Waiver of consent in studies of acute brain injury

被引:41
作者
Clifton, GL
Knudson, P
McDonald, M
机构
[1] Univ Texas, Sch Med, Vivian L Smith Ctr Neurol Res, Houston, TX USA
[2] Univ Texas, Sch Med, Off Res Support Comm, Houston, TX USA
[3] Univ Texas, Sch Med, Dept Neurosurg, Houston, TX USA
关键词
brain injury; clinical trials; practicability; waiver of consent;
D O I
10.1089/08977150260337930
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
A multicenter trial of hypothermia in patients with acute brain injury, designed to accrue 140 patients per year and randomizing in less than 6 It from injury, enrolled 392 patients. The design was to achieve 33degreesC within 8 h after injury. For the first 9 months of the trial, the only consent mechanism permitted by federal regulations was prospective, informed consent. In the subsequent 33 months, after a change in federal regulations, waiver of consent could be used when family could not be located. Waiver of consent was used in 62% of patients enrolled. In the first 9 months of the trial, accrual was 65 patients. In the subsequent 3 years, an average yearly accrual was 127 patients. In the first 9 months, time from injury to randomization was 4.5 +/- 1.2 h; time to achievement of target temperature was 11.7 +/- 2.6 h. In years when waiver of consent was permitted, randomization time was 4.1 +/- 1.1 h, and time to target temperature was 7.9 +/- 2.7 h. For all years of the study, waiver of consent was used for 53% of minorities, 47% of unskilled workers, 33% of nonminorities, and 29% of skilled or professional workers. Minorities were underrepresented by 30% in the first 9 months of the study. We conclude that it is impracticable and unjust to perform studies of acute brain injury without use of waiver of consent when the treatment window is less than 6 h.
引用
收藏
页码:1121 / 1126
页数:6
相关论文
共 18 条
[1]  
[Anonymous], 1996, FED REG
[2]  
[Anonymous], 1991, FED REG
[3]   A TRIAL OF THE EFFECT OF NIMODIPINE ON OUTCOME AFTER HEAD-INJURY [J].
BAILEY, I ;
BELL, A ;
GRAY, J ;
GULLAN, R ;
HEISKANAN, O ;
MARKS, PV ;
MARSH, H ;
MENDELOW, DA ;
MURRAY, G ;
OHMAN, J ;
QUAGHEBEUR, G ;
SINAR, J ;
SKENE, A ;
TEASDALE, G ;
WATERS, A .
ACTA NEUROCHIRURGICA, 1991, 110 (3-4) :97-105
[4]  
BRAAKMAN R, 1994, J NEUROSURG, V80, P797
[5]   Design and statistical issues in multicenter trials of severe head injury [J].
Choi, SC ;
Bullock, R .
NEUROLOGICAL RESEARCH, 2001, 23 (2-3) :190-192
[6]   Lack of effect of induction of hypothermia after acute brain injury. [J].
Clifton, GL ;
Miller, ER ;
Choi, SC ;
Levin, HS ;
McCauley, S ;
Smith, KR ;
Muizelaar, JP ;
Wagner, FC ;
Marion, DW ;
Luerssen, TG ;
Chesnut, RM ;
Schwartz, M .
NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (08) :556-563
[7]   Intercenter variance in clinical trials of head trauma - experience of the National Acute Brain Injury Study: Hypothermia [J].
Clifton, GL ;
Choi, SC ;
Miller, ER ;
Levin, HS ;
Smith, KR ;
Muizelaar, JP ;
Wagner, FC ;
Marion, DW ;
Luerssen, TG .
JOURNAL OF NEUROSURGERY, 2001, 95 (05) :751-755
[8]   A PHASE-II STUDY OF MODERATE HYPOTHERMIA IN SEVERE BRAIN INJURY [J].
CLIFTON, GL ;
ALLEN, S ;
BARRODALE, P ;
PLENGER, P ;
BERRY, J ;
KOCH, S ;
FLETCHER, J ;
HAYES, RL ;
CHOI, SC .
JOURNAL OF NEUROTRAUMA, 1993, 10 (03) :263-271
[9]   MARKED PROTECTION BY MODERATE HYPOTHERMIA AFTER EXPERIMENTAL TRAUMATIC BRAIN INJURY [J].
CLIFTON, GL ;
JIANG, JY ;
LYETH, BG ;
JENKINS, LW ;
HAMM, RJ ;
HAYES, RL .
JOURNAL OF CEREBRAL BLOOD FLOW AND METABOLISM, 1991, 11 (01) :114-121
[10]  
Department of Health Education and Welfare Office of the Secretary Protection of Human Subjects (DHEW), 1979, DHEW PUBL