Frequently Asked Questions

Q: What questions will this research study help answer?

By testing for antibodies to the SARS-CoV-2 virus that causes COVID-19 in employees who currently have no symptoms of COVID-19, we will be able to determine the proportion of employees who have been infected, regardless of whether they became ill as a result of the infection. The baseline questionnaire will help answer questions about demographics, medical conditions, and exposures to COVID-19 (either at work or outside of work) that may be linked to the presence (or absence) of infection. The blood sample that will be collected separately for the MGB Biobank will help researchers understand more about the nature of the participant’s immune response and also help other researchers who are working on ways to detect and treat COVID-19.

Employees who initially test positive for antibodies will receive 3 more kits to collect blood samples over the course of one year, which will help answer: (1) if having antibodies provides immunity from future infections; (2) how many individuals test positive for antibodies despite never having symptoms; and (3) how long the antibodies remain in the blood. Even if no antibodies are found during the initial test, the follow-up questionnaires will help us find employees who may develop symptoms to COVID-19 throughout the year-long study and to determine if and when they develop antibodies.

Q: Do I have to participate?

No. Participation in this study is completely voluntary.

Q: What is a serology test?

A serology test is a blood test to detect antibodies that the body produces in response to an infection from viruses or other microorganisms. COVID-19 serology tests are designed to detect antibodies against SARS-CoV-2, the virus that causes COVID-19.

Q: What will happen as a result of my participation?

After confirming that you can participate in the study and you provide consent online, you will be instructed to complete an initial short online questionnaire.

Everyone who participates in the study will be mailed a minimum of two test kits to their home, distributed by the Biobank. Some participants will be sent up to two more additional kits (see below).

1. Kit 1 will be mailed shortly after you enter the study and complete the initial questionnaire (ideally within 2-4 weeks).
2. An end-of-study Kit will also be mailed all participants approximately 12 months after joining the study.
3. Each kit will contain instructions and materials to collect blood samples for antibody testing and a mailer to return your specimens to the Biobank.
4. The Biobank will make a record of the receipt of the specimens and forward them to a CLIA-certified laboratory where testing for anti-SARS-CoV-2 antibodies will be performed.
5. After approximately 30-35 days, you will be informed about your antibody results via a link to a secure study Website.
6. If the initial laboratory test finds that you have antibodies (i.e., a positive test), we will send you two additional test kits during the study. You will receive these additional kits approximately 4 and 8 months after you joined the study so that we may test whether these antibodies remain in your blood.
7. Everyone will complete follow-up questionnaires approximately 4, 8, and 12 months after joining the study so that we may follow your health status. Should you develop symptoms of COVID-19 during this follow-up period, you will tell us about these symptoms on the follow-up questionnaire. According to MGB policy, you will also need to contact Occupational Health to tell them about your symptoms. We will then arrange to send you a kit to test for anti-SARS-CoV-2 antibodies. Subjects enrolling in the MGB PROTECTS study will be automatically enrolled in the MGB Biobank after it is confirmed that they have a Medical Record Number (MRN) in one of the MGB-affiliated hospitals.

Q: What does the study measure and what kind of results will I receive?

Using a small sample of your blood that you will obtain by pricking your finger at home using the test kit sent to you, we will be able to measure if you have antibodies to the virus that causes COVID-19. You will receive test results via a secure website approximately 30-35 days after you return your sample. Your test results will not be entered into your medical record and will not be shared with Occupational Health.

The Mass General Brigham Biobank will collect a blood sample at future date, in conjunction with a clinical blood draw. This blood sample will be stored at the Mass General Brigham Biobank. We may also use blood, urine or tissue samples collected as part of your clinical care now or in the future that would otherwise be thrown away. In addition:

• We will look at your medical records now and in the future to update your health information. 
• We will store some of your health information in the study database. 
• We may ask you to complete questionnaires about your health.
• We may contact you in the future to get additional information and ask if you are interested in joining other research studies. 
• A notation that you are taking part in this research study may be made in your electronic medical record.

Generally, the Biobank will not return individual results from research using your samples and data to you or your doctor. Research using your sample is just a stepping-stone in learning about health and disease. 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 the genetic research, if experts from the Biobank decide that research results from your sample are of high medical importance, we will attempt to contact you.

•  When we contact you about research results, you can choose whether you want to know about these results or not. In case you do not want to know about these results, they will not be placed into your medical record. In case you do want to know about these results, they may be placed into your medical record. 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.
•  We may look at variants in genes related to how you respond to certain medications. DNA changes can impact how our bodies react to certain types of medications. For example, DNA changes can impact whether a medication is more likely to work well or cause side effects. If we find a variant that may be important to your health because it relates to how you respond to certain medications, we may provide this information directly to your Mass General Brigham healthcare provider and include your results in your electronic medical record. We may place this information into your medical record for your healthcare provider even if we are unable to contact you.
•  Results about DNA and other biomarker changes may help your healthcare provider take better care of you. They may be able to prevent or find a health condition early. This could help you get better treatment or more appropriate medication.
•  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.

Q: What happens if I am unable to perform the home blood collection (pin prick) correctly? Will there be any teaching materials or extra kits?

We will provide extra testing materials if someone completes the kit incorrectly. For individuals who feel that they are unable to do the fingerprick themselves or do not have someone to help them, we will arrange a location for the test to be performed in the hospital system. Instructions will come with each kit and will be available on this website.

Q: What happens if someone is antibody positive? Do they need to wait to return to work until occupational health clears them? Will they need a follow-up test?

