Consent Decision Research Articles

Structural Influences on Consent Decisions in Participatory Health Research in Eswatini.

Recognition that structural factors influence participation decisions and have potential to coerce participation, emerged relatively recently in research ethics literature. Empirical evidence to elucidate the nature of "structural" coercion and influence is needed to optimise respect for autonomy through voluntary informed consent. We present findings from ethnographic data about community co-researchers' experiences designing and implementing demographic and health survey consent procedures in participatory health research in Eswatini. Informed by Bourdieu's sociological theory of multiple types of capital/power, our findings detail structural influences on research participation decisions, highlight the inherently power-laden dynamics of consent interactions, and suggest that to be optimally ethical, research ethics principles and practices should consider and account for structural power dynamics.

Informed Consent and Shared Decision Making in Women at a Tertiary Care Hospital

Introduction: Informed consent is an important aspect of ensuring good medical care and patient autonomy. In a developing country, the experience of women is often overlooked when deciding methods for obtaining consent. This study assesses the practice of taking informed consent in a hospital setting and factors that affect decision-making for treatment methods among gynecology patients Pakistan. Materials and Methods: Women coming to the Hamdard University Hospital gynecology outpatient department or surgery were asked to participate in the study. The questionnarie asked about informed consent, cultural factors, and interaction between the doctor and the patient. The study was conducted for a duration of 5 months. Descriptive statistics were used to analyze the results. Results: 300 women participated in the study. While all women said that doctors asked for consent before examination, 30.7% said they were not aware they could say no to being examined, 23% said the doctors did not explain the benefits or side effects of the medicines prescribed, and 22.7% were not told about alternative treatments. 91.7% said their husbands signed consent forms for them. Conclusion: This study highlights the need to improve the practice of taking informed consent in the country, as it involves educating the patient about the intervention before obtaining consent. It is important that doctors keep in mind the cultural factors that influence decisions when obtaining consent and informing patients about their treatments and management.

Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial

BackgroundRandomised trials play a vital role in underpinning evidence-based care. However, trials involving adults with impaired capacity to consent raise a number of ethical and methodological challenges, leading to the frequent exclusion of this group from trials. This includes challenges around involving family members as alternative ‘proxy’ decision-makers. Family members are often given little information about their role as a consultee or legal representative. Some family members find making a decision about trial participation difficult and may experience an emotional and decisional burden as a result. Families have reported a need for greater support and guidance when making such decisions, leading to the development of a decision aid (‘Making decisions about research for others’) for family members acting as consultee/legal representative. The decision aid now requires evaluation to determine its effectiveness in supporting families to make more informed decisions.MethodsThis protocol describes a prospective, multi-centre, randomised-controlled Study Within a Trial (SWAT) to evaluate the effectiveness of the decision aid. The SWAT will initially be embedded in approximately five host trials. SWAT participants will be randomised in a 1:1 ratio to either the intervention (decision aid alongside standard information about the host trial provided to consultees/legal representatives) or control (standard information alone). The primary outcome is the quality of proxy consent decision, assessed by the Combined Scale for Proxy Informed Consent Decisions (CONCORD). The SWAT design is informed by previous qualitative research. Initial feasibility will be explored in one host trial, followed by the main SWAT. An embedded process evaluation and economic evaluation will enable the SWAT findings to be contextualised and identify factors likely to affect implementation.DiscussionThis SWAT will generate the first evidence for recruitment interventions for trials involving adults lacking capacity to consent and add to knowledge about the use of decision support interventions in trial participation decisions. The SWAT will be embedded in a range of trials, and the heterogenous nature of the host trials, settings and populations involved will enable the intervention to be evaluated in a wide range of contexts. However, a pragmatic and flexible approach to conducting the SWAT is needed.Trial registrationThe SWAT is registered as SWAT #159 with the Northern Ireland Hub for Trials Methodology Research SWAT repository (registered 09.08.2020). Each host trial will be registered on a clinical trials registry.

