Comprehension Of Informed Consent Research Articles

Patients' comprehension and satisfaction with informed consent at day surgery unit at King Khalid University Hospital, Riyadh, Saudi Arabia

Background: Informed Consent (IC) is a crucial element in medical practice and research. However, additional research is needed to assess the quality of IC in Middle Eastern regions, including Saudi Arabia. This study aimed to measure surgical patients' comprehension and satisfaction with IC and related factors at King Khalid University Hospital (KKUH). Methods: This cross-sectional study investigated postsurgical patients' satisfaction and comprehension of IC at the day surgery unit at KKUH from August to December 2022. Data collection was done through an online questionnaire. Results: A total of 387 patients participated in this study, with over half (56.1%) being women (mean age = 41.4 ± 13.4). More than 88% of the patients were satisfied with all IC components. Patients aged 26-45 reported the highest levels of IC understanding (54.9%, p < 0.05), and female patients demonstrated higher overall comprehension compared to male patients (p = 0.088). Those with higher education and income had the highest comprehension scores (61.2%, p < 0.05) and (28.4%, p < 0.05), respectively. Only 54% of patients read the IC form and were aware of who provided them with the forms. Approximately 92% of the patients signed the IC form themselves, and 72% required less than an hour to consent. Conclusion: Middle-aged patients, women, and those with a high level of education exhibited the highest overall IC comprehension and satisfaction. The findings underscore the importance of personnel delivering therapy introducing themselves and indicating their involvement in the team. The future of the IC process lies in electronic standardization through the use of \"Esihi,\" KKUH's current electronic record system.

Social Determinants of Health and Informed Consent Comprehension for Pediatric Cancer Clinical Trials

Ensuring valid informed consent (IC) prior to enrollment in clinical trials is a fundamental ethical right. To assess whether social determinants of health (SDOH) and related sociocontextual factors are associated with parental IC comprehension in therapeutic childhood cancer clinical trials. This cross-sectional study prospectively enrolled 223 parents of children with newly diagnosed cancer at Rady Children's Hospital San Diego, a large quaternary academic center in California, from October 1, 2014, to March 31, 2021. Linear mixed effects models were used to assess whether IC comprehension overall and by domain (purpose, procedures, and randomization; risks and benefits; alternatives; and voluntariness) were associated with SDOH and sociocontextual factors. Data were analyzed from January 1, 2022, to July 31, 2023. Informed consent for a therapeutic childhood cancer clinical trial. The primary outcome of interest was IC comprehension and its associations with SDOH (marital status, language, educational attainment, employment, insurance type, socioeconomic status, and health literacy) and sociocontextual factors (ethnicity, satisfaction with informed consent, and cancer type). Of 223 parents, 172 (77.1%) were aged 18 to 44 years, 111 (49.8%) were Hispanic, 152 (68.2%) were women, and 163 (73.1%) were married. In terms of race, 2 (0.9%) were American Indian or Alaska Native, 22 (9.9%) were Asian or Pacific Islander, 8 (3.6%) were Black, 149 (66.8%) were White, and 42 (18.8%) were more than 1 race. In multivariable linear mixed-effects analyses, limited vs adequate health literacy was associated with lower comprehension of informed consent overall (mean [SD], 68.28 [11.81] vs 79.24 [11.77]; β estimate, -9.02 [95% CI, -12.0 to -6.07]; P < .001) and with lower comprehension of the purpose, procedures, and randomization (mean [SD], 65.00 [12.64] vs 76.14 [11.53]; β estimate, -7.87 [95% CI, -10.9 to -4.85]; P < .001); risks and benefits (mean [SD], 62.84 [20.24] vs 73.14 [20.86]; β estimate, -10.1 [95% CI, -15.6 to -4.59]; P < .001); alternatives (mean [SD], 54.27 [43.18] vs 82.98 [34.24]; β estimate, -14.3 [95% CI, -26.1 to -2.62]; P .02); and voluntariness (mean [SD], 76.52 [24.33] vs 95.39 [13.89]; β estimate, -9.14 [95% CI, -14.9 to -3.44]; P = .002) domains. Use of Spanish vs English language for medical communication was associated with lower comprehension overall (mean [SD], 66.45 [12.32] vs 77.25 [12.18]; β estimate, -5.30 [95% CI, -9.27 to -1.34]; P = .01) and with lower comprehension of the purpose, procedures, and randomization (mean [SD], 63.33 [11.98] vs 74.07 [12.52]; β estimate, -4.33 [95% CI, -8.43 to -0.23]; P = .04) and voluntariness (mean [SD], 70.83 [24.02] vs 92.54 [17.27]; β estimate, -9.69 [95% CI, -16.8 to -2.56]; P = .009) domains. In this cross-sectional study including parents of children with newly diagnosed cancer who provided IC for their child's participation in a therapeutic clinical trial, limited health literacy and use of Spanish language for medical communication were associated with lower comprehension of IC. These findings suggest that, in this setting, parents with limited health literacy or those who use Spanish language for medical communication may not fully comprehend IC and therefore may not make truly informed decisions. These findings support the investigation of interventions, across pediatric disciplines, tailored to the participant's language and health literacy level to improve IC comprehension, particularly in racial and ethnic minority populations.

