AAN position statement: Ethical issues in clinical research in neurology.

Abstract:

:This update to the American Academy of Neurology's 1998 position statement endeavors to provide guidance for the consistent ethical conduct and review of neurologic research involving human participants. It does so by outlining a widely used ethical framework of 7 principles derived from the foundational documents of modern bioethics, including the Nuremberg Code, the World Medical Association's Declaration of Helsinki, the Belmont Report, and the US Department of Health and Human Service's Common Rule. The position statement then applies this principle-based framework to analyze and produce recommendations for the management of common and important ethical issues encountered in neurologic clinical research. These include institutional review board oversight, equitable research participant inclusion, cognitive impairment in research participants, international studies, the replication crisis, and genetic testing and modification.

journal_name

Neurology

journal_title

Neurology

authors

Tolchin B,Conwit R,Epstein LG,Russell JA,Ethics, Law, and Humanities Committee, a joint committee of the American Academy of Neurology, American Neurological Association, and Child Neurology Society.

doi

10.1212/WNL.0000000000009241

subject

Has Abstract

pub_date

2020-04-14 00:00:00

pages

661-669

issue

15

eissn

0028-3878

issn

1526-632X

pii

WNL.0000000000009241

journal_volume

94

pub_type

杂志文章,评审
  • Spontaneous CSF leaks: underlying disorder of connective tissue.

    abstract::Of 58 consecutive patients with spontaneous CSF leaks, nine exhibited features of connective tissue disorder. One had Marfan's syndrome. Five additional patients had hyperflexible joints, of whom four had arachnodactyly, four were tall and slender, two had hyperextensible skin, and one had a strong family history of a...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.58.5.814

    authors: Mokri B,Maher CO,Sencakova D

    更新日期:2002-03-12 00:00:00

  • Subcortical aphasia: the core profile of capsulostriatal infarction.

    abstract::There has been disagreement about the precise characteristics of "subcortical aphasia." We evaluated 14 patients with aphasia after subcortical lesions and controlled for duration, general anatomic site of lesions (capsulostriatal only), and etiology. The clinical profiles of the patients were quite similar, varying i...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.44.10.1824

    authors: Mega MS,Alexander MP

    更新日期:1994-10-01 00:00:00

  • Interferon beta in the treatment of multiple sclerosis: mechanisms of action.

    abstract::Interferon beta (IFN-beta) has been shown in several clinical trials to have efficacy in MS. Its mechanism of action, however, remains unclear. In this review, several biological activities of IFN-beta are highlighted, including its inhibitory effects on proliferation of leukocytes and antigen presentation. Furthermor...

    journal_title:Neurology

    pub_type: 杂志文章,评审

    doi:10.1212/wnl.51.3.682

    authors: Yong VW,Chabot S,Stuve O,Williams G

    更新日期:1998-09-01 00:00:00

  • Amnesia with hippocampal lesions after cardiopulmonary arrest.

    abstract::A patient developed an amnesic syndrome after cardiopulmonary arrest. Neuropathologic examination revealed pronounced anoxic injury to both hippocampi with little damage to other hemisphere structures. The clinical and pathologic findings suggest that lesions limited to the hippocampus can cause profound amnesia. ...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.34.5.679

    authors: Cummings JL,Tomiyasu U,Read S,Benson DF

    更新日期:1984-05-01 00:00:00

  • Evidence-based guideline: diagnostic accuracy of CSF 14-3-3 protein in sporadic Creutzfeldt-Jakob disease: report of the guideline development subcommittee of the American Academy of Neurology.

    abstract:OBJECTIVE:To assess the available evidence for the diagnostic accuracy of CSF testing for protein 14-3-3 in patients with suspected sporadic Creutzfeldt-Jakob disease (sCJD). METHODS:The authors performed a systematic review of the available literature from 1995 to January 1, 2011, to identify articles involving patie...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/WNL.0b013e31826d5fc3

    authors: Muayqil T,Gronseth G,Camicioli R

    更新日期:2012-10-02 00:00:00

  • Phenotype of adult Refsum disease due to a defect in peroxin 7.

    abstract::The biochemical hallmark of adult Refsum disease (ARD) is an isolated deficiency in the breakdown of phytanic acid. This usually results from a PHYH gene defect, although some cases have been found to carry a PEX7 defect. We describe the phenotype of such a patient, indistinguishable from that of classic ARD. Hence, w...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000255960.01644.39

    authors: Horn MA,van den Brink DM,Wanders RJ,Duran M,Poll-The BT,Tallaksen CM,Stokke OH,Moser H,Skjeldal OH

    更新日期:2007-02-27 00:00:00

  • Right-to-left shunt and lacunar stroke in patients without hypertension and diabetes.

