Clinical research: Protection of the “vulnerable”?

Park, Stephanie S.; Grayson, Mitchell H.

doi:10.1016/j.jaci.2008.01.014

Cited by 23 publications

(20 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Studies in clinical pediatric populations are limited by heterogeneity of the disease, a small population at any one institution, as well as ethical restrictions on a vulnerable population (25). These factors are sufficient to significantly restrict the scientific community's ability to address myocellular factors in pediatric HF.…”

Section: Discussionmentioning

confidence: 99%

“…Importantly, the blockade of the ␤ 2 -AR with carvedilol in the pediatric clinical trial may be responsible, in part, for the lack of clinical benefit in the pediatric population. Unfortunately the pathophysiological importance of these differences in myocardial adaptation of the ␤-AR system is virtually impossible to determine in children due to population-specific protections and characteristics (25).…”

mentioning

confidence: 99%

See 1 more Smart Citation

β-Adrenergic receptor antagonism in mice: a model for pediatric heart disease

Sucharov

Hijmans

Sobus

et al. 2013

Journal of Applied Physiology

View full text Add to dashboard Cite

Children with heart failure are treated with similar medical therapy as adults with heart failure. In contrast to adults with heart failure, these treatment regiments are not associated with improved outcomes in children. Recent studies have demonstrated age-related pathophysiological differences in the molecular mechanisms of heart failure between children and adults. There are no animal models of pediatric cardiomyopathy to allow mechanistic studies. The purpose of the current experiments was to develop a mouse model of pediatric heart disease and test whether the influence of β-adrenergic receptor (β-AR) antagonism could be modeled in this system. We hypothesized that isoproterenol treatment of young mice would provide a model system of cardiac pathology, and that nonselective β-AR blockade would provide benefit in adult, but not young, mice, similar to clinical trial data. We found that isoproterenol treatment (through osmotic minipump implantation) of young and adult mice produced similar degrees of cardiac hypertrophy and recapitulated several age-related molecular abnormalities in human heart failure, including phospholamban phosphorylation and β-AR expression. We also found that nonselective β-AR blockade effectively prevented pathological cardiac growth and collagen expression in the adult but not young mice, and that selective β1-AR blockade was effective in both young and adult isoproterenol-treated mice. In conclusion, we have developed the first model system for β-AR-mediated pediatric heart disease. Furthermore, we have generated novel data suggesting beneficial effects of selective β1-AR blockade in the pediatric heart.

show abstract

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

β-Adrenergic receptor antagonism in mice: a model for pediatric heart disease

Sucharov

Hijmans

Sobus

et al. 2013

Journal of Applied Physiology

View full text Add to dashboard Cite

show abstract

“…With the progress of clinical research, we started having the concern and the understanding that certain ethical standards must be observed when the goal of the study involves human beings 6 .…”

Section: Discussionmentioning

confidence: 99%

Current outlook of ethics in research with human subjects

Takahashi¹,

Ramos²,

Pinheiro‐Neto³

et al. 2011

Braz. j. otorhinolaryngol. (Impr.)

View full text Add to dashboard Cite

in the last decades, medical care has been increasingly permeated by the concept of evidencebased-medicine, in which clinical research plays a crucial role in establishing diagnostic and treatment. Following the improvements in clinical research, we have a growing concern and understanding that some ethical issues must be respected when the subjects are human beings. research with human subjects relies on the principles of autonomy, beneficence, no maleficence and justice. Ordinance 196/96 from the national Health Board adds to the Brazilian legislation such renowned bioethical principles.Aim: discuss the main ethical aspects involved in research with human subjects. Materials and Methods:Critical analysis of Ordinance 196/96 and related literature. Conclusion:Ordinance 196/96 rules research with human subjects; nevertheless, it requires more in-depth discussions regarding the informed consent, use of placebo, research with vulnerable populations and research in developing countries. Braz J Otorhinolaryngol. 2011;77(2):263-6. REVIEW ARTIcLE BJORL

show abstract

“…Vulnerability is a central concept in protecting human subjects in research, and the term, vulnerable populations , was introduced as part of the guidelines for medical ethics in the 1949 Nuremburg Code, World Medical Association Declaration of Helsinki (most recent update: 2008), and the 1979 Belmont Report to protect human subjects involved in research [1, 2]. The US federal regulations for protection of human subjects, in 45 Code of Federal Regulations Part 46 (45 CFR 46) require special protections for three categories of vulnerable populations—pregnant women, fetuses, and neonates (Subpart B), prisoners (Subpart C), and children (Subpart D) [1].…”

Section: Introductionmentioning

confidence: 99%

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

Sengupta

Strauss

et al. 2010

AIDS Behav

View full text Add to dashboard Cite

In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers' ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations' group-based approach to defining vulnerable populations.

show abstract

Clinical research: Protection of the “vulnerable”?

Cited by 23 publications

References 18 publications

β-Adrenergic receptor antagonism in mice: a model for pediatric heart disease

β-Adrenergic receptor antagonism in mice: a model for pediatric heart disease

Current outlook of ethics in research with human subjects

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

Contact Info

Product

Resources

About