Consent Decision Research Articles

Scalarity and divided consent: analysing rape

In this essay, it is submitted that consent comes in degrees and the wrongfulness and harmfulness of conduct is contingent on the degree of voluntariness underwriting the particular consent decision. A fully free decision to consent changes the normative nature of the act: genuine gift-giving is not theft. Lovemaking is not rape. Partially free decisions to consent can change the nature of the act if it makes the act less harmful and thus less wrongful. Partial consent is not about claiming that the conduct was partially justified, but rather about demonstrating the particular act was less harmful and thus deserving of a less serious crime label than is found in the label rape simpliciter. A second theme picked up in this essay is the issue of conditional consent. It is submitted that breaching a condition (conditions such as D is rich, D is a pacifist, D does not have HIV and so on) of consent to sexual intercourse will not change otherwise consensual nature of the sexual intercourse itself, but it may give rise to criminal liability for the collateral harm caused such as HIV infection.

P-342 Improving consent procedures to increase oocyte donation rates

Abstract Study question Can consent procedures for donation of surplus frozen oocytes be changed to improve donation rates? Summary answer Obtaining informed consent for donation of oocytes after freezing could be improved by adapting new consent procedures used in genomic biomedical research for ART contexts. What is known already The widespread adoption of oocyte cryopreservation has led to a rapid accumulation of oocytes in cryostorage, since the number of people who return to use their eggs remains low. Previous studies show that many people intend to donate their surplus cryopreserved oocytes, but few people actually donate them. Increased rates of donation are required to address chronic shortages of eggs available for both reproductive and research purposes. Study design, size, duration This paper examines whether advances in consent procedures in genomic research and biobanking, such as Dynamic Consent interfaces, could be utilised within the ART context to improve patient experience and oocyte donation rates. Ethical issues with dynamic consent are considered as well as the possible benefits of such a system for potential donors and recipients of oocytes. Participants/materials, setting, methods This paper undertakes ethical analysis of the procedures used for obtaining informed consent in egg freezing for donation of surplus eggs. We consider whether these could be improved and argue that adapting advances in consent procedures, such as dynamic consent interfaces, may help to facilitate donation, with benefits to both donors and recipients. Main results and the role of chance While people freezing eggs often express an intent to donate eggs surplus to their own needs at the start of the freezing process, in few cases does this translate to actual donation. Current processes seek consent for donation at limited times throughout the cryostorage period. Further, some countries such as Australia require that eggs be donated to specific active research projects at the time that eggs are to be relinquished from storage. Factors such as these impede donation and fail to facilitate the initial expressed intent to donate surplus eggs. We hypothesise that consent processes can be improved in ways that may boost rates of donation while still satisfying the requirements of informed consent. Dynamic consent allows continuous review of consent decisions through an online interface. Adaptation of this approach to the context of egg cryopreservation and donation may have several benefits, as continuous communication and review opportunities encourage patient engagement. It may enhance understanding of the need for eggs and increase knowledge of opportunities to donate surplus eggs. While dynamic consent may benefit both potential donors and recipients, careful implementation would be required to ensure compatibility with counselling requirements and other ethical standards for reproductive donation in particular. Limitations, reasons for caution We consider the potential benefits to donors and recipients but do not analyse the costs of implementing such a system of consent for clinics. Further, specific clinics may have consent procedures that differ from the model we use here and may be constrained by regulatory contexts Wider implications of the findings Recent research suggests that cryopreserved oocytes are rarely used or donated. Improving procedures for obtaining informed consent promises to increase rates of donation and improve patient experience. Dynamic consent tools have been widely used in biobanking and genomics research to positive effect but would be novel within the ART context. Trial registration number Not Applicable

Impact of Legal Guardian Absence on Research Enrollment in the PICU.

