RESUMEN
Sharing research data has great potential to benefit science and society. However, data sharing is still not common practice. Since public research funding agencies have a particular impact on research and researchers, the question arises: Are public funding agencies morally obligated to promote data sharing? We argue from a research ethics perspective that public funding agencies have several pro tanto obligations requiring them to promote data sharing. However, there are also pro tanto obligations that speak against promoting data sharing in general as well as with regard to particular instruments of such promotion. We examine and weigh these obligations and conclude that all things considered funders ought to promote the sharing of data. Even the instrument of mandatory data sharing policies can be justified under certain conditions.
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Ética en Investigación , Difusión de la Información , Obligaciones Morales , Difusión de la Información/ética , Humanos , Apoyo a la Investigación como Asunto/ética , Conducta CooperativaRESUMEN
BACKGROUND: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. OBJECTIVE: To develop an extension of the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement for the reporting of COIs and funding in policy documents of guideline organizations and in guidelines: the RIGHT-COI&F checklist. DESIGN: The recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network were followed. The process consisted of registration of the project and setting up working groups, generation of the initial list of items, achieving consensus on the items, and formulating and testing the final checklist. SETTING: International collaboration. PARTICIPANTS: 44 experts. MEASUREMENTS: Consensus on checklist items. RESULTS: The checklist contains 27 items: 18 about the COIs of contributors and 9 about the funding of the guideline project. Of the 27 items, 16 are labeled as policy related because they address the reporting of COI and funding policies that apply across an organization's guideline projects. These items should be described ideally in the organization's policy documents, otherwise in the specific guideline. The remaining 11 items are labeled as implementation related and they address the reporting of COIs and funding of the specific guideline. LIMITATION: The RIGHT-COI&F checklist requires testing in real-life use. CONCLUSION: The RIGHT-COI&F checklist can be used to guide the reporting of COIs and funding in guideline development and to assess the completeness of reporting in published guidelines and policy documents. PRIMARY FUNDING SOURCE: The Fundamental Research Funds for the Central Universities of China.
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Lista de Verificación , Conflicto de Intereses , Guías de Práctica Clínica como Asunto , Humanos , Apoyo a la Investigación como Asunto/ética , RevelaciónAsunto(s)
Mutación con Ganancia de Función , Apoyo a la Investigación como Asunto , National Institutes of Health (U.S.)/legislación & jurisprudencia , National Institutes of Health (U.S.)/economía , Apoyo a la Investigación como Asunto/ética , Apoyo a la Investigación como Asunto/legislación & jurisprudencia , Estados UnidosAsunto(s)
Educación de Postgrado en Medicina/estadística & datos numéricos , Medicina/estadística & datos numéricos , Selección de Paciente/ética , Apoyo a la Investigación como Asunto/ética , Australia , Educación de Postgrado en Medicina/economía , Humanos , Medicina/tendencias , Nueva Zelanda , Apoyo a la Investigación como Asunto/economíaRESUMEN
Online supplemental material is available for this article. See also the editorial by Grant in this issue.
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Conflicto de Intereses , Revelación/ética , Apoyo Financiero/ética , Industrias/economía , Industrias/ética , Radiólogos/economía , Radiólogos/ética , Congresos como Asunto , Regulación Gubernamental , Humanos , Apoyo a la Investigación como Asunto/ética , Estudios Retrospectivos , Estados UnidosAsunto(s)
Investigación Biomédica/economía , Investigación Biomédica/ética , Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/ética , Conflicto de Intereses/economía , Apoyo a la Investigación como Asunto/economía , Apoyo a la Investigación como Asunto/ética , Sesgo , Investigación Biomédica/legislación & jurisprudencia , Conflicto de Intereses/legislación & jurisprudencia , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Europa (Continente) , Humanos , Difusión de la Información/ética , Difusión de la Información/legislación & jurisprudencia , Patentes como Asunto/ética , Patentes como Asunto/legislación & jurisprudencia , Edición/economía , Edición/ética , Edición/legislación & jurisprudencia , Apoyo a la Investigación como Asunto/legislación & jurisprudencia , Estados UnidosRESUMEN
Since the last assessment of conflicts of interest (COIs) in dermatology randomized controlled trials (RCTs) in 2004, several countries have introduced transparency databases. We assessed the prevalence of financial COIs in dermatology RCTs and quantified payments from study sponsors to academic/clinical authors using transparency databases, which are available in the USA, France, Australia, Belgium and the Netherlands, while the UK has a noncompulsory transparency database. We included RCTs from the top 10 dermatology journals and the top 7 general medical journals published in 2019. The study assessed 83 RCTs, and COIs were identified in 69%. The highest prevalence was in exclusively industry-funded trials (46/47, 98%), which consisted of personal payments to an academic/clinical author (96% of trials) and having authors who were employees/stockholders (96%). Payments were identified for 31/56 (55%) academic/clinical first/final authors (median payment US$28 746, maximum US$597 299, interquartile range US$17 061-146 253), and 24/31 payments (77%) payments were each > US$10 000.
