CCRE Research

Center faculty and staff are active scholars in the field of research ethics. CCRE personnel are engaged in several ongoing research projects on clinical research ethics, and have a special interest in translational science and research with vulnerable participants. Publications from the last 5 years are listed; links are provided when copyrights permit.

Publications

Dresser, R. (2010). Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation. The Journal of Law, Medicine & Ethics, 38(2), 332–341.

DuBois, J. M., Schilling, D. A., Heitman, E., Steneck, N. H., & Kon, A. A. (2010). Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs. Clinical and Translational Science, early view online article advance of print.

Ross, L.R., Loup, A., Nelson, R. M., Botkin, J.R., Kost, R., Smith, Jr., G.R., & Gehlert, S. (2010). Human subjects protections in collaborative community-engaged research: A research ethics framework. Journal of Empirical Research on Human Research Ethics, 5(1) , 5-17.

Ross, L.R., Loup, A., Smith, Jr., G. R., Kost, R., Botkin, J.R., Nelson, R.M., & Gehlert, S. (2010). Community-academic partnership throughout the life-cycle of a research project: Points to consider. Journal of Empirical Research on Human Research Ethics, 5(1), 19-31.

Ross, L.R., Loup, A., Kost, R., Botkin, J.R., Nelson, R.M., Smith, Jr., G.R., & Gehlert, S. (2010). Nine key functions for a human subjects protection program for collaborative community engaged research: Points to consider. Journal of Empirical Research on Human Research Ethics, 5(1) , 33-47.

Dresser, R. (2009). First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless. The Journal of Law, Medicine & Ethics, 37(1), 38-50.

Dresser, R., & Frader, J. (2009). Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics, 37(3), 476-486, 396.

Dresser, R. (2009). Germline Genetic Modification In B. Gordijn & R. Chadwick (Eds.), Medical Enhancement and Posthumanity (Vol. 2, pp. 191-205): Springer Netherlands.

DuBois, J. M. (2009). What counts as empirical research in bioethics and where do we find the stuff? Am J Bioeth, 9(6-7), 70-72.

DuBois, J. M. (2009). The biomedical ethics ontology proposal: excellent aims, questionable methods. J Empir Res Hum Res Ethics, 4(1), 59-62.

DuBois, J., & Dueker, J. (2009). Teaching and Assessing the Responsible Conduct of Research: A Delphi Consensus Panel Report. Journal of Research Administration, 40(1), 49-70.

DuBois, J. M., Callahan O'Leary, C., & Cottler, L. B. (2009). The Attitudes of Females in Drug Court Toward Additional Safeguards in HIV Prevention Research. Prev Sci.

Iltis, A. S. (2009). Introduction: Vulnerability in biomedical research. J Law Med Ethics, 37(1), 6-11.

Iltis, A. S. (2009). Payments to normal healthy volunteers in phase 1 trials: avoiding undue influence while distributing fairly the burdens of research participation. J Med Philos, 34(1), 68-90.

Iltis, A. S., Wall, A., Lesandrini, J., Rangel, E. K., & Chibnall, J. T. (2009). Federal interpretation and enforcement of protections for vulnerable participants in human research. J Empir Res Hum Res Ethics, 4(1), 37-41.

Beskow, L. M., Grady, C., Iltis, A. S., Sadler, J. Z., & Wilfond, B. S. (2009). Points to consider: The research ethics consultation service and the IRB. IRB, 31(6), 1-9.

Anderson, E. E., & Iltis, A. S. (2008). Assessing and Improving Research Participants' Understanding of Risk: Potential Lessons from the Literature on Physician-Patient Risk Communication. Journal of Empirical Research on Human Research Ethics, 3(3), 27-37.

Dresser, R. (2008). The Role of the Public and Interest Groups in Research. In E. J. Emanuel, C. Grady, R. Crouch, R. Lie, F. Miller & D. Wendler (Eds.), The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press.

