Dr Janet Messer, Director of Approvals
We know that there are people who are keen to take part in research because they want to be part of finding the answers to the diseases or health problems that they face. We also know that researchers can sometimes really struggle to contact people to offer them the opportunity to choose to take part. Why is it so hard?
There are lots of reasons, but the Health Research Authority has been looking into one aspect. You’ve probably heard the terms data protection, information governance or patient confidentiality. These terms all refer to rules about who can look at and use information that is private to people, and how that information needs to be managed to keep it secure. At its heart they are about making sure that people know what is happening to information about them, and wherever possible they have choices about how that information is used. For those rules to work they also need to make sure that information about people is used in ways that are for the benefit of both individuals and society. Balancing all that means the rules can get quite complicated, and different people can interpret the rules in different ways.
We’ve been working with patients, members of the public, researchers and health and care organisations to find out if the laws or rules need changing or making clearer. We don’t have the answers yet, but we’ve used the principles and hall-marks of people-centred research that the HRA has published to come up with this list to guide our recommendations.
- research teams should involve relevant people when designing the methods for identifying and contacting people about research
- it must be clear to people when and how their information is being used, and if it identifiable or not
- when commercial organisations or non-NHS organisations are involved in any step of the process of identifying and contacting people about research, it must be clear and visible what the company’s involvement is and what data it has access to and why. It should be clear if any individual or organisation receives payment from a company
- wherever possible and unless there are other lawful ways to allow research to take place, people must be offered choices about the use of identifiable confidential patient information
- when researchers use patient information to identify and contact people about research, researchers should consider the quality of that information, and whether it is likely to be up-to-date, and tailor their approach appropriately. Information held in medical records may be out of date or missing. People who have not had contact with the health care system, or who are on a waiting list, or who are awaiting diagnosis may not have relevant information in their medical records
- it is important to balance narrowing down the group of people that are contacted for efficiency by searching against specific criteria, against the risk of removing the opportunity for others who may be eligible but do not have up-to-date information in their records
- research teams should consider reviewing the diversity of those being recruited to their research, in order to assess the suitability of the methods used for identifying and contacting people
- it is generally not appropriate or necessary for GPs or consultants to check whether their patients may be worried or physically unable to participate in research, or to assume that they are unwilling or unable to participate. This sort of gatekeeping can prevent research from being diverse and inclusive. Messages contacting people about research should proactively address possible concerns and provide methods for queries to be addressed
- when people feel that their information has been used inappropriately, they should have somewhere to go to raise concerns
These principles aim to make it easier to offer people options to take part in research and build public trust in the way that this is done. Watch out for our next update on this work.