"The Role of Ethics in Science and Public Policy"

Dianne N. Irving
Copyright September 8, 2005
Reproduced with Permission

Note: The unfolding and often ugly details of the current contentious issues of human cloning, human embryonic stem cell research, and patient "therapies" have called into serious question the very integrity of scientists and medical researchers, of their data, of the institutions (both private and public) which fund them, of the politicians and legislators who promote them, and of the scientific and medical research enterprises themselves.

This conundrum has been growing exponentially for decades, with little or no discussion about any "ethics" to reliably repair the personal and social damage caused by such scientific and medical chaos and opportunism other than the federal "bioethics" and the OHRP regulations for the use of human subjects in research concocted out of thin air by Congressional mandate (in the 1978 Belmont Report and the 1981 OPRR Federal Regulations).

While federal "bioethics" has obviously failed miserably (see Irving, "What is 'bioethics'?"), no viable alternative has yet gained acceptance. The problems continue to multiply exponentially, and thus does the need to advance a viable alternative to this federal "bioethics".

For purposes of simply identifying the various elements of this massive problem in science and medicine so that they can then be addressed more adequately, please find below just the concluding section of an alternative ethics proposal I wrote several years ago. If nothing else, these identified problems have expanded into even more areas of science and medicine today. For the more technical academic analysis preceding this application, see the entire article, "Which ethics for science and public policy?", Accountability in Research 1993, 3(2-3):77-99, at: http://www.lifeissues.net/writers/irv/irv_42whichethics1.html.

"[Application]: The Role of Ethics in Science and Public Policy"

If scientists are really serious about "self-regulation" in order to prevent the prevalence of scientific fraud in contemporary science, such "self-regulation" will succeed only to the extent that individual scientists identify for themselves those elements of a viable individual and social ethics - an ethics which ensures the integrity of the scientist who produces the "data", as well as of those social institutions which so deeply impact on the scientific enterprise itself. What, then, is the role that such an ethics could play in science and public policy?

A. The ethical scientist

Individual "ethics" - accurately understood - does not immediately determine the accuracy of scientific data, statistical probability, computer analysis, the peer-review, grant funding, government regulatory or Congressional decisions. But it does immediately affect the integrity of the "man" who is running these machines, and his decisions - i.e., the person behind the starched white lab coat, as Kornberg might have put it! If the "man" or his decisions are factually wrong - or his or her conception of "ethics" is wrong - - - well, "a small error in the beginning ......". It is often easy to loose sight of the fact that first and foremost the "man" is a human being and a moral agent; and then he or she is a scientist, peer-reviewer, granting agent, government official, journalist or Congressman. Indeed, this is precisely why individual ethical responsibility and accountability accrues all along the entire length of the Great-Chain-of-Decision-Making-Circle. Just as important to understand is that when the individual is a part of a "collective" policy decision making process, the impact of the individual's decisions and actions on others - both positive and negative - are greatly multiplied.

Applicable to the individual scientist is the critically important job of starting off the entire chain of decision making with the correct experimental design - which requires the correct information about his or her particular field of science. Thus the first ethical duty as a scientist (because of the expertise possessed) is to be academically competent in the knowledge and information of his or her field. If the scientist is incompetent about the correct empirical facts of the objective physical world which is within his purview, this incompetence becomes disastrous for everyone and everything that follows. Autonomy for everyone who uses this incorrect data is immediately precluded; harm is caused instead of beneficence or justice. Therefore, in terms of the correctness of the experimental design, or the correctness of the interpretations or accuracy of the data, the scientist him or herself takes responsibility for his or her own scientific competence. In this regard, no one has a greater ethical responsibility in the Great Chain than the individual scientist.

But deliberating about the design and analyzing the data can often be seriously affected by outside pressures as well. For example, clinical researchers have expressed their concerns that several pharmaceutical companies - all of which are simultaneously supporting them on grants - put pressures on them simultaneously to design the protocol (or, interpret the data) in such a way as to make their own drugs or devices look better experimentally than they really are. Or - does this scientist or clinician own stock in the drug companies, biogenetic companies, scientific or ethical software, etc., with which they deal - and therefore "fudge" the data for the "company's" benefit, which is thus to their benefit as well? Or, is a favor owed to the colleague in Neurosurgery - who chairs the university grants program, or who also owns stock?

The list of conflicts of interest affecting the scientist's decision making is endless - our point being that even the very design of the protocol - not to mention the production or the interpretation of the data - can be considerably influenced by various pressures which tantalizingly or threateningly weaken the scientist's resistance and lead to not only incorrect, misapplied or even fraudulent data - but to the very breakdown of his or her character, his or her own integrity as a human being, his or her very commitment to objective truth. And this in turn can become habit forming, becoming easier to do each time the occasion arises anew. Aristotle's "reversal" kicks in - the result, bad data. No longer devoted to unraveling the ever-fascinating mysteries of nature, the scientist instead becomes a mere and groveling pawn in the hands of corrupt "others", being corrupted and used, instead of respected and admired.

