SolveCFS Biobank, Who is supporting this on this forum?

[*GG*]

We are pleased to announce that the CFIDS Association of America has completed the rigorous approval process to become part of the Genetic Alliance BioBank, an innovative biobank infrastructure that allows nonprofit organizations to build biobanks. Genetic Alliance has set high standards for participant involvement in research. It provides standardized protocols and allows for ethical re-contact and robust privacy and security protections. The SolveCFS BioBank makes this state-of-the-art system available to eligible chronic fatigue syndrome (CFS) patients and approved researchers.

The SolveCFS BioBank will collect and store a bank of biological samples (such as blood, buccal tissue, cells and DNA) and clinical information at the Genetic Alliance laboratory facility from individuals with CFS and unaffected individuals aged 10 and older. The samples and information will be used by approved researchers to identify biomarkers, explore the causes of and potential treatments for CFS.

The CFIDS Association of America established the SolveCFS BioBank to ensure that privacy and confidentiality are protected and samples are available to researchers whose research projects have been approved by CFIDS Association of America Medical Research Advisory Committee, rather than the lab of just one researcher. Therefore, individuals can enroll once to participate in multiple projects. The CFIDS Association of America and Genetic Alliance are responsible for protecting your privacy and confidentiality throughout the process.

Collection of biological samples and clinical information is for the sole purpose of advancing research. Participants in the SolveCFS BioBank will not receive personal results about any tests performed using their samples. The CFIDS Association of America will periodically inform the patient and research communities 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. Participants may be recontacted from time-to-time by the Association to update demographic, mailing and clinical information, to provide additional samples as new studies are approved, or to participate in other types of follow-up research.

In compliance with the design for the initial BioBank studies, patients are being recruited by collaborating expert CFS clinicians to ensure that subjects in the study have well-characterized CFS. Family members and neighborhood control subjects who are in good health will also be invited to participate. All interested persons must be at least 10 years old to participate and must give informed consent before being enrolled in the SolveCFS BioBank.

If you are interested in learning more about eligibility criteria and what is involved in donating samples and clinical information, please contact the Associations BioBank Coordinator, Gloria E. Smith at (704) 362-2343, or biobank@cfids.org.


http://www.solvecfs.org/SOLVECFSBIOBANK/tabid/99/Default.aspx

 

[*GG*]

I put this under "Active Clinical Trials" because I believe this is what it will be used in and seemed like the best place on the forum.

Did I miss this someplace else on the Forum? Sorry if I did, rather surprised that it has not been posted yet, if not.

Let me know if the poll should be more extensive?!

 

[Cort]

I would put

I hope to participate at some time
I do not plan to participate

Since I'm not with one of the Biobank doctors

 

[*GG*]

I would put

I hope to participate at some time
I do not plan to participate

Since I'm not with one of the Biobank doctors

My bad, I thought this open to any patient?

 

[jspotila]

My bad, I thought this open to any patient?

When the BioBank opened in March, it was restricted to patients diagnosed by four specific clinicians. This was a requirement of the research study currently underway.

But as of June 8th, the enrollment criteria have been substantially widened. The main criteria are: diagnosis of CFS by a licensed physician under the Canadian or Fukuda criteria; post-exertional malaise; cognitive difficulties. There are some other exclusions for age, pregnancy, etc. The BioBank also needs samples from healthy controls, and these can include family, friends, neighbors, etc.

At this stage, the BioBank is collecting clinical data via questionnaire. This will build a database of information. When a researcher is ready to begin an approved study, participants in the BioBank that meet the criteria of that particular study will be invited to submit blood samples at that time. This arrangement enables the BioBank to collect large amounts of information for low cost, and only spend the $400 or more on processing a blood sample when there is a researcher who needs it.

Enrolling participants in research studies can take more than 6 months, and is typically very expensive for researchers. The SolveCFS BioBank will dramatically cut that time, enabling research to move faster and use properly characterized cohorts.

Please consider participating, and inviting your family and friends to participate! Go to the website at http://solvecfs.org for more information!

 

[Hope123]

Jennie,

Can you ask the CAA to clarify whom they want as controls?

When I read some of the info on the site, it said no one related by blood or marriage. When I wrote the coordinator, she stated that relations by marriage (e.g. in-laws) were OK as long as it was not a spouse. If this is true, that should be stated on the site. Wouldn't excluding spouses though take out the possibility of exploring sexual transmission?

The question about blood is also interesting: I thought the webinar encouraged family to enroll so they could track families.

The requirements also stated no one in your household and that they had to live in the same region as you. The exclusion of people not living in the household might exclude interesting studies that could be done to differentiate inherited vs. environmental exposures...e.g. adoptive children or roommates for example. The question about region needs to be clarify re: region where you are now vs. when you first became ill.

 

[jspotila]

Jennie,

Can you ask the CAA to clarify whom they want as controls?

When I read some of the info on the site, it said no one related by blood or marriage. When I wrote the coordinator, she stated that relations by marriage (e.g. in-laws) were OK as long as it was not a spouse. If this is true, that should be stated on the site. Wouldn't excluding spouses though take out the possibility of exploring sexual transmission?

