Mood Patient Powered Research Network

Consent to Participate in a Research Project

What is the purpose of this study?

The purpose of the Mood Patient Powered Research Network (MoodNetwork) project is to actively engage people with mood disorders and their friends and family to share information for research that can improve the health and well being of individuals with mood disorders.

What does this project consist of?

The MoodNetwork is an international project funded by the Patient Centered Outcomes Research Institute (PCORI). The leaders of this project include doctors, patients with mood disorders, and researchers; the Principal Investigator is Dr. Andrew A. Nierenberg of Massachusetts General Hospital. Dr. Nierenberg and the MoodNetwork staff are available to answer any questions you may have.

Participation is voluntary and open to English speakers. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you choose to participate, we hope that you will remain an active member for the long term. We would like to send you occasional e-newsletters to keep you updated about MoodNetwork, with information about new surveys, studies, and other ways to participate. We may email you to tell you about new studies on MoodNetwork. If you do not wish to receive these newsletters, please contact us at Moodnetwork@partners.org.

If you wish to discontinue your participation in this study altogether, please contact us at Moodnetwork@partners.org. As soon as you notify us, we will stop contacting you.

What will happen if I take part in this research project?

We will ask you to complete questionnaires about yourself and your mood disorder.

If you agree to participate in the MoodNetwork, you will be asked to complete a brief questionnaire. This questionnaire will take about 2 minutes in total to complete for most people. After signing up, you will also be able to choose to participate in additional, optional questionnaires. You may choose to update information on these questionnaires every 3 to 6 months or as your health changes. We hope that you choose to remain in the MoodNetwork as long as the study is active, but you can choose to withdraw at any time.

Information collected about you will be combined with information from other participants in the Network to learn more about mood disorders and their treatment. You, along with other participants and researchers, might have the option to view graphs and summaries of the information collected from groups of participants. When this information is shared, your name and other personal information will not be used.

Will I get advice about my health from the project?

No. We will provide you with GENERAL information about symptoms of mood disorders and available treatments, but we will not provide you with specific advice, even if the information you provide us suggests a very serious level of a mood disorder. No one will be reviewing your individual responses to the questionnaires in real time. Your data are collected for research purposes only. We will not be providing any clinical care. Please Note: the health information we provide to you does not in any way substitute for professional medical advice, diagnosis, or treatment that your doctor or other healthcare provider may give you. Always ask the advice of your healthcare provider if you have any questions about a medical condition. Do not disregard professional medical advice or delay seeking care because of something you have read as part of this project. If you need medical help, or are suicidal, you should seek care from local healthcare providers, clinics or hospitals, or emergency resources, such as 911.

If I take part in this research study, how will you protect my privacy?

We will do our best to make sure that the personal information we collect about you is kept private and secure. The MoodNetwork will never sell, rent, or lease your contact information. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Your information will be transmitted and stored using secure systems. The computer network servers where your data are stored are protected by "firewalls" that do not allow unauthorized access and are physically located in a secure server room that can only be accessed by key staff members.

Privacy Policy and Data Security Measures

• Your information will be used for research: Information that might help us predict your future health will be collected about your identity and some of your behaviors. This information will be used in research analyses and results of these analyses will be presented in scientific conferences and published. These presentations and publications will never show any information that identifies you or any other individual in the Network. Summary information that does not contain any identifying information will be shared with others.
• Your information will never be sold, rented or leased.
• MoodNetwork staff will never voluntarily share identifying information about you without your permission.
• You will be able to see some of your study information: When you register to join the Network, you will provide us with a password. You can use this to sign into the Network and see some of the information you've provided to us (e.g., your questionnaires). You should be very careful not to give your login information to anyone else, or he/she could sign in as you and be able to see your information. If you are worried that someone else may be using your login information, please let us know immediately, or change your password yourself through the Study Participant Homepage on the MoodNetwork website.
• Protection Against Involuntary Disclosure of Your Information: MoodNetwork staff will do everything we can to keep your information private.
• All study data is transmitted, stored, and processed in a secure environment. During this research study, identifiable information about your health will be collected. In the rest of this section, we refer to this information simply as "health information." In general, under federal law, health information is private. However, there are exceptions to this rule, and you should know who may be able to see, use, and share your health information for research and why they may need to do so.

