Valid Consent Research Articles

Do we consent to change? An evaluation of oral and maxillofacial outpatient department dentoalveolar consent forms

Obtaining informed consent before performing any dentoalveolar procedure is a professional, ethical, and legal obligation. Prior to this work, in this oral and maxillofacial department, no standardised consent process existed for dentoalveolar procedures. A targeted literature review established localised gold standards for dentoalveolar procedures, and retrospective data from 56 dentoalveolar consent forms over a four-week period assessed baseline compliance with these standards. Data analysis identified that risks of dry socket and trismus were documented in only 7% of cases, and maxillary tuberosity fracture was never documented. Thirty-three per cent of lower third molar cases did not include consent for inferior alveolar nerve injury. Findings were discussed in a departmental audit meeting, and a root cause analysis identified memory failure, repetition fatigue, and varying clinician knowledge and experience, as key drivers. The evidence base and localised gold standards were discussed. A standardised, bilingual, triple-copy dentoalveolar consent form was developed, including predefined indications, additional procedures, and risks, in a tick-box format. This form was presented to the Department of Patient Safety and Quality and gained local approval. Cases completed with the new form will now be evaluated against the localised gold standards, with a mixed-methods feedback survey investigating staff and patient opinions. Local processes for obtaining and documenting valid consent for dentoalveolar treatment were found to be inconsistent and frequently inadequate. Fifteen localised gold standards were set, and a new standardised consent form developed, which will be evaluated for effectiveness and acceptability.

Social and Legal Perspectives on Informed Consent. A Bioethical Approach

In the biolaw literature, the concept of valid consent is sought to be accredited instead of informed consent when discussing medical responsibility and doctor's obligation to inform the patient, as part of their professional obligation, to provide them with treatment/care. In this paper we present a few cases related to ECHR and also a current case of possible malpraxis presented to the Romanian Court, not yet solved at this date.

Should the scope of NIPT be limited by a 'threshold of seriousness'?

Non-invasive prenatal testing (NIPT) has the potential to screen for a wider range of genetic conditions than is currently possible at an early stage of pregnancy and with minimal risks. As such, there have been calls to apply a 'threshold of seriousness' to limit the scope of conditions being tested. This approach is based on concerns about society at large and the potential impact on specific groups within it. In this paper, we argue that limiting the scope of NIPT using the criterion of 'seriousness' is arbitrary, potentially stigmatises certain disabilities over others and fails to respect reproductive autonomy. We contend that concerns about expanded NIPT are more appropriately addressed by the provision of adequate information, counselling and consent procedures. We recommend a decision-making process that helps healthcare providers support prospective parents to make informed decisions about the nature and scope of NIPT screening based on their own values and social context. In addition to addressing concerns about expanded NIPT screening, this process would help clinicians to obtain legally valid consent and discharge their duty of care (including the duty to inform) in the prenatal context.

The teaching and assessment of local anaesthesia in UK dental schools.

Local anaesthesia (LA) is fundamental to successful dental treatment. Graduating hygienists, therapist and dentists should be confident and proficient in delivering LA. There is one previously published article reviewing LA teaching in United Kingdom (UK) dental schools in 2016, and at this time 10 out of 14 schools allowed peer-to-peer administration. The method of teaching LA administration has become an area of debate in terms of legality and morality given the potential complications and issues with valid consent. The aim of the study was to explore current teaching practices and assessment of LA in UK dental schools. Two national surveys (2020 and 2023) were sent out via the ABAOMS Education Committee to all 16 dental schools in the United Kingdom with dental and/or hygiene and therapy programmes. There was a 100% response rate from all schools. There has been a significant shift from peer-to-peer administration of local anaesthesia, with only 4 schools now allowing peer-to-peer administration. The majority of schools use simulation methods to deliver the teaching, including LA models, cadavers and 'cap-on' simulation with a peer. When comparing the timing of teaching between 2020 and 2023, BDS students now administer their first LA injection to a patient later in the programme, and there has been a reduction in intra-professional teaching. Due to the large shift away from practicing LA on peers, there is a need for further development of simulation methods given the drawbacks with current models and the limited development of haptic technology in relation to LA.

Key requirements for obtaining valid informed consent to treatment.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment.

Fulfillment of Permanent Contraception among Patients with Cesarean Delivery in a Multi-Site Cohort.

