The role of the enrolling clinician in emergency research conducted under an exception from informed consent
Katherine Sahan, Ethan Cowan & Mark Sheehan
Theoretical Medicine and Bioethics, 1 April 2025
Open Access
Abstract
The Exception from Informed Consent (EFIC) permits patient enrolment into therapeutic emergency research where obtaining informed consent is challenging. Yet this fails to resolve a core ethical conflict in the research and has generated controversy. This is because existing justification and practice has relied on applying EFIC per study—a wholesale permission to enroll irrespective of circumstance—instead of per patient. Our novel justification for enrolment centers on applying EFIC per patient, which empowers the enrolling clinician to judge whether to enroll patients with an Exception. This contrasts with the idea that clinician judgment is surplus to the judgements already made by institutions in deciding the research may proceed. Instead, we show that enrolling clinician’s judgment is ethically significant and should not be overlooked: attending to this strengthens the research ethically and reduces controversy. There should be a bigger role for the clinician in the research enrolment space.
Month: May 2025
An Iterative Model of Informed Consent: A Trauma-Informed Approach to Consent in Gender-Affirming Surgery
An Iterative Model of Informed Consent: A Trauma-Informed Approach to Consent in Gender-Affirming Surgery
Elijah R. Castle, Rey L. Daigle, Andres Cazares, Nathan Levitt, Augustus Klein
Transgender Health, 31 March 2025
Abstract
Discourse regarding informed consent in trans health care generally addresses overarching interventions (hormones, surgery) and not specific details of these interventions (who will be involved, what kind of and where touch is required), which threatens patient autonomy and bodily agency and reinforces power imbalances inherent in health care. Pelvic care has made the case for a trauma-informed approach to informed consent, which offers a strategy to discuss these specific details and mitigate such threats. In this article, we provide guidance for how clinicians working in gender-affirming surgery can implement a trauma-informed approach to informed consent through an iterative model of informed consent.
Editor’s Note: The article states that “Principles of trauma-informed care stipulate that the clinician should seek consent for each part of the exam and, importantly, that the patient can stop the exam at any time.”
Feasibility, comprehension and applicability of broad consent in the emergency department: an exploratory mixed-methods study
Feasibility, comprehension and applicability of broad consent in the emergency department: an exploratory mixed-methods study
Extended essay
Larissa Eienbröker, Antje Fischer-Rosinský, Martin Möckel, Frank Hanses, Felix Patricius Hans, Sebastian Wolfrum, Johannes Drepper, Daniela Krüger, Philipp Heinrich, Liane Schenk, Anna Slagman
Journal of Medical Ethics, 26 March 2025
Abstract
Background
The German Medical Informatics Initiative (MII) introduced a standardised Broad Consent (BC) form encompassing medical data, insurance data, contact information and biomaterials for health data research. This study assesses the feasibility of MII-BC in emergency departments (EDs), examining patient understanding and identifying implementation facilitators and barriers. Recommendations for implementation of MII-BC in EDs will be derived.
Methods
Mixed-method data were collected in EDs of four German university hospitals (UHs) using pseudonymised participant observation with a focus on patient perspective and surveys from patients. Data included MII-BC acceptance rates, patient understanding, motivation to consent and implementation facilitators and barriers. Quantitative data were analysed descriptively; qualitative data underwent content analysis with deductive–inductive category formation.
Results
The exploratory study involved 12 participant observations from four tertiary UHs, surfacing five key themes: (1) MII-BC patient information in the ED, (2) facilitators and (3) barriers in obtaining MII-BC in the ED, (4) patient perspectives on MII-BC and (5) recommendations for implementing MII-BC in EDs. Survey results (n=225) showed that most patients (89.8%) demonstrated high understanding of MII-BC patient information. Facilitators include empathetic engagement, clear communication and encouragement for questions. Hindering factors include estimating study time frames, ambient noises and study procedure interruptions. Adequate resources, such as trained staff and suitable premises, are crucial.
