biomedical science.

A likely response to this suggestion is for genetics investigators to express concern about the possibility of inducing persons to participate in genetic research for the wrong reasons, namely the hope of financial gain. We certainly do not want to minimize the

problems of inducing research participation with the hope or implication of financial riches. Yet we know that participants in some genetic research projects already get financial pay- ments for participating in the studies and for supplying tissue samples for research purposes. We also suggest that researchers can appear self- serving and paternalistic on this issue when they indicate that ownership and profit should go exclusively to scientific investigators, at least in part so that research participants can be spared problems brought on by the possibility of financial gain. The possibility of that financial gain for research participants may, of course, be no greater than their chances of winning a multistate lottery.

To sum up, we have described how consent documents for genetic research using stored DNA samples frequently fail to provide the kind of information that reasonable persons need to have before consenting to participate in such studies. Yet in the age of molecular biology, even a "simple blood draw" is not as simple as it used to be. To reflect the changing nature of genetic research and to ad- dress the interests and concerns that potential research participants rightly have, genetics investigators need to develop a new generation of consent documents, including consent documents that communicate information about DNA banking. Those documents, we hope, will con- tain the 7 categories of content we have discussed in this paper, categories of content that may become stan- dards for the communication of important information that can help elicit informed participation in genetic research.

Acknowledgments This study was supported as part of

the National Institutes of Health grant for the Cooperative Human Linkage Center based at the University of Iowa (grant 1 P50 HG00835-01).

We want to thank the members of the ELSI committee of the CHLC. They have influenced our thinking about informed consent in research and clinical contexts of contemporary genetics, including research using DNA banking. We are especially grateful to Raymond Crowe, MD, Jeffrey Murray, MD, and several anonymous reviewers for their helpful comments on earlier drafts of this article.

The conclusions in this article do not necessarily reflect the views of the investigators in the CHLC or the members of the ELSI committee that is part of this genome center.

References

12. Different points of view are available in Murray, TH: Who owns the body? On the ethics of using human tissue for commercial purposes. IRB 1986; 8(1):1- 5, and Levine, RJ: Research that could yield marketable products from human materials: The problem of informed consent. IRB 1986; 8(1):6-7.

13. Office for Protection from Research Risks, National Institutes of Health: Pr- tecting Human Researh Subjects: Institu- tional Review Board Guidebook Wash- ington, D.C.: U.S. Government Printing Office, 1993; 5-42 to 63.

14. MacKay, CR Discussion points to consider in research related to the human genome. Human Gene Therapy 1993; 4:477-95.

15. Ad Hoc Committee on DNATechnology, American Society of Human Genetics: DNA banking and DNA analysis: Points to consider. AmericanJoumal ofHuman Genetics 1988; 42:781-83.

16. Annas, GJ: Privacy rules for DNA data banks: Protecting coded "future diaries." JAMA 1993; 270:2346-50.

17. Moore v. Regents of University of Califor- nia, 51 Cal. 3d 120, 271 Cal. Rptr. 146, 793 P2d 479 (1990).

The IRB, Ethics, and the Objective Study of Religion in Health by Stephen G. Post

At an April 1995 conference titled "Spiritual Dimensions in Clinical Re- search" sponsored by the National Institute for Healthcare Research (NIHR) and funded by Sir John Marks Templeton a dozen leading clinical empirical researchers presented pa-

Stephen G. Post, PhD, is associate professor of biomedical ethics at the Center for Biomedical Ethics, Case Western Reserve University, School of Medicine, Cleveland, Ohio.

pers on methodological issues, as reported in the Journal of the American Medical Association.' In several pres- entations and audience responses, cases were described in which IRBs at major academic medical centers re- fused to approve scientific research on religion and spirituality on the assumption that these topics are un- suited for scientifically sound inves- tigation. As a speaker at the NIHR conference and as one who has

served on IRBs, it is of concern that the IRB literature has not clarified this matter.

Scientific freedom to study religion should not be violated by IRBs. Critical intelligence requires that this inquiry must be pluralistic- i.e., attentive to religious diversity- and objective-i.e., based on scientific methodology.

