¹ Doubts about society's ability to cope with nuclear fission and atomic energy are rampant,albeit often addressed to short term safety rather than long term human psychic adaptability. More generally, Business Week, May 14, 1979, reporting on results of a national survey released May 3, 1979, states they showed that “only 41% [of the American public] believes we still have technology under control.” And see T ime, May 14, 1979, at 54-59. Certainly, even relatively innocuous technology may be outstripping society's ability to cope with it, and not just in terms of human physical safety. For example, while the computer has undoubtedly proved to be a boon in many respects, it cannot be doubted that it has also been responsible for frequent snarlups of monstrous proportions that seldom, if ever occurred when billing, recordkeeping and reservation personnel—to select a few random examples—could see their paperwork laid out before them and find their inadvertent errors before those errors became exponentially compounded in the labyrinthine circuits of the computer. Moreover, the forced impersonality, and even at times outright depersonalization, that widespread use of computers imposes upon many of the common transactions of life, has inevitably expunged any semblance of graciousness and human warmth from those transactions, to the regret o f many. In still another vein, even corporate users of computers on a grand scale acknowledge inability to deal effectively with them in many respects—and say that care must always be taken in assignments given the computer lest it become the real executive force of the company. See Solving a Mismatch in Computer Management, B usinessW eek, April 12, 1979, at 73.

² “DNA” or deoxyribonucleic acid, is the building block of all living cells. Its structure was elucidated by the pioneering work o f many scientists, among whom Francis Crick and James D. Watson were given the main credit for the discovery, and the Nobel Prize in Medicine and Physiology in 1962. See J. W atson, The Double Helix (1968). “Recombinant DNA” is the term used to signify “recoding” of DNA by making experimental changes in its genetic programming in scientific laboratories. These “recoding” or “recombineing” measures have led to the creation in the laboratory of new bacterial life forms. One such form, developed by General Electric Company, has a voracious appetite for oil and is useful in oil spill salvage operations. See 150 N ational G eographic 355 (Sept. 1976). “Recombinant D N A ” experimentation upon genes of higher animals has also proceeded and has resulted, e.g., in the splicing of a human insulin producing enzyme into the microorganism E. coli, a common human intestinal tract bacterium. 79 N ew S cientist 747 (Sept. 14, 1978). Scientists from a small San Francisco, California, company, Genentech, succeeded last fall in manufacturing a minute amount of human insulin using a synthetic gene inserted into a bacterium. The company has “already filed a number of patents, most of which are very broad” (79 NewS cientist 924, 926), and has entered into an arrangement with pharmaceutical giant Eli Lilly for development of techniques for the commercial production of insulin.For a report of the pioneering work in insulin manufacture at the University of California/San Francisco where insulin genes from rats were used, see 196 S cience 1313 (June 17, 1977); Time (June 6,1977), at 68.

³ In a very real sense, much of the research conducted today has the potential for causingsubstantial biological effects on human beings. We are constantly and belatedly learning that the scientific work conducted one or two decades ago has left a harmful legacy—as witness what we now know about the hazards of feeding diethylstilbestrol (DES) to cattle, of spraying farm animals' pastures with DDT and of including asbestos in insulation for homes and workplaces. While this paper focuses upon genetic experimentation and how society should handle it, many of the thoughts expressed are equally applicable to other areas of scientific endeavor which, per se or in application, pose serious risks to the mental well-being of humanity, if adequate controls are not applied. For instance, the awesome power of “behavior modification” techniques creates a potential for manipulation of humans at least equally alarming to that associated with “genetic engineering.” The procedures have attained a level of refinement which genetic techniques are not likely soon to reach, in part because of heavy governmentsponsored research in the area, conducted primarily by the Department of Defense. Such research receives little public attention, but is available for public scrutiny, because described in the publications of the Advanced Research Projects Agency (ARPA) of the U.S. Department of Defense.