In this study we may collect health information about you from:

• Research procedures, including tests and questionnaires.

Who may see, use, and share your identifiable health information and why they may need to do so:

• Partners, a group of healthcare providers in Massachusetts, and research staff involved in this study.
• The data management team that oversees the data (study information) and safety of this research.
• Non-research staff within Partners who need this information to do their jobs (such as for treatment, payment (billing), or health care operations).
• The Partners ethics board that oversees the research and the Partners research quality improvement programs.
• People from organizations that provide independent accreditation and oversight of hospitals and research.
• People or groups that we hire to do work for us, such as data storage companies, insurers, and lawyers.
• Federal and state agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health, and other US or foreign government bodies that oversee or review research).
• Public health and safety authorities (for example, if we learn information that could mean harm to you or others, we may need to report this, as required by law)
• Other:

Some people or groups who get your health information might not have to follow the same privacy rules that we follow and might use or share your health information without your permission in ways that are not described in this form. We share your health information only when we must, and we ask anyone who receives it from us to take measures to protect your privacy. We will not use or share your information (with any third party) for any mailing or marketing list. However, if your information must be shared outside Partners, we cannot control all the ways that others use or share it and cannot promise that it will remain private.

Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop using or sharing your health information.

The results of this research study may be published in a medical book or journal, or used to teach others. However, your name or other identifying information will not be used for these purposes without your specific permission.

Your Privacy Rights

You have the right not to complete this form that allows us to use and share your health information for research; however, if you don't complete it, you can't take part in this research study.

You have the right to withdraw your permission for us to use or share your health information for this research study. If you want to withdraw your permission, you must notify the person in charge of this research study in writing. Once permission is withdrawn, you cannot continue to take part in the study.

If you withdraw your permission, we will not be able to take back information that has already been used or shared with others.

You have the right to see and get a copy of your health information that is used or shared for treatment or for payment. To ask for this information, please contact the person in charge of this research study. You may only get such information after the research is finished.

Data Security Measures

The following is a technical explanation of the measures we take to protect your data. If you have any questions about this information, please contact us by email at Moodnetwork@partners.org or by phone at 617-643-2076 weekdays between the hours of 9:00am and 5:00pm. You can expect a response within 2 business days.

The Partner HealthCare Research IT Facilities Data Center will host the web and database servers for the MoodNetwork. All information will be stored in linked data tables on MoodNetwork secure network servers. Identifying information (name, email address and date of birth) will be stored in data tables so that health-related data can be viewed by study staff. All systems are secured behind the Partners firewall and follow Partners Healthcare Information Security policies for authenticated, minimum access. All systems are patched, monitored and scanned routinely for vulnerabilities and intrusions by the systems administrator and Partner HealthCare Information Security. The web server and database server are hosted within the Partners Firewall. The web server makes use of 128-bit secure socket layer encryption to protect data in transit.

The MoodNetwork Data Management Center (DMC) is experienced in data management for multicenter clinical studies and utilizes the following data security measures:

• Data Transmission: The MoodNetwork web server (provisioned by Partners Research Computing) currently utilizes 128-bit secure socket layer (SSL) encryption to protect data in transit.
• Antivirus Software: All servers run up-to-date anti-virus software.
• Firewall: The network, including all the servers that will store MoodNetwork data, is behind a secure firewall that does not allow unauthorized access to any research data server.

Will my data be shared with other investigators and used by these investigators for future research?

For this research study, some identifiable information may be collected and stored in the database. This might include information like your name, date of birth or email address. At the end of this project, all identifying information including dates will be removed (de-identified). The de-identified dataset combined with information from other projects will then become available for sharing with other researchers and the study sponsor.

Who can answer my questions about the project?

You can talk with the MoodNetwork study staff about any questions, concerns, or complaints you have about this project by sending an email to Moodnetwork@partners.org or calling 617-643-2076 weekdays between 9:00am and 5:00pm. You can expect a response within 2 business days.

If you'd 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 617-424-4100.