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 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.

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.

Informed consent in neurosurgery - Evaluation of current practice and implementation of future strategies.

Background: In recent times, clinical negligence claims against National Health Service hospitals have doubled, with 8% of claims being made due to "failure to warn/informed consent." This study aimed to assess the current compliance of the neurosurgical division within a large tertiary neuroscience center with the national legal framework and professional guidelines around the issue of surgical consent and to develop strategies to improve the consent process. Methods: Electronic patient records (EPR) were accessed to collect demographic data and information regarding the surgical procedures. Telephone questionnaires were carried out. Neurosurgical registrars were interviewed. The author met with the trust's Legal team, the neuropsychology lead, and the trust's consent lead. Results: Fifty-eight patients were included in the analysis. Of the respondents to the questionnaire, 98% felt that they were adequately informed during the consent process. When consenting patients, all registrars felt that they explained the reason for the procedure, detailed benefits, and major risks, including uncommon and rare risks. However, 50% admitted to not specifically discussing the postoperative recovery time or alternatives. Only 15% admitted to documenting on the EPR or through a letter to the patient's General Practitioner. Conclusion: Informed consent is a delicate moment of communication between a clinician and the patient. Regular training and good communication skills help staff to focus on the most relevant aspects of consent, which should be delivered in an appropriate environment and with family support. Audio-visual aids can support the process but do not replace good communication.

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study.

BACKGROUND: In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts. OBJECTIVE: This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers. METHODS: Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis. RESULTS: Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees. CONCLUSIONS: More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.

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.

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.

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.

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.

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).

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.

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.

Willingness to participate in a personalized health cohort - insights from the swiss health study pilot phase.

BACKGROUND: This paper explores the feasibility of establishing a large-scale population-based cohort and biobank in Switzerland by assessing potential participants' needs, expectations, and concerns about such an infrastructure providing information on health, lifestyle, and exposure trajectories, the development of disease, and risk factors over time. METHODS: We utilized a scenario-based questionnaire in the Swiss Health Study pilot phase (2020-2021), involving 1349 adults aged 20-69 from the cantons Vaud and Bern. We conducted descriptive statistics supported by R and qualitative content analysis of n = 374 open responses related to attitudes towards research. RESULTS: We highlight the benefits and challenges of the scenario-based approach, discuss the sample represented in the pilot phase, and present implications for building a full cohort. We also report on participants' attitudes towards and previous experience with health research. We analyze references regarding informed consent and feedback, attitudes towards the Swiss Health Study, and recommendations on improving its scope, design, and instruments. Results indicate a high interest (90%) in participating in a national health study, with 85% of a random population sample willing to join a long-term cohort. Only 43% were familiar with biobanks, and 44% preferred general consent. Trust was high for Swiss-based public research but lower for researchers from other countries or private sector. Over 95% expressed willingness to complete online questionnaires, undergo physical examination, and donate biosamples. Almost all participants wanted to know the outcomes of the medical tests (99.5%) and the exposure to environmental stressors (95%) from their study center visit. Preferred tools for monitoring sleep, physical activity, and diet were known smartphone apps with automatic data management. CONCLUSION: Overall, the study reveals a positive attitude towards personalized health research, with a strong willingness to share data and samples. Key insights focus the meaning of informed consent for participation, the relevance of sampling and representativeness, as well as the significance and challenges of personalized feedback, especially regarding environmental health concerns. Findings emphasize participants' supportive yet reflexive stances, underscoring the importance of aligning research values with individual values in personalized health research. These insights contribute valuable considerations for refining the scope, design, and instruments of future cohort studies.

Ethical Issues in Implementation Science: A Qualitative Interview Study of Participating Clinicians.

BACKGROUND: Implementation science presents ethical issues not well addressed by traditional research ethics frameworks. There is little empirical work examining how clinicians whose work is affected by implementation studies view these issues. Accordingly, we interviewed clinicians working at sites participating in an implementation study seeking to improve patient handoffs to the intensive care unit (ICU). METHODS: We performed semi-structured interviews with 32 clinicians working at sites participating in an implementation study aiming to improve patient handoffs from the operating room to the ICU. We analyzed the interviews using an iterative coding process following a conventional content analysis approach. RESULTS: Clinicians' greatest concern about involvement was possible damage to interpersonal relations with more senior clinicians. They were divided about whether informed consent from clinicians was necessary but were satisfied with the study's approach of sending out mass communications about the study. They did not think opting out of the implementation portion of the study was feasible but saw this inability to opt out as unproblematic because they equated the study with routine quality improvement. Those clinicians who helped launch the study at their sites recounted several different ways of doing so beyond simply facilitating access. CONCLUSIONS: The risks that clinicians identified stemmed more from their general status as employees than their specific work as clinicians. Implementation researchers should be attuned to the ethical ramifications of involving employees of varying ranks. Implementation researchers using hybrid designs should also be sensitive to the possibility that practitioners affected by a study will equate it with quality improvement and overlook its research component. Finally, the interactions that go into facilitating an implementation study are more various than the "gatekeeping" typically discussed by research ethicists. More research is needed on the ethics of the myriad interactions that are involved in making implementation studies happen.

Are Queer Men Queering Consent? A Scoping Review of Sexual Consent Literature Among Gay, Bisexual, Trans, and Queer Men.

Objectives: To review the literature on Gay, Bisexual, Trans, and Queer (GBTQ) men and sexual consent. Methods: Eight electronic databases were searched in June 2022, yielding 1924 articles; 30 were included for review after screening. Results: We found a growing body of literature focused on GBTQ men, with an increasingly intersectional lens. Most studies adopted a nuanced definition of sexual consent. Many discussed the unique sexual scripts developed by GBTQ men to communicate consent, especially in sex venues, and how unfamiliarity with these scripts creates vulnerability for newly "out" men. A common theme was the impact of heteromasculine norms on sexual encounters between GBTQ men. Conclusions: The reviewed literature problematizes binary definitions of consent and miscommunication theories of assault. It both celebrates and problematizes GBTQ sexual cultures. We encourage future research to adopt more explicitly anti-carceral approaches to studying sexual consent and violence.