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3.
Am J Bioeth ; : 1-25, 2021 Jan 16.
Artículo en Inglés | MEDLINE | ID: mdl-33455521

RESUMEN

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk-benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research (e.g., only for life-threatening conditions). Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study's social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk-benefit ratios for pregnant women and/or fetuses may be acceptable.

5.
Pediatrics ; 147(3)2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33334920

RESUMEN

It is widely agreed that an effective response to the coronavirus disease 2019 pandemic needs to include a vaccine that is safe and effective for minors. However, many current vaccine trials have no plans for when to enroll minors. Others have recently proposed enrolling minors as young as 12 years old. This lack of a systematic approach raises 2 concerns. Waiting too long to enroll minors could unjustly deny minors and their families the benefits of a vaccine and has the potential to delay an effective response to the pandemic by a year or longer. At the same time, enrolling minors too soon runs the risk of exposing them to excessive risks. With these concerns in mind, in the present article, we propose recommendations for when and how to enroll minors in vaccine trials for the coronavirus disease 2019.


Asunto(s)
Ensayos Clínicos como Asunto/normas , Voluntarios Sanos , Menores , Adolescente , /efectos adversos , Niño , Ensayos Clínicos como Asunto/ética , Participación de la Comunidad , Comités de Ética en Investigación , Humanos , Consentimiento Informado de Menores , Pandemias/prevención & control
6.
7.
Intern Med J ; 50(12): 1583-1587, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33354875

RESUMEN

Innovative practice involves medical interventions that deviate from standard practice in significant ways. For many patients, innovative practice offers the best chance of successful treatment. Because little is known about most innovative treatments, clinicians who engage in innovative practice might consider including extra procedures, such as scans or blood draws, to gather information about the innovation. Such information-gathering interventions can yield valuable information for modifying the innovation to benefit future patients and for designing scientific studies of the innovation. However, existing guidelines do not say when or whether it is appropriate to add potentially risky information-gathering interventions for these purposes. As a result, clinicians may assume that information-gathering interventions are ethically inappropriate and should not be used in innovative practice. This assumption can lead to seriously negative consequences, such as increasing the likelihood that harmful or ineffective innovations will be adopted and creating new barriers to the development of genuinely beneficial treatments. We argue that health care institutions need to promote the responsible use of information-gathering interventions as an adjunct to innovative practice, and that these interventions are not clinical research and should not be subject to research oversight.


Asunto(s)
Prestación de Atención de Salud , Humanos
8.
Clin Infect Dis ; 2020 Dec 31.
Artículo en Inglés | MEDLINE | ID: mdl-33383587

RESUMEN

BACKGROUND: Cryptococcal meningoencephalitis (CM) is a major cause of mortality in immunosuppressed patients and previously healthy individuals. In the latter, a post-infectious inflammatory response syndrome (PIIRS) is associated with poor clinical response despite antifungal therapy and negative CSF cultures. Data on effective treatment are limited. METHODS: Between March 2015 and March 2020, 15 consecutive previously healthy patients with CM and PIIRS were treated with adjunctive pulse corticosteroid taper therapy (PCT) consisting of intravenous methylprednisolone 1 gm daily for 1 week followed by oral prednisone 1 mg/kg/d, tapered based on clinical and radiological response plus oral fluconazole. Montreal Cognitive Assessments (MOCA), Karnofsky Performance scores, MRI brain scanning, ophthalmic and audiologic exams, CSF parameters including cellular and soluble immune responses were compared at PIIRS diagnosis and after methylprednisolone completion. RESULTS: The median time from antifungal treatment to steroid initiation was 6 weeks. The most common symptoms at PIIRS diagnosis were altered mental status and vision changes. All patients demonstrated significant improvements in MOCA and Karnofsky scores at 1 month (p<0.0003), which was accompanied by improvements in CSF glucose, WBC, protein, cellular and soluble inflammatory markers 1 week after receiving corticosteroids (CS) (p<0.003). All patients with papilledema and visual field deficits also exhibited improvement (p<0.0005). Five out of 7 patients who underwent audiological testing demonstrated hearing improvement. Brain MRI showed significant improvement of radiological findings (p=0.001). CSF cultures remained negative. CONCLUSIONS: PCT in this small cohort of PIIRS was associated with improvements in CM-related complications with minimal toxicity in the acute setting.

10.
Clin Trials ; 17(6): 696-702, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32806931

RESUMEN

There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of three groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that institutional review boards can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations.

11.
J Adolesc Health ; 67(4): 495-501, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32636140

RESUMEN

PURPOSE: One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear. METHODS: Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children's Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted. RESULTS: Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers' mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required. CONCLUSION: Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.

