Informed consent: The rate-limiting step in trials

Frontiers in Neurology

Volumn OCT, Issue , 2011, Pages

  Rose, David Z ^a   Kasner, Scott E ^b  

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Acute stroke; Cerebral infarction; Clinical trial; Informed consent

Indexed keywords

EID: 84865848207     PISSN: None     EISSN: 16642295     Source Type: Journal    
DOI: 10.3389/fneur.2011.00065     Document Type: Article

References (48)

1. Adams, J. G., and Wegener, J. (1999). Acting without asking: an eth-ical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Ann. Emerg. Med. 33, 218-223.
2. Alexandrov, A. V. (2006). Slow recruit-ment in clinical trials: failure is not an option! Int. J. Stroke 1, 160.
3. Bateman, B. T., Meyers, P. M., Schu-macher, H. C., Mangla, S., and Pile-Spellman, J. (2003). Conduct-ing stroke researchwith an exception from the requirement for informed consent. Stroke 34, 1317-1323.
4. Beauchamp, T. (2004). The legacy and the future. 30 years after the Belmont report, Beauchamp sets the record straight. Prot. Hum. Subj. 1-3.
5. Biros, M. H., Fish, S. S., and Lewis, R. J. (1999). Implementing the Food and Drug Administration's nal rule for waiver of informed consent in certain emergency research cir-cumstances. Acad. Emerg. Med. 6, 1272-1282.
6. Blixen, C. E., and Agich, G. J. (2005). Stroke patients' preferences and val-ues about emergency research. J. Med. Ethics 31, 608-611.
7. Burrows, R. C., and Hodgson, R. E. (1997). De facto gatekeeping and informed consent in intensive care. Med. Law 16, 17-27.
8. Ciccone, A., Sterzi, R., Crespi, V., Defanti,C.A., and Pasetti,C. (2001). Thrombolysis for acute ischemic stroke: the patient's point of view. Cerebrovasc. Dis. 12, 335-340.
9. Dani,K.A.,Mccormick,M.T., andMuir, K. W. (2008). Brain lesion volume and capacity for consent in stroke trials: potential regulatory barriers to the use of surrogate markers. Stroke 39, 2336-2340.
10. Decosta, A., D'Souza, N., Krishnan, S., Chhabra, M. S., Shihaam, I., and Goswami, K. (2004). Community based trials and informed consent in rural north India. J. Med. Ethics 30, 318-323.
11. Del Giudice, A., Plaum, J., Maloney, E., Kasner, S. E., Le Roux, P. D., and Baren, J. M. (2009). Who will consent to emergency treat-ment trials for subarachnoid hem-orrhage? Acad. Emerg. Med. 16, 309-315.
12. Demarquay, G., Derex, L., Nighoghoss-ian, N., Adeleine, P., Philippeau, F., Honnorat, J., and Trouillas, P. (2005). Ethical issues of informed consent in acute stroke. Analysis of the modalities of consent in 56 patients enrolled in urgent thera-peutic trials. Cerebrovasc. Dis. 19, 65-68.
13. Dickens, B. M. (1999). Vulnerable per-sons in biomedical research: 50 years after the Nuremberg Code. J. Int. Bioethique 10, 13-23.
14. Elkins, J. S., Khatabi, T., Fung, L., Rootenberg, J., and Johnston, S. C. (2006). Recruiting subjects for acute stroke trials: a meta-analysis. Stroke 37, 123-128.
15. Faden, R. R., Lederer, S. E., and Moreno, J. D. (1996). US med-ical researchers, the Nuremberg doctors trial, and the Nuremberg Code. A review of ndings of the advisory committee on human radiation experiments. JAMA 276, 1667-1671.
16. Flaherty, M. L., Karlawish, J., Khoury, J. C., Kleindorfer, D., Woo, D., and Broderick, J. P. (2008). How important is surrogate consent for stroke research? Neurology 71, 1566-1571.
17. Food and Drug Administration. (1996). Protection of human subjects; informed consent-FDA. Final rule. Fed. Regist. 61, 51498-51533.
18. Goldstein, J. N., Espinola, J. A., Fisher, J., Pallin, D. J., and Camargo, C. A. (2010). Public opinion of a stroke clinical trial using exception from informed consent. Int. J. Emerg. Med. 3, 385-389.
19. Grotta, J., and Bratina, P. (1995). Sub-jective experiences of 24 patients dramatically recovering fromstroke. Stroke 26, 1285-1288.
20. Halpern, S.D.,Karlawish, J.H.,Casarett, D., Berlin, J. A., Townsend, R. R., andAsch,D.A. (2003).Hypertensive patients' willingness to participate in placebo-controlled trials: implica-tions for recruitment efciency. Am. Heart J. 146, 985-992.
21. Halpern, S. D., Metzger, D. S., Berlin, J. A., and Ubel, P. A. (2001). Who will enroll? Predicting participation in a phase II AIDS vaccine trial. J. Acquir. Immune Dec. Syndr. 27, 281-288.
22. Iwanowski, P., Budaj, A., Czlonkowska, A., Wasek, W., Kozlowska-Boszko, B., Oledzka, U., and Maselbas, W. (2008). Informed consent for clin-ical trials in acute coronary syn-dromes and stroke following the European clinical trials directive: investigators' experiences and atti-tudes. Trials 9, 45.
23. Kane, I., Lindley, R., Lewis, S., and Sandercock, P. (2006). Impact of stroke syndrome and stroke severity on the process of con-sent in the third international stroke trial. Cerebrovasc. Dis. 21, 348-352.
