On Being an Authentic Scientist

On Being an Authentic ScientistAuthor(s): Martin L. SmithSource: IRB: Ethics and Human Research, Vol. 14, No. 2 (Mar. - Apr., 1992), pp. 1-4Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564534 .

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Volume 14 Number 2 March-April 1992

On Being an Authentic Scientist by Martin L. Smith 1

The Eutectic Mixture of Local Anesthetics: Changing the Risk-Benefit Ratio in Pediatric Research by Gideon Koren 4

Ethics in Human Reproduction Research in the Muslim World by Patricia A. Marshall 6

Rate of Refusal to Participate in Clinical Trials by David Shimm and Roy G. Spece, Jr. 7

A Survey of IRB Concerns about Social and Behavioral Research by Joan E. Sieber and Reuel M. Baluyot 9

CALENDAR 8

ANNOTATIONS 11

On Being an Authentic Scientist by Martin L. Smith

The Committee on the Conduct of Science of the National Academy of Sciences recently published an in- sightful, readable, and challenging booklet, On Being a Scientist.' Al- though the report is written primari- ly for those beginning to do scientific research, both novice and "veteran" researchers can find within it a help- ful framework for functioning as an

Martin L. Smith, STD, is an associate in the department of bioethics at the Cleveland Clinic Foundation, Cleveland, Ohio.

authentic, ethical researcher and scientist in the service of science and humanity. As the report's preface states, "[The booklet] seeks to describe some of the basic fea- tures of life in contemporary research and some of the personal and professional issues that researchers will encounter in their work."

Three themes emerge from the three main sections of the report: (1) the relationship between "the objective" and "the subjective" in scientific research, (2) the social mechanisms within science that con-

tribute to its authenticity, and (3) the wider social responsibilities of the scientist. What follows are the author's reflections and commen- tary on each of these themes. Mate- rial excerpted from the booklet is either placed in quotation marks or acknowledged as such.

Members of institutional review boards (IRBs) will have a particular interest in this booklet. Charged with ensuring the ethical and scientific validity of the research carried out at their individual institutions, IRBs appropriately assist researchers through issuing guide- lines, policies, and manuals, and by sponsoring and providing educational experiences and resources. The planning and execution of such activities, as well as the individual IRB member's appreciation and understanding of the scientific process, could be enhanced by the booklet's content.

The general goals and purposes of scientific research and the proper conduct of investigators are a few of the areas of concern in which IRBs can assist researchers. What follows can help IRB members reflect on these areas of concern and suggest topics for educational efforts. IRBs might also consider distributing to investigators copies of the booklet, thus providing a model framework within which researchers ought to conduct their activities at the bench and bedside.

Objectivity: The Consequence of Authentic Subjectivity

The relationship between "the objective" and "the subjective" has been a scientific, historical, and the- ological issue for centuries.2 How do these two bipolar elements of human experience interface and influence each other in the process of human and scientific knowledge, understanding, and articulation about "reality"? Is it possible or even desirable to draw a clear line of de- marcation between objectivity and subjectivity?

In the early days of modern scientific methods and goals (dominated by empiricism, rationalism, and positivism), researchers' examina- tion of the physical world com- menced with the premise that there is an antithesis between the objective and the subjective. Subjectivity and various subjective personal elements (e.g., human interpretation and judgments, relativity, values, cultural expressions and limitations, emotions, biases, and preju- dices) were to be stripped away from

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the discovery process and disre- garded totally, leaving only "objective" physical reality under consideration. The scientist then could arrive at "the facts, only the facts": precise, clear, bold, and bare data and discoveries in their unambigu- ous truth. The operating dictum of this theory of scientific inquiry can be phrased as follows: objectivity is the result of eliminating subjectivity.

But this goal of scientific research, to the extent that it once existed and still exists today, is a myth based on the false assump- tions that (1) the practice of science is simply the registration of facts and their articulations and embodi- ments in the laws of nature, and (2) objectivity and subjectivity can be separated and should be separated at every step of the scientific process if there is to be real scientific progress.

The booklet, On Being a Scientist, while affirming the goal of minimiz- ing and even eliminating clearly de- structive or detrimental subjective elements (e.g., negligence, bias, fraud), presupposes a different and more accurate perspective on the relationship between "the objective" and "the subjective." Closer to reality (as opposed to myth) when deal- ing with and analyzing human experience, observation, and data gathering, is the premise that one can never totally divest oneself of or strip away subjective perspectives, value judgments, curiosity, intui- tion, creativity, limitations, the provisional nature of findings and con- clusions, and cultural and value- laden concepts, language, and ideas. Human scientific discovery (including data gathering) will always be colored by these human subjective elements. There is a necessary unity between objectivity and subjectivity because there is a per- vading interaction and influence between the perceiver and what is per- ceived.3

If objective facts and data can never fully and completely be split from subjective hypotheses, inter- pretations, limitations, values, and language, then what must emerge is a different understanding and de- scription of the relationship between the objective and the subjective, and a different goal for scientific research. If the house of science cannot be built on the myth that objectivity is the result of eliminating subjectivity, a more secure and stable foundation is an understanding and presupposition that

objectivity is the consequence of authentic subjectivity.4 This de- scription recognizes the inherent unity between the objective and the subjective, but poses a new question as to the meaning of the "authentic subjectivity" that gives rise to objectivity.

