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Welcome to the Survey

Information Sheet & Consent Form

Thank you for your interest in participating in the research study on the efficacy of the Flo app in improving health literacy, self-reported symptoms, quality of life and productivity at work in women with moderate to severe premenstrual symptoms.

About the investigational Flo application
Flo is a women’s health application with a mission to help girls, women and everyone who menstruates better understand their cycle and overall health. Flo offers multiple product functionalities, such as symptoms tracking throughout the menstrual cycle, period and ovulation predictions, chatbots that can be used to explore a variety of health topics and an anonymous community forum.

Your participation will allow Flo Health UK Limited (hereinafter “Flo Health”) to determine and analyze self-reported health benefits related to the use of our app. We want to know how Flo Health helps you to manage your PMS/PMDD symptoms, improve your mood, well-being and productivity at work, as well as your knowledge regarding PMS/PMDD and health behavior.  Read more about the study here. 
 
If you decide to participate, we will collect personal data such as: ethnicity, level of education and income, current reproductive health, diagnosis of health conditions, PMS symptoms, mood, work productivity and days of absence, overall quality and satisfaction with your life and wellbeing. In addition, we will collect your email address to link your survey data to Flo app usage data for the purpose of getting a better understanding of whether the level of engagement with the app influences the level of health benefits obtained. Providing the information is voluntary, but if not provided, you may not be able to participate in the study. 
 
During the research analysis stage your responses collected for the study will be aggregated and de-identified, meaning that you will not be personally identified from your responses. We might use this aggregated and de-identified data for research purposes and for creation of marketing materials with study results. You can read more about the types of research we do here. 

Information on personal data that is processed when the Flo app is in use can be found in Flo Health’s privacy policy here. Here, you can also find all information related to your privacy rights, retention terms, and security of your personal data. Your research records will be reviewed by the FDA and WCG IRB. We will never disclose your replies or sell your personal data to any third party. All surveys are being carried out through Survey Monkey. To read more about Survey Monkey and its privacy practices, you can do so here.

Study procedure
Eligibility will be assessed via a screening questionnaire (which includes questions about yourself, such age and employment status, as well as your PMS symptoms and your knowledge about them). Recruits will be split into two groups at random. The interventional group will use Flo to track and monitor their health and symptoms, the control group will just monitor their health and symptoms th
Risks
As in all studies, there are some risks associated with participating and providing your information. One of such risks is loss of confidentiality as a result of study participation (e.g., in case of a data security incident). There may be other unknown risks that you may need to consider as well.

Benefits
You are not expected to directly benefit from participating in this study. However, if you are randomized to be in the intervention group, you may experience some positive impact on your health literacy, self-reported symptoms, quality of life and productivity. Participants in the control group may experience the same at the end of the study when they will be provided with the Flo app. You will also be helping us further our understanding of PMS and its
impact on women’s health regardless of group allocation.

Alternative to study participation
This is not a treatment study.  Your alternative is not to participate in this study.

Questions
If you have questions, concerns, or complaints, or think this research has hurt you or made you sick, talk to the research team at the phone number listed above on the first page.
This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if: 
-You have questions, concerns, or complaints that are not being answered by the research team.
-You are not getting answers from the research team.
-You cannot reach the research team.
-You want to talk to someone else about the research.
-You have questions about your rights as a research subject.

Voluntary participation
Your decision to participate or to stop your participation at anytime during the study will have no penalty or loss of benefit to which you are otherwise entitled.

Withdrawal from the study
You may withdraw at any time by letting the study staff know your decision.  You may also be removed from the study without a reason by the study staff. If at any time you wish to remove yourself from the study and would like to request your personal data to be removed, please contact us at research@flo.health.

Payment for participation
Both control and interventional groups will get Flo Premium for 1 year. Control group will get Flo Premium only after the 3 months upon the study completion. Participants who completed the 3-month study will be invited to take part in a raffle with a chance to win up to $550 (550$ (1x); 500$ (2x); 250$ (5x); 100$ (10x); 50$ (13x)).

Compensation for Injury
If you feel that you may be injured as a result of study participation, contact the study staff on the first page of the consent form. Your study staff will refer you to treatment. You or your insurance company will be responsible for the costs of such treatment.

By choosing to complete the survey, you agree to Flo Health processing your sensitive personal data for the purposes of analysis as described above.

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* 1. I agree to the processing of my personal data under the above mentioned terms

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* 2. Statement of Your Understanding of the Information in this Consent Information Sheet:

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