Neglecting the study of religion and health may result in less than optimal

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patient care. For example, the Ameri- can Psychiatric Association, in its 1990 "Guidelines Regarding Possible Conflict between Psychiatrists' Relig- ious Commitments and Psychiatric Practice," begins with the precept that psychiatrists "should maintain respect for their patients' beliefs."2 While some clinicians did not consider this precept worthy of special comment, "Many other practitioners, however, were of the opinion that this category of antitherapeutic ethical violation occurs frequently enough and with sufficiently important negative consequences to the individual patient"2 to require specific comment. The guidelines provide a pointed example of negative consequence: "A psychiatrist provided interpretations to a devoutly religious man. In doing this, however, she denigrated his long-standing religious commitments as foolishly neurotic. Because of the intensity of the therapeutic relationship, the interpretations caused great distress and appeared related to a subsequent suicide attempt."2

There can be little or no respect for religious beliefs unless the clinician has some appreciation for the exis- tential significance of religion.3 Yet religious attitudes in the patient, a powerful dynamic, are dismissed from scientific measurement.

This can help explain the surpris- ing interest in alternative medicine in an age of expanding technological sophistication. At least some of this interest can be attributed to the divorce of technical and clinical medicine from a more holistic view of human- ness, inclusive of the religious compo- nent of a person's life.

The problem of "setting-aside" the study of religion is at root historical, for we have inherited a western view of the person that is molded in the history of struggles for ascendancy as scientific views countered historical theologies. Because this divorce de- mands the staking of territory and defense of ground gained, practitioners can be indifferent to theological and religious values, if not confronta- tional. In some areas of health care, the result is polarization between professionals and those in need of care.

Given the dramatic success of empirical science in biomedicine, medicine can now afford to apply the scientific method to the religious dimen- sion of human experience without risking embarrassment. The scientific method must be free of either sacred or secular ideological interference in its interpretation of facts, even if perfectly objective interpretation is impossible. Instead, interference is

now manifested as anti-religious positivist ideology that condemns scientific study of the role of religion in health. The neglect of religion as an object of study is amply documented by David B. Larson's systematic re- views of the literature in clinical and scientific journals.4

The Evolution of Religious Studies

Any confessional study of theological beliefs and traditions is fitting for departments of theology, for such study makes no claim to scientific objectivity. Departments of religious studies, however, do seek objectivity, and have thrived in public and private universities over the past two decades. While religious studies empha- sizes empirical method, faculty are sometimes on the defensive because merely mentioning religion can invite suspicions about advocacy from faculty in other departments. One of my colleagues, a social scientist, recently blurted out that "any National Insti- tute of Aging interest in religion and well-being in old age is just right-wing stuff."

The objective empirical method has been applied to religion by sociolo- gists, historians, psychologists, an- thropologists, and political scientists-e.g., Weber, Durkheim, Troeltsch, Wach, Wundt, Coe, Erik- son, Levi-Stauss, Victor Turner, Jung, G. van der Leeuw, Eliade, and Whitehead. Finally, as the Chronicle of Higher Education reported, "Relig- ion began to move into the academic mainstream in the 1960's, when secular colleges and state universities began to set up new academic departments of religious studies."5 This emergence was in part due to the continued widespread public interest in religion. Yet some are still unable to draw the simple distinction between studying religion and teaching people to be religious.

Supreme Court Encouragement

An additional impetus for religious studies in state universities was the U.S. Supreme Court decision ban- ning prayers from public schools (School District of Abington v. Schempp, 374 U.S. 203 [1963]), in which the Court distinguished sharply between the sectarian practice of religion (banished from public institutions) and the objective academic study of religion, judged con- stitutionally legitimate. Justice Clark wrote for the majority,

It might well be said that one's education is not complete with-

out a study of comparative religion or the history of religion and its relationship to the advance- ment of civilization ... Nothing that we have said here indicates that such study of the Bible or religion when presented objec- tively as a secular part of the program of education may not be effected and consistent with the first amendment.6

This judicial authorization led to the recruitment of faculty to develop programs in religious studies free of sectarian bias or advocacy. The "field" of religious studies brings to- gether all disciplines that contribute to understanding a complex phenomenon. As is their right and freedom, church-affiliated schools such as Boston College or Notre Dame maintain departments of theology, in which a degree of advocacy is permissible. A department of theology is, however, distinct from a department of religion, although the latter may still include objective courses on the history of religious thought and culture.