The use of "authentic" in this con- text goes beyond simple definitions or descriptions such as "real" and "not imaginary." Authentic subjectivity refers to a highly focused and intensive way of being attentive, intelligent, reasonable, and responsible.5 These four identified operations are not arbitrarily jux- taposed. They represent a fourfold normative pattern of recurrent and related operations of the mind that yield cumulative and progressive results.6

Despite many differences, science shares these four human activities with mathematics, philosophy, ethics, and theology. The activities are four steps in a dynamic, induc- tive, epistemological process: (1) gathering of data through attentive- ness to experience; (2) ordering, sift- ing, and understanding the data through intelligent grasp or insight about what is experienced; (3) accurate and reasonable judgment about the truth of what is understood; and (4) responsible decision and action in accord with and in response to the judgments of truth. Further, these subjective activities by neces- sity entail values, culture, finite- ness, and the need for interpretation.

These four operations require concentrated effort and substantial achievement if objectivity and creativity are to result. The authentically subjective scientist then is one who is actually attentive, intelligent, reasonable, and responsible.

More concretely, what does it mean to be an authentic researcher contributing to scientific discovery through one's authenticity? Authentic subjectivity in the pursuit of objectivity can be understood to include trying to eliminate whatever distorts good data collection, or distorts the interpretation of the data and the understanding of the physical reality being examined, although from the outset we must concede that distortions can never be totally or perfectly removed.

On Being a Scientist discusses, in various places, activities of the researcher that can be interpreted as additional concrete but not exhaus- tive ways of moving toward authentic subjectivity: developing solid hy-

potheses, being aware of and min- imizing biases, avoiding negligence, reducing unintentional error, and using appropriate techniques such as double-blind trials, randomiza- tion, and control groups.

The Social Mechanisms in Science

A significant and additional facet in the promotion of authentic subjectivity, research, and science is "a framework of collaborative creativity."7 Scientific discovery and progress is the result of individual researchers performing their tasks and roles conscientiously, but no individual researcher is an island unto herself. Authentic scientific research is not done in isolation, nor must each scientist "reinvent the wheel" each time a scientific project is begun. Scientific research is a collaborative and social undertak- ing. If, as stated earlier, scientists ought to promote within themselves authentic subjectivity in order to re- duce distortions and enhance objectivity, then the "social mechanisms" already in place within the scientific community can aid in arriving at authentic, objective, scientific discovery. On Being a Scientist discusses some of these social mechanisms, a few of which are sum- marized below.

The first such social mechanism is the communal review of scientific results. Scientists talk to their colleagues and supervisors, over coffee and over the telephone, airing their ideas and modifying them in the light of the responses received. These ideas are exposed to a broader circle of colleagues through presen- tations at conferences and semi- nars. Research results are written and sent to scientific journals, which in turn send the manuscripts to reviewers for further scrutiny. A published paper is accepted or re- jected by the scientific community to the extent that it is used, reacted to, or ignored by other scientists. This communal review" process does

not eliminate the subjective elements from research, but rather helps to minimize subjective biases and distortions while maximizing authentic subjectivity and therefore objectivity.

A second significant social mechanism in science is replication and openness of communication. As On Being a Scientist notes, it is not prac- tical or even necessary to recon- struct all the observations and theoretical constructs that go into a specific investigation; it is assumed

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that previous investigators performed work as reported, adhered to appropriate methods, and so the new can be built upon the old. But on a selective basis, actual replication takes place, especially for ex- periments with unusual importance or for results that conflict with an accepted body of work. This process of peer validation and verification through replication is another social tool for increasing accuracy, for maximizing authentic subjectivity, and achieving greater objectivity. But without some degree of free and open communication among researchers and a willingness (at appropriate times) to share individual or team results, scientific progress and consensus will grind to a halt. The ultimate, open sharing of data, research results, and research tools for others to scrutinize as well as build upon is essential for authentic science in the service of humankind.

A third major social mechanism that promotes objectivity (as the result of authentic subjectivity) is the avoidance of error and fraud. Be- cause science is progressive, limited, and provisional, scientific theories are always open to being reexamined and, if necessary, re- placed. In a sense, much of the progress in scientific research can be viewed as the discovery and correc- tion of errors, as new theories and better methods enable investigators to extend and revise earlier conclu- sions.' On a different level, because scientists are not infallible, even the most responsible and conscientious researcher can make honest mistakes. Human limitations and subjectivity should be acknowledged at the start, and when such honest errors result and are then dis- covered, they should be admitted and corrected.

But not all errors should be ex- cused too easily. Mistakes can result from negligence, carelessness, inattention, poor work habits, or vi- olating methodological standards. Such errors are preventable, are hindrances to objectivity, and are reflections of what should be elimi- nated in the achievement of authentic subjectivity.

In an entirely different category, and a major affront to the social mechanisms of authentic research, is fraud. What seems most clearly to distinguish honest mistakes and most negligence from fraud is inten- tion: when scientists commit fraud, they deliberately and intentionally choose to mislead and deceive. The intentional concealing of data,

"trimming" data to meet expectations, and outright fabrication of results are all devastating betrayals of authentic research and ultimately of society. To quote the booklet from the National Academy of Sciences: "Of all the violations of the ethos of science, fraud is the greatest."

A fourth and final social mechanism to be commented upon here is credit and responsibility in collaborative research. In the standard scientific paper, credit is explicitly acknowledged in two places: at the beginning, in the list of authors, and at the end, in the list of references or citations. Conflicts over proper credit arise in both places. Issues of authorship, coauthorship, original- ity, dependence on others' work, and significance of a contribution all get played out when scientists collaborating with each other face the question of who gets credit for what. It is impossible to provide an easy formula of rules that would guarantee the proper allocation of credit and responsibility in collaborative research, and thus avoid all conflicts in all situations. Nevertheless, frank and open discussion about this issue within research groups, as early as possible in the process leading to a published paper, could eliminate many diffi- culties. This discussion should include the conventions of a particular discipline or research group, such as the implications of being first in the list of authors, or whether a supervisor's name should appear on every paper that comes out of a particular laboratory regardless of the supervisor's contribution. In general, the listing of "honorary authors" who had little or nothing to do with the genesis or completion of the research project and paper di- lutes the credit due to the people who actually did the work.9

Finally, there is a clear, general consensus within the scientific community regarding plagiarism (i.e., the systematic, unacknowledged use of techniques, data, words, or ideas of others): it is unethical and to be avoided. An appropriate conclusion about authentic research is that it takes responsibility and gives credit where credit and responsibility are due.

Social Responsibilities of the Scientist

These questions of the social mechanisms of science can be seen as part of a consideration of the scientist's social responsibilities. To

be attentive, intelligent, and reasonable, and to uphold these and other social mechanisms is to ac- cept one's responsibilities to the wider community and society. But as On Being a Scientist indicates, further responsibilities can be added to the set. These include at- tention to the fairly familiar social concerns of the impact of scientific discovery and progress on the en- vironment; the appropriate use of animals and animal models leading to human experimentation; the need to respect the dignity of human research subjects, most notably and frequently manifested through a proper informed consent process; and the active participation of scientists (and other professionals) in such issues as nuclear disarma- ment, public health, education, and food distribution. Although these are social, cultural, and economic problems, they are also issues that appropriately engage scientists and researchers directly, and that have a significant ethical dimension.

But the circle encompassing the social responsibilities of the authentic scientist can be drawn even larger. Individual researchers and teams of researchers should peri- odically reflect on and become informed about the wider, at times distant, consequences of their work. How might an area of research and discovery be used for the detriment of humankind and the physical world? If research results can be foreseen to be open to potential abuse, what kind of safeguards can the scientific community put in plac.e to prevent such future abuses? To quote the National Academy of Sciences' report: "World-changing discoveries can emerge from seemingly arcane areas of science." Although the purview of an IRB does not include the possible long-range effects of applying knowledge gained in the research under review, this certainly does not preclude individual researchers or teams from being attentive to such risks. o

The Genome Project now under- way throughout the world can il- lustrate the need for the authentic scientist to be aware of "the bigger picture" and some of the wider consequences of scientific research. The Genome Initiative-the global multi-billion dollar effort to reveal the detailed anatomy of human DNA-promises control or preven- tion of a vast array of diseases and biologic processes influenced by genetic factors." But there has been

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in the past, and there may be in the future, a dark side to human genetics. As a science of human differences, genetics can serve as a tool for those who would exploit, ex- clude, subjugate, or slaughter other human beings. The eugenics move- ment in Nazi Germany sixty years ago inserted into the pages of human history the absolutely worst example of science and research gone wrong. History need not repeat itself, and it can be argued that the historical, cultural, and scientific milieu is significantly different at the end of the 20th century than at the beginning. But reflection and vigilance by the scientific community and by individual researchers relative to the Genome Project are needed nevertheless to help assure that advances in genetics are made in responsible ways that respect human dignity and human values, both in the research to generate the knowledge and in its application.12

The occurrence and consequences of discoveries in basic research are frequently impossible to foresee. Yet authentic science and authentic researchers, attuned to societal expectations and responsibilities, should be attentive, reflec- tive, and informed as much as possible about not only the bright side results of their research, but also the potentially dark side consequences of their work.

