Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.838
Filtrar
1.
J Glob Health ; 13: 04012, 2023 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-36655916

RESUMO

Background: It is unknown if changes have been made to the original participant's information sheet/informed consent form (PIS/ICF) provided by the WHO Solidarity Plus team when it was transferred to participating countries. Methods: National principal investigators from 30 countries were asked if the original PIS/ICF was edited in their countries and, if so, to share with us the one used to recruit participants. We assessed whether the 25 different elements of information from the good clinical practice guidelines and the Declaration of Helsinki were present in, deficiently described, or absent from the PIS/ICFs. Results: Nineteen national principal investigators responded: eight (Argentina, Brazil, Ethiopia, Georgia, Iran, Lebanon, Lithuania, and Malaysia) stated that no edits were introduced to the original PIS/ICF; eight (Canada, Colombia, Philippines, India, Ireland, Pakistan, Portugal, and Switzerland) added some elements of information in the national PIS/ICF; and three (Italy, Peru, and Spain) reported not participating in the trial. None of the elements included in the original PIS/ICF were omitted from the edited PIS/IFC. Six elements of information were omitted and five deficiently described in the original PIS/ICF. The number of elements omitted from the edited PIS/ICFs varied (range = 2-5). Nine PIS/ICFs incompletely described or omitted the informing of study participants about the study results, while five deficiently described or omitted the anticipated expenses for trial participation. Information concerning whom to contact for more information or in case of injury was deficient in six PIS/ICFs. Unlike the original PIS/ICF, all edited PIS/ICFs informed participants about the existence of compensation or treatment for any injury related to the trial. Conclusions: WHO should consider adding three of the omitted elements in PIS/ICFs of future multinational similar trials.


Assuntos
Compreensão , Termos de Consentimento , Humanos , Índia , Redação , Organização Mundial da Saúde
2.
Trials ; 23(1): 1055, 2022 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-36578070

RESUMO

BACKGROUND: For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers' views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers' views on the optimal content and layout of the layered consent materials for a large and complex Bayesian adaptive platform trial (the SNAP trial). METHODS: We conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their carers (2). Interview transcripts were examined using inductive thematic analysis. RESULTS: Consumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form is signed. Three other themes emerged; the need to prioritise participants' information needs; the importance of health literacy; the importance of information about a trial's benefits (over its risks) for decision-making and the interplay between the two. CONCLUSIONS: Our findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial. A 3-page PICF was considered sufficient for decision-making for the SNAP trial, provided that further information was available and accessible.


Assuntos
Letramento em Saúde , Adulto , Adolescente , Humanos , Teorema de Bayes , Grupos Focais , Pesquisa Qualitativa , Termos de Consentimento , Consentimento Livre e Esclarecido
3.
Bull Hosp Jt Dis (2013) ; 80(4): 207-209, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36403946

RESUMO

BACKGROUND: Handwritten consent forms for medical treatment are commonly used despite the associated risk of documentation errors. We performed an internal audit of handwritten surgical consent forms to assess the quality of consenting practices within the department of hand surgery at our orthopedic specialty hospital. METHODS: A sample of 1,800 charts was selected. Con- sents were assessed for procedure type, physician details, abbreviations, consistency, and legibility. RESULTS: A total of 1,309 charts met the inclusion crite- ria. Two hundred and eight consents contained at least one illegible word. The name of the consenting physician was not listed or illegible on 114 forms. Medical abbreviations were found on 1.8% of all included forms, and 19 consent forms contained a crossed-out word or correction. CONCLUSIONS: Although the majority of the handwrit- ten consent forms were complete, accurate, and legible, there were notable errors in the consenting process at our institution. Documentation errors have medical and ethical ramifications. Further research into consenting practices is necessary to improve the quality of consent forms and the process of informed consent.


Assuntos
Compreensão , Procedimentos Ortopédicos , Humanos , Termos de Consentimento , Consentimento Livre e Esclarecido , Documentação
4.
BMC Med Ethics ; 23(1): 113, 2022 11 16.
Artigo em Inglês | MEDLINE | ID: mdl-36384589

RESUMO

BACKGROUND: This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial. METHODS: A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important). RESULTS: A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk-benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants' and parents' viewpoint. None of the items were considered 'slightly important' or lower by more than 20% of the respondents. CONCLUSIONS: For pediatric drug trials, risk-benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants' and parents' needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.


