Analysing and optimising Informed Consent in cooperation with ethics committees and medical researchers

AILA Review ◽  
2021 ◽  
Vol 34 (1) ◽  
pp. 37-56
Author(s):  
Igor Matic ◽  
Gianni De Nardi ◽  
Felix Steiner
Keyword(s):  
Informed Consent ◽  
Ethics Committees ◽  
Point Of View ◽  
Transdisciplinary Approach ◽  
Human Research ◽  
Written Information ◽  
Shared Language ◽  
Medical Researchers ◽  
Complex Procedure ◽  
Improve Patient

Abstract Medical researchers are ethically and legally required to inform participants and get written permission before enrolling them into a human research project (Informed Consent). Accordingly, information and consent represent a complex procedure, and the participant concerned “must receive comprehensible oral and written information” (Swiss legislation: Human Research Act (HRA) Art. 16). A triangle of stakeholders is involved in the procedure: ethics committees that review and approve research projects and Informed Consent (IC) documents, medical researchers who produce the documents and discuss enrolment with patients, and patients who have to be informed comprehensibly. From a linguistic point of view, the question arises as to which perceptions of comprehensibility form the basis of the IC process and how shared language can be established considering the complex relationship between these stakeholders. This contribution presents findings from two perspectives (ethics committees and researchers) while considering the needs of all three stakeholders. Firstly, the conceptualisation of comprehensibility among three ethic committees is presented, and steps toward harmonisation are outlined. Secondly, limitations of how researchers conduct oral IC information are analysed, and the measures that were implemented to improve patient information are discussed. A transdisciplinary approach is key in establishing these solutions because they do not stem from linguistic analysis alone but have been developed in close collaboration with members of ethics committees and medical researchers. Thus, the project shows how the expertise of applied linguistics in cooperation with practitioners can deliver an important impact in both academic analysis and optimisation of professional procedures.

scholarly journals Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Antonia Xu ◽  
Melissa Therese Baysari ◽  
Sophie Lena Stocker ◽  
Liang Joo Leow ◽  
Richard Osborne Day ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Information Disclosure ◽  
Ethics Committees ◽  
Structured Interviews ◽  
Worst Case ◽  
Human Research Ethics ◽  
Written Information ◽  
Human Participants ◽  
The Relationship

Abstract Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.

Informed consent in trauma: Does written information improve patient recall of risks? A prospective randomised study

Injury ◽  
2012 ◽  
Vol 43 (9) ◽  
pp. 1534-1538 ◽  
Author(s):  
Hannah K. Smith ◽  
Joseph G. Manjaly ◽  
Taher Yousri ◽  
Neil Upadhyay ◽  
Hazel Taylor ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomised Study ◽  
Written Information ◽  
Patient Recall ◽  
Improve Patient ◽  
Prospective Randomised Study

scholarly journals How ethical challenges of covert observations can be met in practice

2021 ◽  
pp. 174701612110082
Author(s):  
Nicole Podschuweit
Keyword(s):  
Social Research ◽  
Role Playing ◽  
Great Distance ◽  
Point Of View ◽  
Ethical Challenges ◽  
Research Subjects ◽  
Written Information ◽  
Ethical Debate ◽  
The People ◽  
Almost All

This paper aims to bring into the ethical debate on covert research two aspects that are neglected to date: the perspective of the research subjects and the special responsibility of investigators towards their observers. Both aspects are falling behind, especially in quantitative social research. From a methodological point of view, quantitative forms of covert observation involve a great distance between the researcher and the research subjects. When human observers are involved, the focus is usually on the reliable application of the measuring instrument. Therefore, herein, a quantitative study is used as an example to show how the protection needs of both the observed persons and the observers can be met in practice. The study involved 40 student observers who covertly captured everyday conversations in real-world settings (e.g. in cafés or trains) by a highly standardised observation scheme. The study suggests that the anonymity of the research subjects and their trust in the observers are crucial for their subsequent consent. However, many participants showed only little or even no interest in the written information they were provided. Further, this study strongly emphasises how mentally stressful covert observations are to the observers. Almost all observers were worried in advance that the people they were observing would prematurely blow their cover and confront them. Role-playing and in-depth discussions in teams are good strategies to alleviate such and other fears and to prepare student assistants well for their demanding work in the field.

