University of North Carolina at Chapel Hill Mom Genes Fight PPD Privacy Policy

The University of North Carolina at Chapel Hill (“UNC“) is committed to providing notice about the Personal Information (defined below) collected as part of the Mom Genes Fight PPD (previously called PPD ACT) research study. The formal name of the research study is “MomGenes Fight PPD: Expanding to Increase Participation from Diverse Ancestries” and it is organized by UNC and sponsored by the National Institute of Mental Health (the “Study“). To participate in the Study, you will be required to sign a consent to participate document (“Informed Consent“).

This “Mom Genes Fight PPD Privacy Policy” (“Privacy Policy“) provides information about how we will collect, use, store and share Personal Information about Study participants (“you“).

Participants may take part in two different of the Study:

• Phase I, Completing Surveys: if you consent, during Phase I you will be asked to answer questions to help Study researchers determine if you have ever experienced postpartum depression or postpartum psychosis. We also ask about your experiences with depression, anxiety, discrimination, trauma, and abuse. There are also questions which ask about mental health diagnoses, physical health, and behavior.
• Phase II, Blood Sample & Genetic Analysis: if you are eligible and invited to participate in Phase II, we will again ask for your Informed Consent to provide, through the mail, a sample of your genetic material (DNA) so that researchers can study the link between postpartum depression and genetics. Your DNA would be obtained from a blood  sample.

There is no cost to you as a participant in the Study.

We are not asking you to make any health decisions based on your participation in the Study. You should discuss health decisions directly with your healthcare provider.

How will you consent to this Privacy Policy and the Informed Consent?

The Study website will provide a link to this Privacy Policy. If you enter the Study by clicking “Join the Study” on the Study website, supply Personal Information or answers to questions through the Study, or register for an account with us, that will be your consent to this Privacy Policy. You will be asked to sign the Informed Consent to participate in Phase I of the Study and will not be allowed to proceed in the Study unless you do sign. A copy of the Informed Consent you sign will be sent for your records to the email address you provide as part of the Informed Consent process. You can access or download a copy of this Privacy Policy by going to http://www.momgenesfightppd.org/privacy-policy/.

What does this Privacy Policy cover?

This Privacy Policy covers our treatment of personally identifiable information and other information that might, or might not, personally identify you and is related to the Study. For ease of reference, we will call this information “Personal Information.” This Privacy Policy does not apply to other research studies or other, unrelated activities conducted at UNC or to similar studies conducted at partner universities.

The Study website contains links to external websites that provide resources for PPD support. This Privacy Policy does not cover, and we are not responsible for the privacy policies or practices of websites that may be accessed through these links. When following a link to another website, you should read that website’s privacy policy and make sure that you agree with it.

Your participation in the Study will allow you to provide us with Personal Information as outlined in the Informed Consent(s) and this Privacy Policy.

The Study is designed for adult women. We do not knowingly collect or solicit Personal Information from anyone under the age of 18 and we do not wish to receive it. The Study is limited to participants who live in the United States and are 18 years of age or older, or participants who live in Puerto Rico and are 21 years of age or older. In the event that we gain actual knowledge that we have collected Personal Information from a person under age 18, we will delete that information. If you are a parent or guardian and believe that we might have collected such information, please contact us using the contact information below.

What information does the Study collect?

The purpose of the Study is to understand genetic risks of postpartum depression and postpartum psychosis. Using your internet accessible device, Phase I of the Study must first identify if you are eligible to participate by asking your language preference of English or Spanish, age, country of residence, and whether you have given live birth. If you are eligible to participate and you sign the Informed Consent, the Study will collect personally identifiable information about you such as name, address, and email address. The Study will also ask you several questions about your mood, anxiety, and experiences with discrimination, trauma, and abuse. There are also questions which ask about mental health diagnoses, physical health, and behavior.

If you provide the above-described Personal Information, you may be asked in the Study and by email if you would like to participate in Phase II of the Study. As described above, Phase II involves you submitting a sample of DNA (collected from blood using a device we mail to you) to help researchers determine how genes affect the development of postpartum depression and postpartum psychosis. You would be required to complete a second Informed Consent to participate in Phase II. With your Informed Consent, your DNA sample will be reviewed for genetic markers to try to find any differences between women who experienced postpartum depression or postpartum psychosis and those who did not.

You may choose not to provide us with certain information. You have the chance to skip any questions in the Study that make you uncomfortable, to stop participation at any point, to decline to participate in Phase II of the Study, and to withdraw from the Study completely. Though refusal to provide some Personal Information may exclude you from participation in the Study, it will not affect your relationship with the research team or UNC.

What else does the Study collect?

The Study platform includes tools that automatically collect certain information other than the responses you manually enter. These tools work on an anonymous basis, without collecting personally identifiable information. Through these tools, the Study platform may automatically receive anonymous technical information relating to your operating system, device, features used, content viewed and downloaded, whether crashes occurred, and the dates and times of your interactions with the Study. We may internally use this information to understand, customize and generally improve user experience with the Study.