Assuntos
Termos de Consentimento , Consentimento Livre e Esclarecido , Criança , Humanos , Pais , Medição de Risco , Inquéritos e Questionários , Ensaios Clínicos como Assunto
6.
BMC Med Ethics ; 23(1): 117, 2022 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-36414962

RESUMO

BACKGROUND: The 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. METHODS: The 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. RESULTS: Of 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. CONCLUSION: The 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.


Assuntos
Ética em Pesquisa , Consentimento Livre e Esclarecido , Humanos , Beneficência , Termos de Consentimento , Eletrônica
7.
AORN J ; 116(6): 579-586, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36440937

RESUMO

Surveying the AORN membership for research studies Key words: perioperative research study, research grant, incentive, sample size, power analysis. Informed consent document validity Key words: surgical consent forms, anesthesia consent forms, canceled procedures, rescheduled procedures, documentation. Internet technology updates and fire alarms Key words: 3G phaseout, 5G technology, fire alarm system, cellular communicator, communication loss. Documenting versus recording Key words: documentation, record keeping, logbook, patient health care record (HCR), patient health care information.


Assuntos
Anestesia , Consentimento Livre e Esclarecido , Humanos , Termos de Consentimento , Documentação
8.
BMC Med Ethics ; 23(1): 119, 2022 Nov 24.
Artigo em Inglês | MEDLINE | ID: mdl-36434585

RESUMO

Research involving human participants requires their consent, and it is common practice to capture consent information on paper and store those hard copies, presenting issues such as long-term storage requirements, inefficient retrieval of consent forms for reference or future use, and the potential for transcription errors when transcribing captured informed consent. There have been calls to move to electronic capture of the consent provided by research participants (e-consent) as a way of addressing these issues. A tiered framework for e-consent was designed using the freely available features in the inbuilt REDCap e-consent module. We implemented 'branching logic', 'wet signature' and 'auto-archiver' features to the main informed consent and withdrawal of consent documents. The branching logic feature streamlines the consent process by making follow-up information available depending on participant response, the 'wet signature' feature enables a timestamped electronic signature to be appended to the e-consent documents and the 'auto-archiver' allows for PDF copies of the e-consent documents to be stored in the database. When designing the content layout, we provided example participant information text which can be modified as required. Emphasis was placed on the flow of information to optimise participant understanding and this was achieved by merging the consent and participant information into one document where the consent questions were asked immediately after the corresponding participant information. In addition, we have provided example text for a generic human genomic research study, which can be easily edited and modified according to specific requirements. Building informed consent protocols and forms without prior experience can be daunting, so we have provided researchers with a REDCap template that can be directly incorporated into REDCap databases. It prompts researchers about the types of consent they can request for genomics studies and assists them with suggestions for the language they might use for participant information and consent questions. The use of this tiered e-consent module can ensure the accurate and efficient electronic capture and storage of the consents given by participants in a format that can be easily queried and can thus facilitate ethical and effective onward sharing of data and samples whilst upholding individual participant preferences.


Assuntos
Termos de Consentimento , Consentimento Livre e Esclarecido , Humanos , Pesquisadores , Idioma , Genômica
9.
JAMA Netw Open ; 5(10): e2235888, 2022 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-36219446

RESUMO

Importance: Few studies are available on informed consent (IC) among detained persons, even with ethics being a critical aspect of prison research. In IC research, audiovisual material seems to improve understanding and satisfaction compared with conventional paper-based material, but findings remain unclear. Objective: To compare audiovisual and paper-based materials for 1-time general IC for research in prisons. Design, Setting, and Participants: This cross-sectional randomized clinical trial was conducted in 2 corrections facilities in Switzerland (an adult prison and a juvenile detention center). The study was conducted from December 14, 2019, to December 2, 2020, in the adult prison and from January 15, 2020, to September 9, 2021, in the juvenile detention center. In the adult prison, study participation was offered to detained persons visiting the medical unit (response rate, 84.7%). In the juvenile detention center, all newly incarcerated adolescents were invited to participate (response rate, 98.0%). Interventions: Participants were randomized to receive paper-based conventional material or to watch a 4-minute video. Materials included the same legal information, as required by the Swiss Federal Act on Research Involving Human Beings. Main Outcomes and Measures: The main outcome was acceptance to sign the IC form. Secondary outcomes included understanding, evaluation, and time to read or watch the IC material. Results: The study included 190 adults (mean [SD] age, 35.0 [11.8] years; 190 [100%] male) and 100 adolescents (mean [SD] age, 16.0 [1.1] years; 83 [83.0%] male). In the adult prison, no significant differences were found between groups in acceptance to sign the IC form (77 [81.1%] for paper-based material and 81 [85.3%] for audiovisual material; P = .39) and to evaluate it (mean [SD] correct responses, 5.09 [1.13] for paper-based material and 5.01 [1.07] for audiovisual material; P = .81). Understanding was significantly higher in the audiovisual material group (mean [SD] correct responses, 5.09 [1.84]) compared with the paper-based material group (mean [SD] correct responses, 4.61 [1.70]; P = .04). In the juvenile detention center, individuals in the audiovisual material group were more likely to sign the IC form (44 [89.8%]) than the paper-based material group (35 [68.6%], P = .006). No significant difference was found between groups for understanding and evaluation. Adults took a mean (SD) of 5 (2) minutes to read the paper material, and adolescents took 7 (3) minutes. Conclusions and Relevance: Given the small benefit of audiovisual material, these findings suggest that giving detained adults and prison health care staff a choice regarding IC material is best. For adolescents, audiovisual material should be provided. Future studies should focus on increasing understanding of the IC process. Trial Registration: ClinicalTrials.gov Identifier: NCT05505058.


