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Article
Open AccessTrial participants’ self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck
Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to des...
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Article
Open AccessWhat is the purpose of clinical trial monitoring?
The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitor...
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Article
Open AccessEthical values and principles to guide the fair allocation of resources in response to a pandemic: a rapid systematic review
The coronavirus 2019 pandemic placed unprecedented pressures on healthcare services and magnified ethical dilemmas related to how resources should be allocated. These resources include, among others, personal ...
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Article
Open AccessAn enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that partic...
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Article
Open AccessAn evaluation of the process of informed consent: views from research participants and staff
The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and inform...
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Article
Open AccessAdherence with reporting of ethical standards in COVID-19 human studies: a rapid review
Patients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clin...
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Article
Open AccessPreparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference
In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator’s responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed ...
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Article
Open AccessAn investigation into the factors affecting investigator-initiated trial start-up in Ireland
In common with many countries, Ireland has seen an increasing trend in the number of clinical trials conducted over the past few years. Yet, as elsewhere, trialists in Ireland face several problems and barrier...
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Article
Open AccessHeterogeneity in high-risk prostate cancer treated with high-dose radiation therapy and androgen deprivation therapy
Our aim was to assess the heterogeneity of high-risk (HR) prostate cancer managed with high-dose external beam radiotherapy (EBRT) with androgen deprivation therapy (ADT).
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Chapter
Intussusception
Intussusception represents the most common cause of gastrointestinal obstruction in children aged between 3 months and 3 years. It is the second most frequent acute abdominal surgical emergency in pediatrics a...
