Dear study participant,
This is general consent form. Not all sections apply to this diet study. Please disregard all parts of the consent form that refer to sample collection, and only pay attention to those section that refer to data collection. After you read and sign the consent form below, you will be automatically routed to the diet survey. Thank you!
Michael Levy, MD, PhD
Protocol Title: Study of Rare Diseases using Remote Data and/or Sample Repository
Principal Investigator: Michael Levy, MD, PhD
Site Principal Investigator:
Description of Subject Population: Persons with rare autoimmune diseases of the central nervous system
Collection of Samples and Health Information for Research
About this consent form
Please read this form carefully. It tells you important information about the collection and storage of tissue samples for research. A member of our research team will also talk to you about taking part in this research study. People who agree to take part in research studies are called “subjects.” This term will be used throughout this consent form.
Partners HealthCare System is made up of Partners hospitals, health care providers, and researchers. In the rest of this consent form, we refer to the Partners system simply as “Partners.”
If you decide to take part in this research study, you must sign this form to give your permission. We will give you a signed copy of this form to keep.
Some of the people who are eligible to take part in this study may not be able to give consent because they are less than 18 years of age (minors). Instead we will ask the parent or guardian of the child to give consent. Throughout the consent form, “you” always refers to the person who takes part in the study.
Taking part in this research study is up to you. You can decide not to take part. If you decide to take part now, you can change your mind and drop out later. Your decision won’t change the medical care you get within Partners now or in the future.
The following key information is to help you decide whether or not to take part in this research study. We have included more details about the research in the Detailed Information section that follows the key information.
What is the purpose of this research tissue bank?
The purpose of this research tissue bank is to collect, process, and store samples until researchers need them to do research. Tissue samples in this bank will be used mainly for research on neuroimmunological diseases. Research tissue banks collect and store many types of samples, such as blood, urine or other bodily material.
Researchers who obtain samples from this repository can use samples and information to study medical questions related to these diseases. Potential research questions might include but are not limited to: what causes, prevents, treats, or cures these diseases, and how might these diseases be passed on in families?
Our research tissue bank is located at the MGH neurology laboratories in the Charlestown Navy Yard. There is no set limit to the number of individuals who provide samples to this bank. The more samples and health information that we can collect, the more useful the tissue bank will be for research.
We intend to screen blood samples for new biomarkers of rare neurological diseases. Two recent examples of biomarkers are MOG and AQP4 antibodies that recognize MOG antibody disease and neuromyelitis optica respectively. We expect to find other serological biomarkers of rare neuroimmunological diseases.
MOG, which stands for myelin oligodendrocyte glycoprotein, is a protein in your brain, optic nerves and spinal cord which is targeted by the immune system. When the immune system attacks, it causes swelling and damage leading to your neurological symptoms. AQP4, which stands for aquaporin-4, is the target protein of the immune system in NMO. As with MOG, when the immune system attacks AQP4, it also causes neurological symptoms from inflammation.
Saliva contains DNA. We are interested in DNA samples because we recently discovered a genetic mutation associated with familial transverse myelitis. We expect to find other DNA mutations in familial diseases including transverse myelitis and related conditions.
What will happen if you take part in this research study?
We will ask you to read and sign this consent form before any study procedures are performed. If you decide to take part and sign this consent form, we will give you a copy of it.
You may be asked to do one or more of the following:
□ Donate 20 mL (approximately 4 tablespoons) of blood which will involve placement of a small needle in a vein in your arm to draw blood.
□ Donate up to 20 mL of saliva for DNA collection.
Why might you choose to take part in this research tissue bank?
You will not directly benefit from research conducted on your samples stored in the research tissue bank. We hope that research using the samples and information will help us understand, prevent, treat, or cure the illnesses and conditions studied.
Why might you choose NOT to take part in this research tissue bank?
Taking part in this research tissue bank has some risks that you should consider carefully.
The main risk of allowing us to store and use your samples and certain limited health information for research is a potential loss of privacy. A detailed description of the risks can be found later in this consent form in the section called “What are the risks and possible discomforts from being in this research study?”.
If you have questions or concerns about this research tissue bank, whom can you call?
You can call us with your questions or concerns. Our telephone numbers are listed below. Ask questions as often as you want.
