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FDA’s Recent Draft Guidance on Informed Consent: A Summary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The Food and Drug Administration recently released an Informed Consent Information Sheet: Draft Guidance for IRBs, Clinical Investigators, and Sponsors which Halloran consultants Heather Tokatylan, Samantha Soloway, and Connacht Peterson have summarized here. Informed Consent: A Process, Not Just a Signature The draft guidance emphasizes that the process of informed consent extends beyond a signature on a form, and covers all information provided to potential study participants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

  • Nov032014
    Chief Medical Officer Summit West 2014

    Halloran is pleased to announce President and CEO, Laurie Halloran, will take part in The Conference Forum's 2nd annual Chief…

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  • Nov132014
    New England Clinical Operations Executive Breakfast: Roadmap to an IND – Pre-Competitive Collaboration for the Rest of Us

    You are cordially invited to join us for our New England Clinical Operations Executive Breakfast focusing on Pre-Competitive Collaboration for the Rest…

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  • Nov202014
    Webinar – Top IND Pitfalls & How to Avoid Them

    Halloran Senior Consultant, Heather Tokatlyan, and Consultant, Sam Zappia, present a webinar in partnership with the Life Science Training Institute on November 20, 2014, when they will…

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