Encouraging Centers and Investigators, and ative Groups to utilize caHUB

[Guest guest]

For survivors and advisors of PAL.

Greetings,

As we know, clinical outcomes, such as how we responded to treatment, must

be linked to the information within our cells if we are to accelerate

progress against cancers, which means .

Patients must first CONSENT to having our clinical information shared in

this way, which would be de-identified to protect our privacy - i.e., your

name would be a number. Further, each use of the tissue for specific

research would require your consent - instead of a one-time, vague,

potentially dangerous - " use for general research. "

Second, the tissue must be uniformly captured, prepared, and shipped:

applying the same techniques, storage and shipping methods. Otherwise, the

results of testing would not be reliable -leading to false conclusions.

Third, *the most challenging,* individual Pathology departments / Centers

must give up " ownership " of the extra tissue - agree to have " our " extra

tissue stored and evaluated elsewhere and give up unfettered access to it

for inside research.

Fourth, there must be a world-class biobank system that could actually carry

this out - having all the necessary tools: SOPs, storage, backup systems,

molecular testing tools, a bioinformatics system to publish (share) the

results.

What has changed is that we now have it: 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> http://bit.ly/doVai4

So how do we encourage Centers and Investigators, and ative Groups to

participate in a collaborative effort?

A few proposals (feel free to challenge any, or to add to the list):

Financial incentives:

.. By participating in caHUB your Center will reduce expences on

storage and record maintenance for extra tissue

.. Your Center could receive generous income (grants) instead, to

capture and send biospecimen to caHUB

.. Patients may go to your center over another, because you provide

this valuable research service.

.. Government funding of your center or program could become

dependent on participation.

Research incentives:

.. Your Center / Group will receive training in how to utilize and

contribute to the open-source bioinformatics system, caBIG

.. Your Center / Group receives preferential access to tissue in

caHUB to do biospecimen-based research

.. Centers / investigators / groups can compete with ideas instead of

for ownership of biospecimen.

.. Research will be more productive when done this way - all

researchers (academic and commercial) will have access to high quality data

and clinical results, which will accelerate progress against cancers -

particularly the identification and validation of biomarkers, but also for

the design of new drugs.

.. If adopted, there will be a very large pool of high-quality,

properly annotated biospecimen to support your best ideas for clinical

research - and your ability to discover meaning in the data of others.

Ethical considerations:

.. It may become unethical to store tissue or do substandard

center-based research on biospecimen, now that a world class open system is

available.

.. Consenting for use of tissue for center-based research is probably

inadequate in most centers now that caHUB.

Establish trust:

.. Create a steering committees with respected independent experts

(free of conflict of interest for the individual application) and patient

representatives (as full voting members) to decide on who can use caHUB

tissue for research.

.. As noted above, each use of the de-identified tissue for specific

research will require participant consent (it could not be used for cloning

or some other objectionable research without your consent).

.. caHUB researchers to provide control biospecimens to increase

incentives to maintain the security and privacy of the bioinformatics

system.

Exceptions?

Should centers that conduct high-quality in-house research be exempt from

participation, even if dependent on government grants? Probably yes, if

the clinical research is judged to have merit, independent of the above

system.

Bear in mind that extra tissue is sometimes divisible - it may be that both

can be done for some samples, and there may be instances where the pathology

department has only enough for diagnostic purposes, and nothing to spare.

However, a diagnosis is only as good or complete as the tools applied to it

- and its correlation with clinical outcomes. Thus, caHUB, if adopted, will

also refine the diagnostic process, and will provide an important second

evaluation to guard against mistakes.

As always, your comments, criticisms, and ideas are needed and welcome.

Consider this a draft document. The final version will be used to advocate

for full utilization of caHUB by the research community.

Sincerely,

Karl Schwartz

Participant: NCI Biospecimen Access and Ethical, Legal, and Policy Issues

Workshop

Participant: NCI Custodianship and Ownership Issues in Biospecimen Research

Symposium

Patients Against Lymphoma

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