Informed Consent: Research Staff's Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication

Eeckhout, Delphine; Aelbrecht, Karolien; Straeten, Catherine Van Der

doi:10.1177/15562646221146043

Cited by 3 publications

(1 citation statement)

References 51 publications

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“…A starting point is communicating explicitly how their data may be reused (and re-interpreted) in future research (Ruggiano and Perry, 2019). However, such communication is not necessarily straightforward (Eeckhout et al, 2023). For instance, the difficulties in communication between autistic and non-autistic people has been characterised as the 'double empathy problem'; whereby people with different ways of seeing the world struggle to understand and therefore communicate with one another (Milton, 2012).…”

Section: Reflecting On Questions Surrounding Qualitative Data Sharingmentioning

confidence: 99%

Reflection over compliance: Critiquing mandatory data sharing policies for qualitative research

Prosser,

Bagnall,

Higson-Sweeney

2024

J Health Psychol

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Many journals are moving towards a ‘Mandatory Inclusion of Raw Data’ (MIRD) model of data sharing, where it is expected that raw data be publicly accessible at article submission. While open data sharing is beneficial for some research topics and methodologies within health psychology, in other cases it may be ethically and epistemologically questionable. Here, we outline several questions that qualitative researchers might consider surrounding the ethics of open data sharing. Overall, we argue that universal open raw data mandates cannot adequately represent the diversity of qualitative research, and that MIRD may harm rigorous and ethical research practice within health psychology and beyond. Researchers should instead find ways to demonstrate rigour thorough engagement with questions surrounding data sharing. We propose that all researchers utilise the increasingly common ‘data availability statement’ to demonstrate reflexive engagement with issues of ethics, epistemology and participant protection when considering whether to open data.

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Section: Reflecting On Questions Surrounding Qualitative Data Sharingmentioning

confidence: 99%

Reflection over compliance: Critiquing mandatory data sharing policies for qualitative research

Prosser,

Bagnall,

Higson-Sweeney

2024

J Health Psychol

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Recommendations for developing accessible patient information leaflets for clinical trials to address English language literacy as a barrier to research participation

Wylde,

Brennan,

Johnson

et al. 2024

Trials

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Background Low English language literacy is a common barrier to participation in clinical trials. Patient information leaflets (PILs) used in clinical trials are often lengthy, complex and have poor readability; this is a persistent and prevalent problem common to trials across the world. Simplifying the information provided in PILs can lead to improved understanding, comprehension and knowledge. The aim of this project was to develop recommendations for developing accessible PILs for clinical trials through a literature review of published and grey literature and co-working with marginalised communities, patients, and health and social care charities. Methods A literature review of MEDLINE, Embase and online resources was conducted, and recommendations for developing accessible PILs were extracted from eligible published and grey literature. Grey literature which contained insights into more inclusive forms of communication was also identified and summarised. Meetings were held with two racially marginalised community groups, two groups involving autistic adults and/or adults with learning difficulties and a patient advisory group. Examples of accessible PILs were shared and discussions held about the content and format of the PILs and suggestions for changes/improvements. National Voices, a coalition of health and social care charities in England, held a national online workshop with charities and lived experience partners. Recommendations identified from the multiple sources were coded, collated and refined to develop an overarching framework of recommendations. Results The framework consists of 74 recommendations for developing accessible PILs for clinical trials. Recommendations cover the five topics of formatting, information presentation, writing style, content and accessibility. Conclusions This project has developed a comprehensive framework of recommendations to guide researchers in the development of accessible PILs for clinical trials. Findings from previous research and from co-working with marginalised communities, patients and health and social care charities were collated to ensure that a diverse range of voices and experiences informed the framework. These recommendations aim to support researchers to develop better study information to reduce English language literacy as a barrier to participation in clinical trials.

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How Much Is Enough?

McAllister

2024

Advances in Data Mining and Database Management

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This chapter provides key takeaways for investigators and clinical researchers in healthcare settings doing minimal-risk research and quality improvement. Following an in-depth overview of the current regulations for informed consent (IC) with a focus on the 2018 regulatory revisions, it then describes the current state of IC in quality improvement activities commonly employed in learning healthcare systems and the ethical challenges they present. This chapter does not address the complexities of IC in clinical trials or in research with greater than minimal risk because the IC processes in such activities are well established. Instead, the focus is on what the regulations state regarding the requirements of informed consent; when and how consent can be waived; how research and quality improvement activities differ from the viewpoint of IC; and what information potential research subjects need to make decisions about participating in minimal-risk research and quality improvement in healthcare settings.

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Informed Consent: Research Staff's Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication

Cited by 3 publications

References 51 publications

Reflection over compliance: Critiquing mandatory data sharing policies for qualitative research

Reflection over compliance: Critiquing mandatory data sharing policies for qualitative research

Recommendations for developing accessible patient information leaflets for clinical trials to address English language literacy as a barrier to research participation

How Much Is Enough?

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