The study of religion has come a long way. In 1990, Ninian Smart, J. F. Rowny Professor of Comparative Religions at the University of Califor- nia, Santa Barbara, delivered his in- augural lecture, "The Study of Relig- ion as a Multidisciplinary and Cross- Cultural Presence Among the Human Sciences." He began as follows:

The modern study of religion is one of the great intellectual de- velopments of the recent past. But many academics do not yet understand that we have moved far beyond what used to be called theology, that is, Chris- tian theology, and the kind of enterprise typical of seminaries and divinity schools. Our aim in the comparative or cross-cultural study of religion is to ex- plore religion and religions as a force in human affairs, at vary- ing times and places, weak and strong. It is the power of religion, rather than its truth, that pri- marily concerns us.7

Smart concludes that religious studies has a key role in educating young people in a pluralistic world. Furthermore,

To the historians and social scientists I say: We can let you hear more clearly the sound of sym- bols. To the atheists I say: The exploration of the power of worldviews is compatible with everything you stand for, and everything which you oppose.

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IRB To the pious I say: It is your decision to be pious, our task is analysis and synthesis ...8

Many pious persons function admi- rably in departments of religious studies; they set aside their personal religiosity and become objective. Indeed, pious persons are al- most always exemplary teachers and researchers because an especially serious commitment to objective methods shields them from any accusations of advocacy.

The fact that courses in religious studies exist in virtually all private and public universities and colleges in the United States surely implies that medical schools can also study religion.8

Religious Studies and Health Care

Scholars interested in the study of religion in the context of health care can easily relate to Smart's words. It is historically remarkable that the earliest major national meeting on the formation of religious studies of which I am aware took place at the Indiana University Medical Center, Indianapolis, in October 1964, under the sponsorship of the Society for Re- ligion in Higher Education. Among many distinguished presenters, Rob- ert Michaelsen wrote: "Religion is a fact worth studying. It is important to human life and culture." He continued: "The primary reason for the study of religion in the university is understanding-not indoctrination or conversion or edification or moral uplift, although it is possible that the scholarly study of religion might result in any one of these."6

At this conference, Wilbur G. Katz, the distinguished scholar of constitu- tional law, presented these remarks:

In view of the recent Supreme Court decisions, there should no longer be any substantial doubts as to the legality of the academic study of religion in state universities. The justices emphasized the distinction between inculcation of religious beliefs and habits (through de- votional exercises) and the objective study of religion ...9

Although this conference did not ad- dress religious studies in medical schools per se, the fact that it was purposefully convened at a state medical school campus is signifi- cant.

Why should religious facts be stud- ied as part of health and health care research? Because religious facts are so elemental, so rich, and so perva-

sive in the experience of illness. Ig- noring these facts can only reduce the person affected by illness to a purely biological entity. As Arthur Klienman has written, modern phy- sicians "diagnose and treat diseases (abnormalities in the structure and function of body organs and sys- tems), whereas patients suffer ill- nesses (experiences of disvalued changes in states of being and in social function; the human experience of sickness)."10 Illness is shaped by cultural categories, including religious beliefs, practices, and rituals. Klienman worries about a biomedical approach so shaped by molecular biology and the purely disease model that clinicians lose sight of the subjective phenomenon of illness, which includes subjective coping with disease. Klienman concludes that medical legal problems, poor compliance, and poor clinical care all result from physician ignorance "of the beliefs the patient holds about his illness, the personal and social meaning he attaches to his disorder, his expecta- tions about what will happen to him and what the doctor will do, and his own therapeutic goals."1'0, p.256

In a religious culture such as the United States, the illness experience of most patients is religiously con- structed. But this is more than an American cultural artifact. As innu- merable existentially oriented theolo- gians have indicated, the human self loves to protect itself through the creation of daily routines that provide order and control over existence. When illness breaks in--especially severe illness-the routine is quickly muscled aside by the in-breaking wave of chaos. As in Genesis 1, a seething chaos is still present under the veneer of order and regularity. During illness, we realize that the routine is not real, that human beings are fragile and subject to contingen- cies over which we hold no ultimate control. At this point, many call out to some higher being in the universe who, in contrast to ourselves, does have things under control. One need not be a believer to recognize the ex- istential value of religion in coping with the illness experience.