Assuntos
Consentimento Livre e Esclarecido , Prisões , Adolescente , Adulto , Termos de Consentimento , Estudos Transversais , Atenção à Saúde , Feminino , Humanos , Masculino
10.
S Afr Med J ; 112(9): 744-746, 2022 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-36214040

RESUMO

South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient's death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient's death, the fertility clinic may be committing a civil wrong and a crime. Accordingly, consent forms should not include any provision that deals with the disposition of reproductive material after a fertility patient's death. Instead, to address the practical concern of keeping reproductive material cryopreserved without receiving payment, fertility clinics' storage agreements should use non-payment by fertility patients (or their successors in title) as the trigger event for the disposition of reproductive material. The importance of dealing with reproductive material in both its property rights dimension and its personality rights dimension is highlighted.


Assuntos
Termos de Consentimento , Criopreservação , Humanos , África do Sul
11.
Med J Malaysia ; 77(5): 576-584, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-36169069

RESUMO

INTRODUCTION: Informed consent is the patient's selfdetermination authorization of a choice made by themself before any intervention is performed by the health care provider. It should be a structured process that includes the disclosure of relevant procedural information, benefit, risk, and other treatment option. MATERIALS AND METHODS: An open-label static group comparison experimental design was conducted in a singlecentred study starting from April 2021 until January 2022 among patients who were going for OGDS and Colonoscopy at Hospital Kuala Lipis. The patients were stratified by 2-by- 2 randomization to either the standard hand-written prefilled consent forms. The satisfaction was assessed using Gastrointestinal Endoscopy Satisfaction Questionnaire version 2. The difference in the satisfaction was analyzed using multifactorial ANOVA. RESULTS: The percentage score of satisfaction on the endoscopic procedure using pre-filled was significantly higher than standard form consents (mean difference: 18.36 (95%CI: 14.15, 22.58)) and the effect size was large (partial ή = 0.399). The difference in percentage score of satisfaction was associated with gender (p = 0.003) and medical officers' years of working experience (p < 0.001). CONCLUSION: The pre-filled consent form fulfils the ethical and legal aspects of the informed consent process and should be used in endoscopic and other invasive procedures in Malaysia. It is suggested that a formal training, exposure to course in communication skills, breaking bad news on patient consent among junior doctors need to be taken to improve patients' satisfaction of the endoscopic procedure to make them more satisfied.


Assuntos
Termos de Consentimento , Satisfação do Paciente , Colonoscopia , Hospitais , Humanos , Satisfação Pessoal
12.
Int Orthod ; 20(4): 100689, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36117084

