Biobanking rare gynaecological tumours - How harmonised is data collection?

INTRODUCTION: GYNOCARE, the European Network for Gynaecological Rare Cancer Research, set out to evaluate the current status of biobanks with access to rare gynaecological tumours, with a view to harmonising sample and data collection and associated consent, to facilitate collaborative cross-border research, enabling clinical trials and translational research. METHODS: Two digital surveys were formulated, one covering clinical and scientific parameters and one exploring ethical and regulatory issues around informed consent. RESULTS: Data were analysed for 20 common responses, from 7 European countries. Tissue was the main sample type biobanked with 63 % also banking blood. Documentation of clinical data, treatment regimens and classification systems varied. Eighty percent collected pathological information. Most biobanks were linked to medical records but only one fifth with national registries. The Information Sheet covered governance, benefits/risks, sharing (mainly for non-profit research), return of results and data protection safeguards. Only 37 % informed patients about sample and data storage, although about half stored samples for an indefinite time. Pseudonymisation and Data Protection Officer approval were the prime data safeguards. Less than half explained the difference between anonymisation and pseudonymisation. Broad consent was the norm (84 %) and 95 % granted the right to withdraw consent. Three countries have Biobank legislation. CONCLUSION: These surveys provide a snapshot of the current state of biobanks and highlight divergences in the consent process and data management. More work is needed to understand what parameters are being gathered across more EU countries and thus harmonise the sample and data collection processes to facilitate cross-border research.

Role of procedure-specific consent forms in clinical practice: a systematic review.

INTRODUCTION: Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria. METHODS: This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity. FINDINGS: We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%-100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. CONCLUSIONS: The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

What Is "Key Information"? Consideration of the Reasons People Do or Do Not Take Part in Research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Contraception Requirements in Clinical Research Consent Forms: Assessing and Supporting Gender Inclusive Practices.

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

Longitudinal assessment of an Ebola vaccine trial understanding among healthcare providers in the Democratic Republic of the Congo.

BACKGROUND: The long-term retention of information disclosed during the informed consent in clinical trials lasting over a year cannot be guaranteed for all volunteers. This study aimed to assess the level of participants' retention and understanding of the trial information after two years of participation in a vaccine trial. METHODS: In total, 699 health care providers (HCPs) and frontline workers were enrolled in the EBL2007 vaccine trial conducted between February 2019 and September 2022 in the Health District of Boende, Democratic Republic of the Congo (DRC). Individual scores obtained from a questionnaire (test of understanding, TOU), specifically designed to assess the understanding of the consent at baseline, were collected before the clinical trial started and at one-year and two-year intervals. RESULTS: TOU scores were high in the beginning of the trial (median TOU = 10/10), but significantly decreased in both the first and second years following (median TOU = 8/10 in year 1 and median TOU = 9/10 in year 2, p-value < 0.0001). The decrease in scores was significantly higher among individuals with occupations requiring shorter education such as midwives (median TOU = 7/10 in year 1 and 8/10 in year 2, pvalue = 0.025). Furthermore, older participants exhibited poorer retention of information compared to younger individuals (median TOU = 8/10 vs 9/10, p-value = 0.007). CONCLUSION: We observed a significant decline in the informational knowledge of informed consent, specifically in terms of basic knowledge on the study vaccine and trial procedures. As participant safety and understanding is a paramount ethical concern for researchers, it is crucial for participants to fully comprehend the study's objectives and potential risks. Therefore, our findings suggest the need for clinical researchers to re-explain participants to optimize the protection of their rights and wellbeing during the research.

Redefining informed consent form in cell and gene therapy trials.

Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally, have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable. These therapies, which include cells and gene therapy (GT) labeled as Advanced Therapeutic Medicinal Products globally, have complex mechanisms of action. Owing to their highly personalized and intricate nature of these therapies, developing the latter often presents unique challenges above and beyond those encountered for small molecule drugs. We recently looked through some cell and GT clinical trials and realized the lacunae in the informed consent form (ICF) provided by the investigators. Especially in a country like India, where the general understanding and perception of patients is limited regarding clinical trials, it is felt that any lapses in the consent process may jeopardize the informed decision-making and safety of the participants and tarnish the reputation of India globally. The present article highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies and aims to address all the elements of ICF in light of the challenges associated with these innovative therapies.

Comparative Effectiveness of eConsent: Systematic Review.

