Consent in Limb Lengthening Surgery: Predicting the True Incidence of Material Risk.

Aim: The consent process involves supported decision-making between the surgeon and the patient. Both potential benefits and material risks of the procedure require explanation, with adequate time for reflection. The complexity of limb reconstruction surgery includes the potential for multiple types of complications. In an attempt to delineate the material risks in lower limb lengthening, a literature review was undertaken to ascertain the published rates of complications. Materials and methods: A review of articles from 2003 to 2023 via PubMed and Google Scholar, including keywords 'lengthening', 'tibia', 'lengthening nail' and 'external fixator' was undertaken. Studies with a minimum of 20 patients, undergoing lengthening of the femur, tibia, or both by an external fixator and/or an intramedullary lengthening nail were included for analysis. Complications were reported according to Paley's problems, obstacles, and complications. Results: Twenty-two papers met the inclusion criteria. The commonest complications listed following lengthening using an external fixator were pin site infections (52% in the femur and 18.8% in the tibia), delayed consolidation (8.3%), bone re-fracture (13%), and joint stiffness (18.8%). Following femoral lengthening using the intramedullary lengthening nails reported complication rates were lower, including implant issues (8%) and delayed consolidation (6%). Conclusion: Patients require a full understanding of both benefits and potential harms when undergoing any surgical intervention. Our study has identified the published rates of complications following lower limb lengthening. These figures can be used to guide the consultation and enable surgeons to audit their own surgical results against the published literature. How to cite this article: Makvana S, Robertson A, Britten S, et al. Consent in Limb Lengthening Surgery: Predicting the True Incidence of Material Risk. Strategies Trauma Limb Reconstr 2024;19(2):61-66.

Role of procedure-specific consent forms in clinical practice: a systematic review.

INTRODUCTION: Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria. METHODS: This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity. FINDINGS: We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%-100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. CONCLUSIONS: The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective.

In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long-term, large-scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust-based informed consent and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants' autonomy. Informed consent in long-term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants' rights despite the complexity of modern biomedical research.

Postmortem fertilization: New Italian government guidelines affirm the legitimacy of this procedure.

Although posthumous reproduction (PHR) is viewed unfavorably by some, it may be a desirable option for subjects whose partners died before they could complete their family planning. With particular regard to posthumous embryo implantation, questions arise regarding the definition of "conception" when a couple undergoes in vitro fertilization while both are alive, but the embryo is implanted in a woman's womb after one parent has died. In accordance with Italian Law 40/2004, access to medically assisted reproduction is contingent upon the survival of both partners in a couple. The legislative prohibition remains in effect unless the application of the reproductive technique has already resulted in the formation of embryos, and implantation is permitted to uphold "the rights of all the subjects involved, including the conceived", as stated in Article 1 of Law 40/2004. Since the enactment of the legislation, a number of Italian courts have issued rulings on PHR on a case-by-case basis. Recent government guidelines in Italy have sought to balance these considerations, giving due weight to the will of the woman, the potential unborn child, and the previous consent of the donor partner.

Smart mouthguards and contact sport: the data ethics dilemma.

The use of smart mouthguards in contact sports like rugby aims to enhance player safety by providing real-time data on head impacts. These devices, equipped with sensors, measure collision force and frequency, potentially identifying concussions that might go unnoticed during gameplay. The idea is that such enhanced monitoring will enable teams, physicians and other stakeholders to better protect players from the effects of on-pitch injury through immediate detection of head trauma and the long-term provision of player data. While we welcome the move towards a better understanding of the potential harm that contact sports athletes may experience, introducing a new avenue through which information about player performance and health can be collected brings several areas of ethical concern absent from traditional mouthguards. In this paper, we consider four noteworthy areas: device and data efficacy, player choice, the inherent issues of such data's existence and the harmful consequences of this data's usage and exposure. We argue that failing to identify and address the risks associated with smart mouthguards' employment in the elite sporting sphere not only risks the mistreatment and misapplication of player data but may also jeopardise the acceptability of a novel health monitoring method that has the potential to prevent long-term debilitating diseases.

Universal screening of colorectal tumors for lynch syndrome: a survey of patient experiences and opinions.

