Protecting Your Privacy
The Mass General Brigham Biobank is a research repository that stores samples and data that are linked to each person’s medical information. The goal of the Mass General Brigham Biobank is to make these samples and data available to researchers to study how genes, lifestyle, environment, and other factors affect people’s health and contribute to disease. Samples may be used for many types of research.
Participation in the Mass General Brigham Biobank is voluntary. We ask that you read the Informed Consent Form that provides details on the purpose of the study, how your samples and information may be used, and the risks and benefits of joining this study.
When you provide consent, you allow collection and storage of up to five tubes of blood (about 3 tablespoons), and possibly an additional blood draw of two tubes (about 2 tablespoons); linkage of the blood sample with your Mass General Brigham electronic medical record; and storage of a health information questionnaire that collects additional information about health behaviors, lifestyle, and family history. You are also allowing the Biobank to contact you with information from Biobank research or biomarker results, including genetic findings, and to have pharmacogenetic results place in your medical record if the Biobank leadership conclude that it may be important to your health. When you provide consent, you also agree to be re-contacted by the Mass General Brigham Biobank in the future for additional information or samples, questions, or requests to participate in research.
In order to obtain samples and data, a researcher must first submit a request in writing. This request includes a description of the research to be done, a list of the researchers involved, and what type of samples will be needed. In most cases, the Mass General Brigham Biobank will provide a de-identified sample – in such cases, the sample is assigned a code and the researcher does not receive any information that could be used to identify you.
If a researcher needs identifiable information, he or she must first get approval from the Mass General Brigham Institutional Review Board (IRB). The Mass General Brigham researcher would submit a request to the IRB to access identifiable sample and health information. The IRB evaluates these requests carefully before approving them to help ensure that your privacy is protected and that the research request is sound.
Researchers often work with other researchers who may be at another Mass General Brigham institution, another research institution in Massachusetts, another state or country or a for-profit company. Researchers outside of Mass General Brigham institutions will not be able to see your identifiable information. Researchers outside Mass General Brigham can only get coded samples.
The Mass General Brigham Biobank privacy safeguards are based on laws and federal regulations. One key law is the Privacy Rule that is part of the Health Insurance Portability and Accountability Act commonly known as HIPAA. Another is the Genetics Information Non-Discrimination Act, or GINA which is a federal law that protects genetic information from being used to discriminate against people when they apply for health insurance or employment at companies with less than 15 employees. GINA does not protect people when they are applying for life insurance, disability insurance, or long-term care insurance.
One way we safeguard your identifiable information is by assigning a code to your sample when it is received by the Mass General Brigham Biobank. The key to the code is stored in a secure file that is kept separate from your blood sample and health information. The only people who can see your identifiable information, such as your name, medical record number, and dates, are trained staff from the Mass General Brigham Biobank or Mass General Brigham researchers who have approval from the Mass General Brigham Ethics Committee to use you information for research.
For any research, not just the Mass General Brigham Biobank research project, there are situations in which we must provide identifiable information to others for research oversight, quality control and public health and safety. Groups or individuals who may see your information for these purposes include the Mass General Brigham Ethics Committee, organizations that provide independent accreditation and oversight of hospitals and research, federal and state agencies (such as the Food and Drug Administration), quality control groups, and people or organizations that we hire to do work for us, such as data storage companies, insurers, and lawyers.
We share your identifiable health information with these oversight groups only when we must, and we expect anyone who receives it to protect your privacy. However, once your information is shared outside of Mass General Brigham, we cannot promise that it will remain private.
We hope that this information helps you to understand the important information provided in the Informed Consent Form. After you have read the Informed Consent Form, if you have any additional questions, you can view answers to frequently asked questions in the Frequently Asked Questions of this web site or feel free to contact our staff at the Mass General Brigham Biobank.