Ethical Guidance in Human Paleogenomics: New and Ongoing Perspectives.

Over the past two decades, the study of ancient genomes from Ancestral humans, or human paleogenomic research, has expanded rapidly in both scale and scope. Ethical discourse has subsequently emerged to address issues of social responsibility and scientific robusticity in conducting research. Here, we highlight and contextualize the primary sources of professional ethical guidance aimed at paleogenomic researchers. We describe the tension among existing guidelines, while addressing core issues such as consent, destructive research methods, and data access and management. Currently, there is a dissonance between guidelines that focus on scientific outcomes and those that hold scientists accountable to stakeholder communities,such as descendants. Thus, we provide additional tools to navigate the complexities of ancient DNA research while centering engagement with stakeholder communities in the scientific process.

"Choice of law" in precision medicine research.

Large-scale precision medicine research requires massive amounts of data representing people from all walks of life; thus, in the US, it is often multistate research. Significant legal and ethical quandaries arise as a result of the patchwork of laws states have enacted that may apply to research, are not preempted by federal law, and may impose requirements or provide participant rights and protections that differ from other states. Determining which state's laws apply, and under what circumstances, is not solved by the transition to a single-IRB model and researchers cannot simply choose one state's laws to apply uniformly. At a minimum, the current process of meeting each state's requirements could be made more reliable and efficient. To fundamentally change this status quo, however, requires action at multiple levels. Federally, well-known gaps in the Genetic Information Nondiscrimination Act should be closed, and a coherent system of compensation for research injury-including non-physical injuries-should be developed. States should clarify which of their laws are intended to apply to research and work collaboratively to harmonize them. At the level of individual research projects, numerous policies and procedures could be standardized through authoritative guidelines. Examples include clarifying the scope of broad consent, understanding and upholding Certificates of Confidentiality, offering individual research results responsibly, and consistently disseminating aggregate results to participants and the public. Overall, development of a choice of law framework specific to the research context could significantly promote clarity and consistency.

Sexual Incentive Motivation and Sexual Behavior: The Role of Consent.

The generalized social concern with sexual harassment and nonconsensual sex makes it imperative to incorporate notions of consent in any analysis of human sexual interactions. Such interactions follow an ordered sequence of events, starting with the perception of a sexual incentive, followed by an approach to it, genital interaction, and eventually orgasm. Consent from the partner is needed at every stage. At some points in this chain of events, the individuals involved make cognitive evaluations of the context and predictions of the likelihood for obtaining consent for proceeding to the next phase. Processes such as communication of consent or lack thereof, sexual decision making, and interpretation of cues emitted by the partner are decisive. Increased sexual motivation may influence these processes. However, available data make it possible to ascertain that enhanced motivation has no, or at most minor, effects, thereby invalidating the old assumption that heightened sexual motivation leads to impaired control.

Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent.

BACKGROUND: Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process. OBJECTIVE: We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form. METHODS: We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed. RESULTS: The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form. CONCLUSION: We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.

The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Perception of Polish patients with cancer of the ethical and legal issues related to biobank research.

BACKGROUND: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating. MATERIALS AND METHODS: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer. RESULTS: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence. CONCLUSIONS: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns.

Tips for Testing Adults With Suspected Genetic Kidney Disease.

Genetic kidney disease is common but often unrecognized. It accounts for most cystic kidney diseases and tubulopathies, many forms of congenital abnormalities of the kidney and urinary tract (CAKUT), and some glomerulopathies. Genetic kidney disease is typically suspected where the disease usually has a genetic basis or there is another affected family member, a young age at onset, or extrarenal involvement, but there are also many exceptions to these "rules". Genetic testing requires the patient's written informed consent. When a patient declines testing, another later conversation may be worthwhile. Genetic testing not only indicates the diagnosis but also the inheritance pattern, likely at-risk family members, disease in other organs, clinical course, and possibly effective treatments. Sometimes genetic testing does not identify a pathogenic variant even where other evidence is strong. A variant of uncertain significance (VUS) may be reported but should not be used for clinical decision making. It may be reclassified after more information becomes available without necessarily retesting the patient. Patients should be provided with a copy of their genetic test report, the results explained, and at-risk family members offered "cascade" testing. A referral to a clinical geneticist or genetic counselor helps identify affected family members and in providing advice to assist with reproductive decisions.

Parental request for familial carrier testing in early childhood: The genetic counseling perspective.

