A Multidisciplinary Approach to an Ethic of Biodefense and Bioterrorism

Garland B. , “Bioethics and Bioterrorism,” The Journal of Philosophy, Science & Law 2 (March 2002): available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterror-ism2.cfm> (last visited April 12, 2005).

Buchanan D. R. , An Ethic for Health Promotion: Rethinking the Sources of Human Well-Being (New York: Oxford University Press, 2000): at 168.

Childress J. , “Scarce Resources, Triage and Bioterrorism,” panelist at Bioethics and Bioterrorism Conference, Washington, D.C., February 28, 2002, summarized by Garland B. , The Journal of Philosophy, Science, & Law 2 (March 2002), available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterrorism2.cfm> (last visited April 12, 2005); Pesik N. Keim M. E. , and Iserson K. V. , “Terrorism and the Ethics of Emergency Medical Care,” Annals of Emergency Medicine 37 (2001): 642–46.

Nieburg P. , “Bioterrorism and Public Health,” panelist at Bioethics and Bioterrorism Conference, Washington, D.C., February 28, 2002, summarized by Garland B. , The Journal of Philosophy, Science, & Law 2 (March 2002), available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterrorism2.cfm> (last visited April 12, 2005).

Hamric A. , “The Ethical Duty to Face Danger,” panelist at Bioethics and Bioterrorism Conference, Washington, D.C., February 28, 2002, summarized by Garland B. , The Journal of Philosophy, Science, & Law 2 (March 2002), available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterrorism2.cfm> (last visited April 12, 2005).

American Medical Association, CEJA Report, A Declaration on Professional Responsibility, 5-I-01 (December 4, 2001).

Davis W. , “Medicine and Limits,” panelist at Bioethics and Bioterrorism Conference, Washington, D.C., February 28, 2002, summarized by Garland B. , The Journal of Philosophy, Science, & Law 2 (March 2002), available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterrorism2.cfm> (last visited April 12, 2005).

See Hamric , supra note 6.

The Center for Law and the Public's Health, at <http://www.publichealthlaw.net/> (last visited April 12, 2005).

Feldman E. , “Reconsidering the Common Law Rule of ‘No Duty,’” panelist at Bioethics and Bioterrorism Conference, Washington, D.C., February 28, 2002, summarized by Garland B. , The Journal of Philosophy, Science, & Law 2 (March 2002), available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterrorism2.cfm> (last visited April 12, 2005).

Bresnitz E. , “The New Jersey Anthrax Crisis,” panelist at Bioethics and Bioterrorism Conference, Washington, D.C., February 28, 2002, summarized by Garland B. , The Journal of Philosophy, Science, & Law, 2 (March 2002), available at <http://www.psljournal.com/archives/newsedit/bioethics_bioterrorism2.cfm> (last visited April 12, 2005).

“The Common Rule,” 45 C.F.R. § 46 (2003), applies to seventeen federal agencies funding research while 21 C.F.R. § 50 (2003) applies to Food and Drug Administration funded research. The Common Rule applies when (1) the research is funded by a federal agency; (2) the institute performing the research has given assurances that all human subject research will comply with the common Rule; or (3) the research utilizes an Investigational New Drug, Device, or Biologic regulated by the Food and Drug Administration. If the research meets any of these criteria, a protocol must be submitted to an Institutional Review Board (IRB) which determines whether the benefits outweigh the risks of the research.

Gostin L. O. , Public Health Law: Power, Duty, Restraint (Berkeley: University of California Press; New York: The Milbank Memorial Fund, 2000): at 126.

Id. at 127.

Moreno J. D. , Undue Risk: Secret State Experiments on Humans (New York: Routledge, 2001): at 275.

CIOMS/WHO, Council for International Organizations of Medical Sciences, “International Ethical Guidelines for Biomedical Research Involving Human Subjects.” in Bankowski Z. and Levine R. J. , eds., Ethics and Research on Human Subjects: International Guidelines (Geneva: CIOMS, 1993).

Council of Europe, “Chart of Signatures and Ratifications,” at <http://conventions.coe.int/Treaty/EN/cadreprincipal.htm> (last visited August 28, 2003).

Trigilio M. E. , “The Convention on Human Rights and Biomedicine: Allowing Medical Treatment and Research without Consent on Persons Unable to Give Informed Consent,” Suffolk Transnational Law Review 22 (1999): 641–661, at 655, n. 60. Article 17(2) of the Convention provides an exception to the informed consent requirement even for medical intervention which may not benefit the individual where “(i.) the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition [and]; (ii.) the research entails only minimal risk and minimal burden for the individual concerned….”

United Nations Commission on Human Security, Final Report from the Commission on Human Security, Better Health for Human Security (May 1, 2003), available at, <http://www.humansecurity-chs.org/finalreport/> (last visited May 2, 2005).

