Illinois Institute of Technology
       
 
Prospective Students Current Students Business & Industry Faculty & Staff Alumni Visitors
 

Informed Consent and Disclosure of Information
to Research Subjects

Abbey L. Berg, Herb Alice, and Marsha Hurst. "Cochlear Implants in Children: Ethics, Informed Consent, and Parental Decision Making." Journal of Clinical Ethics 16.3 (2005): 239-250.

Al-Khateeb, Hussam, United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and Weill Cornell Medical College in Qatar. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Doha, Qatar: Weill Cornell Medical College in Qatar, 2006.

Anderson J. R., et al. “The Case of Two Devices: Disclosure to Subjects Following Phase IV (‘post-marketing’) Research.” IRB: A Review of Human Subjects Research 17.3 (May/June 1995): 6-9.

Appelbaum, Paul S. “Commentary: Examining the Ethics of Human Subjects Research.” Kennedy Institute of Ethic Journal 6.3 (September 1996): 283-287.

Appelbaum, P.S., L.H. Roth, C.W. Lidz, P. Benson, and W. Winslade. “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.” Hastings Center Report 17.2 (1987): 20–24.

Backlar, P. “Human Subjects Research, Ethics, Research on Vulnerable Populations.” In Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology, eds. T.H. Murray and M.J. Mehlman, 641–651. New York: Wiley-Interscience, 2000.

Berg, Jessica W. and Paul S. Appelbaum. Informed Consent: Legal Theory and Clinical Practice New York: Oxford University Press, 2001.

Bok, S. (1995, March). “Shading the truth in seeking informed consent for research purposes.” Kennedy Institute of Ethics Journal, 5(1), 1 17.

Brody, Baruch. The Ethics of Biomedical Research: An International Perspective. New York: Oxford UP, 1998.

Brody, Howard. “Transparency: Informed Consent in Primary Care.” Hastings Center Report 19 (1989): 5-9.

Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS, 1993.

Council of Europe. 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. Oviedo: European Treaty Series, 1997.


Cumming, J.F., A.R. Sahni, and G.R. McClelland. “The Importance of the Subject in Informed Consent.” Applied Clinical Trials 15.3 (March 2005): 64-70.

Dawson, Angus. “Informed Consent: Bioethical Ideal and Empirical Reality” in BioEthics and Social Reality. (Value Inquiry Book Series, Volume 165) ed. Hayry, Matti. New York, Rodopi NY, 2005: 93-105.

Darby, Mary and Gerry McGlynn. Informed Consent for Human Subjects: A Primer. Boston: Management Decision and Research Center, Health Services Research and Development Service, Office of Research and Development, Department of Veterans Affairs, 2002.

Denny Colleen, C. and Christine Grady. “Clinical Research Ethics with Economically Disadvantaged Populations.” Journal of Medical Ethics 33.7 (July 1, 2007): 382-385.

Douglas, Charles D. and John R. McPhee. “Informed Consent: A Review of the Ethical and Legal Basis for Medical Decision-Making for the Competent Patient.” ANZ Journal of Surgery 77.7 (July 2007): 521-522.

Doyal, Len. Informed Consent in Medical Research. London: British Medical Journal, 2001.

Doyal, L., and J. Tobais, eds. Informed Consent in Medical Research. London: BMJ Books, 2001.

Dresser, R. Naive expectations endanger biomedical research. The Chronicle of Higher Education 47.43 (2001, July 6): B12.

Eckenwiler, Lisa. "Moral Reasoning and the Review of Research Involving Human Subjects.” Kennedy Institute of Ethics Journal 11.1 (March 2001): 37-69.

Edwards, Sarah J. L. "Research Participation and the Right to Withdraw." Bioethics 19.2 (April, 2005): 112-30.

Edwards, Sarah J.L. “Restricted Treatments, Inducements, and Research Participation.” Bioethics 20.2 (April 2006): 77-91.

Emanuel, Ezekiel J. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore: Johns Hopkins University Press, 2003.

Faden, Ruth R. and Tom Beauchamp. “Decision-making and Informed Consent: A Study of the Impact of Disclosed Information.” Social Indicators Research 7 (1980): 313-336.

Fisher, Jill. “Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry.” Kennedy Institute of Ethics Journal 16.3 (September 2006): 251-268.

Fisher, Jill. “’Ready-to-Recruit’ or ‘Ready-to-Consent” Populations? Informed Consent and the Limits of Subject Autonomy.” Qualitative Inquiry 13.6 (September 2007): 875-894.

Fisher-Jeffes, Lisa, Charlotte Barton and Fiona Finlay. “Clinicians’ Knowledge of Informed Consent.” Journal of Medical Ethics 33.3 (March 2007): 181-184.

Freedman, B. “Scientific Value and Validity as Ethical Requirements for Research: A Proposed Explication.” IRB: A Review of Human Subjects 9.6 (1987): 7–10.

