Pulling Out the Rug on Informed Consent — New Legal Threats to Clinicians and Patients

28 February 2025 ~ paigefitzsimmons ~ Leave a comment

This month we have chosen to highlight an article which appeared in the New England Journal of Medicine, Pulling Out the Rug on Informed Consent — New Legal Threats to Clinicians and Patients, reflecting the impact of changes in US law on informed consent. In their perspective piece, Underhill and Nelson write about the change to Utah’s Malpractice Act which allows the retroactive withdrawal of consent given as a minor, leaving clinicians vulnerable to future litigation. We are highlighting this article as we are concerned about the intersection of politics and ideology here. Consent is an important to the patient as to the physician, and the role of consent should not be used to further an agenda. We are reaching out to the authors to explore potential pathways forward.

Pulling Out the Rug on Informed Consent — New Legal Threats to Clinicians and Patients
Perspective
Kristen Underhill, Kimberly M. Nelson
New England Journal of Medicine, 1 February 2025
Abstract
A legal technique deployed by Utah to restrict gender-affirming care for minors aims at a core component of the clinician–patient relationship: clinicians’ ability to rely on patients’ informed consent.
Excerpt
In recent years, state legislators in large portions of the United States have devised and enacted new legal strategies to limit access to health care for transgender people. To date, 26 states have enacted outright bans on gender-affirming care, which thus far apply only to minors. Other state laws create financial or procedural obstacles to this type of care, such as bans on insurance coverage, requirements to obtain opinions from multiple clinicians, or consent protocols that are stricter than those for other health care…
Allowing patients to withdraw their consent retroactively is an acute threat to the legal infrastructure supporting U.S. healthcare. Informed-consent requirements exist to ensure that patients have the information and agency to participate in their own healthcare. They also protect clinicians. In all practice areas, clinicians expect to rely on patients’ consent at the time of care, without having to guess which patients will later change their minds. If laws eliminate clinicians’ ability to rely on consent at the time of care, the resulting legal instability may undermine access to all types of health care services. Pulling out the rug on informed consent threatens the core of the clinician–patient relationship. Clinicians in every area should recognize that these laws are not just attacking gender-affirming care — they are attacking the foundation of the U.S. health care system.

Spotlight

29 November 2024 ~ paigefitzsimmons ~ Leave a comment

This month we spotlight the new set of principles supporting ethical human genomic data collection and sharing released by the WHO in late November. In this normative guidance, WHO addresses eight principles [detailed below], many of which touch on consent either directly or indirectly. In particular, the first principle [3.1] presents a number of consent-related recommendations which we highlight here:

3.1. To affirm and value the rights of individuals and communities to make decisions
A commitment to affirm and value the rights and interests of individuals with capacity to make informed decisions about their human genome data throughout the data life cycle. In addition, a commitment to affirm the best interests of, and support for, individuals who do not have the capacity to make decisions for themselves.

The use of human genome data has implications beyond the individual, and the relevant views of family members and communities on collection, access to, use and sharing of these data should be taken into account throughout the data life cycle.

Recommendations: [selected]
:: Informed consent should be as specific and granular as possible in relation to the potential uses (including by for-profit entities and the potential to share the data to train artificial intelligence), benefits and harms possibly resulting from the use of human genome data, the infrastructure hosting the data (including location and access modalities), and this information must be tailored to respect social and cultural contexts.
:: The most appropriate informed consent model (e.g. specific, broad, tiered or dynamic informed consent) depends upon the individual/local context.
:: Informed consent should be supported by governance frameworks and processes, and individuals should be informed of such processes…
:: Individuals, families and communities should have access to clear, transparent, accessible, understandable and ongoing communication about their human genome data collection, access, use and sharing, for those who wish to receive that information. This ongoing communication should, where possible, continue throughout the data life cycle.
:: Individuals and their representative communities should be engaged in the governance and decision-making process regarding collection, access to, use and sharing of human genome data, including the development of appropriate informed consent models and processes.
:: Children, when sufficiently mature to understand what is involved in their participation, should be given the opportunity to affirm the informed consent previously given on their behalf or to withdraw their consent from that point onwards….

Below, we provide excerpts from the WHO media release and the full citation/overview of the guidance document.

WHO releases new principles for ethical human genomic data collection and sharing
20 November 2024
The World Health Organization (WHO) has issued a set of principles for the ethical collection, access, use and sharing of human genomic data. Created with guidance from the WHO Technical Advisory Group on Genomics (TAG-G) and other international experts, these principles establish a global approach to help protect individual rights, promote equity and foster responsible collaboration in genomic research…

“The potential of genomics to revolutionize health and disease understanding can only be realized if human genomic data are collected, accessed and shared responsibly,” says Dr John Reeder, Director of WHO’s Research for Health Department. “This document outlines globally applicable principles designed to guide ethical, legal and equitable use of human genome data, fostering public trust and protecting the rights of individuals and communities. It serves as a call to action, urging all stakeholders to adhere to these principles and ensure the benefits of genomic advancements are accessible to everyone.”

