Informed Consent Practices for Publication of Patient Images in Dermatology Journals
Toluwani Taiwo, Bianca Obiakor, Sarah McClung, Kanade Shinkai
Journal of the American Academy of Dermatology, September 2024
Abstract
Clinical images play a crucial role in dermatology for patient care and education. The lack of standardized informed consent for publishing images in dermatology journals creates ambiguity for both patients and authors. This cross-sectional study examined informed consent practices in the top 50 dermatology journals based on the 2022 Clarivate Journal Impact Factor ranking. We reviewed journal websites and patient consent forms during June 28 to July 24, 2023 using an author-created checklist compiled from available best practices for image publication. Approximately 90% of journals specified image consent requirements, though there was notable variability in criteria related to image modification, safeguards for anonymity (e.g., eyebars, cropping, blurring), and the definition of identifiable features. Examples of identifiable features (e.g., tattoos, birthmarks, jewelry) were provided in 14% of journals. Despite the prevalence of social media presence among journals (70%), only 6% acknowledged potential risks associated with image dissemination on these platforms. While around 52% of journals presented journal or publisher-specific consent forms, inclusion of essential components, guided by International Committee of Medical Journal Editors guidelines, varied. Notably, 77% of these forms explicitly addressed how images could be disseminated beyond print publication, with 39% detailing patients’ ability to revoke consent, and 19% considering the possibility of patients benefiting financially from publication. Our assessment revealed inconsistencies in image consent practices across journals and their associated consent forms for patients. These findings highlight important opportunities for improvement, including uniform consent guidelines and standardized definitions of identifiable features to protect patient privacy in medical image publication.
Surgical Options for Breast Cancer and Consent Guidelines for Indigenous Women
Surgical Options for Breast Cancer and Consent Guidelines for Indigenous Women
Book Chapter
Jennifer Erdrich, Felina Cordova-Marks, Amanda Bruegl
Indigenous and Tribal Peoples and Cancer, 31 August 2024 [Springer]
Open Access
Key Points
- Women diagnosed with breast cancer and preparing for surgery can choose between breast-conserving therapy (BCT) and mastectomy. Breast cancer survival for BCT and mastectomy are equivalent.
- Surgical patterns show that American Indian/Alaska Native (AI/AN) women in the United States have more mastectomy and less breast-conserving therapy for early-stage breast cancer compared to non-Hispanic White (NHW) women.
- For all women, regardless of race, informed consent for lumpectomy vs. mastectomy is a complex, time-intensive process entailing comprehensive counseling. Additional historical and cultural considerations must inform consent guidelines for Indigenous women preparing for breast cancer surgery.
- We propose innovative solutions to overcome the challenges that limit Indigenous women’s access to their preferred surgical choice.
Abstract
Breast-conserving therapy (BCT) consists of lumpectomy followed by radiation. A lumpectomy removes the tumor and surrounding rim of normal breast tissue, leaving most of the breast volume and shape intact. A mastectomy removes the entirety of the breast tissue. Randomized trials with long-term follow-up demonstrate that, regardless of the stage of disease, survival is equivalent for both treatment options. While the risk of recurrence with lumpectomy alone is higher, modern multidisciplinary care combining lumpectomy with radiation and various forms of systemic therapy achieves a similar low risk of recurrence, allowing clinicians to offer BCT or mastectomy as equally safe standard care options. This establishes a surgical choice that is highly personal and should be individualized to consider multiple unique factors, including age, family history, hereditary gene mutations, size of the tumor relative to total breast volume, ability to complete multimodality breast care and surveillance, future plans regarding fertility and lactation, and overall best outcome for the individual’s body-image, lifestyle, and peace of mind.
BCT consistently shows decreased surgical complications, decreased pain, faster recovery, more favorable cosmetics, and better-preserved sexuality and body image. This is not to say that it is the best choice for every woman. BCT is contraindicated for women with inflammatory breast cancer. For some, mastectomy is preferred for personal reasons, even with a full understanding of equivalent survival following BCT. Provided the patient is well-informed and has worked with her clinical team to ensure her decisions are safe, she should be supported in her surgical choice.