Conclusion
Implementing MII-BC in the ED is feasible with appropriate resources, though ED-specific challenges must be addressed. Successful MII-BC implementation in EDs hinges on ensuring access to comprehensible information materials, transparent communication and a calm recruitment environment.
Valid and Informed Consent in Orthopaedic Surgery: A Multicentre, Regional Service Evaluation of Current UK Practice
Valid and Informed Consent in Orthopaedic Surgery: A Multicentre, Regional Service Evaluation of Current UK Practice
R Mills, M Sohail, H Sadique, O Adebayo, K Shanmuganathan, G Mamarelis, S Ali, A Sanalla, F Acquaah, A Ali, S Subhash, M Archunan, S Janjua, O Toma, V Matera, A Al-Sukaini, G Hourston, J Barwell, A Adeyeye, A Genena, M Lebe, S Towell, Ch Chan, A MacDowell, P Novak, W Khan, F Bhatti, A Iqbal, H Fawi, J Patel, M Begum, I Marciulynaite, N De Reock, R Tansey, S Hussein, Z Elgheriany, R Munni, T Sandhu, J Rahman, M Popescu, M Loeffler
Georgian Medical News, January 2025
Abstract
Background
In recent years, there has been increasing focus upon tailoring the consent process to reflect patients’ individual needs and concerns. Meanwhile, clinical litigation costs for ‘failure to warn’ as part of ‘informed consent’ remain staggeringly high. We aimed to investigate the validity of the patient consent process in elective lower limb arthroplasty surgery regionally, with a view to ascertaining how it could be improved.
Methods
Regional data across the East of England was collected retrospectively from seven hospital trusts (fifty data sets per hospital) in 2021 and analyzed against predetermined criteria. Data analyzed included operation notes, patient records and clinic letters.
Results
A total of 165 elective knee and 173 elective hip replacement cases were included in the final analysis. Capacity criteria (defined as the ability to understand, retain, weigh up and communicate a decision) were fulfilled in 11.6% of hip and 13.9% of knee replacement surgeries, despite Consent Form 1 (a form commonly used in England to consent adults, deemed to have capacity, for surgical procedures) being completed in 94.8% and 88.5% of these same cases. Procedure-specific consent was obtained in 74.0% and 72.1% of cases, respectively, whilst ‘Type’ and ‘Brand’ of implant were rarely consented for. Alternative treatment options were offered in 67.1% of hips and 62.1% of knee cases. Separate consent clinics were offered in 55.5% of hip and 57.6% of knee cases.
Conclusions
This study demonstrates that there is room for improvement within the current consent process. We propose digitalization, utilizing interactive multimedia and audio-visual demonstrations to explain surgical procedures, as a dynamic and versatile adjunct to the consent process.
Informed Consent Regarding Risk of Stroke from Cervical Spine Manipulation: A Narrative Review
Informed Consent Regarding Risk of Stroke from Cervical Spine Manipulation: A Narrative Review
Steven Brown, James J. Lehman
Journal of the International Academy of Neuromusculoskeletal Medicine, 2025
Open Access
Abstract
Objective
Although the incidence of stroke following cervical spine manipulation (CSM) is low, the potential outcomes are serious. The objective of this study was to perform a narrative review to assess whether informed consent to the risk of stroke from CSM is recommended by chiropractic researchers and practice guidelines.
Methods
An electronic literature search was conducted in February 2025 using PubMed, Google Scholar, and the Index to Chiropractic Literature, covering 1989 to March 2025. Search terms included chiropractic, cervical spine manipulation, stroke, informed consent, and risk. English language peer reviewed studies by chiropractic physicians, along with practice guidelines written in whole or in part by chiropractic physicians, were considered.
Results
There was unanimous support for informed consent to the risk of stroke from CSM in the results. We identified two practice guidelines, two case control studies, three narrative reviews, and one case series authored by chiropractic physicians that recommend such informed consent. We did not find any peer reviewed studies that argued against such informed consent.
Conclusions
Informed consent to the risk of stroke from CSM is recommended by practice guidelines and chiropractic researchers. This lends weight to the view that such informed consent is the standard of care for the chiropractic profession.
