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 → - Apr 23, 2026City of HopeOtherIndividual📎 Attachment
The commenter submitted an informed consent form for a specific clinical research study regarding Kaposi sarcoma-associated herpesvirus and osteosarcoma. The submission does not express a position on the proposed federal action regarding the posting of consent forms.
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 → - Jan 26, 2026Washington UniversityOtherIndividual📎 Attachment
The commenter submitted an informed consent document for a research study on remote limb ischemic conditioning rather than providing a comment on the proposed federal action. The document outlines the study's purpose, risks, and procedures for potential human participants.
Read comment → - Jul 28, 2025The Geneva FoundationOtherIndividual📎 Attachment
The commenter is submitting a clinical trial informed consent form for a study on the drug BE1116. This submission does not express a position on the proposed action regarding the posting of consent forms on federal websites.
Read comment → - Jul 28, 2025The Geneva FoundationOtherIndividual📎 Attachment
The commenter is submitting a Participant Information and Informed Consent Form for a Phase 3 clinical trial regarding a new drug for breast cancer. This submission appears to be a procedural filing of a study document rather than a comment expressing a position on the proposed federal action.
Read comment → - Jul 28, 2025The Geneva FoundationOtherIndividual📎 Attachment
The commenter submitted a research subject consent form for a clinical trial involving an investigational drug for spinal cord injury. The document does not express a position on the proposed federal action regarding the posting of consent forms.
Read comment → - Jun 30, 2025City of Hope Medical CenterOtherBusiness📎 Attachment
City of Hope Medical Center is submitting an informed consent form for a breast cancer research study. The comment does not express a position on the proposed action but rather provides the required documentation to comply with it.
Read comment → - Jun 30, 2025City of Hope Medical CenterOtherBusiness📎 Attachment
City of Hope Medical Center is submitting an informed consent form for a breast cancer research study. The comment does not express a position on the proposed action but rather provides the required documentation to comply with it.
Read comment → - Jun 30, 2025City of Hope Medical CenterSupportBusiness📎 Attachment
City of Hope Medical Center is submitting a specific informed consent form for a cancer research study to comply with the new posting requirement. By providing the document, they are actively participating in and fulfilling the requirements of the proposed action.
Read comment →