- Universal Declaration of Human Rights - Arabic
- World Medical Association Declaration of Helsinki
- The Belmont Report
- Council for International Organizations of Medical Sciences (CIOMS)
- The Islamic Organization for Medical Sciences (IOMS)
A Framework for the Ethics of Clinical Research
Emanuel E, Wendler D, Grady C. What Makes Clinical Research Ethical? Journal of the American Medical Association 2000;283(20):2701-2711
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
- OHRP letter to the ARDSNet: October 7, 2002
- ARDSNet Response Letter to OHRP: March 12, 2003
- ARDSNet Response to the October 7, 2002 OHRP Letter
- OHRP final letter to the ARDSNet: July 3, 2003
Miller F, Emanuel E. The Ethics of Placebo-Controlled Trials - A Middle Ground. New England Journal of Medicine 2001; 345(12):915-919
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.
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.
Miller F. Placebo controlled trials in psychiatric research. An ethical perspective. Biological Psychiatry 2000:49;707-716.
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.
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.
Miller FG, Rosenstein DL. The Therapeutic Orientation to Clinical Trials. New England Journal of Medicine 2003; 348(14):1383-1386.
The Ethics of Subject Recruitment
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.
Dickert N, Emanuel E, Grady C. Paying Research Subjects: Analysis of Current Policies. Annals of Internal Medicine 2002; 136(5):368-393.
The Ethics of Informed Consent
Guidelines for Writing Informed Consent Documents, OHSR, NIH.
Pace C, Grady C, Emanuel E. What we don't know about informed consent. SciDevNet 2003: August 28.
Wendler D, Rackoff J. Informed Consent and Respecting Autonomy: What's a Signature Got to Do With It? IRB 2001; 23(3):1-4.
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
Chen D, Miller F, Rosenstein D. Enrolling Decisionally-Impaired Adults in Clinical Research. Medical Care 2002; 40(suppl):V20-V29.
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.
Miller FG, Rosenstein DL. Independent capacity assessment. A critique. BioLaw 1999: September-October; 432-438
NBAC. >Research involving persons with mental disorders that may affect decisionmaking capacity
Fins JJ, Miller FG. Enrolling decisionally incapacitated individuals in neuropsychiatric research. CNS Spectrums 2000:5 (10);32-42.
Research with Children
Miller FG, Wendler D, Wilfond B. When Do the Federal Regulations Allow Placebo-Controlled Trials in Children? Journal of Pediatrics 2003; 142:102-107.
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
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.
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.
National Bioethics Advisory Commission 2000. Ethical and Policy Issues in International Research, Chapter 4.
Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries, Chapter 9 (London: Nuffield Council on Bioethics, 2002).
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
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
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.
Lie R. Research Ethics and Evidence Based Medicine. Journal of Medical Ethics 2004;30:122-125.
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.
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.
Killen J, Grady C, Folkers G, Fauci A. Ethics of Clinical Research in the Developing World. Nature 2002; 2:210-215.
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.
Abudr Rab M, Mamdouh R. Ethics in health in EMRO: practices and perceptions among health researchers in the Region. Presented at Global Forum for Health Research, Forum 8, Mexico City, November 2004.
HRETIE 2005 Candidates and Faculty. Enhancing Research Ethics Committees In Egypt. Guidelines for Standard Operating Procedures. The Monitor. 2006; 20:49.
Silverman, HJ.Enhancing Research Ethics Capacity: Implications for protection of research subjects, avoiding exploitation, and achieving global health. Middle East Fertility Society Journal 2005; 10:105-109
Afifi, R. Biomedical Research Ethics. An Islamic View. Part I. International Journal of Surgery. 2006
Afifi, R. Biomedical Research Ethics. An Islamic View. Part II. International Journal of Surgery. 2006
Wachbroit R. Research as a Profession. Philosophy & Public Policy Quarterly. 2006; 26:18
Wachbroit R, Wasserman D. Research Participation: Are We Subject to a Duty? The American Journal of Bioethics. 2005; 5:48.
Wasserman D, Hellman DS, Wachbroit R. Physicians as Researchers:Difficulties with the "Similarity Position". The American Journal of Bioethics. 2006; 6:57.
Silverman HJ, Lemaire F. Ethics and research in critical care. Intensive Care Med. 2006; 32:1697-205