Author: Leonard A. Zwelling, MD, MBA
In the January 2, 2015 issue of Science, Editor-in-Chief Marcia McNutt addresses the issue of “Data, eternal.” In essence, she is extolling the virtues of the most critical aspect of science, data collection, its “transparency and…reproducibility…and the need for these data to “do the most good.” She intends to have Science play a key role on “long-term support, and…be…responsive to community needs.” This goal has never been important nor reaching it more challenging.
When the Bayh-Dole Act (1980) first allowed the use of public grant funds to support research that could be commercialized by the universities from discoveries of value to the public, like new cancer treatment, a new dynamic was unleashed. This is the true birth of the biotechnology industry.
For the first time, public money could be used to enhance private gain in the medical drug and device field and, interestingly, the drugs could be priced so high that many Americans whose taxes supported the discoveries could no longer afford access to the drugs their tax dollars had paid to discover and develop.
Obviously, when academics turns entrepreneurial (although few of these “new entrepreneurs” used their own money), how is the public to be protected from patent wars over initial findings and intellectual property ownership, conflicts-of-interest in which faculty members have dual loyalty to the scientific truth and their own bank accounts when that truth may lessen the value of their portfolios, and the general problem of computerized digitized data being far easier to malevolently alter to the benefit of stockholders than that recorded in bound, dated and signed notebooks?
And, as another complexity, how can huge data sets of clinically based data be utilized if HIPAA constrains the identification of individual subjects whose tumors responded unusually well vs. those with resistant cancer? Without the clinical data, the lab data are worthless.
The country and the world have arrived at a time when a new approach to data collection is not only imperative, but required to reduce a major barrier to scientific progress and the road to medical cures.
When I was Vice President for Research Administration at a large academic cancer center, one of my jobs was being the Research Integrity Officer (RIO). The RIO is the institutional official designated by the institution with direct reporting to the Office of Research Integrity at the NIH to perform inquiries and investigations into all allegations of research misconduct—fabrication, falsification and plagiarism. My role as RIO ended in 2007, but toward the end of the role that had begun in 1995, I found that rather than sequestering notebooks with data for faculty committees to review and compare with published work, I was sequestering hard drives for there were no notebooks. Thus, the data were widely open to manipulation by Photoshop and a host of other software packages and there were no “original” data to audit.
This also meant that patent claims were able to be manipulated because certain time and date stamping was not an intrinsic part of the data systems used to collect data that would be needed to support a patent claim.
Clearly, these off the shelf programs being used for data storage were easily hacked into and usually widely available to all the personnel in a single laboratory. The gates to mischief were wide open.
LabArchives is a proven system for data collection that protects institutions and individual investigators and lab chiefs from these problems by being fully secure, unalterable, reliably and ineluctably time and date stamped. It is the record of record.
My belief is that each and every university should acquire a product like this using the site license mode of purchase and give the software to all investigators free of charge with the proviso that all data that will be published must be collected using this system. Furthermore, the federal government ought to create standards for interaction among such systems to allow the secure exchange of all such information.
Finally, it is imperative that the academic community follow the lead of the IOM report of February 2009 and demand Congress address those aspects of the HIPAA law that prevent potentially useful analysis of laboratory data acquired in the clinical setting. Without the clinical data tracking the response of an individual patient’s tumor to a new therapy, the laboratory levels of a biomarkers can never serve as predictive assays for determining optimal therapy.
We obviously see LabArchives as a viable solution to these sorts of problems and realize that others may have solutions as well. If the ability of the various systems to communicate securely, safely, confidentially and transparently can be preserved through federally established standards, we whole-heartedly support this as well.
Disclosure: Dr. Zwelling has received no compensation or remuneration of any kind from LabArchives or any other such system.