BACKGROUND: Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns. OBJECTIVE: This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process ("cycle time") and on-site workload in comparison with traditional paper-based consenting. METHODS: The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having "high" validity if comprehensive assessments were performed using established instruments. RESULTS: Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with "high" validity), acceptability (8/35, 23% of the studies; 1 with "high" validity), and usability (5/35, 14% of the studies; 1 with "high" validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the "high" validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent. CONCLUSIONS: This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.

Continuous quality improvement: reducing informed consent form signing errors.

BACKGROUND: Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors. METHODS: We used the plan-do-check-act (PDCA) cycle to help improve the correctness and validity of ICF signing. RESULTS: Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05). CONCLUSIONS: The proportions of other error types-multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF-did not differ significantly.

Exploring healthcare professionals' perspective of the process of obtaining consent for adult patient's having planned surgery: A scoping review.

AIM: The aim of this scoping review was to provide an overview of the literature about the process of obtaining consent from adult patients undergoing planned surgery from the healthcare professionals' perspective and analyse knowledge gaps. BACKGROUND: The process of obtaining consent for planned elective surgery manifests an individual's fundamental right to decide what happens to their body. The process is often suboptimal and problematic, placing a significant resource burden on health systems globally. Deficiencies in the documentation on consent forms have also been shown to increase the risk of operating room error. DESIGN: Scoping review. METHODS: Arksey and O'Malley's (International Journal of Social Research Methodology, 8, 2005 and 19) five-step scoping review methodology was used. RESULTS: Fifty-three articles were included; 39 primary and 14 secondary research publications. Three key findings were identified; there is currently low-level evidence about surgical consent processes to inform clinical practice; junior doctors obtain surgical consent frequently, yet this process was likely undertaken sub-optimally; and current knowledge gaps include capacity assessment, decision-making and pre-procedural consent checks. CONCLUSION: Planned surgical consent processes are complex, and both surgeons and perioperative nurses are essential during the process. While surgeons have responsibility to obtain consent, perioperative nurses provide a safety net in the surgical consent process checking the surgical consent information is correct and has been understood by the patient. Such actions may influence consent validity and patient safety in the operating room. Knowledge gaps about capacity assessment, decision-making, pre-procedural checks and the impact of junior doctors obtaining consent on patient understanding, safety and legal claims are evident. RELEVANCE TO CLINICAL PRACTICE: This review highlights the importance of the surgical nurse's role in the planned surgical consent process. While the responsibility for obtaining surgical consent lies with the surgeon, the nurse's role verifying consent information is crucial as they act as a safety net and can reduce error in the operating room. NO PATIENT OR PUBLIC CONTRIBUTION: The authors declare that no patient or public contribution was made to this review in accordance with the aim to map existing literature from the healthcare professionals' perspective.

The evolution of informed consent in gastroenterology.

With medical litigation on the rise, physicians require a nuanced understanding of the legalities of consenting patients to reduce their liability while practising evidence-based medicine. This study aims to a) clarify the legal duties of gastroenterologists in the UK and USA when gaining informed consent and b) provide recommendations at the international and physician level to improve the consent process and reduce liability.A bibliometric analysis of the Web of Science database with the MeSH terms "gastroenterology" and "informed consent" yielded 383 articles, of which 228 were excluded due to not meeting the inclusion criteria. Of the top 50 articles, 48% were from American institutions and 16% were from the UK. Thematic analysis showed 72% of the articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation.Both the USA and the UK have progressed from previously paternalistic Natanson case (1960) and Bolam test (1957), respectively, where physicians were held to the standard of a "reasonable and prudent medical doctor". The American Canterbury case (1972) and the British Montgomery case (2015) radically shifted the standard of disclosure during the consent process by requiring physicians to explain all information pertinent to a "reasonable patient".It is our recommendation that a two-pronged approach be taken; a) creation of international guidelines for consenting patients for invasive procedures in gastroenterology, and b) development of internationally standardised endoscopy consent forms containing all the details pertinent to a "reasonable patient".

Design and validation of 2 instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products. / Diseño y validación de 2 instrumentos para analizar y evaluar la calidad formal en el proceso de consentimiento informado de ensayos clínicos con medicamentos.

OBJECTIVE: The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation. METHOD: Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated. RESULTS: Very good concordance was obtained in both checklists (k ≥ 0.81, p < 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items. CONCLUSION: The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

[Translated article] Design and validation of two instruments to analyze and evaluate the formal quality in the informed consent process of clinical trials with medicinal products.