BACKGROUND: Lynch syndrome represents the most common hereditary cause of both colorectal and endometrial cancer. It is caused by defects in mismatch repair genes, as well as EPCAM. Universal screening of colon tumors for Lynch syndrome via microsatellite instability (MSI) and/or immunohistochemistry (IHC) can identify patients and families at risk to develop further cancers and potentially impact surveillance and treatment options. The approach to implementation of universal screening, taking ethical considerations into account, is critical to its effectiveness, with patient perspectives providing valuable insight. METHODS: Patients whose colon tumors underwent universal screening at Penn State Hershey Medical Center over a period of 2.5 years were mailed a survey on universal screening in 2017. Along with the survey, they received a recruitment letter and a summary explanation of research. The survey included both multiple choice and free-response questions that covered topics including respondent knowledge of Lynch syndrome, attitudes toward universal screening and experiences with the screening protocol as implemented. RESULTS: Sixty-six of 297 possible patients (22.2%) responded to the survey, including 13 whose screening results raised concern for Lynch syndrome. 75.8% of respondents supported universal tumor screening without informed consent. 92.4% preferred receiving screening results regardless of outcome. Respondents described benefits to screening for themselves and their families. CONCLUSIONS: While broadly supporting universal tumor screening without informed consent, respondents also wanted more information shared about the screening policy, as well as their results. These patient preferences should be one of many factors considered when implementing universal screening and can also inform practices regarding both tumor profiling and universal genetic testing, which is becoming more prevalent.

Medico-Legal Complaints Against Dermatologists: Data From the Canadian Medical Protective Association, 2013 to 2022.

BACKGROUND: Medico-legal complaints against physicians are a significant source of anxiety and could be associated with defensive medical practices that may correlate with poor patient outcomes. Little is known about patient concerns brought to regulatory bodies and courts against dermatologists in Canada. OBJECTIVE: To characterize factors contributing to medico-legal complaints brought against dermatologists in Canada. METHODS: The Canadian Medical Protective Association (CMPA) repository was queried for all closed cases involving dermatologists over the past decade. Aggregate, anonymized data was reviewed and case outcomes, patient harm, and contributing factors were extracted. RESULTS: Nearly one-fifth of all dermatologists who are CMPA members have been named in at least one medico-legal case between 2013 to 2022. A total of 396 civil-legal actions or College complaint cases involving dermatologists were closed at the CMPA during this timeframe. The most common patient allegations were deficient assessment (34%), diagnostic error (28%), and unprofessional manner (22%). Nearly half of patients experienced a harmful event, the majority of which were asymptomatic or mild. The most frequently identified contributing factors related to providers were poor clinical decision making (n = 73), lack of situational awareness (n = 67), and conduct and boundary issues (n = 59). Team factors included a breakdown of communication with patients (n = 124). CONCLUSIONS: Improved communication with patients for informed consent, treatment plans, clinical follow-up, and documentation of thorough clinical patient assessments can improve patient satisfaction and health outcomes, and mitigate dermatologists' medico-legal risk.

Charting the Ethical Frontier in Newborn Screening Research: Insights from the NBSTRN ELSI Researcher Needs Survey.

From 2008 to 2024, the Newborn Screening Translational Research Network (NBSTRN), part of the National Institute of Child Health and Human Development (NICHD) Hunter Kelly Newborn Screening Program, served as a robust infrastructure to facilitate groundbreaking research in newborn screening (NBS), public health, rare disease, and genomics. Over its sixteen years, NBSTRN developed into a significant international network, supporting innovative research on novel technologies to screen, diagnose, treat, manage, and understand the natural history of more than 280 rare diseases. The NBSTRN tools and resources were used by a variety of stakeholders including researchers, clinicians, state NBS programs, parents, families, and policy makers. Resources and expertise for the newborn screening community in ethical, legal, and social issues (ELSI) has been an important area of focus for the NBSTRN and this includes efforts across the NBS system from pilot studies of candidate conditions to public health implementation of screening for new conditions, and the longitudinal follow-up of NBS-identified individuals to inform health outcomes and disease understanding. In 2023, the NBSTRN conducted a survey to explore ELSI issues in NBS research, specifically those encountered by the NBS community. Since NBS research involves collaboration among researchers, state NBS programs, clinicians, and families, the survey was broadly designed and disseminated to engage all key stakeholders. With responses from 88 members of the NBS community, including researchers and state NBS programs, the survey found that individuals rely most on institutional and collegial resources when they encounter ELSI questions. Most survey responses ranked privacy as extremely or very important in NBS research and identified the need for policies that address informed consent in NBS research. The survey results highlight the need for improved collaborative resources and educational programs focused on ELSI for the NBS community. The survey results inform future efforts in ELSI and NBS research in the United States (U.S.) and the rest of the world, including the development of policies and expanded ELSI initiatives and tools that address the needs of all NBS stakeholders.

Prescribing Information: Elizabeth B. Connell, the Pill, and the (Woman) Patient's Peace of Mind.

