If you’ve ever agreed to take part in a research project, you will probably remember signing a consent form. Consent forms are there to make sure you understand exactly what it is you are volunteering for e.g. being interviewed about life with a rare disease, or running on a treadmill for half an hour wired up to a heart rate monitor, or giving a blood sample for genetic research.
Consent forms also also protect you by putting into writing certain conditions such being able to withdraw from the project at any time without having to give a reason. Some consent forms allow volunteers to give permission for ‘extras’, such as use of direct quotes from interviews in reports or articles. Generally, at the start of a project a researcher will talk through information about the project with you and then ask you to sign a consent form. This is filed safely and is valid throughout the life of the project.
A new approach to consent is emerging, called dynamic consent, which is more flexible over time and more personalised. It allows participants and researchers to continue to communicate about the project even after you have signed up and after you have given your interview, or completed your exercise session, or given your blood sample.
Dynamic consent is done online and has advantages for both participants and for researchers. It can be set up so that you as a participant can choose to continue to receive information about the research, and to be consulted some time down the line on, for example, what third parties can access your data. This could be the case when universities, charities and commercial bodies are interested in using data from genomics projects. Using dynamic consent can allow you to be easily consulted on who can have access, and how your genetic test results are handled – and can give you the flexibility of changing your choices over time. This is helpful for researchers too as a more sophisticated approach to consent is possible, without being impractical to manage.
Dynamic consent websites can provide information in a more friendly way than paper consent forms, for example by using colour, diagrams and easy navigation. For rare disease research, being able to reach potential participants spread far and wide can be a huge help in recruiting enough people to take part. The RUDY study, at the University of Oxford, has an attractive dynamic consent website that provides information and allows people with a relevant rare disease to register for the project online. It is hoped that such sites will help researchers and participants share information e.g. researchers can update participants on how the project is going and participants can give feedback on the way the project is set up. This will hopefully give participants more of a stake and reduce the numbers who drop out. Again this should be especially helpful for research that requires participants to give information or blood samples at several points over time (sometimes over a period of years), such as in many genomics projects.
The pros and cons of dynamic consent were discussed recently at a workshop, in which our own researcher, Amy Simpson took part. The conclusions of the workshop were hopeful that dynamic consent will enhance the communication between participants and researchers, for the benefit of both parties. If you would like to see the paper that has been published from the workshop, it is available here.