Assessment of Consent Comprehension Among Kenyan Adolescents, Young Adults, and Parents: Comparison of Enhanced and Standard Consenting Procedures

PurposeYouth aged 15–19 years and parents of minors aged 15–17 years in sub-Saharan Africa are under-represented in empirical consent research. Thus, knowledge is limited concerning the adequacy of consent procedures and need for strategies to improve consent comprehension among these groups. We assessed comprehension following standard consent procedures and evaluated an enhanced procedure among Kenyan youth and parents. MethodsParticipants were adolescents aged 15–17 years (n = 273), their parents (n = 196), and young adults aged 18–19 years (n = 196). We used a quasi-experimental cohort design to implement standard and enhanced (single condition: extended discussion, test/feedback) consent procedures. Participants completed a 21-item informed consent comprehension assessment instrument. ResultsAfter standard consent procedures, mean comprehension scores were 11.36, 13.64, and 13.43 (score range: 0–21) among adolescents, young adults, and parents, respectively. About 6.2% of adolescents, 19.6% of young adults, and 21.4% of parents answered ≥ 80% of the questions correctly. After the enhanced procedures, comprehension scores (15.87 adolescents, 17.81 young adults, and 16.77 parents) and proportions answering ≥ 80% of the questions correctly (44.9% adolescents, 76.8% young adults, and 64.3% parents) increased significantly. Regression analysis indicated statistically significant differences (p < .001) in comprehension scores between the enhanced and standard groups (β = 3.87 adolescents, β = 4.03 young adults, and β = 3.60 parents) after controlling for sociodemographic factors. DiscussionEnhancing consent procedures with extended discussions, quizzes, and additional explanation where understanding is inadequate is a promising approach for improving comprehension. However, poorer comprehension among adolescents compared to young adults and parents underscores the need for research to identify additional approaches to improve understanding.

Looking ahead: ethical and social challenges of somatic gene therapy for sickle cell disease in Africa.

Somatic gene therapy will be one of the most exciting practices of genetic medicine in Africa and is primed to offer a "new life" for persons living with sickle cell disease (SCD). Recently, successful gene therapy trials for SCD in the USA have sparked a ray of hope within the SCD community in Africa. However, the high cost, estimated to exceed 1.5 million USD, continues to be a major concern for many stakeholders. While affordability is a key global health equity consideration, it is equally important to reflect on other ethical, legal and social issues (ELSIs) that may impact the responsible implementation of gene therapy for SCD in Africa. These include informed consent comprehension, risk of therapeutic misestimation and optimistic bias; priorities for SCD therapy trials; dearth of ethical and regulatory oversight for gene therapy in many African countries; identifying a favourable risk-benefit ratio; criteria for the selection of trial participants; decisional conflict in consent; standards of care; bounded justice; and genetic tourism. Given these ELSIs, we suggest that researchers, pharma, funders, global health agencies, ethics committees, science councils and SCD patient support/advocacy groups shouldwork together to co-develop: (1) patient-centric governance for gene therapy in Africa, (2) public engagement and education materials, and (3) decision making toolkits for trial participants. It is also critical to establish harmonised ethicaland regulatory frameworks for gene therapy in Africa, and for global health agencies to accelerate access to basic care for SCD in Africa, while simultaneously strengthening capacity for gene therapy.

