Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions.
The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-maki...
| Publicado en: | Health Care Analysis Vol. 31; no. 3/4; pp. 135 - 156 |
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| Autores principales: | , , , , , , , |
| Formato: | Artículo |
| Publicado: |
Springer Nature
Dec2023
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| Materias: | |
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=173964107&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 173964107 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 10653058 OFZ jtl: Health Care Analysis issn: 10653058 maglogo: N pubinfo: dt: Dec2023 vid: 31 iid: 3/4 pid: 237 pub: Springer Nature artinfo: ui: 173964107 10.1007/s10728-023-00461-z ppf: 135 ppct: 21 formats: fmt: – @attributes: type: T – @attributes: type: P size: 671KB tig: atl: Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions. aug: au: Feijoo-Cid, Maria Arreciado Marañón, Antonia Huertas, Ariadna Rivero-Santana, Amado Cesar, Carina Fink, Valeria Fernández-Cano, María Isabel Sued, Omar affil: https://ror.org/052g8jq94 Department of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Can Domènech, Edifici M, Campus de la Universitat Autònoma de Barcelona, 08193, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain Grup de REcerca Multidisciplinar en Salut i Societat (GREMSAS), (2017 SGR 917), Barcelona, Spain Hospital Germans Trias i Pujol, Barcelona, Spain Canary Islands Foundation-Health Research (FIISC), Tenerife, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain https://ror.org/01p47g940 Fundación Huésped, Buenos Aires, Argentina su: Argentina Human research subjects Clinical trials Interviewing Patients' attitudes Informed consent (Medical law) Qualitative research Emotions Content analysis Trust HIV infections Anti-HIV agents Patient decision making Research methodology Judgment sampling Thematic analysis Psychology of HIV-positive persons sug: subj: Human research subjects Clinical trials Interviewing Patients' attitudes Informed consent (Medical law) Qualitative research Emotions Content analysis Trust Argentina Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) HIV infections Anti-HIV agents Patient decision making Research methodology Judgment sampling Thematic analysis Psychology of HIV-positive persons keyword: Antiretroviral Clinical trial Decision-making HIV Informed consent Antiretroviral Clinical trial Decision-making HIV Informed consent ab: The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non‐exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
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