1. Use Open Humans to store data, allowing participants to remove or change sharing permissions for data at any time.

2. Use a leather bracelet, sweatband or special tape to adhere the wrist button.

3. If you have a doctor you trust - discuss your participation with them. Think hard ahead of time about what you would like to learn from your data, and what potentially sensitive things YOU might learn about yourself.

4. We all have an investment in making this project ethically upright, and personally useful. Hopefully this translates into upstanding work on all our parts :).

5. If UC Berkeley does not have expressed interest in owning participant-led research, or any discoveries that come from it, it should be clear in the consent and the terms.

<-- Great point -- we currently say that the data will be destroyed (from Azure and UCB's hands at least) following the publication of the study. This fulfills that requirement in one way - but it doesn't address ownership of 'discoveries'. I think we have to be careful with the language here. I (Azure) draw the distinction between personal discoveries (which a participant makes from their own data) and generalizable discoveries (which are made from aggregating multiple individuals' data an assessing common patterns). The former are 100% the intellectual/physical property of the individual participant. I would argue that the later are shared discoveries. In terms of ownership via scientific publication , there is obviously a bias to saying the authors of the paper are the people who made the discovery -- even if other people are acknowledged in the publication. One solution would be to make every participant who wants to take academic ownership of the discovery an author who conforms to the ICJME standards for academic authorship. Another solution is to share the discovery (and its credit) in multiple formats - talks, conferences, blogs, magazine articles and scientific publications. As far as "who can legally make a company and get rich if we discovery X marketable facet of female physiology", I wont chase you down. I also wont seek to patent any algorithms or approaches to analyzing physiological data. The likelihood that anyone at the university would try to track you down is, I think, extremely small. More to come but I'm glad we're getting this conversation documented.

6. This level of transparency requires a "permission granted" of sorts, a profound trust that it's completely ok to be perfectly human, with all our "hidden" patterns, drives and behaviors.

CONSENT TO PARTICIPATE IN RESEARCH

Evaluate Biological Rhythms & Disruption in Relation to Academic Performance

Introduction

My name is Azure Grant. I am a graduate student working with Professor Lance Kriegsfeld and Professor Frederic Theunissen in the Department of Psychology and Helen Wills Neuroscience Institute at the University of California, Berkeley. We are planning to conduct a research study, which I invite you to take part in.

We are inviting you to participate in this study because you expressed interest in joining on a preliminary questionnaire.

Purpose

The purpose of this research study is to investigate the structure of ultradian (hourly), circadian (daily) and menstrual rhythms to identify features that are predictive of academic performance. Approximately 20 people (who may be non-students) at a time will take part in the initial pilot phase of the study; eventually we may enroll up to 250 student individuals.

Through a generous donation of devices, we have a chance to characterize interactions among sleep, daily rhythms, and menstrual rhythms, and their effects on academic performance at unprecedented resolution, using the commercially available Oura Ring wearable device. In the past, our group has published impacts of sleep-and-circadian-rhythm instability on academic performance, using indirect measures such as journals and online activity as a proxy for activity phase (Smarr 2015, Smarr and Schirmer 2018).

We aim to extend our findings to make within-individual predictions by utilizing these high temporal resolution physiological outputs. This will provide a much more detailed, within-person characterization of biological rhythms and may permit personalization of our previous predictive analyses.

Procedures

If you agree to be in this study, you will be asked to do the following:

Before you begin the main part of the study:

You will need to have the following screening tests/procedures to find out if you can be in the main part of the study. These procedures will occur after submitting this consent form. For the pilot portion of the study, you must be assigned-female-at-birth. For the academic performance segment of the study, you must be a current full-time student at UC Berkeley and have an iPhone or Android smart phone.

At the beginning of the study, we will request your name, email, phone number, sex assigned at birth, and student id number. We will also ask you if you have an iphone or an android (which are necessary for participation), and if any of your next-semester courses will use bcourses.

