Dr Rebecca Wang, a consultant geriatrician, wants to investigate the effectiveness of a new cognitive intervention for patients with mild dementia. Her proposed study would randomise 200 patients to either the new intervention or standard care over 12 months. However, she faces several ethical challenges: Many participants have fluctuating capacity to consent Family members are eager for their relatives to access the “new treatment” The intervention requires participants to attend weekly sessions, creating travel burden Some participants may deteriorate during the study and lose capacity completely The research team includes her own clinical colleagues who treat some potential participants Initial pilot data suggests the intervention might be particularly beneficial for women, but including this in recruitment might create selection bias Dr. Wang needs to submit applications to both the NHS Research Ethics Committee and her university ethics committee, and she’s uncertain about several key ethical considerations. 1. I’d like the group to analyse the core ethical principles at stake in Dr. Wang’s study. Which of the four fundamental ethical principles (autonomy, beneficence, non-maleficence, and justice) present the greatest challenges here, and how might these principles conflict with each other? Please bring evidence from established ethical frameworks to support your discussion. 2. Considering the capacity and consent issues with this vulnerable population, what specific strategies should Dr Wang implement to ensure truly informed consent? I want you to think beyond standard consent forms – how can she address fluctuating capacity, family pressure, and ongoing consent throughout the study? Additionally, consider how similar consent challenges might arise in educational research (student-teacher power dynamics) or organisational research (employee-manager hierarchies) 3. Dr Wang is concerned about the dual role of her clinical colleagues as both treating clinicians and researchers. What are the potential ethical implications of this situation, and what safeguards should be put in place? Please consider both the participant perspective and broader research integrity issues. How might similar dual-role challenges arise in educational research (teacher-researcher roles) or organisational research (manager-researcher positions)? What universal principles apply across these contexts? 4. Looking at the regulatory landscape, I’d like the group to map out the approval pathway Dr. Wang needs to follow. While you’ll primarily be using university ethics committees for your professional projects, understanding the NHS pathway through IRAS (Integrated Research Application System) provides valuable insight into research governance standards. How do the requirements for NHS REC review via IRAS (detailed methodology justification, comprehensive risk assessment, robust consent processes) inform and strengthen your approach to university ethics applications? What are the key differences between NHS REC and university ethics committee review, and how can awareness of IRAS standards enhance your preparation for university ethics submission? The following articles could help you: Beauchamp, T.L. and Childress, J.F. (2019) Principles of Biomedical Ethics. 8th ed. New York: Oxford University Press. Health Research Authority (2025) UK Policy Framework for Health and Social Care Research. Available at: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/ Emanuel, E.J., Wendler, D. and Grady, C. (2000) ‘What makes clinical research ethical?’, JAMA, 283(20), pp. 2701-2711. Available at: https://www.dartmouth.edu/cphs/docs/jama-article.pdf My Research Project (n.d.) Help with Using IRAS. Available at: https://www.myresearchproject.org.uk/help/hlpusingiras.aspx

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