Improving diversity in clinical research for patients undergoing surgery (PROTECT-DIVERSITY)
| ISRCTN | ISRCTN14173025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14173025 |
| Integrated Research Application System (IRAS) | 350756 |
| Central Portfolio Management System (CPMS) | 65329 |
| Grant Code | WKR0-2023-0016 |
| Sponsor | Queen Mary University of London |
| Funders | British Journal of Anaesthesia, Academy of Medical Sciences |
- Submission date
- 26/11/2025
- Registration date
- 04/12/2025
- Last edited
- 05/08/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The lack of diversity in clinical trials is an important issue, which limits external validity. We are doing this study to check whether consent forms in several different languages can improve access to research for patients having surgery. We will also compare the accuracy and completeness of diversity data collection using different methods such as in your medical records, as part of questionnaires and by asking participants questions.
Who can participate?
Adults aged 18 years and over undergoing elective surgery.
What does the study involve?
Patients will be asked to consent to be part of the PROTECT Trial. The consent materials will either be in a traditional paper format or an electronic format, and presented at random in multiple languages. Information such as sex, ethnicity, partnership status, disability, pregnancy status, religion, sexual orientation, gender and gender identity will be collected as part of the PROTECT trial, and patients can refuse to answer any questions they do not want to.
What are the possible benefits and risks of participating?
The information collected may improve how we collect diversity information for patients taking part in clinical trials in the future. There are no disadvantages to taking part in this study.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
The study is starting in December 2025 and will run for 2 years.
Who is funding the study?
The British Journal of Anaesthesia and the Academy of Medical Sciences
Who is the main contact?
Dr Tom Abbott, protect-admin@qmul.ac.uk
Contact information
Scientific, Public, Principal investigator
Royal London Hospital
London
E1 1FR
United Kingdom
| Phone | +44 203 594 0348 |
|---|---|
| t.abbott@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Single |
| Purpose | Health services research |
| Participant information sheet | ISRCTN14173025 PROTECT-DIVERSITY Participant Information Sheet v3.0 18.06.2026 clean.pdf |
| Scientific title | Diversity in perioperative research |
| Study acronym | PROTECT-DIVERSITY |
| Study objectives | 1. Compare the impact of using multi-lingual consent forms with consent forms in English on the ethnic diversity of patients included in the study. 2. Compare the accuracy and completeness of protected characteristics data collection using different methods. |
| Ethics approval(s) |
Approved 10/02/2025, London – South East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8222; londonsoutheast.rec@hra.nhs.uk), ref: 24/LO/0887 |
| Health condition(s) or problem(s) studied | Adult patients undergoing elective surgery |
| Intervention | Current interventions, as of 05/08/2026: The master protocol is registered at https://www.isrctn.com/ISRCTN14639555 The method of informed consent will use either an electronic or paper method, which is consistent with the master protocol. For this comparison, the language of the consent form materials will be determined at random before approaching the patient, which includes consent for entry into the platform. Since the intervention in question is the process of consent, it will not be possible to obtain consent before the ‘intervention’ i.e. the consent process. In this case, there will be a waiver of consent to randomise to intervention or usual care (multi-lingual consent materials vs. english consent materials ). After randomisation, the patient will complete the consent process using either multi-lingual consent documents or consent documents in English, according to group allocation. This process supersedes the procedure for timing of informed consent detailed in the master protocol section nine, which will apply to consent for inclusion in the platform (master protocol) and this comparison. Electronic consent materials will be translated into Polish, Romania, Panjabi, Urdu, Portuguese and Bengali. Translations will be undertaken by an approved/certified provider _____ Previous interventions: The master protocol is registered at https://www.isrctn.com/ISRCTN14639555 The method of informed consent will use either an electronic or paper method, which is consistent with the master protocol. For this comparison, the mode of consent (electronic or paper) will be determined at random before approaching the patient, which includes consent for entry into the platform. Since the intervention in question is the process of consent, it will not be possible to obtain consent before the ‘intervention’ i.e. the consent process. In this case, there will be a waiver of consent to randomise to intervention or usual care (electronic consent or paper consent). After randomisation, the patient will complete the consent process using either electronic multi-lingual consent documents or paper consent documents in English, according to group allocation. This process supersedes the procedure for timing of informed consent detailed in the master protocol section nine, which will apply to consent for inclusion in the platform (master protocol) and this comparison. Electronic consent materials will be translated into Polish, Romania, Panjabi, Urdu and Portuguese, which are the five most common languages for people where English/Welsh is not their first language. Translations will be undertaken by an approved/certified provider |
| Intervention type | Other |
| Primary outcome measure(s) |
Reciprocal diversity index for ethnicity on a scale of 0 to 100 at end of trial |
| Key secondary outcome measure(s) |
1. Completeness of data collection for protected characteristics at trial end |
| Completion date | 01/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 532 |
| Key inclusion criteria | 1. Patients aged 18 years and over undergoing elective surgery |
| Key exclusion criteria | 1. Inability to provide informed consent 2. Co-enrolment in PROTECT CTIMP comparisons 3. Previous enrolment to the PROTECT-DIVERSITY comparison |
| Date of first enrolment | 06/03/2026 |
| Date of final enrolment | 01/08/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
80 Newark Street
London
E1 2ES
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Consent form | 19/06/2025 | 01/12/2025 | No | No |
| Other files | Protocol appendix version 4.0 |
18/06/2026 | 05/08/2026 | No | No |
| Participant information sheet | version 3.0 | 18/06/2026 | 05/08/2026 | No | Yes |
| Protocol file | version 3.0 | 19/06/2025 | 01/12/2025 | No | No |
Additional files
- 48563 PROTECT-DIVERSITY Participant Informed Consent Form 2.0 19.06.2025 clean.pdf
- Consent form
- 48563 PROTECT-DIVERSITY Protocol 19.06.2025 v3.0.pdf
- Protocol file
- ISRCTN14173025 Protocol PROTECT-DIVERSITY Appendix 4.0 18.06.2026 signed.pdf
- Protocol appendix
- ISRCTN14173025 PROTECT-DIVERSITY Participant Information Sheet v3.0 18.06.2026 clean.pdf
- Participant information sheet
Editorial Notes
05/08/2026: The following changes were made to the study record:
1. The participant information sheet v3.0 was uploaded as an additional file.
2. An appendix to the protocol was uploaded as an additional file.
3. The Completion date was changed from 01/02/2027 to 01/08/2028.
4. The interventions were changed.
5. The Date of final enrolment was changed from 01/01/2027 to 01/08/2028.
6. The plain English summary was updated to reflect these changes.
13/03/2026: The date of first enrolment was changed from 01/02/2026 to 06/03/2026.
26/11/2025: Study's existence confirmed by the NIHR.