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Conflicto de Intereses/economía , Dermatología/ética , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Apoyo a la Investigación como Asunto/ética , Investigación Biomédica/ética , Estudios Transversales , HumanosAsunto(s)
Ética en Investigación , Genoma Humano , Genómica/ética , Consentimiento Informado , Investigadores , Sujetos de Investigación/psicología , Confianza , África/etnología , Investigación Biomédica/organización & administración , Investigación Biomédica/tendencias , Conflicto de Intereses , Humanos , Difusión de la Información , Consentimiento Informado/ética , Apoyo a la Investigación como Asunto/ética , Poblaciones VulnerablesRESUMEN
OBJECTIVE: To investigate the association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. DESIGN: Systematic review. ELIGIBILITY CRITERIA: Studies that compared the association between conflicts of interest and favourable recommendations of drugs or devices (eg, recommending a drug) in clinical guidelines, advisory committee reports, opinion pieces (eg, editorials), or narrative reviews. DATA SOURCES: PubMed, Embase, Cochrane Methodology Register (from inception to February 2020), reference lists, Web of Science, and grey literature. DATA EXTRACTION AND ANALYSIS: Two authors independently extracted data and assessed the methodological quality of the studies. Pooled relative risks and 95% confidence intervals were estimated using random effects models (relative risk >1 indicates that documents with conflicts of interest more often had favourable recommendations than documents with no conflicts of interest). Financial and non-financial conflicts of interest were analysed separately, and the four types of documents were analysed separately (preplanned) and combined (post hoc). RESULTS: 21 studies that analysed 106 clinical guidelines, 1809 advisory committee reports, 340 opinion pieces, and 497 narrative reviews were included. Unpublished data were received for 11 studies (eight full datasets and three summary datasets). 15 studies showed risk of confounding because the compared documents could differ in factors other than conflicts of interest (eg, different drugs used for different populations). The relative risk for associations between financial conflicts of interest and favourable recommendations for clinical guidelines was 1.26 (95% confidence interval 0.93 to 1.69; four studies of 86 clinical guidelines), for advisory committee reports was 1.20 (0.99 to 1.45; four studies of 629 advisory committee reports), for opinion pieces was 2.62 (0.91 to 7.55; four studies of 284 opinion pieces), and for narrative reviews was 1.20 (0.97 to 1.49; four studies of 457 narrative reviews). An analysis of all four types of documents combined supported these findings (1.26, 1.09 to 1.44). In one study that investigated specialty interests, the association between including radiologists as authors of guidelines and recommending routine breast cancer was: relative risk 2.10, 95% confidence interval 0.92 to 4.77; 12 clinical guidelines). CONCLUSIONS: We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. Limitations of this review were risk of confounding in the included studies and the statistical imprecision of individual analyses of each document type. It is not certain whether non-financial conflicts of interest influence recommendations. SYSTEMATIC REVIEW REGISTRATION: Cochrane Methodology Review Protocol MR000040.