Throughout the 1970s and 1980s, commercialized reproductive technologies experienced a reputational crisis as news about the hormonal birth control pill's possible side effects reportedly caused 18-30% of women to stop taking it. While secondary literature has followed patients' and legislatures' actions, few histories have focused on physicians' responses. How did physicians manage this public crisis of confidence? This article contributes to existing literature through a backstage look at the work of Elizabeth B. Connell (1925-2018), whose wide-ranging career in medicine, academia, government, industry consulting, and popular writing embroiled her at the center of these controversies. To counter critique from legislatures and consumer reformers, Connell became a mediator for medicine in the public sphere, dispensing select information and arguing for limits on others - for the patient's sake. If legislative inquiry's primary havoc was unleashing information, Connell would help the profession moderate it. Because Connell was a woman doctor whom health feminists who were her contemporaries denied was a feminist doctor, the existing scholarship has occluded her. This article reconstructs the contributions of this important and flawed doctor, illuminating how she contorted herself to suit her various public messages, constrained by her conflicting, dual identities as woman and doctor.

The effect of subjective understanding on patients' trust in AI pharmacy intravenous admixture services.

Introduction: Medical services are getting automated and intelligent. An emerging medical service is the AI pharmacy intravenous admixture service (PIVAS) that prepares infusions through robots. However, patients may distrust these robots. Therefore, this study aims to investigate the psychological mechanism of patients' trust in AI PIVAS. Methods: We conducted one field study and four experimental studies to test our hypotheses. Study 1 and 2 investigated patients' trust of AI PIVAS. Study 3 and 4 examined the effect of subjective understanding on trust in AI PIVAS. Study 5 examined the moderating effect of informed consent. Results: The results indicated that patients' reluctance to trust AI PIVAS (Studies 1-2) stems from their lack of subjective understanding (Study 3). Particularly, patients have an illusion of understanding humans and difficulty in understanding AI (Study 4). In addition, informed consent emerges as a moderating factor, which improves patients' subjective understanding of AI PIVAS, thereby increasing their trust (Study 5). Discussion: The study contributes to the literature on algorithm aversion and cognitive psychology by providing insights into the mechanisms and boundary conditions of trust in the context of AI PIVAS. Findings suggest that medical service providers should explain the criteria or process to improve patients' subjective understanding of medical AI, thus increasing the trust in algorithm-based services.

Informed consent and coercion in recruitment advertisements for oocyte donors.

BACKGROUND: As the use of donor eggs for in vitro treatment has increased, both medically affiliated and private donor egg agencies have turned to online advertisements to recruit donors. The American Society for Reproductive Medicine provides recommendations encouraging ethical recruitment of donors, however there is no formal regulation for the informed consent process for egg donor recruitment and compensation. Underrepresentation of risks and targeted financial incentives may pose a risk to the informed consent process. METHODS: Data from online advertisements for egg donors active between January 1 - August 31, 2020, were collected to analyze content related to risks, Covid-19 precautions, donor payment, and desired donor characteristics. Advertisements for egg donors on Google, Craigslist, and social media were analyzed. Primary outcomes included the mention of the risks of egg donation, including the risk of Covid-19 exposure, in donor egg advertisements. Secondary outcomes included language targeting specific donor characteristics and financial compensation. RESULTS: 103 advertisements were included. 35.9% (37/103) of advertisements mentioned some risk of the egg donation process, and 18.5% (19/103) mentioned risks or precautions related to Covid-19 exposure. Of advertisements for private donor egg agencies, 40.7% (24/59) mentioned any risk, compared to 29.6% (13/44) of medically affiliated egg donation programs; the difference was not statistically significant (p-value = 0.24). Agencies targeting students and donors of a specific race were more likely to offer payments over $10,000 for an egg donation cycle. Among advertisements offering over $20,000 for donor compensation, 72.7% (8/11) recruited women under the age of 21. CONCLUSION: Egg donor recruitment advertisements, for both medically affiliated programs and private agencies, were unlikely to mention risks including the risk of exposure to Covid-19. Non-medically affiliated private donor egg agencies were more likely to violate multiple American Society for Reproductive Medicine ethics guidelines, including offering higher than average compensation, and recruiting donors from young and vulnerable populations.

Unveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.

Background: Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels. Methods: We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024. Results: Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years. Conclusions: The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.

Factors Influencing the Quality and Extent of the Informed Consent Process in Patients Undergoing Surgical Procedures: A Cross-Sectional Study.

