| BIOSCIENCE TODAY |
| thought leadership |
A Tale of Two CrisEs
Unfortunately, it appears that being slow to recognise a crisis is part of the human condition, and medical research has had its fair share. Often there needs to be a key event (or series of events) to highlight the situation and signal a turning point. Robert Hewitt, MB BS, PhD, of Biosample Hub, looks at two examples with differing outcomes. BIOBANKING A number of crises have shaped the field of biobanking. One of the most noteworthy was the UK organ retention scandal of 1999 (Bauchner & Vinci, 2001). The problem came to light because a bereaved mother investigating the death of her child, demanded a copy of her medical records. Here she found a letter revealing the fact her child’s heart had been removed at autopsy and retained without permission (The Guardian, 2003). From the public inquiry that followed, it emerged that it was common practice in many hospitals for pathologists performing autopsies on infants to retain whole organs like the brain and heart for education and research purposes, without having the informed consent of the parents. When this information was publicised in the news media, parents who had already suffered a bereavement came to learn that their child’s organs had been retained without their knowledge. This resulted in a huge public outcry; it became obvious that major cultural change was necessary. The report of the Royal Liverpool Children’s inquiry, published in January 2001, made many recommendations including amendment of national law to clarify the fact that informed consent is required for organ retention at autopsy. In response to these and other recommendations, the Human Tissue Act of 2004 came into force. In addition, a regulatory body called the Human Tissue Authority (HTA) was set up in 2005. The
HTA serves to regulate organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public (HTA website). Its aim is to ensure that such organisations follow legal requirements and so it promotes understanding of these requirements through codes of practice and other guidance.
BIOSAMPLES Biotech companies play a vital role in medical research. But three years ago, the annual report of a UK agency called Medicines Discovery Catapult (MDC) came up with a disturbing finding: 80% of small to medium sized biotechs found accessing samples from the National Health Service unexpectedly difficult with the result that 75% imported samples from abroad (SODN, 2018). We need to see this for the crisis it is. There is no shortage of samples—in the UK there are more than 150 hospital-associated biobanks—but there is a failure to share samples with biotech companies. This is partly because public sector biobanks are established by hospitals and universities to support research in academic centres rather than industry. This is not just a UK issue, it is global. It is well-known that biotech companies around the world rely mainly on commercial tissue brokers to obtain clinical samples. Commercial brokers serve a valuable purpose in that they provide biotech companies with
20
