Tuesday, May 29, 2012

The UK Biobank: Showing the World How to Bank on Trust

By Margaret Anderson, Executive Director, FasterCures

If you have ever had blood drawn, been biopsied, or had surgery, chances are good that some piece of you, even if microscopic, is stored somewhere in a healthcare facility or laboratory. Most states have laws requiring that laboratories retain such materials for a period of time for clinical, diagnostic, and legal reasons. Current regulations allow those facilities to use those materials for research, so long as they are no longer needed for your care and all identifying material has been stripped from them.

Human biological material—whether cells, tissues, organs, or subcellular structures such as DNA—have become one of the most valuable research resources available to science. Although scientists have long studied human cells to understand, diagnose, and treat disease, technological breakthroughs and powerful new molecular techniques allow cellular information to be mined in ways never before possible.

However, their use raises ethical issues because such material also contains information that is unique to the individual from whom it came —for example, the existence of tiny mutations that affect health and predict future disease.

The increasing demand in the biomedical research community for access to large collections of human biological materials has led to the creation of “biobanks.” Sometimes, technical and scientific needs dictate that material be collected prospectively for current and future studies. Other times, existing collections, of which there are thousands, can provide material of sufficient quantity and quality to explore some fundamental research questions.

Yet, the debate about biobanks continues, mostly centered on whether donors could be harmed in some way by the information contained in the material or by a database getting into the hands of someone who does not have the best interests of the donor in mind or who does not know how to interpret the information. While the scientific value of biobanks is not at issue, what remains contested is how much individuals need to be told, when they need to be told, and what they can be allowed to decide for themselves about how materials will be used in research.

In response to these concerns, numerous regulatory and statutory requirements have made our current biobanking system nearly unworkable. The growing systems of protections of privacy and the tendency to allow individual autonomy to trump generosity have created obstacles that are onerous, expensive, and excessive when compared to the level and likelihood of risk. Privacy rules make it difficult, if not impossible, for researchers to share data across institutions. Current policy proposals could make research even more difficult, if enacted, by insisting that consent be obtained for research use of all materials, even those that have been stored for years, even decades, and for which the identity of the donor has been entirely removed.

If we want to be able grow biobanks, and reap a research return on what we, as healthy volunteers and patients, invest in them, we need to build a system of trust, not distrust. The UK Biobank is a large-scale model of just how to do that.

The UK Biobank is a massive national effort, with nearly 500,000 participants between the ages of 40 and 69 registered to participate. It is a registered charity, funded by public and private interests. To gain public trust and encourage participation, the UK Biobank has undergone rigorous review and consultation at all levels. The biobank sought approval in England and Wales from the Patient Information Advisory Group—representatives of patient groups, healthcare professionals, and regulatory bodies—for gaining access to information that would allow the project to invite people to participate. In part, the project’s success is due to the availability of national healthcare in the UK, which eliminates fears about loss of insurance and access to healthcare based on pre-existing or emerging medical conditions. The British public has been eager to participate.

Recently, the UK biobank announced another move that will enhance the return on investment. For a nominal fee, it will provide more than 1,000 bits of data on each of its volunteers to any scientist, regardless of nationality, aiming to understand the development and treatment of human disease. Prime Minister David Cameron has embraced the goal of turning every user of the UK’s National Health Service into a “research patient,” in which biobank materials will be anonymously linked to data in the participants’ medical records.

Russian writer Anton Chekhov once said “You must trust and believe in people or life becomes impossible.” Like the UK, we need to lay the groundwork for a biobanking system in which trust prevails. The key to achieving success lies in building the foundations of trust among patients, advocacy groups, healthcare providers, and researchers. Those who are collecting and using samples for research must earn the trust of those who donate their samples.

There are a number of ways to earn that trust. Sophisticated encryption systems and public policies that outlaw medical discrimination seem preferable to slowing or restricting critical research efforts through unnecessarily restrictive interpretations of what constitutes informed consent or sufficient privacy protection. Medical progress is dependent on wide participation in research, including investing ourselves, literally, in biobanks. The benefits of donating biobank materials for research accrue to all individuals and future generations.

Relevant FasterCures Resources:
• Publication: Banking on Trust: The Future of Research with Human Biological Materials
• Webinar Archive: Bits and Bytes: Making Patient Information Available and Meaningful to Researchers

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