Abstract
The outsourcing of medical research has become a strategic imperative in the global pharmaceutical industry. Spurred by the challenges of competition, the need for speed in drug development, and increasing domestic costs, pharmaceutical companies across the globe continue to outsource critical parts of their value chain activities, namely contract clinical research and drug testing, to sponsors across the globe, typically into emerging markets. While it is clear that important ethical issues arise with this practice, unraveling moral responsibility and the allocation of responsibility is not so clear, considering that contracts, by their very definition transfer responsibility from the principal to the agent. This research provides a framework for exploring some of the ethical issues, including attributions of moral responsibility associated with Contract Medical Research. Using a theory of strategic and moral behavior, the research shows that both clients and sponsors in contract research have individual and collective responsibility to ensure that due care and diligence is exercised in the performance of clinical research. The research suggests some guidelines for stakeholder action.
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References
Abbas, E. E. (2007). Industry-sponsored research in developing countries. Contemporary Clinical Trials, 28, 677–683.
Alicke, M. D. (1992). Culpable causation. Journal of Personality and Social Psychology, 63, 368–378.
Ashby, S., Chuah, S., & Hoffmann, R. (2004). Industry self-regulation: A game-theoretic typology of strategic voluntary compliance. International Journal of the Economics of Business, 11(1), 91–106.
Bodenheimer, T. (2000). Uneasy alliance: Clinical investigators and the pharmaceutical industry. Health Policy Report, 342(20), 1539–1544.
Cekola, J. (2007). Outsourcing drug investigations to India: A comment on U.S., Indian, and International Regulation of clinical trials in cross-border pharmaceutical research. Northwestern Journal of International Law & Business, 28(1), 125–145.
Clark, T. D. (2009). The case for globalization: Ethical and business considerations in clinical research. Fort Lauderdale, FL: Value of Insight Consulting Inc.
Council Directive. (2001). Directive 2001/20/EC of the European Parliament and the Council. Official Journal of the European Communities, April, pp. 34–44.
Daemmrich, A. (2003). Regulatory laws and political culture in the United States and Germany. In J. Abraham & H. L. Smith (Eds.), Regulation of the pharmaceutical industry (pp. 15–21). Hampshire, UK: Palgrave Macmillan.
Deigh, J. (2008). Can you be morally responsible for someone’s’ death if nothing you did cause it? In W. Sinnott-Armstrong (Ed.), Moral psychology, Vol. 2: The cognitive science of morality: Intuition and diversity (pp. 449–458). Cambridge, MA: MIT Press.
Delios, A., & Beamish, P. (1999). Ownership Strategy of Japanese Firms: Transactional, institutional and experience influences. Strategic Management Journal, 20, 711–727.
Detomasi, D. A. (2007). The multinational corporation and global governance: Modeling global public policy networks. Journal of Business Ethics, 71, 321–334.
Donaldson, T. (1989). The ethics of international business. New York, NY: Oxford University Press.
Driver, J. (2008). Attributions of causation and moral responsibility. In Wr. Sinnott-Armstrong (Ed.), Moral psychology, Vol. 2: The cognitive science of morality: Intuition and diversity (pp. 403–411). Cambridge, MA: MIT Press.
Dukes, M. N. G. (2005). The law and ethics of the pharmaceutical industry. New York, NY: Elsevier.
Dulmin, R., & Mininno, V. (2003). Supplier selection using a multi-criteria decision aid method. Journal of Purchasing and Supply Management, 9(4), 177–187.
Dunning, J. (1994). Multinational enterprises and the globalization of innovatory capacity. Research Policy, 2, 67–88.
Faerman, S. R., McCaffrey, D. P., & Van Slyke, D. M. (2001). Understanding interorganizational cooperation: Public-private collaboration in regulating financial market innovation. Organization Science, 12(3), 372–388.
Feinberg, J. (1970). Doing and deserving: Essays in the theory of responsibility. Princeton, NJ: Princeton University Press.