Development of a measure to assess the quality of proxy decisions about research participation on behalf of adults lacking capacity to consent: the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale)

BackgroundRecruitment of adults lacking the capacity to consent to trials requires the involvement of an alternative ‘proxy’ decision-maker, usually a family member. This can be challenging for family members, with some experiencing emotional and decisional burdens. Interventions to support proxy consent decisions in non-emergency settings are being developed. However, the ability to evaluate interventions is limited due to a lack of measures that capture outcomes of known importance, as identified through a core outcome set (COS).MethodsUsing established measure development principles, a four-stage process was used to develop and refine items for a new measure of proxy decision quality: (1) findings from a recent scoping review and consensus study were reviewed to identify items for inclusion in the scale and any existing outcome measures, (2) assessment of content coverage by existing measures and identification of insufficiency, (3) construction of a novel scale, and (4) cognitive testing to explore comprehension of the scale and test its content adequacy through interviews with family members of people with impaired capacity.ResultsA range of outcome measures associated with healthcare decision-making and informed consent decisions, such as the Decisional Conflict Scale, were identified in the scoping review. These measures were mapped against the key constructs identified in the COS to assess content coverage. Insufficient coverage of areas such as proxy-specific satisfaction and knowledge sufficiency by existing instruments indicated that a novel measure was needed. An initial version of a combined measure (the CONCORD scale) was drafted and tested during cognitive interviews with eleven family members. The interviews established comprehension, acceptability, feasibility, and content adequacy of the scale. Participants suggested re-phrasing and re-ordering some questions, leading to the creation of a revised version.ConclusionsThe CONCORD scale provides a brief measure to evaluate the quality of decisions made on behalf of an adult who lacks the capacity to consent in non-emergency settings, enabling the evaluation of interventions to improve proxy decision quality. Initial evaluation indicates it has content adequacy and is feasible to use. Further statistical validation work is being undertaken.

Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation for Traumatic Brain Injury Study: Part I.

This is the first article in a two-part series describing subject and family perspectives from the central thalamic deep brain stimulation for the treatment of traumatic brain injury using the Medtronic PC+S first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury, with subjects who were deemed capable of providing voluntary informed consent. In this article, we report on interviews conducted prior to surgery wherein we asked participants about their experiences recovering from brain injury and their perspectives on study enrollment and participation. We asked how risks and benefits were weighed, what their expectations and fears were, and how decisions were reached about trial participation. We found that informed consent and enrollment decisions are fraught. Subjects and families were often split, with subjects more focused on putative benefits and families concerned about incremental risk. Both subjects and families viewed brain injury as disruptive to personal identity and relationships. As decisions were made about study enrollment, families struggled with recognizing the re-emergent agency of subjects and ceding decision-making authority to subjects who had previously been dependent upon them for protection and guidance. Subjects and family members reported a hope for the relief of cognitive disabilities, improved quality of life, normalization of interpersonal interactions, and a return to work or school as reasons for study participation, along with altruism and a desire to advance science. Despite these aspirations, both subjects and families appreciated the risks of the intervention and did not suffer from a therapeutic misconception. A second essay to be published in the next issue of Cambridge Quarterly of Healthcare Ethics-Clinical Neuroethics will describe interviews conducted after surgery, the effects of cognitive restoration for subjects, families, and challenges presented to the social structures they will call upon to support them through recovery. This subsequent article will be available online prior to its formal publication in October 2023.

Recruitment interventions for trials involving adults lacking capacity to consent: methodological and ethical considerations for designing Studies Within a Trial (SWATs)

BackgroundThe number of interventions to improve recruitment and retention of participants in trials is rising, with a corresponding growth in randomised Studies Within Trials (SWATs) to evaluate their (cost-)effectiveness. Despite recognised challenges in conducting trials involving adults who lack capacity to consent, until now, no individual-level recruitment interventions have focused on this population. Following the development of a decision aid for family members making non-emergency trial participation decisions on behalf of people with impaired capacity, we have designed a SWAT to evaluate the decision aid in a number of host trials (CONSULT). Unlike in recruitment SWATs to date, the CONSULT intervention is aimed at a ‘proxy’ decision-maker (a family member) who is not a participant in the host trial and does not receive the trial intervention. This commentary explores the methodological and ethical considerations encountered when designing such SWATs, using the CONSULT SWAT as a case example. Potential solutions to address these issues are also presented.DiscussionWe encountered practical issues around informed consent, data collection, and follow-up which involves linking the intervention receiver (the proxy) with recruitment and retention data from the host trial, as well as issues around randomisation level, resource use, and maintaining the integrity of the host trial. Unless addressed, methodological uncertainty about differential recruitment and heterogeneity between trial populations could potentially limit the scope for drawing robust inferences and harmonising data from different SWAT host trials. Proxy consent is itself ethically complex, and so when conducting a SWAT which aims to disrupt and enhance proxy consent decisions, there are additional ethical issues to be considered.ConclusionsDesigning a SWAT to evaluate a recruitment intervention for non-emergency trials with adults lacking capacity to consent has raised a number of methodological and ethical considerations. Explicating these challenges, and some potential ways to address them, creates a starting point for discussions about conducting these potentially more challenging SWATs. Increasing the evidence base for the conduct of trials involving adults lacking capacity to consent is intended to improve both the ability to conduct these trials and their quality, and so help build research capacity for this under-served population.

