Research Ethics


Basic biomedical research and clinical trials have been the means of understanding disease and discovery of effective treatments. While research science is portrayed as an objective, empirical field, it too is confronted with specific ethical issues and dilemmas. Yet medical and scientific research at times in its history has not always reflected a genuine concern for the principled research and particularly a commitment to the protection of human subjects. Building on such foundation documents as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, modern research ethics emphasizes the importance of human subjects research protections in the an increasingly complex research environment spanning all areas of biomedical and biotechnological research and beyond, as well as the increasingly international and global nature of such research endeavors. Relevant issues to research ethics include among others: global and national governance, privacy, scientific integrity, reproducibility, conflicts of interest, therapeutic misconception, unintended and secondary findings, use of placebos, responsibilities of researchers to indigenous populations, and issues surrounding informed consent and autonomy.


  • Michael Sleasman and Paige Comstock Cunningham, “Exploitation in the Global Medical Enterprise: Bioethics & Social Injustice.”
  • C. Ben Mitchell, “Scientists, Ethics, and Public Engagement.”
  • Nancy Jones, “The Interface Between Science and Ethics: Probing the Deeper Questions.”
  • Heather Zeiger, “Big Data in Medicine.”


Pediatric Research Ethics

  • Alderson, Priscilla and Viginia Morrow. The Ethics of Research with Children and Young People: A Practical Handbook. 2nd ed. Sage Publications, 2011.
  • Kodish, Eric. Ethics and Research with Children: A Case-Based Approach. New York: Oxford University Press, 2005.
  • Ross, Lainie Friedman. Children in Medical Research: Access versus Protection. New York: Oxford University Press, 2008.
  • Wendler, David S. The Ethics of Pediatric Research. New York: Oxford University Press, 2010.

Research with Human Subjects

  • Cohen, I. Glenn, and Holly Fernandez Lynch, eds. Human Subjects Research Regulation: Perspectives on the Future. Basic Bioethics. Cambridge, MA: MIT Press, 2014.
  • Cooper, Melinda, and Cathy Waldby. Clinical Labor: Tissue Donors and Research Subjects in the Global Bioeconomy. Experimental Futures. Durham, NC: Duke University Press, 2014.
  • García San José, Daniel I. European Normative Framework for Biomedical Research in Human Embryos. Cizur Menor, Navarra: Thomas Reuters Aranzadi, 2013.
  • Goodman, Jordan, et al., eds. Useful Bodies: Humans in the Service of Medical Sicence in the Twentieth Century. Baltimore: The John Hopkins Univ Press, 2008.
  • King, Nancy M.P. and Jane Stein, Beyond Regulations: Ethics in Human Subjects Research. Chapel Hill, NC: University of North Carolina Press, 1999.
  • Mazur, Dennis J. Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members. Baltimore: John Hopkins University Press, 2007.
  • President's Commission for the Study of Bioethical Issues. ""Ethically Impossible": STD Research in Guatemala from 1946 to 1948. Washington, DC, 2011. (Available at
  • Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research. 2011. (Available at
  • Schneider, Carl. The Censor’s Hand: The Misregulation of Human-Subject Research. Basic Bioethics. Cambridge, MA: MIT Press, 2015.
  • United States Department of Health and Human Services. Office for Human Research Protections. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjection of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, D.C.: Government Printing Office, 1979. (Available at
  • United States Department of Health and Human Services. Office of Human Subject Protections. “Protection of Human Subjects.” Code of Federal Regulations Title 45, Part 46, 2009. (Available at
  • United States National Institutes of Health. Office of Human Subjects Research. “Nuremberg Code.”
  • World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.

Research Ethics (General)

  • Comstock, Gary. Research Ethics: A Philosophical Guide to the Responsible Conduct of Research. New York: Cambridge University Press, 2013.
  • Danis, Marion, Emily Largent, Christine Grady, and David Wendler. Research Ethics Consultation: A Casebook. New York: Oxford University Press, 2012.
  • DuBois, James. Ethics in Mental Health Research: Principles, Guidance, and Cases. Oxford University Press, 2007.
  • Emanuel, Ezekiel J., Christine Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, and David Wendler. The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press, 2008
  • Emanuel, Ezekiel J., Robert A. Crouch, John D. Arras, Jonathan D. Moreno, and Christine Grady, eds. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore, MA: The Johns Hopkins University Press, 2003.
  • Fisher, Jill A. Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. New Brunswick, NJ: Rutgers University Press, 2009.
  • Garrett, Jeremy R., ed. The Ethics of Animal Research: Exploring the Controversy. Basic Bioethics. Cambridge, MA: MIT Press, 2012.
  • Hawkins, Jennifer and Ezekiel Emanuel, eds. Exploitation and Developing Countries: The Ethics of Clinical Research. Princeton University Press, 2008.
  • Iltis, Ana Smith, ed. Research Ethics. Routledge Annals of Bioethics. New York: Routledge, 2006.
  • Lavery, James V., Christine Grady, Elizabeth R. Wahl, and Ezekiel J. Emanuel, eds. Ethical Issues in International Biomedical Research: A Casebook. New York: Oxford University Press, 2007.
  • Loue, Sana, and Earl C. Pike. Case Studies in Ethics and HIV Research. New York: Springer, 2007.
  • Macklin, Ruth. Double Standards in Medical Research in Developing Countries. Cambridge, UK: Cambridge University Press, 2004.
  • ______. Ethics in Global Health: Research, Policy and Practice. New York: Oxford University Press, 2012.
  • Menikoff, Jerry. What the Doctor Didn’t Say: The Hidden Truth About Medical Research. New York: Oxford University Press, 2006
  • Murphy, Timothy F. Case Studies in Biomedical Research Ethics. Basic Bioethics. Cambridge, MA: MIT Press, 2004.
  • Murray, Thomas, and Josephine Johnston, eds. Trust and Integrity in Biomedical Research: The Case of Financial Conflicts of Interest. Johns Hopkins Univ Press, 2010.
  • Plomer, Aurora. The Law and Ethics of Medical Research: International Bioethics and Human Rights. New York: Routledge-Cavendish, 2005.
  • Presidential Commission for the Study of Bioethical Issues, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. 2013. (Available at
  • ______, Research across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues. 2011. (Available at
  • Redman, Barbara Klug. Research Misconduct Policy in Biomedicine: Beyond the Bad-Apple Approach. Basic Bioethics. Cambridge, MA: MIT Press, 2013.
  • Sales, Bruce Dennis and Susan Folkman, eds. Ethics in Research with Human Participants. Washington, DC: American Psychological Association, 2000.
  • Shamoo, Adil E. and David B. Resnik. Responsible Conduct of Research. 3nd ed. New York: Oxford University Press, 2009.
  • Smith, Trevor. Ethics in Medical Research: A Handbook of Good Practice. New York: Cambridge University Press, 2015.
  • Tollefsen, Christopher O. Biomedical Research and Beyond: Expanding the Ethics of Inquiry. Routledge Annals of Bioethics. New York: Routledge, 2008.

Out of Print

  • Elliott, Deni and Judy E. Stern, eds. Research Ethics: A Reader. Hanover, NH: University Press of New England, 1997.


  • Beecher, Henry. “Ethics and Clinical Research.” New England Journal of Medicine 274 (1966): 1354-1360.

Position Statement