General Questions
What is the Apple Women’s Health Study?
The Apple Women’s Health Study is the first long-term research study of this scale and scope that aims to advance the understanding of menstrual cycles and their relationship to various health conditions including infertility, menopause, and health across the lifespan using data collected with a mobile application.
Why is this study being done and why should I participate?
Certain behaviors and habits could have an impact on menstrual cycles and gynecologic health conditions including infertility, menopause, and polycystic ovary syndrome (PCOS). This study aims to advance the understanding of the relationship between menstrual cycles, health, behavior, and habits. This will also help inform development of new products for menstrual cycles, as well as early screening and risk assessment of gynecologic conditions.
How does this study work?
You can participate in this study with your iPhone and the Apple Research app. The study will ask you to:
- Provide your consent to collect data from your iPhone and Apple Watch (optional), such as your Health app data, medical history data, sensor data, and other device/Apple Research app related data.
- Complete occasional, short surveys to help researchers understand the relationship between your menstrual cycle, health, behaviors, and habits.
- If you are menstruating, track your menstrual cycle in the Health app with Cycle Tracking or any other menstrual cycle tracking app that writes your data to the Health app.
Who is the sponsor of this study?
Apple.
Who are the principal investigators of this study?
Dr. Michelle A. Williams, Dr. Shruthi Mahalingaiah, Dr. Russ Hauser, and Dr. Brent Coull from Harvard T.H. Chan School of Public Health are the principal investigators of this study and have a team dedicated to this research. They have unparalleled expertise in reproductive epidemiology and women’s health.
Who are the research collaborators of this study?
Harvard T.H. Chan School of Public Health, National Institute of Environmental Health Sciences (NIEHS) and Apple are collaborating to conduct this research. NIEHS is part of the National Institutes of Health (NIH).
How long will this study last?
This study is envisioned to span decades. You can withdraw from the study at any time.
What is the last day I can join this study?
You are welcome to join this study any time, as long as you meet the participation requirements.
Will I be able to see the results of this study?
As study findings are published (for example, in a scientific journal), they will be posted on ClinicalTrials.gov. Note that your name and other directly identifying information will not be used in any study results.
Participation Requirements
Who can participate in this study?
Anyone who meets all of the participation requirements may participate:
- You have menstruated at least once
- You are at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico)
- You live in the United States of America
- You are comfortable communicating in written and spoken English
- You have installed the Apple Research app on your iPhone
- You do not share your iCloud account or iPhone with anyone else
- You are willing and able to provide informed consent to participate in the study
Is this study restricted to people who are currently menstruating?
No. You are eligible to enroll and participate in this study if you have ever menstruated at least once.
I am transgender, can I enroll in this study?
Yes, you can enroll if you have menstruated at least once, even if you are not menstruating now.
I am pregnant, can I enroll in this study?
Yes, you can enroll if you are pregnant. You can also continue participating if you become pregnant during the study.
I have reached menopause, can I enroll in this study?
Yes, you can enroll if you have menstruated at least once, even if you are not menstruating now.
Is this study available in languages other than English?
The study is currently only available in English.
Can I use a friend or family member’s iPhone to participate?
No, you can only use your own iPhone with your own iCloud account. This is to ensure data integrity and confidentiality.
Can I participate in the study if I have family sharing setup for my iCloud account?
Yes, if you have family sharing setup for your iCloud account, you can still participate in the study. Visit the support page to learn more about family sharing.
Do I need an Apple Watch to participate in this study?
No, an Apple Watch is not required to participate in this study.
Can I enroll if I am already participating in another research study?
Yes.
Procedures
How do I enroll in this study?
You will need to download the Apple Research app from the App Store and install it on your iPhone. In the Research app, you’ll find the studies you can enroll in. You will need to select the Apple Women’s Health Study and go through the introduction and consent process.
What will I be expected to do if I participate?
You will be asked to provide your permission to collect your cycle tracking and other health data (such as steps taken and flights climbed). You will control exactly what data you share. You will also be asked to complete surveys that will help researchers understand the relationship between your menstrual cycle, behaviors, and habits.
If you are currently menstruating, you will also be asked to track your menstrual cycle. You can do this in the Health app with Cycle Tracking or any other menstrual cycle tracking app that writes your data to the Health app. Visit the support page to learn more about how to add data from other apps to your Health app.
