Consent Decision Research Articles

Family experiences with non-therapeutic research on dying patients in the intensive care unit

Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well...

Individual’s Own Consent and External Support Shape Consumer Decision towards Healthy Packaged Food Intention

The increasing percentage of processed food has transformed human diseases trends from acute to chronic diseases which are the cause of unhealthy food choices. To educate consumers the food label is the most suitable source of information. The primary objective of the current study is to examine how external factors encourage consumers to purchase package food and to what extent consumers’ inner voice reply. The model was tested on 467 sample size. For the final analysis SEM AMOS was employed. Results have unfolded the fact that there is partial mediation exist. Conscientiousness has made relation weaken which indicates that although external factors such as attitude towards food label and subjective norms are decisive for informed food choices but personality traits’ role is inevitable. The current study has contributed in existing literature but a comprehensive model required in developing consumers’ awareness towards selection of right amount package food. Practical: Food processing companies are designing easy to interpretive labels but the understanding of consumers’ personality traits can give them competitive edge in market.

Facilitators and barriers for parental consent to pediatric emergency research.

Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies. This was a cross-sectional survey assessing parents' willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision. Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited "benefits that research would provide to future children" most strongly influenced their decision to agree. ED investigators should highlight the benefits for future children and inquire about parents' previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated. Obtaining consent for pediatric emergency research is challenging and this study identified factors influencing parental consent for research in EDs. Benefits for future children and parents' previous research experience were two of the most influential factors in parents' willingness to consent to ED research studies. These findings will help to improve enrollment in ED research studies and better our understanding of how to promote the health and well-being of pediatric patients.

Reconsidering Privacy Choices: The Impact of Defaults, Reversibility, and Repetition

Despite significant stated privacy concerns among online consumers, research has found almost uniform acceptance of online consent decisions. In recent years, policy makers have adopted sweeping privacy-related regulations to address these concerns. These regulations change the way that online consent is elicited, in hopes of encouraging more deliberative and self-interested privacy decision making by consumers. This study aims to explore the effects of these changes on consumer consent decisions. We isolate three specific tenets of modern privacy regulation, reduction in privacy consent opted-in by default, reversibility, and repeated consent, and explore their effects on individual behavior. We conduct an online experiment that presents participants with actual disclosure decisions that asks participants to link sensitive disclosures to personal information through the decision to “log-in.” Expectedly, we find that active choice consent structure and a protective opt-out consent structure decrease log-ins significantly compared to default opt-in. However, opposite the expectation that repeated exposure will lead to less susceptibility to choice defaults, we find that repeated exposure increases the effect of choice defaults, further entrenching their impact. For reversible consent decisions, we also find the surprising result that both explicit reversibility and explicit irreversibility increase the impact of protective defaults by up to 50%. We conclude that while opt-out defaults can drive more protective consumer behavior, in combination with reversibility and repeated exposure, they may the unintended effects of an over-reaction by consumers and lead to drastic reductions in consent provided. Our results extend the current privacy literature and have significant implications for consumers, firms, and policy makers.

Can they stomach it? Parent and practitioner acceptability of a trial comparing gastric residual volume measurement versus no gastric residual volume in UK NNU and PICUs: a feasibility study

BackgroundRoutine measurement of gastric residual volume (GRV) to guide feeding in neonatal and paediatric intensive care is widespread. However, this practice is not evidence based and may cause harm. As part of a feasibility study, we explored parent and practitioner views on the acceptability of a trial comparing GRV measurement or no GRV measurement.MethodsA mixed-methods study involving interviews and focus groups with practitioners and interviews with parents with experience of tube feeding in neonatal and/or paediatric intensive care. A voting system recorded closed question responses during practitioner data collection, enabling the collection of quantitative and qualitative data. Data were analysed using thematic analysis and descriptive statistics.ResultsWe interviewed 31 parents and nine practitioners and ran five practitioner focus groups (n=42). Participants described how the research question was logical, and the intervention would not be invasive and potential benefits of not withholding the child’s feeds. However, both groups held concerns about the potential risk of not measuring GRV, including delayed diagnosis of infection and gut problems, increased risk of vomiting into lungs and causing discomfort or pain. Parent’s views on GRV measurement and consent decision making were influenced by their views on the importance of feeding in the ICU, their child’s prognosis and associated comorbidities or complications.ConclusionsThe majority of parents and practitioners viewed the proposed trial as acceptable. Potential concerns and preferences were identified that will need careful consideration to inform the development of the proposed trial protocol and staff training.

