International Research Ethics Course: Readings

Please note that the book, Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C, eds. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Baltimore: Johns Hopkins University Press. 2003), contains important readings related to this course. The readings on this CD are supplementary. The readings on this CD are not copyrighted because they are written by Departemental Faculty who are US federal employees. These readings are, however, not necessarily representative of the range of opinions in the literature on the topics covered.

  A framework for the ethics of clinical research 
 
  1. Emanuel E, Wendler D, Grady C. What Makes Clinical Research Ethical? Journal of the American Medical Association 2000;283(20):2701-2711
  2. Emanuel E, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The Benchmarks of ethical research. Journal of Infectious Diseases 2004;189:930-937.
  The ethics of randomization and placebo controls
 
  1. Miller F, Emanuel E. The Ethics of Placebo-Controlled Trials - A Middle Ground. New England Journal of Medicine 2001; 345(12):915-919
  2. Temple R, Ellenberg S. Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments: Ethical and Scientific Issues. Annals of Internal Medicine 2000; 133(6):455-463.
  3. Ellenberg S, Temple R. Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments: Practical Issues and Specific Cases. Annals of Internal Medicine 2000; 133(6):464-470.
  4. Miller F. Placebo controlled trials in psychiatric research. An ethical perspective. Biological Psychiatry 2000:49;707-716
  5. Horng S, Miller F. Is placebo surgery unethical. New England Journal of Medicine 2202:347; 137-139
  6. Miller FG. Sham Surgery: An Ethical Analysis. Science and Engineering Ethics 2004;10:157-166. [appeared in American Journal of Bioethics 2003;3(4):41-48.]
  7. Silverman HJ, Miller FG. Control group selection in critical care randomized controlled trials evaluating interventional strategies: an ethical assessment. Critical Care Medicine 2004;32(3):852-857.
  8. Horng S, Miller F. Ethical framework for the use of sham procedures in clinical trials. Critical Care Medicine 2003; 31(3)[Suppl.]:S126-S130.
  9. Miller FG, Brody H. A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Center Report. 2003;33(3):19-28.
  10. Miller FG, Rosenstein DL. The Therapeutic Orientation to Clinical Trials. New England Journal of Medicine 2003; 348(14):1383-1386
  11. Miller FG, Brody H. What Makes Placebo-Controlled Trials Unethical? The American Journal of Bioethics 2002; 2(2):3-9.
  12. Miller FG, Shorr AF. Unnecessary Use of Placebo Trials: The Case of Asthma Clinical Trials. Archives of Internal Medicine 2002; 162: 1673-1677.
  The ethics of risks and benefits
 
  1. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How Do IRBs Apply the Federal Risk and Benefit Standards for Pediatric Research? JAMA 2004;291(4):476-482.
  2. Agrawal M, Emanuel E. Ethics of Phase 1 Oncology Studies: Reexamining the Arguments and Data. JAMA 2003;290(8):1075-1082.
  3. Churchill LR, Nelson DK, Henderson GE, King NMP, Davis AM, Leahey E, Wilfond BS. Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can Be Risky. IRB 2003; 25(3):1-3.
  4. Miller FG. Ethical issues in research with healthy volunteers: risk-benefit assessment. Clinical Pharmacology and Therapeutics. 2003;74:513-5.
  5. Horng S, Emanuel E, Wilfond B, Rackoff J, Martz K, Grady C. Descriptions of Benefits and Risks in Consent Forms For Phase I Oncology Trials. New England Journal of Medicine 2002; 347(26):2134-2140.

 
  The ethics of subject recruitment
 
  1. Dickert N, Grady C. What's the Price of a Research Subject? Approaches To Payment for Research Participation. New England Journal of Medicine 1999; 341(3):198-203.
  2. Office of Inspector General, DHHS. Recruiting Human Subjects: Pressures In Industry-Sponsored Clinical Research; OEI-01-97-00195, June 2000
  3. Hull SC, Glanz K, Steffen A, Wilfond B. Recruitment Approaches for Family Studies: Attitudes of Index Patients and Their Relatives. IRB 2004 (In Press).
  4. Emanuel E. Ending Concerns About Undue Inducement. Journal of Law, Medicine & Ethics 2004; 32(1):100-105
  5. Horng S, Grady C. Misunderstanding in Clinical Research Subjects: Distinguishing the Therapeutic Misconception from the Therapeutic Misestimation. IRB: Ethics and Human Research 2003;25(1):11-16.
  6. Dickert N, Emanuel E, Grady C. Paying Research Subjects: Analysis of Current Policies. Annals of Internal Medicine 2002; 136(5):368-393.
  7. Grady C. Payment of research subjects. PM& D SocraSource 36-37
  8. Grady C. Recruitment of research subjects PM&D SocraSource 33-34
  The ethics of alternative and complementary medicine
 
