Getting the best out of biological samples
Hundreds of thousands of biological samples such as blood, urine and tissue blocks are kept in research institutions and hospitals across the UK. Within them may lie the answers to some of the biggest questions in medical research. Getting the best out of samples relies on donors understanding what they may be used for and researchers feeling confident about when they can use and share them. Here Professor James Ironside, Professor of Clinical Neuropathology at the University of Edinburgh, tells us about new MRC guidance on the practicalities and ethics of using biological samples.
“It’s better not to restrict the possible use of the sample because by restricting it you’re increasing the chance that it’ll go to waste. You want the highest probability that something good will come from it.”
Those are the words of a patient surveyed about the public’s views on the use of biological samples in medical research . So how do we go about increasing the chances that samples will be useful?
Samples of human biological material have always been crucial to medical research, but as we move into an era in which huge amounts of data can be analysed easily, getting the best out of each and every sample is becoming more important than ever.
Take stratified medicine — the identification of subgroups of patients with the same disease who may respond differently to treatment, or have a different molecular mechanism causing their disease. Research in this area needs patient samples to look for disease signatures.
And the technology for analysing samples is continuing to advance. ‘Omics’ technologies such as genomics and proteomics allow the screening of hundreds or thousands of samples in a fraction of the time that older techniques did. Using these technologies to unlock the secrets of human health and disease needs a ready supply of samples.
With this greater need for human samples, it’s crucial that researchers have guidance about what they should do, either with samples they have already collected or those they are about to collect.
With this in mind the MRC has revised its Human Tissue and Biological Samples for Use in Research guidance, part of the MRC ethics series.
We brought together a group of experts to work with the MRC Regulatory Support Centre to revise the guidance with a focus on the ethics of using samples, including how to build trust with sample donors, while working within the law and managing health-related findings.
Promoting trust and transparency with donors is fundamental. Respect for donors of biological samples is key to the conduct of good quality ethical research. This means considering the donor population, being sensitive to their ethical, cultural or religious beliefs, or recent bereavement.
Researchers must ask themselves a range of questions. For example, are the samples fit for another purpose? Would donors be happy for samples they donated to be used in other research projects? Is it feasible to ask them? Did they expect samples to be stored exclusively for use by one research team, or to be used more broadly to further medical research?
We’ve provided a decision tree to help researchers navigate through these questions. It explores the instances where ethics review may not be considered necessary, and where it is a requirement of law – where researchers don’t have, and can’t obtain consent — using diagnostic archives, for example. The guidance explores this important role for ethics committees in safeguarding the interest of the public.
Researchers knowing if suitable samples are available is also key. As well as this guidance, the MRC and partners under the UK Clinical Research Collaboration have recently established a National Tissue Directory and Research Collaboration with UCL and Nottingham University.
This initiative will develop a resource directory so that researchers can find existing collections of human samples that may meet their needs; develop and share standards in the collection and management of such samples; and further engage the public and regulators.
It is only through such coordinated working that we’ll get the best out of every sample.
 Consent for the use of human biological samples for biomedical research: a mixed methods study exploring the UK public’s preferences BMJ Open, doi:10.1136/bmjopen-2013-003022 (2013)