Dark and Bright Patterns in Cookie Consent Requests

Dark patterns are (evil) design nudges that steer people’s behaviour through persuasive interface design. Increasingly found in cookie consent requests, they possibly undermine principles of EU privacy law. In two preregistered online experiments we investigated the effects of three common design nudges (default, aesthetic manipulation, obstruction) on users’ consent decisions and their perception of control over their personal data in these situations. In the first experiment (N = 228) we explored the effects of design nudges towards the privacy-unfriendly option (dark patterns). The experiment revealed that most participants agreed to all consent requests regardless of dark design nudges. Unexpectedly, despite generally low levels of perceived control, obstructing the privacy-friendly option led to more rather than less perceived control. In the second experiment (N = 255) we reversed the direction of the design nudges towards the privacy-friendly option, which we title “bright patterns”. This time the obstruction and default nudges swayed people effectively towards the privacy-friendly option, while the result regarding perceived control stayed the same compared to Experiment 1. Overall, our findings suggest that many current implementations of cookie consent requests do not enable meaningful choices by internet users, and are thus not in line with the intention of the EU policymakers. We also explore how policymakers could address the problem.

Informed Consent and Shared Decision Making in Obstetrics and Gynecology: ACOG Committee Opinion Summary, Number 819.

Meeting the ethical obligations of informed consent requires that an obstetrician-gynecologist gives the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment. Shared decision making is a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient's values and priorities. Some informed consent challenges are universal to medicine, whereas other challenges arise more commonly in the practice of obstetrics and gynecology than in other specialty areas. This Committee Opinion focuses on informed consent for adult patients in clinical practice and provides new guidance on the practical application of informed consent through shared decision making. The principles outlined in this Committee Opinion will help support the obstetrician-gynecologist in the patient-centered informed consent process.

Informed Consent and Shared Decision Making in Obstetrics and Gynecology: ACOG Committee Opinion, Number 819.

Meeting the ethical obligations of informed consent requires that an obstetrician-gynecologist gives the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment. Shared decision making is a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient's values and priorities. Some informed consent challenges are universal to medicine, whereas other challenges arise more commonly in the practice of obstetrics and gynecology than in other specialty areas. This Committee Opinion focuses on informed consent for adult patients in clinical practice and provides new guidance on the practical application of informed consent through shared decision making. The principles outlined in this Committee Opinion will help support the obstetrician-gynecologist in the patient-centered informed consent process.

Perceived Benefits and Burdens of Participation for Caregivers of Cancer Patients in Hospice Clinical Trials: A Pilot Study

ContextHospice is a service for those with a life expectancy of six months or less. Family caregivers suffer from depression and anxiety as they care for their loved one until they die. Little is known about how research participants decide to consent to participate in clinical trials in the hospice setting. ObjectivesThis pilot study sought to answer two research questions: 1) In what way do demographic characteristics, mental health, and perceived caregiving experience impact the decision by caregivers to participate in hospice clinical trials? 2) In what ways do the perceived physical, psychological, economic, familial, and social dimensions of caregivers' lives influence their decision to participate in hospice clinical trials? MethodsThe characteristics and stated reasons for consent of hospice caregivers participating in a clinical trial were compared with individuals who refused clinical trial consent and only consented to this pilot study. Demographic, mental health, and perceptions of caregiving experience were measured as influencers to the consent decision. Recruitment calls were recorded and coded using framework analysis to identify perceived benefits and burdens impacting the decision to consent to the clinical trial. ResultsOverall, trial participants were more often adult children to the patient (55% vs. 21%, P = 0.005), younger (56 vs. 63 years, P = 0.04), and employed (47% vs. 24%, P = 0.02) as compared with those who did not consent to participate in the trial. Reported levels of depression, anxiety, and quality of life were not significantly different between those who chose to participate in the clinical trial and those who participated only in this pilot study; however, caregiver burden was higher for those consenting to the clinical trial (4.05 vs. 7.16, P < 0.0001). Perceived benefits expressed by both groups were largely psychological as participants felt positive about contributing to science. Burdens expressed by both groups were predominately physical as they related to hesitation to participate in the intervention because of technology or the burdens of caregiving. ConclusionThe benefits and burdens model for clinical trial participation is applicable to the caregiver experience in the hospice setting. Understanding the perceptions and dimensions of benefits and burdens to potential study participants is critical to not only the intervention design but also the tailoring of recruitment contacts and informed consent process.