RESUMO

BACKGROUND/OBJECTIVE: The valid consent process for medical intervention requires the disclosure of information in a format that is easily understandable by the patient. The aim of this investigation was to assess the readability of orthognathic surgery informed consent forms (OSICFs). METHODS: An online search methodology was conducted to identify OSICFs for analysis. The forms that satisfied inclusion/exclusion criteria were evaluated according to a standardised protocol. The readability of the content was assessed using three validated tools: the Simple Measure of Gobbledegook (SMOG) score, Flesch-Kincaid Grade-Level (FKGL) score and Flesch Reading Ease (FRE) score. RESULTS: Most of the 26 evaluated OSICFs were sourced from websites within the United States (69.2%) and from oral and maxillo-facial surgery practices (76.9%). Two of the assessed forms were template OSICFs available from oral and maxillo-facial professional societies to its members. The scores from the three tools found that the content of 84.6% to 92.3% of the forms were "difficult" to read. The mean (SD) SMOG score for all evaluated OSICFs was 12.31(2.22) [95% CI: 11.42 to 13.21]. The SMOG and FKGL scores were closely correlated (r=0.99, P < 0.0001; 95% CI: 0.9864 to 0.9973). There was no association between SMOG scores and the number of words contained within each consent form (r=-0.047;95% CI: -0.44 to 0.36). CONCLUSIONS: The OSICFs surveyed in this investigation failed to meet recommended readability levels. A significant number of patients are not likely to understand the information contained within the forms. Orthodontists are advised that poor literacy skills of their patients may preclude them from validly consenting to orthognathic surgery treatment procedures.


Assuntos
Letramento em Saúde , Cirurgia Ortognática , Humanos , Compreensão , Termos de Consentimento , Smog
13.
Trials ; 23(1): 794, 2022 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-36131293

RESUMO

BACKGROUND: Participant information sheets and consent forms (PICFs) used in interventional studies are often criticised for being hard to read and understand. We assessed the readability and its correlates of a broad range of Australian PICFs. METHODS: We analysed the participant information sheet portion of 248 PICFs. Readability scores were measured using three formulae: the Flesch Reading Ease, the Flesch-Kincaid Grade Level, and the Simple Measure of Gobbledygook (SMOG). We investigated how various features (including sponsor type and PICF type) correlated with PICF length and readability and examined compliance with other measures known to improve readability. RESULTS: For a sample of 248 PICFs, the mean (standard deviation) Flesch Reading Ease score was 49.3 (5.7) and for the Flesch-Kincaid Grade Level 11.4 (1.1). The mean (SD) SMOG score was 13.2 (0.9). The median document length was 3848 words (8 pages). Commercial PICFs were more than twice as long as non-commercial, but statistically more readable (p = 0.03) when analysed using the SMOG formula. Subgroup analyses indicated that PICFs for self-consenters were statistically more readable than those for proxy consenters. The use of tables, but not the use of illustrations was associated with better readability scores. CONCLUSIONS: The PICFs in our sample are long and complex, and only 3 of the 248 achieved the recommended readability score of grade 8 or below. The broader use of best practice principles for writing health information for consumers and the development of more context-sensitive templates could improve their utility.


Assuntos
Compreensão , Smog , Austrália , Termos de Consentimento , Humanos , Internet , Leitura
14.
AMIA Annu Symp Proc ; 2022: 159-167, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35854712

RESUMO

Healthy diet and dietary behaviors are key components in prevention of chronic disease and management of chronic illness. Nutritional literacy has been associated with dietary behaviors and consumer choice of healthy foods. Nutritional literacy can be measured, for example, by examining consumer food label use, but current research focuses largely on the Nutrition Facts panel of a food product. Ingredients lists are critical for communicating food composition but are relatively unstudied in existing literature. The goal of this work is to measure the readability of ingredients lists on branded food products in the United States using existing metrics. We examined ingredients lists for all 495,646 products listed in the USDA Food Data Central database using four existing readability measures for text written in natural language. Each of these indices approximates the grade level that would be expected to comprehend a text; comparatively, patient consent forms are considered acceptable at an 8th grade reading level or lower. We report a broad variability for in readability using different metrics: ingredients lists recorded at a 9th grade reading level or higher to comprehend are found at rates of 16.5% (Automated Reading Index) to 74.9% (Gunning-Fog Index). Ingredients lists recorded at a 10th grade reading level or higher to comprehend are found at rates of 84.2% (using FRE Index). These results demonstrate the need to further explore how ingredients lists can be measured for readability, both for the purposes of consumer understanding as well as for supporting future nutrition research involving text mining.


Assuntos
Compreensão , Letramento em Saúde , Benchmarking , Termos de Consentimento , Humanos , Internet , Estados Unidos
15.
Ethics Hum Res ; 44(4): 26-33, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35802790

RESUMO

Minority populations have been underrepresented in clinical trials, as well as in research biobanks that are created to conduct research with participants' biospecimens and related medical and research data. Biobank research raises issues about informed consent and privacy and the confidentiality of participants' personal data. Our study involved three focus groups of 10 adults each that were conducted in a medically underserved, predominantly African American community to elucidate questions and concerns regarding an institutional biobank. Transcripts from the discussion were qualitatively analyzed. Three main themes that arose from the focus groups included the importance of trust, the importance of the community in research, and suggestions to improve trust. The concerns identified in this study provide a starting point for future research to help research institutions become more trustworthy to the communities they serve.