Religion is universal. Some cul- tures are entirely dominated by it; in none is it entirely absent; in illness it is nearly ubiquitous. Thus, the com- petent study of religion in health care needs no defense and should be en- couraged by funding agencies, including the National Institutes of Health, unless entire cohorts of health care professionals are to be denied knowledge essential to effec-

tive patient care. Although religious beliefs may be deemed by skeptics as more myth than fact or more aberrant than normal, religiosity remains a measurable fact that can only be ob- scured by ideology in the most negative sense-i.e., the systematic and unscientific denial of those empirical facts that one simply does not want to consider.

Thus, scientific freedom, patient well-being, and physician or nurse competency are compromised when religion is deemed unworthy of study. Therefore, the ethical question is not whether to study religion in health care, but how to study it with methodological sophistication.

Yet an institution as prestigious as the National Academy of Sciences (NAS) resolved in 1981, "Religion and science are separate and mutually exclusive realms of human thought whose presentation in the same context leads to misunderstanding of both scientific theory and religious belief."11 This statement is only ac- ceptable because the context is a report on science and creationism, in- dicating concerns with theological speculations in scientific curricula. If the assumption that religion must be excluded as the object of scientific study is implicit in this passage, then the NAS is being unscientific.

The National Endowment for the Humanities and the National

Institutes of Health

The ethical imperative to study religion has long been endorsed by the National Endowment for the Hu- manities. There are small hints of progress with regard to the National Institutes of Health and private foundations supporting health and health care research. I turn first to the prece- dent set by the NEH in using tax dollars to support the objective and scholarly study of religion.

In 1963, the American Council of Learned Societies, the Council of Graduate Schools in the United States, and the United Chapters of Phi Beta Kappa created the Commission on the Humanities. The twenty members represented a cross section of intellectual, academic, and business leaders. In its 1964 report directed toward the U.S. Congress, the commission sug- gested that a national "foundation" be formed to support the humanities. The result was legislation in 1965 cre- ating the National Endowment for the Humanities. Two decades later, the American Council of Learned Socie- ties issued A Report to the Congress of the United States on the State of the

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September-December 1995

Humanities.12 In this report the study of religion today is contrasted with earlier and narrower approaches. The first section of the report, prepared by the leadership of the 8,000-member American Academy of Religion, dis- tinguishes the return of the study of religion to the university of the 1960s from the study of "nineteenth century WASP theology."1'3

Among the many topic areas in religious studies, the Academy includes "the complex ethics of medical practices in relation to the terminally ill."13 As a former elected chairperson (1989-1993) of the AAR's section on Ethics, Religion, and Healthcare, I can attest to the AAR interest in the study of religion in the health care context.

Over the past decade, the AAR has received major funding from private foundations (e.g., Exxon Education Foundation, Henry Luce Foundation, the Lilly Endowment), and from the NEH itself, including a $300,000 award for the creation of the AAR Scholars Press. The AAR concludes, "We have taken note of the crucial role of the NEH in our development thus far, and of our hopes for continued involvement in the future."13 In addi- tion to decades of support for the AAR, the NEH has also supported the Society of Biblical Literature, which is also a member of the American Coun- cil of Learned Societies. The NEH has both sponsored and supported nu- merous summer research seminars and institutes for faculty in religious studies.

Were the NIH to follow the model of the NEH, all of its institutes would fund research in religious studies and health care. The NIH National Center for Human Genome Research, through its Program on the Ethical, Legal, and Social Implications of Hu- man Genome Research, currently funds projects that examine the inter- face between genetics, ethics, and religious traditions, largely in the form of conference support. The National Institute on Aging (NIA) and the Fetzer Institute cosponsored a two-day conference, "Methodological Advances in the Study of Religion, Health, and Aging," in March 1995. Whether the NIA or other NIH institutes and centers actually decide to fund objective research in religion and health care remains to be seen. A portion of the budget across the NIH, perhaps 1 to 2 percent, should go toward the support of such research. Religious studies has long been neglected and is as important to health care as the study of ethics, psychology, sociology, and anthropology.

Yet despite the relevance of religious studies in health care and research supported by both public and private foundations, negative bias against the study of religion persists. More needs to be said here.

The Trivialization of Religion

The regrettable elimination of scientific concern over religious fact re- flects a trend that Stephen L. Carter of Yale University Law School calls the "trivialization" of religion. Carter ar- gues that secular liberalism has created "a political and legal culture that presses the religiously faithful to be other than themselves, to act publicly, and sometimes privately as well, as though their faith does not matter to them."'14 He cites ample evidence for a gap between secular elites and the largely religious U.S. population.

