Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.

This paper discusses the importance of return of clinical trial data to patients in the context of the FACILITATE project that aims to develop a participant-centric approach for the systematic return of individual clinical trial data. It reflects on the need for an ethical framework to support the return of clinical trial data. The discussion revolves around the developing FACILITATE ethical framework, specifically focusing on the ethical principles that form the foundation of the framework and guidance on how to implement those principles into practice.

Consent for interventions during childbirth: A national population-based study.

OBJECTIVE: To assess the frequency and determinants of medical interventions during childbirth without women's consent at the population level. METHODS: The nationwide cross-sectional Enquête Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2-month postpartum follow-up (n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2-month attrition. RESULTS: Women reporting failure to seek consent were 44.7% (CI: 42.6-47.0) for oxytocin administration, 60.2% (CI: 55.4-65.0) for episiotomy, and 36.6% (CI: 33.3-40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio [aPR] 1.20; 95% CI: 1.06-1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68-0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11-1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13-1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28-1.96). CONCLUSION: Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women's involvement in decision making during childbirth.

The pregnancy rescue case versus typical abortion.

Hendricks' pregnancy rescue case (PRC) tries to show that abortion is typically morally wrong. I argue here that there are at least two morally relevant differences between the abortion in PRC and the typical abortion so that the latter isn't morally wrong even if the former is morally wrong. I develop five modifications to PRC to show that these two differences are morally important. First, in PRC we don't know whether the person gives informed consent to the abortion, nor does the medical professional who will perform the abortion, and so the abortion can't be performed because the patient gives informed consent to it. Second, not preventing the death of the fetus in PRC brings about the death of an additional fetus gestating in a separate pregnant person, whereas most abortions don't entail the termination of another's pregnancy.

Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital.

BACKGROUND: This study aims to investigate the integration of modern sources of patient information, such as videos, internet-based resources, and scientific abstracts, into the traditional patient informed consent process in outpatient elective surgeries. The goal is to optimize the informed consent experience, enhance patient satisfaction, and promote shared decision making (SDM) between patients and surgeons. By exploring different patient informed consent formats and their impact on patient satisfaction, this research seeks to improve healthcare practices and ultimately enhance patient outcomes. The findings of this study will contribute to the ongoing efforts to improve the informed consent process in public hospitals and advance patient-centred care. METHODS: Data collection occurred at the day care clinic of a prominent German public hospital, forming an integral component of a prospective clinical investigation. The study exclusively focused on individuals who had undergone surgical intervention for skin cancer. For the purpose of meticulous data examination, the statistical software SPSS version 21 was harnessed. In the course of this study, a chi-square test was aptly employed. Its purpose was to scrutinize the nuances in patient experiences pertaining to informed consent across four distinct categories, viz., oral informed consent discussion (Oral ICD), written informed consent discussion (Written ICD), video-assisted informed consent discussion (video-assisted ICD), and digitally assisted informed consent discussion (digital-assisted ICD). The primary dataset of this inquiry was diligently gathered via a structured questionnaire administered to a targeted cohort of 160 patients. Within this sample, a balanced representation of genders was observed, encompassing 82 males and 78 females. Their collective age span ranged from 18 to 92 years, with an average age of 71 years. A randomized selection methodology was employed to include participants in this study during the period spanning from July 2017 to August 2018. RESULTS: Significant differences were observed across the groups for all research questions, highlighting variations in patient responses. Video-assisted and digital-assisted IC were rated as superior in patient satisfaction with information compared to written and oral IC. Demographic profiles of the four study groups were found to be comparable. CONCLUSION: The findings of this study indicate that the incorporation of digital technologies in the informed consent process can enhance patient understanding during outpatient elective skin cancer surgeries. These results have important implications for increasing patient satisfaction and improving the SDM process within the hospital environment.

The Collaborative Biobank (CoBi): Donor and recipient samples & data to facilitate future research on hematopoietic cell transplantation.

Biobanking provides benefit for future generations by facilitating medical research and subsequent translation and application of research findings. Long-term storage and research involving biological material and associated data necessitate the proper implementation of ethical and legal standards. A key principle includes recognizing informed consent as a crucial element for legitimizing the collection of biological material and data. Furthermore, any collected material and data must be employed exclusively for the research framework that aligns with the explicit consent provided by the participants. Last but not least, data privacy and security are essential in biobanking. This review elucidates chances and limitations of biobanking in the field of allogeneic hematopoietic cell transplantation. We discuss the practical implementation of the requirements, illustrated by the Collaborative Biobank, a collaborative research platform for research in blood cancer.

