[Broad informed consent or partial informed consent]

[Broad informed consent or partial informed consent]
Y M Zhao
Zhonghua Yi Xue Za Zhi, 9 July 2024
Abstract
The establishment of clinical research resource platforms, including research databases and bio-sample library, is an important development in the field of clinical research. The international academic community proposes broad informed consent to regulate the ethical management of the issue. However, the broad informed consent fails to capture the main features of incomplete informed consent and authorization, misleads researchers and managers and leads to miss ethical management for clinical research projects. Therefore, the author proposes a named partial informed consent to improve ethical management for clinical research projects. Partial informed consent separates ethical management for establishing clinical research resource platforms and clinical research projects. After reviewing the legal and ethical foundation of clinical research ethics management, the author discussed the similarities and differences between project management and task management in the two informed consent solutions, the basis for approval of exempted informed consent signatures by the ethics committee, issues to be noted in the ethics management of multi-center research at the task level, and explained the substantive differences between broad informed consent and partial informed consent.

Editor’s note: This a Chinese language publication.

Informed proxy consent for ancient DNA research

Informed proxy consent for ancient DNA research
Comment
Victoria E. Gibbon, Jessica C. Thompson, Sianne Alves
Communications Biology, 4 July 2024
Open Access
Abstract
We argue for implementation of informed proxy or relational autonomy consent in human aDNA research, where the deceased may be represented by living people the research affects. Embracing the underlying principles and process of informed proxy consent has the potential to transform research by (1) enriching outcomes by learning from and collaborating with interested and affected persons; (2) empowering people potentially impacted by research to stipulate evidence for information flow; (3) guarding researchers against actual or perceived violations by providing a common set of guidelines; and (4) highlighting the essential nature of long-term consultation and community partnerships to research outcome success.

Clarifying the ethical landscape of psychedelic-assisted psychotherapy

Clarifying the ethical landscape of psychedelic-assisted psychotherapy
Research Article
Christopher Kochevar
Philosophical Psychology, 27 June 2024
Abstract
This paper attempts to integrate ongoing conversations about the nature and ethics of psychedelic-assisted psychotherapy (PAP) in order to clarify some outstanding ethical questions. First, I address a debate about whether informed consent is possible for “transformative” therapies like PAP, and I conclude that reasonable approaches to informed consent should not be considered especially difficult for PAP. Next, I argue that a focus on potential barriers to information about PAP has obscured a more central risk for the therapy – that posed by a PAP patient’s radical susceptibility to environmental influence, or what I call epistemic vulnerability. After expanding on this concept, I conclude that warnings about epistemic vulnerability should be a part of informed consent to PAP in all cases. Finally, I discuss more broadly the complexities of informed consent in PAP, drawing on analogous concerns for regular psychotherapy that may be addressed by a “process view” of consent. I propose that a “nondirective” approach to PAP may be more ethically supportable than other approaches, in part because of the theoretical benefit to patients from managing their own experience, prioritizing the potential for autonomous transformation.

Informed Consent: A Monthly Review
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July 2024 :: Issue 67

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_July 2024

Obtaining Informed Consent in Veterinary Clinical Trials Mini Review

Obtaining Informed Consent in Veterinary Clinical Trials Mini Review
Carol Frederick
Frontiers in Veterinary Science, 11 June 2024
Abstract
In September 2023 the US Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.

Current Calls For Public Consultation    

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].

Global Consultation: First Draft Text of UNESCO Recommendation on Ethics of Neurotechnology
UNESCO – 10 June 2024, This survey remains available until 12 July 2024 (midnight Paris time)
Overview
    UNESCO has embarked on a two-year process to elaborate the first global Recommendation on the ethics of neurotechnology. This Recommendation is expected to define shared values, principles, and ethical challenges as well as identify concrete policy actions to promote and strengthen an ethical development, deployment and use of neurotechnology worldwide.
The purpose of this questionnaire is to collect feedback from different actors bringing in different perspectives and points of views on the first version of a draft text of a Recommendation, elaborated by an Ad Hoc Expert Group (AHEG) during their first meeting at UNESCO HQ (Paris, 22-26 April 2024). This meeting will be followed by a second meeting (Paris, 26-30 August) to embed inputs received through a wide range of consultations, including inputs received through this online consultation.
Your participation will help enrich the first draft of the Recommendation with your views about how to harness the potential benefits of neurotechnology and mitigate the risks. The questionnaire is structured to provide you with the option to comment on the different parts of the text: definition and scope, approach, values principles and rights and policy actions.
To efficiently reply to this questionnaire, you are invited to consult the first draft of the Recommendation.]attached] For more information on UNESCO Social and Human Sciences Sector’s work on the Ethics of Neurotechnology, please visit our website. 

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.

Informed Consent: A Monthly Review
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June 2024 :: Issue 66

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_June 2024 

Relational, Culturally-Conditioned, Decolonized Consent 

Editor’s Note:

We recognize a growing literature which argues [in whole or in part] that norms requiring the individual, prior, free, express and informed consent of persons to be involved in research must accommodate notions which integrate terms such as ‘community-driven’, ‘decolonized’, or ‘culturally-appropriate’ and which insist that consent processes “prioritize local/indigenous values and protocols.” As an editorial policy, we have decided to group such literature together in this section of the digest.

More broadly, we recognize that this literature raises critically important issues around consent integrity. Our Center for Informed Consent Integrity is actively developing a position on this matter, mindful of core guidance in research involving human participants overall, and selected instruments such as the Universal Declaration on Bioethics and Human Rights [2005]which notes:

Article 12.  Respect for cultural diversity and pluralism
The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.

We will keep readers advised of our progress. If you have an interest in participating in our working group, please contact Paige Fitzsimmons [paige.fitzsimmons@ge2p2global.org].

Informed Consent: A Monthly Review
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May 2024 :: Issue 65

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_May 2024

Informed Consent: A Monthly Review
_________________

April 2024 :: Issue 64

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_April 2024