Consent Practices Research Articles

Informed consent practices for exome sequencing: An interview study with clinical geneticists in the Netherlands.

BackgroundGenomic sequencing is being used more frequently in the clinic, not only by clinical geneticists, but also by other specialists (“mainstreaming”). The use of genomic sequencing gives rise to challenges regarding informed consent, as it can yield more, and more complex results.MethodsThis study maps the informed consent process for exome sequencing in the Netherlands by means of semistructured interviews with 14 clinical geneticists. Interviewees were asked about their strategies for informing patients about exome sequencing and supporting patients in their decision making, about what they think of as essential information elements, about the challenges they experience, and about their preferences for future policy and practice.ResultsClinical geneticists typically discuss the following topics: the nature and aim of the test, the possible results (including unsolicited or incidental findings and Variants of Uncertain Significance) of the test and the consequences of those results for the patient and their family members. Some clinical geneticists use a layered approach to informed consent, meaning that they give short and concise information at first, and provide more detailed information depending on the situation or the needs of the patient.ConclusionDuring pre‐test counseling for genomic sequencing, clinical geneticists use various strategies to enhance patient understanding and personalization of the informed consent process. Going forward, layering information may be part of a solution to ethical challenges of informed consent, also in mainstream settings.

Informed consent, genomic research and mental health: A integrative review.

BackgroundResearch on genomics has increased while the biobank activities are becoming more common in different countries. In the mental health field, the questions concerning the potential participants’ vulnerability as well as capacity to give the informed consent can cause reluctancy in recruiting persons with mental health problems, although the knowledge and understanding of mental health problems has remarkable changed, and practice is guided with inclusive approaches, such as recovery approach.AimThe aim of this study was to describe the current knowledge of informed consent practices in the context of genomic research on mental health from the nurses’ viewpoint.MethodsAn integrative review was conducted with search from seven international databases. Data consist 14 publications which were analyzed with thematic analysis.Ethical considerationsEthical requirements were respected in every phase of the research process.FindingsMost of the papers were published in USA and between 2000–2010. Eight reports were categorized as discussion papers, four qualitative studies and one quantitative study. The thematic analysis provided information on five themes: complexity with the capacity to consent, mixed emotions towards participation, factors influencing the decision to participate, nurses’ informed consent process competence and variations between consent procedures.DiscussionIn the informed consent practices, there are various aspects which may affect both the willingness to participate in the study and the informed consent process itself. Implications for practice, education, research, and policies are discussed.ConclusionThere is a need for more updated international research on the topic in the context of different international and national guidelines, legislation, and directives. This study provided a viewpoint to the more collaborative research activities with people with lived experiences also in this field of research following the ideas of recovery approach.

Using Principles of Theatrical Intimacy to Shape Consent-based Spaces for Minors

In lieu of an abstract, here is an excerpt: 
 Understanding the way that the adolescent mind may respond to perceived danger and how that response could potentially become a habitualized response encouraged me to research how to adapt the best practices of boundaries and consent for specific developmental stages among minors.
 As I realized the importance of adapting these best practices, I knew that this work would revolutionize middle school and high school theatre and drama programs. However, in order for these best practices to have an ultimately positive and developmentally supportive outcome, I recognized the need to make adjustments based upon the cognitive development of the artists in question. The needs of a minor in a creative environment differ from those of the adult. Through research and experimentation, I began to alter the approaches to the best practices based on the developmental stage of the subject. While the foundations remained the same, the approach and terminology shifted. As we began to work with secondary educators at our workshops, it became apparent that bringing the best practices of Theatrical Intimacy Education to middle and high school educators was an effective next step.

Living Kidney Donor Knowledge of Provided Information and Informed Consent: The PRINCE Study.

Background: Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation. Methods: In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B). Results: In total, 656 pop quizzes were completed (417 in Cohort A, and 239 in Cohort B). The average donor knowledge score was 7.0/25.0 (±3.9, range 0–18) in Cohort A, and 10.5/25.0 (±2.8, range 0–17.5) in Cohort B. Cohort B scored significantly higher on overall knowledge, preparedness, and the individual item scores (p < 0.0001), except for the long-term complications (p = 0.91). Conclusions: Donor knowledge generally improves during the live donor workup, but it is still quite disappointing. Long-term complications, especially, deserve more attention during living kidney donor education.

