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In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.
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Bancos de Espécimes Biológicos , Pesquisa Biomédica , Consentimento Livre e Esclarecido , Humanos , Bancos de Espécimes Biológicos/legislação & jurisprudência , Bancos de Espécimes Biológicos/ética , Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Células HeLa , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Manejo de Espécimes/ética , Estados UnidosRESUMO
This Viewpoint discusses the need to protect participants in clinical research and the opportunity to address this issue as the World Medical Association works to revise its Declaration of Helsinki, which governs medical research ethics.
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Pesquisa Biomédica , Humanos , Estados Unidos , Sujeitos da Pesquisa , Ensaios Clínicos como AssuntoRESUMO
Rules are needed for human research in commercial spaceflight.
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Experimentação Humana , Sujeitos da Pesquisa , Voo Espacial , Humanos , Voo Espacial/ética , Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudênciaRESUMO
This commentary discusses twelve stories in which people who are involved in institutional review board (IRB) administration or serve as IRB members tell the stories of how the COVID-19 pandemic affected their work and lives. Among the aspects of these stories it highlights are the need to focus on the well-being of the institution's employees, and how issues involving protecting vulnerable subjects might relate to current policy debates about underserved communities. The final portion of this commentary focuses in particular on how one might measure success for a program in protecting its research subjects during a pandemic.
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COVID-19 , Comitês de Ética em Pesquisa , Saúde Ocupacional , Pandemias , Sujeitos da Pesquisa , Segurança , Humanos , Narração , Políticas , SARS-CoV-2 , Populações VulneráveisRESUMO
This discussion presents many of the ethical, legal, and financial issues that underlie the contemporary regulatory framework for research with human biospecimens. Some considerations, such as claims of donor control over their biospecimens, could potentially constrain researchers' freedom of action. We first consider concepts underlying consent to donate biospecimens for research. A requirement to obtain consent for donation of a biospecimen could conceptually be based upon the autonomy of the donor, or on property rights of the donor, or a combination of both concepts. If these concepts affect how consent is implemented, it could have significant downstream consequences for research and researchers. We present elements of the revision of the common rule that affect the use of human biospecimens including the current consent regulations based on transparency and autonomy, and the distinction between consent for, and ownership of, biospecimens. One of the major judicial opinions that denied property rights for biospecimens is described together with some implications for the research community of attributing ownership of biospecimens to their donors. We then consider transactional aspects of biospecimen donation. Considering biospecimens as a negotiable commodity presents both constraints and opportunities for donors and researchers. Compensation for biospecimens can be negotiated under contract law. Allowing donor control of the secondary research use of deidentified biospecimens could have an inhibiting effect on research. If donors possessed such control, even deidentification would not necessarily eliminate their ability to influence future research. Accordingly, new models of biospecimen donation are appearing in which the research community will have a substantial interest.
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Pesquisa Biomédica , Doadores de Tecidos , Humanos , PesquisadoresAssuntos
Betacoronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Assunção de Riscos , Vacinação/ética , Vacinas Virais/uso terapêutico , COVID-19 , Infecções por Coronavirus/epidemiologia , Humanos , Pandemias/ética , Pneumonia Viral/epidemiologia , SARS-CoV-2 , Estados Unidos/epidemiologia , Vacinas Virais/administração & dosagemRESUMO
It was the summer of 1972 when a stunned nation first learned of the infamous Tuskegee Syphilis Study, during which hundreds of poor, disease-stricken black men from Macon County Alabama, had been deliberately left untreated for 40 years. Coming on the heels of multiple, earlier examples of unethical human experimentation, the Tuskegee Syphilis Study made it plain that the moral foundation of human subject research was in desperate need of repair. Blind reliance on the Nuremberg Code and the Declaration of Helsinki was no longer going to suffice. It was against this backdrop that Congress resolved to act. Numerous hearings and multiple spirited discussions later, an agreement was struck to constitute the "Commission." The outgrowth of a retreat held at the Smithsonian Institution's Belmont Conference Center, the Belmont Report lays out a principled analytical framework to "guide the resolution of ethical problems arising from research involving human subjects." Durable and ever-present, the Belmont Report, which is the foundational document that reset the ethics of human subject research, must now reckon with all-important novel issues of the day that could not have been foreseen by its drafters.
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Pesquisa Biomédica/ética , Ética em Pesquisa , Experimentação Humana/ética , Justiça Social/ética , Negro ou Afro-Americano , Alabama , Feminino , Humanos , Consentimento Livre e Esclarecido/ética , Masculino , Seleção de Pacientes/ética , Autonomia Pessoal , Sujeitos da Pesquisa , Sífilis/epidemiologia , Estados Unidos , VoluntáriosRESUMO
Cancer therapeutics frequently lead to symptomatic adverse events (AE) that can affect treatment tolerability. The NCI has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic AEs by direct patient self-report. Although longitudinal assessment of patient-reported symptomatic AEs holds promise to better inform treatment tolerability, using patient-reported outcome (PRO) measures to assess symptomatic AEs has raised several regulatory and good clinical practice issues among those who conduct cancer clinical trials. These include concerns regarding trial monitoring, clinical review of PRO results by investigators and delegated clinical staff, whether PRO data on symptomatic AEs require investigational new drug (IND) safety reporting, and how the trial conduct and resultant PRO data will be assessed during clinical investigator site inspections. This article addresses current thinking regarding these issues in cancer clinical trials from the FDA, the NCI, and the Office for Human Research Protections. PRO measures, such as PRO-CTCAE, that assess symptomatic AEs in cancer trials are considered similar to other PRO assessments of symptoms, function, and health-related quality of life and can generate complementary data that may inform tolerability. Clarity on operational concerns related to incorporating PRO measures to inform tolerability is critical to continue the advancement of rigorous PRO assessment in cancer clinical trials. Clin Cancer Res; 24(8); 1780-4. ©2017 AACRSee related commentary by Nipp and Temel, p. 1777.
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Antineoplásicos/uso terapêutico , Ensaios Clínicos como Assunto , Neoplasias/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Antineoplásicos/farmacologia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Revelação , Revisão de Uso de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Drogas em Investigação/farmacologia , Drogas em Investigação/uso terapêutico , Humanos , Projetos de Pesquisa , PesquisadoresAssuntos
Pesquisa Biomédica/legislação & jurisprudência , Ética Clínica , Regulamentação Governamental , Consentimento Livre e Esclarecido/legislação & jurisprudência , Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/legislação & jurisprudência , Humanos , Consentimento Livre e Esclarecido/normas , Sujeitos da Pesquisa/legislação & jurisprudência , Manejo de Espécimes/ética , Estados UnidosAssuntos
Pesquisa Biomédica/normas , Ensaios Clínicos como Assunto/normas , Bases de Dados Factuais , Regulamentação Governamental , Pesquisa Biomédica/legislação & jurisprudência , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/estatística & dados numéricos , Comitês de Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa , Estados Unidos , United States Food and Drug AdministrationRESUMO
A history of past abuses on research with human subjects has led to various sets of rules that are designed to insure ethical practices to protect research subjects appropriately. To understand these rules, it is important to appreciate the significant differences between being a patient, where protecting the best interests of that patient is the primary goal, and being a research subject, where that is generally not the case. In the research setting, there can be a conflict between attempting to answer the research question, and doing what is best for the subject. The rules for conducting research with human subjects attempt to manage this conflict in an ethically acceptable manner. This chapter provides an overview of those rules, including a somewhat extended discussion of the U.S. "Common Rule" as a particular example.