ArticleTrials2021
An evaluation of the process of informed consent: views from research participants and staff.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- Consenting practices to enhance comprehension in research involving individuals with schizophrenia and bipolar affective disorder in Uganda: a qualitative inquiry.BMC psychology · 2026Article
- The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion.Trials · 2026Article
- Co-designing accessible trial information: lessons from designing an inclusive patient information leaflet in the RaCeR2 study.Research involvement and engagement · 2026Article
- Perceptions of health research participation in rural and urban Pennsylvanians.Journal of clinical and translational science · 2026Article
- When genomics companies act as biobanks: governance challenges in an era of genomic assetization.Frontiers in genetics · 2026Article
- Support in Decision-Making for All.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2026Article
- Clinical trial participant information leaflets overstate the harms/risks of participation and understate the benefits.PloS one · 2026Article
- The Effect of Shoulder Joint Isokinetic Muscle Strength, Endurance and Proprioception on Swimming, Agility and Sprint Performance in Water Polo Players.Journal of musculoskeletal & neuronal interactions · 2025Article
- Information seeking by participants enrolled in randomized clinical trials of behavioral interventions.Contemporary clinical trials communications · 2025Article
- Women's Experience of the Consent Process to Planned Caesarean Section and Its Surgical Risk: A Qualitative Study.BJOG : an international journal of obstetrics and gynaecology · 2025Article
- Users' Perceptions and Trust in AI in Direct-to-Consumer mHealth: Qualitative Interview Study.JMIR mHealth and uHealth · 2025Article
- Laser treatment for urinary incontinence in elite female athletes analyzed using a discrete mathematics approach.Scientific reports · 2025Article
- Using dataflow diagrams to support research informed consent data management communications: participant perspectives.Journal of the American Medical Informatics Association : JAMIA · 2025Article
- Developing guidelines for culturally relevant informed consent: an example from Lebanon.PLOS mental health · 2025Article
- Awareness of middle ear pathologies in South Africa: Towards a primordial preventive audiology.The South African journal of communication disorders = Die Suid-Afrikaanse tydskrif vir Kommunikasieafwykings · 2024Article
- Article
- Molecular Prevalence and Subtypes Distribution ofTropical medicine and infectious disease · 2024Review
- Improving patient satisfaction based on service quality in clinical trials: A cross-sectional study.PloS one · 2024Article
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundThe 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 information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.
methodsResearch staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.
resultsResearch participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.
conclusionsResearch participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.
trial registrationNot applicable.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.