Robotic-Assisted Total Knee Arthroplasty: An Assessment of Content, Quality, and Readability of Available Internet Resources

BackgroundThe use of robotic-assisted total knee arthroplasty (TKA) has significantly increased over the past decade. Internet content is largely unregulated and may contain inaccurate and/or misleading information about robotic TKA. Our goal was to assess the content, quality, and readability of online material regarding robotic-assisted TKA. MethodsWe conducted an internet search for the top 50 web sites from each of the 3 most popular search engines (Google, Yahoo, and Bing) using the search term robotic total knee replacement. Each web site was assessed for content, quality, and readability. Web site quality was assessed utilizing the QUality Evaluation Scoring Tool (QUEST). Readability was assessed utilizing the Simple Measure of Gobbledygook, Flesch-Kincaid Grade Level, and Flesch Reading Ease Formula scores. ResultsGeneral risks of TKA were discussed in 47.2%, while benefits were discussed in 98.6% of all web sites. Inaccurate claims occurred at a significantly higher rate in physician/community hospital sources compared to university/academic web sites (59% vs 28%, P = .045). Web sites from university/academic web sites had the highest QUEST scores, while physician/community hospital sources scored the lowest (16.1 vs 10.6, P = .01). Most web sites were written at a college reading level or higher. ConclusionPatients should be counseled on the largely unregulated nature of online information regarding robotic-assisted TKA. Physicians and hospitals should consider revising the readability of their online information to a more appropriate level in order to provide accurate, evidence-based information to allow the patient to make an informed consent decision.

Multiple Purposes, Multiple Problems: A User Study of Consent Dialogs after GDPR

AbstractThe European Union’s General Data Protection Regulation (GDPR) requires websites to ask for consent to the use of cookies forspecific purposes. This enlarges the relevant design space for consent dialogs. Websites could try to maximize click-through rates and positive consent decision, even at the risk of users agreeing to more purposes than intended. We evaluate a practice observed on popular websites by conducting an experiment with one control and two treatment groups (N= 150 university students in two countries). We hypothesize that users’ consent decision is influenced by (1) the number of options, connecting to the theory of choice proliferation, and (2) the presence of a highlighted default button (“select all”), connecting to theories of social norms and deception in consumer research. The results show that participants who see a default button accept cookies for more purposes than the control group, while being less able to correctly recall their choice. After being reminded of their choice, they regret it more often and perceive the consent dialog as more deceptive than the control group. Whether users are presented one or three purposes has no significant effect on their decisions and perceptions. We discuss the results and outline policy implications.

Early Postoperative Mortality Among Patients Aged 75 Years or Older With Stage II/III Rectal Cancer.

Elderly patients with rectal cancer have been excluded from randomized studies, thus little is known about their early postoperative mortality, which is critical for informed consent and treatment decisions. This study examined early mortality after surgery in elderly patients with locally advanced rectal cancer (LARC). Using the National Cancer Database, we identified patients aged ≥75 years, diagnosed with clinical stage II/III rectal cancer who underwent surgery in 2004 through 2015. Descriptive analyses determined proportions and trends and multivariable logistic regression analyses were performed to determine factors associated with early mortality after rectal cancer surgery. Among 11,794 patients with rectal cancer aged ≥75 years, approximately 6% underwent local excision and 94% received radical resection. Overall 30-day, 90-day, and 6-month postoperative mortality rates were 4.2%, 7.8%, and 11.5%, respectively. Six-month mortality varied by age (8.4% in age 75-79 years to 18.3% in age ≥85 years), and comorbidity score (10.1% for comorbidity score 0 to 17.7% for comorbidity score ≥2). Six-month mortality declined from 12.3% in 2004 through 2007 to 10.2% in 2012 through 2015 (Ptrend=.0035). Older age, higher comorbidity score, and lower facility case volume were associated with higher 6-month mortality. Patients treated at NCI-designated centers had 30% lower odds of 6-month mortality compared with those treated at teaching/research centers. Six-month mortality rates after surgery among patients aged ≥75 years with LARC have declined steadily over the past decade in the United States. Older age, higher comorbidity score, and care at a low-case-volume facility were associated with higher 6-month mortality after surgery. This information is necessary for informed consent and decisions regarding optimal management of elderly patients with LARC.

