Impact of restricting enrollment in stroke genetics research to adults able to provide informed consent

Stroke

Volumn 39, Issue 3, 2008, Pages 831-837

  Chen, Donna T ^a,b   Case, L Douglas ^c   Brott, Thomas G ^d   Brown, Robert D ^e   Silliman, Scott L ^f   Meschia, James F ^d   Worrall, Bradford B ^a,b  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c WAKE FOREST SCHOOL OF MEDICINE   (United States)

^d MAYO CLINIC   (United States)

^e MAYO CLINIC   (United States)

^f UNIVERSITY OF FLORIDA   (United States)

Author keywords

Consent bias; Ischemia; Research ethics; Stroke

Indexed keywords

ADULT; AGED; ARTICLE; BRAIN INFARCTION; BRAIN REGION; CEREBROVASCULAR ACCIDENT; CLINICAL FEATURE; COHORT ANALYSIS; DECISION MAKING; DEMOGRAPHY; DISEASE SEVERITY; FEMALE; GENETICS; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; PRIORITY JOURNAL; PROSPECTIVE STUDY; RISK FACTOR; STROKE; BRAIN ISCHEMIA; CASE CONTROL STUDY; CLINICAL TRIAL; COMPARATIVE STUDY; HOSPITALIZATION; MIDDLE AGED; MULTICENTER STUDY; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PERSONNEL MANAGEMENT;

AGED; BIOMEDICAL RESEARCH; BRAIN ISCHEMIA; CASE-CONTROL STUDIES; COHORT STUDIES; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; NERVOUS SYSTEM DISEASES; OUTCOME ASSESSMENT (HEALTH CARE); PERSONNEL SELECTION; SEVERITY OF ILLNESS INDEX; STROKE;

EID: 41249085023     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/STROKEAHA.107.494518     Document Type: Article

References (20)

1. Meschia JF, Brott TG, Brown RD Jr, Crook RJ, Frankel M, Hardy J, Merino JG, Rich SS, Silliman S, Worrall BB, Ischemic Stroke Genetics Study. The Ischemic Stroke Genetics Study (ISGS) protocol. BMC Neurol. 2003;3:4. E-pub 2003 Jul 8.
2. Chen DT, Worrall BB, Meschia JF. Protecting the privacy of family members in research. JAMA. 2001;285:1961-1963.
3. Worrall BB, Chen DT, Meschia JF. Ethical and methodological issues in pedigree stroke research. Stroke. 2001;32:1242-1249.
4. Chen DT, Miller FG, Rosenstein DL. Ethical aspects of research into the etiology of autism. Ment Retard Dev Disabil Res Rev. 2003;9:48-53.
5. Chen DT, Miller FG, Rosenstein DL. Enrolling decisionally impaired adults in clinical research. Med Care. 2002;40(suppl):V20-29.
6. Code of Federal Regulations (CFR): 45CFR46D [database on the Internet]. Washington, DC: US Government Printing Office [updated Apr 12, 2006; cited Dec 19, 2006]. Available at: www.gpoaccess.gov/cfr/index.html. Accessed May 1, 2007.
7. Code of Federal Regulations (CFR): 21CFR50.24 [database on the Internet]. Washington, DC: US Government Printing Office [updated Apr 1, 2006]. Available at: www.gpoaccess.gov/cfr/index.html. Accessed May 1, 2007.
8. Office for Human Research Protections (OHRP). IRB guidebook [monograph on the Internet]. Washington, DC: US Department of Health & Human Services [cited Dec 19, 2006]. Available at: www.hhs.gov/ohrp/irb/irb_guidebook.htm. Accessed May 1, 2007.
9. Bankert EA, Amdur RJ, eds. Institutional Review Board: Management and Function, 2nd ed. Sudbury, MA: Jones and Bartlett; 2006.
10. Kim SY, Appelbaum PS, Jeste DV, Olin JT. Proxy and surrogate consent in geriatric neuropsychiatric research: update and recommendations. Am J Psychiatry. 2004;161:797-806.
11. Kim SY, Appelbaum PS. The capacity to appoint a proxy and the possibility of concurrent proxy directives. Behav Sci Law. 2006;24:469-478.
12. Wendler D, Martinez RA, Fairclough D, Sunderland T, Emanuel E. Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. Am J Psychiatry. 2002;159:585-591.
13. Karlawish JH. Research involving cognitively impaired adults. N Engl J Med. 2003;348:1389-1392.
14. Meschia JF, Brott TG, Chukwudelunzu FE, Hardy J, Brown RD Jr, Meissner I, Hall LJ, Atkinson EJ, O'Brien PC. Verifying the stroke-free phenotype by structured telephone interview. Stroke. 2000;31:1076-1080.
15. Barrett KM, Brott TG, Brown RD, Frankel MR, Worrall BB, Silliman SL, Case LD, Rich SS, Meschia JF; Ischemic Stroke Genetics Study Group. Sex differences in stroke severity, symptoms, and deficits after first-ever ischemic stroke. J Stroke Cerebrovasc Dis. 2007;16:34-39.
16. Stewart A, Davis P, Kittner S, Langenberg P. The effect on risk estimates of excluding cases from a case-control study of ischemic stroke. Neuroepidemiology. 1997;16:191-198.
17. Office of Human Subjects Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research [monograph on the Internet]. Washington, DC: National Institutes of Health; 1979. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed May 1, 2007.
18. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000;283:2701-2711.
19. Wendler D. Informed consent, exploitation and whether it is possible to conduct human subjects research without either one. Bioethics. 2000;14:310-339.
20. Warlow CP. Epidemiology of stroke. Lancet. 1998;352(suppl 3):SIII1-4.