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  • Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials
    UMB Dataset

    Authors
    O'Mareen Spence
    Richie Onwuchekwa Uba
    Seongbin Shin
    Peter Doshi
    Description

    Clinical trial participants are often motivated by the altruistic assumption that study results will contribute to medical knowledge. Additionally, the sharing of research data is rapidly developing into an ethical standard. An evaluation of 144 blank (sample) informed consent forms (ICF) was undertaken to determine the extent to which clinical trial participants were apprised of researchers’ intent to publish results, share de-identified data, and the overall benefit to medical knowledge. This dataset consists of 98 ICFs from industry-funded trials from the European Medicines Agency (EMA) and 46 ICFs from publicly-funded trials listed in the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The documents were reviewed for identification and extraction of stated or implied language for the following 5 aspects of each study: publication of results, sharing de-identified data, data ownership, confidentiality of identifiable data and, whether the trial will produce knowledge that offers public benefit. Results indicate that investigators rarely disclose intent to share de-identifiable data or commitment to publish. All ICFs are available via 2 zip files, one for the industry-funded trials and the other for the trials in BioLINCC. Also included is the study extraction sheet.

    Subject
    Informed Consent
    Access Rights
    Unrestricted access

  • Qualitative study of comprehension of heritability in genomics studies among the Yoruba in Nigeria
    UMB Dataset

    Authors
    Clement A. Adebamowo
    Rasheed O. Taiwo
    John Ipadeola
    Temilola Yusuf
    3 more author(s)...
    Description

    To address concerns about comprehension and adequacy of informed consent, qualitative data was collected to examine whether there are linguistic and cultural concepts used to communicate heritability of characters, traits, and diseases in an indigenous African population. Researchers conducted focus group discussions among 115 participants and key informant interviews among 25 stakeholders and key opinion leaders among Yoruba living in Ibadan, Nigeria. The resulting dataset was contributed to the INDIGENE study which uses qualitative research methods to elicit these words and use them to design “enhanced informed consent” forms that are compared with standard informed consent in a randomized trial.

    Subject
    Informed Consent/ethics
    Geographic Coverage
    International
    Access Rights
    Unrestricted access

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