The University of Queensland ("UQ") is committed to providing notice about the Personal Information (defined below) collected via the PPD ACT research study mobile application ("App"). The formal name of the research study is the "Genomics of Postpartum Depression - Action towards Causes and Treatment," and it is organized by the PACT Consortium and sponsored by The University of North Carolina at Chapel Hill (UNC), with UQ leading the Australian study (the "Study"). To participate in the Study you will be required to sign a consent to participate ("Informed Consent").
The App will be used in different ways for two phases of the Study:
The App is available to you for free however you may incur charges in downloading the App.
You will not need to provide any payment information for the use of the App.
We are not asking you to make any health decisions based on the use of the App. You should discuss health decisions directly with your healthcare provider.
We agree to comply with all laws and applicable codes of conduct in relation to use of the data under the Information Privacy Act 2009 (Qld).
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 Australia and are 18 years old or older. In the event that we gain actual knowledge that we have collected Personal Information from a child 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.
The purpose of the Study is to understand genetic risks of PPD and PPP. Phase I of the Study must first identify if you are eligible to participate by asking your comfort with using the English language on your smart device, gender, age and whether you have given live birth. If you are eligible to participate and you sign the Informed Consent, the Study will collect (through the App) personally identifiable information about you such as name, address, and email address. The App will also ask you about your pregnancy history and mood following childbirth, including questions about medical history and your psychological symptoms (e.g. anxiety) in the postpartum period.
If you provide the above-described Personal Information and it is determined that you experienced PPD or PPP, you may be asked through the App and by email if you would like to participate in Phase II of the Study. Please note that in Australia, Phase II of the Study is currently under consideration.
Should Phase II proceed, Phase II involves you submitting a sample of DNA (collected from saliva you spit into a collection tube we mail to you) to help researchers determine how genes affect the development of PPD and PPP. You would be required to complete a second Informed Consent to participate in Phase II. With your Informed Consent, your DNA sample will be used to measure 500,000 or more genetic markers (or "signposts"). We would like to search for new genetic differences that women with postpartum depression and postpartum psychosis might have.
You may choose not to provide us with certain information. You have the chance to skip any questions in the App 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 UQ, or the wider international study.
The App includes two tools that automatically collect certain information beyond that which you affirmatively provide. One tool collects information about crashes (Crashlytics) and one about use of the App (iTunes Connect). These tools work on an anonymous basis, without collecting personally identifiable information. Through these tools, the App 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 App. We may internally use this information to understand, customize and generally improve user experience with the App and the Study.
Once you provide Informed Consent in the App and enroll in the Study (if eligible), you will receive push notifications regarding the Study. "Push Notifications" are messages that are sent to your smart device within the App. Push Notifications may be sent to ask you to complete questions in the Study after your initial enrollment. You will also receive Push Notifications when we update the App with new questions or features asking you to complete these tasks and surveys, and the information you provide in response will be used and treated the same as other Personal Information you might provide in Phase I of the Study.
The App will also send you Push Notifications and an email (to the email address you provide) throughout your participation in the Study, as necessary, to try and make sure that you know any new information gained during the Study that might affect your willingness to continue to participate. You can choose to receive or not receive updates about the Study and you have the option to control notification settings on your smart device (for example, to turn off any audible notification tone). Lastly, the App may send you a Push Notification and an email to invite you to participate in Phase II of the Study.
All information that is collected through the App will be encrypted through encryption methods currently used at UNC in the United States of America and sent to a protected data server behind UNC's firewall. The encrypted data will be passed to UQ and sent to a protected data server behind UQ's firewall. The decryption key will be held by UQ and decryption of the data will be conducted at UQ. If Phase II of the Study proceeds, and if you participate in Phase II of the Study, your DNA sample and genetic data will also be stored in a protected way at UQ.
UQ will replace the personal information identifiers (or information reasonably identifiable) formation you provide - like your name and address - with a code to help protect your identity. UQ 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.
UQ researchers will keep your Personal Information indefinitely, except if you withdraw from the Study, in which case your Personal Information, will be destroyed from UQ's records and repository. The only people who will have authorized access to the code set with your individual identity are UQ 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. UQ may also share your re-identified Personal Information with others at UQ 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 App on your smart device may be protected by a biometric authentication mechanism (such as Touch ID) or a passcode. You should take these or other steps to prevent unauthorized access to your smart device by protecting and limiting access to your smart device. We strongly recommend that you always use the most updated version of the operating system for your smart 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.
The information collected by the App 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 UQ research team. We intend that the only time your identifiable information will be shared outside of UQ 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 UQ or the public.
Through the App, 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 App undergoes further development. Please note that any information that is automatically uploaded from the App (e.g., dates App used) 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.
You may choose not to install the App. If you choose not to install the App, you cannot participate in the Study.
If you join the Study, you can choose not to answer any question in the App that makes you feel uncomfortable or that you do not want to answer. You can also withdraw from the Study (Phase I or Phase II) at any time by emailing the researchers at firstname.lastname@example.org. When you withdraw from Phase I of the Study we will remove your Personal Information from the Study databases, though we may not be able to remove your de-identified information from research or publications that have already happened.
Once the Study is over, 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, including Phase II of the study. We will probably do this a few times per year.
By downloading and using the App, you agree that you will not do anything to interfere with or disrupt the operation of the App, will provide only accurate and current information through the App, and will not impersonate anyone else in your use of the App.
You further agree not to transmit content that you do not have the right to transmit or that infringes the rights of any party, and you agree to use the App in compliance with all applicable laws. You understand that the App or portions of it may be subject to patent, copyright, trademark and other intellectual property protection and that the ownership of software and other intellectual property related to the App, as well the goodwill associated therewith, remains with UNC or its licensors. You agree that any improvements or other changes to the App or the Study itself are the sole property of UNC or its licensors.
Address: Queensland Brain Institute
Attention: PPD ACT Study Team, c/o Professor Naomi Wray
The University of Queensland