Michael Levy, MD, PhD is the person in charge of this the research tissue bank. You can call him/her at 617-726-0412 Monday through Friday 9 am to 5 pm. You can also call Dr. Levy on his mobile phone at 410-979-8297 with urgent questions about this research study.
If you want to speak with someone not directly involved in this research study, please contact the Partners Human Research Committee office. You can call them at 857-282-1900.
You can talk to them about:
- Your rights as a research subject
- Your concerns about the research
- A complaint about the research
- Any pressure to take part in, or to continue in the research study
What will happen if you take part in this research tissue bank?
As part of your routine care, your doctor may draw blood and/or saliva from you for testing. After the tests for your medical care are completed, part of your samples may be left over. Normally these leftover samples would be thrown away. We are asking you to allow us to collect and store this leftover blood and/or saliva in a research tissue bank. If there are no samples left over for us to use, we may ask you to draw new samples of blood and/or saliva.
If you agree, the samples will be frozen and sent to the bank. We are also asking for your permission to store some of your health information with your samples so that your samples will be more useful for research. We plan to continue to review your medical record to update your health information in the tissue bank computer database.
How are your samples stored?
Staff at the bank will assign your sample a code number and store it in a freezer. They will not keep your name or other information that could identify you with your sample. They will use the code number to connect your sample to your health information that is stored in a computer database. The computer database is protected with a password. Only staff at the bank will know the password. Some of your samples will be stored in freezers, in the Charlestown Navy Yard. Some of these samples may be used for research without being frozen while others may be frozen and sent to the bank.
Which researchers can use your samples and what information about you can they have?
Your samples will be made available to researchers at MGH (Massachusetts General Hospital), BWH (Brigham and Women’s Hospital), and other Partners institutions. Your samples will not be sold to anyone for profit. The tissue bank will usually provide samples with limited information that does not directly identify you.
- As described above, all of the samples stored in the bank are labeled with a code number that connects the sample to medical information related to the sample. The key to the code that links the samples and information to a specific individual will only be available to the tissue bank staff, and will be securely stored.
- Researchers at Partners institutions, whose studies have been approved by the hospital ethics board, may be allowed to review your medical record to collect more health information about you. The ethics board is a group that independently reviews and watches over all research studies involving people. The board follows state and federal laws and codes of ethics to make sure that the rights and welfare of people taking part in research studies are protected.
- Researchers outside of MGH and BWH will not be given the key to the code that links your sample and medical information to your name or other direct identifiers.
For what type of research will your samples be used?
Your samples and information will be used to better understand, prevent, diagnose or treat neuroimmunological diseases, such as yours, and others. The primary purpose of this repository is to:
- Discover new tests and treatments;
- Identify genes, proteins, or other factors that may influence these neuroimmunological diseases;
- Create cell lines (described below) used in the development of new therapeutic products.
This research aims to better understand the mechanisms of these disease in order to find better treatments or a cure. Part of the research is to collect a large sample of genetic information. Most demyelinating and autoimmune diseases are not genetic/inherited. However, current information indicates that genetics can play a role: 1) to put a subject at a higher risk to develop a disease; or 2) to influence the effect of therapies.
We may also perform genetic research on the DNA in your tissue sample. DNA is the material that makes up your genes. All living things are made of cells. Genes are the part of cells that contain the instructions which tell our bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are passed from parent to child.
In order to allow researchers to share test results, the National Institutes of Health (NIH) and other central repositories have developed special data (information) banks that analyze data and collect the results of whole genome studies. These banks may also analyze and store DNA samples, as well. These central banks will store your genetic information and samples and give them to other researchers to do more studies. We do not think that there will be further risks to your privacy and confidentiality by sharing your samples and whole genome information with these banks. However, we cannot predict how genetic information will be used in the future. The samples and data will be sent with only your code number attached. Your name or other directly identifiable information will not be given to central banks. There are many safeguards in place to protect your information and samples while they are stored in repositories and used for research.
We may also perform a whole genome analysis on your DNA sample. Usually researchers study just a few areas of your genetic code that are linked to a disease or condition. In whole genome studies, all or most of your genes are analyzed and used by researchers to study links to neuroimmunological diseases such as yours.