The principles emphasize several core themes:
:: Informed consent and privacy are foundational, with clear guidelines to ensure that individuals understand and agree to how their genomic data will be used. WHO underscores the importance of transparency, requiring that data collection processes are openly communicated and safeguarded against misuse.
:: Another core focus is equity. The principles call for targeted efforts to address disparities in genomic research, especially in low- and middle-income countries (LMICs), and for ensuring that genomic research benefits populations in all their diversity. By prioritizing the inclusion of underrepresented groups, the guidelines aim to promote broader and fairer representation in genomic research and its applications.
:: Recognizing the importance of international collaboration through partnerships across borders and sectors, WHO encourages collaborative efforts between governments, academia and the private sector to maximize the positive impact of genomic research. Responsible data sharing, supported by robust governance structures, is essential for advancing global health while respecting privacy.
:: WHO’s principles also address capacity building in regions with limited genomic infrastructure. By encouraging investment in local expertise and resources, the organization aims to close global disparities in research capacity, making genomic data practices more inclusive and sustainable.

The release of these principles represents a significant step forward in WHO’s mission to promote ethical genomics practices. As the field continues to evolve, these guidelines offer a trusted framework to support genomic research that is equitable, transparent and respectful of individual rights.

Guidance for human genome data collection, access, use and sharing
WHO – Guidance [normative]
20 November 2024 :: 22 pages
Overview
The ethical, legal, and equitable sharing of human genomic data is critical to advancing global health research and ensuring fair access to the benefits of genomics. The WHO’s new document outlines a comprehensive set of globally applicable principles designed to guide stakeholders in the responsible collection, use, and sharing of human genome data. This document serves as a key resource to navigate complex issues surrounding data governance, with the aim of fostering transparency, promoting equity, and safeguarding individual and collective rights. These principles are intended to support the implementation of best practices across diverse settings, thereby enhancing the global capacity for genomic research and its translation into health benefits for all.

Table of Contents [excerpt]
3.0 Principles for human genome collection, access, use and sharing
3.1 To affirm and value the rights of individuals and communities to make decisions
3.2 Social justice
3.3 Solidarity
3.4. Equitable access to and benefit from human genome data
3.5 Collaboration, cooperation and partnership
3.6. Stewardship of human genome data
3.7. Transparency
3.8. Accountability

Glossary [excerpt]
Benefit-sharing refers to profit-sharing agreements, equitable access to diagnostics, therapeutics and technology transfer, as well as capacity-building and -strengthening initiatives. What constitutes a benefit (and the nature of that benefit) is both subjective and context dependent

Human genome data include but is not limited to:
–         DNA sequence(s) from the nuclear and mitochondrial genomes.
–         Transcriptome (complete set of RNA transcripts).
–         Proteome (complete set of proteins produced by an organism, from which the corresponding
–         genetic sequences can be inferred)
–         Methylome and other epigenetic modifications.

Spotlight – Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans

1 November 2024 ~ paigefitzsimmons ~ Leave a comment

SPOTLIGHT

This month we have chosen to spotlight the recently revised Declaration of Helsinki and have provided the World Medical Association press release which positions the revision and how it was achieved below. We invite readers to review the full declaration as consent related issues are interwoven throughout, and we make special note of paragraphs 25-32 which deal with free and informed consent.

Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans
Press Release
World Medical Association, 21 October 2024
The World Medical Association (WMA) has announced the adoption the 2024 Revision of the Declaration of Helsinki (DoH), the global reference for medical research involving human participants, at its General Assembly in Helsinki, Finland.

Newly inaugurated President of the WMA, Dr Ashok Philip said, “This landmark revision of the Declaration of Helsinki highlights the World Medical Association’s commitment to reinforcing the ethical principles that guide medical research involving human participants, to safeguard patient rights and to ensure the integrity of scientific studies.

“This was a mammoth revision process spanning 30 months, and the World Medical Association extends its heartfelt thanks to everyone who participated,” continued Dr Ashok Philip, President of the World Medical Association.

Under the leadership of Dr. Jack Resneck Jr., Chair of the WMA Declaration of Helsinki revision workgroup, the revision team concluded that some areas of the document had to be updated to ensure the Declaration’s continued relevance. The 2024 revision of the Declaration of Helsinki provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research.