This study aimed to assess the association between insurance type and permanent contraception fulfillment among those with cesarean deliveries. Additionally, we sought to examine modification by the scheduled status of the cesarean. We used data from a multi-site cohort study of patients who delivered in 2018-2019 at Northwestern Memorial Hospital in Illinois, MetroHealth Medical System in Ohio, or University of Alabama at Birmingham in Alabama. All patients had permanent contraception as their contraceptive plan in their medical chart during delivery hospitalization. We used logistic regression to model the association between insurance type, scheduled status of cesarean and permanent contraception fulfillment by hospital discharge. The scheduled status of cesarean delivery was examined as an effect modifier. Compared to patients with private insurance, those with Medicaid were less likely to have their desired permanent contraception procedure fulfilled by hospital discharge (89.3% vs. 96.8%, p < 0.001). After adjusting for covariates, patients with Medicaid had a lower odds of permanent contraception fulfillment by hospital discharge (OR: 0.41; 95% CI: 0.21, 0.77). This association was stronger among those who had unscheduled cesarean deliveries (OR: 0.29; 95% CI: 0.12, 0.74) than those with scheduled cesarean deliveries (OR: 0.77; 95% CI: 0.32, 1.88). Compared to patients with private insurance undergoing a cesarean delivery, those with Medicaid insurance were less likely to have their desired permanent contraception fulfilled. Physicians and hospitals must examine their practices surrounding Medicaid forms to ensure that patients have valid consent forms available at the time of delivery.

Implant maintenance in general dental practice: dento-legal considerations for the general dental practitioner.

Before implants are placed, the patient, as part of the consent process, should understand the risks of the treatment but also the importance of a lifelong maintenance programme. This is particularly important if the patient is at risk of periodontitis. There should be arrangements in place for the patient's ongoing care and general dental practitioners who look after the patient need to appreciate their duty of care in monitoring the implants. Excellent record-keeping and valid consent are important factors in delivering care and can also very much help assist a defence in the event of a civil claim or a regulatory investigation.

Caring for Valid Sexual Consent

Caring for Valid Sexual Consent

Informed consent in clinical practice: Old problems, new challenges.

Informed consent is a fundamental tenet of patient-centred clinical practice as it upholds the ethical principle of patient autonomy and promotes shared decision-making. In the medicolegal realm, failure to meet the accepted standards of consent can be considered as medical negligence which has both legal and professional implications. In general, valid consent requires three core components: (1) the presence of mental capacity - characterised by the patient's ability to comprehend, retain information, weigh options and communicate the decision, (2) adequate information disclosure - based on the 'reasonable physician' or 'reasonable patient' standards and (3) voluntariness in decision-making. Nonetheless, in real-world clinical settings, informed consent is not always optimally achieved, due to various patient, contextual and systemic factors. In this article, I herein discuss three major challenges to informed consent in clinical practice: (1) patient literacy and sociocultural factors, (2) psychiatric illnesses and elderly patients with cognitive impairment and (3) artificial intelligence in clinical care, and sought to offer practical mitigating strategies to address these barriers.

Valid consent in the acute hospital setting: perspectives of patients and members of the public

BackgroundPeople who interact with healthcare services have an ethical and legal right to control their own lives, to make informed decisions, and to consent to what happens to them. For consent to be considered ethically and legally valid, three key criteria must be met: consent must be given voluntarily; people must be sufficiently informed of all options; and people should have capacity to make the decision to give or withhold their consent.AimThis study set out to explore, through the use of surveys, the perspectives of patients and public in relation to consent.MethodSurveys were developed for patients and the public and administered paper based (patients) and through social media (public).ResultsOne hundred and forty surveys were posted to patients, with a 38% response rate; 104 responses were received from the public. Ninety-six percent of patients were satisfied that the decision they made was informed; 100% felt they had made a voluntary decision; 98% felt the clinician seemed knowledgeable about the procedure. What matters most to the public were being informed about the risks associated with the proposed procedure and being assured that whatever choice they make they will receive the best care possible.ConclusionsThe results highlight interesting similarities and differences in relation to consent between members of the public thinking about a possible treatment, surgery, or procedure and those patients who have actually been through the process in the past 12 months. Recommendations have been developed on the basis of these findings to co-design improvements in consent practices.

Are we gaining valid consent for dental extractions? A retrospective audit on restorability assessment at one dental institution.