An Apple Watch is not required for this study. If you own an Apple Watch, wearing it will provide additional information to enhance your contribution towards the study.
What is the Cycle Tracking feature in my Health app?
The Cycle Tracking feature on Health app allows you to log details about your menstrual cycle including flow information and symptoms such as headaches or cramps. You can also track your menstrual cycle using the Cycle Tracking app on your Apple Watch. Visit the support page to learn more about how to track your period with Cycle Tracking.
What happens if I become pregnant, have a gender affirming surgery or stop menstruating?
You can continue to participate in the study even if you become pregnant, have a gender affirming surgery or stop menstruating.
What happens if I have health issues while participating in the study?
Participation in this study is not a substitute for medical care or the medical advice you get from your doctor or other health care provider. You should continue to see your regular doctor and keep any scheduled physical exams, screening procedures, and medical appointments. Always seek professional medical advice whenever you need it.
Do I have to sign an informed consent form?
Your participation in the research study is voluntary. In order to participate in the study, you have to sign an informed consent form. The informed consent form will be available for you to read and sign in the Apple Research app. If you choose to join the study, a copy of your signed informed consent form will be made available to you in the Apple Research app as well.
What happens if I change my mind about being in this study?
You can stop participating in the study at any time by opening the Apple Research app, tapping on the Studies tab, and then selecting the Apple Women’s Health Study. “Withdraw from this study” appears at the bottom. If you withdraw, we will not delete study data that we have already collected about you, but we will stop collecting any new information about you and will turn off further notifications. If you delete the Apple Research app, you will not be withdrawn from the study.
Participation
Will participation in this study cost me anything?
There is no direct cost to you for participating in the study. There may be an indirect cost because the data collected as part of the study and transmitted to the study team will count against your phone’s data plan. Additionally, standard phone usage rates may apply if you communicate with study staff via phone.
This study does not provide medical care, and the sponsor and the research team are not financially responsible for any treatment you seek from your own health care provider.
Do I get compensated for my time involved in this study?
No, you will not be compensated for taking part in this study.
What are the potential benefits associated with this study?
You will not receive any direct benefits from taking part in this study. However, your participation may help researchers advance the understanding of the menstrual cycle and gynecologic health conditions. The findings from this study may help others in the future.
Privacy
What data will be collected?
With your permission, the study may collect or access data such as:
- Contact information such as your name, email address, and phone number
- Demographic information such as your date of birth, race/ethnicity and gender identity
- Health app data such as menstruation flow, steps taken, and flights climbed
- Clinical health records data such as medications, family history, and health conditions
- Sensor and usage data from your iPhone and Apple Watch (if applicable) such as how frequently you wear your Apple Watch and number of study related tasks completed within Research app
- Claims data such as hospitalizations, health conditions, medications, and procedures
- Survey responses such as menstrual status, health behaviors, and medical history.
You control what data you share and can stop sharing data with the study at any time.
Please refer to “What data will be collected?” in the informed consent form for more information on the specific data types that may be collected.
You can also view and manage the types of data you share with the study in the Research app by tapping the Your Data tab. Some data types may be modified over time. For example, the Sleep data type was updated in September of 2022 to include sleep stages.
How do I share data with the study?
Data will only be shared with the study after you provide your permission and complete the consent forms to enroll in the study. Once you have enrolled in the study, the study will begin to collect the types of data you have permitted.
How will my data be protected?
Any information collected or accessed by the Research app is stored with encryption if you have a passcode on your iPhone. Information from the Research app will be shared with the study only after you have joined the study by signing the informed consent form, and have authorized the study to collect or access information in the Research app. Your information will be encrypted when transferred to and stored on Apple’s servers that are designed to meet the technical safeguard requirements of the Health Insurance Portability and Accountability Act (HIPAA).
Is this Study covered by a Certificate of Confidentiality?
The Apple Women’s Health Study has recently been granted a Certificate of Confidentiality by the National Institutes of Health providing additional privacy protections for the Study. This means researchers cannot release information that may identify you in any regulatory or legal action unless you say it is okay. This protection covers federal, state, civil, criminal, administrative, legislative, and other proceedings, such as court subpoenas or lawsuits.
The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from accessing or sharing your own information. Researchers may also still release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers, or any other persons not connected with the research.