Piloting a tool for informed consent comprehension in a cardiovascular clinical trial in South Africa: An IMPI-2 pilot trial substudy (ICC Study)

Background. Informed consent is a key requirement in research. However, the comprehension of information presented is rarelyevaluated prior to or during the research. Ensuring that participants understand the key issues in trials is important, not just forethical reasons, but also because it can help set patient expectations. We evaluated the feasibility of using the University of California Brief Assessment of Capacity to Consent (UBACC) questionnaire to guide informed consent comprehension in the pilot study for the second Investigation of the Management of Pericarditis in Africa (IMPI-2) trial. IMPI-2 is a randomised control trial (RCT) on the use of alteplase-facilitated pericardial drainage, compared with routine care among patients with large pericardial effusion. We used an abbreviated version of the UBACC to evaluate participant comprehension of key elements of the consent documentation and to guide discussions.Method. Comprehension was assessed using a 10-item UBACC at baseline, 6 weeks, 3 months and 6 months follow-up to reiterate the information about the trial. Each response was scored from 0 to 3 and the sum at each visit was recorded to represent comprehension. A UBACC score ≥25 was considered adequate comprehension. Bivariate logistic regression was performed to evaluate comprehension over time. A multivariate analysis was conducted to identify predictors of UBACC score.Results. The Informed Consent Comprehension (ICC) Study included 71 participants with a median age of 42 years; 45% were females and 49% had at least a secondary level of education. Level of comprehension improved with time; the odds of passing the evaluation at baseline compared with 6 months was higher (odds ratio (OR) 1.39, 95% confidence interval (CI) 1.17 - 1.65, p&lt;0.001). Not using interpreters and having a secondary level of education were associated with higher comprehension. Despite knowing that they were participating in research, many participants still did not accept that the trial drug may have no effect.Conclusion. It is feasible to use the UBACC questionnaire for informed consent comprehension evaluation in RCTs. Repeated learning during follow-up improves comprehension over time, while a low level of education and use of interpreters reduces comprehension.

Parental informed consent comprehension in childhood cancer clinical trials: Associations with social determinants of health.

6512 Background: Adequate informed consent (IC) comprehension is an ethical right prior to participation in clinical trials. Research investigating IC comprehension and associations with social determinants of health (SDoH) is lacking. We assessed whether SDoH and related contextual factors were associated with parental IC comprehension in therapeutic childhood cancer clinical trials. Methods: We prospectively enrolled parents of children with newly-diagnosed cancer. Univariable and multivariable regression were used to assess whether objective IC comprehension and related domains ( Purpose/Procedures/Randomization, Risks/Benefits, Alternatives, and Voluntariness) were associated with SDoH (ethnicity, marital status, language, education attainment, employment, insurance, socio-economic status, health literacy [HL]) and contextual factors (cancer type, voluntariness, satisfaction with IC). Results: Of 223 parents included, 112 (50%) were Hispanic and 38% of Hispanics were monolingual Spanish-speaking. In adjusted multivariable analyses, limited HL was significantly associated with lower overall IC comprehension (β = -7.22; 95% CI, -10.9 to -3.59; P &lt; 0.001) and lower comprehension of Purpose/Procedures/Randomization (β = -7.53; 95% CI, -11.3 to -3.73; P &lt; 0.001), Risks/Benefits (β = -8.14; 95% CI, -15.5 to -0.772; P = 0.031), and Alternatives (β = -17.0; 95% CI, -30.5 to -3.57; P = 0.013). Preferred Spanish language of written/verbal medical information was significantly associated with lower comprehension of Purpose/Procedures/Randomization (β = -8.50; 95% CI, -15.1 to -1.89; P = 0.012) and Voluntariness (β = -20.1; 95% CI, -34.9 to -5.33; P = 0.008). Lower satisfaction with informed consent (β = 0.988; 95% CI, 0.460 to 1.52; P &lt; 0.001) and single marital status (β = -4.42; 95% CI, -7.81 to -1.02; P = 0.011) were significantly associated with lower IC comprehension. Conclusions: Among parents of children with newly diagnosed cancer who provided consent for their child’s participation in a therapeutic clinical trial, limited HL was consistently associated with lower IC comprehension in all domains analyzed, except for Voluntariness. Spanish language preference for medical information was associated with lower comprehension of two domains; and lower satisfaction was associated with lower overall IC comprehension. These findings suggests that parents with limited HL, limited English-proficiency, and lower satisfaction may not fully comprehend the IC and thereby not truly make informed decisions. Our findings highlight the potential role of language-concordant interventions tailored to the participant’s HL level in order to ultimately improve IC comprehension and contribute to a reduction of disparities in clinical trial participation and promote equitable translation of discoveries and treatments to underserved groups.