    abstract::We analyzed the frequency of cardiac embolic sources in 62 patients with acute lacunar stroke vs 50 controls. In post hoc analysis, 11 patients with lacunar stroke having neither hypertension nor diabetes mellitus (non-HDM group) had a higher frequency of right-to-left shunt (RLS) (82%) than patients with risk factors...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000253197.83777.c7

    authors: Ueno Y,Kimura K,Iguchi Y,Shibazaki K,Inoue T,Urabe T

    更新日期:2007-02-13 00:00:00

  • Cognitive profiles differ in autopsy-confirmed frontotemporal dementia and AD.

    abstract:BACKGROUND:Frontotemporal dementia (FTD) is currently distinguished from AD primarily on the basis of behavioral features because studies of cognition have shown negligible or inconsistent differences. However, the poor discriminability of cognitive measures may relate to reliance on imprecise clinically diagnosed grou...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.58.12.1801

    authors: Rascovsky K,Salmon DP,Ho GJ,Galasko D,Peavy GM,Hansen LA,Thal LJ

    更新日期:2002-06-25 00:00:00

  • Vestibular function assessment using the NIH Toolbox.

    abstract:OBJECTIVE:Development of an easy to administer, low-cost test of vestibular function. METHODS:Members of the NIH Toolbox Sensory Domain Vestibular, Vision, and Motor subdomain teams collaborated to identify 2 tests: 1) Dynamic Visual Acuity (DVA), and 2) the Balance Accelerometry Measure (BAM). Extensive work was comp...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/WNL.0b013e3182872c6a

    authors: Rine RM,Schubert MC,Whitney SL,Roberts D,Redfern MS,Musolino MC,Roche JL,Steed DP,Corbin B,Lin CC,Marchetti GF,Beaumont J,Carey JP,Shepard NP,Jacobson GP,Wrisley DM,Hoffman HJ,Furman G,Slotkin J

    更新日期:2013-03-12 00:00:00

  • Molecular basis of hypokalemic myopathy caused by 17alpha-hydroxylase/17,20-lyase deficiency.

    abstract::We describe a 28-year-old woman presenting with hypokalemic myopathy caused by 17alpha-hydroxylase/17,20-lyase deficiency caused by a homozygous mutation consisting of a G-to-C transition in the initiation codon in exon 1 of the CYP17 gene resulting in expression of an enzymatically inactive truncated P450c17 protein....

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.51.6.1748

    authors: Satoh J,Kuroda Y,Nawata H,Yanase T

    更新日期:1998-12-01 00:00:00

  • Imipramine in absence and myoclonic-astatic seizures.

    abstract::A double-blind crossover study with imipramine was conducted in 10 patients with absence and myoclonic-astatic seizures who had not responded to conventional medications. Imipramine produced a significant initial decrease in seizure frequency in 5 of the 10 patients, and in 2 patients the beneficial effect was maintai...

    journal_title:Neurology

    pub_type: 临床试验,杂志文章

    doi:10.1212/wnl.28.9.953

    authors: Fromm GH,Wessel HB,Glass JD,Alvin JD,Van Horn G

    更新日期:1978-09-01 00:00:00

  • Revised Airlie House consensus guidelines for design and implementation of ALS clinical trials.

    abstract:OBJECTIVE:To revise the 1999 Airlie House consensus guidelines for the design and implementation of preclinical therapeutic studies and clinical trials in amyotrophic lateral sclerosis (ALS). METHODS:A consensus committee comprising 140 key members of the international ALS community (ALS researchers, clinicians, patie...

    journal_title:Neurology

    pub_type: 共识发展会议,杂志文章

    doi:10.1212/WNL.0000000000007242

    authors: van den Berg LH,Sorenson E,Gronseth G,Macklin EA,Andrews J,Baloh RH,Benatar M,Berry JD,Chio A,Corcia P,Genge A,Gubitz AK,Lomen-Hoerth C,McDermott CJ,Pioro EP,Rosenfeld J,Silani V,Turner MR,Weber M,Brooks BR,Miller

    更新日期:2019-04-02 00:00:00

  • Prevention of stroke with ticlopidine: who benefits most? TASS Baseline and Angiographic Data Subgroup.

    abstract::We examined the baseline characteristics of patients in the Ticlopidine Aspirin Stroke Study (TASS) to determine if the effects of the two treatments in preventing stroke differed in various subgroups. Patients with the following characteristics did less well on aspirin: elevated creatinine, hypertension or diabetes r...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.42.1.111

    authors: Grotta JC,Norris JW,Kamm B

    更新日期:1992-01-01 00:00:00

  • The acoustic startle reflex in ischemic stroke.