Dissenting voices in a consenting village: lessons from implementation of free, prior and informed consent at a REDD+ pilot in Tanzania

Free, prior and informed consent (FPIC) is a key institutional tool in meeting social safeguards. Its implementation ensures respect of the local people's rights in an intervention. This paper presents a case of FPIC implementation at a REDD+ pilot site. Data were obtained through key informant interviews and focus group discussions with proponents and village members of the Lindi REDD+ project. Findings indicate that the inclusive approach to FPIC by taking the consultations to the hamlet level did not deliver a flawless process. The consent decision was reached by a majority vote, not consensus. There was some dissent, prompting the early establishment of project implementation committees. Consent was obtained, though it was not absolutely free, prior and informed. Future REDD+ projects should consider having FPIC as an independent and earlier process, separate from the main implementation of the project in order to uphold local peoples' rights in a less anxious process.

Situational user consent for access to personal Information: Does purpose make any difference?

Privacy literature in recent years has emphasized the role of context and situation in individuals' privacy regulation. While most research is focused on understanding situational effects on self-disclosure, the role of situational factors in users’ decision to consent for third-party access to information, a common practice with significant privacy implications, has been barely investigated. The current study bridges this gap by adopting the framework of situational privacy to examine the effect of the purpose for information collection on participants' consent. An online experiment examined users' consent to allow access to their Facebook profile to an unknown entity, with requests distinguished by the framing of the purpose for collecting information as related to security, commercial or academic research. Contrary to the study’s hypothesis, consent rate was similar between groups and purpose was non-significant in explaining participants’ decisions. Furthermore, in all three groups- compensation amount and general willingness to disclose information explain user consent, regardless of purpose. However, some specific factors significantly correlate with consent in each group separately. The study concludes that due to blurring boundaries and uncertainties regarding real uses of information, when it comes to consent for third-party access, predetermined attitudes and preferences are main factors influencing users’ decisions, thus a situational framework is partly adequate for explaining variations in user consent decisions.

Notice After Notice-and-Consent: Why Privacy Disclosures Are Valuable Even If Consent Frameworks Aren't

AbstractThe dominant legal and regulatory approach to protecting information privacy is a form of mandated disclosure commonly known as “notice-and-consent.” Many have criticized this approach, arguing that privacy decisions are too complicated, and privacy disclosures too convoluted, for individuals to make meaningful consent decisions about privacy choices—decisions that often require us to waive important rights. While I agree with these criticisms, I argue that they only meaningfully call into question the “consent” part of notice-and-consent, and that they say little about the value of notice. We ought to decouple notice from consent, and imagine notice serving other normative ends besides readying people to make informed consent decisions.

Notice After Notice-and-Consent: Why Privacy Disclosures Are Valuable Even If Consent Frameworks Aren't

Abstract The dominant legal and regulatory approach to protecting information privacy is a form of mandated disclosure commonly known as “notice-and-consent.” Many have criticized this approach, arguing that privacy decisions are too complicated, and privacy disclosures too convoluted, for individuals to make meaningful consent decisions about privacy choices—decisions that often require us to waive important rights. While I agree with these criticisms, I argue that they only meaningfully call into question the “consent” part of notice-and-consent, and that they say little about the value of notice. We ought to decouple notice from consent, and imagine notice serving other normative ends besides readying people to make informed consent decisions.

Automating Dynamic Consent Decisions for the Processing of Social Media Data in Health Research.

Social media have become a rich source of data, particularly in health research. Yet, the use of such data raises significant ethical questions about the need for the informed consent of those being studied. Consent mechanisms, if even obtained, are typically broad and inflexible, or place a significant burden on the participant. Machine learning algorithms show much promise for facilitating a "middle-ground" approach: using trained models to predict and automate granular consent decisions. Such techniques, however, raise a myriad of follow-on ethical and technical considerations. In this article, we present an exploratory user study (n = 67) in which we find that we can predict the appropriate flow of health-related social media data with reasonable accuracy, while minimizing undesired data leaks. We then attempt to deconstruct the findings of this study, identifying and discussing a number of real-world implications if such a technique were put into practice.

Impact of prior hysterectomy on surgical outcomes for laparoscopic adnexal surgery.