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

BackgroundIt is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants’ understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This protocol describes a study to evaluate whether an enhanced PIL/ICF and website help research participants to understand important information about a human immunodeficiency virus (HIV) randomised clinical trial.MethodsThis Study Within A Trial (SWAT) is a prospective, multi-centre, randomised, controlled, parallel-group study embedded in a host clinical trial. The host trial (the SWIFT trial; EudraCT: 2019-002314-39) is a prospective, multi-centre, randomised, open-label, controlled trial investigating if semaglutide along with dietary advice assists individuals with HIV and obesity to lose weight, compared to dietary advice alone. For the SWAT, participants will be randomised in a 1:1 ratio to either the control (standard PIL/ICF) or the intervention (an enhanced PIL/ICF and a website which includes animations). The enhanced PIL/ICF and website were developed in line with the guidance from organisations which promote plain English and accessible public-facing materials in conjunction with HIV Ireland, a HIV advocacy organisation, and our previous work on consent documents. The primary outcome of the SWAT is the quality of informed consent, assessed by a validated comprehension test—the modified Deaconess Informed Consent Comprehension Test (DICCT). The DICCT will be administered within 48 h of consent to the host trial. The secondary is recall, measured by the modified DICCT questionnaire scores 2 weeks post-consent to the host trial.DiscussionThe results of this SWAT will add to the methodological evidence base on the use of multimedia to improve the quality of informed consent to randomised clinical trials.Trial registrationClinicalTrials.govNCT04174755. EudraCT 2019-002314-39. SWAT 160, Northern Ireland Hub for Trials Methodology Research SWAT repository (Clarke M, et al., Trials. 16:P209, 2015).

Enhancing consent forms to support participant decision making in multimodal learning data research

AbstractAdvances in the field of multimodal learning analytics (MMLA) research is often accomplished by actively exploring new technologies and techniques related to the collection and analysis of data. Exploration of ethical principles and procedures for governing the use of new technologies and techniques, however, is not as readily pursued. As collected data grow in complexity and invasiveness, potentially, a growing need is arising to scrutinize ethical aspects of MMLA research. In our study, we introduce an informed consent comprehension test for educational technology research and assess the effects of enhancing MMLA consent forms on comprehension of informed consent and on rates of enrollment in a MMLA study. One form is written from a researcher perspective and the other from a participant perspective. Results of the study involving first‐year undergraduate students suggest that the overall level of comprehension did not differ between conditions. Yet, the participant‐oriented consent form resulted in significantly lower rates of enrollment. Implications for MMLA researchers are discussed.

&lt;p&gt;An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature&lt;/p&gt;

&lt;p&gt;An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for clinical trial participation and a review of the literature&lt;/p&gt;

Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.

An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study

ObjectiveTo adapt and validate a questionnaire originally developed in a research setting for assessment of comprehension of consent information in a different cultural and linguistic research setting.DesignThe adaptation process involved...

Informed consent comprehension among vulnerable populations in Ecuador: video-delivered vs. in-person standard method

ABSTRACTThe informed consent comprehension process is key to engaging potential research subject participation. The aim of this study is to compare informed consent comprehension between two methods: standard and video-delivered. We compared the in-person and video-delivered informed consent process in the Familias Unidas intervention. We evaluated comprehension using a 7-item true/false questionnaire. There were a total of 152 participants in the control group and 87 in the experimental. General characteristics were similar between both groups (p > 0.05). First-attempt informed consent comprehension was higher in the intervention group but was not statistically significant (80% and 78% respectively p = 0.44). A video-delivered informed consent process did not differ from the standard method of informed consent in a low educational and socioeconomic environment.

Mapping the Quality of Informed Consent for Major Surgical Procedures in Public Dental Hospitals in Khartoum State, Sudan, 2017: A Cross Sectional Study

Background: Informed Consent (IC) is a valuable document that remains central to medical ethics because it supports patient autonomy. Even after signing an IC document, many patients in developing countries are still illinformed. Little is known about the quality of the IC document and the process related to surgical dental procedures in Sudan. Objectives: This study was conducted to determine the availability of consent form and to assess the quality of IC form and its processing in Khartoum governmental dental hospitals by comparing them to international standards and between each other with regard to comprehensiveness and simplicity of the form. Methodology: A cross-sectional study was carried out in three public dental hospitals- 1) United Police Force Hospital (UPFH), 2) Khartoum Dental Teaching Hospital (KDTH) and 3) Military Hospital-Omdurman (MH-O) in which 12 consent forms were reviewed during the period from January to March 2017 and a total of 50 patients were recruited. The study sample was taken from patients who underwent major oral and maxillofacial surgical procedures in these hospitals. International standards on availability and quality of IC document were used to elaborate checklists to collect appropriate data. Patients were also interviewed to assess their comprehension of IC. Descriptive and inferential statistics have been done to analyze the quality of IC and patients comprehension. Results: A generic type of IC was available in all governmental dental hospitals but was not modified according to the type of major surgical procedure. The available IC elements in the MH-O found in comparison to international standards was (61.5%), (53.8%) in KDTH and (46.2%) in UPFH. In regards to the comprehensiveness of each IC element and the use of local understandable language, it was found to be average in MH-O and KDTH and low in UPFH. Patient’s comprehension of IC was poor with a total of 54% of all patients that did not understand the IC at all, 42.3% of those being illiterate. Age and level of education was significantly associated with an understanding of IC elements. Conclusion: The Governmental dental hospitals in Sudan do not have tailored IC. The IC was neither comprehensive nor understandable to the patients.