Professional guidelines generally caution against carrier testing in minors, though prior research indicates parents request and providers sometimes facilitate testing for unaffected siblings of a child affected by a genetic disorder. We investigated the perspectives of genetic counselors in North America regarding carrier testing prior to adolescence. Practicing genetic counselors (n = 177) responded to an electronic survey assessing their willingness to facilitate testing in four hypothetical scenarios and their evaluation of parental motivations. Participants did not find parental arguments for testing persuasive, and most were unwilling to facilitate carrier testing in children. A significant interaction effect indicated the presence of nonactionable carrier-associated health risks in adulthood made participants significantly less hesitant when the mode of inheritance was X-linked. Participants considered parental motivations that center the child's interests as significantly more persuasive. This study suggests genetic counselors are resistant to carrier testing for familial disorders in young children and tend to align with current guidelines, yet they recognize nuance in various cases. Further investigation into this topic is warranted to support genetic counselors facing these requests as the ethics of pediatric carrier testing continues to be debated.

Mother, father, son and the Italian Law 40/2004. No 'delete' key.

Assisted reproductive technology (ART) has emerged in recent years as a point of significant innovation in the medical field but is also controversial from a bioethical and legal standpoint. In the Italian context, this matter is regulated by Law 40/2004, which specifically requires that informed consent should be obtained from both members of a couple before proceeding with any ART procedure. This consent is deemed irrevocable at the moment of egg fertilization. Recently, a ruling by the Italian Constitutional Court on this matter elicited controversy. The decision permitted embryo transfer even in a case of parental separation, notwithstanding the father's explicit opposition. The Court emphasized the priority of the woman's psychophysical health over the man's, highlighting the traumatic consequences of interrupting the undertaken path. As a result, both the man's right to self-determination regarding the decision to become a father and the need for informed consent at every stage of medical procedures have been downplayed. Moreover, the extensive utilization of procedures like embryo cryopreservation, with associated parental implications, particularly concerning the time frame and the actuality of informed consent, is posing challenges to the initial application framework of Law 40/2004. The objective of this Commentary is to scrutinize and discuss the issues mentioned above.

The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice.

The "A Randomized Trial of Induction Versus Expectant Management" trial (ARRIVE trial) published in 2018 suggested that induction of labor can be considered a "reasonable option" for low-risk nulliparous women at ≥39 weeks of gestation. The study results led some professional societies to endorse the option for elective induction of labor at 39 weeks of gestation in low-risk nulliparas, and this has begun to change obstetrical practice. The ARRIVE trial provided valuable information supporting the benefits of induction of labor; however, the trial is insufficient to serve as the primary justification for widespread elective induction of labor at 39 weeks of gestation in low-risk nulliparas because of concerns about external validity. Thus, the French ARRIVE trial was designed to test the hypothesis in a different setting that elective induction of labor at 39 weeks of gestation in low-risk nulliparas leads to a lower cesarean delivery rate than expectant management. This ongoing trial has been criticized as "pseudoscientific" and telling "women where, when, and how to give birth." We reject these allegations and extensively examine the ethical framework that should govern clinical and research interventions, including elective induction of labor at 39 weeks of gestation in low-risk nulliparas. This study aimed to discuss the ethical issues that emerge from randomized trials of elective induction of labor at 39 weeks of gestation in low-risk nulliparas and the ethics of the clinical practice itself. The analysis of existing evidence shows the importance of further research on induction of labor at 39 weeks of gestation in low-risk women. Certain aspects of research ethics in this area, particularly the consent of pregnant women in a context where autonomy remains fragile, call for vigilance. In addition, we emphasize that childbirth is not only a medical object but also a social phenomenon that cannot be regarded only from the perspective of a health risk to be managed by clinical research. Further research on this issue is needed to allow pregnant women to make informed decisions, and the results should be integrated with social issues. The perspective of women is required in constructing, evaluating, and implementing medical interventions in childbirth, such as induction of labor at 39 weeks of gestation.

Close contacts of xenograft recipients: Ethical considerations due to risk of xenozoonosis.

