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.
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)
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
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
Antivirus Software: All servers run up-to-date
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
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
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.
It is advised that you print a copy of this consent form for your records.