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Comités Consultivos/ética , Conflicto de Intereses , Testimonio de Experto/ética , Guías de Práctica Clínica como Asunto , Literatura de Revisión como Asunto , Sesgo , Conflicto de Intereses/economía , Humanos , Apoyo a la Investigación como Asunto/éticaAsunto(s)
Ensayos Clínicos Fase III como Asunto/economía , Neoplasias/tratamiento farmacológico , Apoyo a la Investigación como Asunto/organización & administración , Ensayos Clínicos Fase III como Asunto/ética , Conflicto de Intereses/economía , Interpretación Estadística de Datos , Humanos , Apoyo a la Investigación como Asunto/economía , Apoyo a la Investigación como Asunto/éticaAsunto(s)
Organización de la Financiación/legislación & jurisprudencia , Internacionalidad/legislación & jurisprudencia , Investigadores/ética , Investigadores/legislación & jurisprudencia , Apoyo a la Investigación como Asunto/legislación & jurisprudencia , United States Government Agencies/legislación & jurisprudencia , China , Confidencialidad/legislación & jurisprudencia , Conflicto de Intereses/legislación & jurisprudencia , Organización de la Financiación/organización & administración , Fraude/legislación & jurisprudencia , National Institutes of Health (U.S.)/economía , National Institutes of Health (U.S.)/legislación & jurisprudencia , Selección de Personal/ética , Selección de Personal/legislación & jurisprudencia , Apoyo a la Investigación como Asunto/ética , Estados Unidos , United States Government Agencies/economía , Universidades/economía , Universidades/legislación & jurisprudenciaRESUMEN
The development of medicines for certain rare diseases can be frustrated by lack of funding. In certain cases the patients themselves, or their relatives, occasionally fund the clinical trial in which they will be treated with the investigational medicine. There are 3models of self-funded research: 2of them, "pay to try" and "pay to participate", have already been put into practice. The third, the "plutocratic" proposal, which has been recently put forward is still a theoretical model. In this work the scientific, social and ethical benefits and risks of the 2clinical research models, "pay to participate" and the "plutocratic" proposal, are reviewed. Patient-funded clinical trials are frequently performed through crowdfunding. The most controversial aspects of this funding modality are also addressed in this article from several perspectives. Finally, a future scenario that would allow the launching of self-funded clinical trials in Spain by the "plutocratic" proposal is proposed.
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Ensayos Clínicos como Asunto/economía , Producción de Medicamentos sin Interés Comercial/economía , Selección de Paciente , Enfermedades Raras/tratamiento farmacológico , Apoyo a la Investigación como Asunto/métodos , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/organización & administración , Colaboración de las Masas/economía , Colaboración de las Masas/ética , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/ética , Humanos , Producción de Medicamentos sin Interés Comercial/ética , Selección de Paciente/ética , Enfermedades Raras/economía , Apoyo a la Investigación como Asunto/ética , España , Estados UnidosRESUMEN
OBJECTIVE: To (1) investigate the extent to which recently published meta-analyses report trial funding, author-industry financial ties and author-industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporting funding sources of included RCTs; and (3) compare reporting among recently published Cochrane meta-analyses to Cochrane reviews published in 2010. DESIGN: Review of consecutive sample of recently published meta-analyses. DATA SOURCES: MEDLINE database via PubMed searched on 19 October 2018. ELIGIBILITY CRITERIA FOR SELECTING ARTICLES: We selected the 250 most recent meta-analyses listed in PubMed that included a documented search of at least one database, statistically combined results from ≥2 RCTs and evaluated the effects of a drug or class of drugs. RESULTS: 90 of 107 (84%) Cochrane meta-analyses reported funding sources for some or all included trials compared with 21 of 143 (15%) non-Cochrane meta-analyses, a difference of 69% (95% CI 59% to 77%). Percent reporting was also higher for Cochrane meta-analyses compared with non-Cochrane meta-analyses for trial author-industry financial ties (44% versus 1%; 95% CI for difference 33% to 52%) and employment (17% versus 1%; 95% CI for difference 9% to 24%). In multivariable analysis, compared with Cochrane meta-analyses, the odds ratio (OR) for reporting trial funding was ≤0.11 for all other journal category and impact factor combinations. Compared with Cochrane reviews from 2010, reporting of funding sources of included RCTs among recently published Cochrane meta-analyses improved by 54% (95% CI 42% to 63%), and reporting of trial author-industry financial ties and employment improved by 37% (95% CI 26% to 47%) and 10% (95% CI 2% to 19%). CONCLUSIONS: Reporting of trial funding sources, trial author-industry financial ties and trial author-industry employment in Cochrane meta-analyses has improved since 2010 and is higher than in non-Cochrane meta-analyses.