Ethical Issues and Consent in Oral and Maxillofacial Surgery
Ethical Issues and Consent in Oral and Maxillofacial Surgery
Book Chapter
Ahmad Nazari
Handbook of Oral and Maxillofacial Surgery and Implantology, 13 April 2024 [Springer]
Abstract
Oral and maxillofacial surgery, encompassing a wide range of procedures from corrective jaw surgery to facial trauma repair, sits at a complex intersection of aesthetics, functionality, and patient well-being. This specialty, therefore, faces unique ethical challenges, particularly in the realm of patient consent. Obtaining informed consent is not merely a legal formality but a fundamental ethical principle that honors patient autonomy and ensures shared decision-making. Surgeons must navigate these waters with care, ensuring patients understand the potential risks, benefits, and alternatives of proposed treatments. This chapter delves into the ethical nuances of consent in oral and maxillofacial surgery, exploring how surgeons can foster an environment of trust and transparency. It highlights the importance of clear communication, patient education, and the ethical considerations necessary to guide both routine and complex surgical decisions.
A rapid review of the benefits and challenges of dynamic consent
A rapid review of the benefits and challenges of dynamic consent
Review Article
Winnie Lay, Loretta Gasparini, William Siero, Elizabeth K Hughes
Research Ethics, 9 September 2024
Open Access
Abstract
Dynamic consent is increasingly recommended for longitudinal and biobanking research; however, the value of investing in such systems is unclear. We undertook a rapid review of the benefits and challenges of implementing dynamic consent by searching five databases (Ovid Medline, Ovid Embase, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature – CINAHL) for articles published up to May 2023 that report on participants’ or researchers’ experience of dynamic consent. From 1611 papers screened, 12 met inclusion criteria. Guided by thematic analysis with an inductive approach, we synthesised 31 benefits and 8 challenges. Benefits included: enhanced participant experience through improved consent management and tailoring; greater participant engagement and retention through increased autonomy, trust and communication; reduced costs and burden and increased accessibility and inclusivity. Participants and researchers also valued additional features that dynamic consent platforms facilitate such as two-way communication and return of research updates. The main challenges included the digital divide and consent fatigue. The papers gave recommendations to mitigate these challenges, for example by supplementing with other communication tools and allowing a broad consent approach, respectively. Overall, dynamic consent was described as a valuable consent approach with many benefits and some surmountable challenges. Most included literature was qualitative, so further research is needed to quantify the impact of dynamic consent on recruitment, retention, and participant experience. Further long-term investigations are necessary to explore whether participants want to and do change their consent over time, as well as the impact of dynamic consent on participant privacy.
Quantifiable Bodies: The Influence of Biometric Technologies in Patient Consent
Quantifiable Bodies: The Influence of Biometric Technologies in Patient Consent
Morgan Banville, Elena Kalodner-Martin
Surveillance & Society, 7 September 2024
Abstract
While research has been done to identify the potential implications of biometric technology on marginalized populations’ privacy and autonomy, this paper contributes to existing research by examining these technologies in healthcare settings. Drawing from insights across surveillance studies, rhetoric of health and medicine, and technical communication, we identify how one leading healthcare institution in New York City has employed rhetorics of efficiency, effectiveness, safety, and security regarding its biometric technology system. This employment of biometric technologies often contributes to patients’ marginalization and dismissal. As we explore, interrogating the language used by the healthcare institution to describe biometrics opens opportunities for us—surveillance studies scholars, patients, allies, students, and more—to ensure that innovations within the healthcare system promote equity, agency, and improved outcomes for all.
The research relationship: participant perspectives on consent in biobanking
The research relationship: participant perspectives on consent in biobanking
Research Article
Rachel Thompson, Kate Lyle, Gabrielle Samuel, Jo Holliday, Fenella Starkey, Susan Wallace, Anneke Lucassen
BMC Medical Ethics, 26 August 2024
Abstract
Background
This paper examines the ethical challenges associated with the governance of large-scale biobanks. As the collection and interrogation of population-scale data is increasingly positioned as the route to new understandings of health and disease, these large-scale biobanks that rely on health research governance are becoming essential elements of research infrastructure. However, their longitudinal nature presents growing challenges for governance. Typically, health research governance uses a one-off consent model where participants agree to specific activities, but evolving technologies make it difficult to anticipate future research applications at the time of consent. Using a recent case study from UK Biobank, we demonstrate how trying to reconcile new research activities with old consent forms risks overlooking critical ethical issues —particularly how the proposed activity aligns with participants’ understanding and expectation of biobank research.
