A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.

Abstract

The current paper highlights real life examples of how ethical issues can arise during public involvement activities at the research design stage. We refer to "the research design stage" as the time between the generation of the research ideas and when formal permissions to start the work including ethical approval are granted. We argue that although most researchers work ethically at this early stage, some may still benefit from being informed about ethically conscious approaches to involving the public. The paper highlights 10 ethical issues that we have observed with involving the public at the research design stage. We provide examples of these observed scenarios to illustrate the issues and make suggestions for how they can be avoided to help researchers become more ethically conscious when involving the public at the research design stage. Currently the draft framework comprises: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement. The draft framework will help researchers to recognise the ethical issues when involving the public and is intended to be used voluntarily in a self-regulatory way. We believe that the draft framework requires further consultation and input from the wider research community and the public before endorsement by national UK bodies such as INVOLVE and the Health Research Authority (HRA)