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 This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all.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].

 

Call for submissions for Open-ended intergovernmental working group on an optional protocol to the Convention on the Rights of the Child
Issued by Working Group on an optional protocol to the Convention on the Rights of the Child
Deadline 18 May 2025
Background
On 10 July 2024, the Human Rights Council adopted resolution 56/5, in which it decided to establish an openended intergovernmental working group of the Human Rights Council with the mandate of exploring the possibility of, elaborating and submitting to the Human Rights Council a draft optional protocol to the Convention on the Rights of the Child with the aim to:

1. Explicitly recognize that the right to education includes early childhood care and education;
2. Explicitly state that, with a view to achieving the right to education, States shall:
   1. Make public pre-primary education available free to all, beginning with at least one year;
   2. Make public secondary education available free to all;
3. Recall that States shall promote and encourage international cooperation in matters relating to education;
4. Consider a provision that would allow for States parties to the Convention on the Rights of the Child to incorporate all reporting on their obligations under the optional protocol into their reports submitted under article 44 of the Convention, eliminating the need for an initial or other separate reports.

Key questions and types of input/comments sought
Respondents are requested to limit their comments to a maximum of 5 pages. Additional supporting materials, such as reports, academic studies, and other types of background materials may be annexed to the submission.

1. What are the main barriers to public pre-primary education available free to all in law, policy, and practice in your country and what is their impact on the rights of the child? Please consider the specific situation of marginalized children and those in vulnerable situations in your response.
2. What are the main barriers to public secondary education available free to all in law, policy, and practice in your country and what is their impact on the rights of the child? Please consider the specific situation of marginalized children and those in vulnerable situations in your response.
3. What are examples of innovative and sustainable financial mechanisms to support the full and effective implementation of public pre-primary and secondary education available free to all children in your country?
4. What steps is the Government taking to remove barriers and make public pre-primary and secondary education available free to all, including through the allocation of adequate resources and cross-sectoral and international cooperation? Please provide examples of specific laws and regulations, measures, policies, and programmes.

Call for submissions: draft of general comment No. 27 on children’s right to access to justice and to an effective remedy
Issued by CRC
Deadline 30 June 2025
Background
During its 95th session in January 2024, the Committee on the Rights of the Child decided to draft a general comment on children’s right to access to justice and to an effective remedy. The concept note of the general comment is here.

Consultations on the concept

• In May 2024, the Committee issued a call for submissions inviting all interested parties to provide contributions to clarify terms, approaches and actions States should take in order to implement the right of all children to access justice and effective remedies.
• The consultation guidance from UNICEF was available here, and information from Child Rights Connect for organizers of focus group discussions or consultations with children was available here. Stakeholders specified their plans for consultations here to promote collaboration.
• The Committee received 315 submissions as well as outcomes from over 141 consultations held on the general comment, of which over 82 consultations involved the participation of at least 7,215 children.

Call
The Committee on the Rights of the Child now seeks contributions from all interested stakeholders on the draft of the general comment. The draft is available here. Information for children by Child Rights Connect and UNICEF is available here. Background information about the general comment here.

Ethical Guidelines for Research Using Pervasive Data
A Notice by the U.S. National Telecommunications and Information Administration on 12/11/2024
Public comment period that ends 01/15/2025.
SUMMARY:
The National Telecommunications and Information Administration (NTIA) is seeking public input on the potential writing of ethical guidelines for the use of “pervasive data” in research. “Pervasive data” refers to data about people gathered through online services. NTIA will rely on these comments, along with stakeholder engagements, in considering whether to draft and issue non-binding guidelines to assist researchers working with pervasive data. Such guidelines, if warranted, would detail how independent third-party researchers [3] can work with pervasive data while meeting ethical expectations of research and protecting individuals’ privacy and other rights…

The goal of ethical guidelines would be to outline principles and best practices that researchers, research institutions, data intermediaries,[4] and online service providers can choose to follow when involved in research with pervasive data…

Pervasive data can be drawn from global networks and may be analyzed by an international community of researchers. Therefore, it is increasingly important to use a global lens to address ethical issues in pervasive data. Advancements in research using pervasive data may benefit from international collaboration and agreed-upon norms for ethical research and the protection of privacy and other rights…

Risks to data subjects presented by research with pervasive data include reidentification of anonymous user accounts; release or inference of information that can be used to perpetuate a range of privacy and other individual-level harms, including fraud, impersonation, discrimination, reputational harms, and emotional distress; and decreased willingness to post and access information online and engage in the digital economy…

Sample Questions:

6. Consent and autonomy are key principles in human subjects research ethics. However, users of online services may be required to divulge certain personal information and/or have no ability to freely make decisions about its use.^[44] How should researchers working with pervasive data consider consent and autonomy?
7. What, if any, would be an appropriate consent model for research with pervasive data? How and how often should consent occur?
8. Are there alternative models to traditional consent that either support autonomy or provide protections for data subjects in cases where autonomy is limited?
9. How, if at all, is user autonomy influenced by context, such as the need to use online services for school, work,^[45] or socializing?
10. What existing ethical frameworks, such as those from professional organizations ^[64] or government agencies,^[65] should be considered when drafting national-level ethical guidelines for research with pervasive data?
11. To what extent do existing frameworks apply to the collection and use of pervasive data?
12. What modifications of existing frameworks might be necessary to ensure that those frameworks are applicable to the needs of research with pervasive data?

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].

See Spotlight [page 2]

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
Draft Guidance
FDA Roundup: September 6, 2024
…Today, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle”. This guidance, when finalized, is intended to provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making processes. It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence. On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance. Please submit comments under docket number FDA-2015-D-1580 at www.regulations.gov by Dec. 5, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance…

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.

UPCOMING 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].

Request for Information: Soliciting Input on Opportunities, Gaps, and Challenges in Global Health Research in Neurological Diseases and Stroke
Notice Number: NOT-NS-24-018 Response date: July 1, 2024
The National Institute Neurological Diseases and Stroke (NINDS) has released a Request for Information from all stakeholders to identify global health research priorities, capacity building and training needs, and best practices or strategies that could facilitate equitable global health research in neurological disorders. Information requested

This RFI is intended to help NINDS identify global health research priorities, capacity building and training needs, and best practices or strategies that could facilitate equitable global health research in neurological disorders. The NINDS invites input from all stakeholders, including researchers, health care providers, people with lived experience (e.g., patients with neurological conditions, family members, caregivers), patient advocates, health advocacy organizations, scientific or professional organizations, federal agencies, non-profit and private sector organizations, as well as other interested members of the public. Organizations may consider submitting a response on behalf of the organization or share this RFI link with its members.

 

Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning
Posted on May 21, 2024 Comments must be received by July 22, 2024
   NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.

NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramuralresearch-program-policy-promoting-equity-through-access-planning.

In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024. More information on the agenda and how to register will be provided shortly.

For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Questions may be sent to SciencePolicy@od.nih.gov.

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].

Invitation for Public Comment: WHO principles for human genome access, use and sharing
8 April 2024  Consultation Period:  8th April 2024 – 3 May 2024
Background
For the potential of genomics to be realized, access to, use, and the sharing of human genome data is critical. Following the WHO’s Science Council 2022 Report on Accelerating access to genomics for global health: promotion, implementation, collaboration, and ethical, legal, and social issues, WHO is implementing a programme of activities to promote equitable and fair access to genomics technologies for the benefit of people worldwide. As part of this, WHO is developing guiding principles for human genome data access, use and sharing. To develop these principles, a virtual consultation was held in January 2024 with an interdisciplinary group of participants. This consultation discussed the diverse perspectives on issues related to human genome data access, use and sharing; how a global set of principles from WHO may enable data access, use and sharing; and proposed initial principles. This was followed by an in-person meeting in March 2024 that considered in detail the proposed principles. Following this meeting, a draft document was developed and comments on this document and the principles are now invited.

Feedback on the WHO Principles for human genome data access, use, and sharing

Public feedback on this document is being solicited through this public consultation using the comment form.

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].

 Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
Food and Drug Administration, HHS.
Scheduled Pub. Date: 12/22/2023   FR Document: 2023-28210   PDF: https://downloads.regulations.gov/FDA-2023-D-5259-0002/attachment_1.pdf     8 Pages (109 KB)
Submit either electronic or written comments on the draft guidance by February 20, 2024
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Master Protocols for Drug and Biological Product Development.” The draft guidance addresses the design and analysis of trials conducted under a master protocol as well as the submission of documentation to support regulatory review. The primary focus is on randomized umbrella and platform trials that are intended to contribute to a demonstration of safety and substantial evidence of effectiveness. The considerations in this guidance apply to a range of therapeutic areas. The draft guidance is intended to clarify the Agency’s thinking on the use of master protocols in drug and biological product development, which was previously addressed in FDA’s guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.” FDA is also announcing the withdrawal of the guidance entitled “COVID–19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.
Excerpt
250  C. Informed Consent
252  The informed consent process should cover all treatment arms in the trial to which the subject
252  could be randomized.^13,14 In a platform trial allowing drugs to enter and leave the trial over time,
253  the consent form should be modified over time to reflect the drugs currently under evaluation…
256  The informed consent process should occur prior to a subject’s randomization and avoid
256  substudy-specific consent. Consent that occurs after subjects have been randomized to one of the
257  substudies may result in subjects with different prognostic characteristics across substudies,
258  raising concern about the comparability of each drug group with the shared control group
259  (comprised of control subjects from different substudies). To illustrate the concern, consider a
260  master protocol with two drugs (drug A and drug B) in which the subject consents to screening
261  and randomization to a substudy as part of the master protocol, with a substudy-specific
262  informed consent process to occur after randomization to that substudy; after the substudy-
263  specific consent, the subject is then randomized to the drug or its matched control. With this
264  process, comparing drug A against the shared control arm (including subjects who received
265  either control for drug A or control for drug B) may result in noncomparable groups if subjects
266  who would consent to participating in the drug A substudy differ from subjects who would
267 consent to participating in the drug B substudy.