Background Informed consent is an essential component of medical practice, particularly in surgical procedures, as it guarantees that patients are thoroughly informed of the risks, benefits, and alternatives prior to receiving treatment. Nevertheless, research has demonstrated that patients frequently fail to recall critical information that was conveyed during the informed consent process, which emphasizes the potential for communication and comprehension deficiencies. Objective The objective of this study was to evaluate the quality of informed consent and the decision-making preferences of patients who are undergoing surgical procedures. Methodology A cross-sectional survey was conducted among 239 hospitalized patients who were scheduled for elective surgeries at a tertiary hospital in Muscat. The survey assessed patients' satisfaction with the process, preferences for decision-making, and comprehension of informed consent. Non-parametric correlation analysis was implemented to analyze the data. Results The consent form was signed by the majority of patients themselves (96.7%), with a median age range of 36-45 years and a relatively balanced gender distribution. For the remaining cases, where patients were unable to sign, the consent forms were signed by surrogates. The majority of patients were Omani nationals (96.7%), with a mixture of school and postgraduate education. The study did not identify any substantial disparities in the provision of informed consent between patients who received consent details in the outpatient clinic and those who received them in the ward. Although a small number of patients, particularly those with higher education, found the explanations unclear, the quality of the explanations was generally rated as explicit and sufficient. The ability to ask further questions, the degree of explanation, the explanation of alternative options, involvement in decision-making, the time to consider before making a decision, and the ability to repeat the explanation given were all positively correlated with satisfaction with the informed consent process. Conclusion The study emphasizes the significance of patient engagement and effective communication in the informed consent process. In order to improve patient satisfaction and comprehension, healthcare providers should prioritize interactive and comprehensive communication. It is imperative that policymakers establish policies that guarantee patients are afforded sufficient time and opportunity to comprehend the risks, advantages, and alternatives of surgical procedures.

Beyond neural data: Cognitive biometrics and mental privacy.

Innovations in wearable technology and artificial intelligence have enabled consumer devices to process and transmit data about human mental states (cognitive, affective, and conative) through what this paper refers to as "cognitive biometrics." Devices such as brain-computer interfaces, extended reality headsets, and fitness wearables offer significant benefits in health, wellness, and entertainment through the collection and processing and cognitive biometric data. However, they also pose unique risks to mental privacy due to their ability to infer sensitive information about individuals. This paper challenges the current approach to protecting individuals through legal protections for "neural data" and advocates for a more expansive legal and industry framework, as recently reflected in the draft UNESCO Recommendation on the Ethics of Neurotechnology, to holistically address both neural and cognitive biometric data. Incorporating this broader and more inclusive approach into legislation and product design can facilitate responsible innovation while safeguarding individuals' mental privacy.

Exploring Patient Preferences for Information About CT Radiation Exposure: Bridging the Gap Between Patient Preference and Physician Practice.

Background: CT scan utilizes ionizing radiation poses a danger to the patient's health. Thus, telling the patient about ionizing radiation would be critical in promoting shared decision-making and improving patient-doctor communication. However, few studies have examined this topic broadly. Objective: The study was conducted to identify the frequency of physicians informing patients about the radiation risk before ordering a CT scan, as well as to examine the association between patients' demographic characteristics and their awareness of the radiation risks associated with CT scans. Methods: A cross-sectional study was conducted among 387 patients who had undergone CT scans at a tertiary hospital in Riyadh, Saudi Arabia. Data were collected via phone interviews using a structured questionnaire. Chi-squared tests were employed to assess associations between patients' demographic characteristics and their awareness of CT scan radiation risks. Results: When examining knowledge, 58% of patients knew that CT involves harmful radiation. This knowledge was significantly associated with higher education level and previous experience with CT scans. Regarding doctors' practice of providing information to patients about the scan, 344 (88.9%) patients indicated that their doctor had explained to them why they needed the scan. Only 28 (7.2%) patients stated that their doctor had mentioned the amount of radiation, and 74 (19.1%) patients indicated that doctors mentioned the risks associated with the radiation of the scan. Almost all patients (96.9%) preferred to be told about why they needed a CT scan. Conclusion: The vast majority of patients who underwent CT scans did not receive enough information about the harm of the scans. However, most of them preferred to know about this harm.

Informed Consent in Clinical Training: Perspectives from Medical Students and Faculty in Portugal.

