Frequently Asked Questions
What is the purpose of this study?
The IMPACT study is an affiliate study of the PROMISE or PCROWD Studies and will analyze blood samples for up to one year to study the relationship between COVID-19 exposure and the immune system.
All participants enrolled in IMPACT will receive a free antibody test to determine if they have been exposed to the virus causing COVID-19.
Why am I being asked to participate?
You are being asked to participate because you have risk factors for blood cancer and its precursor conditions. We are inviting individuals currently enrolled in the PROMISE and PCROWD research studies to participate. We are specifically studying people who have been identified at an increased risk for blood cancer so we can learn how COVID-19 affects them.
That means either:
1. You qualify to enroll in the PROMISE STUDY if --
• You are between the ages of 45 and 75; and
• You are of Black or African American;
• You have a first-degree relative, such as a parent, a sibling, or a child, who has been diagnosed with multiple myeloma or one of the following related plasma cell conditions: MGUS , SMM. or Waldenstrom’s macroglobulinemia.
2. You qualify to enroll in the PCROWD STUDY because --
You are 18+ years and have a diagnosis of one of the following:
Clonal Hematopoiesis of Indeterminate Potential (CHIP)
Monoclonal B cell Lymphocytosis (MBL)
-such as Polycythemia Vera, Essential Thrombocythemia, or Myelofibrosis
Myelodysplastic Syndrome (MDS)
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Myeloproliferative Neoplasms (MPN)
Smoldering or Indolent Multiple Myeloma (SMM)
Smoldering Waldenström Macroglobulinemia (SWM)
OTHER precursor hematological condition
Do I have to participate in this study?
No. Taking part in this study is voluntary. Even if you decide to participate, you can change your mind and leave the study at any time. However, if you do agree to participate, some of your testing results, along with the blood samples you provide, will remain in our data and sample repositories.
Will I benefit from participating?
By participating in this study, you may learn that you have COVID-19 antibodies.
This may be helpful information for you as an individual to make informed decisions about your risks.
It is also helpful for researchers to know as we continue to learn more about the virus and how it affects certain groups of people. We will research your immune system as being at risk for blood cancer and how that impacts your response to COVID-19 and potential vaccinations.
Your participation in this study could help the medical community learn more about who is most at risk and why. This knowledge could help doctors provide better COVID-19 treatment and/or vaccine options to future patients. It could also help future patients make better decisions about their overall health risks.
Although taking part in this research study may not directly benefit you, the information gained from your participation could potentially help other people who test positive for COVID-19.
What does this research study involve?
After you sign your consent and join the study, test kits will be mailed to your home.
You will take the kit to a Quest Diagnostic lab where a small blood sample will be taken.
In gathering your samples, at first, we are asking your permission to:
A) Obtain a small sample of blood (2-4 tablespoons).
B) Check your blood for COVID-19 antibodies.
C) Participants will receive the COVID-19 antibody test results from Quest Diagnostics by email.
We will send you a research kit to submit peripheral blood (2-4 tablespoons) to the research team at DFCI at 3 months, 6 months, and 1-year post-screening. Take the kit to one of the 2,200 Quest Diagnostics labs in the U.S.
Can I stop being in the research study and what are my rights?
You have the right to choose not to enroll in this study. If you decide not to sign enrollment forms, you cannot participate in this research study.
You can stop being in the research study at any time. Tell the research doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop. Any samples of yours that were anonymized (identifying information removed) will not be discarded. Leaving the research study will not affect your medical care outside of the research study.
Will it cost me anything to participate?
The testing antibody testing will be covered by Quest Diagnostic Labs and will provided for free to you.
What if I have questions?
If you have any questions, please email IMPACTstudy@partners.org or call 617-532-8544.
Will my private information be protected?
We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data.
Federal law requires that DFCI protect the privacy of the information that identifies you. If you agree to participate in this study, you are authorizing the researchers at participating institutions to access and use your private information. Because the research will be ongoing, your authorization will not expire unless you withdraw it in writing by contacting the Office of Human Research Studies, 450 Brookline Avenue, Boston, MA 02215.
The results of this research study may be published. You will not be identified in publications without your permission.
How is the Antibody Test different from a COVID Swab Test and a Rapid COVID Test?
There are currently two important types of testing related to the COVID-19 virus in the United States.
1. Diagnostic tests (Answering the question, "Do I have the virus?")
2. Antibody tests (Measuring, "Is my body already making disease-fighting antibodies?")
Diagnostic tests detect an
active infection with COVID-19.
Antibody tests are done through a blood test to detect a previous infection with or exposure to COVID-19. This study provides antibody tests only.
These infection tests can be done through a nasal swab or a saliva sample.
They look for active infections by detecting a molecular polymerase chain reaction (PCR) or by detecting antigens – strands of proteins that make up the virus.
Learn more about COVID-19 testing on https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics
Specimens & Use
Are there risks to me if I participate in this study?
Drawing blood may cause some discomfort. In addition, it is also possible that the analyses and/or results, including the identification of genetic abnormalities in you, could be seen by unauthorized individuals.
We have procedures and security measures in place to ensure that it will be extremely difficult for this to happen.
Learning that you may have the COVID-19 antibody may cause anxiety, fear, or general stress. This worry may be countered by knowing you have an opportunity to learn that you may have been infected with COVID-19 at some time in the past and never knew it. It may mean that you have some immunity to the COVID-19 virus. However, more research is needed to help us better understand the role COVID-19 antibodies play in a person who has been exposed to the virus.
While it is possible that public knowledge of your genetic factors or the diagnosis COVID-19 could lead to problems with insurance or employment, the confidentiality of participant identities will be strictly preserved under this study, minimizing such risks in this context. Genomic information will not be included in your medical record.
What types of research projects will researchers do with my specimens and health information?
Examples of the studies that may be done include, but are not limited to, studies that will help us:
Some of these studies may be published.
To identify how often (or common) the COVID-19 virus occurs in people at increased risk for blood cancer.
To understand how COVID-19 may affect risks for blood cancers like multiple myeloma.
To define changes that occur in blood of people who are at increased risk for blood cancer and have been infected with COVID-19.
Who will use my samples and see my information?
Your specimens and health information will be available to researchers at the Dana-Farber/Harvard Cancer Center who have approval from the DFCI Institutional Review Board to use your samples and health information for research that is conducted under this research study.
No information that could identify you will be sent with your specimens. In addition, if you agree, we will share your results with central data repositories (such as the National Institutes of Health and others), which may share information without your permission. Your name or other directly identifiable information would not be provided to these central repositories.