Ethical standards

We are aware of the sensitivity of this subject and the need for high ethical standards, including obtaining approval from the relevant Research Ethics Committees before any contact is made with people who may take part in the study.

There are three main areas of ethical consideration in this study:

The appropriateness and sensitivity of our research methods and the potential for distress among participants.
The inclusion of people with cognitive impairment and obtaining consent on an ongoing basis.
The confidentiality and security of data collected.

Appropriateness and sensitivity

The combined research experience of the team leads us to the view that our approach is sufficiently sensitive and that our method is flexible enough to allow participants to maintain maximum control over the interview process. Invitations to join the study will come from GPs. Anyone who accepts the invitation will be able to nominate a supporter to provide them with assistance during the process of the research. The supporters, who will be invited to remain involved for the duration of the study, should facilitate the gathering of data when circumstances make it difficult for participants to express their views or for us to interview participants directly.

The longitudinal design will make it easier for researchers to develop relationships of trust with participants so that sensitive issues can more easily be discussed.

Consent to participate

All participants must be able to consent to participate in the first instance, but we recognise that it is quite possible that some will become cognitively impaired during the course of the study. We believe that we have included in the study the necessary checks and balances to ensure that such participants will not be exploited or disadvantaged. Our protocol has been developed from the research team’s extensive experience, by reference to the Mental Capacity Act 2005 and from guidance given by the local NHS Research Ethics committee.

Confidentiality and security of data

Personal addresses will be given only to the three members of the team conducting interviews (Dr Kate White, Dr Liz Lloyd and Professor Michael Calnan). All written and recorded responses from participants will be anonymised and stored securely.