Dresser, R. (2008). The sex kitten of bioethics? Research ethics comes of age. Hastings Cent Rep, 38(5), 5.

DuBois, J. M. (2008). Hidden data for research ethicists: an introduction to the concept and a series of papers. J Empir Res Hum Res Ethics, 3(3), 3-5.

DuBois, J. M., Dueker, J. M., Anderson, E. E., & Campbell, J. (2008). The development and assessment of an NIH-funded research ethics training program. Acad Med, 83(6), 596-603.

DuBois, J. M., Volpe, R. L., & Rangel, E. K. (2008). Hidden Empirical Research Ethics: A Review of Three Health Journals from 2005 through 2006. J Empir Res Hum Res Ethics, 3(3), 7-18.

Iltis, A. S. (2008). Harm Reduction Research: Ethics and Compliance. In R. M. Green, A. Donovan & S. A. Jauss (Eds.), Global Bioethics: Issues of Conscience for the Twenty-First Century (pp. 117-140). New York: Oxford University Press.

Iltis, A. S., Matsuo, H., & DeVader, S. R. (2008). Currents in contemporary ethics: ethical and practical concerns in developing payment policies for research involving children and adolescents. J Law Med Ethics, 36(2), 413-418.

Anderson, E. E., & DuBois, J. M. (2007). The need for evidence-based research ethics: a review of the substance abuse literature. Drug Alcohol Depend, 86(2-3), 95-105.

DuBois, J. M. (2007). Ethics in Mental Health Research. New York: Oxford University Press.

Iltis, A. S. (2007). Ethics in Human Subjects Research. In S. Boslaugh & L. McNutt (Eds.), Encyclopedia of Epidemiology (pp. 341-346). Thousand Oaks, CA: SAGE.

Iltis, A. (2007). Pediatric Research Posing a Minor Increase Over Minimal Risk and No Prospect of Direct Benefit: Challenging 45 CFR 46.406. Accountability in Research, 14(1), 19 - 34.

Dresser, R. (2006). Investigational drugs and the constitution. Hastings Cent Rep, 36(6), 9-10.

Dresser, R. (2006). Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics. Theor Med Bioeth, 27(2), 115-139.

Dresser, R. (2006). Protection of human subjects and scientific progress: can the two be reconciled? Hastings Cent Rep, 36(1), 7; author reply 9.

Iltis, A. S. (2006). Colonizing Bioethics: A Review of H. Tristram Engelhardt, Jr. In T. H. Engelhardt (Ed.), Global Bioethics: The Collapse of Consensus M & M Scrivener Press

Iltis, A. (2006). Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk. Bioethics, 20(4), 180-190.

Iltis, A. S. (2006). Research, Development, and the Availability of Health Care Products: The Market, Regulation, and Legal Liability. The Journal of Value Inquiry, 40(2-3), 195-208.

Iltis, A. (Ed.). (2006). Research Ethics. London: Routledge.

Iltis, A. S., DeVader, S., & Matsuo, H. (2006). Payments to children and adolescents enrolled in research: a pilot study. Pediatrics, 118(4), 1546-1552.

Dresser, R. (2005). Clinical trial registration and the ICMJE. JAMA, 293(2), 157; author reply 158.

Dresser, R. (2005). Research Ethics and Maternal-Fetal Surgery. In R. Kodish (Ed.), Ethics and Research with Children: A Case-Based Approach (pp. 223-240). New York: Oxford University Press.

Dresser, R. (2005). Stem cell research: the bigger picture. Perspect Biol Med, 48(2), 181-194.

DuBois, J. M. (2005). Ethics in behavioral and social science research. In A. S. Iltis (Ed.), Research Ethics (pp. 102 - 120): Routledge.

DuBois, J. M. (2005). They're not Just Shorter: The Ethics of Research on Children. Ethics and Behavior, 15(4), 361-356.

DuBois, J. M. (2005). Vulnerability in Research. In R. Amdur & E. Bankert (Eds.), Institutional review Board: Management and Function (2 ed.). Boston: Jones and Bartlett.