⁴ This is not to say that there has been no public attention to the problem. The U.S. Department of Health, Education and Welfare (including the National Institutes of Health(NIH) which held a series of hearings on the original and revised DNA research guidelines), the Subcommittee on Health and Scientific Research of the Committee on Human Resources, U.S. Senate, the Governor of Massachusetts, the Attorney General of New York, the City Council of Cambridge, Massachusetts—to mention a few—have studied or spoken out on recombinant DNA research and its short term risks. But these important deliberations have not been front-page news and it is safe to say that only a minuscule percentage of the world's people would recognize, much less be able to give a reasonably accurate definition of, the term “recombinant DNA.” Moreover, long term implications of the research have received relatively little attention.Since 1976 four committees of the U.S. Congress have held nine series of hearings to consider the issues related to DNA research. These hearings have touched upon the proposals of a number of bills, among which are: S. 621, S. 945 and S. 1217 (all in the 95th Congress, 1st session), and H.R. 3191, H.R. 3591, H.R. 3592, H.R. 4759, H.R. 4849, H.R. 5020, H.R. 6158, H.R. 7897 (all in the 95th Congress, 1st Session). Perhaps the bill that has attracted the most attention and debate is S. 1217, sponsored by Senator Edward M. Kennedy, which proposed government licensing of all scientific projects involving recombinant DNA, whether government-funded or not. Last year the Senator changed his mind about the need for such federal licensing, after reaching an agreement with representatives of the private sector about their voluntary compliance with National Institutes of Health guidelines. However, he has urged that the Food and Drug Administration employ its existing administrative machinery to extend the guidelines to private industry via the withholding o f clearance for new drug products in the DNA field produced by research conducted outside the guidelines. In addition, he was successful last term in promoting legislation creating a permanent President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (92 STAT. 3438, 42 USC 300v, P.l. 95-622, 11/9/78), one of the functions o f which is to evaluate the ethical implications of future research and serve as a sort of “early warning system” on DNA research. See note 11, infra.

⁵ Quoted in Recombinant DNA: A Critic Questions the Right to Free Inquiry, 194 S cience 303,304 (Oct. 15, 1976).

⁶ Quoted in Time, April 18, 1977 at 32.

⁷ The group includes, e.g., Wald, Harvard's George , a Nobel laureate in physiology andmedicine for work on the biochemistry of vision, and Columbia's retired, highly respected DNAspecialist, Erwin Chargaff, plus a number of other scientific luminaries. See Chargaff, On the Dangers of Genetic Meddling, 192 Science 938 (June 4, 1976)Google Scholar; Wald, The Case Against Genetic Engineering, The Sciences at 6-11, (Sept.-Oct. 1976); Novick, , Present Controls are Just a Start, Bulletin of the Atomic Scientists at 16-22, (May 1977)CrossRefGoogle Scholar.

⁸ See Time, supra note 7.

⁹ Watson, In Defense of DNA, T he N ew R epublic at 11, (June 25, 1977).Watson was one o f eleven eminent scientists who in April 1974 called for a moratorium oncertain types of recombinant DNA experimentation. This moratorium was a forerunner of theAsilomar Conference, referred to infra, note 25, which in its turn produced the first version ofthe NIH guidelines. For the moratorium document, see 71 P roc. N atl. A cad. Sci. USA 2593(1974). Watson, along with several of his cosigners, is now on record as regretting theconsequences of this unprecedented and seminal call to action. See, in addition to Watson's owncited article, e.g. Cohen, Recombinant DNA: Fact and Fiction, 195 S cience 654 (Feb. 18, 1977).

¹⁰ See Decision o f the Director, National Institutes o f Health, to Release Guidelines for Research on Recombinant DNA Molecules, 41 Fed. Reg . 27902 (July 7, 1976). The guidelines themselvesare reported at 41 F ed. R eg. 27911-943 (July 7,1976).As published by NIH, the guidelines were entitled NIH, Guidelines for Research I nvolvingR ecombinant DNA Molecules (1976) and were accompanied by an environmental impactstatement which assessed the risks and benefits implied in the guidelines. See NationalInstitutes of Health, Draft Environmental Impact Statement, Guidelines for Research Involving Recombinant DNA Molecules (Aug. 19,1976), reported in 41 F ed. R eg. 38426-483 (Sept. 9,1976).The revised guidelines now in effect appear at 43 Fed. Reg. 60080-60135 (Dec. 22, 1978).

¹¹ Although the revised guidelines do not purport to control the DNA experiments conductedby private industry, Secretary of Health, Education and Welfare Joseph Califano has opinedthat the Food and Drug Administration (FDA) “could under existing authority require any firmseeking approval of a product which may be the end product of recombinant DNA research tocertify to the Agency that it has complied with the NIH guidelines on recombinant DNA.”(Letter to Senator Adlai Stevenson cited in 43 F ed. R eg. 60104 (Dec. 22, 1978). In a letter toSecretary Califano, Senator Kennedy requested that the FDA use this existing authority fully,as well as additional authority allegedly granted by Section 361 of The Public Health ServiceAct (58 Stat. 703; 42 U.S.C. 269), 43 F ed. R eg. 60103-4 (Dec. 22, 1978). The FDA has indicated an intention to propose regulations along these lines. 43 F ed. R eg. 60134, (Dec. 22, 1978).Currently in the “comment” phase o f development, these regulations are not expected to emergeuntil February 1980.Considerable doubt exists in the legal community as to the validity of this mechanism forextending the NIH guidelines to nonfederally funded research since the FDA would therebyregulate the process, as well as the product, of research.

