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 → - Dec 27, 2023The Geneva FoundationOtherIndividual📎 Attachment
The commenter is providing a clinical trial informed consent form for a study on abemaciclib for prostate cancer. This is a submission of a document rather than a comment expressing a position on the proposed federal action.
Read comment → - Dec 27, 2023The Geneva FoundationOtherIndividual📎 Attachment
The commenter submitted a clinical trial informed consent form for a study on GS-9674 for Primary Sclerosing Cholangitis. The submission does not express a position on the proposed action regarding the posting of consent forms on federal websites.
Read comment → - Dec 27, 2023The Geneva FoundationOtherIndividual📎 Attachment
The commenter is providing a clinical trial informed consent form for a study on Ozanimod for Crohn's disease. This is a submission of a document rather than a comment expressing a position on the proposed federal action.
Read comment → - Dec 27, 2023The Geneva FoundationOtherIndividual📎 Attachment
The commenter is providing a clinical trial consent form for a study on Ozanimod for Crohn's disease. This is a submission of a document rather than a comment expressing a position on the proposed federal action.
Read comment → - Dec 27, 2023The Geneva FoundationOtherOther📎 Attachment
The commenter has submitted a clinical trial consent form for a Phase 3 study on Ozanimod for Crohn's disease. This is a document submission rather than a comment expressing a position on the proposed federal action.
Read comment → - Dec 27, 2023The Geneva FoundationOtherOther📎 AttachmentRead comment →
- Feb 24, 2023The Geneva FoundationOtherOther📎 AttachmentRead comment →
- Jan 4, 2023The Geneva FoundationOtherIndividual📎 Attachment
The commenter submitted a multi-page informed consent form for a clinical study regarding sacroiliac pain treatment. This submission appears to be an administrative filing or a request for inclusion in the docket rather than a statement of support or opposition to the revised Common Rule.
Read comment → - Aug 17, 2022Harvard TH Chan School of Public HealthOtherIndividual📎 Attachment
The commenter is providing an informed consent form for a clinical trial involving HIV-1 infected children and adolescents in Botswana. This submission appears to be a practical fulfillment of the posting requirement rather than a statement of support or opposition to the rule itself.
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