Your tissue sample may be used to create a living tissue sample (called a “cell line”) that can be maintained in the laboratory. Cells lines are colonies of cells that grow from a sample taken from you and grown in a petri dish. This allows researchers to have an unlimited supply of your cells in the future without asking for more samples from you.
How long will your samples and information be kept?
There is no scheduled date on which your samples and information in the bank will be destroyed. Your samples may be stored for research until they are used up, damaged, decayed, or otherwise unfit for analysis. Your sample may be used to create a living tissue sample, which may be stored and used for research indefinitely (described earlier as cell lines). The code linking your samples to your medical record may be kept indefinitely so that your samples and updated health information may be used for research in the future.
For minors: Samples collected from participants who less than 18 years of age at the time of the consent/assent will be kept beyond the time the child becomes an adult. These samples will become anonymized by default– that is, all personal information linked to the sample will be removed. In order to re-link the sample, the participant will need to provide consent, this time as an adult.
Can you stop allowing your samples and information to be stored and used for research?
Yes. You have a right to withdraw your permission at any time. If you do, your samples and your information will be destroyed. However, it will not be possible to destroy samples and information that have already been given to researchers. If you decide to withdraw your permission, you should contact the tissue bank’s staff in writing: Michael Levy, 114 16th St., #3150, Charlestown, MA 02114.
Will you get results of research done using your samples?
No. The research we are doing is only a stepping stone in understanding the science of these diseases. Therefore, information from this research will not be returned to you or your doctor. Tests done for research using your samples will not be useful in directing your medical treatment. This information will not be placed in your medical records.
Generally, we will not return individual results from research using your samples and data to you or your doctor. Most of the findings that come from studying your sample will not be relevant to your personal health. However, in the future, this may change.
It is important to remember that research results are not always meaningful and are not the same as clinical tests. While you should not expect to receive any results from your participation in this research, if we decide that research results from your sample are of high medical importance, we will attempt to contact you. In some situations, follow up testing might be needed in a certified clinical lab. You and your medical insurer may be responsible for the costs of these tests and any follow up care, including deductibles and co-payments.
It is possible that you will never be contacted with individual research findings. This does not mean that you don’t have or won’t develop an important health problem.
You will not receive any medical or financial benefit from participating in this research. By agreeing to participate, you authorize the use of your tissue for research that may benefit others. The study of your tissue may help to prevent or cure diseases. In the future, medical or scientific products may result from research with your tissue. Should this occur, you will not receive financial compensation related to those medical or scientific products. Scientific knowledge advances slowly, but it may greatly benefit future generations. Researchers at Massachusetts General Hospital consider you an important partner in the battle against disease and are grateful to those who choose to participate.
What are the risks?
The main risk of allowing us to store and use your samples and certain limited health information for research is a potential loss of privacy. We will protect your privacy by labeling your samples and information only with a code, and keeping the key to the code in a password protected database.
Information that could be used to identify you will only be shared with researchers within Partners who have approval of the Partners ethics board. Information that likely could be used to identify you will not be shared with researchers outside Partners.
Genetic information that results from this study does not have medical or treatment importance at this time. However, there is a risk that information about taking part in a genetic study may influence insurance companies and/or employers regarding your health. To further safeguard your privacy, genetic information obtained in this study will not be placed in your medical record.
Taking part in a genetic study may also have a negative impact on family or other relationships. If you do not share information about taking part in this study, you will reduce this risk.
Your doctor will explain the risks of the routine medical procedure you are having. In some cases, your doctor will ask you to sign a separate clinical consent form that explains the risks of the procedure. Allowing your samples to be placed in the bank will not change the risks of the medical procedure itself.
Blood Draws. A blood draw may cause pain, bruising and/or bleeding at the needle site. Occasionally, a person feels faint when blood is drawn. Rarely, an infection may develop, which can be treated.
What are the costs to you to take part in the research tissue bank?
There is no cost to you to have your samples in the bank or for the research using your samples. The medical care you received that resulted in these leftover samples will be billed as usual to you and your health insurance company.
Will you be paid for your samples?
We will not pay you to allow us to store your samples and to allow research to be done with your samples.
We may use your samples and information to develop a new product or medical test to be sold. The Sponsor, hospital, and researchers may benefit if this happens. There are no plans to pay you if your samples or information are used for this purpose.