OBJECTIVE: The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation. METHODS: Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated. RESULTS: Very good concordance was obtained in both checklists (k ≥ 0.81, p b 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items. CONCLUSION: The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.

Parent Engagement with a School-Based Health Center Consent Process Predicts Student Attendance and School Transition.

BACKGROUND: School-based health centers (SBHCs) fill critical pediatric health care access gaps but typically require parental consent for enrollment. Families' responses to SBHC consent form outreach efforts may reflect broader school engagement. This study investigated whether SBHC consent form return predicted subsequent chronic absenteeism and school transition, indicators of student and family school engagement. METHODS: Multivariable logistic regression was used to compare the odds of being chronically absent or transitioning out of a US elementary/middle school (n = 1917) during 2015-2016 and 2016-2017 for those who declined SBHC enrollment or did not return a consent form, compared to those who enrolled. RESULTS: Compared to enrolled students, those who declined had 78% lower odds of chronic absenteeism [95% CI: 0.09, 0.54]. Families who did not respond had 2.8 times greater odds of their student transitioning out of school [95% CI: 2.15, 3.58] but were no more likely to be chronically absent. CONCLUSIONS: Consent form return may predict aspects of broader students and family school engagement.

Agência e poder na pesquisa: algumas reflexões sobre os termos de consentimento livre e esclarecido / Agency and power in research: some thoughts about informed consent forms

Resumo Neste artigo, discutimos algumas premissas do termo de consentimento livre e esclarecido (TCLE), partindo do princípio que elas não são dadas. Argumento que o uso de um termo de consentimento deve ser compreendido dentro de uma relação de pesquisa, que é ao mesmo tempo uma relação intersubjetiva entre duas ou mais pessoas posicionadas socialmente. Desenvolvo esta reflexão a partir de minhas experiências recentes de pesquisa antropológica sobre gestação e parto, nas quais apresentei um TCLE em duas etapas do estudo, mas não em uma intermediária, que se dedicava a explorar mais as relações familiares durante a gravidez do que a experiência corporal em si. Assim, comparando essas três situações, examino suas especificidades na obtenção do consentimento, para discutir as dimensões de agência, poder e ética na pesquisa social.

Abstract This article discusses some premises that constitute informed consent forms, assuming they should not be taken for granted. I argue that the use of informed consent forms should be understood within a research relationship, which is always an intersubjective relation between two or more socially positioned individuals. I develop these reflection based on my recent experiences of anthropological research on pregnancy and birth, during which I used an informed consent form in two stages but not in an intermediary phase, which was dedicated to focus on kinship relations during pregnancy more than the bodily experience itself. Thus, by comparing these three situations, I examine their particularities in obtaining consent, discussing agency, power, and ethics in social research.

Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial.

The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. METHODS: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. RESULTS: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. CONCLUSIONS: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.

No-Fault Compensation and Anti-COVID-19 Compulsory Vaccination: The Italian Context in a Broad View.

Italy, like other European countries, has produced a series of regulations during the COVID-19 pandemic. Compulsory vaccination has been introduced for the Italian population. Meanwhile, the Decree-Law 27 January 2022 n. 4 provided for the compensation mechanism for those who have received damage of the psycho-physical integrity due to the anti-SARS-CoV-2 vaccination recommended by the Italian Health Authority. Law 1992 no. 210 already provided for the indemnity system for persons damaged by irreversible complications due to compulsory vaccinations, transfusions, and the administration of blood products. The legislator intended to attribute the right to an indemnity that is not compensatory in order to repair a wrong connected to some hypothesis of liability, but it rather has a welfare character in the broad sense, being attributable to Constitutional fundamentals. In the Italian panorama, although the vaccination damages have been fully included in the already existing law no. 210/1992, to date, no precise indications have been provided regarding the ascertainment of the causal link and the extent of the compensable damage. In the near future, the interest of the scientific community will focus on the evaluation of applications for access to the benefit.

Family caregivers support their patient's decision to participate in a phase 1 clinical trial: Weighing the pros and cons, bearing the costs.

