Optional Biological Sample Collection
If you are willing to donate a blood sample for study purposes, please read the below information.
If you consent to the optional biological sample portion of this study, we will mail you a blotting paper, an alcohol swab, a band-aid and a lancet, along with a pre-stamped return mail envelope. We will also provide instructions indicating how to disinfect your fingertip, prick your finger tip, and put a drop of blood on each circle on the blotting paper. You will then fold the blotting paper, insert it in the envelope and mail it to us. Once the blotting paper is returned to us, we will test it for anti-covid antibodies.
For a random subset of 500 MS and 500 non-MS individuals who consent to this portion of the study, we will ask for an additional blood draw (10 ml for plasma, 10 ml for serum, 5 ml for DNA, 70 ml for cryopreservation of peripheral blood mononuclear cells), which can be collected either in person at Columbia University Irving Medical Center or through the mail. In the latter case, we will ship you a box with a complete kit and a set of instructions. You can then go to your health provider or laboratory chain which offers phlebotomy. Once you collect the blood, we will ask that you ship it to us using FEDEX and a pre-filled, pre-paid FEDEX label.
We will freeze your sample until it is ready to be used in experiments data. We will generate molecular profiles using a variety of substrates (DNA, RNA, protein, metabolites) and approaches (mass spectrometry, antibody-based evaluations, cytometry, single cell characteization). The approaches include large-scale sequencing efforts for DNA and RNA. We expect that we will perform a very detailed genetic test. There are several versions of this, and this will ultimately include sequencing your entire genome, i.e. we will "read" all of your DNA. No genetic information gathered from this test, or any other test conducted during the course of this study, will become part of your medical record. We will not return any information to you since the sequencing measurements that will be performed are research-quality but not clinical quality information. Genetic tests that are expected to include sequencing of your entire human genome will be performed on the DNA derived from your blood sample.
What will happen to my biological samples and/or data?
As indicated above, if you agree to this portion of the study, you will provide biological samples that contain your DNA. Genetic tests will be performed on the DNA that is in these samples and such tests will produce genetic data about you.
Your samples and/or data may be retained for the life of this study. After the study is concluded, we will, with your permission, retain and use the samples and data indefinitely. Whether or not your samples are destroyed at the end of the study, some of these databases permit only controlled access to the data. Researchers who request access to data must promise that they will protect the data, only share data as permitted by the database rules, report any data breaches and not seek to identify any individual from the data.
The data may be the combined or individual data of many people. Any data that is submitted will not be labeled with your name or other information that could be used to easily identify you. However, it is possible that the information from your genome, when combined with information from other public sources, could be used to identify you. We believe that this is unlikely to happen.
If you agree that we may retain and use your samples and/or data indefinitely, they will be stored at CUIMC either with the researchers on this study or in a central storage facility called a repository in identifiable form in a coded manner. This means that your samples and/or data will be identified by a unique code number that is linked to your name. The key to the code will be stored securely on an encrypted electronic device.
Also with your permission, your samples and/or data may be used by other Columbia researchers or researchers at other institutions, including commercial companies, for research on the Study Medical Condition or other medical conditions. If they are given to researchers who are not researchers on this study, they will only be given in deidentified form. This means that your name and other identifying information have been removed from your samples and/or data or that your samples and/or data are coded and the researchers who will use them will not have the key that links your name to the code number.
What are Whole Exome Sequencing and Whole Genome Sequencing?
We are requesting your permission to perform genetic testing on your biological samples to identify variants and consider their relationship to the Study Medical Condition. Genetic research is evolving rapidly. We expect that we will perform whole genome and/or exome sequencing, but other genetic tests in addition to, or in place of, whole exome sequencing (WES) or whole genome sequencing (WGS) may be performed, including new genetic tests that may be developed in the future.
WES and WGS are very detailed types of genetic tests. WES searches through the exome for DNA variations that can cause disease. WGS searches through all of the genome, including areas outside of the exome. Because WES and WGS examine a larger portion of the genetic material than traditional tests, they may be able to find causes of disease where other tests did not. WES and WGS may also reveal information about unexpected diseases. Because WES and WGS are more comprehensive than other genetic tests, it is particularly important that you understand what is involved. The researcher conducting this study will tell you more about WES and WGS. You may also wish to obtain professional genetic counseling prior to signing this consent form. Genetic counseling is not provided as part of this
study.
However, in regards to your participation in this research, if you are asked in the future whether you have undergone any clinical genetic testing, you may truthfully answer that you have not.
What results will be returned to me?
No results of the genetic testing will be reported to you as this is a research study.
Any future testing or research using your samples and/or data may lead to the development and use of information, products, tests and/or treatments having commercial value. You will not receive any compensation that may result from these tests or treatments.