Convention for the Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine, Convention on Human Rights and Biomedicine and Explanatory Report, ETS No. 164 (December 17, 1996), available at, <http://conventions.coe.int/Treaty/EN/Reports/Html/164.htm> (last visited May 2, 2005).

Id. at Chapter V. If medical treatment proceeds with informed consent and it does not benefit the individual, then two additional requirements must be met under the Convention: that the procedure benefits others and that there will be minimal risk to the individual.

See Garland , supra note 1.

Leopold A. , A Sand County Almanac (New York: Oxford University Press, 1966): at 238.

Fast L. Neufeldt R. C. , and Schirch L. , “Toward Ethically Grounded Conflict Interventions: Reevaluating Challenges in the 21st Century,” International Negotiation: A Journal of Theory and Practice 7 (2002): 185–207.

See Moreno , supra note 16 at 240.

The litigation was recently settled in 1999. See In re Cincinnati Radiation Litigation, 874 F. Supp. 796 (S.D. Ohio 1995), 187 F.R.D. 549 (S.D. Ohio 1999); “OH Judge Gives Final OK to $3.5 Million Radiation Exposure Class Settlement,” Toxic Chemicals Litigation Reporter (June 7, 1999): At 10.

Moreno J. D. , “Lessons Learned: A Half-Century of Experimenting on Humans,” The Humanist 59 (1999): 9–15.

See Moreno , supra note 16 at 240.

28 U.S.C. § 1346(b) (2004).

“First, it is the nature of the conduct, rather than the status of the actor, that governs whether the discretionary function exception applies in a given case. As the Court pointed out in Dalehite, the exception covers ‘[not] only agencies of government…but all employees exercising discretion.’ 346 U.S., at 33. Thus, the basic inquiry concerning the application of the discretionary function exception is whether the challenged acts of a Government employee – whatever his or her rank – are of the nature and quality that Congress intended to shield from tort liability. Second, whatever else the discretionary function exception may include, it plainly was intended to encompass the discretionary acts of the Government acting in its role as a regulator[*814] of the conduct of private individuals. United States v. Varig, 467 U.S. at 814–15 (1984), quoting Dahelite v. United States, 346 U.S. at 33 (1953).

Nevin v. United States, 696 F.2d 1229 (9th Cir. 1983).

Roe v. Wade, 410 U.S. 113 (1973).

Smart J. , “Chapter 2: Medical Aspects of Chemical and Biological Warfare, History of Chemical and Biological Warfare: An American Perspective,” Brig. Gen. Zajtchuk R. and Bellamy R. M.D., eds., Textbook of Military Medicine (Office of the Surgeon General, Dept of the Army, 1997): At 4–5.

“Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction,” Signed by the parties April 10, 1972, entered into force March 26, 1975. Available at, <http://www.opbw.org/convention/conv.html> (last visited May 2, 2005).

See Smart , supra note 34, at 64.

Fletcher J. , “The Courts and Euthanasia,” Law, Science, and Health Care 15 (1987–1988): 223–224.

Cruzan v. Director, Missouri Department of Health , 497 U.S. 261 (1990), opining that the Constitution requires clear and convincing evidence of a patient's directive to end life-sustaining support.

Moreno J. D. , “Bioethics after the Terror,” American Journal of Bioethics 2 (2001): 60–64, at 60.

Shapiro M. , Bioethics and Law: Cases, Materials and Problems (St. Paul, MN: West Publishing Company, 2003): at 128.

Id. at 129.

Gostin L. , Public Health Law and Ethics: A Reader (Berkeley: University of California Press; New York: Milbank Memorial Fund, 2002), available at, <http://www.publichealthlaw.net/reader> (last visited May 2, 2005); Callahan D. and Jennings B. , “Ethics and Public Health: Forging a Strong Relationship,” American Journal of Public Health 92 (2002): 169–176.; Childress J. F. , “Public Health Law, Society, and Ethics: Public Health Ethics: Mapping the Terrain,” Journal of Law, Medicine & Ethics 30 (2002): 170–78, at 170.

See Gostin , supra note 42 at Childress J. F. , at 170–71.

Id. Childress J. F. , at 170–71, available at, <http://www.publichealthlaw.net/Reader/ch1/ch1.htm> (last visited May 3, 2003).

See Callahan and Jennings , supra note 42.

“We do not explore here the overlaps among public health ethics, medical ethics, research ethics, and public policy ethics, although some areas of overlap and difference will be evident throughout the discussion. Further work is needed to address some public health activities that fall within overlapping areas – for instance, surveillance, outbreak investigations, and community-based interventions may sometimes raise issues in the ethics of research involving human subjects.” See Childress , supra note 42 at 177 n.7.

