Before You Give Consent

June 26, 2013

If you meet eligibility criteriaDonateNow03 for our current studies, you will be invited to donate blood and cells from a scraping of the inside of your cheek (buccal cells) and your clinical information for research into CFS. Before giving your signed consent, please read this information carefully and take as much time as you need. Ask questions about anything you do not understand now, or when you think of them later.

Donation of your sample and clinical information is strictly voluntary and you can change your mind about it at any time. If children aged 10 and older are included, the word “you” will refer to both you and your child.

Why am I being asked to donate a sample?
The Solve ME/CFS Initiative is a member of the Genetic Alliance BioBank that provides storage facilities and support for organizations like Solve ME/CFS Initiative to collect biological samples and clinical information to help advance research.

The Solve ME/CFS Initiative is currently collecting samples from people diagnosed with CFS by selected healthcare professionals and from unaffected people aged 10 and older. We are also collecting clinical information from people who donate a sample. If you meet current study criteria, we would like to include your sample and your clinical information in the SolveCFS BioBank located at the Genetic Alliance laboratory facility. Your samples and clinical information will be made available to approved researchers who are studying CFS to help understand the disease. Your samples could also be used for research on other diseases, if you give your permission by checking a box on the last page of the consent form. Samples will only be given to researchers who have research projects that have been approved by the Solve ME/CFS Initiative ’s Medical Research Advisory Committee. The SolveCFS BioBank is funded by the Solve ME/CFS Initiative .

It is up to you to decide if you want to give a sample to the SolveCFS BioBank. No matter what you decide to do, it will not affect your health care or the services the Solve ME/CFS Initiative provides to you. You can change your mind and withdraw your consent and participation at any time. Please read the rest of this information to help you make your informed decision.

What will happen if I decide to donate a sample?
If you agree to donate a sample, the following will occur:

  1. You will sign a consent form, keep a copy for yourself and send the original by mail to Gloria E. Smith at the Solve ME/CFS Initiative .
  2. When Gloria receives your consent form, a unique identifying number (ID number) will be created for you. The file linking your name to the ID code will be kept in a secured, locked location.
  3. Gloria will contact you by phone to determine what is the best way for you to provide your clinical history information to the SolveCFS BioBank; for example using paper forms and the US Postal Service or entering your information using the internet. Your name and clinical information will be used to assign you a unique identification (ID) number. This ID number is unique to you and is used to keep your information secure.
  4. At the same time, Gloria will give your name, ID number and address to the Genetic Alliance BioBank.
  5. The Genetic Alliance BioBank laboratory will mail a kit to you that will contain tubes and detailed instructions for getting a sample of blood and buccal cells. The tubes in the kit will be labeled with a unique number and your first name. There will also be a pre-addressed and paid mailing envelope to send the samples back to the bank. If you have any questions about the instructions, there will be a name and phone number on the instructions to call.
  6. You, or the place you have the blood drawn, will ship the sample to the laboratory. Your sample will be processed and stored until it is requested for research. Your samples will be labeled only with your ID number and a number created by the Genetic Alliance laboratory facility.
  7. You will be asked to provide your clinical information using either paper forms or by filling in forms using the internet. Paper forms will be mailed to the Solve ME/CFS Initiative . Your name will be removed from the clinical history form and replaced with your ID number. The clinical history form will be stored in a locked, secured location. The information on the clinical history form will be entered into a clinical information system stored on secure servers at the Genetic Alliance laboratory facility.
  8. Researchers who would like to study CFS will submit research protocols to the Solve ME/CFS Initiative . If the Medical Research Advisory Committee approves the study, some of your sample and corresponding clinical information may be sent to the researcher. We will give them your ID number only, so that only designated CFIDS Association staff can connect your name to the results of the new research. The samples or the clinical form will not contain any identifying information about you. If researchers want to contact you for more information, we will forward the request to you, but we will never give researchers your name.
  9. You will not be notified if your sample is used. You will not be notified about any individual research results using your sample.
  10. You will be notified if the research discovers something that is important to you for your medical well-being, that is, something that is clinically significant.
  11. If you change your mind at any time, you can tell us and we will destroy any of your sample that is in use or in storage and we will destroy the clinical questionnaires and files that contain your information.