(Re)Conceptualising ‘good’ proxy decision-making for research: the implications for proxy consent decision quality

People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes ‘good’ proxy decision-making for research has remained unexplored. Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of ‘good’ proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients’ values and preferences.

Secondary use of health care data and left-over biosamples within the ‘Medical Informatics Initiative’ (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process

BackgroundData collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process.MethodsWe performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through.ResultsQuestionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups.ConclusionsThe willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room.

The efficacy and safety of anti–PD-1 antibody toripalimab combined with surufatinib in neoadjuvant treatment of locally advanced thyroid cancer: A phase II study.

6084 Background: Surgery is the primary treatment for locally advanced thyroid cancer. However, some locally advanced patients are not candidates for R0/1 resection. There is limited evidence of neoadjuvant treatment in locally advanced thyroid cancer. Surufatinib targets multiple kinases (VEGFR1-3, FGFR1 and CSF-1R) involved in tumor angiogenesis and tumor immune evasion. It is efficient, tolerable and safe for patients with radioiodine-refractory differentiated thyroid cancer to receive surufatinib. In addition, surufatinib plus toripalimab (an anti-PD-1 antibody) showed encouraging antitumor activity and an acceptable safety profile in advanced solid tumors. This study aimed to evaluate the efficacy and safety of surufatinib plus toripalimab in locally advanced thyroid cancer in the neoadjuvant setting. Methods: In this single-arm phase II study, patients with pathologically confirmed diagnosis of unresectable or borderline resectable differentiated thyroid cancer were eligible and received a combination of 250 mg surufatinib (oral, qd) with 240 mg toripalimab (IV, q3w). Treatment was continued until satisfied for curative surgery, disease progression, withdrawal of consent, unacceptable toxicity or investigator decision. Primary endpoint was objective response rate (ORR) by RECIST 1.1. Secondary endpoints included R0/1 resection rate, disease control rate (DCR), time to remission (TTR), adverse events (AEs), etc. Results: This study is ongoing. 10/10 patients were enrolled. 6 patients received ≥4 cycles of surufatinib plus toripalimab treatment and were also evaluated for efficacy. The ORR was 66.7% with 4 partial response (PR) and 2 stable disease (SD). 4 PR and 1 SD patients received R0 resections after neoadjuvant treatment. The safety was consistent with previously reported. No grade ≥3 AEs were observed. Specific AEs data are still being counted. Conclusions: Surufatinib in combination with toripalimab as neoadjuvant therapy for locally advanced thyroid cancer was feasible and majority of patients achieved R0 resection. AEs were mainly grade 1-2, and this combination was well-tolerated. The combination of these two agents should be further investigated for neoadjuvant treatment of locally advanced thyroid cancer based on good results. Clinical trial information: NCT04524884.

Primary motivations for and experiences with paediatric minimally invasive tissue sampling (MITS) participation in Malawi: a qualitative study

ObjectiveTo understand family member consent decision-making influences and experiences in Malawi in order to inform future minimally invasive tissue sampling (MITS) studies.DesignQualitative study.SettingQueen Elizabeth Central Hospital (QECH) in Blantyre, Malawi,...

Foundations for Meaningful Consent in Canada's Digital Health Ecosystem: Retrospective Study.