12.
Trends Genet ; 36(9): 630-632, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32660785

RESUMEN

The biorights movement argues that current treatment of biospecimen donors is unfair. To evaluate this claim, the present Science & Society article identifies the standards used to determine credit and compensation in research, and applies them to donors. This analysis suggests most donors deserve credit and, contrary to current practice, some deserve compensation.

13.
Am J Trop Med Hyg ; 103(1): 528-536, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32394875

RESUMEN

Data-sharing helps advance scientific research and assures the benefits of research data are maximized. Previous work has highlighted ethical challenges, especially in low- and middle-income countrie (LMIC) countries. This study examined the views of researchers in a middle-income country, Thailand, regarding the most important data-sharing challenges. The target researchers worked in biomedical and related research. The survey was distributed to 38 academic and health-science institutes, 18 university hospitals, 84 nonuniversity hospitals, and 22 research institutes across Thailand; 229 researchers in clinical/basic and social/behavioral sciences, and pubxxlic health/policy participated. Thai researchers were less concerned with informed consent and the feasibility of conducting research and sharing data, focusing on the importance of safeguards when handling data, including transfer to others, and possible lack of control over subsequent data use. The respondents felt that researchers should decide what types of project data are shareable and which data are likely useful to the scientific community. They were more concerned with appropriate acknowledgment and protecting the legal rights of the primary data collectors and providers. Although they had concerns about data access conditions, they rated sharing sufficient data and metadata to reproduce the analysis of the primary outcomes as highly important. These results are important for future efforts of the LMIC countries to develop efficient data-sharing frameworks and establish institutional data access committees. They highlight the importance, for the sustainability and fairness of these efforts, to ensure that parties in LMIC countries receive appropriate credit and are involved in determining where/when/how their data may be used.


Asunto(s)
Actitud , Investigación Biomédica , Difusión de la Información , Investigadores , Costos y Análisis de Costo , Exactitud de los Datos , Países en Desarrollo , Ética en Investigación , Femenino , Política de Salud , Humanos , Propiedad Intelectual , Masculino , Política Organizacional , Salud Pública , Ciencias Sociales , Encuestas y Cuestionarios , Tailandia
14.
Ethics Hum Res ; 42(2): 34-40, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32233115

RESUMEN

The use of deception is typically prohibited in studies that pose greater than minimal risk overall. This approach prevents researchers from using deception to conceal significant risks or to deceive participants about the purpose, potential benefits, or other aspects of a study that are relevant to deciding whether to accept such risks. Yet this approach also mistakenly blocks appropriate research. In particular, it keeps researchers from using deception in studies that pose greater than minimal risk, even when participants are informed accurately about the risks and other aspects of the study that are relevant to deciding whether to participate. Rather than prohibiting deception when the overall study poses greater than minimal risk, policies should prohibit deception when the aspect of the study about which participants are deceived poses greater than minimal risk.


Asunto(s)
Decepción , Ética , Experimentación Humana/ética , Investigadores/ética , Sujetos de Investigación , Medición de Riesgo/normas , Humanos , Consentimiento Informado
16.
J Cancer Educ ; 35(2): 292-300, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-30612315

RESUMEN

To examine whether (a) non-minority participants differed from racial minority participants in the understanding of biospecimens collected for research purposes, (b) patients differed from comparison group in their understanding of the ways their biospecimens could be used by researchers, and (c) participants received adequate information before consenting to donate blood for research studies. We analyzed cross-sectional data from female breast cancer patients scheduled to receive chemotherapy at the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical sites and a healthy comparison group. After reading a consent form related to biospecimens and consenting to participate in a clinical trial, participants' understanding of biospecimen collection was evaluated. Linear models were used to compare scores between non-minority and racial minority participants as well as cancer and non-cancer comparisons adjusting for possible confounding factors. A total of 650 participants provided evaluable data; 592 were non-minority (Caucasian) and 58 participants were a racial minority (71% Black and 29% other). There were 427 cancer patients and 223 comparisons. Non-minority participants scored higher than racial minorities on relevance-to-care items (diff. = 0.48, CI 0.13-0.80, p = 0.001). Comparison group scored higher than cancer patients on relevance-to-care items (diff. = 0.58, CI 0.37-0.78). A moderate number of the participants exhibited a poor understanding of biospecimen collection across all racial/ethnic backgrounds, but racial minority participants' scores remained lower in the relevance-to-care subscale even after adjusting for education and reading level. Differences were also noted among the patients and comparison group. Researchers should facilitate comprehension of biospecimen collection for all study participants, especially racial minority participants.


