Information Sheet

Survey of Functional Gastrointestinal Disorder (FGID) Development in COVID-19 Exposed Healthcare Providers

This is a research study. In this voluntary research study, we want to learn more about the development of Functional Gastrointestinal Disorders (FGIDs) in healthcare providers exposed and/or infected with the COVID-19 virus. FGIDs include IBS (irritable bowel syndrome), constipation, nausea, and dyspepsia.

If you have been caring for patients during the COVID 19 pandemic , are 18 years or older of age, and would like to assist in the better understanding of the development of FGIDs, you may participate in this survey. A total of 300 people will participate. You are expected to complete the questionnaires once every 3 months for the next two years. The questionnaires will ask you to provide your general information (electronic email address, age, gender), FGID history, trauma history, current GI symptoms, and current anxiety and/or depression symptoms.

All submissions will be kept de-identified, unless you wish to provide name and contact information at the end of the surveys to learn about future studies. The only people who will have access to the email you provide in order to complete the surveys are study staff. This is optional. Involvement in the present study will end when you submit the last questionnaires at the 2-year timepoint. This study does not involve any treatment or diagnosis.

Major risks and discomforts are not anticipated. It is possible that in completing some of the questionnaire that asks about trauma or symptom history, you may feel discomfort. For this reason, if you wish to withdraw from the study at any point, you may do so without penalty. Deciding not to participate will not affect medical care you receive at Partners now or in the future, or any benefits you receive now or have a right to receive.

This study will utilize encrypted Partner's computers for online data storage and REDCap, a Partners approved data repository, for data capture. Your information will not be used or shared with other researchers. Information provided through this survey will not be used for you clinical care. No information will be gathered from other sources (i.e. medical records).

Kyle Staller, MD, MPH from Massachusetts General Hospital's Gastrointestinal Unit is leading this study. For questions about the study or your rights as a study participant, please contact the researchers at 617-726-2132. If you want to speak to someone not directly involved in this research study about your rights as a research subject, or any concerns or complaints you may have about research, contact the Partners Human Research Committee at 857-282-1900.

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 (see Partners Privacy Notice*). 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.