14
Oct2022

The Benefits and Challenges of Decentralized Clinical Trials by Michele Russell-Einhorn and Julie Ozier

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14 Oct

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The concept of Decentralized Clinical Trials means bringing the activities of the trial to non-centralized places, such as away from a doctor’s office or clinic, so that participants have better access to the interventions and measures needed to conduct a trial. A few ways researchers are decentralizing clinical trials include engaging home health groups to come to the home to collect or administer study tasks. These trials seem to be the wave of the future and have many advantages for participants. For more information on this topic register for PRIM&R 2022 Annual Conference session, PRIM&R Service Award Presentation, and Plenary IX: Decentralized Clinical Trials (DCTs): Considerations of and for IRB review (Location: Livestreamed) Thursday, December 15, 2022, 10 AM - 11:30 AM. Read more

11
Oct2022

This blog summarizes the major provisions of the second NPRM, which is focused primarily on harmonizing language, definitions, and informed consent requirements in 21 CFR 50—Protection of Human Subjects, and on harmonizing provisions around continuing review, IRB review generally, and IRB membership, in 21 CFR 56—Institutional Review Boards. Read more

4
Oct2022

FDA proposes new rule on Cooperative Research to harmonize with Common Rule by Elisa A. Hurley, PRIM&R executive director

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FDA new rule on Cooperative Research to harmonize Common Rule

4 Oct

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On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) aimed at harmonizing the FDA regulations for the protection of human subjects and institutional review boardsRead more

29
Sep2022

The Ever Increasing Importance of Financial Conflict of Interest

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29 Sep

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It has been eleven years since the NIH last updated their federal regulations on financial conflict of interest. But, during that time, and especially over the past four years, a lot has been discussed about conflict of interest. What started out as concerns over the loss of intellectual property has now morphed into overall requirements for research security, with conflict of interest as the lynchpin. Read more

21
Sep2022

Research Ethics Roundup: open access research policy, clinical ethicists, and more

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21 Sep

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This week's research ethics roundup covers efforts by Black scientists to develop oxygen sensors for darker skin; the ethical challenges faced by clinical ethicists; new policy guidance for immediate open access to research findings; and the use of electronic health record data to study pregnancy outcomes. Read more