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Amending Federal Regulations to Counteract Language Barriers in the Informed Consent Process

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

Leave me out: Patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence.

Opt-out procedures are sometimes used instead of standard consent practices to enable patients to exercise their autonomous preferences regarding research participation while reducing patient and researcher burden. However, little is known about the characteristics of patients who opt-out of research and their reasons for doing so. We gathered such information in a large pragmatic clinical trial (PCT) evaluating the effect of theory informed text messages on medication adherence.Eligible patients, identified through electronic health records, were sent information about the study and provided with an opportunity to opt-out. Those opting out were asked to complete a voluntary survey regarding their reasons for doing so. Demographic data were compared among patients opting-out vs those included in the study using chi-squared tests and a log binomial regression model.Of 9046 patients receiving study packets, 906 (10.0%) patients returned opt-out forms. Of those, 451 (49.8%) returned the opt-out survey. Patients who opted out were more likely to be older, white, and nonHispanic than those who were included in the PCT. Survey respondents expressed high levels of trust in their health care providers, research, and system. Nearly half (46.6%) reported concerns about time as a reason to opt-out.In this PCT, 10% of patients receiving packets opted out, with significant differences in age, race, gender, and ethnicity compared to those included. Future trials should further investigate representativeness and reasons patients choose to opt-out of participating in research.

“If Their Face Starts Turning Purple, You Are Probably Doing Something Wrong”: Young Men’s Experiences with Choking During Sex

Choking/strangulation during sex has become prevalent in the United States. Yet, no qualitative research has addressed men’s choking experiences. Through interviews with 21 young adult men, we examined the language men use to refer to choking, how they first learned about it, their experiences with choking, and consent and safety practices. Men learned about choking during adolescence from pornography, partners, friends, and mainstream media. They engaged in choking to be kinky, adventurous, and to please partners. While many enjoyed or felt neutral about choking, others were reluctant to choke or be choked. Safety and verbal/non-verbal consent practices varied widely.

"It Was Scary, But Then It Was Kind of Exciting": Young Women's Experiences with Choking During Sex.

Choking/strangulation during sex is prevalent among young adults, with one study finding that 58% of women college students had ever been choked during sex. However, no qualitative study has examined women’s experiences with choking/strangulation during sex outside of intimate partner violence. The purpose of our qualitative interview study was to investigate women’s experiences with choking and/or being choked during partnered sex. Through in-depth interviews with 24 undergraduate and graduate women students ages 18 to 33, we sought to understand how women communicate about choking, their learning about and initiation into choking, their feelings about being choked and choking others, as well as consent and safety practices used in relation to choking. We found that women had first learned about choking through diverse sources including pornography, erotic stories, magazines, social media, friends, and partners. While all 24 women had been choked during sex, only 13 of 24 had ever choked a partner. They described having engaged in choking with men as well as women and with committed as well as more casual partner types. Participants described consensual and non-consensual choking experiences. While many women enjoyed choking, others did it largely to please their sexual partner. Women described different methods and intensities of having been choked. Although very few had ever sought out information on safety practices or risk reduction, and only some had established safe words or safe gestures with partners, participants consistently expressed a belief that the ways in which they and their partner(s) engaged in choking were safe.

Advanced considerations in organ donors.

The rising need for lung transplantation over recent years has not paralleled the availability of suitable lung allografts. The number of lung transplantations performed each year in the United States remains limited by an inadequate supply of suitable donors as well as low donor utilization rates. While several methods have been proposed for increasing the donor pool, there is considerable disparity between acceptance and utilization of these practices among transplant centers. In this review article, we explore various approaches for enhancing donor selection and expanding the donor pool. We discuss the use of “extended criteria” donors including high risk groups such as drug overdose donors, and we examine the role of techniques in donor assessment and selection such as the use of computed tomography for accurate size matching. We review topics in donor management such as the establishment of specialized donor care facilities and the implementation of lung-focused resuscitation protocols, and we discuss advancements in donor procurement such as the utilization of local procurement teams. We also review barriers to donation, such as variability in organ procurement organization (OPO) consent practices, as well as patient-specific factors such as religious or cultural beliefs. Addressing these aspects of donor evaluation, management, and accessibility is essential in maximizing the number of lungs available for transplantation within the existing donor pool.

Practice and Factors Associated with Informed Consenting Process for Major Surgical Procedures Among Health-Care Workers, South Eastern Ethiopia.