Can you still get medical care within Partners if you don’t take part in this research tissue bank or if you stop taking part?
Yes. Your decision won’t change the medical care you get within Partners now or in the future. There will be no penalty, and you won’t lose any benefits you receive now, or have a right to receive.
Taking part in the bank is up to you. You can decide not to allow your samples and information to be placed in the bank. If you decide to take part now, you can change your mind and drop out later.
What happens if you are injured as a result of taking part in this research study?
We will offer you the care needed to treat any injury that directly results from taking part in this research study. We reserve the right to bill your insurance company or other third parties, if appropriate, for the care you get for the injury. We will try to have these costs paid for, but you may be responsible for some of them. For example, if the care is billed to your insurer, you will be responsible for payment of any deductibles and co-payments required by your insurer.
Injuries sometimes happen in research even when no one is at fault. There are no plans to pay you or give you other compensation for an injury, should one occur. However, you are not giving up any of your legal rights by signing this form.
If you think you have been injured or have experienced a medical problem as a result of taking part in this research study, tell the person in charge of this study as soon as possible. The researcher's name and phone number are listed in the next section of this consent form.
If you take part in this research study, how will we protect your privacy?
Federal law requires Partners to protect the privacy of health information and related information that identifies you. We refer to this information simply as “identifiable information.”
In this study, we may collect health information about you from:
Past, present, and future medical records
Research procedures, including research office visits, tests, interviews, and questionnaires
Who may see, use, and share your identifiable health information and why they may need to do so:
- Partners research staff involved in this study
- The sponsor(s) of this study, and the people or groups it hires to help perform this research
- Other researchers and medical centers that are part of this study and their ethics boards
- A group that oversees the data (study information) and safety of this research
- Non-research staff within Partners who need this information to do their jobs (such as for treatment, payment (billing), or health care operations)
- The Partners ethics board that oversees the research and the Partners research quality improvement programs.
- People from organizations that provide independent accreditation and oversight of hospitals and research
- People or groups that we hire to do work for us, such as data storage companies, insurers, and lawyers
- Federal and state agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health, and other US or foreign government bodies that oversee or review research)
- Public health and safety authorities (for example, if we learn information that could mean harm to you or others, we may need to report this, as required by law)
Some people or groups who get your health information might not have to follow the same privacy rules that we follow and might use or share your health information without your permission in ways that are not described in this form. For example, we understand that the sponsor of this study may use your health information to perform additional research on various products or conditions, to obtain regulatory approval of its products, to propose new products, and to oversee and improve its products’ performance. We share your health information only when we must, and we ask anyone who receives it from us to take measures to protect your privacy. The sponsor has agreed that it will not contact you without your permission and will not use or share your information for any mailing or marketing list. However, once your information is shared outside Partners, we cannot control all the ways that others use or share it and cannot promise that it will remain private.
Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop using or sharing your health information. Your permission to use and share your identifiable information does not expire.
The results of this research study may be published in a medical book or journal, or used to teach others. However, your name or other identifying information will not be used for these purposes without your specific permission.
Your Privacy Rights
You have the right not to sign this form that allows us to use and share your health information for research; however, if you don’t sign it, you can’t take part in this research study.
You have the right to withdraw your permission for us to use or share your health information for this research study. If you want to withdraw your permission, you must notify the person in charge of this research study in writing. Once permission is withdrawn, you cannot continue to take part in the study.
If you withdraw your permission, we will not be able to take back information that has already been used or shared with others.
You have the right to see and get a copy of your health information that is used or shared for treatment or for payment. To ask for this information, please contact the person in charge of this research study. You may only get such information after the research is finished.
Informed Consent and Authorization for Collection of Samples and Health Information for Research
Statement of Study Doctor or Person Obtaining Consent
- I have explained the research to the study subject.
- I have answered all questions about this research study to the best of my ability.
Statement of Person Giving Informed Consent and Authorization
- I have read this consent form.
- This research study has been explained to me, including risks and possible benefits (if any), other possible treatments or procedures, and other important things about the study.
- I have had the opportunity to ask questions.
- I understand the information given to me.
Signature of Subject:
I give my consent to take part in this research study and agree to allow my health information to be used and shared as described above.