Informed consent in pragmatic trials: results from a survey of trials published 2014–2019

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research.

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Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

Current Drug Safety ◽

10.2174/1573403x16666200615144946 ◽

2020 ◽

Vol 15 (3) ◽

pp. 181-189

Author(s):

Omotayo Fatokun

Keyword(s):

Informed Consent ◽

Drug Use ◽

Perceived Risk ◽

Adverse Drug Events ◽

Community Pharmacists ◽

Risk Minimization ◽

Cross Sectional Survey ◽

Cross Sectional ◽

Off Label ◽

Written Informed Consent

Background: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists’ beliefs regarding these measures in Malaysia. Objectives: This study examined community pharmacists’ beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures. Methods: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia. Results: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002). Conclusion: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

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Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

American Journal of Law & Medicine ◽

10.1017/s0098858800002690 ◽

2002 ◽

Vol 28 (4) ◽

pp. 361-408

Author(s):

Lars Noah

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Patient Autonomy ◽

College Campuses ◽

Human Experimentation ◽

Experimental Therapy ◽

Academic Literature ◽

Medical Experimentation ◽

Disclosure Rules ◽

Near Unanimity

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

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274 Tumoral and peripheral immunophenotype of refractory vs relapse to PD-(L)1 blockade in patients with advanced non-small cell lung cancer

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0274 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A299-A299

Author(s):

Maria Ascierto ◽

Matthew Hellmann ◽

Nathan Standifer ◽

Song Wu ◽

Han Si ◽

...

Keyword(s):

Gene Expression ◽

Informed Consent ◽

Checkpoint Inhibitors ◽

Patient Response ◽

Calcium Dependent ◽

Immune Exhaustion ◽

Previously Treated ◽

Expression Pathways ◽

Relapsed Disease ◽

Written Informed Consent

BackgroundDespite the encouraging successes of immune checkpoint inhibitors, many patients do not benefit and are either refractory or relapse. The mechanisms of refractory or relapsed disease following PD-(L)1 blockade are largely unknown. To identify characteristics associated with refractory or relapsed disease we explored the immune and genomic landscape of samples derived from NSCLC patients who previously received PD-(L)1 blockade and had blood and fresh tumor biopsies collected at the time of progression.MethodsPatient response categories were defined prospectively; ‘refractory’ defined as progression within 16 weeks of initiating PD-(L)1 and ‘relapse’ defined as initial clinical benefit (CR, PR, SD) followed by progression. RNAseq (n=52) and PD-L1 IHC (n=22) were performed on tumor tissue. Immune profiling of whole blood was assessed using flow cytometry or Biomark HD (Fluidigm) gene expression panel (n=54 and n=62, respectively). Differential gene expression was defined as unadjusted p<0.05 and fold-difference >1.5. Pathways analysis was conducted by David tool. Patient samples were collected during screening for clinical trial of second line immunotherapy. Written informed consent was obtained from the patients for publication of this abstract.ResultsIn patients with NSCLC previously treated with PD-(L)1 blockade, tumors of relapsed patients were characterized by increased expression of genes associated with interferon signaling (e.g. CXCL9, SPIC, IFNg), immune suppression (e.g. ARG1, TGFB), immune exhaustion (e.g. ADORA2A), and increased PD-L1 expression (by gene expression and IHC). Refractory disease was associated with increased cadherin signaling and calcium-dependent-cell-adhesion gene expression pathways. In the periphery, reduced quantities of B cells and activated (HLA-DR+ or CD38+) or proliferating (Ki67+) CD8+ T cells were observed in refractory patients.ConclusionsThe tumor and peripheral compartments of patients with NSCLC previously treated with PD-(L)1 blockade differ based on prior response. Relapsed patients tend to have signals of sturdy immune activation and chronic inflammation thus ultimately leading to immune exhaustion. These results may help inform rational therapeutic strategies to overcome resistance to PD-(L)1 blockade in NSCLC.Trial RegistrationNCT02000947Ethics ApprovalResearch on human samples here analyzed have been performed in accordance with the Declaration of Helsinki.ConsentWritten informed consent was obtained from the patient for publication of this abstract.