Your identifiable data can only be released by Study researchers in a few additional circumstances. For example, researchers are still required to comply with federal, state, or local laws that require reporting in certain instances. These include laws that require reporting of child or elder abuse, some infectious diseases, and threats to harm yourself or others. Researchers may also still disclose information about the Study and participants to organizations who are responsible for oversight of safe research practices such as the Study’s Institutional Review Boards (IRB), the Food and Drug Administration (FDA), and agencies with the United States federal or state governments.
Who will have access to my data?
Only certain authorized people and institutions will have access to the study data. These include Apple (the sponsor), the Harvard T.H. Chan School of Public Health, the National Institute of Environmental Health Sciences (one of the National Institutes of Health), and the Research Studies Support Center (operated by Apple’s third-party service provider). Advarra Institutional Review Board and certain regulatory or government agencies (such as the Department of Health and Human Services) may also have access to the study data under certain circumstances.
Study data that directly identifies you (such as your name, email address, and phone number) will be kept separate from the rest of your study data and replaced with a random code that is unique to you, but which is not based on any information about you. Most authorized people and institutions will only have access to Research app data with directly identifying information removed. However, identifiable information will be made available to a limited number of study staff at the Harvard T.H. Chan School of Public Health who need this to administer the study, or to the Research Studies Support Center if you reach out for support. When required by law, legal process or litigation, study data in identifiable form may also be made available to the Advarra Institutional Review Board and certain regulatory or government authorities.
Please refer to “Who will have access to my study data?” in the informed consent form for more information about who has access to the study data and what types of study data they may access.
Will Apple have access to any information that directly identifies me or know that I’m participating in a study?
Apple will not be able to access any information that directly identifies you (such as your name, email address, and phone number) that is collected through the Research app.
However, if you call the Research Studies Support Center regarding a technical issue with the Research app, the Research Studies Support Center may ask you if you want to be transferred to AppleCare for additional support. With your consent, you may be transferred to help address your technical question(s), in which case Apple may have access to certain information that directly identifies you and may know that you are participating in a study.
Apple Research App
What is the Apple Research app?
The Apple Research app can be used to find available Apple research studies, understand the goals of the study, see the data it will collect, and enroll and participate in the studies by providing consent.
How do I install the Apple Research app?
You can install the Apple Research app by searching for it in the App Store on your iPhone.
How can I control the notifications from the Apple Research app?
Notifications from the Apple Research app can be controlled in your iPhone by going to: Settings > Notifications.
What happens if I upgrade or downgrade my iPhone?
Please ensure that you backup your iPhone information, and then restore from backup in order to prevent loss of any information. Visit the support page to learn more about how to backup your iPhone information.
If you do not backup your iPhone information, and wish to continue to participate in the study, you will need to complete the onboarding and consent process for the study again. If you have iCloud Keychain enabled, your participant identifier may be preserved, allowing researchers to link your previously collected data with the new data after you re-join.
What happens if I delete the Apple Research app?
If you delete the Apple Research app, it will disable notifications and end all study data collection. Please note that deleting the Apple Research app will not withdraw you from the study.
If you re-install the Apple Research app after deleting it and wish to continue participating in the study, you may complete the onboarding and consent process for the study again. If you have iCloud Keychain enabled, your participant identifier may be preserved, allowing researchers to link your previously collected data with the new data after you re-join.
Contact Information
Who can answer my questions about this study?
If you have questions about the study that are not covered by the FAQs or you think you have an injury or illness as a result of the study, please call the Research Studies Support Center at 833-237-3881 (a toll-free number staffed during business hours, Pacific Time (PT)).
The Research Studies Support Center is hosted by Apple’s third-party service provider and is staffed by employees of the service provider who are trained to handle study issues and certain technical issues related to the Research app. Please do not reach out to Apple directly with any questions about the study.
If you experience a technical issue related to the Research app, the Research Studies Support Center may ask you if you want to be transferred to AppleCare for additional support.
Who should I contact for medical emergencies?
For medical emergencies, please call 911 or local emergency services.
What is an IRB? How can I contact it?
An institutional review board (IRB) is an independent research ethics committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact:
- By mail: Study Subject Adviser, Advarra IRB, 6100 Merriweather, Suite 600, Columbia, MD 21044
- or call toll free: 877-992-4724
- or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser at Advarra IRB: Pro00037562.