¹² Since its proposal more than ten years ago by Dr. Kantrowitz of the Avco Everett ResearchLaboratory, the “Science Court” has attracted the attention of a number of eminent scientists,government-sponsored committees and members of the judiciary. A sampling o f sources includesKantrowitz, March 16, 1967 Statement Before the Subcommittee on Government Research, Senate Committee on Government Operations, 113 C ong. R ec. 15256 (1967); Kantrowitz,Controlling Technology Democratically, 63 A m. S cientist 505 (1975).The concept has attracted increased attention in recent years, as both the complexity and theincidence of technological conflicts has begun seriously to overburden courts and regulatoryagencies. Interest in the Science Court led to a convocation of a colloquium on the subject,sponsored by the U.S. Department of Commerce, the National Science Foundation and theAmerican Association for the Advancement of Science. See P roceedings of the C olloquium onthe S cience C ourt, held by the U.S. Dept, of Commerce, September 19-21, 1976 in Leesburg,Va. (U.S. Dept, of Commerce, Washington, D.C., 1977). David Bazelon, Chief Judge of the U.S. Court of Appeals for the District of Columbia Circuit,is skeptical about the supposedly bright line distinction between fact and value that is drawn byproponents of this “Court,” pointing out that “Experts usually disagree not so much about theobjectively verifiable facts, but about the inferences that can be drawn from those facts … . If it[the Science Court] did try to resolve such essentially unresolvable issues, however, it is hard tosee how it could do much more than affix a 'seal of approval’ to a majority or ‘establishment'point of view—and that might simply discourage dissent.” Bazelon, Coping With Technology Through the Legal Process, 62 C ornell L.R. 817, 827-8, (June 1977). Another drawback of this“court” is that is seemingly could, at best, focus only on precisely defined issues of predominantlyshort term consequentiality, since only such issues are normally considered “justiciable”in the law courts of most countries.

¹³ For a carefully reasoned defense of the scientist's right to conduct research at his own will,see Robertson, The Scientist's Right to Research: A Constitutional Analysis, 51 So. Cal. L.R.1203 (1978).

¹⁴ These “other scientists” include those in industry and those in government. Thus, forexample, in the United States, NIH is almost exclusively staffed by scientists. Its awards offunding for grant proposals are based upon a system of review and recommendations by acommittee of the proposer's peers which includes competing scientists in nongovernmentalinstitutions as well as NIH employee-scientists. Procedures for selection of the so-called “StudySections” which evaluate proposals are outlined in the NIH Manual, an NIH administrativedocument. A thorough discussion of the whole NIH grant evaluation process, including theselection of study section members is given in the January 31 issue of the periodical 8 NIHG uides for G rants and C ontracts (Jan. 31,1979).

¹⁵ The Watson article supra, note 9, espouses that “we adjust our actions to the magnitude ofrisk” (at 12), but adds that “[w]hen no measurement is possible because we have never faced aparticular situation before, we must not assume the worst” (at 12-13). In short, since riskscannot be calculated in the great unknown, Watson would place no brakes on scientific inquiryexcept, possibly, in instances where science already knows enough to extrapolate the probabledanger. The latter instances, however, must almost always be short step situations rather thanmomentous scientific breakthroughs. The result is that “risk-benefit” analyses by scientists arenot designed to, and probably could not control the thrust of scientific research on recombinantDNA in any significant respect.