To identify the frequency of which a legal guardian is at the bedside of children admitted to the PICU that are eligible for research studies. A prospective, observational study. Three tertiary Canadian PICUs. Two hundred one patients were admitted to the PICU between September 2021 and March 2023 (site 1), from March 2019 to March 2020 and March 2022 to March 2023 (site 2), and from March 2019 to March 2020 and July 2020 to November 2021 (site 3). None. At each center, the duration of consent encounters was recorded for patients eligible for research by documenting the length of each attempt (min). The frequency of parental presence at bedside and the ability for a guardian to make a decision were also recorded. Thirty-five percent of patients eligible for research did not have a legal guardian at the bedside on the first attempted consent encounter. Twenty-three percent of approached patients were not enrolled due to an inability for a consent decision to be made by the child's legal guardian or an inability to contact the guardian before discharge. The absence of legal guardians in the PICU poses a barrier to the enrollment of critically ill children in pertinent research studies and suggests that a model of deferred consent or implied consent would aid in the future of critical care research.

Understanding moderators of consent regarding the sharing of supermarket shopping data in ALSPAC.

Introduction & BackgroundShopping data is a valuable resource, offering insights into consumer behaviour and health. In recent years, there has been a growing interest in using shopping data for the purposes of health research. However, little is known about the characteristics of those who are willing to share their shopping data with researchers. Objectives & ApproachThis study aims to investigate the factors that influence individuals' decisions to consent to sharing their shopping data for research purposes. We will leverage data from a cohort study – the Avon Longitudinal Study of Parents and Children (ALSPAC) – to address this question. We will draw upon the responses of a 2018 survey, which asked ALSPAC participants about their use of supermarket loyalty cards, their perceived acceptability of sharing this data with ALSPAC, and their perspectives on potential privacy concerns. Of the 4,462 respondents, 65.4% indicated ownership of at least one major UK supermarket or store loyalty card. Among these, 88.4% expressed a potential willingness to share this data with ALSPAC for research purposes. In the present day – around 2023 – participants have explicitly either granted or withheld consent for the sharing of this data. Our analysis approach will consider factors such as biological gender, ethnicity, education, employment, socioeconomic status, and anxiety as potential moderators to the consent process. We plan to employ a mix of standard statistical methods to analyse sampling biases in the dataset, including regression modelling and correlation tests. Relevance to Digital FootprintsOur study will contribute to the growing body of literature on data linkage between cohort studies and digital footprints datasets. ResultsThe findings from this study will offer valuable insights into the factors influencing participants' consent decisions regarding data sharing. We will contribute to ongoing discussions about privacy and the ethical use of digital footprints data, informing the development of more inclusive consent processes in this field. Conclusions & ImplicationsThis study will inform consent practices in the realm of digital footprints, identifying and addressing potential barriers to consent, and contributing to the ongoing discourse on the responsible and ethical use of shopping data.

Exploring Parental Knowledge, Attitudes, and Factors Influencing Decision-Making in Stem Cell Banking: Rising the Future of Medical Treatment.

Stem cellbanking (SCB) is a promising area of modern medicine with the potential to yield innovative treatments and cures. To effectively educate parents and implement laws and regulations that address parental concerns and encourage informed decision-making, it is imperative to emphasize parental viewpoints and their consequences for future healthcare. The study aims to establish the Saudi Arabian population's level of understanding regarding SCB and to comprehend the elements influencing parental knowledge, attitudes, and SCB decision-making processes. A cross-sectional study was conducted among the population in the Makkah region of Saudi Arabia. Demographic data, knowledge levels, attitudes, and decision-making variables were gathered from 380 respondents. The study reveals a lack in their comprehension of the objectives and possible uses of SCB, together with the main sources of information on those banks and conveniently available banking choices. It showed varied results regarding attitudes about considering an SCB for their children. In addition, the majority of respondents had not made a consent decision about SCB for their children. It also illuminates the factors that could influence participants' decisions about SCBfor their children and shows that a lack of information and understanding is the main obstacle faced by parents regarding SCB. It highlights that participants were generally in favor of learning more about SCB for their children. This study broadens our understanding of parental decision-making toward SCB and clarifies the elements influencing parents' opinions and worries and offers significant ramifications for lawmakers, medical professionals, and SCB. These implications can be utilized to enhance communication strategies, create instructional programs, and ease the fears of concerned parents.

