CURRENT CALLS FOR PUBLIC CONSULTATION

We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].

 Agency Information Collection Request; 30-Day Public Comment Request
A Notice by the Health and Human Services Department on 08/19/2024   Comments on the ICR must be received on or before September 18, 2024.
[IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation]
Abstract:
   The Office of the Assistant Secretary for Health, Office for Human Research Protections is requesting a three-year extension of the Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation, OMB No. 0990-0260.
Information reported to the Federal departments and agencies under the Common Rule with respect to a satisfactory assurance is used to ensure that an institution engaged in non-exempt research involving human subjects conducted or supported by a Common Rule department or agency has (1) established adequate administrative policies and procedures for protecting the rights and welfare of human subjects in research, and (2) accepts that responsibility. Other reporting requirements are used to: assess whether the institution is following the established procedures; ensure that Federal funds are not expended for unapproved human subjects research; and determine if the approved status of an awarded grant, contract, or cooperative agreement should be reviewed, with the ultimate goal of maintaining or increasing human subject protections.

Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study
A Notice by the Food and Drug Administration on 08/28/2024
Written submissions may be made to the contact person  on or before October 3, 2024. Oral presentations on or before September 25, 2024
The meeting will be held on October 30, 2024, from 10 a.m. to 5 p.m. Eastern Time.
Agenda:
On October 30, 2024, the Committee will discuss and make recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.” The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.
   FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.
    Background material and the link to the online teleconference and/or video conference meeting will be available at https://www.fda.gov/​AdvisoryCommittees/​Calendar/​default.htm
Procedure:
 Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person  on or before October 3, 2024. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person (and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 25, 2024. Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993-0002, Letise.Williams@fda.hhs.gov.