Announcement
Details
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- Title
- Announcement
The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision. No obligations to post such consent forms apply before January 21, 2019. At this time two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.
- Posted
- Aug 15, 2018
- Comment period
- Aug 15, 2018 – Jan 1, 2100
- Topics
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- Jun 26, 2026University of MichiganOtherAcademic📎 Attachment
The University of Michigan submitted an informed consent form for a research study regarding the effects of Aquamin® on gastrointestinal permeability. The submission appears to be a procedural response to the requirement to post consent forms on a public federal website rather than a statement of opinion on the rule itself.
Read comment → - Jan 28, 2026Washington UniversityOtherIndividual📎 Attachment
The commenter submitted an informed consent form for a pediatric research study titled "ECHO" (Environmental Influences on Child Health Outcomes). The submission does not express a position on the proposed federal action regarding the posting of consent forms.
Read comment → - Dec 27, 2023The Geneva FoundationOtherIndividual📎 Attachment
The commenter is submitting a clinical trial informed consent form for a study on the efficacy of Tipifarnib in patients with head and neck squamous cell carcinoma. The submission does not express a position on the proposed federal action regarding the posting of consent forms.
Read comment → - Jun 16, 2023HuxleyOtherIndividual📎 Attachment
The commenter submitted an informed consent form for a clinical research study involving a sleep apnea device. This submission does not express a position on the proposed action regarding the posting of consent forms on federal websites.
Read comment → - Jan 4, 2023The Geneva FoundationOtherIndividual📎 AttachmentRead comment →
- Jun 16, 2026Caique MelloOtherOther📎 Attachment
The commenter submitted a Spanish-language informed consent form for a clinical trial regarding a nonavalent HPV vaccine for men living with HIV. This is a research document and does not express a position on the proposed federal action regarding the posting of consent forms.
Read comment → - Mar 15, 2026Anonymous AnonymousOtherOther📎 AttachmentRead comment →
- May 27, 2025Ella MuccioloOtherAcademic📎 Attachment
The University of Iowa's Department of Community and Behavioral Health and the Driving Safety Research Institute are submitting an informed consent document for a research study on teen driver hazard anticipation. The submission is intended to fulfill the requirement to post consent forms on a publicly available federal website as part of the revised Common Rule.
Read comment → - Apr 11, 2025Lindy ComradaOtherIndividual📎 Attachment
The commenter is submitting an informed consent form for a research study on cardiovascular responses to cold-water immersion conducted at the University of Oregon. This is a submission of a required document rather than a statement of support or opposition to the proposed rule.
Read comment → - Apr 2, 2025Emma ReedOtherIndividual📎 Attachment
The commenter is submitting an informed consent form for a research study regarding intramuscular temperature during far-infrared sauna bathing. This is a submission of a specific document rather than a comment expressing a position on the proposed federal action.
Read comment →