If the screening shows that you can be in the study and you choose to continue, this is what will happen next:

During the main part of the study:

This study involves wearing a non-invasive, wearable device to collect skin temperature, inter-beat interval, and activity data. The wearable device is a small, hypo-allergenic ring that requires charging ~ once per week and is paired with an app. It will collect your: activity (steps), body temperature, inter-beat-interval (for calculation of heart rate and heart rate variability).

If you have a menstrual cycle and participate in phase one, we will request that you keep track of your dates of menstruation using a tracking form provided for the study.

Please review the Oura Ring Terms of Use before signing this form: https://ouraring.com/terms-of-use/ . Most notably, the terms of use state that you may request that Oura delete your data at any time, but that Oura will lose control of your data if they are acquired by another company in the future.

Open Humans will be used to access and organize your data, but you may opt out of using this service if you wish. Open Humans is useful because it allows you to remove your data at any time during the project should you wish to cease participation. Please read the Open Humans terms of use at: https://www.openhumans.org/terms/ before signing this form. These terms of use state that you may delete your Open Humans Data at any time. Our project will be listed as “private” on Open Humans, meaning that the data you store there will be only visible to you and to me.

Please see the Risks section of this form for more information on risks associated with data collection by third parties (in this case, Oura Ring and Open Humans).

Additionally, if you are a student you will have academic performance paired with your Oura Ring data. We will request access, via your student ID, to your course performance-related data, specifically your midterm grades, final grades, assignment grades, and bcourses login activity for the semester of the study from the campus educational technology services (ETS) and Office of the Registrar staff. These data will be extracted by the ETS/Registrar staff.

Finally, we may request to interview you at the finale of the study about your experience. These interviews would be audio-recorded. If you decide to conduct an interview with me, it will take place at a time and location of your choice. The interview will involve questions about your satisfaction with your participation in this project, and any suggestions you have to make future projects better. It should last about 30 minutes. With your permission, I will audiotape and take notes during the interview. The recording is to accurately record the information you provide, and will be used for transcription purposes only. If you choose not to be audiotaped, I will take notes instead. If you agree to being audiotaped but feel uncomfortable or change your mind for any reason during the interview, I can turn off the recorder at your request. Or if you don't wish to continue, you can stop the interview at any time.

The study will be concluded when devices will be collected/offered for purchase. You may withdraw your participation at any time. There will be no monetary penalty if the device is broken, but we do ask that you treat the equipment respectfully.

Study time

Participation in this study will involve a total of 20 minutes per week of your time for charging your device, for 3-6 months if you join the pilot (the length of three of your ovulatory cycles determines the duration of your participation), or 6 months (one semester) if you join the academic performance phase. The beginning of the study may be more time intensive, up to 1 hour per week for the first three weeks due to onboarding/device use training. Onboarding includes communicating with study leader Azure Grant, and reading the Oura website, which explains how to use your device.

Study location

All study procedures will be self-administered by you, the participant. You will be asked to wear the device(s) you are loaned, to sync them with your phone daily, and to charge them every one to two weeks.

Benefits

· You may benefit directly from this study in the following ways:

-You will have a better understanding of how your biological rhythms change under different conditions (flu-season, holiday travels, relaxing time, stress, ovulatory cycle phase). This may result in personal learning about the potential value of schedule stability.

- You will have access to a state-of-the-art wearable sensor, app, and associated cloud platform.

- You will have access to your own high-temporal resolution heart rate, body temperature, and other physiological data.

- You will have access to research expertise on building personalized analyses of these physiological markers. The researchers are open to carrying out analyses based on interests of the participants, and participants are encouraged to bring their questions to the project. (E.g., a participant may request I plot their data and label times they did some significant event, like running a race.)

- You will obtain a several month "snapshot" of your biological rhythms. This is a "dynamic baseline" to which one's future biomarkers could be compared.

- You will be able to delete your data/halt participation at any time. Your data can be deleted by logging into your Open Humans account and clicking “delete data”.

· We hope that the information gained from the study will help...

a) Provide the most detailed description of within-individual physiological networks ever collected.

b) Generate personalized, predictive estimates of academic performance based on individual network parameters.

c) Provide the most detailed description of within-individual physiological change across the menstrual cycle, which may incidentally provide non-invasive estimates of menstrual cycle phase.

d) Provide a mutual exchange of knowledge between researchers and individuals curious about their own physiological dynamics.