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Written Informed Consent—Translating into Plain Language. A Pilot Study

Healthcare ◽

10.3390/healthcare9020232 ◽

2021 ◽

Vol 9 (2) ◽

pp. 232

Author(s):

Agnieszka Zimmermann ◽

Anna Pilarska ◽

Aleksandra Gaworska-Krzemińska ◽

Jerzy Jankau ◽

Marsha N. Cohen

Keyword(s):

Informed Consent ◽

Plain Language ◽

Consent Forms ◽

Software Analysis ◽

Informed Consent Form ◽

Education Levels ◽

Polish Language ◽

University Degree ◽

Study Participants ◽

Written Informed Consent

Background: Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability. Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

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Impact of Written Informed Consent on the Number of Intravenous Contrast−Enhanced CT and MR Studies

Academic Radiology ◽

10.1016/j.acra.2005.10.013 ◽

2006 ◽

Vol 13 (2) ◽

pp. 258-261 ◽

Cited By ~ 3

Author(s):

Yukihiro Hama ◽

Yutaka Sakurai ◽

Shigeru Kosuda

Keyword(s):

Informed Consent ◽

Mr Studies ◽

Intravenous Contrast ◽

Contrast Enhanced Ct ◽

Contrast Enhanced ◽

Enhanced Ct ◽

Written Informed Consent

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Informed consent: Patient autonomy and physician beneficence within clinical medicine

HEC Forum ◽

10.1007/bf01463346 ◽

1994 ◽

Vol 6 (5) ◽

pp. 323-325 ◽

Cited By ~ 2

Author(s):

Stephen Wear ◽

Jonathan D. Moreno

Keyword(s):

Informed Consent ◽

Patient Autonomy ◽

Clinical Medicine

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Medical terminology circulation and interactional organisation in interpreter-mediated medical encounters

Linguistica Antverpiensia, New Series – Themes in Translation Studies ◽

10.52034/lanstts.v11i.299 ◽

2021 ◽

Vol 11 ◽

Author(s):

Sara Pittarello

Keyword(s):

Informed Consent ◽

Active Participation ◽

Point Of View ◽

Personal Interest ◽

Medical Terminology ◽

Institutional Talk ◽

Italian Hospital ◽

Ethical Approval ◽

Medical Interpreters ◽

Written Informed Consent

Two medical encounters taking place in a Northern Italian hospital are analysed in this paper from a qualitative point of view, based on the author’s previous research. The aim is to reveal the strategies adopted by medical interpreters, in these two specific cases, to translate medical terminology and promote/exclude interlocutors’ active participation. This latter aspect is influenced by the way the interaction is socially and linguistically organised and, in particular, by how interlocutors’ utterances are translated. The prevalence of dyadic or triadic sequences and especially the shifts between such communication exchanges are pivotal in fostering or hindering interlocutors’ participation. Furthermore, medical interactions, as a form of institutional talk, enshrine specific expectations, which are mainly of a cognitive nature but may also be affective, as in the two encounters observed. By conveying such expectations and expressions of personal interest, interpreters have proved to contribute to the fair distribution of active participation among primary interlocutors. Hospital ethical approval and subjects’ written informed consent have been obtained.

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Psychometric Properties of the Bern Illegitimate Tasks Scale – Spanish Version

Frontiers in Psychology ◽

10.3389/fpsyg.2021.593870 ◽

2021 ◽

Vol 12 ◽

Author(s):

Denisse Lizette Valdivieso Portilla ◽

Angélica Gonzalez Rosero ◽

Geovanny Alvarado-Villa ◽

Jorge Moncayo-Rizzo

Keyword(s):

Factor Analysis ◽

Informed Consent ◽

Confirmatory Factor Analysis ◽

Psychometric Properties ◽

Exploratory Factor Analysis ◽

Work Stress ◽

Factor Model ◽

Spanish Version ◽

Confirmatory Factor ◽

Written Informed Consent

In recent years, a new factor for work stress has been studied along with stress as an offense to self-theory. Illegitimate tasks refer to assignments that are unnecessary or are not related to the employee’s role. Because of this, the Bern Illegitimate Tasks Scale was developed, which measures illegitimate tasks in terms of unreasonable tasks and unnecessary tasks. There are no studies in Latin America on illegitimate tasks, so the purpose of this research is to translate and validate the Bern Illegitimate Tasks Scale. The study was performed with a sample of nursing staff from a hospital in Guayaquil, Ecuador. Written informed consent was obtained from each of the participants. The reliability of the questionnaire was evaluated and its structural validity was verified by exploratory factor analysis and confirmatory factor analysis. The internal consistency of the whole scale, measured by Cronbach’s alpha, was 0.857. Moreover, the unnecessary and unreasonable subscales measure were 0.846 and 0.841, respectively. The exploratory factor analysis supported a two-factor model that explained 73.96% of the variance. Additionally, the confirmatory factor analysis showed good indexes of fit (GFI = 0.915, CFI = 0.955, TLI = 0.933, SRMR = 0.084, and RMSEA = 0.087). The Spanish version of the Bern Illegitimate Tasks Scale presents good psychometric properties and can be applied to nurses in the Ecuadorian population.

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