What are the risks or discomforts for donating a blood or buccal cell sample?.
The risks of drawing blood include brief pain, slight bruising, and rarely, infection at the site of the needle insertion. The laboratory or clinic where the blood is drawn will take every precaution to prevent infection. Some people feel dizzy when they have blood drawn, but this goes away when the person lies down.

The risks of getting a scraping of cheek cells include brief pressure or slight discomfort. The cheeks should not be scraped hard enough to draw blood.

If you are physically hurt because of donating a sample, we will help you to get medical care through your usual doctor. You or your health insurer will need to pay for any such care that you receive.

How will you keep my information private?
All of the procedures used to create and maintain the SolveCFS BioBank have been approved by an Institutional Review Board that protects human subjects enrolled in research projects.

Once we have your consent form, we will assign you a unique ID number. Your sample and clinical history information will contain that number. We will remove your name and any other information that points to or identifies you. We will keep files that link your name to your ID number at the Solve ME/CFS Initiative main office in a secure location. The SolveCFS BioBank where the sample is stored will also have a file that links your name with your ID number. We will only allow the study staff to look at these files and they have signed an agreement that they will not reveal the information to anyone else. Your name or other facts that might identify you will not appear if we present any study findings or publish results using your sample. Although all of your identifying information will be stripped from your clinical history, it is still possible that your family or clinical history will allow identification of you, even if the information is published anonymously.

What are the benefits to me?
There will be no direct benefit to you from allowing your sample to be included in the SolveCFS BioBank. You will not receive any personalized information from any research that uses your sample. However, we hope information gained from researchers who obtain samples from the SolveCFS BioBank will help in the early detection, objective diagnosis and effective treatments and interventions of individuals affected by CFS. From time to time, the Solve ME/CFS Initiative will provide information in the newsletter, website or at other events about what research studies have been supported through the approved distribution of samples and clinical information.

Are there any financial considerations?
There is no payment to you for donating a sample. We will not charge you for donating a sample. The laboratory or clinic drawing the blood may request payment; however, if they know that the sample is for research, they may waive that payment.

Once you have donated your sample the Solve ME/CFS Initiative will own the sample. Researchers who use the sample may make a discovery that has commercial value. You will not be entitled to any compensation due to discoveries that are made and commercialized using your samples.

What are my alternatives?
You may choose not to donate. Your decision to participate or not will have no effect on your healthcare, or the services that the Solve ME/CFS Initiative offers to you, either now or in the future.

How long will my sample and clinical history be stored?
Your sample and the clinical history and information will be stored for an indefinite period of time. You may be recontacted from time-to-time to update your information, provide additional samples as new studies are approved, or participate in other types of follow-up research.

Will my sample be used for anything else?
The purpose of the SolveCFS BioBank is to promote research into biomarkers and treatments for CFS. However, researchers who are studying other diseases may find CFS samples valuable to their area of research as well that may benefit patients with CFS or other patient populations. You have the option of giving permission to use your sample just for research in CFS or for other medical research as well.

Can I change my mind and withdraw my sample?
You can change your mind about donating a sample at any time. Just contact Gloria Smith at our office. Your sample that is in use or in storage and your clinical history information will be destroyed.

What about other samples I have donated to research in the past?
It is important to know if there is any possibility that another sample of yours already exists in the Genetic Alliance BioBank. If you have donated a sample in the past to a researcher, please let Gloria know.

Where can I go for answers to any questions I may have now or in the future?
You can contact Gloria E. Smith at (704) 362-2343 or biobank@cfids.org if you have other questions now or in the future.