Callahan D. , ed., Promoting Health Behavior: How Much Freedom? Whose Responsibility? (Washington, D.C.: Georgetown University Press, 2000).

See Buchanan , supra note 3, at 168.

See Callahan and Jennings , supra note 42.

See Buchanan , supra note 3, at 168.

Harris R. and Paxman J. , A Higher Form of Killing: The Secret History of Chemical and Biological Warfare (New York: Random House, 2003): at 155.

Id. at 156–57. The specialists in the United States government concluded in their December 27, 1947 report that: “Evidence gathered in this investigation has greatly supplemented and amplified previous aspects of this field. It represents data which have been acquired by Japanese scientists at the expenditure of many millions of dollars and years of work. Information has accrued with respect to human susceptibility to these diseases as indicated by specific infectious doses of bacteria. Such information could not be obtained in our own laboratories because of scruples attached to human experimentation…. It is hoped that individuals who voluntarily contributed this information will be spared embarrassment because of it…”

Mills J. L. , “The Future of Governmental Ethics: Law and Morality,” Dickinson Journal of International Law 17 (1999): At 405.

Gostin L. O. , Public Health Law: Power, Duty, Restraint (Berkeley: University of California Press; New York: The Milbank Memorial Fund, 2000): at 20.

See Fast Neufeldt , and Schirch , supra note 25.

Mann J. M. , “Medicine and Public Health, Ethics and Human Rights,” The Hastings Center Report 27 (1997): 6–13, at 11–12.

Koplow D. , Smallpox: The Fight to Eradicate A Global Scourge (Berkeley and Los Angeles: University of California Press, 2003): at 104–37 and 179–204.

See Leopold , supra note 24 at 240.

Id. at 240.

See Smart , supra note 34, at 12.

Niccolo Machiavelli (1469–1527), was an Italian diplomat and political philosopher who wrote The Art of War (1521) and The Prince (1532).

Bobbitt P. , The Shield of Achilles, War, Peace, and the Course of History (New York: Knopf, 2002): at 86.

Fenn E. A. , “Biological Warfare in Eighteenth-Century North America: Beyond Jeffrey Amherst,” Journal of American History 86, no. 4 (March, 2000): 1552–1580, at 1553. “Our preoccupation with Amherst has kept us from recognizing that accusations of what we now call biological warfare-the military use of smallpox in particular-arose frequently in eighteenth-century America. Native Americans, moreover, were not the only accusers. By the second half of the century, many of the combatants in America's wars of empire had the knowledge and technology to attempt biological warfare with the smallpox virus. Many also adhered to a code of ethics that did not constrain them from doing so. Seen in this light, the Amherst affair becomes not so much an aberration as part of a larger continuum in which accusations and discussions of biological warfare were common, and actual incidents may have occurred more frequently than scholars have previously acknowledged.”

Waterhouse E. , A Declaration of the State of the Colony and Affaires in Virginia (London, 1622).

Prentiss A. M. , Chemicals in War: A Treatise on Chemical Warfare (New York: McGraw-Hill, 1937): at 343–477.

See Smart , supra note 34, at 29.

Torok T. J. , “A Large Community Outbreak of Salmonellosis Caused by Intentional Contamination of Restaurant Salad Bars,” JAMA 278 (1997): 389–95. (This was the first medical publication to confirm that what had been kept secret by the federal government for over a decade had indeed been an intentional biological terrorism event.)

The Ethics of War, available at, <http://www.bbc.co.uk/religion/ethics/war/jwintro.shtml> (last visited May 3, 2005).

See note supra 62.

It is evident that there is great concern for minimizing suffering of the animal subjects in the discussion of the care of the macaques (monkeys) during the outbreak of Reston ebola in USAMRIID's laboratory, and the necessary destruction of the animals. Peters C. J. and Olshaker M. , Virus Hunter: Thirty Years of Battling Hot Viruses Around the World (Anchor Books: New York, 1998): at 259.

Estate of Amos v. City of Page, 257 F.3d 1086 (9th Cir. 2001).

Harris G. , “U.S. Creates Ethics Panel on Priority for Flu Shots,” The New York Times October 28, 2004.

Harris R. and Paxman J. , A Higher Form of Killing: The Secret History of Chemical and Biological Warfare (New York: Random House, 2002): at 156–57.

Persephone from a Greek myth is an innocent girl who is kidnapped and forced to spend part of her time in Hades and part on Earth, accounting for the cycles of growth and decay and referring to the misuse of science, which is otherwise published for positive use by the scientific community.

“Life Sciences Publishers Take Steps to Address Bioterrorist Potential,” Bioterrorism Week, March 10, 2003, at 8.

See generally, Alibek K. and Handelman S. , Biohazard: The Chilling True Story of the Largest Covert Biological Weapons Program in the World – Told from Inside by the Man Who Ran It (New York: Dell Publishing, 1999).