RESUMO
In the early days of a pandemic, repurposing biospecimens from established research projects could prove to be extraordinarily useful in achieving substantial and timely public health benefits. Nonetheless, there are potential ethical and regulatory uncertainties that may impede access to those valuable biospecimens. In this article, we argue that there should be a presumption in favor of using previously collected identifiable research biospecimens without reconsent to directly address an infectious disease pandemic, assuming certain conditions are met. This argument fills a unique yet critical gap in decision-making where the specific consent accompanying the identifiable biospecimens would not otherwise permit repurposing. Further, it suggests that even if gaining reconsent is feasible, doing so in a fast-moving crisis is not necessary. This analysis also attempts to address the ethical concerns of public health authorities who already may have the power to use such specimens but are reluctant to do so.
Assuntos
Bancos de Espécimes Biológicos/ética , Pesquisa Biomédica/ética , Consentimento Livre e Esclarecido/ética , Pandemias , Saúde Pública/ética , HumanosAssuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Estudos Clínicos como Assunto/ética , Experimentação Humana/ética , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/uso terapêutico , Desenvolvimento de Medicamentos/ética , Humanos , Medição de RiscoRESUMO
The near-routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway-from protocol development, to IRB review, and ultimately trial execution-that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can."
Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/normas , Gestantes , Medicamentos sob Prescrição/administração & dosagem , Projetos de Pesquisa , Feminino , Humanos , Entrevistas como Assunto , Gravidez , Pesquisa Qualitativa , Projetos de Pesquisa/legislação & jurisprudência , Projetos de Pesquisa/normas , Medição de RiscoRESUMO
Congenital bilateral renal agenesis has been considered a uniformly fatal condition. However, the report of using serial amnioinfusions followed by the live birth in 2012 and ongoing survival of a child with bilateral renal agenesis has generated hope, but also considerable controversy over an array of complex clinical and ethical concerns. To assess the ethical concerns associated with using serial amnioinfusions for bilateral renal agenesis, we assembled a multidisciplinary group to map the ethical issues relevant to this novel intervention. The key ethical issues identified were related to 1) potential risks and benefits, 2) clinical care compared with innovation compared with research, 3) counseling of expectant parents, 4) consent, 5) outcome measures, 6) access and justice, 7) conflicts of interest, 8) effects on clinicians, 9) effects on institutions, and 10) long-term societal implications. These ethical issues should be addressed in conjunction with systematic efforts to examine whether this intervention is safe and effective. Future work should capture the experiences of expectant parents, women who undergo serial amnioinfusions, those born with bilateral renal agenesis and their families as well as clinicians confronted with making difficult choices related to it.
Assuntos
Âmnio , Anormalidades Congênitas/diagnóstico por imagem , Anormalidades Congênitas/terapia , Infusões Intralesionais/ética , Nefropatias/congênito , Rim/anormalidades , Oligo-Hidrâmnio/terapia , Resultado da Gravidez , Feminino , Doenças Fetais/diagnóstico por imagem , Doenças Fetais/terapia , Humanos , Consentimento Livre e Esclarecido , Rim/diagnóstico por imagem , Nefropatias/diagnóstico por imagem , Nefropatias/terapia , Saúde Materna , Oligo-Hidrâmnio/diagnóstico por imagem , Gravidez , Medição de Risco , Ultrassonografia Pré-Natal/métodosRESUMO
U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services' regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions.
Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Tomada de Decisões , Advogados , Gestantes , Sujeitos da Pesquisa/legislação & jurisprudência , Ensaios Clínicos como Assunto/ética , Indústria Farmacêutica/organização & administração , Feminino , Humanos , Responsabilidade Legal , Gravidez , Gestão de RiscosRESUMO
Scarce research with pregnant women has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring. In this paper, we highlight three aspects of the landscape in which pregnant women are included or, more frequently, excluded from research: international ethics guidance, regional and national regulatory frameworks, and prevailing practices. Our paper suggests that, in some cases, regulatory frameworks can be more restrictive than international ethics guidance, and that even when regulations permit research with pregnant women, practical challenges-as well as the prevailing practices of stakeholders, such as ethics review committees and investigators-may lead to the generalized exclusion of pregnant women from research.