The student-patient relationship represents the cornerstone of medical education, shaping future doctors' knowledge, skills and attitudes. While most patients allow student involvement in their care, some may express discomfort. Thus, obtaining explicit consent is essential to respect patients' right of autonomy. This study mainly aims to assess the practical application of informed consent by medical students and teachers regarding students' presence and participation in patients' care. An observational cross-sectional study was performed, and an online questionnaire was given to students and teachers at a single medical school, via institutional email. The study included 289 participants, namely 232 students and 57 teachers. While 81% of teachers reported always asking the patient's consent for students' presence, only 28% of students claimed this to be the case. Despite challenges like overcrowding and limited time, involving students in healthcare benefits both students and patients. Moreover, medical ethics education is crucial to foster compassionate care and promote ethical reasoning. The disparities found between teachers' practices and students' perspectives highlight the need to intervene and provide them with an adequate education on ethical values in clinical practice. Strategic interventions at institutional levels are required for a simultaneous high quality of patient care and clinical training.

Partnering with the woman who declines recommended maternity care: Development of a statewide guideline in Queensland, Australia.

BACKGROUND: Choice, a fundamental pillar of woman-centred maternity care, depends in part on the right to decline recommended care. While professional guidance for midwives and obstetricians emphasises informed consent and respect for women's autonomy, there is little guidance available to clinicians or women about how to navigate maternity care in the context of refusal. AIM: To describe the process and outcomes of co-designing resources to support partnership between the woman who declines recommended maternity care and the clinicians and health services who provide her care. MATERIALS AND METHODS: Following a participatory co-design process involving consumer representatives, obstetricians, midwives, maternal fetal medicine specialists, neonatologists, health service executives, and legal and ethics experts, implementation of the resources was trialled in seven Queensland Health services using Improvement Science's Plan-Do-Study-Act cycles. RESULTS: Resources for Partnering with the woman who declines recommended maternity care have now been implemented statewide, in Queensland, including a guideline, two consumer information brochures (available in 11 languages), clinical form, flowcharts, consumer video, clinician education, and culturally capable First Nations resources. Central to these resources is an innovative shared clinical form, that is accessible online, may be initiated and carried by the woman, and where she can document her perspective as part of the clinical notes. CONCLUSION: Queensland is the first Australian jurisdiction, and perhaps internationally, to formally establish this kind of guidance in clinical practice. Such guidance is identified as an enabler of choice in the national Australian strategy Woman-centred care: Strategic directions for Australian maternity services.

Education in the National Transplant Law as an ethical pathway for the construction of the health care value in Colombia / La enseñanza de la Ley Nacional de Trasplante como camino ético para la construcción del valor de la atención en salud en Colombia.

The national transplant law in Colombia, Law 1805 of 2016, modified the Colombian legislation regarding how a person accesses an organ transplant, but above all, it changed the donor figure, establishing the term derived from the presumptive consent right. This term implies a person's hypothetical willingness to be an organ donor as a manifestation of solidarity and charity towards another person in a situation of need and vulnerability concerning his/her health and the dimensions that define it. In the following text, seven moments are considered fundamental facts when constructing a culture about the value of healthcare in the national transplant policy in Colombia.

La Ley Nacional de Trasplantes en Colombia, Ley 1805 de 2016, modificó la legislación colombiana en cuanto a cómo se accede a un trasplante de órganos, pero, sobre todo, cambió la figura de donatario y dispuso el término derivado del derecho del consentimiento presuntivo. Este define la hipotética voluntad de una persona de ser donante de órganos como manifestación de solidaridad y beneficencia con otra persona en situación de necesidad y vulnerabilidad relacionada con su salud y las dimensiones que la definen. En el siguiente texto se presentan siete momentos que se consideran hechos fundamentales en la construcción de una cultura del valor de la atención en salud en la política nacional de trasplantes de Colombia.

Ethics of gene and cell therapy development for neurologic disorders.

In this chapter, I provide a condensed overview of nine recurring policy and ethical challenges encountered with the development of gene and cell therapies for neurologic disease. These include the question of when to initiate first-in-human trials, the ethics and policy of expanded/special access, the conduct of individualized therapy trials, subject selection in trials, designing trials for negative results, unintended effects of interventions on personal identity, comparator choice in randomized trials, consent and therapeutic misestimation, and cost and access for effective therapies. Broadly speaking, I argue that early in their development, the justification of risk in trials of gene and cell therapies derives from the social and scientific value of a trial and not the therapeutic value for trial participation. This generates strong imperatives to justify, design, and report trials appropriately and select patient populations that incur the least burden and opportunity cost for trial participation. Late in intervention development, policy makers must contend with the fact that proven effective interventions will almost certainly amplify strains in healthcare budgets as well as the ethical justifications standing behind reimbursement decisions.

Ethical Considerations for Enrolling "Invested Parties" in Large-Scale Clinical Studies: Insights from the RECOVER Initiative.

Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.