When the Solve ME/CFS Initiative launched its expanded research initiative in mid-2007, we heard loudly and clearly from the CFS community that research was its top priority. In response, we:
- recruited a full-time scientific director;
- issued a Request for Applications focused on biomarkers and methods for early detection, objective diagnosis and effective treatment of CFS;
- adopted updated funding policies;
- strengthened our peer review system;
- awarded six innovative grants;
- established the first funded network of linked investigators;
- convened an intensive three-day meeting of experts;
- conducted site visits of funded projects; and
- kept the community informed about our progress using a host of print and electronic publications, recently expanded to include regular webinar programs.
When scientific director Suzanne D. Vernon, PhD, joined our staff in late 2007, one of her goals was to fill scientific “infrastructure” gaps she believed were barriers to attracting new investigators and validating some of the known biological markers published by research groups in the U.S. and other countries. Linking bench researchers to well-defined clinical populations was one of the foremost challenges.
In September 2009, Suzanne completed her certificate in public health genomics at Sarah Lawrence College and she met leaders from Genetic Alliance (GA), a network of more than 1,000 disease-specific advocacy organizations committed to transforming health through genetics. Suzanne discovered how GA had created a centralized registry and repository to enable translational research for a host of underfunded and rare conditions, addressing the cohort access issue.
Genetic Alliance president Sharon Terry recounts her goal in establishing the GA BioBank with other leaders in disease research advocacy: “The Genetic Alliance BioBank was built with organizations like the Solve ME/CFS Initiative in mind – to provide them with the infrastructure to pursue sophisticated, novel research collaborations with academia and industry to develop new diagnostics and therapeutics to better understand and treat disease.”
Suzanne conducted her own careful research, comparing the Genetic Alliance model to several others, weighing the costs and benefits to the organization, the patient community and researchers in academia and industry. Summarizing her findings, she told our board of directors last fall, “The Genetic Alliance uses a cooperative, cost-sharing model that translates into a tightly controlled, comprehensive infrastructure for biobanking. Organizations that start from scratch often spend millions of dollars just to put the systems and documentation in place before a single sample is collected.”
Genetic Alliance set high standards for participant involvement in research, exceeding requirements of all applicable federal, state and local laws, rules and regulations. The GA BioBank earned a Certificate of Confidentiality from the National Institutes of Health. The GA’s board of directors oversees the fiscal management and annual audit. It provides standardized protocols and allows for ethical re-contact and robust privacy and security protections. Our legal counsel agreed with the assessment.
In December, the Association’s board of directors approved plans to join the Genetic Alliance BioBank and to apply for approval from GA’s Internal Review Board (IRB) for the SolveCFS BioBank. Chairman of the board Adam Lesser recalls the discussion about initiating a biobank. “It was the next logical step to advance research in CFS, and Genetic Alliance offered tremendous capacity to augment our research program.” Final approvals were granted by the IRB earlier this month.
On behalf of the board of directors and staff of the Solve ME/CFS Initiative , I am delighted to introduce the SolveCFS BioBank. The SolveCFS BioBank will collect and store a bank of biological samples (such as blood, tissue, cells and DNA) and clinical information at the GA BioBank laboratory facility from individuals with CFS and healthy individuals (controls) aged 10 and older from the U.S. and other countries. It ensures that individual privacy and confidentiality are protected and that samples are available to researchers whose research projects have been reviewed and approved by the Solve ME/CFS Initiative Medical Research Advisory Committee.
Through the SolveCFS BioBank, individuals can enroll once and will then contribute information to multiple projects, advancing our understanding of CFS on multiple fronts. Because the SolveCFS BioBank’s purpose is dedicated to research and in order to preserve the privacy and security of all participants’ information, participants do not receive personal results about any tests performed using their samples. The Association will provide regular updates about how SolveCFS BioBank samples are being used, as well as the results of research conducted. Researchers will be required to publish their results in peer-reviewed medical journals.
Since securing approval for the SolveCFS BioBank, the Association has established its first study collaboration. We are working with several clinical and academic collaborators and major industry partners. As such, enrollment criteria for the inaugural study will be rather strict. As Suzanne indicates, “The SolveCFS BioBank is an innovative research resource that will be used for validation of promising biomarkers, genetic studies, family studies and genomics research. It will be a resource for discovery, diagnostics and targeted treatments. We hope to have adequate funding soon to expand recruitment beyond the inaugural study requirements. This will truly empower more people affected by CFS to participate in this exciting research, and will ultimately lead to the answers we all seek.”
We have recently updated our SolveCFS.org website to house extensive information about the SolveCFS BioBank. We look forward to sharing additional updates, news about expanded recruitment and, best of all, results from research that utilizes the SolveCFS BioBank.March 29, 2010