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.

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

Objetivo: la actividad de los promotores y Comités de Ética de la Investigación con medicamentos ha aumentado en los últimos años. El objetivo fue diseñar y validar 2 instrumentos para analizar y evaluar la calidad formal de la hoja de información al participante y el formulario de consentimiento informado de ensayos clínicos con medicamentos, acorde con la legislación.Métododiseño (Buenas Prácticas Clínicas y normativas europea y española); validación (método Delphi y consenso de expertos: concordancia ≥ 80%); fiabilidad (método inter-observadores, índice Kappa). 40 hojas de información al participante/consentimientos informados evaluados.Resultadosse obtuvo muy buena concordancia en ambos instrumentos (k ≥ 0,81, p < 0,001). Las versiones definitivas estaban formadas por: checklist-hoja de información al participante: 5 secciones, 16 ítems y 46 sub-ítems; checklist-consentimiento informado: 11 ítems.Conclusioneslos instrumentos desarrollados son válidos, fiables y facilitan el análisis, la evaluación y la toma de decisión sobre las hojas de información al participante/consentimientos informados de ensayos clínicos con medicamentos. (AU)

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.MethodDesign (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.ResultsVery 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.ConclusionThe 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. (AU)

[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.

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.

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.

Analysis of ethical review issues of informed consent form for clinical trials of registered anti-tumor drugs in our hospital / 中国药房

OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）. CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.

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.

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.

Metformin with neoadjuvant chemoradiation to improve pathologic response in rectal cancer: A pilot phase I/II trial.

PURPOSE: Neoadjuvant radiotherapy with or without chemotherapy decreases the risk of local recurrence after surgery for rectal cancer. Emerging data suggest that diabetic patients on metformin may have improved cancer outcome after radiotherapy. A single institutional pilot study was performed to determine if metformin given concurrently with long course chemoradiation (CRT) may improve pathologic complete response (pCR) in non-diabetic rectal cancer patients. The study was designed to construct a confidence interval (CI) for the pCR rate to determine the sample size for a phase 2 trial. METHODS: Non-diabetic patients with biopsy confirmed rectal cancer deemed candidates for long course neoadjuvant CRT were invited to participate. Radiation consisted of 50.4 Gy in 28 daily fractions with concurrent daily capecitabine (825 mg/m2 twice daily). Participants self-administered metformin (500 mg of twice daily) 2 weeks prior to, during and for 4 weeks after CRT. RESULTS: A total of 16 patients were accrued. One patient withdrew from the study. Only grade 1 or 2 adverse events were observed. Three patients had a clinical complete response (cCR) and did not undergo surgery. Of the 12 patients who underwent surgery, there were two pCRs. For the combined pCR/cCR rate of 33% (95% CI 19-47%), a total of 85 patients will be required to yield a 95% CI with a 10% margin of error. CONCLUSIONS: Adding metformin to neoadjuvant CRT for rectal cancer does not appear to enhance toxicities. These results will be used to refine the design and conduct of a future phase 2 trial to determine whether adding metformin to CRT improves pCR/cCR rates.

Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study.

BACKGROUND: Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients' anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. METHODS: The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. DISCUSSION: The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients' competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners' acceptance of evidence-based informed consent forms meeting legal requirements could be increased. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04669483 . Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571 . Registered 15 December 2020.

Assessing the periprocedural magnitude of platelet count change in response to lusutrombopag.

BACKGROUND & AIMS: Despite limitations, platelet transfusion has been used to minimise bleeding risk in patients with thrombocytopaenia. Lusutrombopag is an oral, thrombopoietin receptor agonist approved for treatment of thrombocytopaenia associated with chronic liver disease in patients undergoing planned invasive procedures. This post-hoc analysis assessed the magnitude of platelet count change based on the integrated per-protocol population from 2 similar phase III multicentre, randomised, double-blind, placebo-controlled trials. METHODS: Adults with chronic liver disease-induced thrombocytopaenia and platelet count <50 (× 109/L) received lusutrombopag 3 mg or placebo ≤7 days before invasive procedure scheduled 9-14 days after randomisation. Platelet transfusion was required per protocol if the platelet count remained <50 no more than 2 days before the planned invasive procedure. Post-hoc analysis included: proportion of patients with platelet count ≥50, ≥1.5-fold increase, and a doubling of platelet count; maximum and maximum change in platelet count; and platelet count time course. RESULTS: Platelet count ≥50, a platelet count increase ≥1.5-fold, and at least a doubling in platelet count were achieved in 88.3%, 86.9%, and 52.6% of patients in the lusutrombopag group (n = 137) vs. 58.6%, 32.3%, and 6.0% of patients in the placebo group (n = 133), respectively. In the lusutrombopag group, median maximum platelet count across baseline platelet counts of <30, ≥30 to <40, and ≥40 was 46, 76, and 87, respectively. Median maximum change in platelet count by baseline platelet count was +24, +42, and +40, respectively. Patients who received lusutrombopag without platelet transfusion achieved a median platelet count ≥50 for 3 weeks. CONCLUSIONS: Patients treated with lusutrombopag experienced a clinically relevant response in platelet count for a substantial duration of time. LAY SUMMARY: Patients with low platelet counts caused by chronic liver disease may not receive planned invasive procedures or surgeries because of an increased risk of bleeding. Lusutrombopag has previously demonstrated efficacy in raising platelet counts and is approved to treat chronic liver disease patients with low platelet counts in advance of a planned surgery. Physicians need to understand more clearly what to expect in terms of platelet count change when using lusutrombopag; this integrated analysis provides data to help guide its clinical application.

Harmonising the human biobanking consent process: an Irish experience.

Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by documentation in the form of Participant Information Leaflets and Informed Consent Forms (PILs/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation (GDPR) and the related Irish Health Research Regulation (HRR) presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, GDPR/HRR-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

Termo de consentimento informado: impacto na decisão judicial / Informed consent: impact on court decisions / Formulario de consentimiento informado: impacto en la decisión judicial

Resumo O termo de consentimento informado é fundamental na relação jurídica entre médico e paciente. Visando avaliar seu impacto na sentença judicial, realizou-se estudo retrospectivo de 70 processos de responsabilidade civil envolvendo procedimentos médicos estéticos cirúrgicos e não cirúrgicos com termo de consentimento assinado pelos pacientes. Os casos analisados, julgados entre 2014 e 2016, foram selecionados nos sites dos tribunais brasileiros e classificados em dois grupos: médicos absolvidos (51%) e condenados (49%). No primeiro grupo, 39% das absolvições se embasaram na apresentação adequada do termo de consentimento informado, enquanto, no segundo, 50% dos médicos foram condenados por não o ter incluído. Portanto, o termo de consentimento informado se destaca nos julgamentos de erro médico. O dever de informar é um dos pilares da responsabilidade civil desse profissional e, quando negligenciado, constitui fator substancial para condenação.

Abstract The informed consent form is essential in the physician-patient relationship. To evaluate its impact on court decisions, we conducted a retrospective study of 70 civil suits involving surgical and non-surgical aesthetic medical procedures with an informed consent form signed by patients. The cases, judged between 2014 and 2016, were selected from Brazilian courts websites and classified into two groups: acquitted (51%) and convicted (49%) doctors. In the first group, 39% of acquittals were based on the proper presentation of the informed consent form, whereas in the second 50% of the professionals were convicted for not including the document. The informed consent thus stands out when judging medical errors, and the duty to warn is one of the pillars of the professional liability and, when neglected, becomes a substantial factor for their conviction.

Resumen El formulario de consentimiento informado es fundamental en la relación jurídica entre médico y paciente. Para evaluar su impacto en sentencias judiciales, se realizó un estudio retrospectivo con 70 procesos de responsabilidad civil relacionados con procedimientos médicos estéticos quirúrgicos y no quirúrgicos con el formulario de consentimiento firmado por los pacientes. Los casos analizados, juzgados entre 2014 y 2016, fueron seleccionados en los sitios web de los tribunales brasileños y clasificados en dos grupos: médicos absueltos (51%) y condenados (49%). En el primer grupo, el 39% de las absoluciones se basaron en la presentación adecuada del formulario de consentimiento; en el segundo, en el 50% de los casos se condenaron a los médicos por no incluir este documento. Por tanto, el formulario de consentimiento informado se destaca en los juicios por error médico. El deber de informar es uno de los pilares de la responsabilidad civil del médico, y su incumplimiento constituye un factor sustancial de condena.

Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report.

The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.

Physicians' Attitudes and Ethical Obligations to Pharmacogenetic Testing.

INTRODUCTION: Despite the increased utilization of pharmacogenetic (PGt) testing to guide drug therapy, little is known about the ethical challenges posed by the use of these genetic tools. METHODS: This cross-sectional study aimed to address ethical issues related to ancillary genetic information, consent forms, and potential confidentiality breaches from physicians' perspectives. A questionnaire was administered to all practicing physicians working in KAUH. RESULTS: Almost 49% and 65% of physicians were willing to recommend PGt testing for adult and pediatric patients, respectively. The findings showed that physicians attitudes towards the clinical utility of PGt testing became more preceptive. The majority (73.7%) indicated that PGt testing should not be treated as other routine laboratory tests. The finding also focused on potential conflicts regarding ancillary genetic information, in which 78.8% indicated that they would like to preserve the confidentiality and privacy of the patients and only 14.4% of physicians did not feel obligated to let patients know about any future risk that might be uncovered using PGt testing. The findings showed that collecting both verbal and written consents was imperative prior to testing. Seriousness and predictability of the diseases were reported to be legitimate circumstances that allow disclosure of genetic information. DISCUSSION: Unless the field of PGt testing addresses the ethical challenges that might be encountered during PGt treatment, these issues might influence its acceptance in routine clinical settings. Establishing a minimal set of ethical standards may help emphasize the role of physicians and thus facilitate the implementation of PGt tests.

Informed Consent Form Challenges for Genetic Research in Jordan.

BACKGROUND: Informed consent is an obligatory requirement for research engaging human subjects. Informed consent form (ICF) should be provided for human subjects to confirm their willingness for voluntary participation in a study. Ethical and legal obligations necessitate the presence of informed consent essential items to be built into the ICF. OBJECTIVE: To evaluate the content of ICFs obtained from different genetic studies accomplished in Jordan and their adherence to ethical guidelines proposed by the International Conference on Harmonization-Good Clinical Practice (ICHGCP). METHODS AND MEASURES: A total of 44 ICFs obtained from master theses and grant proposals at two major universities in Jordan were analyzed according to the good clinical practice criteria proposed by ICHGCP. ICFs were scored for the presence or absence of ICF main items/categories. RESULTS: Results show inadequate information present in the examined ICFs. The highest information score was 17 out of 20, while the lowest score was one out of 20. The average score for all studied ICFs was 6.18±3.65. Among essential items/categories that were absent from the majority of studied ICFs were a statement about voluntary participation, confidentiality of data, compensation to study participants, risk/benefits of the study, and researchers' contact information. CONCLUSION: The ICFs were missing a number of required items. This could reflect inadequate knowledge about minimal informed consent requirements among Jordanian investigators highlighting the need for research ethical training in the country.