¹⁶ One no table institution has gone beyond sterile, and often pat, “cost-benefit ” thinking to take up these prickly questions. The Institute of Society, Ethics and the Life Sciences,headquar tered at the Hastings Center in Hastings-on-Hudson , New York , regularly tackles the“e thics of miracles ” in its journal , The Hastings Center Report, and in the writings of itsfellows . See particularly the Decemb er 1978 issue of the report: Smith, Scientific Knowledge and Forbidden Truths, 30-35; and McCartney, Encephalitis and Ara-A: An Ethical Case Study, 5-7.The Institute also publishes, yearly , acomp rehensive bibliography of source materials on ethicsand thelife sciences. See, e.g., Bibliography of Society, Ethics and the Life Sciences, 1979-80(1978). Another notable institution in the same field is the Center for Bioethics in George townUniversity ’s Joseph and Rose Kennedy Institute of Ethics,founded in 1971.Beginning in 1977,this Center assumed greatly expanded responsibilities for the teaching of value-relatedhumanities in the University's Medical Center.SeeGeorge town University Magazine, 2-6(Mar.-Apr. 1979). These limited efforts in only the ethical field, are not only isolated, but do not go far enough:human beings may have wholly valid objections to permitting science to learn how togenetically redesign them that fall outside ethics.

¹⁷ U.S. Health, Education and Welfare Secretary Joseph Califano has noted that “NIH hasbeen addressing the policy questions involving the safety of this research, not the ‘potentialfuture application … to the altering of the genetic character of higher forms of life, includingman’ … . In light of public concern, a study is warranted of the ethical, legal, and socialimplications of these techniques. The National Commission for Protection of Human Subjects ofBiomedical and Behavioral Research considered, but was unable to initiate, such a study.” (43Fed. Reg. 60103, (Dec. 22,1978), quoting his earlier statements in the July 28,1978, issue o f theRegister). That Commission expired in October of 1978, but its functions have been subsumed andcontinued by the new President's Commission for the Study of Ethical Problems in Medicine andBiomedical and Behavioral Research, which is currently in the process of assembling staff. Theex-director of the now defunct National Commission, Michael Yesley, has expressed the hopethat the new President's Commission would broadly deal with the ethical implications of futureresearch and constitute an “early warning system” for DNA research. See Senate Approves a Permanent Ethics Commission, 201 S cience 138 (July 14, 1978). It is doubtful that the President's Commission will do so, however, In a private communication,its new staff director has expressed doubt about the need for further study of DNAresearch, allegedly because this area constitutes only a small part o f the Commission's mandatefor study of “ethical problems in medicine.” More probably, the reluctance to study DNA isattributable to the legislative history of Section 1802 (a) (3) of the implementing legislation forthe President's Commission, Public Law 95-662 (92 Stat. 3413) which shows Congressionaldisagreement as to the need for such study. One author who is unequivocal about the need for expanding current debate from the level of“safety” to a broader and more humanistic social realm is chemist Allen R. Utke, who hasproposed a 10-year moratorium on “artificial inovulation research, the development of artificialwombs, attempts to clone small mammals and humans, cell fusion experiments, and recombinantDNA research” even though he feels that such benefits as the conquering of cancer mightsoon result from the research. Utke likens the research to a “biological Tower of Babel.” A.U tke, Bio-Babel: Can We Survive the New Biology? (1978), reviewed in T he F uturist, at331-332 (Oct. 1978). For a less polemic expression of a similar viewpoint, see Smith, supra note 16.

¹⁸ “The World Health Organization (WHO) first addressed the subject o f DNA research in 1975,when its Advisory Committee on Medical Research endorsed the value of such research, “underappropriate safeguards.” This recommendation led to the creation of a Special Program onSafety Measures in Microbiology intended to review and coordinate international DNA researchactivity. Plainly, national controls will be ineffective to regulate DNA research by large, multinationalpharmaceutical firms. N ature magazine reports that “[ajlready some U.S. corporations withinterests in recombinant DNA research are supporting the activities of foreign companies” (278N ature 385, 386 (Mar. 29, 1979)). If the rationale behind the American NIH guidelines is soundin the narrow context of “safety,” it should be applied at the international level, since biohazard,if it exists, will respect no political or geographic boundaries. Far more importantly, however,the broader question of whether the world's people are ready or able to cope with the fruits ofgenetic research has not received WHO attention.

