Frequently Asked Questions: SolveCFS BioBank
What are the current eligibility criteria?
The current eligibility criteria for the SolveCFS BioBank are available on our web site. We are continually updating this document to clarify descriptions of current criteria, and to reflect changes in symptoms or characteristics that may include or exclude CFS patients or controls.
The exclusions for the set of inaugural studies are intentionally very strict. As many people have commented, they leave a lot of people out. We understand why this decision would be disappointing for those who are not eligible for the inaugural studies. In order to establish the BioBank our initial collaborations require the most strictly defined group of CFS patients. We have limited the list of referring physicians to a small group of experts who have many years of experience distinguishing CFS from other conditions to help us launch this project in the most effective and efficient manner.
If you donít fit the current criteria, please watch for announcements about future opportunities to enroll. We will regularly update CFIDSLink readers about the SolveCFS BioBank, so make sure you are a subscriber.
I meet the current criteria and am eager to participate. What do I do next?
If you meet current eligibility criteria and are interested participating, please contact our SolveCFS BioBank Coordinator, Gloria Smith, at email@example.com or 704-362-2343.
Why is the initial study limited to patients who have a flu-like, acute or subacute onset? Does that restriction really help advance research?
Our initial group of collaborators is interested in potential infectious triggers for CFS and to facilitate this research, we have drawn a tight circle around CFS patients who might help provide more clues to these particular research questions. We anticipate being able to expand the onset criteria as BioBank collaborations and resources permit.
I read that BioBank participants wonít receive their individual study results. Is it standard to exclude patients from getting their own study results?
While the ethical requirements that govern each research study may differ, the Institutional Review Board that governs the Genetic Alliance BioBank and all of the biobanks that are part of its network requires that study results are presented only in the aggregate. This requirement helps ensure the privacy and anonymity of all BioBank participants.
Itís also important for participants to understand that their clinical information and/or blood and/or tissue samples may not be used in every approved BioBank study. As the SolveCFS BioBank matures, collaborators may be interested in accessing information and/or samples from patients (and controls) meeting certain characteristics. For example, a study of long-duration CFS may establish a cut-off of 10 years of illness or more as a study entry point. Therefore, only the information and samples from patients meeting this criterion would be accessed and sent to the approved investigator(s).
Before giving informed consent, we want all potential BioBank participants to have the opportunity to consider all aspects of participating in research.
Why isnít my doctor on the list of approved physicians for the current study?
For this inaugural set of studies, we determined that it would be most effective to collaborate with a small group of clinicians who had the capacity to and interest in referring well-characterized patients to the SolveCFS BioBank. As resources permit and study criteria change, we anticipate expanding beyond this small group of physicians to include patients with other verifiable CFS diagnoses, and eventually an even wider group of patients.
Lyme disease is one of the exclusions, but the testing criteria for a Lyme diagnosis are controversial. What do you consider a ďpositiveĒ Lyme test?
A person with a positive ELISA and a positive IgG Western blot is considered to have Lyme Disease by CDC surveillance criteria and is not eligible to participate in the SolveCFS BioBank as a CFS subject at the present time.
What do you mean by clinical information?
Every SolveCFS BioBank participant will be asked to complete a series of questionnaires collecting valuable information about symptoms, medical history, family history, medication use and function. This information will be protected with the same security and privacy measures as tubes of blood. This information will also be mined for important patterns and characteristics by researchers approved through our Medical Research Advisory Committee.
How much does the BioBank cost the CFIDS Association of America?
There is an annual membership fee paid to Genetic Alliance to access its biobanking infrastructure and support. This is a fixed cost of $20,000 per year and does not change depending on the number of subjects enrolled and samples collected and stored. There are also variable costs charged for the collection and storage of clinical information, blood samples, tissue samples and DNA samples. The Association will be charged for each subject enrolled, depending on the specific requirements for processing the samples that are obtained from that individual. Those requirements will change to reflect the nature of studies conducted. It is important to reinforce that the cost is borne by the Association, not the BioBank subject.
What costs are incurred by BioBank participants?
The only cost we are asking the subject to bear is the cost for phlebotomy. Many clinics will waive this fee if they are told that the collection of blood samples is for medical research. Otherwise, costs range from $10-40. Collection tubes, shipping costs and materials are provided by the SolveCFS Biobank directly to the participant.
Where is funding for the SolveCFS BioBank coming from?
The start-up funds to support the SolveCFS BioBank have come from general and research donations made by individuals and family foundations. Over time, we will seek to diversify funding sources, attracting greater support from individuals, foundations, corporations and industry so that the SolveCFS BioBank is sustained indefinitely as a valuable resource for discovery.
I am eligible to participate in the SolveCFS BioBank and my immediate family would like to contribute samples, too. Can they participate?
Family and genetic studies are crucial to advancing our understanding of CFS. While we cannot recruit healthy family members as participants at the present time, we hope to be able to offer this opportunity in the (near) future.
I would like to donate tissue, organs or my body upon my death. Can I direct my survivors to contact the SolveCFS BioBank?
At the present time, we are not equipped to handle post-mortem donations, but over time, we hope to expand our capacity to accept these types of donations.
Iím having surgery soon. What kind of tissue samples are you collecting?
At the current time, we are only approved to collect blood and buccal tissue (scraped from inside the cheek). Other types of tissue require different processing and storage protocols that we are not presently able or approved to handle.
I read online that samples from the BioBank were going to be used in a pharmaceutical company study. Is that true?
Since we announced the SolveCFS BioBank on March 29, there has been tremendous enthusiasm about the opportunity to participate in this type of ground-breaking research. However, until all the required institutional approvals are obtained by all parties required to initiate BioBank-based studies, we are not able to share information or comment on reports initiated by others about studies being planned. In the interim, please refer to our March 29, 2010 announcement about the SolveCFS BioBank and updated eligibility criteria. We hope that you agree that adhering to protocols established for confidentiality, privacy and the ethical conduct of research serve the interests of all of us dedicated to advancing understanding of CFS. We regret any confusion that may have been generated and we look forward to regularly sharing news about the SolveCFS BioBank and approved studies.
Support validating CFS research with your gift to the CFIDS Association of America. Donate now!