Ethical dilemmas in Clinical Research - Insights from Clinical research nurses

2024-02-08

Upholding ethical standards in research involves acknowledging various factors that influence the voluntary participation of patients. Clinical research nurses possess first-hand experience in facing ethical dilemmas and play a pivotal role in maintaining ethical practices and adhering to the principles of informed consent in clinical research. A recent study published in the journal Trials examines the ethical challenges they encounter while obtaining informed consent for clinical research. 

Clinical research nurses (CRNs) are tasked with recruiting participants to clinical research, where rushed decision-making and low comprehension pose significant challenges. According to the CRNs, patients’ decision-making is often experienced as hurried during the informed consent process. They highlighted that patients demonstrated limited understanding of the complicated consent forms, raising concerns about their capacity to make well-informed decisions. Another issue highlighted by the CRNs is that during the informed consent process, many patients place significant trust in their physicians' recommendations. This trust could influence their comprehension of the information, possibly impacting their capacity to make independent and autonomous decisions.

One ethical issue raised by CRNs is that even patients show willingness to participate in research also among patients who have cognitive disabilities or where there is a language barrier, clinical research nurses observe that these patients were frequently excluded and that the eligibility criteria lacked clear justifications for this. This exclusion can lead to a lack of diversity in clinical trials, raising ethical and scientific concerns. The authors suggest this could be mitigated by initiatives that promote the inclusion of underrepresented groups. Specifically targeting minority ethnic groups and individuals with cognitive disabilities, to increase the likelihood of patient participation in clinical research.

“Among the valuable takeaways from this study are the recommendations to include the examination and justification of eligibility criteria and also implementing accessible study designs,” says Tove Godskesen, researcher at the Centre for Research Ethics & Bioethics at Uppsala University and one of the authors behind the study. “Clinical research nurses face a challenge of navigating time constraints and information overload in informed consent processes while ensuring that the patient understands what they are getting into. Our results show the complexity of the research nurses’ role in balancing patient autonomy with scientific requirements and offer personalised care while upholding study principles. And the importance of creating an environment where they can obtain informed consent in an ethical way.”

By Märta Karlén

Godskesen, T., Björk, J., Juth, N., 2023. Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences. Trials 24. https://doi.org/10.1186/s13063-023-07844-6

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Last modified: 2022-01-10