Adnexal surgery is believed to be more complex in patients with prior hysterectomy; however, there is little data regarding surgical outcomes. Understanding of individualized risks improves counseling, informed consent, and preoperative planning. We performed a retrospective cohort study with a control group; we evaluated 744 patients undergoing laparoscopic adnexal surgery at an academic tertiary care center from 2011 to 2015. Comparisons were made using Chi square, Fisher's exact, or Wilcoxon-rank sum tests. We used log-binomial regression to calculate risk ratio and 95% confidence interval. Patients with prior hysterectomy were more likely to have intraoperative or postoperative complications at the time of laparoscopic adnexal surgery when compared to patients without prior hysterectomy [17.7% vs. 10.2%, p = 0.02, risk ratio (RR) 1.7, 95% confidence interval (CI) 1.1-2.7]. Patients with prior hysterectomy were four times more likely to have intraoperative complications (3.2% vs. 0.8%, p = 0.047, RR 4.0, 95% CI 1.1-14.7), and five times more likely to have conversion to laparotomy (5.6% vs. 1.1%, p = 0.004, RR 5.0, 95% CI 1.8-14.0). Patients with prior hysterectomy were more likely to need additional procedures, including lysis of adhesions (69.4% vs. 26.0%, p < 0.001), ureterolysis (15.3% vs. 4.8%, p < 0.001), and cystoscopy (28.2% vs. 8.1%, p < 0.001). They had longer operative time [101.5min (IQR 59.5-135.0) vs. 78.0min (IQR 53.0-109.0, p < 0.001)], and were less likely to have outpatient surgery (56.5% vs. 84.8%, p < 0.01). Postoperative complications were also more common (15.3% vs. 9.4%, p = 0.046). Patients with prior hysterectomy were 70% more likely to have a complication at the time of laparoscopic adnexal surgery than patients without hysterectomy. Increased risk of complications in subsequent adnexal surgery may influence the informed consent process or decisions regarding ovarian conservation. Awareness of potential need for additional surgical procedures may guide availability of equipment, choice of operating site, or referral to an advanced pelvic surgeon.

Association of Preoperative Disclosure of Resident Roles With Informed Consent for Cataract Surgery in a Teaching Program

Cataract surgery is the most commonly performed intraocular surgery. Academic centers have mandates to train the next surgeon generation, but resident roles are often hidden in the consent process. To investigate associations of full preoperative disclosure of the resident role with patient consent rates and subjective experience of the consent process. Full scripted disclosure of residents' roles in cataract surgery was delivered by the attending surgeon. Qualitative analysis was conducted from recorded interviews of patients postoperatively regarding consent process experience and choice of whether to allow resident participation. Associations were sought regarding demographic characteristics and consent rates. Patients were recruited though a private community office. Surgery was performed at a single hospital where resident training was routinely conducted. The study included systemically well patients older than 18 years with surgical cataract. They had no previous eye surgery, English fluency, and ability to engage in informed consent decision-making and postsurgery interview. Patients were ineligible if they had monocular cataracts, required additional simultaneous procedures, had history of ocular trauma, or had cataracts that were surgically technically challenging beyond the usual resident skill level. Eligible patients received an informed consent conversation by the attending physician in accordance with a script describing projected resident involvement in their cataract surgery. Postoperatively, patients were interviewed and responses were analyzed with a quantitative and thematic qualitative approach. Consent rates to resident participation and qualitative experience of full disclosure process. Ninety-six patients participated. Participants were between ages 50 and 88 years, 53 were men (55.2%), and 75 were white (85.2%). A total of 54 of 96 participants (56.3%; 95% CI, 45.7%-66.4%) agreed to resident involvement. There were no associations between baseline characteristics and consent to resident involvement identified with any confidence, including race/ethnicity (60% [45 of 75] in white patients vs 30.8% [4 of 13] in nonwhite patients; difference, 29.2%; 95% CI, -0.7% to 57.3%; Fisher exact P = .07). Thematically, those who agreed to resident involvement listed trust in the attending surgeon, contributing to education, and supervision as contributing factors. Patients who declined stated fear and perceived risk as reasons. Our results suggest 45.7% to 66.4% of community private practice patients would consent to resident surgery. Consent rates were not associated with demographic factors. Because residents are less often offered the opportunity to do surgery on private practice patients vs academic center patients, this may represent a resource for resident education.

Challenges in informed consent decision-making in Korean clinical research: A participant perspective.

ObjectivesThis study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea.MethodsThrough purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis.ResultsThemes raised throughout the interviews were categorised into ‘disclosure’ and ‘understanding’ of clinical information and ‘decision’. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants’ level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent.ConclusionThere is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.