In assessing the medical context, Carter claims that patients who re- fuse medical treatment for religious reasons are generally viewed with suspicion, even when tolerated. There is a tendency to pressure people to act "rationally"-even if this involves setting aside religious tenets. Belief sys- tems that are "the fundaments upon which the devout build their lives" are viewed as "passing beliefs."14 Carter describes the trivialization of religious belief: "Pray if you like, worship if you must, but whatever you do, do not on any account take your religion seri- ously." '4, p.5 Freedom of conscience is fine, but "privatize" your religion (i.e., do not act on it publicly).

This ignorance and trivialization of religion then trivializes the lives and dignity of religious patients. The skeptic's request that patients set aside religious identities in order to sit at the table of reasoned consensus simply misses the point: these identities are too essential to set aside. It is futile to ask a devout Muslim to set aside the Koran and be "reasonable" about decisionmaking, or a pious or- thodox Jew to set aside the Talmud and be "reasonable" about whole brain criteria for death, or a Jehovah's Witness to be "reasonable" about ac- cepting blood. What the critic of religion views as archaic and perhaps quaint is vital to the lives of those who prefer to live under a demanding sacred canopy. Because religious iden- tity and conscience are essential to believing patients, it is important that they be respected. They cannot be respected if they are not even under- stood.

The American experiment in liberty confers respect and rights upon the religious individual. By dishonoring

the religious factor through ignorance, caregivers violate a sphere of freedom and experience that lies at the core of our political heritage. By discriminating against the study of religion, we contribute to discrimina- tion against persons and the deterio- ration of therapeutic empathy. The basic principles of morality, including "respect for persons," "do no harm," and "beneficence" all point toward the duty to study religion in the context of health and health care. IRBs should understand this.

References

1. Marwick C: Spiritual aspects ofwell-being considered. JAMA 1995; 273:1561-62.

2. American Psychiatric Association Commit- tee on Religion and Psychiatry Guide- lines regarding possible conflict between psychiatrists' religious commitments and psychiatric practice. American Jour- nalofPsychiatry 1990; 147:542.

3. Post, SG: Psychiatry and ethics: The problematics of respect for religious meanings. Cture, Medicine and Psychia- try 1993; 17:363-83.

4. Larson, DB et al.: Mental health and religion Eh opeia ofBiethics. New York: Macmillan, 1995, vol. 3, pp. 1704-11.

5. Winkler, KJ: Afteryears in academic limbo, the study of religion undergoes a revival of interest among scholars. Chron- ide ofHigher Educaion, 3 February 1988.

6. Cited by Michaelson, R The scholarly study of religion in the state university. In A Report on an Invitational Corrence on the Stdy of Religon in the State Uni- Lrsity, held Oct 23-25, 1964 at Indiana University Medical Center, Indianapolis. New Haven, Conn.: The Society for Relig- ion in Higher Education, 1964, pp. 80- 83, at 81.

7. Smart, N: The study of religion as a multidisciplinary and cross-cultural presence among the human sciences. Santa Barbara, Calif.: University of Califomnia, Department of Religious Studies, 1990.

8. McLean, MD, ed.: Religious Studies inPub- lic Universities. Carbondale, .ll: Southern Illinois University, 1967.

9. Katz, WG: Comments on the legal issue. In A Report on an Invitational Conference on the Study ofReligion in the State Uni- versity, p. 94.

10. Kleinman, A, Eisenberg, L, and Good, B: Culture, illness, and care. Annals of Inter- nalMedicine 1978; 88:251-58, at 251.

11. National Academy of Sciences: Science and coationisnr A viewfivm the National Academy of Sciences. Washington, D.C.: National Academy Press, 1984, p. 6.

12. American Council of Learned Societes: A Report to the Congress of the United States on the State of the Humanities. New Yorkc The American Council of Learned Societies, 1985.

13. American Academy of Religion State- ment. In A Report to The Congress of the United States on the State of the Humani- ties, pp. 1-16.

14. Carter, SL: The Culture of Disbelief How Law and Iblitics Trivialize Religious ev. tionrL NewYoric Basic Books, 1993, p. 3.

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the irb, ethics, and the objective study of religion in health

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