Ellenberg SS: Informed consent: Protection or obstacle? Some emerging issues. Controlled Clinical Trials. 1997, 18 (6): 628-636. 10.1016/S0197-2456(96)00130-4.
Gillam S, Brooks F: New Beginnings: Towards Patient and Public Involvement in Primary Health Care. 2001, London , King’s Fund
Hazelgrove J: The Old Faith and the New Science: The Nuremberg Code and Human Experimentation Ethics in Britain, 1946-73. Social History of Medicine. 2002, 15 (1): 109-135. 10.1093/shm/15.1.109.
Kaufman SR: The World War II plutonium experiments: contested stories and their lessons for medical research and informed consent. Culture, Medicine and Psychiatry. 1997, 21: 161-197. 10.1023/A:1005360928209.
Angell M: The ethics of clinical research in the Third World. The New England Journal of Medicine. 1997, 337 (12): 847-849. 10.1056/NEJM199709183371209.
Kale R: Commentary: Failing to seek patients' consent to research is always wrong. BMJ. 1997, 314: 1081-
Luce JM: Is the concept of informed consent applicable to clinical research involving critically ill patients?. Critical Care Medicine. 2003, 31 (3): S153-S160. 10.1097/01.CCM.0000054901.80339.01.
Adams JG, Wegener J: Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Ann Emerg Med. 1999, 33 (2): 218-223. 10.1016/S0196-0644(99)70398-7.
Vanpee D, Gillet JB, Dupuis M: Clinical trials in an emergency setting: Implications from the fifth version of the declaration of Helsinki. Journal of Emergency Medicine. 2004, 26 (1): 127-131. 10.1016/j.jemermed.2003.04.007.
Baren JM, Fish SS: Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent?. Academic Emergency Medicine. 2005, 12 (11): 1071-1077.
Quest T, Marco CA: Vulnerable populations in emergency medicine research. Academic Emergency Medicine. 2003, 10 (11): 1294-1298.
Tobias JS, Souhami RL: Fully informed consent can be needlessly cruel. BMJ. 1993, 307: 1199-1201.
Taylor KM, Margolese RG, Soskolne CL: Physicians' reasons for not entering eligible patients in a randomised clinical trial of surgery for breast cancer. The New England Journal of Medicine. 1984, 310 (21): 1363-1367.
Kottow M: The battering of informed consent. Journal of Medical Ethics. 2004, 30: 565-569. 10.1136/jme.2003.002949.
McLean S: Commentary: No consent means not treating the patient with respect. BMJ. 1997, 314: 1076-
Farnell SM: Medical Research: Why trouble the patient for informed consent?. Medical and Pediatric Oncology. 2002, 39: 207-209. 10.1002/mpo.10109.
Foex BA: The problem of informed consent in emergency medicine research. Emergency Medicine Journal. 2001, 18: 198-204. 10.1136/emj.18.3.198.
Fost N: Waived consent for emergency research. Am J Law Med. 1998, 24 (2-3): 163-183.
Sayre MR, White LJ, Brown LH, McHenry SD: The National EMS Research Agenda Executive Summary. Annals of Emergency Medicine. 2002, 40 (6): 636-643. 10.1067/mem.2002.129241.
Margo CE: When is surgery research? Towards an operational definition of human research. Journal of Medical Ethics. 2001, 27: 40-43. 10.1136/jme.27.1.40.
Cone DC, O'Connor RE: Are US informed consent requirements driving resuscitation research overseas?. Resuscitation. 2005, 66 (2): 141-148. 10.1016/j.resuscitation.2005.03.007.
Nichol G, Huszti E, Rokosh J, Dumbrell A, McGowan J, Becker L: Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research?. Resuscitation. 2004, 62 (1): 3-23. 10.1016/j.resuscitation.2004.02.013.
Goldkind SF, Carome M: Exception from informed consent for emergency research: brief highlights. [http://www.fda.gov/ohrms/DOCKETS/dockets/06d0331/06d-0331-ts00002-vol2.pdf]
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 2001
O'Doherty E, Clumeck N: The EU Directive: practical implications for clinical research teams. Applied clinical trials. 2004
Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamas D, Pesenti A, Pimentel J, Ranieri M: The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patients. Intensive Care Medicine. 2005, 31: 476-479. 10.1007/s00134-005-2574-8.
Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006. Statutory Instrument 2006 No 2984. [http://www.opsi.gov.uk/si/si2006/20062984.htm]
Health and Social Care Act 20012001 CHAPTER 15, Part 1, Section 11. 2001,
Smithline HA, Gerstle ML: Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med. 1998, 16 (1): 90-91. 10.1016/S0735-6757(98)90074-2.
Booth MG, Lind A, Read E, Kinsella J: Public perception of emergency research: a questionnaire. European Journal of Anaesthesiology. 2005, 22: 933-937. 10.1017/S0265021505001596.
McClure KB, DeIorio NM, Gunnels MD, Ochsner MJ, Biros MH, Schmidt TA: Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification.[erratum appears in Acad Emerg Med. 2003 Jun;10(6):690]. Acad Emerg Med. 2003, 10 (4): 352-359.
Abboud PA, Heard K, Al-Marshad AA, Lowenstein SR: What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent. Journal of Medical Ethics. 2006, 32: 468-472. 10.1136/jme.2005.012633.
Goldstein J, Delaney K, Pelletier A, Fisher J, Blanc P, Halsey M, Pallin D, Camargo C: A brief educational intervention does not change patient attitudes towards research involving an emergency exception from informed consent. Academic Emergency Medicine. 2007, 14 (5 Suppl 1): S150-1. 10.1197/j.aem.2007.03.1128.