Assessing the impact of mixed reality-assisted informed consent: A study protocol.

Informed consent is a crucial aspect of modern medicine, but it can be challenging due to the complexity of the information involved. Mixed reality (MR) has emerged as a promising technology to improve communication. However, there is a lack of comprehensive research on the impact of MR on medical informed consent. The proposed research protocol provides a solid foundation for conducting future investigations and developing MR-based protocols that can enhance patients' understanding and engagement in the decision-making process. This study will employ a randomized controlled trial design. Two arms will be defined: MR-assisted informed consent (MRaIC) as the experimental arm and conventional informed consent (CIC) as the control arm consent, with 52 patients in each group. The protocol includes the use of questionnaires to analyze the anxiety levels and the awareness of the procedure that the patient is going to perform to study the impact of MRaIC versus CIC before medical procedures. The study will evaluate the impact of MR on patients' information comprehension, engagement during the process of obtaining informed consent, emotional reactions, and consent decisions. Ethical concerns will be addressed. This study protocol provides a comprehensive approach to investigate the impact of MR on medical informed consent. The findings may contribute to a better understanding of the effects of MR on information comprehension, engagement during the process of obtaining informed consent, psychological experience, consent decisions, and ethical considerations. The integration of MR technology has the potential to enhance surgical communication practices and improve the informed consent process.

Factors Influencing Parental Willingness to Consent to a Survey Study for Patients in the Pediatric Emergency Department.

To identify factors that impact parental willingness to consent to research studies conducted for their children during visits to pediatric emergency departments (EDs). Parents and guardians of children receiving care in our pediatric ED were approached and asked if they would be willing to let their child participate in a research study requiring the child to complete an electronic questionnaire. No such questionnaire existed, however, because the primary purpose was to ascertain the parent's willingness to let their child participate. All parents were debriefed and informed of the true purpose of the study and asked to complete a survey themselves to help understand factors that influenced their initial decision of whether to consent. Bivariate tests and logistic regression were used to evaluate unadjusted and adjusted associations between parent and patient characteristics and parental consent decision. We approached 431 eligible parents about the hypothetical research study involving their children, and 386 (89.6%) consented for their children to participate. After the debriefing, 392 (91.0%) parents consented to complete the parental survey. We observed statistically significant associations between shorter length of ED stay to approach for consent for the study ( P = 0.048) as well as longer travel time ( P = 0.03) and willingness to consent in bivariate analysis, though this did not hold in regression analysis. Regression analysis revealed parents of children who have previously participated in research had 79 times lower odds of consenting to participate in our study adjusted for parent race, ethnicity, actual and perceived length of stay, travel time to the ED, and altruism. A high proportion of parents consented to their child participating in research in our ED with previous child participation in research being associated with lower odds of parental consent even when adjusted for other factors. Our findings may inform future research practices and studies investigating parental perceptions and motivations surrounding research studies.

Participant characteristics and reasons for non-consent to health information linkage for research: experiences from the ATHENA COVID-19 study

BackgroundThe linkage of primary care, hospital and other health registry data is a global goal, and a consent-based approach is often used. Understanding the attitudes of why participants take part is important, yet little is known about reasons for non-participation. The ATHENA COVID-19 feasibility study investigated: 1) health outcomes of people diagnosed with COVID-19 in Queensland, Australia through primary care health data linkage using consent, and 2) created a cohort of patients willing to be re-contacted in future to participate in clinical trials. This report describes the characteristics of participants declining to participate and reasons for non-consent.MethodsPatients diagnosed with COVID-19 from January 1st, 2020, to December 31st, 2020, were invited to consent to having their primary healthcare data extracted from their GP into a Queensland Health database and linked to other data sets for ethically approved research. Patients were also asked to consent to future recontact for participation in clinical trials. Outcome measures were proportions of patients consenting to data extraction, permission to recontact, and reason for consent decline.ResultsNine hundred and ninety-five participants were approached and 842(85%) reached a consent decision. 581(69%), 615(73%) and 629(75%) consented to data extraction, recontact, or both, respectively. Mean (range) age of consenters and non-consenters were 50.6(22-77) and 46.1(22-77) years, respectively. Adjusting for age, gender and remoteness, older participants were more likely to consent than younger (aOR 1.02, 95%CI 1.01 to 1.03). The least socio-economically disadvantaged were more likely to consent than the most disadvantaged (aOR 2.20, 95% 1.33 to 3.64). There was no difference in consent proportions regarding gender or living in more remote regions. The main reasons for non-consent were ‘not interested in research’ (37%), ‘concerns about privacy’ (15%), ‘not registered with a GP’ (8%) and ‘too busy/no time’ (7%). ‘No reason’ was given in 20%.ConclusionYounger participants and the more socio-economically deprived are more likely to non-consent to primary care data linkage. Lack of patient interest in research, time required to participate and privacy concerns, were the most common reasons cited for non-consent. Future health care data linkage studies addressing these issues may prove helpful.