“Previously, the Declaration of Helsinki addressed WMA members and constituents. The new version of the Declaration says that as physicians, it’s part of our moral obligation to ensure that our patients and the participants in research are respected and treated with dignity,” said Dr Jack Resneck Jr.

“The revised Declaration of Helsinki calls on everybody involved in the research enterprise now to uphold those principles, whether they are individuals or teams or organizations across the medical research activity,” he continued.

Dr Resneck Jr. highlighted some new language in the sixth paragraph of the Declaration as important, saying, “To really address the theme of distributive and global justice, this change means that the Declaration of Helsinki calls on researchers to carefully consider how the benefits, the risks, the burdens of research are distributed.”

The substantive changes to the Declaration of Helsinki can be categorised in two areas:

Participant-centered inclusion, respect and protection, including recognition of participant vulnerability, calls for community engagement, pursuit of global justice, obtaining informed consent, and use of participant-centered language.
Research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks and burdens.

More information

See the Declaration of Helsinki 2024 full text here.
See JAMA Viewpoint Revisions to the Declaration of Helsinki on Its 60th AnniversaryA Modernized Set of Ethical Principles to Promote and Ensure Respect for Participants in a Rapidly Innovating Medical Research Ecosystem, by Dr Jack Resneck Jr.
Listen to JAMA Author Interview with Dr Jack Resneck Jr. Declaration of Helsinki Addresses New Ethical Challenges.
Jama published a number of relevant papers on the date the revision was approved, these papers are available here.
See WMA Declaration of Helsinki 2024 interview with Dr Jack Resneck Jr.
Read Background information on the Declaration of Helsinki here.

New Normative/Regulatory Guidance/Analysis Referencing Consent

30 September 202430 September 2024 ~ paigefitzsimmons ~ Leave a comment

Guidance for best practices for clinical trials
WHO, 25 September 2024
Overview [excerpted from WHO announcement and guidance executive summary]
The World Health Organization (WHO) today released guidance to improve the design, conduct and oversight of clinical trials in countries of all income levels. This guidance aims to support stronger country-led research and development (R&D) ecosystems to advance health science so that new, safe and effective health interventions can be made more accessible and affordable globally for people everywhere, faster.

The guidance was developed in response to World Health Assembly resolution WHA 75.8 in an extensive and inclusive process, involving nearly 3000 stakeholders from various sectors across 48 countries. The guidance covers trials for any health intervention, including, but not limited to pharmaceutical medicines; vaccines; diagnostics; nutritional measures; cognitive, behavioural and psychological interventions; preventive care; digital and public health approaches; and traditional or herbal measures.

This document aims to complement other guidance in order to support implementation of universal ethical and scientific standards in the context of clinical trials, with a focus on under-represented populations; it does not represent a legal standard and does not supersede any existing guidance. In particular, this guidance shares many common concepts and principles with guidance produced by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (5), especially the ICH E8(R1) General Considerations for Clinical Studies guideline (6), (the draft ICH E6(R3) Good Clinical Practice guideline (7), and the ICH E9 statistical principles guideline (8) and its associated addendum (9). In addition, it shares attributes with two further recent guidance documents that were highlighted through WHO’s public consultation process in 2022: those of the Council for International Organizations of Medical Sciences (CIOMS) on clinical research in resource-limited settings (10) and the Good Clinical Trials Collaborative (GCTC) (11).

Both the CIOMS and GCTC guidance have served as sources, with adaptations as needed, for this document. Additional sources highlighted through the consultation include the World Medical Association’s (WMA) Declaration of Helsinki (12) on medical research involving human subjects, the WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks (13) and CIOMS’ International Ethical Guidelines on Health-related Research involving Humans (2016) (14).

Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language

31 May 2024 ~ paigefitzsimmons ~ Leave a comment

Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language
National Institute of Health, May 2024
Key Points

This resource provides points to consider and sample language for informed consent of research studies which plan to use digital health technologies. The use of this resource is completely voluntary.
The considerations and sample language provided in this resource may not apply to all studies or cover all potential contexts of use. Users of this resource should apply relevant considerations/sample language as applicable to their study. Points to consider and sample language below are included in the most relevant sections, although they may be relevant to multiple sections.
This resource does not take the place of an informed consent document. The considerations and sample language included in this resource are specific to the inclusion of digital health technologies in a study; other general and population-specific informed consent considerations and language still apply. The sample language provided in this resource should be tailored for individual studies and may need further revision or clarification when used in an informed consent.
The sample language provided in this resource does not alone satisfy the regulatory requirements for informed consent as described in the 2018 revised Common Rule at 45 CFR46.116 or the FDA’s regulations governing the protection of human participants (i.e., 21 CFR parts 50 and 56).
Within this resource, the term digital health technology refers to wearable devices, sensor technologies, and mobile software applications (“apps”) most often used with tablets, watches, or phones. The resource does not address considerations for implantable devices, artificial intelligence, or other types of digital health technologies.
This consent resource does not address future use of data collected from digital health technologies, which may have additional considerations when developing or reviewing informed consent.