Assuntos
Bancos de Espécimes Biológicos , Termos de Consentimento , Adulto , Humanos , Consentimento Livre e Esclarecido , Privacidade
16.
Ethics Hum Res ; 44(4): 14-25, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35802793

RESUMO

We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.


Assuntos
Consentimento Livre e Esclarecido , AVC Isquêmico , Ensaios Clínicos como Assunto , Termos de Consentimento , Humanos , Consentimento Livre e Esclarecido/ética , AVC Isquêmico/terapia , Ativador de Plasminogênio Tecidual/uso terapêutico
17.
Stud Health Technol Inform ; 290: 777-781, 2022 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-35673123

RESUMO

Informed consent process assures that research study participants are properly informed about the study prior to their consent. Due to the increasing significance of electronic informed consent (eIC) platforms, particularly during the COVID-19 pandemic, we conducted a scoping review of eIC systems to address the following characteristics: 1) technological features of current eIC platforms, 2) eIC platforms usability and efficacy, and 3) areas for future eIC research. We performed a literature search using publically available PubMed repository, where we included studies discussing an eIC platform or multimedia educational module given to patients prior to signing a consent form. In addition, we tracked first author, year of publication, sample size, study location, eIC procedure, methodology, and eIC's comparison to paper consent. Our results showed that with a few noted exceptions, electronic consent improves patient usability, satisfaction, knowledge, and trust scores when compared to traditional paper consent.


Assuntos
COVID-19 , Pandemias , Termos de Consentimento , Eletrônica , Humanos , Consentimento Livre e Esclarecido
18.
Evid Based Dent ; 23(2): 52-53, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35750724

RESUMO

Design Single-blind randomised controlled trial.Intervention Patient and parent pairs were randomly assigned via a random number generator to Group A or B. Both groups were given ten minutes to read a modified consent document. Group A (rehearsal) were given printouts that showed images of four core and four custom risks with handwritten descriptions of each risk and consequences. Group B were given an audio-visual presentation instead (PowerPoint). Interviews of each group were completed immediately after the informed consent and at six-month follow-up to assess recall and comprehension of information provided.Case selection Patients aged 11-18 years old and their parents attending for comprehensive orthodontic treatment at Ohio State University graduate orthodontic clinic. All subjects needed to be able to communicate in English, have no developmental disabilities or urgent medical conditions and neither the patients or parents or subjects' siblings were to have had orthodontic treatment in the last five years.Data analysis 1) Exploratory analysis to test for differences in demographics and anxiety between the two groups; 2) Multiple linear regression analysis was used to assess percentage of accurate responses at baseline and six months and the change between the two different groups, with differing baseline characteristics (p <0.05 was considered statistically significant); and 3) Intra- and inter-rater reliability was assessed using intra-class correlation.Results There were no significant differences in information retention and understanding between the two methods at six-month follow-up. For both groups, recall was significantly lower six months following consent-taking. Specific domains whereby information recall and comprehension are poor include: treatment method, risks, resorption and discomfort.Conclusions There is no superior method of consent-taking to ensure patients' and parents' information retention in the months following commencement of treatment. However, the study highlighted that current consent practices which are considered 'best practice' may be deficient.


Assuntos
Consentimento Livre e Esclarecido , Ortodontia , Adolescente , Criança , Compreensão , Termos de Consentimento , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Método Simples-Cego
19.
Rev. bioét. (Impr.) ; 30(2): 423-433, abr.-jun. 2022. tab, graf
Artigo em Português | LILACS | ID: biblio-1387739

RESUMO

Resumo A Resolução do Conselho Nacional de Saúde 466/2012 estabelece a obrigatoriedade de termo de assentimento para pesquisas realizadas com crianças. No entanto, a resolução apresenta a definição de assentimento livre e esclarecido sem especificar os elementos necessários para o documento. Essa lacuna torna atual e pertinente a abordagem desse tema proposta pelo presente estudo, que tem como objetivo discutir a participação de crianças em pesquisas. Os resultados apresentam um arcabouço teórico a partir do qual se pode refletir sobre a ética em pesquisas com crianças, tendo em vista sua vulnerabilidade, que pode levar a situações irreparáveis. Conclui-se que o tema deve permanecer nos debates acadêmicos e profissionais, pois, além de a realidade ser dinâmica, muitas são as especificidades desse segmento populacional.