Development of a New Tool for Writing Research Key Information in Plain Language.

The complexity of research informed consent forms makes it hard for potential study participants to make informed consent decisions. In response, new rules for human research protection require informed consent forms to begin with a key information section that potential study participants can read and understand. This research study builds on exiting guidance on how to write research key information using plain language. The aim of this study was to develop a valid and reliable tool to evaluate and improve the readability, understandability, and actionability of the key information section on research informed consent forms. We developed an initial list of measures to include on the tool through literature review; established face and content validity of measures with expert input; conducted four rounds of reliability testing with four groups of reviewers; and established construct validity with potential research participants. We identified 87 candidate measures via literature review. After expert review, we included 23 items on the initial tool. Twenty-four raters conducted 4 rounds of reliability testing on 10 informed consent forms. After each round, we revised or eliminated items to improve agreement. In the final round of testing, 18 items demonstrated substantial inter-rater agreement per Fleiss' Kappa (average = .73) and Gwet's AC1 (average = .77). Intra-rater agreement was substantial per Cohen's Kappa (average = .74) and almost perfect per Gwet's AC1 (average = 0.84). Focus group feedback (N = 16) provided evidence suggesting key information was easy to read when rated as such by the Readability, Understandability and Actionability of Key Information (RUAKI) Indicator. The RUAKI Indicator is an 18-item tool with evidence of validity and reliability investigators can use to write the key information section on their informed consent forms that potential study participants can read, understand, and act on to make informed decisions. [HLRP: Health Literacy Research and Practice. 2024;8(1):e29-e37.].

Informed consent process experience in Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer’s Disease Colombia trial

AbstractBackgroundRecruiting cognitively‐unimpaired volunteers at high genetic risk of developing dementia into the Alzheimer’s Prevention Initiative (API) Colombia trial, and maintaining study adherence for at least 5 years has been a monumental challenge. Major barriers included inclusion criteria, protocol visit schedule, long informed consent form (ICF), low levels of education of participants, misconceptions about participating in a clinical trial, and blinding to genetic status and treatment arm. We explain how our group went out of the conventional and traditional schemes of informed consent while adhering to good clinical practice and developed a novel approach to the consent process for potential candidates.MethodThe identification, community education, and follow‐up of affected PSEN1 E280A families for the past three decades was the initial fundamental step to initiate a proper ICF process for the study. Then the launch of API Colombia Registry in 2010 was the base for appropriate preparation for the prevention trial. The process for API Colombia trial included step by step strategies, such as: a pre‐screening process developed by the team, pre‐consent informational meeting with the principal investigator in small groups of potential candidates, illustrated materials like a booklet titled “What I should know about informed consent and my decision to participate”, and detailed infographics as a complementary material to main study ICF, use of a voluntary pre‐selection survey. The screening visit was divided in parts: discussion with the sub‐investigator about clinical trial participation, review of participant’s questions, and signatures according to regulatory requirements.ResultFrom 623 potentially eligible registrants for pre‐screening, 319 were consented and underwent full eligibility screening and 252 were randomized. After eight years of study duration, 94% of participants completed the protocol, 90.5% completed the trial on treatment. Most participants who dropped out of the study did it due to incompatibility with work, unexpected pregnancy, or the decision to have children.ConclusionWe attribute successful trial adherence to the consent process that led to a well‐informed, voluntary, and responsible decision, and the participant’s understanding of the unique contribution they can make to change the world by participating in clinical research.

