Greetings,
How many of us can recall reading the consent document regarding the use of our extra biopsy tissue? And if we did, how could we be expected to understand its implications, … or our other choices?
Only recently considered “waste tissue,” the evaluation of biospecimen – particularly when correlated with clinical information (response to therapy, etc.) – is considered the key INFORMATION to making progress against lymphomas and other cancers, heterogeneous conditions, which can have variable clinical courses and underlying biology – even within the same diagnosis.
See about the critical importance of high-quality biospecimens for cancer research and patient care, an NCI video on this page: http://bit.ly/c41Iyz
Presently, pathology departments, the institutions, the investigators, the cooperative groups, even NCI, argue for use of it. The patient community unaware that it has become so valuable, and that “ownership” of it has become so problematic!
Importantly, with the recent advent of caHUB*, we now have an alternative to a fragmented system where tissue remains unused because of ownership battles, or the use of it defaults to individual researchers in the center who have access to the refrigerator. Done in isolation, on relatively small numbers sample, without clinical annotation, this use of patient tissue is unlikely to achieve anything of clinical importance.
* caHUB is a “national biobank, or biorespository, of human tissue, blood, and other biological materials–collectively known as biospecimens–that can be used for medical research. It will help ensure that an adequate and continuous supply of biospecimens is available to accelerate cancer research and the development of molecularly-based diagnostic and therapeutic agents that will further enable personalized medicine.” See for details on caHUB: http://bit.ly/doVai4
So I think the cancer patient communities need legal counsel regarding the use of biopsy tissue for research and government regulation to standardize consent and ownership practices — to protect the interests of patients and to save the gifted, well-meaning, human, all-to-human, researchers from themselves.
Proposing a carrot: Institutions that participate in caHUB, should be awarded generous grants and public acknowledgments.
See Request for Input on the Biospecimen Procurement Program for the NCI’s cancer Human Biobank (caHUB) http://bit.ly/9729P3
And a stick: institutions who do not offer this option to patients, must discard the extra tissue unless they can show its use has a true potential to advance clinical science, and the institutions have provided patients with adequate consenting and knowledge of the alternative.
And to establish trust and best use: Empower an NCI steering committees with independent experts and STRONG PATIENT REPRESENTATION to determine best use of the tissue for research. Noting that access to the biological and de-identified clinical INFORMATION will be available to all, including commercial entities – through the caBIG bio-informatics system, so that researchers can COMPETE WITH IDEAS instead of for ”ownership.”
The reason patient intervention (through legislation) is needed is to make possible what caHUB offers, and apparently what most researchers will not accept in practice, even when they agree with the concept. To illustrate, I copy comment of an unnamed investigator on the competition for use of biospecimen:
“Doctors who work in the field disagree. Many individual sites disagree with the NCI – e.g. many good centers don’t participate in cooperative group studies because they disagree, don’t like, or have other priorities. Our XYZ lymphoma committee often disagrees with the NCI CTEP staff – so for us to send samples from our patients to the NCI to be used on studies we don’t favor is problematic if we disagree – we will not be motivated to participate – it’s very very challenging. …
When patients have a biopsy, the operative consent form generally mentions “waste tissue” – this falls into that category. As I understand it, the patient has no clear rights to “waste tissue”, which would generally not be needed for diagnostic purposes and is therefore discarded. The generic consent form says that this may be used by the institution for research or other purposes (as it is otherwise waste) in a de-identified way.”
What is step one? First, we need feedback from the NCI and research community to make sure our concerns are legitimate and the proposed remedy is feasible. Noting that we really don’t care what method is used to get there, only that we do.
“The patients are waiting.” The alternative to having reliable biomarkers for cancers is a high risk of unproductive and irreversible toxicities – the patient all too often receiving no benefit and significant harm from cancer interventions.
The answer to Who Owns It is that it belongs no one, not even the participants. Its use must be earned and the results must be shared with the entire research community.
Who Can Use it Productively? Productive use requires not only the tissue, but also a robust bioinformatics and clinical annotation system that give meaning to the information in the cells. It is basically worthless without annotation – the clinical history of the participant … which few single centers, if any, are equipped to do. Example: molecular mutation A found in the cancer cells of hundreds of samples from multiple institutions, correlated with durable responses to Treatment B or, as importantly, failure to respond.
The patient community has no conflict of interest, except the use of our tissue in ways that best serves clinical science. Presently, we have no voice in this matter, despite being the primary stakeholders – and there is little authentic enthusiasm among investigators and individual institutions to receive our input.
~ Karl Schwartz
President, Patients Against Lymphoma