13 Some consent processes allow a subject to be randomized in the trial even if the subject only consents to a subset of the drugs under evaluation; under such a process, subjects should not have the potential to be randomized to drugs for which they do not consent.
14 See the guidance for IRBs, Clinical Investigators, and Sponsors Informed Consent (August 2023).

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].

Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
ICH – The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.
   Public consultation dates:
ANVISA, Brazil – Deadline for comments by 31 August 2023
EC, Europe – Deadline for comments by 26 September 2023
FDA, United States – Deadline for comments by 5 September 2023
HSA, Singapore – Deadline for comments by 30 September 2023
Health Canada, Canada – Deadline for comments by 20 October 2023
MHLW/PMDA, Japan – Deadline for comments by 9 September 2023
MHRA, UK – Deadline for comments by 31 August 2023
NMPA, China – Deadline for comments by 31 August 2023
Swissmedic, Switzerland – Deadline for comments by 26 September 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023 

Public consultation on WHO guidance for best practices for clinical trials
WHO -19 July 2023
Call for consultation: Deadline 15 Sep 2023

WHO launches a global stakeholder survey on solutions for strengthening clinical trial infrastructure and capacity
This global stakeholder survey will be open until 10^th September 2023.
   The outcomes of the public consultation and the global survey will guide the WHO in a series of upcoming regional and global consultations with Member States and non-State-actors towards the implementation of the WHA resolution 75.8 on clinical trials.

UPCOMING 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 is not 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].

Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
   The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation” on the ICH Reflection Paper page. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2. E6(R3) Draft Guideline.  [See Section 2.8 – Informed Consent of Trial Participants]

Public consultation dates:
ANVISA, Brazil – Deadline for comments by 31 August 2023
EC, Europe – Deadline for comments by 26 September 2023
MHRA, UK – Deadline for comments by 31 August 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023

 

FDA Announces Additional Steps to Modernize Clinical Trials
https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials
ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3)
June 06, 2023 Comment period: Aug 6 2023
   Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise…

This draft guidance, once finalized, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements. These elements have the potential to make trials more efficient and less burdensome. Additionally, the modernized GCP recommendations encourage the use of fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors could potentially facilitate more agile data collection and assist with patient recruitment.

 

Public consultation on WHO guidance for best practices for clinical trials
WHO – 19 July 2023
Call for consultation: Deadline 15 Sep 2023
Draft Guidance PDF: https://cdn.who.int/media/docs/default-source/research-for-health/2023-07_who-guidance-for-best-practices-for-clinical-trials_draft-for-public-consultation.pdf?sfvrsn=7a5c9fa5_3
Overview
   In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. WHO is launching a public consultation on draft guidance developed in line with this request. We aim to obtain input from all relevant stakeholders, spanning all diseases and health conditions during this consultation, so that these inputs can be taken into account in revision of this draft, following advice from the WHO Technical Advisory Group established to support this process.

Important stakeholder groups for this technical guidance include, (but are not restricted to): public sector researchers, private sector entities engaged in clinical trials, national health authorities or research councils involved in health research, clinical trial registries, research ethics bodies, national or transnational medicinal product regulatory authorities, decision-making bodies making use of evidence such as guidelines developers, and health technology assessment bodies, healthcare practitioners, patient engagement and community engagement entities, and professional associations in disciplines for whom clinical trials of health interventions are relevant. There may also be some relevance to medical journals.

We would like to receive your overall comments on what the draft guidance does well and less well at the moment, as well as comments on the sections of the document and line by line if desired. Please review the request for guidance development in WHA resolution 75.8 before providing comments…

[See Section 2.2.2 – Relevant Consent]