Testing positive for antibodies suggests prior infection with COVID-19. Employees who do not have symptoms and have positive antibody results after being tested are not required by MGB policy to get specific testing for the virus itself (PCR testing).  This means that you can continue working so long as you were not symptomatic within the preceding 14 days before being antibody tested. If you DO have symptoms consistent with COVID-19, it is your responsibility to contact Occupational Health. They will guide you on actions to take and may suggest a standard-of-care nasal swab.

If Occupational Health requests additional testing, you may not be allowed to come to work and will be furloughed in accordance with MGB Occupational Health Policy. You will also need to self-isolate at home during this period. Occupational Health will provide additional instructions depending on the results of the tests.

All employees, regardless of evaluation for return to work, must do the following:
    • Follow mask policy at all times while in the healthcare facility, and
    • Adhere to hand hygiene, respiratory hygiene, and cough etiquette (e.g., cover nose and mouth when coughing or sneezing, dispose of tissues in waste receptacles), and
   • Self-monitor for symptoms, and seek re-evaluation from Occupational Health if symptoms develop.

Q: What paperwork do I complete if I choose to sign up?

There is no physical paperwork to complete. The enrollment process is electronic and will be completed online. Participation in this research study is completely voluntary. If you choose to participate, you will have to read the study information sheet and check an electronic box documenting your agreement to participate in this study, and to have your samples housed in the Mass General Brigham Biobank. The MGB Biobank is a larger research program designed to help researchers understand how people’s health is affected by their genes, lifestyle, and environment.

Q: What is the purpose of the Biobank blood sample and how will they collect this sample?

Blood samples collected as part of the Mass General Brigham Biobank (https://biobank.partners.org) will be used to help investigators answer critical questions about how to understand, prevent and treat COVID-19,  and many other conditions such as, heart disease, cancer, diabetes, mental illness, or reproduction to name a few. Genetic research may include looking at some or all of your genes and DNA to see if there are links to different types of health conditions.

The Biobank blood sample will be drawn at a separate time and can be done at the same time as a medical visit or on its own. Up to 3 tubes of blood (30 mL or 2 tablespoons) will be drawn at one visit.

Q: If someone is already in the Biobank, will they need to give another blood sample?

That will not be necessary if the Biobank sample has already been collected by a CLIA-certified phlebotomist.

Q: Can Biobank blood samples be obtained at any lab in the system?

The Biobank order is placed in the electronic medical record and can be filled at many Mass General Brigham outpatient clinical pathology labs.

Q: Will the Biobank sample only be tested for COVID-19 antibodies or are you also testing for other things?

The fingerstick home testing kit will be used to detect antibodies to SARS-CoV-2, the virus that causes COVID-19. If you sign up for the Biobank, Biobank Investigators may genotype or sequence your DNA. If an actionable abnormality in your genes is detected, the Biobank will attempt to inform you of that information, but you may also “opt-out” of having this information returned to you.

Q: Could my blood tests lead to disciplinary action if I have used illegal drugs?

No. No blood samples from this study will be tested for drugs.  There are no disciplinary actions that your employer can take against you for participating in this study.

Q: Could there be any disciplinary action if I choose to not participate in this study?

There will be absolutely no disciplinary actions if you choose not to participate.  This study is completely voluntary.

Q: Are any other studies related to COVID-19 antibody testing being conducted at MGB?

Yes, there may be other IRB-approved research studies involving COVID-19 antibodies being conducted at this organization. Participation in another study is voluntary and if you are eligible, you may choose to participate. If you choose to participate in another study, you will follow the procedures of that study separately from MGB PROTECTS study procedures.

Q: What if I am already participating in a COVID-19 research study for Brigham and Women’s Hospital employees?

There are two concurrent studies at Mass General Brigham that are recruiting employees to collect blood samples and analyze them for the presence of COVID-19 antibodies. The first study is called “Biorepository for samples from those at increased risk for or infected with SARS CoV-2 in collaboration with the Mass General Brigham Biobank: Prospective SARS-CoV-2 serological surveillance of Brigham Health employees”. This study is only enrolling Brigham Health employees and is collecting blood samples at clinical phlebotomy sites at BWH. The second study is called “MGB PROTECTS”, which stands for “Mass General Brigham Prospective Repository of Organization-wide Testing for COVID-19 to Track Serology”. This second study is enrolling all Mass General Brigham Health employees, regardless of specific affiliation, and is collecting blood samples via at-home kits that are sent in the mail. Both of these studies are working in collaboration with the Mass General Brigham Biobank.

Both of these studies have similar objectives: to understand the risk of SARS-CoV-2 (the virus that causes COVID-19) infection and immunity amongst different groups that work at our institutions. However, they are leveraging different blood collection procedures as well as different study protocols (e.g., both studies have survey requirements, but the surveys are different and are administered at different time intervals). Both studies are using the same antibody test.

Brigham Health employees are welcome to participate in both studies – in such cases, they will need to provide a blood sample at a clinical pathology site at BWH for the Brigham-focused study AND return the blood collection at-home kit that is mailed to them for the PROTECTS study. All other employees are welcome to participate in MGB PROTECTS.

In both cases, the studies are working in collaboration with the Mass General Brigham Biobank. This means that all blood samples are managed by the Biobank, and all signed consent forms are reconciled against one unique subject ID. That being said, data is not being shared between the studies, and each study has its own distinct protocol and sample collection procedure.

Both studies are returning the results of the antibody tests to participants. The Brigham Health study is returning positive antibody test results by phone and negative results by email. The MGB-wide study is returning all results via a web portal that requires login with your MGB user name and password. Former employees will receive results via a send secure email.

Q: Who should I contact if I have additional questions?

Please email us at Biobank@partners.org or call the Biobank help desk at 617-525-6700.