Introduction This paper explores the widely relevant topic of obtaining valid consent in dental practice, focusing on assessing restorability of teeth planned for extraction. The General Dental Council stresses discussing treatment options, benefits and risks for informed decision-making. The study evaluates if pertinent factors, including tooth structure, endodontic status, periodontal health and patient considerations, are considered before consent.Aim To ensure restorability has been assessed and all options communicated with patients for completeness of the consent process before tooth extraction.Objective To assist clinicians in their systematic assessment of a tooth's restorability and provide a framework for contemporaneous documentation.Materials and methods A two-week retrospective audit of oral surgery outpatients at a dental hospital in London was conducted, analysing the frequency of restorability discussions and patient involvement in decision-making. A simplified restorability guide and educational interventions were introduced to target the set standard of 100% of consenting clinicians to discuss restorability with patients.Results Results from two audit cycles show a significant increase in documented restorability discussions and consideration of patient factors.Discussion The study recognised restorability assessment subjectivity, thus creating a simplified tool for clinicians. Patients may lack awareness of restorability options, consequences of edentulism, future costs and tooth replacement considerations, emphasising the importance of documented discussions.Conclusion Educational interventions and a simplified restorability guide proved beneficial and showed significant improvement in communication with patients regarding restorability and gaining valid consent. Further consideration should be given to barriers patients face when opting for tooth extraction of their restorable teeth, including discussions regarding long-term consequences.

Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process?

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.

Orthodontic Risk Perspectives among Orthodontists during Treatment: A Descriptive Pilot Study in Greece and Slovakia.

This study explores orthodontists' perspectives on risks associated with orthodontic treatment, as described by Greek and Slovak orthodontists. Informed by the foundational importance of effective communication of risk perspectives in health sciences, particularly in facilitating valid consent and shared decision-making, this research addresses gaps identified in the literature concerning the consistent communication of potential treatment risks based on demographic and cultural characteristics. This study identifies 15 potential critical risks during orthodontic treatment. These risks include root resorption; temporary undesired changes to the occlusion; sleep difficulties; not achieving an ideal result; development of black triangles between teeth; taking additional X-rays; speech difficulties; using a protective splint during sports; duration of treatment; number of visits; transmission of infectious diseases; and swallowing orthodontic appliances. A questionnaire, distributed electronically to orthodontists in Greece (N1 = 570) and Slovakia (N2 = 210) from September 2022 to December 2022, aimed to assess risk communication practices, taking into consideration socio-demographic factors, such as country, gender, age, and academic-degree-related variations. A total of 168 valid questionnaires (91 from Slovakia and 77 from Greece) were obtained, indicating significant disparities in the risks emphasized and preferred forms of consent. The Greek orthodontists focused more on the risks involved, such as relapse, root resorption, temporal occlusal changes, and failure of desired movement, while the Slovak practitioners tended to be more interested in sleeping difficulties, temporal occlusal changes, and not achieving an ideal result. They also obtained written or digital consent from patients or their parents/guardians more frequently than the Greek team. Male orthodontists discussed specific risks more frequently, including relapse and extractions, whereas females preferred written or digital consent. PhD-trained orthodontists prioritized certain risks, indicating the need for tailored approaches. This study underscores the dynamic nature of risk assessment in orthodontic practice, emphasizing its ethical and strategic dimensions. The findings advocate for tailored risk communication strategies that recognize individual, contextual, and cultural factors, and the need for an orthodontic informed consent protocol for a tailored communication approach for patients to elevate the standard of care in European orthodontics. The reliance on digital tools reflects contemporary trends in enhancing patient understanding, thereby supporting ongoing innovation in orthodontic practices.

The Donation of Human Biological Material for Brain Organoid Research: The Problems of Consciousness and Consent

Human brain organoids are three-dimensional masses of tissues derived from human stem cells that partially recapitulate the characteristics of the human brain. They have promising applications in many fields, from basic research to applied medicine. However, ethical concerns have been raised regarding the use of human brain organoids. These concerns primarily relate to the possibility that brain organoids may become conscious in the future. This possibility is associated with uncertainties about whether and in what sense brain organoids could have consciousness and what the moral significance of that would be. These uncertainties raise further concerns regarding consent from stem cell donors who may not be sufficiently informed to provide valid consent to the use of their donated cells in human brain organoid research. Furthermore, the possibility of harm to the brain organoids raises question about the scope of the donor’s autonomy in consenting to research involving these entities. Donor consent does not establish the reasonableness of the risk and harms to the organoids, which ethical oversight must ensure by establishing some measures to mitigate them. To address these concerns, we provide three proposals for the consent procedure for human brain organoid research. First, it is vital to obtain project-specific consent rather than broad consent. Second, donors should be assured that appropriate measures will be taken to protect human brain organoids during research. Lastly, these assurances should be fulfilled through the implementation of precautionary measures. These proposals aim to enhance the ethical framework surrounding human brain organoid research.