Gertson, Linda L. and J. Regis McNamara. “Factors Influencing a Person’s Reaction to Informed Consent.” Psychological Reports 54.1 (1984): 112-114.

Getz, Kenneth. Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston: CenterWatch, 2002.

Goldstein, Adam O., Pamela Frasier, Peter Curtis et al. “Consent Form Readability in University-Sponsored Research.” Journal of Family Practice 42.6 (1996): 606-611.

Gostin, Lawrence O. “Biomedical Research Involving Prisoners.” JAMA: Journal of the American Medical Association 297.7 (February 21, 2007): 737-740.

Gostin, Lawrence O. “Informed Consent, Cultural Sensitivity, and Respect for Persons.” Journal of the American Medical Association 274 (1995): 844-45.

Gostin, Lawrence O. and Cori Vanchieri. Ethical Considerations for Research Involving Prisoners. Washington D.C.: National Academies Press, 2007 <http://fermat.nap.edu/catalog/11692.html>

Gray, Bradford H., Robert A. Cooke and Arnold S. Tannenbaum. “Research Involving Human Subjects: The Performance of Institutional Review Boards is Assessed in this Empirical Study.” Science 201.4361 (1978): 1094-1101.

Green, Ronald Michael. “What Does it Mean to Use Someone as "A Means Only": Rereading Kant.” Kennedy Institute of Ethics Journal 11. 3 (September 2001): 247-261.

Guerrini, Anita. Experimenting with Humans and Animals: From Galen to Animal Rights. Baltimore: Johns Hopkins University Press, 2003.

Habiba, Marwan A. “Examining Consent Within the Patient-Doctor Relationship.” Journal of Medical Ethics 26.3 (June 2000): 183-87.

Hampel, Jürgen. “Different Concepts of Risk: a challenge for risk communication.” International Journal of Medical Microbiology 269. Supplement 1. (May 2006): 5-10.

Hershey, Nathan and Stanley H. Bushkoff. Informed Consent Study: The Surgeon’s Responsibility for Disclosure to Patients. Pittsburgh: Aspen Systems Corporation, 1969.

Herz, David A., Janice E. Looman and Shirley Kane Lewis. “Informed Consent: Is It a Myth?” Neurosurgery 30.3 (1992): 453-58.

Huang, David T. and Mehrnaz Hadian. “Bench-to-Bedside Review: Human Subjects Research – Are More Standards Needed?” Critical Care 10.6 (2006) (Published Online http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1794482) Full text available December 15, 2008).

Hunt, Linda M. and Katherine B. De Voogd. “Are Good Intentions Good Enough? Informed Consent Without Trained Interpreters.” Journal of General Internal Medicine 22.5 (May 2007): 598-608. <http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1855271>

Huntington, Ian and Walter Robinson. “The Many Ways of Saying Yes and No: Reflections on the Research Coordinator’s Role in Recruiting Research Participants and Obtaining Informed Consent.” IRB: Ethics and Human Research 29.3 (May/June 2007): 6-10.

Iltis, Ana. “Lay Concepts in Informed Consent to Biomedical Research: The Capacity to Understand and Appreciate Risk.” Bioethics 20.4 (2006): 180-90.

Jansen, Lynn A. “The Problem with Optimism in Clinical Trials.” IRB: Ethics & Human Research 28.4 (Jul/Aug 2006): 13-19.\

Joffe, Steven. “Altruistic Discourse and Therapeutic Misconception in Research Informed Consent.” American Journal of Bioethic 6.5 (September 2006): 53-54.

Kahn, J.P., A.C. Mastroianni, and J. Sugarman, eds. 1998. Beyond Consent: Seeking Justice in Research. New York: Oxford University Press.

Kass, Nancy E., Jeremy Sugarman, Ruth Faden et al. “Trust: The Fragile Foundation of Contemporary Biomedical Research.” Hastings Center Report 26.5 (1996): 25-29.

Kettle, Nancy M. “Informed Consent in Clinical Practice.” Healthcare Ethics Committee Forum: An Interprofessional Journal on Healthcare Institutions Ethical and Legal Issues. 15.3 (March 2003): 42-54.

Kishore, R.R. “Biomedical Research and the Mining of the Poor: The Need for their Exclusion.” Science and Engineering Ethics. 12.1 (Jan 2006): 175-183.

Kopelman, Loretta M. “Moral Problems in Assessing Research Risk.” IRB: A Review of Human Subjects Research 22.5 (Sept.-Oct. 2000): 3-6.

Kottow, M. “The Battering of Informed Consent.” Journal of Medical Ethics 30.6 (Dec 2004): 565-569.

Kristinsson, S. “Autonomy and Informed Consent: A Mistaken Association?” Medicine, Healthcare and Philosophy 10.3 (September 2007): 253-264.