¹⁹ This question of the permissible limits of human experimentation generally (rather thanspecifically in the genetic context) has been approached strictly from the “cost-benefit” stanceby the U.S. Department of Health, Education and Welfare in 45 C.F.R. §§ 46.101-.301 (1976). The subsumed question of how far human fetal experimentation may range—one whichoverlaps with the human genetic research problem—has likewise received “cost-benefit”treatment from the National Commission for the Protection of Human Subjects of Biomedicaland Behavioral Research in its Report and Recommendations: Research on the Fetus (DHEWPub. No. (OS) 76-127, 1975). See Pilon, Cost-Benefit Ethics: The Utilitarian Approach to Fetal Research, 22 V illanova L.R. 395 (1976-7), and the papers collected in DHEW Pub. No. OS-128(1975), the Appendix to the aforementioned Commission Report. As a dissenting Commissionmember, David W. Louisell, commented, the “cost-benefit” approach ignores what is, in theUnited States and other democracies, “our society's most basic moral commitment: the essentialequality of all human beings.” (22 V illanova L.R. at 315). While Louisell's comment is to beunderstood in the light of his premise that human fetuses are human beings and should betreated as such, his approach reveals the sterility of the “cost-benefit” rationale as applied torecombinant DNA research. Pointedly, i f this research should be channeled toward eventualattainment of the ability, e.g. (i) to clone human beings to ensure controlled size groups ofidentical individuals of predetermined intelligence quotient or (ii) to eradicate people havingcertain skin, hair or eye color, or those lacking certain athletic or artistic or intellectual talentsor (iii) to otherwise control those human characteristics that are, or may be at least partly ofgenetic origin, the “essential equality” and basic dignity o f all human beings will certainly beaffronted.

²⁰ Just such lack of perspective among narrow scientist specialists was responsible for theseveral now recognized and realized hazards enumerated in note 3, supra. Even as a paintchemist may not have any conception o f what his new paint formula may do to a child or animalthat ingests the product, so a biologist specializing in pancreatic enzymes will not be able toguess how tinkering with them in a human being might affect his brain, lungs or heart. This, ofcourse, is another reason why “risk-benefit” and “cost-benefit” analyses by interested scientistsare defective even in the short term, as sole determinants of where, and how fast, recombinantDNA research should be permitted to go.

²¹ Quoted in Recombinant DNA: The Last Look Before the Leap, 192 Science 236, 237 (Apr. 16,1976).

²² See note 14, supra. The “scientific community,” is used here to include all scientists, whetherthey pursue their research in university laboratories or at research foundations, for industrialor commercial concerns or in a governmental agency in any capacity.

²³ Judson, Fearful of Science, Harper'S Magazine at 70 (June 1975).

²⁴ Id. at 76.

²⁵ Bennett and Gurin, Science that Frightens Scientists, 239 A tlantic 43, 49 (Feb. 1977),speaking of the 1975 International Conference on Recombinant DNA Molecules, held at theAsilomar Conference Center in Pacific Grove, California.

²⁶ Bacon, Of Truth, E ssays I.

²⁷ Chief Judge David Bazelon of the U.S. Court of Appeals for the District of Columbia haswritten that,The idea that nonscientists can or should have anything to do with science is a relativelyrecent one, and one that may not be entirely welcome to the scientific community. Scientistshave sometimes likened their profession to an autonomous,, self-governing “republic.” Toqualify for citizenship in this republic, one's scientific credentials would have to be in order.And only its “citizens”—that is, only scientists—would be entitled to a voice in the way thescientific community is governed; only they could participate in the process of mutualcriticism that keeps science valid. As Gerard Piel, the publisher of Scientific American,recently wrote, “A scientist can accept no authority but his own judgment and conscience… .” Recently, however, we have begun to reexamine our relationship with the so-called“republic of science.” Coping with Technology Through the Legal Process, C ornell L.R.,supra note 12.

²⁸ There are always, of course, small dissident groups, such as “Ban the Bomb” demonstratorsand the “antifluoridation” groups of the fifties. These groups have been perceived as mildly toseriously paranoid by most of society, and, hence, simply dismissed. Only lately has a modicumof general, but often diffuse, fear about where science may be taking us begun to manifest itself.See e.g., such articles as Smith, Scientific Knowledge and Forbidden Truths, 30 H astingsC enter R eport (Dec. 1978); The Emerging Plastic Image o f Man, S aturday R eview, June 20,1977, at 35.

²⁹ The vagaries of the guild system are traced, e.g., by V. Mund in Monopoly- A History andT heory (1932). A distinction between the guilds and the scientists is that, in general, the guildsworked to suppress technological progress in order to strengthen their own strangleholds overevery aspect of the production and sale o f goods within their assigned areas and insure their owneconomic positions, whereas scientists today are interested in maintaining their own controlover scientific progress and its direction but do not want to suppress technology.