24. Kasner, S. E., Baren, J. M., Le Roux, P. D., Nathanson, P. G., Lamond, K., Rosenberg, S. L., and Karlawish, J. (2010). Community views on neu-rologic emergency treatment trials. Ann. Emerg. Med. 57, 346-354.
25. Kasner,S. E.,Del Giudice,A.,Rosenberg, S., Sheen, M., Luciano, J. M., Cucchiara, B. L., Messe, S. R., Sansing, L. H., and Baren, J. M. (2009). Who will participate in acute stroke trials? Neurology 72, 1682-1688.
26. Kilmarx, P. H., Ramjee, G., Kitayaporn, D., and Kunasol, P. (2001). Pro-tection of human subjects' rights in HIV-preventive clinical trials in Africa andAsia: experiences and rec-ommendations. AIDS 15(Suppl. 5), S73-S79.
27. Kim, S. Y., and Karlawish, J. H. (2003). Ethics and politics of research involving subjects with impaired decision-making abilities. Neurology 61, 1645-1646.
28. Kulynych, J., and Korn, D. (2002). The effect of the new federal medical-privacy rule on research. N. Engl. J. Med. 346, 201-204.
29. Leira, E. C., Kaldjian, L. C., Ludwig, B. R., Torner, J. C., Olalde, H. M., Hacke, W., and Adams, .H. P. (2010). Lack of inter-national consensus on ethical aspects of acute stroke tri-als. J. Stroke Cerebrovasc. Dis. doi:10.1016/j.jstrokecerebrovasdis.2 010.06.008. [Epub ahead of print].
30. Lynoe, N., Sandlund, M., Jacobsson, L., Nordberg, G., and Jin, T. (2004). Informed consent in China: quality of information provided to partici-pants in a research project. Scand. J. Public Health 32, 472-475.
31. Lynoe, N., Sandlund, M., Westberg, K., and Duchek, M. (1998). Informed consent in clinical training - patient experiences and motives for partici-pating. Med. Educ. 32, 465-471.
32. Marshall, P. A. (2006). Informed con-sent in international health research. J. Empir. Res. Hum. Res. Ethics 1, 25-42.
33. Marwick, C. (1997). Assessment of exception to informed consent. JAMA 278, 1392-1393.
34. Morgenstern, L. B., Bartholomew, L. K., Grotta, J. C., Staub, L., King, M., and Chan,W. (2003). Sustained benet of a community and profes-sional intervention to increase acute stroke therapy. Arch. Intern. Med. 163, 2198-2202.
35. Morris, M. C., Nadkarni, V. M., Ward, F. R., and Nelson, R. M. (2004). Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest. Pediatrics 114, 776-781.
36. National Commission for the Pro-tection of Human Subjects of Biomedical and Behavioral Research. (1979). Protection of human subjects; Belmont report: notice of report for public comment. Fed. Regist. 44, 23191-23197.
37. Prentice, E. D. (1999). Informed consent: the most important protector. Acad. Emerg. Med. 6, 774-775.
38. Salzman, J. G., Frascone, R. J., God-ding, B. K., Provo, T. A., and Gert-ner, E. (2007). Implementing emer-gency research requiring exception from informed consent, community consultation, and public disclosure. Ann. Emerg. Med. 50, 448-455; 455 e441-444.
39. Sanossian, N., Starkman, S., Eck-stein, M., Stratton, S., Pratt, F., Conwit, R., and Saver, J. L. (2010). Intercontinental elicitation of informed consent for enrollment in stroke research. Cerebrovasc. Dis. 30, 323-324.
40. Saver, J. L., Kidwell, C., Eckstein, M., Ovbiagele, B., and Starkman, S. (2006). Physician-investigator phone elicitation of consent in the eld: a novel method to obtain explicit informed consent for prehospital clinical research. Prehosp. Emerg. Care 10, 182-185.
41. Saver, J. L., and The FAST-MAG Investigators. (2011). Patient versus proxy explicit informed consent for enrollment in a pre-hospital stroke treatment trial, International Stroke Conference Oral Presentations. Stroke 42, e58.
42. Saver,R. S. (1996). Critical care research and informed consent. North Carol. Law Rev. 75, 205-271.
43. Schats, R., Brilstra, E. H., Rinkel, G. J., Algra, A., and Van Gijn, J. (2003). Informed consent in trials for neu-rological emergencies: the exam-ple of subarachnoid haemorrhage. J. Neurol. Neurosurg. Psychiatr. 74, 988-991.
44. Simmons, F. B. (1964). Regarding the Nuremberg code. Arch. Otolaryngol. 80, 118-119.
45. The National Institute of Neurolog-ical Disorders and Stroke Rt-PA Stroke Study Group. (1995). Tis-sue plasminogen activator for acute ischemic stroke. N.Engl.J.Med. 333, 1581-1587.
46. Tu, J. V., Willison, D. J., Silver, F. L., Fang, J., Richards, J. A., Lau-pacis, A., and Kapral, M. K. (2004). Impracticability of informed con-sent in the registry of the Canadian stroke network. N.Engl.J.Med. 350, 1414-1421.
47. World Medical Association. (2000). Declaration of Helsinki: ethicalprinciples for medical research involving human subjects. JAMA 284, 3043-3045.
48. World Medical Association. (2004). Declaration of Helsinki: ethical principles for medical research involving human sub-jects. J. Int. Bioethique 15, 124-129.