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FDA’s Recent Draft Guidance on Informed Consent: A Summary

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The Food and Drug Administration recently released an Informed Consent Information Sheet: Draft Guidance for IRBs, Clinical Investigators, and Sponsors which Halloran consultants Heather Tokatylan, Samantha Soloway, and Connacht Peterson have summarized here. Informed Consent: A Process, Not Just a Signature The draft guidance emphasizes that the process of informed consent extends beyond a signature on a form, and covers all information provided to potential study participants including recruitment material and dialogue. Potential subjects must be provided with: Adequate information to allow for an informed decision about participation. Facilitation of comprehension of that information. Adequate opportunities to ask questions. The draft text emphasizes that this process continues throughout the duration of the study for all enrolled patients. Communication Methods The Agency recognizes the rapidly changing methods of communication and is interested in alternatives beyond the traditional face-to-face conversations to review paper Informed Consent Forms (ICFs) which are currently the industry standard practice, but that allow for “adequate exchange of information and documentation” and also establish identity. Examples include a phone consent interview followed by an exchange of the signed ICF by facsimile. Parties interested in alternative methods of consent are encouraged to contact the FDA, as the Agency is “considering alternative methods...

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Upcoming Events

  • Oct272014
    Webinar – Identifying And Closing The Training Gap In Clinical Research

    Halloran President and CEO, Laurie Halloran, presents a webinar, Identifying and Closing the Training Gap in Clinical Research,  in partnership with the Life Science Training Institute on October 27,…

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  • Oct272014
    Science Club for Girls Catalyst Awards 2014 Celebration

    Join us as we support the Science Club for Girls at their annual Catalyst Awards 2014 Celebration on October 27, 2014…

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  • Oct282014
    Webinar – Clinical Finance: Key Strategies To Stay In Control Of Your Study Budget

    Halloran Senior Consultant, Dyana Boutwell, presents a webinar in partnership with the Life Science Training Institute on October 28, 2014, when she will be teach the course Clinical Finance: Key Strategies…

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