  1. Franklin G. Miller et al. Ethical issues concerning research in complementary and alternative medicine JAMA 2004;291:599-604
  The ethics of research with stored biological samples and medical records
 
  1. National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Executive Summary And Chapter 1, August 1999.
  2. American Society of Human Genetics, ASHG Report: Statement Of Informed Consent for Genetic Research. American Journal of Human Genetics 1996;59:471-474.
  3. American Society of Human Genetics, Ad Hoc Committee on DNA Technology; DNA Banking and DNA Analysis: Points To Consider. American Journal of Human Genetics 1988;42:781-783.
  4. Hull SC, Gooding H, Klein AP, Warshauer-Baker E, Metosky S, Wilfond BS. Genetics Research Involving Human Biological Materials: A Need to Tailor Consent Forms. IRB 2004; 26(3):1-7.
  5. Kass NE, Natowicz MR, Hull SC, Faden RR, Plantinga L, Gostin LO, Slutsman J. The Use of Medical Records in Research: What Do Patients Want? Journal of Law, Medicine & Ethics 2003;31:429-433.
  6. Wendler D, Emanuel E. The Debate Over Research On Stored Biological Samples: What Do Sources Think? Archives of Internal Medicine 2002; 162:1457-1462
  7. Wendler, D. What Research With Stored Samples Teaches Us About Research With Human Subjects. Bioethics 2002; 16(1):33-54. .
  The ethics of informed consent
 
  1. Guidelines for Writing Informed Consent Documents, OHSR, NIH.
  2. Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials, NCI, NIH.
  3. Pace C, Grady C, Emanuel E. What we don't know about informed consent. SciDevNet 2003: August 28, http://www.scidev.net/dossiers/ethics/.
  4. Lie RK. The Absolute Ethical Requirement of Individual Informed Consent: A Commentary on Barrett and Parker. Monash Bioethics Review 2003;22(3):18-22.
  5. Wendler D, Rackoff J. Consent for Continuing Research Participation: What Is It and When Should It Be Obtained? IRB: Ethics and Human Research 2002; 24(3):1-6.
  6. Wendler D, Rackoff J. Informed Consent and Respecting Autonomy: What's a Signature Got to Do With It? IRB 2001; 23(3):1-4.
  7. Wendler, D. Informed Consent, Exploitation, and Whether It Is Possible to Conduct Human Subjects Research Without Either One. Bioethics 2000; 14(4):310-339.
  Ethics of decisionally impaired participants
 
  1. Rosenstein DL, Miller FG. Ethical considerations in psychopharmacological research involving decisionally impaired subjects. Psychopharmacology. 2003;171:92-7
  2. Wendler D, Shah S, Whittle A, Wilfond B. Non-beneficial research with individuals who cannot consent: is it ethically better to enroll health or affected individuals? IRB 2003;25(4):1-4.
  3. Chen D, Miller F, Rosenstein D. Enrolling Decisionally-Impaired Adults in Clinical Research. Medical Care 2002; 40(suppl):V20-V29.
  4. Wendler D, Martinez R, Fairclough D, Sunderland T, Emanuel E. Views of Potential Subjects Toward Proposed Regulations for Clinical Research With Adults Unable to Consent. American Journal of Psychiatry 2002; 159(4):585-591.
  5. Wendler D, Prasad K. Core Safeguards for Clinical Research with Adults Who Are Unable to Consent. Annals of Internal Medicine 2001; 135(7):514-523.
  6. Miller FG, Rosenstein DL. Independent capactiy assessment. A critique. BioLaw 1999: September-October; 432-438
  7. NBAC. Research involving persons with mental disorders that may affect decisionmaking capacity
  8. Fins JJ, Miller FG. Enrolling decisionally incapacitated individuals in neuropsychiatric research. CNS Spectrums 2000:5 (10);32-42
  Research with children
 
