Chronic Disease Research Biorepository Fact Sheet
Study Title: Chronic Disease Research Biorepository
Principal Investigator: Jorge Chavarro, ScD, MD,
Contact information: firstname.lastname@example.org
Purpose of this research
The purpose of this research is to collect blood, urine, and stool samples to study how biological markers may be associated with cardiovascular and pulmonary diseases. The long-term goals of the research are to learn how to better understand, prevent, diagnose or treat congenital heart disease, stroke, chronic obstructive pulmonary disease (COPD), and asthma.
Sponsor of this research
The investigators of the Nurses’ Health Studies and Growing Up Today Study are conducting this study. The Partners Human Research Committee monitors the study. This research is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Who takes part in this research and why
About 5000 participants will take part in this research study. All subjects are also participants in the Nurses’ Health Study 3 or Growing Up Today Study. Many participants take part in this research because they believe cardiovascular and pulmonary diseases are an important topic of research. We couldn’t do this research without our participants.
Confidentiality and data security
The only foreseeable risk associated with this study is the unlikely and minimal risk of a breach of confidentiality. We believe risks are minimal given the protections in place to maintain confidentiality of information on the studies’ computing system. These protections include maintaining data in a secure, password-protected computing system, which is kept totally separate from the contact information of study participants. Participant names and contact information reside on a separate server. Access to the data is provided through secure logins and granted on an as-needed basis per the Principal Investigator of the cohorts. The login can be deactivated by the IT team at any time. Your biological samples will be stored at the Brigham and Women’s Hospital/Harvard Cohort Biorepository. Staff at the biorepository 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. We have never experienced a breach in confidentiality.
Data sharing with other researchers
Your de-identified information may be used or shared with other researchers without your additional informed consent.
Data linkage with data from other studies
You may also be participating or planning to participate in a separate smartphone application sub-study, Beiwe, which we previously contacted you about. The encrypted data from the app study will be received and stored by study investigators in our secure servers; investigators will be able to match participants’ app sign-up emails with data IDs. Thus, the Beiwe app study data, data collected from this online survey, and the historical data will all be linkable using participants’ data IDs for analyses.
Any risks associated with participation
The only foreseeable risk associated with this study is the unlikely and minimal risk of a breach of confidentiality. Protections are in place as described above. There may be sensitive questions related to anxiety, depression, financial loss, job security, and other mental health issues. Responding to these questions is completely voluntary, and you can skip questions for any reason.
Your participation is voluntary, and you can stop at any time. As always, not participating in a sub-study does not affect your status as a valuable member of the NHS3 main study. If you receive care at Mass General Brigham, deciding not to participate won’t affect medical care you receive at Mass General Brigham now or in the future, or any benefits you receive now or have a right to receive.
- Collecting a first morning urine sample in your home
- Collecting a stool sample in your home
- Traveling to your nearest Quest Diagnostics Patient Service Center to provide a blood sample
- Completing a brief questionnaire
- Returning your stool collection kit to our biorepository using a prepaid label
Contact information for questions
If you have questions about this sub-study, please contact us at email@example.com
IRB contact information
If you would like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Mass General Brigham Human Research Committee at (857) 282-1900.
Privacy of Health Information
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.