³⁰ History teaches that patent systems in England and on the Continent were an outgrowth ofsovereign efforts to encourage the introduction of new and improved trades into their respectiverealms, notwithstanding the constraints of existing guild monopolies. Evidence of the grant of“patents” giving the exclusive right to practice new or better technologies free from interferenceby the relevant guilds goes back to the thirteenth century in England and well before the 1474adoption of a formal patent statute in the City State of Venice. See, e.g., Prager, A History of Intellectual Property from 1545 to 1787, 26 J. Pat. Off. SoC'Y. 711 (1944); Prager, The Early Growth and Influence o f Intellectual Property, 34 J. Pat. Off. Soc'Y. 106 (1952). H. Fox ,Monopolies and Patents (1947). Today, virtually every country of the world has some form of patent law requiring inter aliathat subject matter may qualify for patent protection only i f it is previously unpublicized. See, e.g” 35 U.S.C. 101, 102.

³¹ In the United States, a recent decision of the Court of Customs and Patent Appeals quitecorrectly holds that new strains of microorganisms produced by genetic manipulation arepatentable, In re Bergy and In re Chakrabarty, Appeals Nos. 76-712 and 77-535,_F 2 d _,decided Mar. 29,1979. The thus-sustained hope o f obtaining patents—and hence a right to sharein profits of commercial exploitation of scientific discoveries—is a powerful spur toward holdingpending scientific investigations under the traditional cloak of secrecy.“Other emoluments of private gain,” availability of which encourages preexperimentationsecrecy, include trade secret protection, governed by statute or precedent in many countries.There are also nonstatutorily regulated emoluments, such as prizes (among them the NobelPrize) and industrial and academic advancements which often depend upon demonstratedscientific achievement.Concern about loss o f proprietary rights due to insufficient restraints on NIH dissemination isnow even inhibiting commercial firms' compliance with NIH guidelines. Under the guidelines,laboratories desiring to employ more than 10 liters of culture in their research—a categorywhich effectively includes all private firms gearing up for commercial production—mustformally apply to NIH for exemption, describing fully the planned research and its objectivesincluding trade secrets and other proprietary information. See Dickson, U.S. Drug Companies Push for Changes in Recombinant DNA Guidelines, 278 N ature 385 (Mar. 29, 1979) and Wade,Senator Chides Gene Debate Doubters, 202 S cience 724 (Nov. 17, 1978).

³² S. 414, 96th Cong., 2d Sess., jointly sponsored by Senators Robert Dole and Birch Bayh.

³³ In the United States, James Madison wrote o f man's “property in the free use of his facultiesand free choice of the objects on which to employ them” in National Gazette for March 29, 1792.See T he C omplete M adison 267-9 (Padover ed. 1953). This and similar thinking underlies theBill of Rights to the U.S. Constitution. In many European countries, society has for the last two centuries recognized a naturalproperty right of each man in his own ideas, supposedly of Thomist natural law origin. SeeMachlup and Penrose, The Patent Controversy in the Nineteenth Century, 10 J. E con. H istory 1(1950). This view is rejected in the United States; see e.g., Shaw v. Cooper, 32 U.S. (7 Pet.) 292(1833) and H.R. R ep. No. 1494, 52d Cong., 1st Sess. (1894); H.R. R ep. No. 2222, 60th Cong., 2dSess. 7 (1909); Graham v. John Deere & Co., 383 U.S. 1, 7 (1966).

³⁴ Importantly, trade secret law protects only against breaches of confidence by those to whominformation has been given in confidence, and not against independent creation by others. See e.g., Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470 (1974).

³⁵ See e.g., 26 U.S.C. 1249 relating to U.S. preferential federal income tax treatment oftransfers of patented and unpatented technology. The qualified immunity from antitrust laws that a patent owner or trade secret owner mayclaim in the United States has been the subject of numerous books and articles. Among themany cases which illustrate Supreme Court recognition of this qualified immunity are UnitedStates v. General Electric Co., 272 U.S. 476 (1926) and Standard Oil Co. (Indiana) v. UnitedStates, 283 U.S. 163 (1931).