A 25-year scoping review of the organ donation system in Malaysia: past, present, and future.

Organ donation and transplantation are integral components of modern medicine. This scoping review thoroughly explores the historical evolution, current status, and future prospects of organ donation and transplantation in Malaysia. Historically, Malaysia faced significant challenges in establishing a robust organ transplantation system, with various factors hindering organ donation efforts. Currently, Malaysia continues to struggle with stagnant donation rates despite collaborative efforts from various sectors. There is an urgent need to amend the 50-year-old Human Tissue Act to strengthen the legal framework for organ donation and address ethical concerns. Looking to the future, Malaysia could adopt a soft opt-out system and prioritize advancements in organ preservation techniques by exploring new sources of organs through the donation after circulatory death program. Continued efforts are necessary to enhance education programs for professionals and the public, dispelling myths about organ donation and effectively educating on the concepts of brain death. Malaysia strives to create a more accessible future for organ transplantation, aligning with the Sustainable Development Goals to reduce the burden of organ failure and improve the population's health and well-being.

Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing.

This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data - without express consent - and considers the impact of genomic data sharing settings, and respondent attributes, on public trust. Survey results (N = 3013) show some circumstances are more conducive to public trust than others, with waivers endorsed when future research is beneficial and when privacy is protected, but receiving less support in other instances. Still, results imply attitudes are influenced by more than these specific circumstances, with different data sharing settings, and participant attributes, affecting views. Ultimately, this research raises questions and concerns in relation to the criteria HRECs use when authorising waivers of consent in Australia.

Understanding the Appropriate and Beneficial Use of Before and After Photos in Breast Surgery: A North American Survey.

Introduction: Before and after photographs (BAPs) in breast surgery have been identified as important components of the informed consent process. Currently, there is limited consensus on the contents and presentation of BAPs. This study collected the opinions of prior and prospective patients on this topic. Methods: A survey, based on criteria identified by our previous nominal group technique (NGT) study, was designed to obtain patient perspectives on BAPs in breast surgery. Amazon Mechanical Turk, a validated crowd-sourcing tool, was used to identify and survey a group of 72 participants who indicated that they had undergone or were planning to undergo breast surgery. Likert items were analyzed using either chi-squared or Fisher's exact test. Results: Most respondents were cis-gendered-women (89%), Caucasian (83%), and between 31 and 41 years old (38%). Respondents agreed that BAPs are important to the consent process, for enabling patient-centered care, and should be presented in standardized sets. BAPs should be more accessible through different platforms, display multiple time points to show the healing process, and have multiple views including close-ups of scars. Photos should be unaltered except for de-identification, and have more diversity with regard to patient gender, age, skin color, and body mass index. These results align with results from our NGT study. Conclusion: Through this study we have identified many criteria that BAPs should meet according to prior and prospective breast surgery patients. Surgeons should think critically about how they present BAPs during the consent process to ensure effective patient-centered care.

Introduction : En chirurgie mammaire, les photos avant-après (PAP) font partie des aspects importants du processus de consentement éclairé. À l'heure actuelle, le consensus sur le contenu et la présentation des PAP est limité. La présente étude visait à recueillir l'avis de patientes passées et prospectives sur le sujet. Méthodologie : Les chercheurs ont préparé un sondage reposant sur les critères qu'ils avaient établis lors de leur étude antérieure sur la technique du groupe nominal (TGN) pour obtenir les points de vue des patients sur les PAP en chirurgie mammaire. Ils ont utilisé l'outil de production participative validé MechanicalTurk d'Amazon pour repérer et sonder un groupe de 72 participants qui ont indiqué avoir subi ou planifié de subir une chirurgie mammaire. Ils ont analysé les énoncés de l'échelle de Likert au moyen du test du chi carré ou de la méthode exacte de Fisher. Résultats : La plupart des répondants étaient des femme cisgenres (89%), blanches (83%), âgées de 31 à 41 ans (38%). Ces répondants ont convenu que les PAP constituent un aspect important du processus de consentement, qu'elles favorisent des soins axés sur les patients et qu'elles doivent être présentées sous forme d'ensembles standardisés. Les PAP devraient être plus accessibles sur diverses plateformes, présenter divers moments du processus de guérison et de multiples points de vue, y compris des gros plans des cicatrices. Les photos devraient être inaltérées, à part pour la désidentification, et refléter une plus grande diversité de genres, d'âges, de couleurs de peau et d'indices de masse corporelle. Ces résultats concordent avec ceux de l'étude antérieure par la TGN. Conclusion : Grâce à la présente étude, les chercheurs ont relevé de nombreux critères que doivent respecter les PAP selon les patients passés et prospectifs en chirurgie mammaire. Les chirurgiens devraient recourir à la réflexion critique quant à la manière de présenter les PAP pendant le processus de consentement pour s'assurer de prodiguer des soins efficaces axés sur les patients.