What about security for Personal Information? How long will UNC keep it?

All information that is collected through the Study will be encrypted through encryption methods currently used at UNC and sent to a protected data server behind UNC’s firewall. If you participate in Phase II of the Study, your DNA sample and genetic data will also be stored in a protected way at UNC. (See the section below on “Sharing” for information about storage of your DNA sample and genetic data at the National Institutes of Health).

UNC will replace the direct identifiers you provide – like your name and address – with a code to help protect your identity. UNC will encrypt the direct identifiers and store them separately. Because the remaining information is coded, researchers using this information should not be readily able to identify which information pertains to you.

UNC researchers will keep your Personal Information indefinitely, except if you withdraw from the Study, in which case your Personal Information, including your DNA sample, will be destroyed from UNC’s records and repository. (See the section below on “Choices” for information about removal of your de-identified DNA sample and genetic data from the National Institutes of Health repositories). The only people who will have authorized access to the code set with your individual identity are UNC study personnel, who will retain the ability to re-identify your Personal Information if doing so is needed for research integrity purposes or legal purposes. UNC may also share your re-identified Personal Information with others at UNC who need to see such information to ensure that the research meets legal, regulatory or institutional requirements.

You too can help with security. For example, access to the Study on your device may be protected by a biometric authentication mechanism (such as Face ID or fingerprint) or a passcode. You should take these or other steps to prevent unauthorized access to your device by protecting and limiting access to your device. We strongly recommend that you always use the most updated version of the operating system for your device. You should review the privacy and security settings often and restrict any unnecessary access.

No matter our efforts, we cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of your Personal Information.

Will UNC share any of the information it receives?

The information collected by the Study and through the DNA sampling kit will only be used for research purposes. Your name will never be used in publications or presentations when the results of the study become available.

As described above, your Personal Information will be coded. The code will be stored separately and in a protected way. The only people who will have permission to access this code will be the UNC research team. We intend that the only time your identifiable information will be shared outside of UNC is when required by law. For example, we might believe disclosure is necessary to comply with a regulatory requirement, judicial proceeding, court order, or legal process served on us, or to protect the safety, rights, or property of UNC or the public.

Some information will be stored at a controlled repository at the U.S. National Institute of Health. This information will include summaries of some survey responses and genetic data. It is important to note that this information will not be linked to your personally identifiable information such as your name, address, or e-mail address. This de-identified (coded) information will be stored in “dbGAaP,” which is a controlled repository run by the U.S. National Institutes of Health (“NIH”). As part of these repositories, your de-identified information may also be made available by the NIH to other qualified researchers studying genetic indicators of medical conditions, if those other researchers sign a contract with the NIH promising not to try to identify or contact you.

What Personal Information can I access?

Through the Study platform, you may access the following information you’ve provided to us: name, mailing address, and email address.

When you update information, however, we may maintain a copy of the unrevised information in our records to track the data entry into the Study. The information you can view and update may change as the Study undergoes further development. Please note that any information that is automatically saved as part of the Study (e.g., dates and times a survey is completed) cannot later be changed or updated. If you have any questions about viewing or updating information you have provided to us, please contact us using the contact information below.

What choices do I have?

If you join the Study, you can choose not to answer any question that makes you feel uncomfortable or that you do not want to answer. However, some questions are needed to allow you to continue further in the Study. You can also withdraw from the Study (Phase I or Phase II) at any time by emailing the UNC researchers at momgenes@unc.edu. When you withdraw from Phase I of the Study we will remove your Personal Information from the Study databases and, if you participated in and withdraw from Phase II of the Study, we will remove your DNA and genetic information from the UNC repository, though we may not be able to remove your de-identified information from research or publications that have already happened. If you withdraw from Phase II, we will also make efforts to remove your de-identified genetic results from the NIH repositories and ask the NIH to instruct other researchers who may have obtained controlled access to it to not include your data in their research though, again, this may not be able to affect the inclusion of your de-identified information in research that has already happened.

Re-Contact

As part of the Informed Consent process, we will ask if we can recontact you once the Study is over. To do this, we may use your Personal Information to contact you in the future, sometimes just to make sure we know your contact details are still accurate, sometimes to ask if you would be willing to participate in additional research opportunities. We will may do this a few times per year.

Effective Date and Changes to this Privacy Policy

This Privacy Policy is effective as of April 16, 2025. We may amend this Privacy Policy from time to time in our good faith discretion. New versions of this Privacy Policy are effective when they are posted to our website at the following link: http://www.momgenesfightppd.org/privacy-policy/. Use of information we collect now is subject to the version of the Privacy Policy in effect at the time such information is used.

Questions or concerns?

If you have any questions or concerns regarding the topics addressed in this Privacy Policy, please send a message using the contact information below.

Contact Information
Email: momgenes@unc.edu

Address:
Attention: MomGenes Study Team, c/o Dr. Guintivano
University of North Carolina at Chapel Hill
Department of Psychiatry, Campus Box #7462
Chapel Hill, NC 27599