Triner W, Jacoby L, Shelton W, Burk M, Imarenakhue S, Watt J, Larkin G, McGee G: Exception from informed consent enrollment in emergency medical research: attitudes and awareness. Academic Emergency Medicine. 2007, 14: 187-191.
Richardson LD, Wilets I, Fish Ragan D, Holohan J, Smirnoff M, Rhodes R, Winkel G, Rodriguez M, Ricci E: Research without consent: community perspectives from the Community VOICES study. Academic Emergency Medicine. 2005, 12 (11): 1082-1090.
Koops L, Lindley RI: Thrombolysis for acute ischaemic stroke: consumer involvement in design of a new randomised controlled trial. BMJ. 2002, 325: 415-418. 10.1136/bmj.325.7361.415.
Ali K, Roffe C, Crome P: What patients want: consumer involvement in the design of a randomized controlled trial of routine oxygen supplementation after acute stroke. Stroke. 2006, 37: 865-871. 10.1161/01.STR.0000204053.36966.80.
Contant C, McCullough LB, Mangus L, Robertson C, Valadka A, Brody B: Community consultation in emergency research. Critical Care Medicine. 2006, 34 (8): 2049-2052. 10.1097/01.CCM.0000227649.72651.F1.
Blixen CE, Agich GJ: Stroke patients' preferences and values about emergency research. J Med Ethics. 2005, 31 (10): 608-611. 10.1136/jme.2004.010488.
Shah AN, Sugarman J: Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community. Annals of Emergency Medicine. 2003, 41 (1): 72-78. 10.1067/mem.2003.14.
Levine RJ: Research in emergency situations: The role of deferred consent. JAMA. 1995, 273 (16): 1300-1302. 10.1001/jama.273.16.1300.
Abramson NS, Safar P: Deferred consent: use in clinical resuscitation research. Annals of Emergency Medicine. 1990, 19 (7): 781-784. 10.1016/S0196-0644(05)81703-2.
Mariner WK: Research in emergency care without consent: new proposed FDA rules. Lancet. 1995, 346 (9 December 1995): 1505-1506. 10.1016/S0140-6736(95)92045-5.
Bateman BT, Meyers PM, Schumacher HC, Mangla S, Pile-Spellman J: Conducting stroke research with an exception from the requirement for informed consent. Stroke. 2003, 34 (5): 1317-1323. 10.1161/01.STR.0000065230.00053.B4.
Gammelgaard A, Mortensen OS, Rossel P: Patients' perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial. Heart. 2004, 90 (10): 1124-1128. 10.1136/hrt.2003.021931.
Ågård A, Hermeren G, Herlitz J: Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?. Heart. 2001, 86 (6): 632-637. 10.1136/heart.86.6.632.
Richardson LD, Quest TE, Birnbaum S: Communicating with communities about emergency research. Academic Emergency Medicine. 2005, 12 (11): 1064-1070.
Watters D, Sayre MR, Silbergleit R: Research conditions that qualify for emergency exception from informed consent. Academic Emergency Medicine. 2005, 12 (11): 1040-1044.
Brody BA, McCullough LB, Sharp RR: Consensus and controversy in clinical research ethics. JAMA. 2005, 294 (11): 1411-1414. 10.1001/jama.294.11.1411.
Marwick C: Assessment of exception to informed consent. JAMA. 1997, 278 (17): 1392-1393. 10.1001/jama.278.17.1392.
Kremers MS, Whisnant DR, Lowder LS, Gregg L: Initial experience using the Food and Drug Administration guidelines for emergency research without consent. Ann Emerg Med. 1999, 33 (2): 224-229. 10.1016/S0196-0644(99)70399-9.
McGee G, McErlean M, Triner W, Verdile V: Toward a pragmatic model for community consultation in emergency research. Academic Emergency Medicine. 2005, 12 (11): 1019-1021.
Jenkins V, Fallowfield L: Reasons for accepting or declining to participate in randomised clinical trials for cancer therapy. British Journal of Cancer. 2000, 82 (11): 1783-1788. 10.1054/bjoc.2000.1142.
Stead M, Eadie D, Gordon D, Angus K: "Hello, hello - it's English I speak!": a qualitative exploration of patients' understanding of the science of clinical trials. Journal of Medical Ethics. 2005, 31: 664-669. 10.1136/jme.2004.011064.
Moreno JD: Goodbye to all that: the end of moderate protectionism in human subjects research. Hastings Center Report. 2001, 31 (3): 9-17. 10.2307/3527549.
Wilets I, O'Rourke M, Nassisi D: How patients and visitors to an urban emergency department view clinical research. Academic Emergency Medicine. 2003, 10 (10): 1081-1085.
McRae AD, Weijer C: Lessons from everyday lives: a moral justification for acute care research.[see comment]. Crit Care Med. 2002, 30 (5): 1146-1151. 10.1097/00003246-200205000-00032.
Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical?. JAMA. 2000, 283 (20): 2701-2711. 10.1001/jama.283.20.2701.
Rhodes R: Rethinking research ethics. The American Journal of Bioethics. 2005, 5 (1): 7-28. 10.1080/15265160590900678.
Silverman HJ, Lemaire F: Ethics and research in critical care. Intensive Care Medicine. 2006, 32: 1697-1705. 10.1007/s00134-006-0305-4.
Nee PA, Griffiths RD: Ethical considerations in accident and emergency research. Emerg Med J. 2002, 19 (5): 423-427. 10.1136/emj.19.5.423.