Page 1: Information about the survey

Background

Mental capacity and informed consent for research – who decides?

Informed consent is an essential requirement before involving anyone in a research study. However, sometimes people are unable to provide informed consent for themselves due to a condition that affects their ability to make decisions. This may be due to a profound learning or intellectual disability, accident, acute illness or medical treatment, or may be as a result of a neurodegenerative condition such as dementia. These may lead to a temporary or permanent incapacity, or situations where a person’s mental capacity fluctuates over time. Involving people with such conditions in research is essential in order to improve their care and treatment, therefore alternative arrangements for their participation are possible through involving others in the decision about whether they should take part in a research study.

Doctors, nurses, allied health professionals and social care practitioners are often involved in these decisions. However, these decisions can be complex and we know that healthcare professionals caring for people who are unable to make their own decisions are sometimes concerned about how such decisions should be made, and what their role should be.

About this study:

We are conducting a study to look at healthcare professionals’ views and understanding of how decisions are made for people who are unable to provide their own informed consent for research, in England and Wales. You have been invited to take part in a survey as a healthcare/social care professional whose role involves patients/service users/research participants, some of whom may be unable to make decisions for themselves (i.e people without mental capacity). We are interested in the views of as wide a range of professionals as possible, in order to understand any similarities and differences between those with different roles and responsibilities, and in different specialities. All views are very important to us.

What topics are covered in this survey?

The survey covers questions about your views and understanding about mental capacity and the processes of informed consent for research, using hypothetical cases where a decision is being made about whether a patient/service user may take part in a research study. We will also ask you to provide some information about yourself, your role, and area of practice in order to understand any similarities or differences between those responding to the survey.

Following completion of the survey, if you would like a summary of the legislation governing proxy consent for research participation by adults lacking capacity in England and Wales, or information about how the law applies to the scenarios used in the survey, please click on the link at the end of the survey.

Who is running the study?

This study is part of a postgraduate research project being conducted at Cardiff University as part of a National Institute of Health Research Fellowship funded by Health and Care Research Wales.

Your participation is voluntary, and you can chose to withdraw from the study at any time. Results of the study may be published or otherwise made publicly available, however no names or personal information will be used.

How long will the survey take to complete?

The survey will take approximately 10 - 15 minutes to complete.

What if I have any questions?

If you would like more information about the study, or have any questions, please contact:

Victoria Shepherd, Division of Population Medicine & Centre for Trials Research, Cardiff University, Heath Park, Cardiff CF14 4YS

Tel: +44(0)29 20687641 Email: ShepherdVL1@cardiff.ac.uk

Thank you for taking the time to consider our study.