BackgroundCanadians are increasingly gaining web-based access to digital health services, and they expect to access their data from these services through a central patient access channel. Implementing data sharing between these services will require patient trust that is fostered through meaningful consent and consent management. Understanding user consent requirements and information needs is necessary for developing a trustworthy and transparent consent management system.ObjectiveThe objective of this study is to explore consent management preferences and information needs to support meaningful consent.MethodsA secondary analysis of a national survey was conducted using a retrospective descriptive study design. The 2019 cross-sectional survey used a series of vignettes and consent scenarios to explore Canadians’ privacy perspectives and preferences regarding consent management. Nonparametric tests and logistic regression analyses were conducted to identify the differences and associations between various factors.ResultsOf the 1017 total responses, 716 (70.4%) participants self-identified as potential users. Of the potential users, almost all (672/716, 93.8%) felt that the ability to control their data was important, whereas some (385/716, 53.8%) believed that an all or none control at the data source level was adequate. Most potential users preferred new data sources to be accessible by health care providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Prior digital health use was associated with greater odds of granting default access when compared with no prior use, with the greatest odds of granting default access to digital health service providers (odds ratio 2.17, 95% CI 1.36-3.46). From a list of 9 information elements found in consent forms, potential users selected an average of 5.64 (SD 2.68) and 5.54 (SD 2.85) items to feel informed in consenting to data access by care partners and commercial digital health service providers, respectively. There was no significant difference in the number of items selected between the 2 scenarios (P>.05); however, there were significant differences (P<.05) in information types that were selected between the scenarios.ConclusionsA majority of survey participants reported that they would register and use a patient access channel and believed that the ability to control data access was important, especially as it pertains to access by those outside their care. These findings suggest that a broad all or none approach based on data source may be accepted; however, approximately one-fifth of potential users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for potential users to make informed consent decisions. Understanding their information needs will be critical, as these needs vary with the use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.

Updated efficacy and safety of KEYNOTE-224: a phase II study of pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib

ObjectivePembrolizumab, a PD-1 inhibitor, demonstrated anti-tumour activity and tolerability in patients treated with sorafenib and with advanced hepatocellular carcinoma in KEYNOTE-224. Longer-term efficacy and safety after ∼2.5 years of additional follow-up are reported. Patients and methodsAdults with confirmed hepatocellular carcinoma who experienced progression after or intolerance to sorafenib treatment received pembrolizumab 200 mg every 3 weeks for ≤35 cycles or until confirmed progression, unacceptable toxicity, withdrawal of consent or investigator decision. The primary end-point was objective response rate assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours v1.1. The secondary end-points included duration of response, disease control rate, time to progression, progression-free survival, overall survival and adverse events. ResultsEfficacy and safety were assessed in 104 patients. The median time from first dose to data cutoff was 45.1 months (range, 41.3–49.3). Objective response rate was 18.3% (95% CI: 11.4–27.1), and median duration of response was 21.0 months (range, 3.1 to 39.5+). Disease control rate was 61.5%, and median time to progression was 4.8 months (95% CI: 3.9–7.0). Median progression-free survival was 4.9 months (95% CI: 3.5–6.7) and median overall survival was 13.2 months (95% CI: 9.7–15.3). Of 104 patients, 76 (73.1%) patients reported treatment-related adverse events; most were low grade in severity (grade 3–4, n = 26 [25.0%]; grade 5, n = 1 [1.0%]). Immune-mediated hepatitis occurred in 3 patients (all grade 3). No viral-induced hepatitis flares occurred. ConclusionsAfter ∼2.5 years of additional follow-up, pembrolizumab continued to provide durable anti-tumour activity and no new safety concerns were identified. ClinicalTrials.gov identifierNCT02702414.

Protecting Their Daughters with Knowledge: Understanding Refugee Parental Consent for a U.S.-Based Teen Sexual Health Program

Due to limited knowledge and exposure to sexual health information, refugee adolescent girls need health education programming and research studies that oftentimes require parental consent. We sought to understand the parental consent decision-making process of thirteen refugee parents from eight different countries who consented for their 15–17-year-old daughters to participate in a sexual health promotion program. Interviews with eight mothers and five fathers provided insight into motivations and concerns driving their decision, as well as barriers and facilitators for obtaining consent. In-depth qualitative thematic analysis revealed five predominant themes: (1) Protecting our daughters with knowledge; (2) A different country, a different approach to protection; (3) Consent and understanding can be different; (4) Parents cannot do it all; and (5) My daughter gained a voice. These findings are useful for developing consent protocols and tailored programming to meet the needs of this understudied population.

Sovereign Digital Consent through Privacy Impact Quantification and Dynamic Consent

Digitization is becoming more and more important in the medical sector. Through electronic health records and the growing amount of digital data of patients available, big data research finds an increasing amount of use cases. The rising amount of data and the imposing privacy risks can be overwhelming for patients, so they can have the feeling of being out of control of their data. Several previous studies on digital consent have tried to solve this problem and empower the patient. However, there are no complete solution for the arising questions yet. This paper presents the concept of Sovereign Digital Consent by the combination of a consent privacy impact quantification and a technology for proactive sovereign consent. The privacy impact quantification supports the patient to comprehend the potential risk when sharing the data and considers the personal preferences regarding acceptance for a research project. The proactive dynamic consent implementation provides an implementation for fine granular digital consent, using medical data categorization terminology. This gives patients the ability to control their consent decisions dynamically and is research friendly through the automatic enforcement of the patients’ consent decision. Both technologies are evaluated and implemented in a prototypical application. With the combination of those technologies, a promising step towards patient empowerment through Sovereign Digital Consent can be made.