New Regulatory Guidance Referencing Consent

31 December 2023 ~ paigefitzsimmons ~ Leave a comment

FDA: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
FDA – Final rule.
Summary
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
…Summary of the Major Provisions of the Final Rule
The final rule amends FDA’s regulations to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations. For an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the rule requires an IRB to find and document five criteria that are consistent with the revised rule entitled “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (January 19, 2017)). FDA believes the amendment provides appropriate safeguards to protect the rights, safety, and welfare of the human subjects participating in such clinical investigations. We are also making conforming amendments to FDA’s regulations.

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; Availability
Food and Drug Administration, HHS.
Final guidance. Scheduled Pub. Date: 12/22/2023 FR Document: 2023-28262
PDF: https://downloads.regulations.gov/FDA-2021-D-1128-0066/attachment_1.pdf 8 Pages (112 KB)
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. This guidance finalizes the draft guidance of the same title issued on December 23, 2021.
Consent
Risk Considerations When Using Digital Health Technologies
p.19 …3. Informed Consent
FDA regulations at 21 CFR part 50 set forth the requirements for obtaining the informed consent of participants⁵⁹ in clinical investigations. DHTs can be used to obtain electronic informed consent in a clinical investigation.⁶⁰ Some considerations for what information to include in the informed consent process regarding the DHT being used in a clinical investigation include but are not limited to the following:

The informed consent process must describe any reasonably foreseeable risks or discomforts to participants (see sections IV.F.1 and IV.F.2 of this guidance), including reasonably foreseeable risks or discomforts related to the use of the DHT in the clinical investigation.⁶¹ Information regarding what may be done to mitigate serious risks, and risks and discomforts more likely to occur, should also be considered for inclusion.
When appropriate, a statement must be included indicating that use of the DHT during the clinical investigation may involve risks to the participant (or to the embryo or fetus if the participant is or may become pregnant) which are currently unforeseeable.⁶²
The informed consent process should explain the type of information that will be collected by the DHT and how that information will be used and monitored. When relevant, participants should be informed of what action to take in case of any concerning sign, symptom, or abnormal clinical event (e.g., hypoglycemia or abnormal cardiac rhythm) detected by a DHT, such as seeking emergency medical attention, if appropriate.
The informed consent process should specify who may have access to data collected through the DHT during or after the clinical investigation (e.g., sponsors, investigators, participants, DHT manufacturers, other specified third parties) and during what time frame.⁶³
An explanation of measures to protect participant privacy and data, and limitations to those measures, when DHTs are used should be included.
If participants may incur additional expense because they are taking part in the clinical investigation, the consent process must explain the added costs,⁶⁴ which could include costs for the participants that may result from using the DHT during the clinical investigation (e.g., data use charges).
DHTs or other technologies may be covered by end-user license agreements or terms of service as a condition of use, which may, among other things, allow DHT or other technology manufacturers and other parties to gain access to personal information and data collected by the DHT or other technology. When applicable, sponsors and investigators should ensure that the informed consent process explains to participants that their data may be shared outside of the clinical investigation, according to the end-user license agreement or terms of service. End-user license agreements and terms of service typically are lengthy and use complex terminology. Sponsors and investigators proposing use of DHTs for data collection should understand how such agreements or terms of service may affect trial participants and address this information when developing informed consent documents.⁶⁵

61 See 21 CFR 50.25(a)(2).
62 See 21 CFR 50.25(b)(1).
63 In addition, the informed consent process must note the possibility that FDA will inspect records identifying the participants (21 CFR 50.25(a)(5)).
64 21 CFR 50.25(b)(3).
65 For further information, see the Secretary’s Advisory Committee on Human Research Protections webpage “Attachment B-Clarifying Requirements in Digital Health Technologies Research,” available athttps://www.hhs.gov/ohrp/sachrp-committee/recommendations/april-7-2020-attachment-b/index.html.
66 See 21 CFR 312.57,312.58,312.62, and 312.68.
67 See 21 CFR 812.2(b)(1)(v)and(vi), 812.140, 812.145, and 812.150.
68 See FDA Study Data Standards Resources, available athttps://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources,and the Data Standards Catalog, available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog.