Project description:BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.

Project description:BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

Project description:ImportanceEnsuring valid informed consent (IC) prior to enrollment in clinical trials is a fundamental ethical right.ObjectiveTo assess whether social determinants of health (SDOH) and related sociocontextual factors are associated with parental IC comprehension in therapeutic childhood cancer clinical trials.Design, setting, and participantsThis 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.ExposuresInformed consent for a therapeutic childhood cancer clinical trial.Main outcomes and measuresThe 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).ResultsOf 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.Conclusions and relevanceIn 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.

Project description:BackgroundObtaining informed consent (IC) is vital for ethically and effectively recruiting participants in research projects. However, traditional in-person IC approaches encounter notable obstacles, such as geographic barriers, transportation expenses, and literacy challenges, which can lead to delays in enrollment and increased costs. Telehealth, especially teleconsent, offers a potential way to overcome these obstacles by facilitating the IC process in a digital setting. Nonetheless, there are concerns about whether teleconsent can achieve levels of understanding and involvement that are equivalent to those of in-person IC meetings.ObjectiveThis study aims to evaluate comprehension and decision-making in participants undergoing teleconsent versus traditional in-person IC. We used validated assessments to determine whether teleconsent is a viable alternative that maintains participants' understanding and decision-making abilities.MethodsA randomized comparative study design was used, recruiting potential participants for a parent study assessing patient experiences with patient portals. Participants were randomly assigned to 2 groups: teleconsent and in-person consent. The teleconsent group used Doxy.me software, allowing real-time interaction between researchers and participants while reviewing and electronically signing the IC documents. Recruitment involved using an institutional web-based platform to identify interested individuals, who were then contacted to assess eligibility and gather demographic information. The Decision-Making Control Instrument (DMCI) survey was used to assess the perceived voluntariness, trust, and decision self-efficacy. The Quality of Informed Consent (QuIC) was used to measure the comprehension level of the consent form. The validated Short Assessment of Health Literacy-English tool was used to measure participants' health literacy levels.ResultsA total of 64 participants were enrolled in the study, with 32 in the teleconsent group and 32 in the in-person group. Of 64 participants, 32 (50%) were in the teleconsent group, 54 (84.4%) were females, 44 (68.7%) were aged 18-34 years, 50 (78.1%) were White, and 31 (48.4%) had a bachelor degree. The mean SAHL-E scores were different between the teleconsent and in-person groups (16.72, SD 1.88 vs 17.38, SD 0.95; P=.03). No significant differences were found between the average scores at baseline and follow-up for QuIC part A (P=.29), QuIC part B (P=.25), and DMCI (P=.38) within the teleconsent and in-person groups. Additionally, there were no significant differences in QuIC or DMCI between subgroups based on age, sex, and ethnicity.ConclusionsThis study assessed the effectiveness of IC processes through telehealth compared to traditional in-person visits. Findings indicate that telehealth offers similar participant understanding and engagement while overcoming geographic and accessibility barriers. As health care adopts digital solutions, these results highlight telehealth's potential to improve recruitment and retention in clinical research, suggesting that policy makers should integrate telehealth practices into regulations for better access and health outcomes.

Project description:Background Informed consent is the first step of every medical procedure and is considered a standard of care for patients undergoing medical interventions. Our study seeks to evaluate patients' understanding of the procedure they consented to and the factors affecting the degree of understanding. Methods In this cross-sectional study, we used an anonymous postprocedural questionnaire to assess our patients' understanding of the procedure being performed and their level of satisfaction. It was conducted between June 2021 and January 2022 on every consenting patient who declined English interpreter services and was undergoing a first elective lumbar epidural steroid injection. Results The mean age of 201 subjects was 57.3 (23–90) years, with a race distribution of Black (44.3%), White (31.8%), and other races (23.9%). 15.9% of our subjects worked in the medical field. Older age and patients identified as Black and other races had a positive correlation with the propensity to predict a poor understanding of consent. This study failed to demonstrate any difference in understanding of informed consent content between the different subgroups when stratified by assigned sex at birth, level of education, and profession. Patients' expectation from the treatment was classified as desperate (will take any help they can) in 78 patients (38.8%), feeling hopeful (expecting partial improvement in their symptoms) in 52 patients (25.9%), and being optimistic (will obtain full recovery from this injection) in 71 patients (35.3%). 192 patients (95.5%) were very satisfied with the consent process. Seven patients (3.5%) stated that they wanted more information, and 2 patients (1.0%) did not understand the explanation. 180 patients (89.6%) were satisfied with the overall experience, while 21 patients (10.4%) were not. The Wilks test (likelihood-ratio test) resulted in a p value of 0.023 and was deemed statistically significant for a relationship between understanding of consent and the satisfaction of the patient from the procedure. Conclusions Although patients carry a variable expectation of procedures, most patients in our pain clinic have a high level of satisfaction despite having a poor understanding of the procedure provided via informed consent. Although our patients' level of objective comprehension is low, those with a better understanding of the procedure tend to have a more satisfactory experience.

Project description:BackgroundPatient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent.Purpose. To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely.Conclusions. A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

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Compliance with research ethics in epidemiological studies targeted to conflict-affected areas in Western Ethiopia: validity of informed consent (VIC) by information comprehension and voluntariness (ICV)

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