Individual scientists themselves need to effectively identify and resist these corrupting outside pressures. Every scientist is a moral human agent himself, and responsible for his or her own decisions and actions. And they should be respected as such by the "others". Better for a scientist to refuse complicity, rather than to allow one's self to be corrupted. A scientist's integrity should come to be recognized by the scientific community and political institutions as more important than racking up the publications, volumes of articles and books; millions of dollars in grants; medals, honors and accolades in boundless quantities - or even Nobel Prizes - especially if all of these are really built on a house of cards that will fall, eventually, dragging him or her down with it, and causing real harm to all of those "others" along the way as well.

"Harm" is often not considered by the bench scientist. But a scientist is not an island unto him or herself; he or she does not work in a vacuum - as some would often like to believe. Particularly today, when a scientist's work is applied in myriads of ways, he or she can no longer glory in the absolute "freedom of inquiry" in which we all were educationally drenched. "Absolute Freedom of Inquiry" is as mythical as "Absolute Autonomy", "Pure Beneficence", or "Perfect Justice" are in bioethics - they are all really myths or fictions - and sometimes actually only rationalizations. There are limits or bounds to what any one can do - and that includes a scientist. If a scientist's work is going to be applied to potentially millions of innocent human beings or to our shared environment, then this cherished "vacuum" of absolute solitude evaporates - and the scientist does bear moral responsibility of harm or injury done to those "others" because of his or her scientific incompetence, or freely choosing to succumb to corrupt institutional pressures. This is particularly true of the clinical researcher, who's incompetence and moral cracks are born by his or her very vulnerable human patients whose good, or so it is espoused, is primarily the goal.

B. Ethical institutions

On the "collective" level, such "institutions" also do not immediately determine the accuracy of the information or data. But as an integral part of the Great Chain-Circle, they do immediately cause such excessive and misdirected influences and pressures that, again, these influences and pressures in turn can seriously compromise the integrity of the individual scientist and the "others" with whom he or she are affiliated, eventually causing similar harm along the entire length of the Great Chain-Circle, calling into question the integrity of the institution and indeed of the entire scientific enterprise itself. "Collectively" this is perhaps even more problematic, given the hundreds and thousands of individuals whom these institutions directly influence and pressure on a daily basis.

Rather than fostering the common good, institutions can in fact abuse as well as use the scientist - in politics, committees, or organizations; or through unrealistic or overburdening regulations; or by the media. These outside pressures also affect the scientist's decision making processes. For example, inappropriate or inordinate pressures might sometimes be placed on the scientist to conform to supposedly "standard" or currently popular, or politically correct, or politically motivated "scientific" frameworks of reference or explanation - even if those basic "frameworks" might be objectively false. The "politicization" of science seems to be running at an all time high.

Similarly, unimaginative and stubborn resistance to innovation is one thing; blocking it, because a committee, organization, industry or political party with power and influence does not want the old "status quo" to be demonstrated wrong - is ethically reprehensible. It corrupts the scientist as both human being and scientist by bringing sometimes unbearable pressures on him or her. It also corrupts the other co-committee members who are also pressured into compromising themselves as moral human agents in consort with each other. And it often corrupts the institution itself. Such pressures or influences require nothing less than the rejection or suppression of the true facts about nature and the substitution of incorrect facts in their place - which facts in turn are used as the false starting point of the Great Chain-Circle.

Or again, a scientist can be abused by oppressive and costly governmental over-regulating, which crushes creativity and unnecessarily bogs down the entire scientific enterprise itself. Nor should undo pressures influence the scientist to produce "perfectly auditable" data, which must sometimes be made to artificially conform to a "financial set" theory. How many times in the history of science have major breakthroughs occurred because of creative and innovative approaches or explanations, or because of simple errors which were honestly recorded and admitted - and which turned out to be true, even though they threw the T-test off?

Nor should scientists be abused by pressures from a media which can hype up the public with unrealistic caricatures, supposedly promising new "miracle" cures or treatments; or which misconstrues or misinterprets a scientific "controversy" - again misinforming the public, sometimes even breaking confidentiality and destroying the reputations and careers of scientists - in order to get a "great story" out first.

On a higher "collective" level, research institutions are causing numerous pressures and challenges among themselves which at times are conflicting. For example, there are great pressures on universities to cash in on their discoveries (Sugawara, 1993); yet at the same time there are serious concerns about the presence of a conflict of interest (Shamoo, 1992A, 1993A). There are pressures on the FDA to accelerate drug approvals, e.g., for AIDS patients; yet the FDA must continue to be concerned with the safety and efficacy of these drugs (Stolley and Lasky, 1992). There are pressures from universities on funding agencies to use merit in funding research projects; yet universities themselves exercise the power of pork barrel to achieve an increasing amount of funding, bypassing all peer-review systems (Marshall, 1992).

Finally, consider the effect on the integrity of decision making of the current "fad" of "consensus ethics". Probably due initially to fear of legal liability, many group or institutional decisions are now often based on what the majority agrees upon, or the "consensus" of the group. This is not necessarily an ethical judgment or decision, and is unfortunately sometimes used only as a means by which to dilute the moral (or legal) responsibilities of the members. And given that such institutional policies themselves are often the targets of outside pressures, their construction and promulgation by others often serve to provide merely a psychological cover of semi-anonymity for many of those individuals taking part in such collective decision making processes.

It is worth considering that "majority" or "consensus" decisions - even on the national scale - have at times been simply wrong and unethical. Most of the time it seems to work - but not necessarily always. We need to question constantly whether the "collective" decision of the majority actually compromises the integrity of each of the individuals in the minority - or of the institution itself? Ethically, at least, each and every member of that committee or institution taking part in that "consensus" bears the individual moral responsibility and accountability for his or her own decision.

In addition to "consensus ethics", we are now seeing a move toward "consensus science". But how can we ensure that this "consensus science" is actually scientifically correct? The scientific establishment wants "consensus science" to be the only science accepted in the courtrooms (Marshall, 1993). These same groups complain bitterly about government guidelines to be used for ensuring the integrity of scientific data. Such guidelines, they complain, will stifle new and creative science, and by definition these guidelines are not approved by "consensus". Yet often there is simply no consensus within science itself on important and critical issues.

For example, there is the major ongoing debate about the very definition of "scientific misconduct" itself between the two most important agencies of the federal government which fund science - the NSF and the NIH. NSF would like to retain in the definition of "scientific misconduct" the broad clause: "or other serious deviation from accepted practices in proposing, carrying out, or reporting results". Yet NIH has dropped this section from their definition (Zurer, 1993), thus narrowing the definition as well as tying the hands of future investigative bodies. The claim that scientists are usually objective and unbiased would seem to run contrary to NIH's insistence on such a narrow definition of "scientific misconduct" because they fear potential abuse if the definition is "too broad". Such lack of objectivity within this scientific institution calls to mind Gerald Geison's comments on Pasture's "scientific objectivity". "Pasteur's message for contemporary science" was to puncture the "hopelessly misleading" image of science as "simply objective and unprejudiced," a myth that scientists have perpetuated in order to advance their work and attain a "privilege status" (Russell, 1993). Will the scientists' call for "self-regulation" be ultimately a myth as well?


One last check on reality, then. There are no easy answers to the questions about government regulations vs. self-regulation. But if overly-burdensome government regulations, required to assure the integrity of scientific data - as well as the public policies which are often based on that data - is so objectionable to scientists, "self-regulation" is in order. Scientists can't have it both ways. Especially in view of the very real harm which scientific fraud can and does cause, it must be dealt with clearly, firmly and unambiguously - one way or the other.

Yet "self-regulation", invoked by the scientific community to assure scientific integrity, must be based on much more than what is "consensual", "efficient", "productive", or statistically valid. It involves more than considerations of protocol designs and accurate data. Cryptically or not, the wisdom of the empirical experience of the centuries is unmistakably clear: real "self-regulation" requires a consideration of the integrity of the individual scientist as a human being and as an individual decision maker and actor. It also involves consideration of the integrity of the many institutions whose decisions and actions heavily influence and supposedly foster the scientist both as an individual and as a member of a "collective". This requires a grounding in a theoretically and practically viable personal and social ethics, itself grounded in a realistic and objectively based philosophy. The only other viable alternative, we would argue, is governmental regulation.

There is more at stake, then, than the integrity of experimental designs, the integrity of information, or the integrity of the data. More fundamentally at stake is the integrity of us as human beings - whether scientist, clinical researcher, quality analyst or controller, peer-reviewer, university, industry or government funder, regulator, journalist or Congressman. The Great Chain does not just "start" with "information" - but with a human being - who produces, insures, reviews, funds, regulates, reports on or governs - or, to complete the Great Circle, who is harmed by or compromised by not only the information or data, but by each other in their various levels of relationships, decisions and actions. Ultimately, it is the scientific enterprise itself, we would suggest, that is at stake.


*** An edited version of this paper was originally presented by Dr. Irving at the Third Conference on Research Policies and Quality Assurance, Baltimore MD, May 2, 1993.

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