"Teach-to-Goal" to Better Assess Informed Consent Comprehension among Incarcerated Clinical Research Participants.

Correctional health research requires important safeguards to ensure that research participation is ethically conducted. In addition to having disproportionately low educational attainment and low literacy, incarcerated people suffer from health-related conditions that can affect cognition (e.g., traumatic brain injury, substance use disorders, mental illness). Yet modified informed consent processes that assess participants' comprehension of the risks and benefits of participation are not required by relevant federal guidelines. A push to assess comprehension of informed consent documents is particularly timely given an increase in demand for correctional health research in the context of criminal justice reform. We argue that comprehension assessments can identify persons who should be excluded from research and help those who will ultimately participate in studies better understand the risks and benefits of their participation.

Racial/ethnic differences in comprehension of biospecimen sharing/banking: University of Rochester Cancer Center NCI Community Oncology Research Program (URCC-NCORP) nationwide study in 710 cancer and healthy subjects.

e18077 Background: Informed consent documents containing language about biospecimen storage/sharing (BSS) may be a barrier to minority participation in cancer research. We explored this issue in a nationwide URCC-NCORP observational study by assessing whether breast cancer patients and healthy control subjects, who provided consent to a cognitive function study, differed in their understanding of the ways their BSS could be used by researchers. Methods: We analyzed cross-sectional data from female breast cancer patients scheduled to receive chemotherapy at NCORPs and healthy controls. After reading a consent form related to BSS and consenting to participate in a study about cognitive function, participants’ understanding of BSS was evaluated using four items for biospecimen sharing (score 0-4); three items for relevance to care (score 0-3); nine items for biospecimen use (score 0-9); and six for research purpose (score 0-6); a higher score indicates better understanding. Linear models were used to compare the mean scores between white and non-white subjects, adjusting for education and baseline reading comprehension (WRAT). Results: 461Breast cancer patients and 249 healthy controls completed the survey. The adjusted linear models showed that white subjects scored higher than non-whites (mean scores 14.43 vs. 13.43) on the survey questions overall (p &lt; 0.05), after accounting for education and WRAT. White subjects were more likely than non-whites to correctly answer all the questions for the biospecimen use (42.1% vs. 34.4%, p &lt; 0.22), biospecimen sharing (31.3% vs. 28.1%, p &lt; 0.74), relevance to care (35.1% vs. 17.2%, p &lt; 0.01), and research purpose (4.1% vs. 1.4%, p &lt; 0.97). Conclusions: Our research suggests that informed consent comprehension related to BSS is low overall across all racial/ethnic backgrounds, but non-white subjects’ scores remained lower than whites even after adjusting for education and WRAT. Efforts should be made by researchers to make it easier for all study subjects, especially non-white subjects, to understand informed consent form and BSS.

THE INTERNATIONAL GOOD CLINICAL PRACTICES GUIDELINES: TIME FOR A REVISION?

BackgroundThe Good Clinical Practices (GCP) codes of the World Health Organization and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written...

Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting

BackgroundMaximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process.MethodsA cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively.ResultStudy recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001).ConclusionLevels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0127-z) contains supplementary material, which is available to authorized users.

Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent. A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. A total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Telemedicine is noninferior to F2F consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials.

Determinants of Informed Consent Comprehension among Fisher Folk Cohort in HIV Vaccine Preparatory Studies in SW Uganda

Determinants of Informed Consent Comprehension among Fisher Folk Cohort in HIV Vaccine Preparatory Studies in SW Uganda

Comparison of closed-ended, open-ended, and perceived informed consent comprehension measures for a mock HIV prevention trial among women in Tanzania.

Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood.