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- Godskesen, ToveUppsala universitet,Centrum för forsknings- och bioetik,Nord Univ, Fac Nursing & Hlth Sci, Bodo, Norway. (author)
Challenges regarding informed consent in recruitment to clinical research : a qualitative study of clinical research nurses' experiences
- Article/chapterEnglish2023
Publisher, publication year, extent ...
- BioMed Central (BMC),2023
- electronicrdacarrier
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- LIBRIS-ID:oai:DiVA.org:uu-519111
- https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-519111URI
- https://doi.org/10.1186/s13063-023-07844-6DOI
- http://kipublications.ki.se/Default.aspx?queryparsed=id:154420920URI
Supplementary language notes
- Language:English
- Summary in:English
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- SwePubSwePub
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Notes
- Background: Clinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.Methods: A qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis.Results:The analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians' recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments.Conclusions: In conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.
Subject headings and genre
- MEDICIN OCH HÄLSOVETENSKAP Hälsovetenskap Omvårdnad hsv//swe
- MEDICAL AND HEALTH SCIENCES Health Sciences Nursing hsv//eng
- Clinical research
- Informed consent
- Nursing ethics
- Research ethics
- Qualitative content analysis
Added entries (persons, corporate bodies, meetings, titles ...)
- Björk, JoarUppsala universitet,Centrum för forsknings- och bioetik,Karolinska Inst, Stockholm Ctr Healthcare Eth CHE, Stockholm Ctr Healthcare Ethics CHE, Stockholm, Sweden.;Reg Kronoberg, Dept Res & Dev, Växjö, Sweden.(Swepub:uu)joabj689 (author)
- Juth, Niklas,1973-Karolinska Institutet,Uppsala universitet,Centrum för forsknings- och bioetik,Karolinska Inst, Stockholm Ctr Healthcare Eth CHE, Stockholm Ctr Healthcare Ethics CHE, Stockholm, Sweden.(Swepub:uu)nikju566 (author)
- Uppsala universitetCentrum för forsknings- och bioetik (creator_code:org_t)
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- In:Trials: BioMed Central (BMC)241745-6215
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