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Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Proposed Rule) – Preliminary Regulatory Impact Analysis

The proposed rule would help enable the conduct of certain minimal risk clinical investigations for which the requirement to obtain informed consent is waived or for which certain elements of informed consent are waived or altered. We expect benefits in the form of healthcare advances from such minimal risk clinical investigations and from harmonization of FDA's informed consent regulations with the Common Rule's provision for waiver of informed consent for certain minimal risk research. We do not anticipate additional costs associated with this rulemaking. The benefits that we are able to quantify are the cost savings to IRBs because the time burdens of reviewing certain minimal risk clinical investigations under differing requirements would be reduced.

Regulatory Impact Analysis

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Proposed Rule) (PDF - 191KB)

Federal Register: 83 FR 57378 (November 15, 2018)

Docket: FDA-2018-N-2727