The question about blood is also interesting: I thought the webinar encouraged family to enroll so they could track families.

The requirements also stated no one in your household and that they had to live in the same region as you. The exclusion of people not living in the household might exclude interesting studies that could be done to differentiate inherited vs. environmental exposures...e.g. adoptive children or roommates for example. The question about region needs to be clarify re: region where you are now vs. when you first became ill.

Hope,

I think you are referring to the control criteria that were in effect in March when the BioBank first opened. The new broadened criteria do not exclude family members, etc. Here are the exclusion criteria for controls:

Exclusion Criteria for Controls
1. Control subjects do not have a disorder causing immunosuppression including, but not limited to cancer, severe infections, HIV, or other immunosuppressive disorders.
2. Alcohol or substance abuse defined as an average weekly intake of more than 14 drinks for males or more than 7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
3. Unwillingness or inability to follow the procedures outlined in the protocol.
4. Subject is mentally or legally incapacitated.

The BioBank website has the full criteria available: http://solvecfs.org/SOLVECFSBIOBANK/tabid/99/Default.aspx

 

[Hope123]

Jennie,

This is what I see when I go to the "Healthy Control Subjects Needed" tab. Although the paragraph refers to "the current Biobank study," it might be confusing to send this info to my friends/ family that might be interested in being controls. It might be clearer to say we will accept anyone without the exclusion criteria (as you listed above) but we're prioritizing people with the following criteria for our current already active study. My concern would be you might be losing potential controls if it is confusing for people.

http://www.solvecfs.org/SOLVECFSBIOBANK/HEALTHYCONTROLSUBJECTSNEEDED/tabid/114/Default.aspx

 

[Dolphin]

Just wondering whether you just want people from the US to enrol or can people from other countries sign up?

Also, the screening menu questionnaire asks about overlapping diagnoses (FMS, IBS, etc.) - they're not exclusions are they?

Apologies, I imagine these questions have been answered somewhere already.

 

[jspotila]

Just wondering whether you just want people from the US to enrol or can people from other countries sign up?

Also, the screening menu questionnaire asks about overlapping diagnoses (FMS, IBS, etc.) - they're not exclusions are they?

Apologies, I imagine these questions have been answered somewhere already.

We want to hear from people outside the US. There are some obstacles to shipping biologicals from outside the US, but we still want to hear from you. Perhaps those logistics can be worked out. And IBS, FM, etc are not exclusionary criteria to my knowledge.

Hope this helps!

 

[Dolphin]

Thanks Jennie.

 

[*GG*]

We want to hear from people outside the US. There are some obstacles to shipping biologicals from outside the US, but we still want to hear from you. Perhaps those logistics can be worked out. And IBS, FM, etc are not exclusionary criteria to my knowledge.

Hope this helps!

Yes, this is open to people all over the world, just like this forum(s)!

 

[Lynn]

You can see the names of the voters on the poll. Maybe that is why not many people have voted.

Lynn

 

[*GG*]

You can see the names of the voters on the poll. Maybe that is why not many people have voted.

Lynn

Really, How do you see this?

 

[Lynn]

Really, How do you see this?

Click on VIEW POLL RESULTS.

Lynn

 

[Dolphin]

You can see the names of the voters on the poll. Maybe that is why not many people have voted.

Lynn

In case people get paranoid: most of the polls on the site aren't set up like this.

 

[Dolphin]

Or is it just that this time the names are visible to us and usually they are only visible to the forum owners and administrators?

No idea on these forums but there is a distinction between this poll and other polls on the site.

With yahoogroups, either the names are visible to everyone or they are not to anyone on the list.

 

[*GG*]

In case people get paranoid: most of the polls on the site aren't set up like this.

Not sure if I can change this, let me know how and I will try, not trying to name gather here. But I did click on the number of voters and could see how people voted, not exactly obvious way of seeing who voted. I am just curious about how people feel about the project! I know there is a lot of controversy with CAA.

 

[Dolphin]

Not sure if I can change this, let me know how and I will try, not trying to name gather here.

I think you may have to restart it. But I'm not an expert. That's what you have to do on yahoogroups.

If you restart it, you might want to be more specific in the wording or start a new thread.
The thread title is:

SolveCFS Biobank, Who is supporting this on this forum?

but the vote asks:

Are you going to participate?

They are not necessarily the same question.

Personally, I think the CAA should be congratulated for doing this. Also, one could like them doing this but still disagree with them on other issues. One could even not like them about virtually everything and still participate!

Many people in the US may not know but many, if not most, national ME/CFS groups around the world aren't financially supporting biomedical research. Some have quite big budgets e.g. AfME is in and around 1m (in the region of US$1.5m) (ok, it's giving a tiny bit from a fundraiser a supporter organised in 2006 but generally hasn't been financially supporting research over the last 10 years). Many/most regional and smaller groups in the US and elsewhere don't raise money for research - either for themselves or for other funds. Personally, I'm pleased that the CAA is really getting behind financially supporting research. We need more groups around the world to do likewise, IMO.

 

[BEG]

Just received a call from the CAA asking me if I was still interested in joining the Biobank. I said ABSOLUTELY.

BEG