Incidence of depression in pregnant and postpartum women in tertiary care hospital using Edinburg postpartum depression scale: A prospective observational clinical study

Abstract Background: Depression is a mood disorder characterized by physical symptoms like fatigue, pain, sleep disturbances, and/or a persistently low mood. Antenatal depression refers to a nonpsychotic depressive condition that starts during pregnancy. Postpartum depression, on the other hand, emerges within a month after childbirth and can persist for up to 1 year. The objective of this study is to determine the occurrence of depression among women during both the antenatal and postnatal periods by utilizing the Edinburgh Postnatal Depression Scale (EPDS). Materials and Methods: From 1 August 2022 to 1 September 2023, 246 women responded to the EPDS questionnaire during and after childbirth. Valid consent was obtained from all participating subjects before the study’s commencement. Results: The study revealed that depressive disorders affected 23.2% of women during the antenatal period and 20.3% during the postnatal phase. A higher prevalence of depression was observed among multiparous women (53.7%) and those aged between 25 and 34 years (64.2%). Additionally, significant associations between depression and risk factors like cesarean delivery (54.1%) were identified. Conclusion: Both the postpartum period and pregnancy pose increased risks for the onset of various psychiatric disorders. This research assisted in screening, classifying, and identifying high-risk individuals and providing guidance and support to those requiring additional assistance and counseling. Therefore, regular EPDS screening can potentially enhance maternal and child health outcomes.

CONSENT IN THE DECISION-MAKING PRACTICE OF THE SLOVAK DPA

Consent in personal data regulation presents one of the legal bases that legitimizes personal data processing realised by the controller. Despite the controller’s frequent referral to consent as a legal basis for such processing, the fulfilment of legal conditions for valid consent provision can prove challenging to many controllers. In this regard, the paper examines the existing decision-making practice of the national data protection authority – the Office for Personal Data Protection of the Slovak Republic – concerning the deficiencies regarding data subject’s consent provision that resulted in the initiation of administrative proceedings before this office and in the issuance of sanctions for the infringement of the applicable regulation on consent provision.

A cross-sectional study of noninfectious - nonvenereal genital dermatoses among adult males at tertiary care hospital in South Gujarat.

A number of dermatoses affect the genitalia in a unique and distinct manner. Nonvenereal dermatoses may not be restricted to genitalia alone; it may affect other body sites and mucous membranes as well. Dermatoses involving genital areas are not necessarily sexually transmitted. Skin lesions of the genitalia may be physiological, venereal, or nonvenereal in origin. Studies on genital dermatoses of only nonvenereal and noninfectious origin among adults are not commonly documented in India. The objectives of this study were to determine the clinical pattern and frequency of noninfectious nonvenereal genital dermatoses. A total of 261 patients with noninfectious nonvenereal genital dermatoses attending tertiary care hospital were enrolled from August 2019-July 2020. Cases of more than 18 years of age who had given informed valid consent were included in the study, whereas venereal or infectious dermatoses were excluded from this study. The diagnosis was established based on a detailed history, examination, biopsy, and relevant investigations. Data collection was done using predesigned pro forma, and analysis was perfomed using MS Excel. Maximum participants were middle aged with a mean age of 43.38 ± 9.45 years. The most common nonvenereal genital dermatoses were vitiligo (23.37%), followed by physiological conditions (19%-92%), papulosquamous dermatosis (18.77%), lichen simplex chronicus (16.48%), premalignant conditions (6.51%), vesiculobullous conditions and benign conditions (4.98%) each, adverse cutaneous drug reactions (4.21%), and malignant conditions (0.77%). About 78.54% of participants had dermatosis over genitalia only. Focal vitiligo was the most common dermatosis involving only genitalia. This study is novel as participants enrolled only of noninfectious, nonvenereal genital dermatoses among males.

