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    Home » Newsletters » IRB Advisor

    IRB Advisor

    www.reliasmedia.com

    February 1, 2019

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    As a valued Relias Media subscriber, you can find the latest issue of your publication online. The articles below provide timely strategies and research for healthcare providers:
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    Low Health Literacy Is Major Barrier to Research Participation

    Researchers may design an informed consent form at a fifth-grade reading level, but even that is too high, according to experts.

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    Study Sheds Light on Improving Informed Consent Readability

    A small study about improving readability of informed consent examines how investigators and IRBs can make research understandable to people with very limited reading skills.

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    Right to Try Off to a Cautious Start

    While the federal Right to Try law enacted last year essentially bypassed IRB oversight of patients seeking investigational drugs, research ethics panels and their institutions can codify a requirement for local oversight into their policies and procedures.

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    FDA Unveils Real-World Data Initiative

    The FDA recently opened a promising path to capture real-world data and evidence to complement traditional clinical trials and open new avenues of research.

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    Research Program Closely Monitors ClinicalTrials.gov Compliance

    Compliance with the 2017 changes to ClinicalTrials.gov registration can be time-consuming, as at least one organization has learned over the past year.

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    Earning the Trust of Research Subjects

    Achieving trust in human research can be challenging in an age of precision medicine that calls for long-term relationships and potential unintended consequences far beyond a simple informed consent document.

    Read More

    Click here to check out our FREE podcast on assessing healthcare risks!

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    IRB Advisor

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    IRB Advisor (Vol. 19, No. 2) - February 2019
    February 1, 2019

    Table Of Contents

    Low Health Literacy Is Major Barrier to Research Participation

    Study Sheds Light on Improving Informed Consent Readability

    Right to Try Off to a Cautious Start

    FDA Unveils Real-World Data Initiative

    Research Program Closely Monitors ClinicalTrials.gov Compliance

    Earning the Trust of Research Subjects

    Begin Test

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    Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.

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