The Efficacy and Safety of Surufatinib Combined with Anti PD-1 Antibody Toripalimab in Neoadjuvant Treatment of Locally Advanced Differentiated Thyroid Cancer: A Phase II Study.

Surgery is the primary treatment for locally advanced differentiated thyroid cancer (DTC). However, some locally advanced patients are not candidates for R0/1 resection. There is limited evidence of neoadjuvant treatment in locally advanced DTC. Surufatinib targets multiple kinases, which is efficient, tolerable, and safe in patients with radioiodine-refractory DTC. In addition, surufatinib plus toripalimab (an anti-PD-1 antibody) showed encouraging antitumor activity in advanced solid tumors. This study was designed to evaluate the efficacy and safety of surufatinib plus toripalimab in locally advanced DTC in the neoadjuvant setting. In this single-arm, phase II study, patients with pathologically confirmed unresectable or borderline resectable DTC were eligible and received a combination of 250mg of surufatinib (orally daily) with 240mg of toripalimab (intravenous, every 3weeks). Treatment continued until satisfied for curative surgery, disease progression, withdrawal of consent, unacceptable toxicity, or investigator decision. Primary endpoint was objective response rate (ORR). Secondary endpoints included R0/1 resection rate, adverse events (AEs), etc. RESULTS: Ten patients were enrolled and received at least 4 cycles of treatment. The ORR was 60%. Nine patients received R0/1 resections after neoadjuvant treatment. The median best percentage change in the sum of the target lesion diameter was 32%. Most adverse events (AEs) were grade 1 or 2. Surufatinib in combination with toripalimab as neoadjuvant therapy for locally advanced DTC was feasible, and the majority of patients achieved R0/1 resection. It represents a new option for locally advanced DTC and needs further investigation.

Barriers to Deceased Donor Procurements: The Saudi Experience.

Barriers to Deceased Donor Procurements: The Saudi Experience.

Data Owner Benefit-Driven Design of People Analytics

With increasingly digitalized workplaces, the potential for sophisticated analyses of employee data rises. This increases the relevance of people analytics (PA), which are tools for the behavioral analysis of employees. Despite this potential, the successful usage of PA is hindered by employee concerns. Especially in Europe, where the GDPR or equivalent laws apply, employee consent is required before data can be processed in PA. Therefore, PA can only provide relevant insights if employees are willing to share their data. One potential way of achieving this is the use of appeal strategies. In the design of PA, the core strategy that can be used is the inclusion of data owner benefits, such as automated feedback, that are given to employees in exchange for sharing their own data. In this paper, we examine benefits as an appeal strategy and develop four design principles for the inclusion of benefits in PA. Then, we describe an exemplary set of analyses and benefits, demonstrating how our principles may be put into practice. Based on this exemplary implementation, we describe and discuss the results of a user study (n = 46) among employees in the EU and UK. Our study investigates the factors that foster or hinder employees' consent to sharing their data with PA. Then, we introduce our data owner benefits and analyze whether they can positively influence this consent decision. Our introduced data owner benefits were, contrary to our expectations, not suited to motivate our participants to consent to sharing their data. We therefore analyze how participants judge the benefits. Participants generally appreciate having them, confirming the value of including data owner benefits when designing PA. Some of our introduced benefits negatively influenced participants' sharing decision, though, meaning that careful consideration of potential risks is required when conceptualizing them.