Methods
We report on our qualitative research with UK Biobank participants, conducting focus groups using individual and group exercises to explore their views on consent and research applications. We conducted thematic analysis of focus group transcripts applying both an inductive and deductive approach to coding, which was done using NVIVO qualitative data analysis software.
Results
Our findings show that participants locate responsibility for research decisions with the biobank, rather than seeking control through their consent. They perceive their consent not as a one-off agreement but as the ‘opening act’ for an enduring research relationship with the biobank.
Conclusions
Prioritising the ongoing research relationship and the practices that sustain it, rather than relying solely on consent procedures, can better support ethical research over time.
The First General Consent Implementation in Swiss Traditional Chinese Medicine Practices. A Prospective One-Year Study
The First General Consent Implementation in Swiss Traditional Chinese Medicine Practices. A Prospective One-Year Study
Xiaying Wang, Xiaoying Lv, Bingjun Chen, Saroj Pradhan, Ralf Bauder, Yiming Li, Michael Furian
medRxiv, 20 August 2024
Abstract
Summary
Background
Traditional Chinese Medicine (TCM) encompasses a wide range of treatments focused on diagnosing and managing illnesses, with increasing adoption in Western countries. TCM is often applied in isolated practices, therefore, rigorous research and real-world data collection remain challenging. The implementation of the General Consent (GC) facilitates this research, therefore, the aim was to investigate the acceptance rate of the GC during the first year of its implementation in TCM practices.
Methods
This prospective cohort study was conducted from 1st January to 31st December 2023 in five TCM practices located in Bad Zurzach, Baden, Lenzburg, Wil, and Zug in Switzerland. GC, together with other registration forms, were sent to patients prior to their appointments, collected during their first visit, and recorded by clinic secretaries. Logistic regression analysis was performed to investigate demographic factors influencing GC acceptance, considering variables such as age, sex, and practice location.
Results
The study recorded 1,095 patients who sought TCM treatments in 2023, of which 73.6% returned a valid GC document. Overall, the GC acceptance rate was 611/1,095 (55.8%); of those returning the GC, the acceptance rate was 611/806 (75.8%). The median[IQR] age of patients was 52[37,64] years and female patients were twice as likely to seek TCM treatments compared to male patients. Logistic regression analysis, odds ratio (95%CI), revealed no difference in GC acceptance rate with older age: 1.015 (0.996 to 1.034), p=0.115; female sex: 1.847 (0.588 to 5.804), p=0.294 and age*female sex: 0.983 (0.962 to 1.004), p=0.119. Significant differences in GC acceptance rates were observed across the five TCM practices.
Conclusion
The GC implementation in TCM practices was feasible, and the GC was well accepted by patients, independent of sex and age. The observed practice-related differences in GC acceptance require further investigation. More TCM practices should implement the GC to enable practice-based TCM research.
Self-Sovereign Identity for Consented and Content-Based Access to Medical Records using Blockchain
Self-Sovereign Identity for Consented and Content-Based Access to Medical Records using Blockchain
Marie Tcholakian, Karolina Gorna, Maryline Laurent, Hella Kaffel Ben Ayed, Montassar Naghmouchi
arXiv, 31 July 2024
Abstract
Electronic Health Records (EHRs) and Medical Data are classified as personal data in every privacy law, meaning that any related service that includes processing such data must come with full security, confidentiality, privacy and accountability. Solutions for health data management, as in storing it, sharing and processing it, are emerging quickly and were significantly boosted by the Covid-19 pandemic that created a need to move things online. EHRs makes a crucial part of digital identity data, and the same digital identity trends — as in self sovereign identity powered by decentralized ledger technologies like Blockchain, are being researched or implemented in contexts managing digital interactions between health facilities, patients and health professionals. In this paper, we propose a blockchain-based solution enabling secure exchange of EHRs between different parties powered by a self-sovereign identity (SSI) wallet and decentralized identifiers. We also make use of a consortium IPFS network for off-chain storage and attribute-based encryption (ABE) to ensure data confidentiality and integrity. Through our solution, we grant users full control over their medical data, and enable them to securely share it in total confidentiality over secure communication channels between user wallets using encryption. We also use DIDs for better user privacy and limit any possible correlations or identification by using pairwise DIDs. Overall, combining this set of technologies guarantees secure exchange of EHRs, secure storage and management along with by-design features inherited from the technological stack.
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].
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…
New Normative/Regulatory Guidance/Analysis Referencing Consent
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).
Center for Informed Consent Integrity 