With increasing volumes of data being held about each of us it’s no wonder the analogy ‘data is the new oil’ has become popular. Organisations are constantly trying to harness information about our hobbies, interests and purchasing history to entice us to buy their latest products and gadgets. They probably know more about us than we do ourselves. But are we happy about them knowing and using our data? Shouldn’t we have more of a say in how they use our information? Now imagine if they actually had a piece of your body. This is exactly what patients give researchers and scientists when they donate tissue samples. That’s why when it comes to managing patient consent it isn’t as simple as yes or no.
The patient consent journey
There are numerous reasons why patients donate their tissue. It might be as part of their own personalised treatment. Or it could be that they want to be part of a trial to help others. Whatever the reasons and drivers behind it, patients want to know their donated samples are going to make a difference.
But for many there may be a reluctance to donate samples. This could be due to past scandals, beliefs, or uncertainty about how you’re going to use their samples and data especially when commercial organisations are involved.
Plus, many patients are also at their most vulnerable when you’re asking them to donate their samples. This naturally impacts their state of mind.
Essentially when it comes to asking patients to donate samples it all comes down to trust.
Obtaining patient consent is more than ethics
Patients want to know an organisation is going to use their samples ethically. In the UK, as well as a moral obligation, there’s a legal requirement on organisations to follow a patient’s wishes when storing and using their samples. Organisations storing and processing human tissue samples have to comply with the Human Tissue Act (HTA). Part of the compliance involves an onsite audit inspection to show evidence that patient consent is in place and any work carried out on samples is in line with the consent given.
Encouraging tissue donation
Life-science research and testing activities rely heavily on processing and analysing human tissue samples. The more patients who donate samples, the more focused your research and the greater your chances of identifying trends and commonalities.
Clearly communicating to patients, and their families, about how you’re planning on using and accessing their samples, and for what purpose could not only help increase a patient’s confidence but also their willingness to donate samples. Providing options where they can choose the types of research or studies in which their samples will be included or excluded can also help. As well as understanding that they can choose to withdraw their consent at any time.
But be careful not to overcomplicate or confuse patients by presenting too many options.
Managing patient consent
In order to comply with a patient’s wishes you need to accurately record the consent information. This includes any restrictions and expiry details. Many organisations often capture and manage consent using paper records which are difficult to control and time-consuming to access. Digitally capturing consent information as part of an eConsent or laboratory information management system (LIMS) can be a more efficient and effective way of handling patient consent.
Achiever Medical LIMS enables you to track patient consent along with any restrictions. The LIMS enables you to record samples alongside the patient and consent. This makes it easier for researchers to confirm if and how samples can be used. What’s more, you can manage study specific restrictions and expiry dates by linking the patient to a study in the LIMS.
The LIMS also includes a process for managing consent withdrawal by presenting all the samples donated by the patient to the user. The user can then manage these in line with your standard operating procedures (SOPs). Plus, the system prevents users from linking samples to research or testing activities following consent withdrawal.
Proactively engaging patients in research
Enabling patients to be actively involved by seeing how you’re using their samples will help increase trust. Plus, it can encourage future donations as well as have a positive influence on others considering donating. Organisations are often concerned about data protection regulations that may prevent them from sharing this information. But this can be achieved with careful consideration around processes, systems and the data that is being shared. For example, Achiever Medical LIMS provides an external facing portal as well as secure communications tools that comply with GDPR. These could help create strong relationships between scientists, patients, and industry.