Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk‐based Mammascreening study.
Introduction: Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk‐based MAmmascreening study (PRISMA). The orig...
| Publicado en: | Health Expectations Vol. 26; no. 3; pp. 1308 - 1318 |
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| Autores principales: | , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Jun2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=163488508&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 163488508 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 13696513 EVY jtl: Health Expectations issn: 13696513 maglogo: Y pubinfo: dt: Jun2023 vid: 26 iid: 3 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 163488508 162885746 163488508 163488508 10.1111/hex.13746 163488508 ppf: 1308 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk‐based Mammascreening study. aug: au: Lutomski, Jennifer E. Rainey, Linda de Jong, Milou Manders, Peggy Broeders, Mireille J. M. affil: Radboud Biobank, Radboud University Medical Center, Nijmegen, The Netherlands sug: subj: Consent (Research) Research Subjects Psychosocial Factors Research Ethics Decision Making Medical Records, Personal Breast Neoplasms Prevention and Control Mammography Cancer Screening Information Management Human Female Middle Age Aged Qualitative Studies Focus Groups Semi-Structured Interview Discussion Thematic Analysis Research Personnel Random Sample Pharmaceutical Companies Privacy and Confidentiality Manufacturing Industry Information Needs Data Security Altruism Relational Autonomy Funding Source Netherlands Tissue Banks Data Analysis Software Health Knowledge Middle Aged: 45-64 years Aged: 65+ years Female ab: Introduction: Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk‐based MAmmascreening study (PRISMA). The original PRISMA informed consent was project‐specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision‐making while maximising the potential re‐use of data. Methods: Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach. Findings: Twenty‐three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de‐identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed. Conclusion: Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision‐making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research. Patient and Public Contribution: Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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