scholarly journals Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

2020 ◽  
Vol 40 (2) ◽  
pp. 119-143 ◽  
Author(s):  
Johanna Glaser ◽  
Sarah Nouri ◽  
Alicia Fernandez ◽  
Rebecca L. Sudore ◽  
Dean Schillinger ◽  
...  
Keyword(s):  
Informed Consent ◽  
Data Extraction ◽  
Meta Analysis ◽  
Size Control ◽  
Group Processes ◽  
Future Research ◽  
Control Group ◽  
Test Feedback ◽  
Patient Comprehension ◽  
Improve Patient

Background. Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension. Purpose. An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent. Data Sources. Systematic searches of MEDLINE and EMBASE (2008–2018). Study Selection. We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent. Data Extraction. Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus. Data Synthesis. Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity. Limitations. Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome. Conclusions. Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

Human research ethics committees members: ethical review personal perceptions

2021 ◽  
Author(s):  
Boris Handal ◽  
Chris Campbell ◽  
Kevin Watson ◽  
Marguerite Maher ◽  
Keagan Brewer ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Human Research ◽  
Human Research Ethics ◽  
Personal Perceptions

scholarly journals Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

2016 ◽  
Vol 9 (2) ◽  
pp. 33-39 ◽  
Author(s):  
Elisabeth De Smit ◽  
Lisa Kearns ◽  
Linda Clarke ◽  
Jonathan Dick ◽  
Catharine Hill ◽  
...  
Keyword(s):  
Observational Study ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Governance ◽  
Research Ethics Committees ◽  
Human Research ◽  
Human Research Ethics

Informed Consent in Human Research

2013 ◽  
Vol 104 ◽  
pp. S17-S22 ◽  
Author(s):  
Robert E. Reiman
Keyword(s):  
Informed Consent ◽  
Human Research

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

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.

A review of the literature surrounding the provision of interpreters in health care, focusing on their role in translating information for non-English-speaking cancer patients and issues relating to informed consent

2007 ◽  
Vol 6 (4) ◽  
pp. 201-209 ◽  
Author(s):  
Niamh Gargan ◽  
Janette Chianese
Keyword(s):  
Health Care ◽  
Informed Consent ◽  
Health Care Professionals ◽  
Family Members ◽  
Fundamental Principle ◽  
Health Care Ethics ◽  
Equal Rights ◽  
Written Information ◽  
English Speaking ◽  
Professional Interpreting

AbstractInformed consent is a fundamental principle of health care ethics. All patients should have equal opportunities in accessing information to help them make informed decisions about their treatments.Literature on informed consent, translators in health care, non-English-speaking patients and the importance of communication and information, most specifically in radiotherapy, were reviewed. Western studies published between 1995 and 2005 were accessed and filtered though two eligibility screens and a critique framework to assess quality.The evidence suggested that many non-English-speaking patients are not in a position to give true informed consent due to lack of interpreters. This may lead to health care professionals giving treatment without full consent. Written information for radiotherapy patients was often only available in English, apart from inner city areas.There appears to be a scarcity of professional interpreters used in the health care setting; the most common practice is to use family members and friends to interpret. This practice results in breach of patient confidentiality, extra pressure on family members and filtration of information.This patient group is often excluded from certain treatment opportunities such as clinical trials. Ideally, a fully accessible professional interpreting service should be available to allow non-English patients equal rights in accessing appropriate health care options and treatments.

Informed consent in psychiatric practice: where does the law now stand?

2011 ◽  
Vol 28 (2) ◽  
pp. 86-90
Author(s):  
Peter Leonard
Keyword(s):  
Informed Consent ◽  
Medical Profession ◽  
Case Law ◽  
Point Of View ◽  
Psychiatric Practice ◽  
Mental Health Legislation ◽  
Clinical Scenarios ◽  
Legal Duty ◽  
Legal Position ◽  
Health Legislation

AbstractThere is an established ethical and legal duty upon psychiatrists to obtain informed consent before treating a patient, although some exceptions do apply under Mental Health Legislation. The required standard for informed consent has been the subject of important case law in Ireland and other common law jurisdictions and this has caused some uncertainty for clinicians. The standard of informed consent can be viewed from the point of view of what the medical profession thinks is appropriate, or alternatively from the position of what a patient would reasonably expect to be told. These contrasting approaches are discussed in detail. A recent decision of the Irish Supreme Court establishes the ‘patient-centred’ standard for informed consent as the relevant standard in Irish law. The current legal position on informed consent is discussed in relation to common clinical scenarios in psychiatric practice.

Sign in / Sign up

Export Citation Format

Share Document