³⁶ Bennett and Gurin, supra note 25, recount that a major impetus for the document drafted atthe 1975 Asilomar conference (which was the blueprint for the original NIH guidelines, nowrevised) was a presentation by four lawyers who warned that … The abstract possibility that experiments were hazardous could have some verypractical consequences, … . researchers could be sued. A lawsuit by laboratory technicians,… would be bad enough, but i f anything should escape from a laboratory to infect theoutside world, the litigation could become unthinkable. Without putting too fine a point onit, the lawyers' presentation highlighted the need for this often diffuse and ramblingconference to reach some decision … . “Still another matter that bears watching is liability,” writes Judith Randal in The Progressive (May 1977). “If the recent experience with the swine flu immunization programserves as a precedent, commercial insurers could refuse to underwrite institutions engaged inexperiments or manufacture for which there is no reliable estimate of risk. Financiallyhard-pressed universities are already concerned about this contingency, and it has beensuggested that even i f insurers were willing to assume the risk, universities would be unable topay the premiums. The upshot could be pressure on Congress to enact for this form of geneticengineering the equivalent o f a Price-Anderson Act, which limits the fiscal responsibility o f thenuclear industry in the event of an accident” (at 11-12).

³⁷ Just as survivors of e.g., air, railroad and train crashes or of victims of medical malpracticeor defective products can collect in many jurisdictions from the unwitting architects of thesecatastrophes, survivors of those killed by experiments gone wrong can be expected to institute,and at least sometimes prevail in, suits against the designers o f the experiments.

³⁸ For example, in Britain, the Official Secrets Acts (1939, c. 121, S 2(1)) are intended toprevent disclosure of such information “as would prejudice the state.” Prohibitions apply to thetransfer of documents or other information from a wide variety of government owned facilitiesas well as certain private held institutions, most notably, to date, in the atomic energy andaerospace industries (Atomic Energy Authority Acts, 1954, c. 32, S. 6 (3-4); 1971, c. 11, S. 17(6)sch. para. 2-3; 1971, c. 75, S. 61 (1-2)). The 1920 Official Secrets Act provides for trial in camerafor offenses arising under the Act (1920, c. 75, S. 8(4)).

³⁹ In the United States, exports o f most commercially available commodities and “know how”are regulated by the Department o f Commerce under the Export Administration Act o f 1969, asamended (50 U.S.C. App. 2401 et seq.), which stipulates that controls may be used to (1) protectnational security, (2) further foreign policy, or (3) prevent excessive drain of scarce materials.

⁴⁰ This is not to say that scientists in academia are close-mouthed once a definite result ofmeaningful proportion has been attained, for they—unlike industrial and governmentalscientists—are inveterately and notoriously loquacious, at least among themselves, at thatstage.

⁴¹ For example, even the weekly newsmagazines tend to pepper their reports liberally withscientists' terminology. See e.g., T ime's Apr. 18, 1977 cover report on recombinant DNA work.The unavailability of readily comprehensible news coverage about recombinant DNA researchunfortunately tends to lend undue emphasis in the minds of many nonscientists to“science fiction” accounts of the most lurid type.

⁴² In the broader approach whereby virtually all experimentation has at least indirectconsequences on humans, we must recognize that our own voluntary and wholly unstudiedactions throughout all of our lives may be construed as experimental forms. To live, to breathe,to eat, to sleep, to marry at will and produce children, to travel, to pursue all the usual andunusual endeavors of mankind bring us unremittingly into contact with chemicals andmicro-organisms of which we are unaware that may react or interact in an unpredictablybeneficial or deterimental way. This argument, carried to its ultimate, is considered by JamesWatson to be favorable toward unmonitored, unrestricted recombinant D N A research pursuedat the whim of individual scientists. See Watson, In Defense o f DNA, T h e N ew R epublic at11-14, (June 25, 1977).

⁴³ Importantly, an accidental “freak” obtained by recombinant DNA experimentation probablycould not be stopped (as, e.g., DDT and DES effects can be) simply by halting manufacture andsale of an offending chemical. Such a living experimental mistake might multiply freely andpersist indefinitely, though it is also possible that it might find ambient conditions inimical, orat least unfavorable, and die out quickly

⁴⁴ See supra note 2.

⁴⁵ For example, recombinant DNA research could be done on human organ tissue preservedoutside the human body in accordance with well-known laboratory techniques, and it would beevident that the results could be applied to the same tissue in the human environment.

⁴⁶ For example, research could be conducted on animal tissues analogous to those o f humans, orin synthetic environments constructed to approximate those of certain human cells, underconditions such that ultimate applicability of results to human beings is foreseeable.Clinicians generally do not commence human experiments until safety is assured.

⁴⁷ For example, the “new drug” clearance procedures of the U.S. Food and Drug Administrationrequire a substantial showing of nontoxicity to several species of laboratory animals suchas rats, mice, guinea pigs, rabbits, goats, monkeys, etc. before “clinical” testing on humans ispermitted. This animal testing is usually preceded by considerable successful so-called “invitro” experimentation upon test tube cultures of the particular disease-causing substance thatthe “new drug” is intended to overcome of neutralize and conducted in tandem with testsshowing effectiveness of the drug in treating laboratory animals.