Assuntos
Pesquisa Biomédica/ética , Seleção de Pacientes/ética , Complicações na Gravidez/tratamento farmacológico , Pesquisa Biomédica/legislação & jurisprudência , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Gravidez , Estados UnidosRESUMO
OBJECTIVE: Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. METHODS: We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. RESULTS: Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. CONCLUSION: Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.
Assuntos
Ensaios Clínicos como Assunto , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Complicações Infecciosas na Gravidez/tratamento farmacológico , Pesquisa Biomédica/ética , Pesquisa Biomédica/tendências , Feminino , Infecções por HIV/transmissão , Humanos , Gravidez , GestantesRESUMO
Multipurpose prevention technologies (MPTs) designed to simultaneously prevent pregnancy and HIV could provide urgently needed tools to address unmet sexual and reproductive health needs of women worldwide. Late-stage clinical trials will be complex given the need to demonstrate efficacy for HIV and contraceptive indications simultaneously from a single product. Currently, HIV and pregnancy prevention trials have distinctive design features that will need to be reconciled in MPT trials. This article identifies several ethical issues uniquely associated with this research that will benefit from future deliberation and guidance to ensure that this globally important research can proceed efficiently and expeditiously.
Assuntos
Ensaios Clínicos como Assunto/ética , Anticoncepção/ética , Infecções por HIV/prevenção & controle , Prevenção Primária/ética , Anti-Infecciosos/uso terapêutico , Antirretrovirais/uso terapêutico , Feminino , Humanos , Masculino , Gravidez , Prevenção Primária/normasRESUMO
Apologies are rare in the medical world, where health care providers fear that admissions of guilt or expressions of regret could be used by plaintiffs in malpractice lawsuits. Nevertheless, some states are moving toward giving health care providers legal protection so that they feel free to apologize to patients for a medical mistake. Advocates believe that these laws are beneficial for patients and providers. However, our analysis of "apology" and "disclosure" laws in thirty-four states and the District of Columbia finds that most of the laws have major shortcomings. These may actually discourage comprehensive disclosures and apologies and weaken the laws' impact on malpractice suits. Many could be resolved by improved statutory design and communication of new legal requirements and protections.
Assuntos
Empatia , Responsabilidade Legal , Imperícia/legislação & jurisprudência , Padrões de Prática Médica/legislação & jurisprudência , Revelação da Verdade , District of Columbia , Humanos , Estados UnidosAssuntos
Surtos de Doenças/prevenção & controle , Planejamento em Saúde/ética , Influenza Humana/prevenção & controle , Saúde Pública/ética , Justiça Social , Populações Vulneráveis , Comitês Consultivos , Doença Crônica , Surtos de Doenças/ética , Planejamento em Saúde/tendências , Política de Saúde , Humanos , Formulação de Políticas , Serviços Preventivos de Saúde/ética , Serviços Preventivos de Saúde/tendências , Saúde Pública/tendências , Estados Unidos , Populações Vulneráveis/classificaçãoAssuntos
Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudência , Opinião Pública , Sujeitos da Pesquisa , Confiança , Compensação e Reparação/legislação & jurisprudência , Aprovação de Equipamentos , Aprovação de Drogas , Ética em Pesquisa , Humanos , Estados Unidos , United States Food and Drug AdministrationAssuntos
Ética em Pesquisa , Experimentação Humana/ética , Sujeitos da Pesquisa/legislação & jurisprudência , Comitês de Ética em Pesquisa , Health Insurance Portability and Accountability Act , Experimentação Humana/legislação & jurisprudência , Experimentação Humana/normas , Humanos , Privacidade , Estados UnidosRESUMO