Phase 1/1b trial of fruquintinib in patients with advanced solid tumors: Preliminary results of the dose expansion cohorts in refractory metastatic colorectal cancer.

93 Background: Fruquintinib (F) is a highly selective, novel, oral tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3. The phase (Ph) 3 FRESCO study (NCT02314819) that investigated F (5mg daily, 3 weeks (wks) on 1 wk off) showed improved median overall survival in patients (pts) with metastatic colorectal cancer (mCRC) in third line and beyond when compared to placebo (9.3 vs. 6.6 months); hazard ratio 0.65 (P &lt; 0.001) and led to its approval in China. Methods: This is an ongoing Ph 1/1b open-label, dose escalation/expansion study conducted in the US. Here we present the preliminary safety and antitumor efficacy data from pts with refractory mCRC in Cohort (Coh) B (progressed on all standard therapies including TAS-102 [TAS] and/or regorafenib [R]) and in Coh C (did not receive TAS or R). Results: As of data cutoff on 27 July 2021, 81 mCRC pts had been treated (41 in Coh B and 40 in Coh C); median age of 57 years (range: 34─77), Caucasian (81.5%), female (44.4%), and ECOG PS 1 (59.3%). In Coh B, the median number of prior therapies was 5 (range: 3-9), 8 pts (19.5%) received R, 19 (46.3%) received TAS and 14 (34.1%) received both R and TAS. In Coh C, the median number of prior therapies was 4 (range: 1-10). Five pts remain on treatment; reasons for treatment discontinuation included: 56 pts (69.1%) due to progressive disease or death, 8 pts (9.9%) due to adverse events (AE), and 12 pts (14.8%) due to withdrawal of consent or physician decision. The median duration of F treatment was 4.4 months (range: 0.7– 20.0) in Coh B and 3.7 months (range: 0.02-14.3) in Coh C. The most frequently reported AEs of any grade in Coh B were fatigue (53.7%), proteinuria (51.2%), and hypertension (HTN; 48.8%). In Coh C the most frequently reported AEs of any grade were HTN (75.0%), proteinuria (40.0%), and myalgia (32.5%). Hand-foot syndrome (HFS) was reported in 29.3% of Coh B pts and 22.5% of Coh C pts. The disease control rate [DCR] was 68.3% in Coh B (1 partial response [PR] and 27 stable disease [SD]) and 59.5% for the 37 patients with at least one post-baseline tumor assessment in Coh C (2 PRs and 20 SDs). Conclusions: F is generally well-tolerated in heavily-pretreated pts with refractory mCRC. Evidence of antitumor activity was observed in cohorts B and C. The multi-cohort dose expansion is ongoing. F is being further investigated in refractory mCRC in a global Ph 3 study (NCT04322539). Clinical trial information: NCT03251378.

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Recruitment, Enrollment, and Retention: Creative Techniques to Overcome Obstacles

The process of recruiting, enrolling, and retaining older adults in research studies has been challenging, even prior to the COVID-19 pandemic. This symposium presents research conducted and lessons learned on recruiting, enrolling, and retaining older adults, including those with cognitive impairment. Insights are provided on what techniques are most beneficial for improving rates of research participation, spanning time prior to and during the pandemic. The first presentation reports on qualitative perspectives of persons living with dementia and their caregivers as to what helped them decide to enroll into a clinical trial together. The second presentation speaks to how variations in incentive payment allocations played a role in consent decisions of patients with amnestic mild cognitive impairment and their study partners. The third presentation discusses the effectiveness of an adapted framework and strategies to increase the recruitment and retention of older Latinos with Alzheimer’s Disease and Related Dementias (ADRD) into a clinical trial. The fourth presentation shares techniques for recruiting older adults for a survey study during the pandemic. The fifth presentation defines challenges during a longitudinal study when the pandemic and other natural disasters occurred and strategies for success. Taken together, these presentations will inform researchers on techniques that could be used to improve recruitment, enrollment, and retention of older adults in clinical research.

