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NIH Policies on Experimental Studies with Humans.

William T Riley1, Melissa Riddle1, Michael Lauer1

  • 1National Institutes of Health.

Nature Human Behaviour
|January 22, 2019
PubMed
Summary

New U.S. National Institutes of Health policies mandate clinical trials registration on ClinicalTrials.gov, specific grant applications, and Good Clinical Practice training for human experimental studies.

Area of Science:

  • Biomedical Research
  • Clinical Research Policy
  • Regulatory Science

Background:

  • The U.S. National Institutes of Health (NIH) oversees a significant portion of biomedical research funding and policy.
  • Clinical trials involving human subjects are a critical component of medical advancement.
  • Ensuring the integrity and transparency of clinical trials is paramount.

Purpose of the Study:

  • To inform researchers and institutions about the updated U.S. National Institutes of Health (NIH) policies for clinical trials.
  • To outline the mandatory requirements for studies involving experimental manipulations of humans.
  • To ensure compliance with new federal regulations for clinical research.

Main Methods:

  • Policy dissemination and communication.

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  • Requirement for registration and reporting on ClinicalTrials.gov.
  • Mandatory grant application procedures under specific funding announcements.
  • Implementation of Good Clinical Practice (GCP) training for all investigators.

    • Main Results:

    • All studies involving experimental manipulations of humans will be subject to NIH clinical trials policies.
    • Registration and reporting in ClinicalTrials.gov are compulsory.
    • Grant applications must adhere to specific NIH clinical trials funding opportunity announcements.
    • Investigators are required to complete Good Clinical Practice training.

    Conclusions:

    • The NIH has established comprehensive policies for clinical trials involving human experimental manipulations.
    • Compliance involves registration, specific grant submissions, and mandatory GCP training.
    • These policies aim to enhance the quality, transparency, and ethical conduct of clinical research funded by the NIH.