The final rule allows an Institutional Review Board (IRB) responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations if the IRB finds and documents five criteria.

The rule does not require any IRB to waive or alter informed consent, nor does it require any person to request such a waiver or alteration. However, we expect costs in the form of affected IRBs, as well as investigators and sponsors of clinical investigations, reading and learning the rule. We also expect costs in the form of drafting new waiver or alteration requests, and additional recordkeeping burdens associated with reviewing and documenting IRB decisions on waiver or alteration requests. The net present value of the estimated costs of the rule are approximately $10.1 million, with a lower bound of approximately $8.1 million and an upper bound of approximately $14.0 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated costs of the rule are approximately $9.1 million, with a lower bound of approximately $7.5 million and an upper bound of approximately $12.4 million. The estimated annualized costs of the rule are approximately $1.2 million, with a lower bound of approximately $0.9 million and an upper bound of approximately $1.6 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated annualized costs of the rule are approximately $1.3 million, with a lower bound of approximately $1.1 million and an upper bound of approximately $1.8 million.

We expect that there will be cost savings from harmonization of FDA’s informed consent regulations with the provision for waiver or alteration of informed consent for certain minimal risk research in the Common Rule. The estimated net present value of the cost savings of the rule are approximately $1.7 million, with a lower bound of approximately $0.9 million and an upper bound of approximately $3.5 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated cost savings of the rule are approximately $1.4 million, with a lower bound of approximately $0.7 million and an upper bound of approximately $2.8 million. The estimated annualized cost savings of the rule are approximately $0.2 million, with a lower bound of approximately $0.1 million and an upper bound of approximately $0.4 million, discounted at 3 percent over 10 years. At a 7 percent discount rate, the estimated annualized costs savings of the rule are approximately $0.2 million, with a lower bound of approximately $0.1 million and an upper bound of approximately $0.4 million.

Regulatory Impact Analysis

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (PDF 309 KB)

Federal Register: 88 FR 88228
Publication Date: 12/21/2023 
Docket: FDA-2018-N-2727