Conclusion

On Being a Scientist rejects the notion that objectivity is the result of eliminating subjectivity. We have argued that objectivity is, rather, the result of authentic subjectivity, which is part of the nature of human knowledge and discovery in general, and scientific research in particular. Authentic subjectivity is itself the result of individual researchers' efforts at being attentive, intelligent, reasonable, and responsible. The authentic subjectivity of the scientist can be advanced and enhanced by the proper utilization of the various social mechanisms that are already part of contemporary processes of scientific discovery and reporting.

References

1. Committedme on the Conduct ofScience, Na- tional Academy of Sciences: On Beitg a Scientist Washington, D.C.: National Academy Press, 1989.

2. Damper, W: A History ofS ienc and its Reattion tohsoqhy and ReigiorL Cambridge: University Press, 1968.

3. Delfgaauw, B: T'venieth Centunj

PTalosIphy. New York Magi Books Inc, 1969.

4. Lonergan, B: _thod inrtheokogy. Londoin Darton, Longnagmn and Todd, 2d ed., 1973.

5. Lonergan, Method in Thology. 6. Mueller, JJ: What Are They Sayng About

TheaoagikMethod? New Yorkc Paulist Press, 1984.

7. Lonergan, Method in rThe•ogy. 8. Relman, AS: An err corrected, a con-

clusion withdrawn, and a lesson learned. NE1M 1990; 323:1482-83.

9. Riesenberg, D and Lundberg GD: The order ofauthorship: Who's on first?. JAMA 1990; 264:1857.

10. Department of Health and Human Ser- vices Rules and Regulations 45 CFR 46.111(aX2) (Revised as of March 8,1983) "Ihe IRB should not consider possible long-range effects ofap ng knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility."

11. Botkln, JR The new genetics: A caution- ary tale. Medical Hu •nities Review 1990; 4:27-31.

12. Miller, J: Mapping and beyond. Hastings CenterReort 1990, 20(6):3-4.

The Eutectic Mixture of Local Anesthetics: Changing the Risk-Benefit Ratio in Pediatric Research by Gideon Koren

Children's fears of needles are well documented and often lead them to resist treatment even with life- saving modalities. In most western countries, because venipuncture is considered to present "minimal risk" it may be performed for research purposes even without ex- pectation of direct benefit to the child involved. The impact of the procedure on pediatric patients, however, is often quite traumatic: in addition to the direct pain and anxiety, many toddlers and children must be physically restrained, thus magnifying the perception of in- vasion of the youngster's body and privacy. For more painful proce- dures such as lumbar puncture, physicians often anesthetize the skin with lidocaine infiltration to ob- viate severe pain; this, of course, entails inflicting one pain to remove another.

During the last few decades various attempts have been made to effectively anesthetize the skin by the use of topical anesthetics. I How- ever, because these molecules are lipid soluble, to achieve enough par- titioning into the epidermis they had to be dissolved in organic solvents that are irritating to the skin. Hence while several mixtures have been shown to be effective in anesthetiz- ing wounds (e.g., the tetracaine- adrenaline-cocaine mixture),2 there

Gideon Koren, MD, is chairman of the Human Subject Review Committee in the department of pediatrics and Research Institute, The Hospital for Sick Children, The University of Toronto.

was no available product to anesthetize intact skin.

This article describes a eutectic mixture of local anesthetics (EMLA). This product, presently approved in Europe and Canada, is likely to be introduced to the United States in 1993. In our experience at The Hospital for Sick Children, this agent is an important advance in pharmacotherapy and an effective means to change the risk-benefit ratio in pediatric research.

Clinical Pharmacology of EMLA

A eutectic mixture is a combina- tion of two or more drugs that, upon mixing, decreases each one's melt- ing point. Table 1 presents the com- ponents of EMLA. The anesthetics lidocaine and prilocaine have been used in medicine for many years and their safety record is well estab- lished. The two were chosen after the manufacturer (Astra Ltd., Sweden) found this particular com- bination to be the most effective. A concentration of 2.5 percent of each is needed to produce an optimal ef- fect, and systemic absorption after topical application of the cream is

Table 1. Formula of EMLA 5%

Lidocaine (base) 2.5 g Prilocaine (base) 2.5 g Arlatone@ 289 1.9 g Carbopol@ 934 1.0 g Sodium Hydroxide 2 M 7.2 g Water purified 100.0 g

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Documents

On Being an Authentic Scientist