InformGen: An AI Copilot for Accurate and Compliant Clinical Research Consent Document Generation
InformGen: An AI Copilot for Accurate and Compliant Clinical Research Consent Document Generation
Zifeng Wang, Junyi Gao, Benjamin Danek, Brandon Theodorou, Ruba Shaik, Shivashankar Thati, Seunghyun Won, Jimeng Sun
arXiv, 2 April 2025
Open Access
Abstract
Leveraging large language models (LLMs) to generate high-stakes documents, such as informed consent forms (ICFs), remains a significant challenge due to the extreme need for regulatory compliance and factual accuracy. Here, we present InformGen, an LLMdriven copilot for accurate and compliant ICF drafting by optimized knowledge document parsing and content generation, with humans in the loop. We further construct a benchmark dataset comprising protocols and ICFs from 900 clinical trials. Experimental results demonstrate that InformGen achieves near 100% compliance with 18 core regulatory rules derived from FDA guidelines, outperforming a vanilla GPT-4o model by up to 30%. Additionally, a user study with five annotators shows that InformGen, when integrated with manual intervention, attains over 90% factual accuracy, significantly surpassing the vanilla GPT-4o model’s 57%-82%. Crucially, InformGen ensures traceability by providing inline citations to source protocols, enabling easy verification and maintaining the highest standards of factual integrity.
Co-designing the consent process of critical care trials with patients and the public: Project protocol
Co-designing the consent process of critical care trials with patients and the public: Project protocol
Timo Tolppa, Arishay Hussaini, Vrindha Pari, Nikhat Ahmed, Arjen Dondorp, Shehla Farooq, Madiha Hashmi, Monaza Khan, Adnan Masood, Saima Saleem, Zahyd Shuja, Marianne Vidler, Shahnaz Zaman, Srinivas Murthy
Wellcome Open Research, 31 March 2025
Abstract
Background
Informed consent processes in critical care trials can be overwhelming for patients and their families as decisions about participation need to be made under distressing circumstances. Existing consent processes have been developed for and by White Western populations, making them less relevant for racialized groups from low- and middle-income countries. One solution is involving patients, their relatives and members of the public from diverse backgrounds in co-designing informed consent processes.
Methods
This project aims to co-design the consent materials and processes for two ongoing critical care trials with an existing Patient and Public Involvement and Engagement group at Ziauddin University in Pakistan. Using experience-based co-design and participatory action research, the process will follow six stages for each trial: (i) Introduction to trial and consent, (ii) Review of existing materials, (iii) Process mapping & recommendations, (iv) Creation of new materials, (v) Vetting, and (vi) Finalization. The final two steps involve collaboration with clinicians, trial teams, sponsors, and members of ethics review boards.
Expected Outcomes
The co-design process will produce new consent materials, aligned with patient and substitute decision-maker needs, that can be implemented to improve the conduct of two active trials. Deliverables include an informed consent process map, recommendations for revising consent materials, and guidelines on patient-centred formats. Additionally, training patient and public members in co-design will build capacity and enable the group to contribute to the design of consent processes of future trials.
Conclusion
Collaboration between patients, researchers and the public has the potential to promote ethical conduct of critical care trials in Pakistan and elsewhere by supporting patient-centered informed decision-making. This co-design process represents the first step towards achieving this goal, with future work evaluating the impact of the new consent materials and processes on trial enrolment rates, participant diversity and consent experiences.