BackgroundMedical malpractice, poor patient outcome and medical suits among health-care workers result from improper consenting practices. Therefore, this study aimed to assess practice and factors associated with the informed consenting process for major surgical procedures among health-care workers in public hospitals of Bale Zone, South Eastern Ethiopia.MethodsAn institutional-based cross-sectional study was conducted from March 9 to 24, 2020, among all nurses, midwives, doctors (general physicians, surgeons, gynecologists), emergency surgery officers, anesthetists) who were working at Bale Zone public hospitals during the study period. A self-administered pretested questionnaire was employed. Variables with a p-value of less than 0.25 (age group, sex, educational profession, working unit, work experience, adequate content of consent form, training on informed consent, policy/regulation in institution, administrative support, average number of patient cared per shift, time spent for consent process, knowledge, attitude) at 95% confidence interval in the binary logistic regression analysis were considered for multivariable regression model to control for possible confounding effect.ResultsOf the total sample size (639 health-care workers), 621 (97.2%) were included in this study, of which 311 (50.1%, 95% CI: 46.1–53.8) practiced proper informed consent during major surgical procedures. Being age above 35 (AOR: 3.032, 95% CI: 1.148–8.010), male (AOR: 1.607, 95% CI: 1.047–2.465), above 10 years of working experience (AOR: 2.339, 95% CI: 1.104–4.955), adequate content of consent form (AOR: 2.785, 95% CI: 1.772–4.377), having training on informed consent (AOR: 2.305, 95% CI: 1.204–4.414), spending more time (>30minutes) for consent process (AOR: 3.014, 95% CI: 1.095–8.298), having good knowledge (AOR: 1.808, 95% CI: 1.195–2.737) and favorable attitude (AOR: 2.188, 95% CI: 1.456–3.287) were significantly associated with good informed consent practice.ConclusionOnly half of health-care workers practiced good informed consent. Further emphasis needs to be given to improve consent practice.

The Three Dimensions of Unsolicited Dick Pics: Men Who have Sex with Men’s Experiences of Sending and Receiving Unsolicited Dick Pics on Dating Apps

The unsolicited “dick pic” (DP), which refers to a photo of a penis that is sent without the consent of the recipient, has been identified as a form of technology-facilitated sexual violence (Powell & Henry, 2017). While men who have sex with men (MSM) experience elevated rates of technology-facilitated sexual violence, much of the research has focused on interactions between heterosexual men and women. This study investigated the experiences that MSM have with sending and receiving unsolicited DPs on dating apps. Analysis of interviews with 25 MSM dating app users in Canada revealed three “dimensions” of unsolicited DPs—consensual, wanted, and typical—that capture users’ experiences of receiving such images relative to consent and sexual violence frameworks. Seven factors, including the attractiveness of the sender and the DP, had an impact on MSM’s experiences. Unsolicited DPs were found to be sent for a variety of reasons, including to compliment the recipient and to coerce them into replying with sexual images. It is argued that MSM have trivialized unsolicited DPs and that these images are, according to current definitions, a form of technology-facilitated sexual violence that MSM experience on dating apps. However, there were variations in participants’ experiences and some participants did not characterize unsolicited DPs as problematic or non-consensual, which challenges the notion that MSM always experience these images as sexually violent. These findings shed light on the complexities of unsolicited DPs and indicate the need to (re)examine definitions of technology-facilitated violence and explore MSM’s consent practices within the context of dating apps.

SP4.1.6 Introduction of Concentric digital and remote consent into clinical practice during the COVID-19 pandemic

IntroductionPaper-based consent processes are associated with errors of omission, illegibility and unwarranted variation. During the COVID-19 pandemic the Royal College of Surgeons (England) released guidelines supporting the use of remote consent. The aim was to evaluate the introduction of Concentric, a digital consent application, into clinical practice.MethodBetween April 2020-Jan 2021, Concentric was used optionally for medical consent during registered service evaluations. Data was obtained from Concentric analytics. User and patient feedback was obtained via optional satisfaction surveys.Results3417 Concentric consent episodes for 356 unique procedures were performed by 170 clinicians across 16 specialties from 13 healthcare providers. Patients were aged 7-101years, (median 58, IQR 30). Of the completed consent episodes (n = 2799), consent was given; remotely in 23% of episodes, and on the day of surgery in 67%. Consent form information was shared digitally with 82% of patients. Average patient user experience was 8.8 out of 10 (1 very poor - 10 excellent, n = 594). 546/594 (91.9%) patients agreed that Concentric provided all the information they needed to know. Clinicians (n = 23) rated the quality of the consent process with Concentric as 4.8 out of 5 with all supporting the use of Concentric across the Trust.ConclusionConcentric has been successfully introduced into clinical practice. Patients and clinicians report high satisfaction scores. Remote consent is feasible and trends in consent practice, such as day of surgery consent can be easily identified and can guide quality improvement work. The introduction of digital consent solutions should be considered for all units.