Iltis, A. S. (2005). Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass. J Med Ethics, 31(7), 410-414.

Iltis, A. S. (2005). Third-party payers and the cost of biomedical research. Kennedy Inst Ethics J, 15(2), 135-160.

Iltis, A. S. (2005). Timing invitations to participate in clinical research: preliminary versus informed consent. J Med Philos, 30(1), 89-106.

Dresser, R. (2004). Designing babies: human research issues. IRB, 26(5), 1-8.

Dresser, R. (2004). Genetic modification of preimplantation embryos: toward adequate human research policies. Milbank Q, 82(1), 195-214.

DuBois, J. M. (2004). Is compliance a professional virtue of researchers? Reflections on promoting the responsible conduct of research. Ethics Behav, 14(4), 383-395.

Iltis, A. S. (2004). Costs to subjects for research participation and the informed consent process: regulatory and ethical considerations. IRB, 26(6), 9-13.

Iltis, A. S. (2004). Placebo controlled trials: restrictions, not prohibitions. Camb Q Healthc Ethics, 13(4), 380-393.

Grants and Contracts

James DuBois, PhD, DsC, Principal Investigator. "Environmental Factors Predictive of Misbehavior in Collaborative Health Research," National Institutes of Health (1R21RR026313-01). 2009-2010. $376,000. 

James DuBois, PhD, DsC, Principal Investigator. "Environmental Factors Associated with Professional Misconduct in Medical Research and Practice," BF Foundation. 2009-2011. $100,000.

Andrew Plunk, MPH, Co-Investigator. "Evaluating the Effects of Phase 4 Trials on Physician Prescribing Behavior," Bander Business Ethics in Medical Research Funding Program. 2009-2010.

Sarah Gehlert, PhD, Co-Principal Investigator. "360 Degrees of Human Subjects Protection in Community-Based participatory Research," Supplement to the CTSA from the National Center for Research Resources, National Institutes of Health. Awarded 2008   

Rebecca Dresser, JD, Principal Investigator. Project support: "Bioethics and Cancer: When the Professional Becomes Personal." Greenwall Foundation. Awarded 2007.

Ana Iltis, PhD, Co-Investigator. "IRB Member Assessment of Decisional Capacity in Psychiatric and Medical Research" NIH Grant 1R01MH075958-01A2. PI: Raymond C. Tait, Ph.D. Awarded 2007

Ana Iltis, PhD, Principal investigator. "Federal Interpretation and Enforcement of Protections for Vulnerable Participants in Research," Saint Louis University Summer Research Award. Awarded 2007.

James DuBois, PhD, DSc, Principal Investigator. "Best Practices in Mental Health Research Ethics Conference Series," National Institute of Mental Health (1R13MH079690). 2007–2011. $200,000.

James DuBois, PhD, DSc, Principal Investigator. "Responsible Conduct of Research Instructional Assessment Project," Office of Research Integrity, Responsible Conduct of Research Resource Development Program, 2006-2007, $50,000.

Ana Iltis, PhD, Principal investigator. "Payments to Children and Adolescents Enrolled in Research: A Pilot Study," Beaumont Faculty Development Award, Saint Louis University. 2005-2006.

James DuBois, PhD, DSc, Principal Investigator. "Behavioral Health Research: An Ethics Case Compendium and Instructional Method," Office of Research Integrity, Responsible Conduct of Research Resource Development Program, 2003-2004, $25,000 direct costs. See www.emhr.net for emerging products.

Rebecca Dresser, JD, Principal Investigator. "Germ Line Interventions and Human Research Ethics," National Human Genome Research Institute, National Institutes of Health Grant Number 1 R01 HG02493–01, 2002-2005.

James DuBois, PhD, DSc, Principal Investigator. "Ethical Issues in Behavioral Health Research," National Institute of Health, 1 T15 HL072453-01, 2002–2005, $527,961 direct costs. See www.emhr.net for information on the training program.