Enhancing informed consent through multimedia tools in pediatric spinal surgery: a comprehensive review.

Pediatric spine surgery is a high complexity procedure that can carry risks ranging from pain to neurological damage, and even death. This comprehensive mini review explores current best practice obtaining valid and meaningful informed consent (IC) prior to pediatric spinal surgery, including modalities that support effective comprehension and understanding. An evaluation of the literature was performed to explore understanding of surgical IC by patients or their guardians and the role of multimedia tools as a possible facilitator. The evidence discussed throughout this review, based on legal and ethical perspectives, reveals challenges faced by patients and guardians in achieving comprehension and understanding, especially when facing stressful medical situations. In this context, the introduction of multimedia tools emerges as a patient-centered strategy to help improve comprehension and decrease pre-operative uncertainty. This review highlights the need for a tailored approach in obtaining IC for pediatric patients and suggests a potential role of shared decision-making (SDM) in the surgical discussion process.

CLARA-MeD Tool - A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish.

We present an NLP web-based tool to help users understand consent forms (CFs) and clinical trial announcements (CTAs) in Spanish. For complex word identification, we collected: 1) a lexicon of technical terms and simplified synonyms (14 465 entries); and 2) a glossary (70 547 terms) with explanations from sources such as UMLS, the NCI dictionary, Orphadata or the FDA. For development, we extracted entities from 60 CTAs, 60 CFs and 60 patient information documents (PIDs). To prepare definitions for new terms, we used ChatGPT and experts validated them (28.99% needed to be fixed). We tested the system on 15 new CTAs, 15 CFs, and 15 PIDs, and we achieved an average F1 score of 82.91% (strict match) and of 94.65% (relaxed). The tool is available at: http://claramed.csic.es/demo.

Ethics of Wearable-Based Out-of-Hospital Cardiac Arrest Detection.

Out-of-hospital cardiac arrest is a major health problem, and immediate treatment is essential for improving the chances of survival. The development of technological solutions to detect out-of-hospital cardiac arrest and alert emergency responders is gaining momentum; multiple research consortia are currently developing wearable technology for this purpose. For the responsible design and implementation of this technology, it is necessary to attend to the ethical implications. This review identifies relevant ethical aspects of wearable-based out-of-hospital cardiac arrest detection according to 4 key principles of medical ethics. First, aspects related to beneficence are related to the effectiveness of the technology. Second, nonmaleficence requires preventing psychological distress associated with wearing the device and raises questions about the desirability of screening. Third, grounded in autonomy are empowerment, the potential reidentification from continuously collected data, issues of data access, bystander privacy, and informed consent. Finally, justice concerns include the risks of algorithmic bias and unequal technology access. Based on this overview and relevant legislation, we formulate design recommendations. We suggest that key elements are device accuracy and reliability, dynamic consent, purpose limitation, and personalization. Further empirical research is needed into the perspectives of stakeholders, including people at risk of out-of-hospital cardiac arrest and their next-of-kin, to achieve a successful and ethically balanced integration of this technology in society.

Retrospective Radiology Research: Do We Need Informed Patient Consent?

While knowledge of the population's view on the need for informed consent for retrospective radiology research may provide valuable insight into how an optimal balance can be achieved between patient rights versus an expedited advancement of radiology science, this is a topic that has been ignored in the literature so far. To investigate the view of the general population, survey data were collected from 2407 people representative of the Dutch population. The results indicate that for non-commercial institutions, especially hospitals (97.4 per cent), respondents agree with the retrospective use of imaging data, although they generally indicate that their explicit consent is required. However, most respondents (63.5 per cent) would never allow commercial firms to retrospectively use their imaging data. When including only respondents who completed the minimally required reading time of 12.3 s to understand the description about retrospective radiology research given in the survey (n = 770), almost all (98.9 per cent) mentioned to have no objections for their imaging data to be used by hospitals for retrospective research, with 57.9 per cent indicating their consent to be required and 41.0 per cent indicating that explicit patient consent to be unnecessary. We conclude that the general population permits retrospective radiology research by hospitals, and a substantial proportion indicates explicit patient consent to be unnecessary when understanding what retrospective radiology research entails. However, the general population's support for the unrestricted retrospective use of imaging data for research purposes without patient consent decreases for universities not linked to hospitals, other non-commercial institutions, government agencies, and particularly commercial firms.