⁴⁸ Even if society is content to let DNA research proceed unquestioned until it is ready forhuman testing, there are indications that differences in complexity between human and loweranimal genes and gene control mechanisms may in some instances disqualify animal researchas a reliable basis for extrapolation to human beings in the DNA field. See for example, therecent work of Sir Francis Crick reported in 204 S cience 264 (Apr. 20, 1979). Discussing therecently discovered fact that the architecture of the genes of higher organisms differs radicallyfrom that of bacterial genes, Crick predicted that “new discoveries will turn up which willradically alter our ideas about the details of the evolutionary process.” (Quoted in 82 N ewS cientist 452, (May 10, 1979).) The basic difference concerns the process by which theorganism's genetic code is copied for purposes of the construction of protein chains outside the cell nucleus. It appears that in higher organisms, or eucaryotes, the formation of the so-called'messenger RNA’ which carries a cell's genetic code from the nucleus into the cytoplasm forproduction of protein chains, takes place by means of a spontaneous splicing of the ‘primaryRNA transcript’ of the chromosomal DNA. Although it is known that the splicing takes place bymeans of enzymes, Dr. Roger Lewin reports that No one yet knows how many enzymes are involved in the so-called splicing process. Therecould be just two—one to snip and one to join—that are common to all split gene products, orthere may be several hundred, each specific to a particular type of gene transcript orsegment within a gene transcript. The more enzymes there are the more possibility there isthat the inserts could be part of some kind of system controlling the expressiongenes … . Whether the splicing enzymes are involved in sophisticated control of genefunctioning or are merely part of more mundane housekeeping, they have to be absolutelyprecise in the way they remove the inserts [noncode material in the primary RNAtranscript]: if any part of the gene segment is removed with the insert, or if part of the insertremains behind, the whole sense of the gene will be thrown awry … . (S)o far the precisedetails of splicing remain elusive.82 N ew S cientist 452, 453. Thus it may be that the fundamental difference between eucaryotes (higher organisms) andprocaryotes (such as bacteria) in translating genetic code into proteins may be matched bysimilar, though less fundamental, differences in the way separate species, or even separategenes within one species, control gene expression. In these circumstances, the question ofwhether to permit direct research on humans—or at least on human tissue cultures—seemsunavoidable.

⁴⁹ See Lappe, and Martin, , The Place of the Public in the Conduct of Science, 51 So. Cal. L.R.1535, 15 47-1554 (1978)Google Scholar. These guidelines evolved from knowledge of Nazi experimentation onhumans gleaned at the Nurem be rgtrials. See 2 Trials of War Criminals Before the NurembergMilitary Council, at 181 (1949).

⁵⁰ See The Declaration of Helsinki: Recommendations Guiding Doctors in Clinical Research,World Medical Association, 1964.

⁵¹ These guidelines, supra note 50, set out “basic principles” which are not wholly applicable torecombinant DNA research, because they are oriented to short term physical safety considerations.It is doubtful that “laboratory and animal experiments” and “other scientificallyestablished facts” will provide a beacon for much of the possible human DNA research; see supranote 49. Similarly, “a qualified medical man,” in many instances, may not have the knowledgeand experience requisite to supervise recombinant DNA research significant to the humanorganism. Hence, these “basic primarys ” while instructive, are only marginally useful in theDNA context.

⁵² See The Delcaration, supra note 50 for the principles applicable when the patient's health isthe main object.

⁵³ See the more rigorous guidelines, supra note 50, applicable when experimental informationis the object.

⁵⁴ B. Haring, Medical Ethics (1973).

⁵⁵ See e.g., Barber, The Ethics o f Experimentation with Human Subjects, S cientific A merican(Feb. 1976); McCartney, Encephalitis and Ara-A: An Ethical Case Study, H astings C enterReport (Dec. 1978). In a more recent study of the “Institutional review boards” (IRBs) created by the UnitedStates National Research Act of 1974 to review medical research with human subjects—commissioned by the National Commission for the Protection of Human Subjects of Biomedicaland Behavioral Research and performed by the University of Michigan—empirical findingsshowed that the “informed consent” presently obtained by medical researchers at hospitals anduniversities alike was highly imperfect, from the points of view of completeness and readability.See 201 Science 1094