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      O papel da remuneração na decisão de participar de pesquisa na saúde Translated title: The role of remuneration in the decision to participate in health research Translated title: El paper de la remuneració en la decisió de participar en la recerca en salut Translated title: El papel de la remuneración en la decisión de participar en la investigación en salud

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          Abstract

          Resumo O processo de consentimento informado para participação de pesquisa com seres humanos visa fornecer as informações adequadas ao indivíduo possibilitando que este tome a decisão de participar de maneira voluntária, livre de pressões externas. A possibilidade de remuneração poderia interferir na voluntariedade deste processo de consentir. O presente estudo objetivou avaliar percepção de influência da remuneração monetária por meio de simulações de pesquisa que variam em nível de risco (Bioequivalência e de Fase I) e tipo de remuneração monetária (com e sem). Participaram do estudo 80 voluntários. Os resultados sugerem que a remuneração não constituiu uma interferência na voluntariedade do processo de consentimento, visto que participantes aceitaram convite para participar da primeira pesquisa para a qual foram convidados e não se sentiram influenciados indevidamente.

          Translated abstract

          Abstract The process of informed consent for research participation with human beings aims to provide appropriate information to individuals enabling him or her to make the decision to participate voluntarily, free of external pressures. The possibility of remuneration could interfere in the willingness to consent. The present study aims to evaluate the perception of influence of the monetary payment through research simulations that vary in the level of risk (Bioequivalence and Phase I) and type of monetary payment (with and without). Eighty volunteers participated in the study. The results suggest that remuneration did not interfere with the willingness of the consent process, as participants accepted an invitation to participate in the first research option to which they were invited to and did not feel undue influence.

          Translated abstract

          Resum El procés de consentiment informat per a la participació de subjectes humans en recerca té per objecte donar la informació adequada a l'individu, permetent que prengui la decisió de participar de manera voluntària i lliure de pressions externes. La possibilitat de remuneració podria interferir en la voluntarietat d'aquest procés de consentir. El present estudi avalua la percepció de la influència de la remuneració monetària a través de simulacions de recerca que varien en nivell de risc (Bioequivalencia i de Fase I) i tipus de remuneració monetària (amb i sense). Van participar de l'estudi 80 voluntaris. Els resultats suggereixen que la remuneració no va constituir una interferència en la voluntarietat del procés de consentiment, ja que els participants van acceptar una invitació per a participar en la primera enquesta a la qual van ser convidats i no es van sentir influenciats incorrectament.

          Translated abstract

          Resumen El proceso de consentimiento informado para la participación de sujetos humanos en investigación tiene por objeto dar la información adecuada al individuo, permitiendo que tome la decisión de participar de manera voluntaria y libre de presiones externas. La posibilidad de remuneración podría interferir en la voluntariedad de este proceso de consentir. El presente estudio evalúa la percepción de la influencia de la remuneración monetaria a través de simulaciones de investigación que varían en nivel de riesgo (Bioequivalencia y de Fase I) y tipo de remuneración monetaria (con y sin). Participaron del estudio 80 voluntarios. Los resultados sugieren que la remuneración no constituyó una interferencia en la voluntariedad del proceso de consentimiento, ya que los participantes aceptaron una invitación para participar en la primera encuesta a la que fueron invitados y no se sintieron influenciados incorrectamente.

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          Payment of clinical research subjects.

          Offering payment to clinical research subjects, in an effort to enhance recruitment by providing an incentive to take part or enabling subjects to participate without financial sacrifice, is a common yet uneven and contentious practice in the US. Concern exists regarding the potential for payment to unduly influence participation and thus obscure risks, impair judgment, or encourage misrepresentation. Heightening these concerns is the participation not only of adults but also of children in pediatric research trials. Thorough assessment of risks, careful eligibility screening, and attention to a participant's freedom to refuse all serve to reduce the possibility of compensation adversely affecting the individual and/or the study. Institutional review boards currently evaluate payment proposals with minimal guidance from federal regulations. Here, reasons for providing payment, payment models, ethical concerns, and areas for further research are examined.
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            More than the money: a review of the literature examining healthy volunteer motivations.

            Few existing data report the motivations of healthy volunteers in clinical research trials. Some worry that volunteers consider only financial motivations. This study summarized and analyzed existing empirical research on self-reported motivations of healthy volunteers participating in studies not intended to offer benefit from participation. A systematic PubMed search was conducted. Inclusion criteria captured English-language empirical studies on the self-reported motivations, reasons, or factors influencing the decision of healthy volunteers to enroll in clinical research. Thirteen studies involving more than 2000 healthy volunteers met the criteria and were included in this review. Independent review by the authors and extraction of information about the sample, methodology and objectives of the motivations study, description of the clinical trial and whether participation was actual or hypothetical, reported primary and secondary motivations of the healthy volunteers, risk evaluation, and reported differences in motivations related to sociodemographic variables. This review showed that although financial reward is the primary motivation for healthy volunteers to participate in clinical trials, financial motivations are one among many other reported motivations, including contributing to science or the health of others, accessing ancillary healthcare benefits, scientific interest or interest in the goals of the study, as well as meeting people and curiosity. Volunteers consider risk when making a decision about participation. Although financial incentives are important in recruiting healthy volunteers, their motivations are not limited to financial motivations. Further research is needed to examine motivations in different contexts and countries, the decision making of healthy volunteers, and the dynamics of repeat participation. Published by Elsevier Inc.
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              A Framework for Ethical Payment to Research Participants

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                Author and article information

                Journal
                bioetica
                Revista de Bioética y Derecho
                Rev. Bioética y Derecho
                Observatori de Bioètica i Dret - Cátedra UNESCO de Bioética (Barcelona, Barcelona, Spain )
                1886-5887
                2020
                : 50
                : 407-423
                Affiliations
                [6] Porto Alegre Rio Grande do Sul orgnamePontifícia Universidade Católica do Rio Grande do Sul orgdiv1Hospital de Clínicas de Porto Alegre (HCPA) e Faculdade de Medicina orgdiv2Serviço de Bioética e Laboratório de Pesquisa em Bioética e Ética na Ciência (LAPEBEC) Brazil
                [5] Porto Alegre orgnameHospital de Clínicas de Porto Alegre (HCPA) orgdiv1Serviço de Bioética e Laboratório de Pesquisa em Bioética e Ética na Ciência (LAPEBEC) Brasil
                [2] Porto Alegre orgnameHospital de Clínicas de Porto Alegre (HCPA) orgdiv1Laboratório de Pesquisa em Bioética e Ética na Ciência (LAPEBEC) Brasil
                [1] Porto Alegre orgnameHospital de Clínicas de Porto Alegre (HCPA) orgdiv1Laboratório de Pesquisa em Bioética e Ética na Ciência (LAPEBEC) Brasil
                [4] Porto Alegre orgnameHospital de Clínicas de Porto Alegre (HCPA) orgdiv1Laboratório de Pesquisa em Bioética e Ética na Ciência (LAPEBEC) Brasil
                [3] Porto Alegre orgnameHospital de Clínicas de Porto Alegre orgdiv1Laboratório de Pesquisa em Bioética e Ética na Ciência (LAPEBEC) orgdiv2Centro de Pesquisas em Álcool e Drogas (CPAD) Brasil
                Article
                S1886-58872020000300024 S1886-5887(20)00005000024
                d09852fd-1030-43f9-9231-2e3f4dd57d1e

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 15 April 2020
                : 11 December 2019
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 35, Pages: 17
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                SciELO Spain


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