Lane, H., & Grodin, M. Ethical issues in cochlear implant surgery: An exploration into disease, disability, and the best interests of the child. Kennedy Institute of Ethics Journal 7.3 (1997): 231 251

Levine, Carol. Ruth Faden and Christine Grady. “The Limitations of ‘Vulnerability’ as a Protection for Human Research Subjects.” American Journal of Bioethics 4.3 (Summer 2004): 44-86.

Levine R. Balance of Harms and Benefits. Ethics and the Regulation of Clinical Research (2nd ed.). New Haven: Yale University Press, 1988:37–65.

Li, Benfu. "Informed Consent in Research Involving Human Subjects." Journal of Clinical Ethics 15.1 (Spring 2004): 35-47.

Lo, Bernard. “Research with Vulnerable Participants.” Journal of Clinical Ethics 15.1 (Spring 2004): 55-60.

Lott, Jason. “Module Three: Vulnerable? Special Participant Populations.” Developing World Bioethics 5.1 (March 2005): 30-54.


Macklin, Ruth. “The Problem of Adequate Disclosure.” Ethical Issues in Social Science Research. Eds. Tom L. Beauchamp et al. Baltimore: Johns Hopkins Press, 1982. 193-214.

Manson, Neil C. and Onora O’Neill. Rethinking Informed Consent in Bioethics. New York: Cambridge University Press: 2007.

Mazur, Dennis J. and David H. Hickham. “Patient Interpretations of Terms Connoting Low Probabilities when Communicating about Surgical Risk.” Theoretical Surgery 8 (1993): 143-45.

McConnell, Terrance C. Inalienable Rights: the Limits of Consent in Medicine and Law. New York: Oxford University Press. 2000.

Menikoff, J. "Full Disclosure: Telling Patients When Not Being a Research Subject is a Good Choice." Perspectives in Biology and Medicine 48.SUPPL. 1 (2005).

Meredith, Philip. “Patient Participation in Decision-Making and Consent to Treatment: The Case of General Surgery.” Sociology of Health and Illness 15.3 (1993): 315-36.

Miller, Paul B. and Charles Weijer. “Moral Solutions in Assessing Research Risk.” IRB: A Review of Human Subjects Research 22.5 (Sept.-Oct. 2000): 6-10.

National Bioethics Advisory Commission (NBAC). Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. 2 vols. Rockville, MD: U.S. Government Printing Office, 1999.

---. Ethical and Policy Issues in Research Involving Human Participants. Volume I: Report and Recommendations of the National Bioethics Advisory Commission, Full Report. [Ch. 4: “Assessing Risks and Potential Benefits and Evaluating Vulnerability”]. Volume II: Commissioned Papers. Bethesda, MA: NBAC, 2001.
URL Available: http://www.georgetown.edu/research/nrcbl/nbac/pubs.html

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Government Printing Office, 1979.

Newton, Sam K. and John Appiah-Poku. “The Perspectives of Researchers on Obtaining Informed Consent in Developing Countries.” Developing World Bioethics 7.1 (April 2007): 19-24.

Nord, Erik. “Utilitarian Decision Making of Informed Consent.” American Journal of Bioethics 6.3 (May 2006): 65-67.

Northoff, George. "Neuroscience of Decision Making and Informed Consent: An Investigation in Neuroethics." Journal of Medical Ethics 32.2 (2006): 70-3.

Ogloff, James R. P. and Randy K. Otto. “Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research.” Ethics and Behavior 1.4 (1991): 239-52.

Parascandola, Mark. “Patient Autonomy and the Challenge of Clinical Uncertainty.” Kennedy Institute of Ethics Journal 12.3 (September 2002): 245-264.

Perry, Clifton. “Informed Consent in Research.” National Forum 79.3 (Summer 1999): 22-25.

Plomer, Aurora. “Rights Principles and Political Values in Medical Research: The Achre Report and the Council of Europe’s Convention on Human Rights and Biomedicine.” In Ethical Issues for the Twenty-First Century. Adams, Frederick (ed.) Charlottesville, Philosophy Documentation Center, 2005. 283-296.

Priluck, I. A., D. M. Robertson and H. Buettner. “What Patients Recall of the Preoperative Discussion after Retinal Detachment Surgery.” American Journal of Ophthalmology 87.5 (May 1979): 620-3.

“Research on Human Subjects” (Special Issue). The Park Ridge Center Bulletin 18 (Nov.-Dec. 2000).

Rivera, Roberto et al. “Informed Consent: An International Researchers’ Perspective.” American Journal of Public Health 97.1 (January 2007): 25-30.

--- Results of a study investigating the different perspectives international researchers on what information should be included in the informed consent process. Of the researchers interviewed from Africa, Europe and the United States, only limited consensus was found. These findings indicate a need to involve a variety of individuals and stakeholders, with different research and cultural perspectives to develop an informed consent process for research undertaken in international settings.