  1. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How Do IRBs Apply the Federal Risk and Benefit Standards for Pediatric Research? JAMA 2004;291(4):476-482.
  2. Whittle A, Shah S, Wilfond B, Gensler G, Wendler D. IRB Practices regarding assent in pediatric research. Pediatrics 2004 (In Press).
  3. Coffey MJ, Wilfond B, Ross LF. Ethical Assessment of Clinical Asthma Trials Including Children Subjects. Pediatrics 2004;113(1):87-94.
  4. Wendler D, Forster H. Why We Need Legal Standards for Pediatric Research. Journal of Pediatrics 2004;144:150-153.
  5. Wendler D. Establishing risk standards for pediatric research: Lessons from the Grimes case. Kennedy Institute of Ethics Journal 2004;14:189-200.
  6. Miller FG, Wendler D, Wilfond B. When Do the Federal Regulations Allow Placebo-Controlled Trials in Children? Journal of Pediatrics 2003; 142:102-107.
  7. Wendler D, Shah S. Should Children Decide Whether They Are Enrolled in Non-Beneficial Research? American Journal of Bioethics 2003;3:1-7.
  8. Wendler D, Rackoff J, Emanuel E, Grady C. The Ethics of Paying for Children's Participation in Research. Journal of Pediatrics 2002;141:166-171.
  Function and performance of ethical review
 
  1. Emanuel E, Wood A, Fleischman A, Bowen, A, Getz KA, Grady C, Levine C, Hammerschmidt DE, Faden R, Eckenwiler L, Tucker C, Sugarman J. Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals. Annals of Internal Medicine 2004 (In Press).
  2. Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. Special Scrutiny: A more targeted form of Protocol Review to Protect Research Participants. Annals of Internal Medicine 2004; 140:220-223.
  3. Sugarman J, Eckenwiler L, Emanuel E. Research Oversight through New Lenses: The Consortium to Examine Clinical Research Ethics. IRB2003; 25(1):9-10.
  4. Davis AM, Hull SC, Grady G, Wilfond BS, Henderson GE. The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection. Journal of Law Medicine and Ethics 2002; 30(3):411-419.
  5. Sugarman J, Eckenwiler L, Emanuel E. Research Oversight through New Lenses: The Consortium to Examine Clinical Research Ethics. IRB 2003;25(1):9-10.
  6. Silverman H, Hull SC, Sugarman J. Variability Among Institutional Review Boards' Decisions Within the Context of a Multicenter Trial. Critical Care Medicine 2001; 29(2):235-241.
  International Research
 
  1. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Fair Benefits for Research in Developing Countries. Science 2002: 298; 2133-213
  2. National Bioethics Advisory Commission 2000. Ethical and Policy Issues in International Research, Chapter 4.
  3. Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries, Chapter 9 (London: Nuffield Council on Bioethics, 2002).
  4. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Moral standards for research in developing countries. From "Reasonable Availability" to "Fair Benefits". Hastings Center Report 2004:34 (no 3) 17-26
  5. Wendler D, Emanuel E, Lie R. The standard of care debate: Can researchers be ethical and helpful in developing countries? American Journal of Public Health 2004: 94;923-927
  6. Lie R, Emanuel E, Grady C, Wendler D. The Standard of care debate: The Declaration of Helsinki versus the international consensus opinion. Journal of Medical Ethics 2004;30:190-193.
  7. Lie R. Research Ethics and Evidence Based Medicine. Journal of Medical Ethics 2004;30:122-125.
  8. Miller FG, Silverman HJ. The Ethical Relevance of the Standard of Care in the Design of Critical Care Trials. American Journal of Respiratory and Critical Care Medicine 2004;169:562-564.
  9. Richardson H, Belsky L. The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care that Researchers Owe Their Subjects. Hastings Center Report2004; 34(1):25-33.
  10. Killen J, Grady C, Folkers G, Fauci A. Ethics of Clinical Research in the Developing World. Nature 2002; 2:210-215.
  11. Forster H, Emanuel E, Grady C. The 2000 Revision of the Declaration of Helsinki: A Step Forward or More Confusion? The Lancet 2001; 358:1449-1453
  Genetics research
 
  1. Freund C, Clayton E, Wilfond B. Natural Settings Trials-Improving the Introduction of Clinical Genetic Tests. The Journal of Law, Medicine & Ethics 2004;32(1):106-110
  2. Plantinga L, Natowicz NR, Kass NE, Hull SC, Gostin LO, Faden RR. Disclosure, Confidentiality, and Families: Experiences and Attitudes of Those with Genetic Versus Non-Genetic Medical Conditions. American Journal of Medical Genetics 2003;119C:51-59. .
  3. Wendler D, Prasad K, Wilfond B. Does the Current Consent Process Minimize the Risks of Genetics Research? American Journal of Medical Genetics 2002; 113:258-262.
  4. Nelson RM, Botkin JR, Kodish ED, Levetown M, Truman JT, Wilfond BS, Harrison CE, Kazura A, Krug E 3rd, Schwartz PA, Donovan GK, Fallat M, Porter IH, Steinberg D. Ethical issues with genetic testing in pediatrics. Pediatrics 2002; 107:1451-1455.