EP.WE.162Correct consenting for Vascular Patient

Abstract Introduction Surgeons must establish and maintain effective relationships with patients and, where appropriate, with their supporters. Before surgery, surgeons should strive to have an honest and sensitive discussion with patients about their options for treatment that leads to informed and deliberate consent. The aim of this study is to compare our consent practice in the vascular department in Royal Stoke Teaching Hospital against consent guideline in the Best surgical practice and to if we are meeting patient satisfaction. Method A prospective study of 30 patients from 21/09/2020 to 21/10/2020. Questionnaire form was designed based on the best surgical practice guideline and was given to the patient to fill. We include patients admitted for elective vascular procedures, wide range ages. The questionnaire Results Most of the of the patient (90%) were consented by the professionals who provide the treatment. 63% of the patients asked for further information in the form pf leaflets or websites. 70% of them request to know the recent guidelines of their procedures. Only 13% of them had a copy of the consent prior to surgery. Recommendations We must provide the patients with further information, Recent guidelines, and a copy of the consent to take home prior to surgery day. This can be achieved by consenting them before the operation day.

SP7.2.7 Consenting practice in open inguinal hernia mesh repair and compliance with the British Hernia Society Standards

Abstract Aims Inguinal hernia repairs (IHRs) are one of the most frequently performed procedures worldwide with approximately 100,000 taking place in the UK each year. This study analyses open IHR consent practice against British Hernia Society standards, in particular, whether the term ‘mesh’ and significant postoperative complications were stated on consent forms. We also identified whether adequate post operative advice was given upon discharge in order to prevent recurrence. Methods This was a retrospective audit of all patients above 18 years old, who underwent open IHR 1 January - 31st December 2019. A total of 94 patients were included. Results Although in all cases a prolene mesh was inserted, 8.5% of patients received no mention of mesh in either the clinic letter or consent form. Postoperative readmission was 5.3% at one week, and 8.5% at one month. Reasons for readmission included pain (1%), haematoma (2%), and wound dehiscence (1%). In over 90% of consent forms, non-specific complications (bleeding, infection) were documented. However, common IHR postoperative complications, such as chronic pain (not mentioned in 15%), were not mentioned in consent forms. Only 38% of patients received written postoperative advice. Conclusion Adherence to consenting standards benefits both patients and doctors. Our study highlights that further intervention is required to ensure surgeons are consenting patients adequately, as well as providing sufficient postoperative advice. We advise use of pre-filled forms and patient information leaflets, both in line with GMC guidance, to improve the quality of service offered.

108 Neck of Femur Fractures: Streamlined Approach to Improve Consenting Practices

Abstract Aim Neck of femur fractures (NOFs) are synonymous with frailty, and successful outcomes are achieved with operative fixation. The United Kingdom’s General Medical Council guidance governing consent highlights the importance of thorough pre-operative discussion of risk with the patient. We aimed to audit consenting practices in NOF patients within our unit against the British Orthopaedic Association’s (BOA) criteria, with the addition of delirium as a risk factor. Method In cycle one all operatively managed NOFs over a two-month period in October-November 2019 were retrospectively reviewed. Consent forms 1 (CF1) and 4 (CF4) were assessed against BOA-endorsed criteria. Our intervention included a standardised sticker detailing 14 important risks was introduced and a departmental seminar on delirium. A second cycle was undertaken from August-October 2020 to close the audit loop Results No consent form documented all BOA-approved risk factors in cycle one (N = 35). Of cycle two’s 35 patients, 70.8% CF1 were completed using the novel sticker. All of these had 100% BOA-approved risk documentation. Consent forms without the sticker in cycle two documented 9/14 risks (mean value). No CF4 had any risks documented in either cycle. Delirium was documented in 51% in total and in 75% patients with CF1. Delirium documentation improved from 2.9% in cycle one to 51.4% in cycle two. Conclusions Clear lapses in operative consenting processes were identified, especially regarding delirium and CF4 documentation. The introduction of a novel consent sticker drastically improved compliance with BOA guidance for CF1. Recognition and departmental education regarding delirium significantly reduced incidence between cycles.