Variations in Payment Allocation to Persons Living With Cognitive Impairment and Study Partners

There is a paucity of research focused on monetary incentives for recruiting dyads (participants with cognitive impairment and study partners) into research. Our objective was to evaluate if two different variations in allocating compensation among dyads changed consent rates in one clinical trial, Memories2. This trial is evaluating cognitive and functional outcomes of obstructive sleep apnea treatment in patients with amnestic mild cognitive impairment (aMCI). Prior to phone screening, participants were randomly assigned to one of two groups (1) $200 to participant with aMCI or (2) $100 to participant with aMCI and $100 to study partner at consent visit. Allocating all the payment to the participant with aMCI yielded a 2.6% consent rate, while splitting the payment yielded at 1.7% consent rate. We will also discuss how demographic factors affected consent decision by group. This study provides insight into novel strategies that may enhance enrollment of dyads into clinical trials.

An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study.

BackgroundObtaining explicit consent from patients to use their remnant biological samples and deidentified clinical data for research is essential for advancing precision medicine.ObjectiveWe aimed to describe the operational implementation and scalability of an electronic universal consent process that was used to power an institutional precision health biobank across a large academic health system.MethodsThe University of California, Los Angeles, implemented the use of innovative electronic consent videos as the primary recruitment tool for precision health research. The consent videos targeted patients aged ≥18 years across ambulatory clinical laboratories, perioperative settings, and hospital settings. Each of these major areas had slightly different workflows and patient populations. Sociodemographic information, comorbidity data, health utilization data (ambulatory visits, emergency room visits, and hospital admissions), and consent decision data were collected.ResultsThe consenting approach proved scalable across 22 clinical sites (hospital and ambulatory settings). Over 40,000 participants completed the consent process at a rate of 800 to 1000 patients per week over a 2-year time period. Participants were representative of the adult University of California, Los Angeles, Health population. The opt-in rates in the perioperative (16,500/22,519, 73.3%) and ambulatory clinics (2308/3390, 68.1%) were higher than those in clinical laboratories (7506/14,235, 52.7%; P<.001). Patients with higher medical acuity were more likely to opt in. The multivariate analyses showed that African American (odds ratio [OR] 0.53, 95% CI 0.49-0.58; P<.001), Asian (OR 0.72, 95% CI 0.68-0.77; P<.001), and multiple-race populations (OR 0.73, 95% CI 0.69-0.77; P<.001) were less likely to participate than White individuals.ConclusionsThis is one of the few large-scale, electronic video–based consent implementation programs that reports a 65.5% (26,314/40,144) average overall opt-in rate across a large academic health system. This rate is higher than those previously reported for email (3.6%) and electronic biobank (50%) informed consent rates. This study demonstrates a scalable recruitment approach for population health research.

Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research.

Objective Proxy consent respects patients' autonomy when they are incapable of providing consent for research participation. Healthcare providers need to understand the ethical regulations and practices relevant to the proxy consent process. Thus, this study aimed to assess the knowledge and attitudes of healthcare providers about research proxy consent in the ICU setting. Methods A cross-sectional survey-based design was used in the study. Study participants were resident and specialist physicians, registered nurses, and registered pharmacists from ICU units in Jordan. Participants were asked to fill out a questionnaire developed to assess their knowledge and attitudes towards informed proxy consent for research studies conducted at the ICU. Results In this study, 145 healthcare providers completed the study questionnaire. The healthcare providers agreed that the purpose of the proxy consent is to inform the participants about the potential benefits (66.9%) and risks (66.9%) related to the research to study and respect patient's autonomy (44%), to discuss alternative options (62.1%), and to protect the researchers from any litigation (84.1%). Regarding the assessment of proxy consent, 65.5% of respondents believed that relatives are considered as an authorized legal representative for an informed consent decision on behalf of their ICU patients (65.5%) as they are knowledgeable about patients' values and preferences and have the desire to provide the necessary help. Respondents also agreed that the informed consent process should explain research protocols and procedures (76.6%), therapeutic alternatives (84.1%), potential benefits (41.4%), and potential risks (44.1%) and that participation in the research is voluntary (66.9%). No significant differences in the responses were found among different groups of healthcare providers. Conclusion The majority of healthcare providers had inadequate awareness about the ethical aspects regarding the informed proxy consent process. Providing training regarding the informed consent process can improve the quality of the proxy consent process in clinical research studies in the ICU setting.