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ICH - Good Clinical Practice

Research Subject to ICH-GCP 4.8.5 and 4.8.10 

The International Conference on Harmonisation (ICH) of Good Clinical Practice (GCP) provides guidance related to informed consent in the Investigator section:

  • A description of the WVU IRB and its role
  • The probability for random assignment, if any
  • Any subject responsibilities
  • The reasonably foreseeable risks to an embryo, fetus, or nursing infant, if any
  • When there is no intended clinical benefit to the subject, a statement to that effect
  • Statement that the monitors, auditors, IRB, and regulatory authorities will be granted direct access to the subject's original medical records for verification of clinical trial procedures and data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent document, the subject or the subject's legally acceptable representative is authorizing such access.
  • Statement that if the results of the trial are published, the subject's identity will remain confidential