Is Automated Consent in Solid GDPR-Compliant? An Approach for Obtaining Valid Consent with the Solid Protocol

Is Automated Consent in Solid GDPR-Compliant? An Approach for Obtaining Valid Consent with the Solid Protocol

Exploring the complexities of posthumous reproduction in fertility preservation for oncology patients with poor prognosis.

The field of fertility preservation (FP) for oncology patients has evolved significantly in recent years, offering new possibilities for individuals with life-threatening illnesses. We commend Jones et al. for their comprehensive ethical review of offering FP to patients with poor prognoses, acknowledging the potential benefits that it may bring. "Poor prognosis" in this context implies a high likelihood of death due to cancer progression. We highlight the importance of considering posthumous reproduction, involving the use of cryopreserved gametes or embryos to conceive a child after one or both partners have passed away, a topic briefly mentioned by Jones et al. Posthumous reproduction raises complex ethical, logistical, and legal questions. Distinctions between cryopreserved sperm and oocytes are discussed, with each scenario presenting unique challenges. The article also examines the complexities faced by same-sex couples in posthumous reproduction, addressing issues related to donor selection, legal parentage, and rights. Legal and regulatory aspects play a crucial role, including obtaining clear and legally valid consent, defining parental rights, navigating surrogacy laws, and addressing inheritance and estate planning. Ethical dilemmas require healthcare professionals to ensure informed decision-making, consider psychological impacts, and offer information on alternative family-building options.

DARIAH-HR digital tools in the frame of Open Science

Responsibility, ethics, inclusiveness, and the principles of Open Science are central to the advancement of scholarly research and publishing. By embracing these values, we can create a more transparent, collaborative, and accessible research ecosystem, as proposed by UNESCO (2022). However, there is a pressing need for effective tools that aid researchers in practising Open Science while addressing the specific requirements of disciplines such as the Humanities and Arts, especially in the context of the welldocumented prevalence of STEM disciplines over the Humanities in the development of Open Science and Open Access trends (Eve, 2014). The Digital Research Infrastructure for the Arts and Humanities (DARIAH-EU) consortium, formed by "researchers for researchers", is uniquely positioned to address this inequality while driving the development of an open ecosystem that naturally evolves from authentic community practices and needs (Tóth-Czifra, 2021). Croatia as a member country with its DARIAH-HR coordination office readily follows it in this endeavour by organising workshops, creating one-of-a-kind digital platforms and tools, etc.In this poster presentation we aim to introduce several digital tools designed or codesigned by DARIAH-HR for scholars in the fields of the Humanities and Arts (and broader): 1) a digital tool for the creation of thesauri, 2) a digital tool for creating registers, 3) a digital tool for generating GDPR-compliant forms for obtaining consent from data subjects and 4) a software for modelling, processing and representation of monumental heritage and culture of memory. While the first and second tools represent pioneering efforts to encompass the widest community of humanists and researchers in Croatia, the third and fourth tools provide in-depth solutions in their respective areas of focus, extending their reach to an international level and catering to a diverse audience that includes researchers as well as tourists.The digital thesaurus creation tool “tezaurus.hr” is designed to streamline the process of developing structured vocabularies relevant to the Humanities and Arts. The digital register development tool “DH Register” provides a user-friendly interface (currently in development) that enables researchers to create and curate registries, incorporating metadata standards while adhering to the requirements of the FAIR principles (as recommended in, e.g., Hahnel &amp; Valen, 2020). The “Consent Form Wizard” (CFW) is a tool developed by the DARIAH-EU working group Ethics and Legality in Digital Arts and Humanities (ELDAH) to support humanities researchers within the European Union in obtaining valid consent for data processing in the context of their specific professional activity. “Monument Heritage Map” is a digital platform that allows the implementation of available data and methods for data collection, processing, multimodal visualisation and mapping of cultural monuments.When integrated into an Open Science framework, these tools provide researchers with efficient means to enhance knowledge organisation, resource sharing, and collaboration while upholding responsible research practices and promoting inclusivity within the academic community. Enabling researchers to create user-friendly thesauri and registers also facilitates the discoverability, interoperability, and accessibility of research outputs. Conclusively, it contributes to the development of a robust and interconnected research infrastructure.Through the presentation of these digital tools and their implications, this poster seeks to contribute to the discourse surrounding responsible and inclusive research in the context of the Humanities and Arts. It emphasises the significance of training, education, and capacity building for Open Science.