Fisher, J. A. (2008). Practicing research ethics: Private-sector physicians and pharmaceutical clinical trials. Social Science and Medicine, 66, 2495–2505.
Flavell, D. J., Flavell, S. U., & Sullivan, R. (2003). European clinical trials directive: Responses made to MHRA consultation letter MLX 287. The Lancet, 362(9393), 1415.
Fombrun, C., & Shanley, M. (1990). What’s in a name? Reputation building and corporate strategy. Academy of Management Journal, 33, 233–258.
Goodin, R. (1985). Protecting the vulnerable. Chicago, IL: University of Chicago Press.
Gray, B. (1989). Collaborating: Finding common ground for multiparty problems. San Francisco, CA: Jossey-Bass.
Hale, J. E., Dulek, R. E., & Hale, D. P. (2005). Crisis response communication challenges: Building theory from qualitative data. Journal of Business Communication, 42, 112–134.
Hara, T. (2003). Innovation in the pharmaceutical industry: The process of drug discovery and development. Northampton, MA: Edward Elgar.
Hart, H. L. A., & Honoré, T. (1959). Causation in the law. Oxford: Clarendon Press.
Heide, J. B., & John, G. (1992). Do norms matter in marketing relationships? Journal of Marketing, 56(April), 32–44.
Hepeng, J. (2007). Chinese manufacturers vie for piece of outsourcing pie. Nature Biotechnology, 25(12), 1337–1338.
Jiang, B., Reinhardt, G., & Young, S. T. (2007). BOCOG’s outsourcing contract: The vendor’s perspective. Omega, 36, 941–949.
Jonsen, A. R., Siegler, M., & Windale, W. J. (1992). Clinical ethics (3rd ed.). New York: McGraw Hill.
Joseph, J. (2008). Entering the contract research industry in India. Contemporary Clinical Trials, 29, 311–313.
Kern, T., Willcocks, L., & Heck, E. (2002). The winners curse in IT outsourcing: Strategies for avoiding relational trauma. California Management Review, 44, 47–69.
Knobe, J., & Fraser, B. (2008). Causal judgment and moral judgment: Two experiments. In W. Sinnott-Armstrong (Ed.), Moral psychology, Vol. 2: The cognitive science of morality: Intuition and diversity (pp. 441–447). Cambridge, MA: MIT Press.
Kuzu, N., Ergin, A., & Zencir, M. (2006). Patient’s awareness of their rights in a developing country. Public Health, 120(4), 290–296.
Laughton, A. H. (2007). Somewhere to run, somewhere to hide: International regulation of human subject experimentation. Duke Journal of Comparative and International Law, 18, 181–212.
Lawrence, J. B. (2009). In search of an enforceable medical malpractice exculpatory agreement: Introducing confidential contracts as a solution to the doctor-patient relationship. New York University Law Review, 84, 850–880.
Lawrence, T. B., & Hardy, C. (1999). Building bridges for refugees. Toward a typology of bridging organizations. Journal of Applied Behavioral Science, 35, 48–70.
Leslie, J. (1991). Ensuring two bird deaths with one throw. Mind, 100, 73–86.
Lewis R. (2008). How to negotiate liability clauses. International Financial Law Review, March. 49–51.
Maiti, R., & Raghavendra, M. (2007). Clinical trials in India. Pharmacological Research, 56, 1–10.
Meckling, W. H., & Jensen, M. C. (1976). Theory of the firm: Managerial behavior, agency costs and ownership structure. Journal of Financial Economics, 3(4), 1–77.
Nature. (2008). Trails on trial. Nature, 453, 427–428.
Naverson, J. (2002). Collective responsibility. The Journal of Ethics, 6(2), 179–198.
Nelson, J. (2008). FDA redraws the rules for international drug trials. Science Progress. www.scienceprogress.org.
Nundy, S., & Gulhati, C. M. (2005). A new colonialism? Conducting clinical trials in India. The New England Journal of Medicine, 352(16), 1633–1637.
Olson, M. (1965). The logic of collective action. Cambridge, MA: Harvard University Press.