With decades of pre-clinical studies culminating in the recent clinical application of xenotransplantation, it would appear timely to provide recommendations for operationalizing oversight of xenotransplantation clinical trials. Ethical issues with clinical xenotransplantation have been described for decades, largely centering on animal welfare, the risks posed to the recipient, and public health risks posed by potential spread of xenozoonosis. Much less attention has been given to considerations relating to potentially elevated risks faced by those who may care for or otherwise have close contact with xenograft recipients. This paper examines the ethical and logistical issues raised by the potential exposure to xenozoonotic disease faced by close contacts of xenotransplant recipients-defined herein as including but not limited to caregivers, household contacts, and sexual partners-which warrants special attention given their increased risk of exposure to infection compared to the general public. We discuss implications of assent or consent by these close contacts to potentially undergo, along with the recipient, procedures for infection screening and possible quarantine. We then propose several options and recommendations for operationalizing oversight of xenotransplantation clinical trials that could account for and address close contacts' education on and agency regarding the risk of xenozoonosis.

Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties.

INTRODUCTION: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. METHODS: We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. RESULTS: The main outcomes were language complexity (measured using Flesch-Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch-Kincaid Grade Level and Flesch Reading Ease indices. CONCLUSIONS: Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.

Critical Appraisal of Content Quality of YouTube Videos on the Whipple Pancreaticoduodenectomy.

INTRODUCTION: The coronavirus pandemic has demonstrated profound issues with using the Internet to research health information. For patients recommended a complex operation, such as the Whipple pancreaticoduodenectomy, the quality of health information online has not been appraised. The objective of this study was to define the readability and content quality of YouTube search results for the Whipple pancreaticoduodenectomy. METHODS: The first 100 search results for "whipple procedure" less than 10 min long in English with audio and or text were transcribed. The Flesch-Kincaid Grade defined the reading grade level. High content quality videos were accredited by YouTube in accordance with principles specified by the National Academy of Medicine or mentioned the standard components for a surgical consent. The Anderson-Lau score is a composite of these consent criteria out of a maximum of 8/8. The simplicity of videos for patient education was defined by the DISCERN tool. RESULTS: The reading level of 23% of the top 100 search results met the American average (8th grade). Accreditation was present for 45% and associated with an earlier median search ranking (36 versus 68, P = 0.002) and more 5th-8th grade level material (70% versus 38%, P = 0.014). The median Anderson-Lau score was 3/8 (range = 0/8-7/8) with only 5% achieving 7/8. Only 4% were high quality per DISCERN. CONCLUSIONS: Although accredited videos were more readable, most videos, especially those targeting patients, were beyond the comprehension of the average American. Simpler and higher quality educational materials are needed to inform patients on Whipple pancreaticoduodenectomy beyond their date of clinical diagnosis or surgical consenting.

Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England.

England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England's ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals' decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals.

Waiving the consent requirement to mitigate bias in observational precision medicine research.

Consent bias is a type of selection bias in biomedical research where those consenting to the research differ systematically from those not consenting. It is particularly relevant in precision medicine research because the complexity of these studies prevents certain subgroups from understanding, trusting, and consenting to the research. Because consent bias distorts research findings and causes inequitable distribution of research benefits, scholars propose two types of schemes to reduce consent bias: reforming existing consent models and removing the consent requirement altogether. This study explores the possibility of waiving consent in observational studies using existing data, because they involve fewer risks to participants than clinical trials if privacy safeguards are strengthened. It suggests that data protection mechanisms such as security enhancement and data protection impact assessment should be conducted to protect data privacy of participants in observational studies without consent.

Closing the gaps: consent and preoperative assessment for children and young people.

The changing ethical and legal landscape in the UK means that anaesthetists should routinely be discussing the risk of death during the consent process. To do this effectively means expanding anaesthetic preassessment services for children and young people, something that has been recognised as a priority, but which still needs investment and an appreciation of its value at the trust level.

Do patients actually understand? An evaluation of the informed consent process for endoscopic procedures in rural Uganda.