    abstract::The authors recorded the acoustic startle response in 32 patients with stroke, 6 patients with incomplete cervical cord lesions, and 26 controls. Increased startle occurred in about one quarter of both stroke and spinal cord injury patients. The response in biceps demonstrated the greatest deviation from normal, with ...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000101711.48946.35

    authors: Jankelowitz SK,Colebatch JG

    更新日期:2004-01-13 00:00:00

  • Prognosis of photoparoxysmal response in nonepileptic patients.

    abstract::Photoparoxysmal response (PPR) is sometimes incidentally encountered in EEGs performed for evaluation of nonepileptic symptoms. We conducted the first long-term study of a cohort of nonepileptic patients to determine their risk of having seizures subsequent to incidental recording of PPR. After 6 to 12 years (mean, 9 ...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.43.9.1719

    authors: So EL,Ruggles KH,Ahmann PA,Olson KA

    更新日期:1993-09-01 00:00:00

  • Importance of the imaging modality in decision making about carotid endarterectomy.

    abstract:OBJECTIVE:To determine the influence of all possible imaging strategies on the appropriateness ratings for carotid endarterectomy, because less accurate noninvasive techniques are replacing contrast angiography, which was used in the major efficacy trials. METHODS:An expert panel, using appropriateness methodology, ra...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000115097.61748.bf

    authors: Kennedy J,Quan H,Ghali WA,Feasby TE

    更新日期:2004-03-23 00:00:00

  • The BAER profile: a method for reporting electrophysiologic brainstem examinations in clinical practice.

    abstract::We present a method for graphically reporting the results of brainstem auditory evoked response examinations on the basis of multiple parameters. The method is based on a transform that normalizes the many latency and amplitude measures obtained from the averaged evoked responses of normal subjects tested under standa...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.29.2.242

    authors: Lolas F,Hoeppner TJ,Morrell F

    更新日期:1979-02-01 00:00:00

  • Nonoperative management of cubital tunnel syndrome: an 8-year prospective study.

    abstract::This study reports the results of a prospective trial of nonoperative management of the cubital tunnel syndrome in 128 patients. Forty-three of the patients had bilateral ulnar nerve compression. At study's end, information was available on 94% of patients and 164 managed extremities, at a mean of 58.6 months of follo...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.43.9.1673

    authors: Dellon AL,Hament W,Gittelshon A

    更新日期:1993-09-01 00:00:00

  • Differential changes in neurochemical markers of striatal dopamine nerve terminals in idiopathic Parkinson's disease.

    abstract::To determine the extent that different dopamine (DA) neuronal markers provide similar estimates of striatal (caudate and putamen) DA nerve terminal loss in idiopathic Parkinson's disease (PD), we compared, in postmortem striatum of 12 patients with PD and 10 matched controls, levels of five different DA neuronal marke...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.47.3.718

    authors: Wilson JM,Levey AI,Rajput A,Ang L,Guttman M,Shannak K,Niznik HB,Hornykiewicz O,Pifl C,Kish SJ

    更新日期:1996-09-01 00:00:00

  • Cerebral vasculitis and hemorrhage associated with phenylpropanolamine.

    abstract::A 20-year-old woman using an oral diet aid preparation containing phenylpropanolamine presented with an intracerebral hemorrhage and angiographic evidence of cerebral vasculitis. Gas chromatography demonstrated phenylpropanolamine in the urine. Even when used within recommended guidelines, phenylpropanolamine usage sh...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.35.3.405

    authors: Fallis RJ,Fisher M

    更新日期:1985-03-01 00:00:00

  • Effect of age at onset on progression and mortality in Parkinson's disease.

    abstract::We examined longitudinal disability scores in 54 patients with Parkinson's disease followed for 6 years at UCLA. We sorted data into 3 groups based on age at onset of symptoms: group A, onset under 50 years; group B, 50 to 59 years; group C, 60 years or older. There were no significant differences between groups initi...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.39.9.1187

    authors: Diamond SG,Markham CH,Hoehn MM,McDowell FH,Muenter MD

    更新日期:1989-09-01 00:00:00

  • Use of neuroimaging to guide the treatment of patients beyond the 8-hour time window.

    abstract::Revascularization time windows for patients with acute ischemic stroke are generally restricted to 8 hours. Later treatment attempts require more accurate prediction of risk and benefit, as safety and efficacy at these time strata are less well demonstrated. Advanced imaging techniques identify irreversible infarction...

    journal_title:Neurology

    pub_type: 杂志文章,评审

    doi:10.1212/WNL.0b013e3182695826

    authors: Janjua N

    更新日期:2012-09-25 00:00:00

  • Extensive brain calcifications, leukodystrophy, and formation of parenchymal cysts: a new progressive disorder due to diffuse cerebral microangiopathy.

    abstract::A new cerebral disorder, described in three unrelated children, has recognizable clinical, radiologic, and neuropathologic findings. The onset occurs from early infancy to adolescence with slowing of cognitive performance, rare convulsive seizures, and a mixture of extrapyramidal, cerebellar, and pyramidal signs. CT s...

