Ischemic stroke survivors' opinion regarding research utilizing exception from informed consent

Cerebrovascular Diseases

Volumn 32, Issue 4, 2011, Pages 321-326

  Kleindorfer, Dawn ^a   Lindsell, Christopher J ^a   Alwell, Kathleen ^a   Woo, Daniel ^a   Flaherty, Matthew L ^a   Eilerman, Jane ^a   Khatri, Pooja ^a   Adeoye, Opeolu ^a   Ferioli, Simona ^a   Kissela, Brett M ^a  

^a UNIVERSITY OF CINCINNATI   (United States)

Author keywords

Acute stroke; Angiography; Brain imaging; Stroke care; Transient ischemic attack

Indexed keywords

ARTICLE; BRAIN ISCHEMIA; CLINICAL RESEARCH; EXCEPTION FROM INFORMED CONSENT; FEMALE; FOLLOW UP; HUMAN; INFORMED CONSENT; INTERVIEW; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; PRIORITY JOURNAL;

ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; ATTITUDE TO HEALTH; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; CONTINENTAL POPULATION GROUPS; FEMALE; HUMANS; INFORMED CONSENT; LOGISTIC MODELS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RETROSPECTIVE STUDIES; SEX FACTORS; STROKE; SURVIVORS;

EID: 80052667302     PISSN: 10159770     EISSN: 14219786     Source Type: Journal    
DOI: 10.1159/000328815     Document Type: Article

References (15)

1. Code of Federal Regulations 2008: 21CFR50.24.
2. 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: 1317-1323. (Pubitemid 36547535)
3. Demarquay G, Derex L, Nighoghossian N, Adeleine P, Philippeau F, Honnorat J, et al: Ethical issues of informed consent in acute stroke. Analysis of the modalities of consent in 56 patients enrolled in urgent therapeutic trials. Cerebrovasc Dis 2005; 19: 65-68. (Pubitemid 40278664)
4. Mosesso VN Jr, Cone DC: Using the exception from informed consent regulations in research. Acad Emerg Med 2005; 12: 1031-1039. (Pubitemid 41503529)
5. 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: 3-23. (Pubitemid 38916588)
6. Mitka M: Aiding emergency research aim of report on exceptions to informed consent. JAMA 2007; 298: 2608-2609. (Pubitemid 350254969)
7. Halperin H, Paradis N, Mosesso V Jr, Nichol G, Sayre M, Ornato JP, et al: Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's 'Exception from informed consent requirements for emergency research': A special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: Endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine. Circulation 2007; 116: 1855-1863. (Pubitemid 350287110)
8. Lecouturier J, Rodgers H, Ford GA, Rapley T, Stobbart L, Louw SJ, et al: Clinical research without consent in adults in the emergency setting: A review of patient and public views. BMC Med Ethics 2008; 9: 9.
9. Goldstein JN, Delaney KE, Pelletier AJ, Fisher J, Blanc PG, Halsey M, et al: A brief educational intervention may increase public acceptance of emergency research without consent. J Emerg Med 2008; 39: 419-435.
10. 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. Acad Emerg Med 2003; 10: 352-359. (Pubitemid 36437793)
11. Smithline HA, Gerstle ML: Waiver of informed consent: A survey of emergency medicine patients. Am J Emerg Med 1998; 16: 90-91. (Pubitemid 28056078)
12. Triner W, Jacoby L, Shelton W, Burk M, Imarenakhue S, Watt J, et al: Exception from informed consent enrollment in emergency medical research: Attitudes and awareness. Acad Emerg Med 2007; 14: 187-191. (Pubitemid 46157191)
13. Brown M, Moyer A: Predictors of awareness of clinical trials and feelings about the use of medical information for research in a nationally representative US sample. Ethn Health 2010; 15: 223-236.
14. Del Giudice A, Plaum J, Maloney E, Kasner SE, Le Roux PD, Baren JM: Who will consent to emergency treatment trials for subarachnoid hemorrhage? Acad Emerg Med 2009; 16: 309-315.
15. Williams LS, Yilmaz EY, Lopez-Yunez AM: Retrospective assessment of initial stroke severity with the NIH Stroke Scale. Stroke 2000; 31: 858-862. (Pubitemid 30198428)