RESUMEN
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.
Asunto(s)
Investigación Biomédica , Humanos , Estados Unidos , Sujetos de Investigación , Ensayos Clínicos como AsuntoRESUMEN
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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Investigación Biomédica/ética , Ética en Investigación , Experimentación Humana/ética , Justicia Social/ética , Negro o Afroamericano , Alabama , Femenino , Humanos , Consentimiento Informado/ética , Masculino , Selección de Paciente/ética , Autonomía Personal , Sujetos de Investigación , Sífilis/epidemiología , Estados Unidos , VoluntariosAsunto(s)
Investigación Biomédica/legislación & jurisprudencia , Ética Clínica , Regulación Gubernamental , Consentimiento Informado/legislación & jurisprudencia , Investigación Biomédica/ética , Comités de Ética en Investigación/legislación & jurisprudencia , Humanos , Consentimiento Informado/normas , Sujetos de Investigación/legislación & jurisprudencia , Manejo de Especímenes/ética , Estados UnidosAsunto(s)
Betacoronavirus/inmunología , Infecciones por Coronavirus/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Asunción de Riesgos , Vacunación/ética , Vacunas Virales/uso terapéutico , COVID-19 , Infecciones por Coronavirus/epidemiología , Humanos , Pandemias/ética , Neumonía Viral/epidemiología , SARS-CoV-2 , Estados Unidos/epidemiología , Vacunas Virales/administración & dosificaciónRESUMEN
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 Muestras Biológicas , Investigación Biomédica , Consentimiento Informado , Humanos , Bancos de Muestras Biológicas/legislación & jurisprudencia , Bancos de Muestras Biológicas/ética , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Células HeLa , Consentimiento Informado/legislación & jurisprudencia , Consentimiento Informado/ética , Manejo de Especímenes/ética , Estados UnidosRESUMEN
Rules are needed for human research in commercial spaceflight.
Asunto(s)
Experimentación Humana , Sujetos de Investigación , Vuelo Espacial , Humanos , Vuelo Espacial/ética , Experimentación Humana/ética , Experimentación Humana/legislación & jurisprudenciaRESUMEN
The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize-and may improve-protections for research participants. The authors discuss underutilized options, including research that need not be classified as human subjects research, categories of studies that can be exempt from ethical review, studies that need only undergo expedited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter research by using the IRB of 1 institution. The authors speculate on multiple reasons for the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process.
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Revisión Ética , Experimentación Humana/ética , Revisión Ética/clasificación , Comités de Ética en Investigación , Humanos , Estudios Multicéntricos como Asunto/éticaRESUMEN
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 , Comités de Ética en Investigación , Salud Laboral , Pandemias , Sujetos de Investigación , Seguridad , Humanos , Narración , Políticas , SARS-CoV-2 , Poblaciones VulnerablesRESUMEN
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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Investigación Biomédica , Donantes de Tejidos , Humanos , InvestigadoresRESUMEN
When seriously ill patients for whom existing treatments are inadequate are invited to participate in clinical trials that offer a new treatment, should those persons be considered "vulnerable"? And if so, what additional protections should they be accorded? This article attempts to provide some answers.
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Experimentación Humana/ética , Experimentación Humana/legislación & jurisprudencia , Sujetos de Investigación , Poblaciones Vulnerables , Investigación Biomédica/ética , Investigación Biomédica/legislación & jurisprudencia , Regulación Gubernamental , Humanos , Competencia Mental , Selección de Paciente , Estados UnidosAsunto(s)
Investigación Biomédica/normas , Ensayos Clínicos como Asunto/normas , Bases de Datos Factuales , Regulación Gubernamental , Investigación Biomédica/legislación & jurisprudencia , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Ensayos Clínicos como Asunto/estadística & datos numéricos , Comités de Ética en Investigación , Humanos , Consentimiento Informado , Sujetos de Investigación , Estados Unidos , United States Food and Drug AdministrationAsunto(s)
Ensayos Clínicos como Asunto/ética , Comités de Ética en Investigación/organización & administración , Estudios Multicéntricos como Asunto/ética , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Regulación Gubernamental , Experimentación Humana/legislación & jurisprudencia , Estados UnidosRESUMEN
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.