Parexel’s pharmaceutical R & D statistical sourcebook. (2001). Barnett International, Needham, MA.
Pierlott, M. F. (2004). Moral considerations in outsourcing to foreign labor. International Journal of Social Economics, 31(5/6), 582–592.
Rhee, M., & Valdez, M. E. (2009). Contextual factors surrounding reputation damage with potential implications for reputation repair. Academy of Management Review, 34(1), 146–168.
Santiago-Rodriguez, F. (2008). Facing the trial of internationalizing clinical trials to developing counties: With some evidence from Mexico. Working Paper Series (pp. 1–26). United Nations University, Maastricht, The Netherlands.
Santoro, M. A. (2005). Introduction to part 1: Profits, patients, rights and scientific progress: The ethics of clinical research conducted in private enterprises. In M. A. Santoro & T. M. Gorrie (Eds.), Ethics and the pharmaceutical industry (pp. 9–20). New York, NY: Cambridge University Press.
Santoro, M. A., & Gorrie, T. A. (Eds.). (2005). Ethics and the pharmaceutical industry. New York, NY: Cambridge University Press.
Shah, S. (2006). The body hunters: Testing new drugs on the world’s poorest patients. New York, NY: New Press.
Shapiro, H. T., & Meslin, E. M. (2001). Ethical issues in the design and conduct of clinical trials in developing countries. The New England Journal of Medicine, 345(2), 139–143.
Singh, S. (2007). Indian pharma enters the global arena. Cell, 128(March), 811–814.
Sinha, G. (2004). Outsourcing drug work: Pharmaceuticals Ship R & D and clinical trials to India. Scientific American Online, August 16.
Sosa, D. (1993). Consequences of consequentialism. Mind, 102, 101–122.
Stephens, J. (2000). As drug testing spreads, profits and lives hang in balance. The Washington Post, December 17.
Thompson, J. J. (1987). The decline of cause. The Georgetown Law Journal, 76, 137–150.
Treviño, L. K., & Brown, M. E. (2004). Managing to be ethical: Debunking five business ethics myths. Academy of Management Executive, 19(2), 69–81.
Valdez-Martinez, E., Turnbull, B., Garduna-Espinosa, J., & Porter, J. D. H. (2006). Descriptive ethics: A quality study of local research ethics committees in Mexico. Developing World Bioethics, 6(2), 95–105.
Van Tulder, R., & Mol, M. (2002). Reverse auctions or auctions reversed: First experiments by Phillips. European Management Journal, 20, 47–69.
Vogel, J. R. (1999). Maximizing the benefits of SMOs. Applied Clinical Trials, 8(11), 56–62.
Waters, J. A., & Bird, F. (1987). The moral dimension of organizational culture. Journal of Business Ethics, 6(1), 15–22.
Williamson, O. (1981). The economics of organization. American Journal of Sociology, 87, 548–577.
Williamson, O. (1985). The economic institutions of capitalism. New York, NY: Free Press.
Wilson, T. E., & Grimlund, R. A. (1990). An examination of the importance of an auditor’s reputation. Auditing: A Journal of Practice and Theory, 9(1), 43–59.
World Medical Association. (1999). Proposed revision of the Declaration of Helsinki. Bulletin of medical ethics, 147, 18–22.
Wortuba, T. R. (1997). Industry self-regulation: A review and extension to a global setting. Journal of Public Policy & Marketing, 16(1), 110–116.
Acknowledgments
The author acknowledges the valuable feedback received from Robert Angle, Ronald McMullen, Mary Meixell, and Angela Mattie on previous versions of this manuscript. The author would also like to thank the two anonymous reviewers for their pertinent comments and thoughtful suggestions throughout the review process.
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Adobor, H. Ethical Issues in Outsourcing: The Case of Contract Medical Research and the Global Pharmaceutical Industry. J Bus Ethics 105, 239–255 (2012). https://doi.org/10.1007/s10551-011-0964-0
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DOI: https://doi.org/10.1007/s10551-011-0964-0