Consent and ethics
Participation in a JLA survey is anonymous and no personal data will be published. However, some people, when responding to questionnaires, describe their uncertainties by telling a personal story. The questionnaire must make it clear exactly what the data will be used for. This may include the publication of the uncertainties on the JLA website and, potentially, the use of the data in the PSP's final report and dissemination materials. PSPs that have a plan for processing their out-of-scope or 'answered' questions may also want to make it clear who that data will be passed on to.
A PSP must make it clear that people's uncertainties may be published anonymously and that questions which fall outside the scope of the PSP may be reported on anonymously to other organisations. The Steering Group should consider early in the process whether they might want to use the data in any other ways later. If this is likely, the group needs to consider how to make this clear to those completing the survey. The survey should either ask explicitly for consent or make it clear that participation in the survey assumes consent.
When collecting and storing identifiable data about individuals there are legal requirements. The organisation holding the data is responsible for complying with data protection legislation.
The valuable contributions of the many un-named individuals deserve acknowledgement in reports. Naming partner organisations indicates the wide range of people contributing their ideas.
To see an example of wording that explains that participation in the survey automatically indicates consent for anonymous publication of questions, please see the Autism PSP survey, available in the Key Documents section of that PSP on the JLA website.
Although it is important to choose and apply priority setting methods ethically, PSPs do not normally come under the remit of Health Research Authority (HRA) approvals, where research priority setting is seen as service evaluation and development. More information is available from the HRA, along with a decision tool to help identify whether or not a study would be considered 'research' by the NHS. It may be helpful for PSPs to record evidence of having used the HRA decision tool to identify whether or not the work is research, in case of later queries.
Despite not normally requiring ethics approval, if PSP work is being done within certain NHS settings, local Research and Development department approvals may be required. Please check with the relevant NHS care organisation(s) what review arrangements or sources of advice apply to projects of this type.
If necessary, applications for permissions and approvals can be submitted through the Integrated Research Application System (IRAS).
A statement was developed by the HRA and INVOLVE, to provide clarity and guidance on patient and public involvement in research and the requirements of research ethics review.
Ethics advice and approval may also be sought from within institutions hosting a PSP.
For PSPs working outside of the UK, Steering Groups should check the ethical approvals required for that country.
“Applying for and receiving ethics approval is a key part of the PSP process in Canada (it isnt required in the UK). Approval is typically required for any initiative that involves consulting with the broader community, but it also provides oversight and facilitates the publication of study results in scientific journals. Depending on the affiliations of the lead investigator, organizations will have the option to apply either to an institutional Research Ethics Board (REB) at a hospital or university, or a community-based ethics board. Receiving approval may take several months depending on the workload of the Board and their understanding of the project so you will need to plan accordingly. A high level of detail is required for the application, so be prepared to provide information about how participants will be recruited, how participant anonymity will be preserved, how data will be stored, how inclusiveness will be ensured in your survey population, etc. Our main recommendation would be to budget more time than you think is necessary to receive approval, and start this process as soon as possible to avoid delaying the PSP timeline. Amaya Singh, Epilepsy (Canada) PSP”