Alive and Well: The Research Imperative

Jones J. H. , “The Tuskegee Syphilis Experiment,” in Emanuel E. Grady C. Crouch R. , and Lie R. eds., The Oxford Handbook of Clinical Research Ethics (New York: Oxford University Press, 2008): 86–96.

Id., at 90. See also Reverby S. , Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (Chapel Hill, NC: University of North Carolina Press, 2009): at 37–55, discussing this and other scientific problems with the study. In 2011, the Presidential Commission for the Study of Bioethical Issues found that the U.S.-sponsored 1940s syphilis studies in Guatemala were scientifically worthless because of their methodological flaws. See Presidential Commission for the Study of Bioethical Issues, “‘Ethically Impossible’ STD Research in Guatemala from 1946 to 1948,” September 2011, at 95, 101, available at <www.bioethics.gov/cms/node/306> (last visited December 7, 2012).

The term “research imperative” comes from an article that theologian Paul Ramsey wrote about the ethics of research involving children. See Callahan D. , What Price Better Health? Hazards of the Research Imperative (Berkeley, CA: University of California Press, 2003): at 2–3 (citing Ramsey P. , “The Enforcement of Morals,” Hastings Center Report 6, no. 4 [1976]: 2). Ramsey claimed that Richard McCormick's acceptance of a research imperative explained the latter's permissive stance toward so-called nontherapeutic research on children.

Id., at 4.

Id., at 3. See also Callahan D. , “The ‘Research Imperative’: Is Research a Moral Obligation?” President's Council on Bioethics Meeting Transcript, July 24, 2003, available at <http://bioethics.georgetown.edu/pcbe/transcripts/july03/session1.html> (last visited December 7, 2012).

See Callahan , supra note 3, at 1.

Id., at 259–76.

Callahan D. , Taming the Beloved Beast: How Medical Technology Costs Are Destroying Our Health Care System (Princeton, NJ: Princeton University Press, 2009).

Id. at 3.

Callahan , supra note 3, at 270. In his 2003 American Association for the Advancement of Science President's Address, neuroscientist Floyd Bloom acknowledged that U.S. research priorities weren't consistent with improving the American health system. A research agenda with such an objective would devote more resources to social science-based research on health promotion and disease prevention, he said, “rather than…awaiting the expected evolution of gene-based explanations and interventions based on future genetic discoveries.” See “AAAS President Calls to Restore American Health System,” February 13, 2003, available at <http://eurekalert.org/pub_releases/2003-02/aaft-apc020303.php> (last visited December 7, 2012). In a similar vein, physician Atul Gawande has remarked on the disproportionate attention we pay to innovations like “personalized genomics, vaccines against heart disease,” and new drugs for cancer, while we pay “disastrously little attention” to ensuring that clinicians have the ability to make good use of those innovations.” Gawande A. , “Personal Best,” The New Yorker, October 3, 2011: 44–53, at 53.

Callahan D. , “Death and the Research Imperative,” New England Journal of Medicine 342, no. 9 (2000): 654–656.

Callahan , supra note 3, at 253.

Id. Here Callahan is speaking of priority setting at the National Institutes of Health, but his point could be extended to other research funding contexts.

Id. at 251. For more discussion on research priority setting, see Dresser R. , When Science Offers Salvation: Patient Advocacy and Research Ethics (New York: Oxford University Press, 2001): at 73–108.

London A. Kimmelman J. , and Emborg M. , “Beyond Access vs. Protection in Trials of Innovative Therapies,” Science 328, no. 5980 (2010): 829–830.

Id.

See Psaty B. and Ray W. , “FDA Guidance on Of-Label Promotion and the State of the Literature from Sponsors,” JAMA 299, no. 16, (2008): 1949–50. See also Robertson C. , “The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment,” American Journal of Law & Medicine 37, nos. 2 & 3 (2011): 358–387; Elliott C. , “Useless Studies, Real Harm,” New York Times, July 28, 2011, available at <http://www.nytimes.com/2011/07/29/opinion/useless-pharmaceutical-studies-real-harm.html> (last visited December 7, 2012).

Zarin D. Tse T. Williams R. Catliff R. , and Ide N. , “The ClinicalTrials.gov Results Database – Update and Key Issues,” New England Journal of Medicine 364, no. 9 (2011): 852–860.

Marshall E. , “Unseen World of Clinical Trials Emerges from U.S. Database,” Science 333, no. 6039 (2011): 145.

Naik G. , “Mistakes in Scientific Studies Surge,” Wall Street Journal, August 10, 2011, at A1, A12.

See Contopoulos-Ioannidis D. Alexiou G. Gouvias T. , and Ioannidis J. , “Life Cycle of Research for Medical Interventions,” Science 321, no. 5894 (2008): 1298–1299.

See Kimmelman J. , Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation (New York: Cambridge University Press, 2010) for an extensive discussion of early-stage impediments to translation.

Westfall J. Mold J. , and Fagnan L. , “Practice-Based Research – ‘Blue Highways’ on the NIH Roadmap,” JAMA 297, no. 4 (2007): 403–406.

Wayne K. and Glass K. , “The Research Imperative Revisited,” Perspectives in Biology and Medicine 53, no. 3 (2010): 373–387.

Id., at 384, citing Devolder K. and Savulescu J. , “The Moral Imperative to Conduct Embryonic Stem Cell and Cloning Research,” Cambridge Quarterly Journal of Healthcare Ethics 15, no. 1 (2006): 7–21. Wayne and Glass describe similar arguments made in McGee G. and Caplan A. , “The Ethics and Politics of Small Sacrifices in Stem Cell Research,” Kennedy Institute of Ethics Journal 9, no. 2 (1999): 151–58.

National Institutes of Health, Stem Cell Basics, available at <http://stemcells.nih.gov/info/basics/basics6.asp> (last visited December 7, 2012).

See, e.g., West M. , The Immortal Cell (New York: Doubleday, 2003).

Dresser R. , “Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation,” Journal of Law, Medicine & Ethics 38, no. 2 (2010): 332–341, at 336.

These questions have also been neglected in debates about the ethics of other high-profile research areas, such as gene transfer research. See Callahan , supra note 3, at 120–21.

See, e.g., Harris J. , “Scientific Research Is a Moral Duty,” Journal of Medical Ethics 31, no. 4 (2005): 242–228; Rhodes R. , “Rethinking Research Ethics,” American Journal of Bioethics 5, no. 1 (2005): 7–28; Schaefer G. Emanuel E. , and Wertheimer A. , “The Obligation to Participate in Biomedical Research,” JAMA 301 (2009): 67–72.

Several of these points are made in Rennie S. , “Viewing Research Participation as a Moral Obligation: In Whose Interests?” Hastings Center Report 41, no. 2 (2011): 40–47; Melo-Martin I. , “A Duty to Participate in Research: Does Social Context Matter?” American Journal of Bioethics 8, no. 10 (2008): 28–36. See also Dresser R. , “Volunteering for Research,” in Dresser R. , ed., Malignant: Medical Ethicists Confront Cancer (New York: Oxford University Press, 2012).

See Kimmelman , Gene Transfer, at 90. Kimmelman calls research value the “dark matter of research ethics,” commenting that social value is almost always cited as a justification for research, but “a search of the scholarly literature turns up only a handful of conceptual papers amid thousands on consent, risk, inducement, and privacy.” Id.