Identity and Antibiogram of Bacterial Isolates from Owerri Modern Abattoir, Imo State, Nigeria

Aim: The identity and antibiogram of bacterial isolates from Owerri modern abattoir in Imo State, Nigeria, was investigated with the aim of determining the bacterial profile of the abattoir and their susceptibility pattern to commonly used antibiotics.&#x0D; Study Design: Cross sectional study&#x0D; Place and Duration of Study: This study was carried out in Owerri Modern Abattoir located within Owerri metropolis from June to November, 2020.&#x0D; Methodology: Questionnaires were used to obtain participants’ consent, demographic data and sanitary practices in the abattoir. Samples were taken and bacteriological analysis of the samples done using pour plate method. Disc diffusion antibiotic susceptibility testing and minimum inhibitory concentration were performed after colony counting, identification and characterization of the isolates using standard microbiological and biochemical techniques.&#x0D; Results: Mean viable bacterial counts were generally high with highest counts from contaminated soil (6.13x106CFU/ml) and least from workers hands (1.17x106CFU/ml). Escherichia coli had the highest prevalence (18.0%), with the highest counts from soil (3.10%). Vibrio cholerae recorded the least prevalence (0.62%), and was isolated only from washing water. High resistance to antibiotics was observed.&#x0D; Conclusion: Government authority and the general public are advised to ensure adequate environmental sanitation and proper cooking of meat before consumption in order to mitigate the incidence of infection and antibiotic resistance.

Sexual Consent Across Diverse Behaviors and Contexts: Gender Differences and Nonconsensual Sexual Experiences.

Sexual consent refers to people’s internal willingness to engage in sexual activity with another person—as well as their external communication of that willingness. Internal and external sexual consent can vary by type of sexual behavior; however, previous research on sexual consent has primarily only assessed “typical” sexual behaviors such as genital touching, oral sex, and vaginal–penile sex without providing further context or acknowledging people’s sexual diversity. Therefore, we provided an initial account of people’s sexual consent—and lack thereof—for a broader array of sexual behaviors and contexts in which they occur. Using an online cross-sectional survey of participants in the United Kingdom and the United States (N = 658, 50.5% women), we examined event-level internal and external sexual consent for 20 sexual behaviors or contexts. Women reported significantly lower levels of sexual consent feelings than men for 12 of the 20 sexual behaviors and lower levels of active consent communication for 7 of them. Almost a third of participants (31.0%) had experienced at least one of the listed sexual behaviors against their will. Of those, participants on average reported nonconsensual experiences with 3.1 of the 20 types of sexual behavior listed, ranging from 1 to 11. More women reported at least one nonconsensual experience with one of the sexual behaviors assessed compared with men (47.9% versus 22.3%, respectively). We discussed several behavior-specific findings regarding sexual consent and the lack thereof. We also made recommendations for initiatives aimed at promoting healthy sexual consent practices: embrace sexual diversity, emphasize sexual agency, and encourage active consent communication.

Communicating consent in sport: A typological model of athletes’ consent practices within combat sports

This paper provides a systematic attempt to empirically describe the ways in which athletes’ consent to take part in sport is socially constructed, communicated and understood by others. Due to a notable lack of prior research on this topic, we draw on insights from sex research to theorise consent as a communicative social practice, specifically applying this notion to interpreting the world of competitive combat sports. To do so, we combine data from across numerous studies using the method of concatenated exploration, producing a post hoc, longitudinal, cross-contextual qualitative analysis of the ways in which consent is practiced in such settings. We then outline a four-point typology of how consent is performed, including the following categories: overt communication; subtle communication; assumed consent and deferred consent. We conclude by arguing that the apparent predominance of subtle, assumed and deferred consent presents some worrying implications for athletes’ freedom, potentially undermining the morally transformative potential of consent within these ostensibly ‘violent’, often injurious sports contexts.

Reshaping the review of consent so we might improve participant choice

Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.