Data sharing in child and adolescent psychiatry research: Key challenges (and some potential solutions)
Data sharing in child and adolescent psychiatry research: Key challenges (and some potential solutions)
Case Study
Beth Oakley, Alexandra Lautarescu, Tony Charman, Christopher Chatham, Eva Loth, Christian Beckmann, Thomas Bourgeron, Florence Campana, Rosie Holt, Eliza Eaton, Pierre Violland, Katrien Van den Bosch, Siofra Heraty, Scott Wagers, Jan Buitelaar, Declan Murphy, Amy Goodwin, Emily Jones
Open Research Europe, 31 March 2025
Open Access
Abstract
Background
The field of biomedical research is entering a new era, in which public data sharing is increasingly the norm. There are many advantages of embracing data sharing initiatives, including tackling the replication crisis through enhanced transparency and publication of null findings, facilitating global collaborations to accelerate research progress, enhancing cost-effectiveness by reducing duplication of efforts, and making scientific advances more accessible to the public. However, there are also several crucial ethical and logistical challenges that must be addressed to maximise the benefits of data sharing and minimise risks. The potential, and increasingly recognised, risks of unregulated data sharing (e.g., data reidentification, misuse, and lack of representativeness due to variability in who agrees to share data) have also been exemplified by high profile data breaches and directly clash with efforts to make research more robust, accessible, and global.
Methods/Results
Here, we narratively outline current challenges for data sharing from the perspective of child and adolescent psychiatry, one area where they may be particularly acute. For example, child and early adolescent research often requires caregivers to consent on behalf of a minor – increasing the responsibility of researchers to consider how the science of today may evolve into the future (when those individuals are no longer minors). We use data from our research consortium Autism Innovative Medicines Study – 2 – Trials (AIMS-2-TRIALS; https://www.aims-2-trials.eu/) to illustrate the points raised in this perspective piece.
Conclusions
We also propose some potential solutions to begin to address current challenges for data sharing, focusing on key priorities, including shared control of data curation between researcher and participant communities and equity of access by research groups to the tools and resources needed to conduct responsible and sustainable data sharing.
Improving shared decision‑making between paediatric haematologists, children with sickle cell disease and their parents: an observational post-intervention study
Improving shared decision‑making between paediatric haematologists, children with sickle cell disease and their parents: an observational post-intervention study
Ricardo Orlando Wijngaarde, Samantha C. Gouw, Dirk T. Ubbink
Research Square, 31 March 2025
Abstract
Background
Children with sickle cell disease (SCD) suffer from a chronic disease that can lead to serious co-morbidity and impacts their quality of life. During the course of their disease, a variety of health-related decisions need to be made for and by SCD-patients, depending on their age and health status, together with their parents and paediatric haematology clinicians. Shared decision-making (SDM) may improve health outcomes of chronically ill children but is still not commonly applied. We assessed the level of SDM among paediatric haematologists after the introduction of SDM-interventions.
Methods
An observational post-intervention study was conducted in a paediatric outpatient clinic of a university hospital. After an SDM consultation training of the three paediatric haematologists and introduction of SDM-supporting tools for both paediatricians and (parents of) patients with SCD, two evaluators independently and objectively analysed the level of patient involvement in decision-making from audio-recordings of the consultations using the OPTION-5 instrument. SDM-Q-9 and SDM-Q-Doc questionnaires were used to measure the level of SDM as perceived by patients/parents and paediatricians, respectively. Scores were expressed as a percentage, ranging from 0% (no SDM observed) to 100% (exemplary level of SDM).
Results
Participants were 9 female and 9 male patients between 3 months and 17 years old, with a mean age of 7.6 years (SD 5.5). Eighteen consultations (six per paediatrician) in which a decision was to be made about SCD treatment options were analysed. Median OPTION-5 score was 50 (Interquartile Range [IQR] 40–65%). Median SDM-Q-9 and SDM-Q-Doc scores were 73% (IQR 52.2–91) and 62.2% (IQR 55.6–71.1), respectively.
Conclusion
After the introduction of SDM training and tools, paediatric haematologists reached a moderately good level of SDM. This level had doubled as compared to the baseline level, as assessed in a previous study.
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].
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:
- Explicitly recognize that the right to education includes early childhood care and education;
- Explicitly state that, with a view to achieving the right to education, States shall:
- Make public pre-primary education available free to all, beginning with at least one year;
- Make public secondary education available free to all;
- Recall that States shall promote and encourage international cooperation in matters relating to education;
- 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.
- 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.
- 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.
- 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?
- 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.
Center for Informed Consent Integrity 