UC Comment Letters

This comment letter responds to the FDA’s Guidance for Sponsors, Investigators, and  Institutional Review Boards on Key Information and Facilitating Understanding in Informed Consent. UC generally supports FDA’s proposed guidance on key information and facilitating understanding in informed consent, including harmonization with the Revised Common Rule, use of plain language, conflict-of-interest disclosure, and flexibility for study-specific presentation. UC raises concerns that the suggested bubble format may create accessibility, equity, IRB-review, and administrative problems, and recommends adding contact information and clearer language on consent elements while deleting recommendations for glossaries, references, tables of contents, and page-number cross-references that could increase burden and undermine plain-language consent.