Think Ethics: Insights from the Health Research Authority Approval Process for Antimicrobial Stewardship During COVID-19 Research at an English NHS Foundation Trust

Rasha Abdelsalam Elshenawy, Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom | r.a.elshenawy@herts.ac.uk | 09 January 2024
Think Ethics: Insights from the Health Research Authority Approval Process for Antimicrobial Stewardship During COVID-19 Research at an English NHS Foundation Trust
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Introduction:

The journey in securing Health Research Authority (HRA) approval for a research project at One English NHS Foundation Trust was a defining experience in my academic career (1). This project comprised two studies: a retrospective review of NHS patient records and a prospective survey questionnaire of healthcare professionals at the Trust. Navigating the application process via the Integrated Research Application System (IRAS) was initially daunting, but the system's user-friendly design, which included auto-population of relevant fields and an average completion length of about 20 pages, made it manageable (2).

Key Processes for HRA Approval:

The HRA approval process involves a thorough review by the NHS Research Ethics Committee (REC) and checks for regulatory compliance and research governance by HRA staff. This streamlined approach replaced the need for multiple reviews by various NHS organisations, allowing them to focus on assessing their capacity to deliver the study.

Requirements for HRA Approval:

In the process of obtaining approval for our research, which necessitated access to confidential patient information without consent, I rigorously adhered to the Confidentiality Advisory Group (CAG) application requirements, including a cover letter, signed application form, research protocol, data protection registration, and a Caldicott Guardian endorsement, with the approval contingent on Health Research Authority (HRA) and Research Ethics Committee (REC) endorsements (3). Concurrently, the REC application was integral to ensuring the protection of participant rights and dignity, necessitating a detailed submission of documents via the Integrated Research Application System (IRAS), including the research protocol and participant information sheets, with the REC's evaluation process spanning full committee reviews or streamlined proportionate reviews, each with its own timeframe. 

Application Submission and Validation Process:

Booking a REC meeting slot through IRAS was straightforward, with clear guidance provided (4-6). Once the meeting was booked, the REC Manager assessed the application's validity, and a validation letter was issued. The REC meeting was an opportunity to address any ethical concerns directly with the committee.

Post-Approval Process:

After receiving the REC's favourable opinion, it was crucial not to start the research until all regulatory approvals were in place. The study had to commence within 12 months of approval, and any significant amendments required re-approval. 

Lessons Learned:

Understanding ethics requirements enhances research by ensuring relevance, improving study design, and fostering ethical standards. Attracting materials, like healthcare posters, encourage participant involvement. Registering research increases visibility and aligns with global standards. Effective project management, responding to feedback, and regular communication with committees ensure research integrity and timely completion. SWOT analysis evaluates factors impacting NHS research success.

Conclusion:

The HRA application process, guided by the 'Think Ethics' principle, was an enlightening journey that enhanced our research skills and project management capabilities. It advocated the necessity of extensive preparation, ethical consideration, and clear communication in research. These experiences have substantially contributed to my professional development and to the quality and integrity of my research project.

Reference:

  1. NHS. Homepage [Internet]. Health Research Authority. 2017. Available from: https://www.hra.nhs.uk/.
  2. IRAS. Integrated Research Application System [Internet]. Myresearchproject.org.uk. 2019. Available from: https://www.myresearchproject.org.uk/SignIn.aspx.
  3. Confidentiality Advisory Group [Internet]. Health Research Authority. Available from: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/confidentiality-advisory-group/.
  4. Our role is to protect research participants [Internet]. Health Research Authority. Available from: https://www.hra.nhs.uk/about-us/what-we-do/our-role-protecting-research-participants/.
  5. Governance arrangements for Research Ethics Committees [Internet]. Health Research Authority. Available from: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/.
  6. https://www.hra.nhs.uk/about-us/committees-and-services/online-booking-service/.
  7. ISRCTN [Internet]. www.isrctn.com. Available from: https://www.isrctn.com/ISRCTN14825813.

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