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Autoria , Conflicto de Intereses , Industria Farmacéutica/ética , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Apoyo a la Investigación como Asunto/ética , Estudios Transversales , Industria Farmacéutica/economía , Empleo , Humanos , Oportunidad Relativa , Ensayos Clínicos Controlados Aleatorios como Asunto/economíaRESUMEN
OBJECTIVE: There are concerns that some non-profit organisations, financed by the food industry, promote industry positions in research and policy materials. Using Freedom of Information (FOI) requests, we test the proposition that the International Life Sciences Institute (ILSI), one prominent non-for profit in international health and nutrition research, promotes industry positions. DESIGN: U.S. Right to Know filed five FOI from 2015 to 2018 covering communications with researchers at four US institutions: Texas A&M, University of Illinois, University of Colorado and North Carolina State University. It received 15 078 pages, which were uploaded to the University of California San Francisco's Industry Documents Library. We searched the Library exploring it thematically for instances of: (1) funding research activity that supports industry interests; (2) publishing and promoting industry-sponsored positions or literature; (3) disseminating favourable material to decision makers and the public and (4) suppressing views that do not support industry. RESULTS: Available emails confirmed that ILSI's funding by corporate entities leads to industry influence over some of ILSI activities. Emails reveal a pattern of activity in which ILSI sought to exploit the credibility of scientists and academics to bolster industry positions and promote industry-devised content in its meetings, journal and other activities. ILSI also actively seeks to marginalise unfavourable positions. CONCLUSIONS: We conclude that undue influence of industry through third-party entities like ILSI requires enhanced management of conflicts of interest by researchers. We call for ILSI to be recognised as a private sector entity rather than an independent scientific non-profit, to allow for more appropriate appraisal of its outputs and those it funds.
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Academias e Institutos/ética , Disciplinas de las Ciencias Biológicas/organización & administración , Industria de Alimentos/ética , Política Nutricional , Apoyo a la Investigación como Asunto/ética , Colorado , Conflicto de Intereses , Humanos , Illinois , North Carolina , Organizaciones/ética , Sector Privado/ética , TexasAsunto(s)
Autoria , Cannabidiol/uso terapéutico , Conflicto de Intereses , Industria Farmacéutica/ética , Humanos , Publicaciones Periódicas como Asunto/ética , Publicaciones Periódicas como Asunto/estadística & datos numéricos , Apoyo a la Investigación como Asunto/ética , Apoyo a la Investigación como Asunto/estadística & datos numéricosRESUMEN
The Belmont Report has provided a useful and virtually universal framework for protecting human subjects from research abuses. However, it provides little to no guidance on the substance of human research. In an environment where major decisions concerning health-care access, funding, and regulation hinge on human research, this omission leaves downstream users of human research virtually unprotected and with few tools or frameworks to protect against a variety of practices that compromise the social value of human research. This essay advocates for the addition of a fourth principle to the Belmont three: "scientific integrity." Such a principle would seek to train human research on important social objectives while maximizing the accessibility, credibility, and generalizability of findings.
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Investigación Biomédica/ética , Ética en Investigación , Experimentación Humana/ética , United States Dept. of Health and Human Services/organización & administración , Participación de la Comunidad , Humanos , Consentimiento Informado/normas , Política , Apoyo a la Investigación como Asunto/ética , Apoyo a la Investigación como Asunto/normas , Mala Conducta Científica/ética , Estados Unidos , United States Dept. of Health and Human Services/normasRESUMEN
Physicians in training and their mentors must be cognizant of ethical concerns related to industry interactions. Mentors perceived to have conflicts of interest or to be engaging in misconduct can unconsciously and profoundly affect the learning and academic environment by implying certain values and expectations. Despite increased awareness of ethical concerns related to industry interactions in clinical practice and research, there remains a need for interventions to prevent ethical transgressions. Ethics education is essential and a move in the right direction, but it alone is likely inadequate in preventing unethical behavior. Education should be supplemented with ethical environments at institutions.