Aim To explore Young People’s (YP) opinions of informed consent, including deferred and opt out consent in a multi-national clinical research study.
Background Informed consent is requiredfor the use of identifiable patient data and samples in clinical research. Little is known about Young People’s opinions of consent processes in research.
The PERFORM study aims to improve the diagnosis and management of fever using a novel test to differentiatebetween fevercaused bybacterial infections andother causes. Participants will be asked to give blood samples and data will be collected.
Method We ran twointeractive sessions with Young Person’s Advisory Group North England(YPAG NE) looking at different consent scenarios. One scenario discussed deferred consent and the second opt out consent. Qualitative comments were recorded and common themes identified independently by two authors (EL, ME). The second session included feedback and further discussion.
Results Generally YP felt that deferred consent was acceptable. However, some felt they were ‘taken advantage of’ or even ‘violated’. Most felt after sufficient clear and detailed information they would agree to take part. Deferred consent was viewed as an opportunity to take part in research under specific circumstances and potentially help others in the future.
There was more concern about opt out consent. They recognised the potential for this model to ‘help loads of people’. It was seen as the best model for researchers but not necessarily for patients.YP believed it was not acceptable to use opt out consent to take blood samples but was reasonable to collect data.
They believed every effort must be made to gain consent prior to sampling. General information about clinical research should be readily availableto help participantsunderstand the consent process. The National Research and Ethics Committee accepted YPAG NE comments and asked them to review consent processes within a year.
Conclusion YP felt that deferred consent in clinical research was acceptable. Opt out consent was less acceptable.Information around research and consent should be available and be presented in engaging formatsincluding digital platforms
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