DataUnions: A privacy-by- decentral-design

Privacy by design suggests seven principles to embed privacy into systems, but artificial intelligence (AI) and data practice shows a ‘privacy paradox’ in the behaviour of users. The ever-evolving AI capabilities outpace privacy policies and people require more insight into the possible use of their data to make informed consent decisions. Keeping the human in the loop for reconsenting brings huge efforts and is disproportional to agile development. Decentral data management approaches promise efficient ways to handle crowd ownership, rights and their governance involvement, supporting privacy-by-design. This paper illustrates how a DataUnion approach for data-centric AI can efficiently combine decentralised, privacy-preserving features such as data non-fungible tokens (NFTs), federated learning, marketplaces, provenance or value sharing. The discussion concludes on data provenance being a key lever leading to the need for a blockchain protocol that makes privacy contributions an incentivised asset along the data value chain of enriching, verifying and governing data for AI. The quest for explainability in a model-centric approach is the quest for provenance in a data-centric approach.

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study.

Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data. Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach. Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed. Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research. Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.

Editorial

Editorial

Is a partially informed choice less autonomous?: a probabilistic account for autonomous choice and information

The standard account for the role of information in patients’ consent decisions was provided by Faden and Beauchamp. According to this account, in order to make a substantially autonomous choice, a patient needs to receive and understand all the information material to the choice. But the scope of material information is controversial, and it is difficult to determine whether a choice based on partial information is substantially autonomous or not. In order to solve the problem, this paper tries to use “autonomy-undermining ignorance” to capture Faden and Beauchamp’s view of how ignorance undermines autonomous decision-making. It is believed that autonomy-undermining ignorance is key to understanding the relationship between autonomous choices and information in the clinical context. A probabilistic account of this relationship is presented. According to this account, one’s choice can be regarded as substantially autonomous as long as one minimizes the risk of autonomy-undermining ignorance (provided that other conditions of autonomous choice are satisfied). In order to do this, one needs to receive and understand as much accessible information as possible that is likely to be material to a particular choice. This means that sometimes one’s choice based on partial information can also be regarded as substantially autonomous. The practical implication of the probabilistic account is that it allows patients to reasonably choose the information needed for autonomous decision-making in light of a specific situation, rather than invariably requiring them to receive and understand sufficient information to make a consent decision in the clinical context.

Ethical Need for a Fertility Decision-Aid for Transgender Adults of Reproductive Age

Ethical Need for a Fertility Decision-Aid for Transgender Adults of Reproductive Age

A GDPR-Compliant Dynamic Consent Mobile Application for the Australasian Type-1 Diabetes Data Network.

Australia has a high prevalence of diabetes, with approximately 1.2 million Australians diagnosed with the disease. In 2012, the Australasian Diabetes Data Network (ADDN) was established with funding from the Juvenile Diabetes Research Foundation (JDRF). ADDN is a national diabetes registry which captures longitudinal information about patients with type-1 diabetes (T1D). Currently, the ADDN data are directly contributed from 42 paediatric and 17 adult diabetes centres across Australia and New Zealand, i.e., where the data are pre-existing in hospital systems and not manually entered into ADDN. The historical data in ADDN have been de-identified, and patients are initially afforded the opportunity to opt-out of being involved in the registry; however, moving forward, there is an increased demand from the clinical research community to utilise fully identifying data. This raises additional demands on the registry in terms of security, privacy, and the nature of patient consent. General Data Protection Regulation (GDPR) is an increasingly important mechanism allowing individuals to have the right to know about their health data and what those data are being used for. This paper presents a mobile application being designed to support the ADDN data collection and usage processes and aligning them with GDPR. The app utilises Dynamic Consent-an informed specific consent model, which allows participants to view and modify their research-driven consent decisions through an interactive interface. It focuses specifically on supporting dynamic opt-in consent to both the registry and to associated sub-projects requesting access to and use of the patient data for research purposes.

Informed Consent and Shared Decision Making in the Perioperative Environment.

Informed consent and shared decision making (SDM) are crucial portions of preoperative patient management. Informed consent is a standard for surgery from both a legal and ethical standpoint, involving disclosure of potential risks of a procedure and ensuring patient understanding of these risks. SDM is a process in which a clinician and patients decide between two or more treatment plans, taking into account the patient's goals and values. SDM is a particularly important aspect of patient-centered care when two or more treatment options exist or in situations where an indicated treatment may not align with the patient's long-term goals. This article details aspects of and issues surrounding informed consent and SDM.