COVID-19 Sub-study Fact Sheet

Purpose of the research:

This is a research study to test the hypothesis that 1) the COVID-19 pandemic will have a profound impact on occupational health, mental health, physical health, and nutrition and that 2) COVID-19 infection has long-term health consequences.

Sponsor of the 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.

Why we are asking you to participate, and how many people will participate

We are inviting participants of the Nurses’ Health Study II (NHSII), Nurses’ Health Study3 (NHS3) and Growing Up Today Study (GUTS) to participate. By including these Harvard cohorts with participants ranging in age from 18 to 75 years, some of whom are healthcare workers and some who are not, we will be able to assess the impact of the COVID-19 pandemic in a wide swath of the population. The information collected in this study will be linked to the wealth of data that has been prospectively collected over decades from these participants. Because each cohort continues to be followed for other disease outcomes, we will be well positioned to examine the potential long-term health consequences of COVID-19 infection.

Confidentiality and data security and risk of a breach of confidentiality

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. Participant data are identified by ID number only. 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. 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 COVID Symptom Tracker app study, 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 COVID Symptom Tracker 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.

Participation

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 NHSII, NHS3, or GUTS main studies.

If you receive care at Partners HealthCare, deciding not to participate won't affect medical care you receive at Partners now or in the future, or any benefits you receive now or have a right to receive.

The purpose of this study is to understand the broad health impact of COVID-19 in our communities. Whether you are on the frontline working with patients, performing other essential roles, or staying home to help flatten the curve, your participation will help us understand how COVID-19 is changing our lives and our health.

Participation involves:

Effective July 14, 2020, the questionnaire schedule was revised in order to make it easier to participate.

NEW SCHEDULE:

Phase 2: Months 3 and beyond

• Once every 3 months, all participants will be invited to complete a 15-minute questionnaire

• Once a month, healthcare workers will be invited to complete a 5-minute questionnaire to track health status and access to PPE

Phase 1: Weeks 1-11

• Once a month, all participants will be invited to complete a 15-minute questionnaire

• Once a week, healthcare workers will be invited to complete a 5-minute questionnaire to track health status and access to PPE

Additional notes:

• Each participant’s questionnaire schedule is set by their initial enrollment date.

• As part of this schedule change, we plan to continue this sub-study for 12 months or beyond, as funding allows and as the situation merits.

Contact information for questions

If you have questions about this sub-study, please contact us at nhscovid@channing.harvard.edu

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 Partners 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.