Abstract The Resolution 466/2012 of the National Council of Health establishes the term of assent as compulsory for research carried out with children. However, the resolution presents the definition of assent without specifying the terms necessary for the document. This gap makes current and pertinent the approach of this topic by this study, which aims to discuss the participation of children in research. The results present a theoretical framework from which we can reflect on the ethics of Research with children, considering their vulnerability, which can lead to irreparable situations. We conclude that the theme must remain in the academic and professional debates since, on top of being a dynamic reality, this population segment has many specificities.


Resumen La Resolución del Consejo Nacional de Salud 466/2012 brasileño dispone que el término de asentimiento es obligatorio en las investigaciones que involucran a niños. La resolución trae la definición de asentimiento informado, pero no detalla los elementos que deben contener el documento. Con base en esta laguna actual y relevante, este estudio pretende discutir la participación de los niños en investigación. Se presenta un marco teórico desde el cual se reflexiona sobre la ética en la investigación que involucra a niños dada su vulnerabilidad, lo que puede llevar a situaciones irreparables. Se concluye que el tema tiene que seguir en los debates académicos y profesionales, porque, además de que la realidad es dinámica, existen muchas especificidades para esta población.


Assuntos
Criança , Termos de Consentimento , Ética em Pesquisa , Comitês de Ética em Pesquisa , Ética
20.
Invest. educ. enferm ; 40(2): 95-106, 15 de junio 2022. tab
Artigo em Inglês | LILACS, BDENF - Enfermagem, COLNAL | ID: biblio-1379479

RESUMO

Objective. To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation. Methods. This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis. Results. Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study. Conclusion. The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.


Objetivo. describir la importancia del Formulario de Consentimiento Informado para los niños y adolescentes invitados a participar en un estudio clínico aleatorizado y sus principales reacciones a su explicación. Métodos. se trata de una investigación exploratoria descriptiva con abordaje cualitativo, realizada con 17 niños y adolescentes, quienes fueron invitados a participar de un estudio clínico en el área de oncología en un hospital ubicado en Río de Janeiro (Brasil). A los datos se les realizó análisis temático. Resultados. Luego de la interpretación de los datos, se generaron 2 unidades temáticas: la firma del formulario de consentimiento y la comprensión del estudio. Los niños y adolescentes entendieron las etapas del estudio contenidas en la firma del Término de Asentimiento y se interesaron, haciendo preguntas para aclarar sus dudas sobre la investigación. Conclusión. El consentimiento informado era importante para que los participantes entendieran la investigación y tuvieran autonomía sobre su participación. Al potenciar el protagonismo de los niños y adolescentes en el proceso de investigación, recomendamos que debe fomentarse su uso en los estudios con población pediátrica.


Objetivo. Descrever a importância do Termo de Assentimento para crianças e adolescentes convidados a participar de um estudo clínico e suas principais reações quanto à explicação do mesmo. Métodos. Trata-se de uma pesquisa do tipo descritiva exploratória com abordagem qualitativa, realizada com 17 crianças e adolescentes, que foram convidados a participar de um estudo clínico na área da oncologia em um hospital localizado no Rio de Janeiro (Brasil). Os dados foram analisados empregando-se a análise temática. Resultados. Após a interpretação dos dados, foram geradas 2 unidades temáticas: a assinatura do termo de assentimento em que os participantes se sentiram protagonistas frente a possibilidade de expressarem a concordância ou não em participar da pesquisa, e a compreensão sobre o estudo quando elas mostraram que entenderam as etapas do estudo fazendo perguntas pertinentes para esclarecer suas dúvidas. As crianças e adolescentes compreenderam as etapas do estudo que constavam no Termo de Assentimento e tiveram interesse, fazendo perguntas para esclarecer suas dúvidas com relação à pesquisa. Conclusão. O termo de assentimento foi importante para os participantes compreenderem sobre a pesquisa e para terem autonomia sobre sua participação. Por potencializar o protagonismo de crianças e adolescentes no processo de pesquisar conclui-se que seu uso em estudos que envolvem a população pediátrica deve ser incentivado.


Assuntos
Humanos , Criança , Adolescente , Criança , Adolescente , Comitês de Ética em Pesquisa , Termos de Consentimento , Consentimento Informado por Menores
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...