Supporting positive experiences and sustained participation in clinical trials

looking beyond information provision

Kate Gillies, Vikki A. Entwistle

    Research output: Contribution to journalArticle

    25 Citations (Scopus)

    Abstract

    Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge. Copyright Article author (or their employer) 2012.
    Original languageEnglish
    Pages (from-to)751-756
    Number of pages6
    JournalJournal of Medical Ethics
    Volume38
    Issue number12
    DOIs
    Publication statusPublished - Dec 2012

    Fingerprint

    Communication
    Clinical Trials
    Guidelines
    Patient Participation
    participation
    Ethics
    Decision Making
    experience
    Psychology
    Research
    Participation
    voluntariness
    staff
    communication
    drop-out
    employer
    autonomy
    moral philosophy
    Thinking
    decision making

    Cite this

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    abstract = "Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge. Copyright Article author (or their employer) 2012.",
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    Supporting positive experiences and sustained participation in clinical trials : looking beyond information provision. / Gillies, Kate; Entwistle, Vikki A.

    In: Journal of Medical Ethics, Vol. 38, No. 12, 12.2012, p. 751-756.

    Research output: Contribution to journalArticle

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