Rosoff, Arnold J. “Informed Consent in the Electronic Age.” American Journal of Law and Medicine 25. 2/3 (1999): 367-86.

Rozovsky, Fay A. Consent to Practice: a Practical Guide. New York: Aspen Publishers, 2007.

Rozovsky, F. A., and Rodney K. Adams. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance. 1st ed. San Francisco: Jossey-Bass, 2003.

Sandrick, K. “Codified Principles Enhance Physician/Patient Communications.” Bulletin of the American College of Surgeons 83.11 (Nov. 1998): 13-17.

Sankar, Pamela. “Communication and Miscommunication in Informed Consent to Research.” Medical Anthropology Quarterly (Dec. 2004) 18.4: 429-446.

Schmitz, Dagman and Peter C. Reinacher. “Informed Consent in Neurosurgery: Translating Ethical Theory into Action.” Journal of Medical Ethics 32.9 (September 2006): 497-498.

Sears, Jeanne M. “Context is Key for Voluntary and Informed Consent.” American Journal of Bioethics 5.1 (Jan/Feb. 2005): 47-48.

Siegler, Mark, Megan E. Collins, and David C. Cronin. "Special Challenges to the
Informed Consent Doctrine in the United States." Journal of Clinical Ethics 15.1 (Spring 2004): 33-47.

Sugarman, Jeremy et al. “Empirical Research on Informed Consent: An Annotated Bibliography.” Hastings Center Report 29.1 (1999): S1-S42.

Taub. Harvey A. “Comprehension of Informed Consent for Research: Issues and Directions for Future Study.” IRB: Ethics and Human Research 17.3 (November 1986): 7-10.

Titus, Sandra L. and Moira A. Keane. “Do You Understand? An Ethical Assessment of Researchers’ Descriptions of the Consenting Process.” Journal of Clinical Ethics 7.1 (1996): 60-68.

United States. “President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.” Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Washington D.C: United States Printing Office, 1982-

Veatch, Robert M. The Patient as Partner: A Theory of Human-Experimentation Ethics. Bloomington: Indiana University Press, 1987.

Verheggen F. W., R. Jonkers and G. Kok. “Patients’ Perceptions on Informed Consent and the Quality of Information Disclosure in Clinical Trials.” Patient Education and Counseling 29.2 (Nov 1996): 137-53.

Verheggen, F. W. and F. C. van Wijman. “Myth and Reality of Informed Consent in Clinical Trials.” Medicine and Law 16.1 (1997): 53-69.

Wadey, Veronica and Cy Frank. “The Effectiveness of Patient Verbalization on Informed Consent.” Canadian Journal of Surgery 40.2 (1997): 124-28.

Wendler, David and Jonathan E. Rackoff. “Informed Consent and Respecting Autonomy: What’s a Signature Got to Do with It?” IRB: Ethics and Human Research 23.3 (May/June 2001): 1-4.

Weijer, Charles M. “The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation.” National Bioethics Advisory Commission. 2001. Ethical and Policy Issues in Research Involving Human Participants. Volume II: Commissioned Papers. P1 – P29.

---. “Protecting Communities In Research: Philosophical And Pragmatic Challenges.” Cambridge Quarterly of Healthcare Ethics: The International Journal for Healthcare Ethics and Ethics Committees 8.4 (Fall 1999): 501-513.

---. “Research Involving the Vulnerable Sick.” Accountability in Research 7 (1999): 21–36.

---. “Selecting Subjects for Participation in Clinical Research: One Sphere of Justice.” Journal of Medical Ethics 25 (1999): 31–36.

Weijer, Charles and Ezekiel J. Emanuel. “Protecting Communities in Biomedical Research.” Science 289 (2000): 1142-44.

Weijer, Charles, Gary Goldsand, and Ezekiel J. Emanuel. “Protecting Communities in Research: Current Guidelines and Limits of Extrapolation.” Nature Genetics 23 (1999): 275-80.

Wendler, Dave. “Informed Consent, Exploitation and Whether It Is Possible to Conduct Human Subjects Research without Either One.” Bioethics 14.4 (October 2000): 310-339.

---.“When Should ‘Riskier’ Subjects Be Excluded from Research Participation?” Kennedy Institute of Ethics Journal 8.3 (September 1998): 307-327.

Wilkinson, T.M. “Research, Informed Consent, and the Limits of Disclosure.” Bioethics 15.4 (August 2001): 341-363.

Wilson, James. “Is Respect for Autonomy Defensible?” Journal of Medical Ethics 33.6 (June 2007): 353-356.

© 2008 Illinois Institute of Technology 3300 South Federal Street, Chicago, IL 60616-3793 Tel 312.567.3000