Asunto(s)
Bancos de Muestras Biológicas/estadística & datos numéricos , Neoplasias de la Mama/etnología , Ensayos Clínicos como Asunto/estadística & datos numéricos , Comprensión , Grupos Étnicos/educación , Grupos Étnicos/psicología , Disparidades en el Estado de Salud , Adulto , Afroamericanos/educación , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/psicología , Estudios de Casos y Controles , Estudios Transversales , Grupo de Ascendencia Continental Europea/educación , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Persona de Mediana Edad , Participación del Paciente , Manejo de Especímenes , Adulto Joven
17.
Perspect Biol Med ; 63(2): 346-358, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33416657

RESUMEN

Forty years ago, the Belmont Report counseled that a "systematic, nonarbitrary analysis of risks and benefits" is vital to ensuring the ethical appropriateness of research with human subjects. Since then, research ethics has devoted considerable attention to the first half of this advice, emphasizing the ethical importance of assessing and minimizing the risks of research with human subjects. Significantly less attention has been devoted to a systematic assessment of the potential benefits of research participation. To the extent that benefits for individual participants are considered at all, commentators tend to focus on their potential to undermine the goal of minimizing risks. A chance for clinical benefit may obscure the fact that research poses risks not present in clinical care, while an offer of financial compensation or ancillary care may induce individuals to accept risks that conflict with their long-term interests. This article argues that, while undoubtedly important, minimizing risks fails to offer sufficient protection for research participants, especially those who cannot consent, because it neither ensures that the risks of research are justified nor protects participants from exploitation. Belmont's advice to develop systematic and nonarbitrary ways to ensure that research participants receive appropriate benefits needs to be heeded as well.

18.
PLoS One ; 14(10): e0223619, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31600282

RESUMEN

Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries (LMICs). Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs.


Asunto(s)
Miembro de Comité , Países en Desarrollo , Comités de Ética en Investigación , Renta , Investigadores/ética , Encuestas y Cuestionarios , Femenino , Humanos , Masculino , Proyectos de Investigación , Tailandia
19.
BMC Med Ethics ; 20(1): 37, 2019 05 29.
Artículo en Inglés | MEDLINE | ID: mdl-31142291

RESUMEN

BACKGROUND: Sickle cell anemia (SCA) is a major genetic disease with the greatest burden in sub-Saharan Africa. To try to help reduce this burden, some churches in Nigeria conduct premarital sickle cell hemoglobin screening and refuse to conduct weddings when both individuals are identified as carriers of sickle cell trait. MAIN BODY: This paper explores the ethical challenges involved in such denials. We assess whether churches have the right to decline to marry adults who understand the risks and still prefer to get married, and whether couples should be denied church weddings based on the risk that their child may suffer from sickle cell anemia. We examine the moral and ethical dimensions of such denials and explore the underlying socio-cultural context involving the purpose of marriage and the meaning of the wedding ceremony in societies where premarital screening is one of the few tools available to reduce the risk of having children with SCA. The potential role of the church is also examined against the background of church beliefs, the duty of the church to its members and its role in reducing the suffering of its members and /or their children. CONCLUSION: We argue that the church should impose these burdens on couples only if doing so promotes a sufficiently compelling goal and there is no less burdensome way to achieve it. We then argue that the goal of reducing the number of individuals in Nigeria who have SCA is compelling. However, testing earlier in life offers a less burdensome and potentially even more effective means of achieving this goal. This suggests that, advocating for earlier screening and helping to support these programs, would likely better promote the church's own goals of helping its parishioners, increasing the number of church weddings, and reducing the burden of SCA in Nigeria.


Asunto(s)
Pruebas Genéticas/ética , Hemoglobinas/genética , Matrimonio , Exámenes Prenupciales/ética , Religión y Medicina , Rasgo Drepanocítico/genética , Adolescente , Adulto , Anemia de Células Falciformes/genética , Anemia de Células Falciformes/prevención & control , Femenino , Humanos , Masculino , Persona de Mediana Edad , Nigeria , Adulto Joven
20.
Pediatrics ; 143(3)2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30787097

RESUMEN

US regulations allow institutional review boards to approve pediatric clinical trials only when the risks are minimal or (in some cases) a minor increase over minimal, or when the risks are justified by a potential for direct benefit to the participants. But how should an institutional review board determine if the risks of pediatric clinical trials are justified by a potential for participant benefit? In this Ethics Rounds article, we consider which potential benefits can justify which research risks with a focus on randomized clinical trials.


Asunto(s)
Investigación Biomédica/métodos , Investigación Biomédica/normas , Comités de Ética en Investigación/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Administración Intravenosa , Atresia Biliar/diagnóstico , Atresia Biliar/tratamiento farmacológico , Niño , Glucocorticoides/administración & dosificación , Humanos , Metilprednisolona/administración & dosificación , Estudios Prospectivos , Medición de Riesgo
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