Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4386538 | PMC |
| http://dx.doi.org/10.2105/AJPH.2014.302403 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Background: Clinical trial sponsors rely on research sites to identify and enroll appropriate study participants and to correctly and reliably assess symptom severity and function over the course of the trial. Low-recruiting sites represent a large financial and operational burden and may negatively impact trial success either by selecting inappropriate participants and/or high prevalence of data quality issues. We previously reported that >60% of sites in schizophrenia clinical trials recruited ≤5 participants.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Imperial College London, London, United Kingdom; Division of Neurology, Department of Brain Sciences, Imperial College London, United Kingdom, London, London, United Kingdom.
Background: Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue licensed for the treatment of type 2 diabetes mellitus (T2DM). Preclinical evidence in transgenic models of Alzheimer's disease suggests that liraglutide exerts neuroprotective effects by reducing amyloid oligomers, normalising synaptic plasticity and cerebral glucose uptake, and increasing the proliferation of neuronal progenitor cells.
Method: This is a multi-centre, randomised, double-blind, placebo-controlled, phase IIb trial of liraglutide in participants with mild to moderate Alzheimer's dementia, conducted at several centres in the UK.
Background: Phase 3 randomized clinical trials within Alzheimer's Disease (AD) typically last over 18 months. Post-baseline participants can use additional treatment for Alzheimer's disease, potentially impacting the cognitive ability as evaluated by the primary endpoint. Consequently, this could overestimate or underestimate the treatment effect, depending on the distribution of usage between treatment arms.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
University of California, Irvine, Irvine, CA, USA.
Background: Recruitment registries are tools to decrease the time and cost required to identify and enroll eligible participants into clinical research. Despite their potential to increase the efficiency of accrual, few analyses have assessed registry effectiveness. We investigated the outcomes of study referrals from the Consent-to-Contact (C2C) registry, a recruitment registry at the University of California, Irvine.
View Article and Find Full Text PDFBackground: Pivotal Alzheimer's Disease (AD) trials typically require thousands of participants, resulting in long enrollment timelines and substantial costs. We leverage deep learning predictive models to create prognostic scores (forecasted control outcome) of trial participants and in combination with a linear statistical model to increase statistical power in randomized clinical trials (RCT). This is a straightforward extension of the traditional RCT analysis, allowing for ease of use in any clinical program.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!