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# Issues Raised on Proposed IRB Consent Waiver
- URL: https://www.fdaweb.com/issues-raised-on-proposed-irb-consent-waiver/
- Published: 2019-02-14T12:00:00.000Z
- Updated: 2026-09-15T01:04:20.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5143390

Public Citizen says that unless an FDA proposed rule on institutional review board (IRB) waiver or alteration of informed consent for minimal risk clinical investigations is clarified, it could increase the risks to human subjects while undermining their right to informed consent before being enrolled in clinical trials. The group’s comment [letter](https://www.regulations.gov/document?D=FDA-2018-N-2727-0037&ref=fdaweb.com) says Public Citizen is “deeply concerned that once FDA finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to subjects…. It is imperative that when the agency finalizes the proposed rule, it simultaneously issues detailed guidance that clearly describes the types of research that would and would not qualify for an IRB waiver of informed consent under FDA’s human subject protection regulations. The guidance should include specific examples of each type of clinical investigation….”

AdvaMed [says](https://www.regulations.gov/document?D=FDA-2018-N-2727-0038&ref=fdaweb.com) that the proposed rule appropriately implements requirements in the 21st Century Cures Act. The association also says FDA should provide clarification or advisory text for sponsors, investigators, and IRBs to carefully consider the specific data elements to be collected as part of the research to determine the applicability of HIPAA Privacy Rule requirements.

The Association of Clinical Research Organizations (ACRO) [says](https://www.regulations.gov/document?D=FDA-2018-N-2727-0029&ref=fdaweb.com) future harmonization with the fifth criterion of the Common Rule is unnecessary, but may be helpful. The association also advises that instances where sponsors would anticipate requesting a waiver or alteration of informed consent from the IRB for FDA-regulated minimal risk clinical investigations seem rare.