PURPOSE: To identify best practices in education related to the responsible conduct of clinical research (RCCR). METHOD: American Society for Bioethics and Humanities (ASBH) members involved with teaching RCCR were asked to complete an online survey, followed by an in-depth telephone interview. The online survey asked about respondents' RCCR teaching, trainees, and institutional context. The phone interview involved discussions about teaching strategies, institutional context, and needs. The study was conducted between 2003 and 2005. RESULTS: Forty-eight respondents to the online survey indicated a breadth of topics being covered in RCCR curricula; 35 respondents indicated that their RCCR teaching applied toward institutional RCCR requirements. Among the 21 instructors interviewed, many described a wide variety of teaching responsibilities. Recommended teaching strategies included fostering interactive discussion, using skills-based exercises such as designing IRB applications, accommodating students' individual interests in curriculum design, involving experienced researchers, involving trainees early in their careers as well as requiring continuing education, and designing a curriculum with a clear view of educational objectives. Interviewees described the institutional supports they needed, and they noted that insufficient support sometimes undermines RCCR teaching goals. Participants generally agreed that RCCR education should be required. CONCLUSIONS: Strong agreement among participants concerning recommended strategies for teaching RCCR provides useful, if provisional, guidance to instructors and institutions charged with providing such training. The study suggests a need for substantial investments in RCCR training, studying outcomes, and developing mechanisms to ensure the quality of instruction.
Assuntos
Pesquisa Biomédica/educação , Currículo , Ética em Pesquisa/educação , Ensino/métodos , Atitude , Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Humanos , Entrevistas como Assunto , Sociedades Científicas , Inquéritos e Questionários , Estados Unidos , Carga de TrabalhoAssuntos
Difusão de Inovações , Cirurgia Geral/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Experimentação Humana/legislação & jurisprudência , Gestão da Segurança/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência , Comitês de Ética em Pesquisa/legislação & jurisprudência , Governo Federal , Cirurgia Geral/métodos , Cirurgia Geral/tendências , Regulamentação Governamental , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Responsabilidade Legal , Imperícia/legislação & jurisprudência , Autonomia Profissional , Medição de Risco/legislação & jurisprudência , Responsabilidade Social , Sociologia Médica , Estados UnidosRESUMO
During the nearly 10 years since its introduction, preimplantation genetic diagnosis (PGD) has been used predominantly to avoid giving birth to a child with identified genetic disease. Recently, PGD was used by a couple not only to test IVF-created embryos for genetic disease, but also to test for a nondisease trait related to immune compatibility with a child in the family in need of an hematropoetic stem cell transplant. This article describes the case, raises some ethical and policy issues, highlights gaps in U.S. policy, and finally makes some recommendations for addressing advancing genetic and reproductive technologies.
Assuntos
Doação Dirigida de Tecido , Histocompatibilidade , Diagnóstico Pré-Implantação , Reprodução/ética , Irmãos , Transplante de Células-Tronco , Comitês Consultivos , Doação Dirigida de Tecido/ética , Destinação do Embrião , Transferência Embrionária , Análise Ética , Revisão Ética , Anemia de Fanconi , Fertilização in vitro , Sangue Fetal/transplante , Testes Genéticos/ética , Humanos , Recém-Nascido , Motivação , Pais , Diagnóstico Pré-Implantação/ética , Política Pública , Controle Social Formal , Transplante de Células-Tronco/ética , Estados UnidosAssuntos
Ética , Saúde Pública , Saúde Global , Direitos Humanos , Humanos , Princípios Morais , Justiça SocialRESUMO
The legal case of Grimes v. Kennedy Krieger Institute, Inc, has raised concerns in the public health research community regarding the acceptable level of risk in research involving children, parental authority for informed consent, and exploitation of research subjects for the benefit of public health. We provide an overview of the case and discuss the impact of the court's decision and its possible effect on future research protection policies and practices.