federal_register: 2018-24822

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2018-24822 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations Proposed Rule The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations. 2018-11-15 2018 11 https://www.federalregister.gov/documents/2018/11/15/2018-24822/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical https://www.govinfo.gov/content/pkg/FR-2018-11-15/pdf/2018-24822.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement to obtain...

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