Parental views on prospective consent: Experience from a pilot randomised trial recruiting extremely preterm infants during the perinatal period.

AIM: To explore parental perceptions of the consenting process and understanding of the study in a pilot randomised controlled trial wherein extremely premature infants (<29 weeks' gestation) were recruited either antenatally or by 4 h of life. METHODS: We prospectively surveyed parents who had consented, declined consent or were eligible infants in the Positioning Preterm Infants for Neuroprotection study, a low-risk intervention study in the first 72 h of life. Structured interview questions explored the process and acceptability of the consenting approach by the parents and their knowledge of the study. Additional comments made by the parents were transcribed verbatim. RESULTS: Sixty-two parents participated in the surveys; of those, 41 had provided their consent, 8 declined consent and 13 were parents of missed eligible infants. Overall, most parents reported they understood the study well before providing their consent and approaching them for consenting did not create a burden for them. A verbal explanation of the study by the study team, especially by the medical practitioners, was viewed as beneficial. Where consent was obtained in the birthing unit (imminent births and within 4 h of birthing), it was suggested that the 4-h period for obtaining post-natal consent may be too short. A deferred consent with a follow-up opportunity for obtaining informed consent could be a suitable alternative. CONCLUSION: Parents found the consenting process acceptable and indicated they had sufficient understanding of the study to provide an informed consent. Deferred consent should be explored for future, low-risk intervention studies as an alternative to prospective consent where extremely preterm infants need to be recruited in the immediate neonatal period.

Other Specified Paraphilic Disorder: Patterns of Use in Sexually Violent Predator Evaluations.

"Sexually violent predator" (SVP) legislation requires, in part, that an individual has a mental abnormality that causes difficulty in controlling sexual behavior. Previous research has found paraphilia not otherwise specified (NOS) as one of the most prevalent diagnoses proffered in SVP evaluations. However, the fifth edition of the Diagnostic and Statistical Manual (DSM-5) modified paraphilia NOS diagnosis in two ways. First, this diagnosis was divided into two new diagnostic categories: other specified paraphilic disorder (OSPD) and unspecified paraphilic disorder. Second, OSPD required an added specifier to indicate the individual's source of sexual arousal. To date, no study has systematically explored how the revision to paraphilia NOS has affected diagnoses within SVP evaluations. The current study explored the frequency and diagnostic reliability of paraphilic disorders in a sample of 190 adult men evaluated for SVP civil commitment using the DSM-5. Results indicated that OSPD was the second most common paraphilic disorder, next to pedophilic disorder. However, there was poor to fair agreement (kappa = 0.21, p < .01) between independent evaluators in providing this diagnosis. Additionally, the two most common OSPD specifiers were non-consent and hebephilia, despite recent debate and rejection of these constructs from the DSM-5. While these constructs were the most prevalent, the specifiers contained quite varied terminology, suggesting vague diagnostic tendencies within these evaluations. Given that the presence of a mental abnormality is the cornerstone to the constitutionality of SVP commitment, diagnostic practices should be based in reliable and valid techniques.

[Importance of documentation. Not documented is deemed to be not done]. / Bedeutung der Dokumentation. Nicht dokumentiert gilt als nicht gemacht.

Only a few physicians are willing to comprehensively concern themselves with how a legally watertight treatment documentation should be structured, in addition to their practical activities; however, the importance of the documentation cannot be emphasized enough, not only for a potential case of liability but also for the medical (further) treatment. This article therefore illustrates the legal foundations of the mandatory documentation and the most important questions associated with it for the practice, in particular on the content of the documentation, the timing of the documentation, the preservation of treatment documents and on the conduct in cases of an impending incident.

Cripping and queering gender-based violence prevention: bridging disability justice, queer joy, and consent education.

Although frequently relegated to the periphery in conversations about gender-based violence prevention, the disabling impacts of traumatised subjectivity both affect survivors' abilities to fully participate in sex and contribute to survivors being more than twice as likely to be sexually (re)victimised compared to peers without trauma histories. In this paper, we seek to crip and queer approaches to gender-based violence prevention, particularly consent education, by learning from 2SLGBTQ+ and disabled trauma survivors' affective experiences of queer, crip sexual joy and the radically messy ways in which they establish their own care networks for deeply pleasurable sex through the principles of disability justice. Refusing pathologising understandings of survivors as those who need to be cured, we highlight traumatised subjectivity as emblematic of the ambiguity and ambivalence inherent in sex as well as the possibilities for caring, consensual sex that moves beyond the concept of consent employed in colonial, neoliberal capitalist societies' binary (Yes/No) consent laws. Drawing on the work of crip and queer theorists such as Mia Mingus, Alison Kafer, Leah Piepzna-Samarasinha, and J. Logan Smilges, we reveal how disability justice principles, such as interdependence, collective access, and access intimacy, offer transformative understandings for anti-violence efforts.

Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial.

BACKGROUND: Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use. METHODS: SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18-65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively. RESULTS: Participants found that group eConsent was an efficient method that it allowed them to hear each other's questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies. CONCLUSION: Group eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement. TRIAL REGISTRATION: ClinicalTrials.gov NCT05471440 (registered on 22nd of July, 2022).

The use and ethics of dental photography and social media at an oral healthcare training centre in South Africa.

Background: The ethics surrounding the use and sharing of photographs on social media has come under the spotlight as the Protection of Personal Information Act (POPI Act) has come into play. Aim: The aim is to determine the use, ethical practice and sharing of dental photography on social media among qualified and undergraduate oral health practitioners at a dental school in South Africa. Methods: A cross-sectional study design was used on staff and students at the University of the Western Cape's Dental Faculty in 2022. Chi-squared and Fisher's exact tests were used to determine associations between the different graduation statuses and various demographic factors. Results: From the 80 undergraduate students and 46 qualified oral healthcare practitioners, the majority were aware that photography could be used in dentistry, and 87.3% (n = 110) took photographs of the dental treatments performed on their patients. Only 60.3% of the participants attended an ethical course that addressed issues with social media and digital photography. Almost 80% (n = 100) of the participants did not feel that they needed to mention all the social media platforms that they would use with their patients' photographs before sharing. Conclusion: Dental photography is being used and sometimes shared on social media platforms by some students and staff at university level. Not all participants have attended an ethical course on clinical photography. Dental training needs to include an ethical course on dental photography and the use of sharing photographs on social media. Contribution: Good ethical practice regarding clinical photographs in all undergraduate and postgraduate curriculums, to eliminate any uncertainty.

Are clinicians ethically obligated to disclose their use of medical machine learning systems to patients?

It is commonly accepted that clinicians are ethically obligated to disclose their use of medical machine learning systems to patients, and that failure to do so would amount to a moral fault for which clinicians ought to be held accountable. Call this 'the disclosure thesis.' Four main arguments have been, or could be, given to support the disclosure thesis in the ethics literature: the risk-based argument, the rights-based argument, the materiality argument and the autonomy argument. In this article, I argue that each of these four arguments are unconvincing, and therefore, that the disclosure thesis ought to be rejected. I suggest that mandating disclosure may also even risk harming patients by providing stakeholders with a way to avoid accountability for harm that results from improper applications or uses of these systems.

Impact of nitrous oxide use on parturient recall of neuraxial analgesia risks.

STUDY OBJECTIVE: Nitrous oxide affects memory and recall. We aimed to determine if using nitrous oxide during labor affected patients' ability to learn and recall the risks and benefits of neuraxial analgesia. DESIGN: Single-center, prospective cohort study. SETTING: Labor and delivery unit in a large academic medical center. PATIENTS: Nulliparous patients with spontaneous or planned induction of labor. INTERVENTIONS: Parturients chose whether to use nitrous oxide during labor. At the discussion for epidural consent, 4 risks were described: headache, infection, nerve damage, bleeding. MEASUREMENTS: Labor pain score, time from nitrous oxide discontinuation, and cervical dilation were documented at the discussion of epidural risks. Patients were assessed for unprompted recall and prompted recall of epidural risks on postpartum day 1 and unprompted recall at postpartum week 6. The number and proportion of patients who indicated each true risk (unprompted and prompted recall) or distractor (prompted recall only) were summarized by treatment group and results compared using Pearson χ2 tests. MAIN RESULTS: Of the 403 enrolled patients, 294 (73%) did not use nitrous oxide, and 109 (27%) did. The 2 groups were similar except women who used nitrous oxide were more likely to be cared for by midwives and had higher pain scores at their epidural request. Scores for unprompted or prompted recall of epidural risks were not different between women who received or did not receive nitrous oxide. All 4 risks were recalled unprompted by only 3% in the nitrous oxide group and by 6% in the group not receiving nitrous oxide (P = .18). CONCLUSIONS: The use of nitrous oxide for labor analgesia does not adversely influence a parturient's ability to recall the risks of epidural placement. Patients who receive nitrous oxide for labor analgesia should be considered eligible to provide consent for subsequent procedures.