OBJECTIVES: When patients with advanced cancer pursue phase 1 clinical trials, family caregivers are impacted as they adopt new roles and responsibilities in time-pressured, uncertain circumstances. This study explored the nature of the caregivers' participation in patients' decision to pursue phase 1 clinical trials and the early impact of the decision on the caregiver. METHODS: Semi-structured interviews were conducted with 19 family caregivers of advanced cancer patients who had agreed to participate in phase 1 clinical trials. They were coded for information about the caregiver's relationship with the patient, typical style of decision-making together, understanding of the patient's prognosis and trial, contributions to decision-making and the initial impacts of the trial on the caregiver. Codes illuminating the research questions were grouped into categories and themes, compared across transcripts and examined against the literature. RESULTS: Caregivers unequivocally supported the patients' decision to pursue the phase 1 trial as they hoped that the patient would derive medical benefit from the trial. They withheld their opinions and fears about the trial from the patients to support patient autonomy during the decision-making process. The patient's decision to participate increased the caregivers' burdens and deprived them of time spent on pleasurable activities at end of life. CONCLUSIONS: Respecting the patients' personal autonomy, caregivers supported the trial, despite the complex caregiving required. As the success of phase 1 trials relies on caregiver involvement, it is imperative that healthcare professionals be sensitized to the support needs of these caregivers.

Compreensão do consentimento informado em pesquisa clínica de vacina contra o Zika vírus: estudo transversal / Understanding of informed consent in clinical research for a vaccine against Zika virus: a cross-sectional study / Comprensión del consentimiento informado en la investigación clínica de una vacuna contra el virus del Zika: un estudio transversal

OBJETIVO: avaliar a compreensão das informações do Termo de Consentimento Livre e Esclarecido pelos participantes de uma pesquisa clínica de vacina contra o Zika vírus. MÉTODO: estudo transversal com amostra por conveniência e participação de 101 voluntários de uma pesquisa clínica em Belo Horizonte, Minas Gerais. Utilizou-se um questionário estruturado. A análise dos dados foi realizada no programa R, segundo a estatística descritiva e inferencial. RESULTADOS: a média de acertos dos participantes sobre as informações do documento de consentimento foi de 66,9%. A maioria dos participantes assinou o documento sem o conhecimento suficiente das informações da pesquisa. O Índice de compreensão foi maior entre os participantes que tinham se voluntariado em pesquisas prévias (p=0,039). CONCLUSÃO: verificaram-se limitações importantes na compreensão dos participantes sobre informações do termo de consentimento, o que comprometeu a decisão autônoma. São necessárias adaptações e melhorias nos processos de consentimento informado em prol da sua validade.

OBJECTIVE: to assess the understanding of the information contained in the Informed Consent Form by the participants of a clinical trial of a vaccine against the Zika virus. METHOD: cross-sectional study using intentional sampling, including a total of 101 volunteers in clinical research in Belo Horizonte, Minas Gerais. A structured questionnaire was used. Data analysis was performed using R software, according to descriptive and inferential statistics. RESULTS: the mean of correct answers of the participants regarding the information in the consent form was 66.9%. Most participants signed the document without sufficient knowledge of the research information. The comprehension index was higher among participants who had volunteered in previous research (p=0.039). CONCLUSION: there were important limitations in the participants' understanding of information in the consent form, which compromised the autonomous decision. Adaptations and improvements are necessary in the processes of informed consent for its validity.

OBJETIVO: evaluar la comprensión de las informaciones contenidas en el Término de Consentimiento Libre e Informado por los participantes de un ensayo clínico de una vacuna contra el virus del Zika. MÉTODO: estudio transversal con muestra de conveniencia y participación de 101 voluntarios en una investigación clínica en Belo Horizonte, Minas Gerais. Se utilizó un cuestionario estructurado. El análisis de datos se realizó mediante el programa R, según estadística descriptiva e inferencial. RESULTADOS: el promedio de aciertos de los participantes con respecto a las informaciones del documento de consentimiento fue de 66,9%. La mayoría de los participantes firmó el documento sin conocimiento suficiente de las informaciones de la investigación. El índice de comprensión fue mayor entre los participantes que se habían ofrecido como voluntarios en investigaciones anteriores (p=0,039). CONCLUSIÓN: hubo limitaciones importantes en la comprensión de las informaciones del formulario de consentimiento por parte de los participantes, lo que comprometió la decisión autónoma. Son necesarias adecuaciones y mejoras en los procesos de consentimiento informado para su validez.

Health care users' acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda.

Background: Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Biorepository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a shortened informed consent form (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda. Methods: A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental ICF for this study was developed and attached to the Laboratory investigation form. Results: Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. Compared to participants who perceived that the informed consent information is understandable (OR=0.10, CI [0.03-0.32], participants who either partly or totally disagreed were significantly less likely to perceive information as understandable (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health. Conclusion: Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.