INTRODUCTION: Improving surgical access in low- and middle-income countries is vital for the 5 billion people who lack safe surgical care. Tailoring a culturally sensitive approach to consent is essential for patient comprehension and comfort, thereby alleviating the effects of resource constraints and advancing equitable care. This study examines the consenting process for endoscopy at Kyabirwa Surgical Center in Kyabirwa, Jinja, Uganda, to assess patients' knowledge and attitudes as a potential barrier to participating in endoscopic procedures. METHODS: All adult upper endoscopy (EGD) and colonoscopy patients were recruited to participate in a survey of their demographics, knowledge, and attitudes toward their procedure. All patients received a standard consultation explaining the procedure and its risks and benefits. RESULTS: 75 patients were included; median age was 54 years and 56% (n = 42) were women. 92% (n = 69) of patients had never had an endoscopy before and 73% (n = 55) of patients were scheduled for an EGD while the remaining 27% (n = 20) were scheduled for a colonoscopy. Most patients 80% (n = 60) had a basic understanding of what an endoscopy is and 87% (n = 65) its diagnostic purpose. Few patients 15% (n = 11) knew of the most common side effects or if they would have a surgical scar 27% (n = 20). Overall, 46.7% (n = 35) of patients were moderately or severely fearful of getting an endoscopy. Additionally, 45.3% (n = 34) of patients were moderately or severely fearful of receiving anesthesia during their endoscopic procedure. Despite this fear, most patients 85.3% (n = 64) stated that they understood the benefits of the procedure either very well or extremely well. CONCLUSIONS: Most patients understood the role that an endoscopic procedure plays in their care and its potential benefits. Despite this, many patients continued to have high levels of fear associated with both the endoscopic procedure and with receiving anesthesia during their procedure. Future patient education should focus on addressing patients' fears and the risks of undergoing an endoscopy, which may improve the utilization of surgical services.

Video consent significantly improves patient knowledge of general surgery procedures.

INTRODUCTION: Informed consent is essential in ensuring patients' understanding of their medical condition, treatment, and potential risks. The objective of this study was to investigate the impact of utilizing a video consent compared to standard consent for patient knowledge and satisfaction in selected general surgical procedures. METHODS AND PROCEDURES: We included 118 patients undergoing appendectomy, cholecystectomy, inguinal hernia repair, and fundoplication at two hospitals in Omaha, NE. Patients were randomized to either a standard consent or a video consent. Outcomes included a pretest and posttest objective knowledge assessment of their procedure, as well as a satisfaction survey which was completed immediately after consent and following discharge. Given the pre-post design, a linear mixed-effect model was estimated for both outcomes. A two-way interaction effect was of primary interest to assess whether pre-to-post change in the outcome differed between patients randomized to standard or video consent. RESULTS: Baseline characteristics were mostly similar between groups except for patient sex, p = 0.041. Both groups showed a statistically significant increase in knowledge from pretest to posttest (standard group: 0.25, 95% CI 0.01 to 0.51, p = 0.048; video group: 0.68, 95% CI 0.36 to 1.00, p < 0.001), with the video group showing significantly greater change (interaction p = 0.043) indicating that incorporating a video into the consent process resulted in a better improvement in patient's knowledge of the proposed procedure. Further, both groups showed a decrease in satisfaction post-discharge, but no statistically significant difference in the magnitude of decrease between the groups (interaction p = 0.309). CONCLUSION: Video consent lead to a significant improvement in a patient's knowledge of the proposed treatment. Although the patient satisfaction survey didn't show a significant difference, it did show a trend. We propose incorporating videos into the consent process for routine general surgical procedures.

Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial.

BACKGROUND: Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting. METHODS: We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants' satisfaction with the consent discussion. RESULTS: We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen's d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen's effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen's effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants' self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149). CONCLUSION: The addition of digital education platform to standard verbal consent significantly improves patient's early and delayed understanding of risks and benefits of LC in an acute care setting.

Young Love "Locked Down": Adolescent and Young Adult Perspectives on Sexting During the Covid-19 Pandemic in England.

There were limited opportunities for in-person social, intimate, and sexual interactions in England during 2020-2021, due to restrictions imposed by the UK government in response to the Covid-19 pandemic. While previous studies examined the effects of lockdown on intimate relationships, there is less qualitative research regarding young people's perspectives on and experiences of digitally mediated intimacy (sexting) during the period. This paper discusses findings from focus groups with 80 adolescents and interviews with 38 young adults that explored the topic. Analysis identified a normalization of non-consensual distribution of intimate images within adolescent peer culture and a reluctance to report or intervene in response to incidents of non-consensual distribution that are witnessed or experienced. The adolescent girls and young adult women also described other forms of unwanted and invasive image-sharing and requests for images. Young adults held various perspectives on sexting during lockdown, with some describing sexting as unfulfilling and/or "risky" and others sharing experiences of using sexting to generate intimacy and, among some, engaging in unwanted sexting with partners. By considering both adolescent and young adult perspectives obtained through focus groups and interviews, the study highlighted how group-level norms and meanings surrounding the risks and rewards of sexting may be reproduced or reworked as individuals transition from adolescence to young adulthood. The study underscores the need to support adolescents and young adults in cultivating healthy digital sexual cultures and interpersonal relationships.