Risks/Discomforts

· Risk is minimal. The device chosen for this study is small, non-invasive, hands-free, can easily be placed on and removed off, and requires minimal technical training to utilize appropriately.

· As is possible with the use of any wearable device, some participants may become aware of less-than-optimal physiological states (e.g., high overnight heart rate, low number of steps per day,), which may cause some participants anxiety. The Oura ring or app does not offer medical advice, and nor will the researchers. You will be encouraged that as this is one of the largest scale studies to be conducted with continuous data of these types, it is not actually known what patterns are normal and what patterns are definitely a cause for concern. The project is not intended to diagnose any condition, nor is the device vetted to do so.

· In any study involving a wearable device manufactured by a private company, data ownership and security are at risk. We ask that you read the brief terms of use and privacy policy provided by Oura at http://ouraring.com.These terms state that you as a participant have the right of erasure and access to your personal data, but, as is typical of such agreements, that terms may be changed in the future by the company. We ask that you consider these terms before deciding to participate.

· Please read the Open Humans Terms as well. We believe that risks are minimal with Open Humans, as your data will be de-identified (the only key will be held by me) before being transferred there by Oura. The benefit of you being able to delete your data at any time, we believe, outweighs the risk of breach of anonymized data. https://www.openhumans.org/terms/

· Breach of confidentiality: As with all research, there is a chance that confidentiality could be compromised - e.g., in the bcourses system (course performance learning management system) or Oura Ring or Open Humans. however, we are taking precautions to minimize this risk.

· All risks are deemed minimal and unlikely.

Confidentiality

Your study data will be handled as confidentially as possible. If results of this study are published or presented, individual names and other personally identifiable information will not be used.

To minimize the risks to confidentiality, we will do the following:

· We will not maintain a link between your identity and the research data past the end of the data analysis period.

· Personal identifiers will be removed after the data collection period

· Your research records, including oura ring data, will be stored in an encrypted format on the Oura Cloud and Open Humans Platform, and will be analyzed on a password-protected computer by the project organizers. Your data can be removed from Open Humans by you at any time.

· This study is marked as "private" in Open Humans, meaning that only the study participants and myself can access/download the data.

· You can decline to use Open Humans simply by notifying me you don’t want to use the platform, in which case I will provide your Oura device’s ID code to an engineer at Oura who will personally email me the data.

· Academic Performance records will be obtained only at the end of the study, and will be delivered to researchers to UC Berkeley Educational Technology Services staff. These data will be encrypted, and analyzed on a password-protected computer by the researchers before being deleted.

· Only myself, Dr. Benjamin Smarr and faculty advisor Lance Kriegsfeld have access to your de-identified study records.

· Only I will have access to your labelled (identified) data. This will allow me to match your academic performance or dates of menstruation data with your Oura Ring data.

We will keep your study data as confidential as possible, unless it is certain information that we must report for legal or ethical reasons, such as child abuse, elder abuse, or intent to hurt yourself or others.

Future use of study data:

The research data will be deleted from the researchers’ possession at the end of the study, following write up of the results.

Compensation/Payment

You will not be compensated for your participation in this study.

Costs

You will not be charged for any of the study activities.

Rights

Participation in research is completely voluntary.

You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.

Questions

If you have any questions or concerns about this study, you may contact Azure Grant at 530 592 9174 or azuredominique@berkeley.edu. Or you may contact Benjamin Smarr, the study partner, at smarr@berkeley.edu.

If you have any questions or concerns about your rights and treatment as a research subject, you may contact the office of UC Berkeley's Committee for the Protection of Human Subjects, at 510-642-7461 or subjects@berkeley.edu.

Consent

You have been given a copy of this consent form to keep.

If you wish to participate in this study, please sign and date below.

_______________

Participant's Name (please print) Date

_______________

Participant's Signature Date

Azure Grant

_______________

Person Obtaining Consent Date