Methods: Health Research Authority (HRA) Assessment Review Portal (HARP) database was searched, using search terms (ophthalmic diagnoses) derived from the International Classification of Diseases 11th Revision (ICD-11), to identify ophthalmology-related research applications submitted to an NHS REC within a two-year period (Jan 2022 to Jan 2024).

Of the 150 applications retrieved, 100 fulfilled the criteria for inclusion and were analysed.

A mixed-methods approach was used, incorporating both quantitative and qualitative techniques.

Results: Ophthalmology accounted for 1.8% of all UK health research applications during the review period.

The most common search terms within the applications were:

• age-related macular degeneration (27%),
• cataract (21%),
• and glaucoma (11%).

Sponsors of ophthalmology-related studies included NHS organisations (32%), academic institutions (27%), pharmaceutical companies (20%), and medical device manufacturers (14%).

The mean time to an ethics decision was31 days.

Of the applications

• 78% received a provisional ethics opinion from the REC; meaning that changes to the application were needed prior to approval.
• 22% of applications received a favourable ethics opinion meaning that there were no changes, or only very minor changes required.

A total of 696 ethics issueswere identified.

• The majority (n= 438, 63%) concerned the informed consent process and adequacy of participant information; particularly issues relating to accessibility and readability of information for visually impaired participants, communication of data protection arrangements, and the provision of more toned down information about potential benefits. (Table 1a)
• Second most common (n= 93, 13%) ethics issues related to the care and protection of research participants including: reimbursement processes, participant welfare safeguards, and ensuring that participants were given sufficient time to make a decision about whether to take part in the study. (Table 1b)

All studies ultimately secured a favourable ethics opinion following amendment.

Conclusion: First study to systematically analyse ethics review outcomes for UK ophthalmic research.

We have identified recurring shortcomings in applications submitted to RECs, and present practical strategies to enable researchers to anticipate and address these ahead of submission to REC review. 

Practical strategies include:

• Tailoring participant information to adjust for visual impairment,
• Ensuring plain language is used throughout information provided to participants
• Involving patients in study design, and proactively addressing how potential ethical issues have already been addressed and mitigated in the submission to the REC.