    journal_title:Neurology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1212/wnl.46.5.1297

    authors: Labrune P,Lacroix C,Goutières F,de Laveaucoupet J,Chevalier P,Zerah M,Husson B,Landrieu P

    更新日期:1996-05-01 00:00:00

  • Early developmental trajectories associated with ASD in infants with tuberous sclerosis complex.

    abstract:OBJECTIVE:We performed a longitudinal cohort study of infants with tuberous sclerosis complex (TSC), with the overarching goal of defining early clinical, behavioral, and biological markers of autism spectrum disorder (ASD) in this high-risk population. METHODS:Infants with TSC and typically developing controls were r...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/WNL.0000000000000568

    authors: Spurling Jeste S,Wu JY,Senturk D,Varcin K,Ko J,McCarthy B,Shimizu C,Dies K,Vogel-Farley V,Sahin M,Nelson CA 3rd

    更新日期:2014-07-08 00:00:00

  • Alzheimer disease risk associated with APOE4 is modified by STH gene polymorphism.

    abstract::The association of the STH gene polymorphism with Alzheimer disease (AD) is debated. In the analysis of two genetically and diagnostically distinct groups of Alzheimer patients from the USA and Italy, the authors did not find an association with the STH polymorphism. However, the APOE-4-associated risk of AD greatly i...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000125693.59817.31

    authors: Seripa D,Matera MG,D'Andrea RP,Gravina C,Masullo C,Daniele A,Bizzarro A,Rinaldi M,Antuono P,Wekstein DR,Dal Forno G,Fazio VM

    更新日期:2004-05-11 00:00:00

  • Accelerated lymphocyte recovery after alemtuzumab does not predict multiple sclerosis activity.

    abstract:OBJECTIVE:To test the hypothesis that accelerated peripheral blood mononuclear cell recovery after alemtuzumab treatment of multiple sclerosis is associated with recurrent disease activity and to investigate the claim that CD4 counts greater than 388.5 × 10(6) cells/mL at 12 months can be used to identify patients who ...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/WNL.0000000000000520

    authors: Kousin-Ezewu O,Azzopardi L,Parker RA,Tuohy O,Compston A,Coles A,Jones J

    更新日期:2014-06-17 00:00:00

  • Nicotine-sensitive paresis.

    abstract::Immediately after a patient with myoclonus epilepsy smoked a nicotine-containing cigarette, tetraparesis and hyperreflexia with ankle clonus developed, but disappeared within several minutes. During paresis, the H-reflex size of the soleus muscle increased, EEG showed more slow waves than before smoking, and the cereb...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.42.2.382

    authors: Yokota T,Kagamihara Y,Hayashi H,Tsukagoshi H,Tanabe H

    更新日期:1992-02-01 00:00:00

  • Relationship between inflammatory lesions and cerebral atrophy in multiple sclerosis.

    abstract:OBJECTIVE:To investigate the temporal relationship between inflammation and cerebral atrophy in a longitudinal study of 19 patients with relapsing-remitting multiple sclerosis (RRMS) using serial monthly contrast enhanced MRI examinations and monthly measurements of brain fractional volume (BFV) for an average of 4 (ra...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000197982.78063.06

    authors: Richert ND,Howard T,Frank JA,Stone R,Ostuni J,Ohayon J,Bash C,McFarland HF

    更新日期:2006-02-28 00:00:00

  • Mechanisms and clinical features of posterior border-zone infarcts.

    abstract:BACKGROUND:Previous studies link posterior border-zone cerebral infarcts between the middle cerebral artery (MCA) and the posterior cerebral artery (PCA) to hemodynamic causes, not embolism. OBJECTIVE:To study the cause of these infarcts. METHODS:We studied 21 patients (unilateral = 18, bilateral = 3) with acute, sym...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/wnl.53.6.1312

    authors: Belden JR,Caplan LR,Pessin MS,Kwan E

    更新日期:1999-10-12 00:00:00

  • Elevated cortical zinc in Alzheimer disease.

    abstract:OBJECTIVE:To determine whether changes in brain biometals in Alzheimer disease (AD) and in normal brain tissue are tandemly associated with amyloid beta-peptide (Abeta) burden and dementia severity. METHODS:The authors measured zinc, copper, iron, manganese, and aluminum and Abeta levels in postmortem neocortical tiss...

    journal_title:Neurology

    pub_type: 杂志文章

    doi:10.1212/01.wnl.0000223644.08653.b5

    authors: Religa D,Strozyk D,Cherny RA,Volitakis I,Haroutunian V,Winblad B,Naslund J,Bush AI

    更新日期:2006-07-11 00:00:00