INFORMED CONSENT AND RELEASE
Study Title: <<Trifolium>>
Study Lead Researcher: <<Hasan Shibly>>, <<firstname.lastname@example.org>>
This is a voluntary study undertaken by Lionbridge (“Research Company”) on behalf of Apple Inc. (“Study Sponsor”).
WHAT IS THE PURPOSE OF THIS CONSENT?
You are receiving this Informed Consent Form (“Consent”) because you have been asked to participate in a voluntary research study. This Consent is intended to inform you of:
- The purpose of this study and what you will be asked to do as part of this study;
- The information that may be collected from you as part of this study and how your information will be used or disclosed in the study;
- The potential risks and discomforts associated with this study; and
- How you may withdraw from the study and what happens to your information after you withdraw.
Your decision to participate in this study is completely voluntary and you may decline to participate or stop/withdraw your participation at any time. If you do not take part in the study, you will not lose any benefits to which you are otherwise entitled. You do not have to sign this Consent, but if you do not, you will not be able to participate in this study.
This Study may involve participants who are under 18 and therefore may not have the capacity to legally consent to take part in this Study. When the participant cannot legally consent to part in the study, the pronouns “you” and “yours” should be read as referring to the participant and not the person (the parent/guardian) who is signing this Consent for the participant.
PLEASE READ THIS CONSENT CAREFULLY BEFORE SIGNING IT.
WHY IS THIS STUDY BEING DONE? The objective of this study is to collect information, including video images such as video of participants walking, moving their hands and fingers, and clapping, that will enable the Study Sponsor to better understand how to design and develop its products, technologies, and services.
WHO CAN PARTICIPATE IN THIS STUDY?
Before entering this Study, you must meet all of the following criteria:
- You must be at least 13 years old and no older than 60 years old;
- You must have your own device that captures videos at a minimum 12MP resolution;
- You must have some props to hold in your hands such as a pen/pencil/mouse, sports ball, dolls, gloves, sunglasses, or other props as may be requested by the Research Company; and
- You must be able to comfortably complete the procedures in this Study.
WHAT WILL HAPPEN IF I TAKE PART IN THIS STUDY?
Intake / Receipt of Instructions (5 – 15 minutes):
- Before you begin your data collection, you will be provided with this Consent, which explains what data you will be asked to collect and why. Please review this Consent carefully and feel free to ask questions.
- A member of the study team from Research Company will provide you with additional instructions regarding what activity(ies) to perform and how to capture the video and provide it to Research Company.
- You will be asked to undertake the data collection for the study with another participant living in your household who you will designate and who will also sign a separate but identical Consent (the “Partner Participant”).
Video Capture (1-2 minutes):
- You will be asked to work with your Partner Participant to capture a video while performing particular actions, such as walking, moving your hands and fingers, clapping, or extending/contracting your arms. Please perform any actions as naturally as possible.
- You may be asked to capture a few (up to 15) videos with specific variations, including: different camera angles, in different lighting scenarios (i.e., indoors/outdoors, night/day, bright light/low light), at various distances from the camera, while moving your hands and arms at varying speeds (i.e., fast or slow movement), while wearing gloves or interacting with other props, with front and back-facing camera, while moving in front of the camera away and towards the camera, using a sports ball to perform actions of playing the sport, wearing face masks or other face covering with or without sunglasses or (in some cases) while interacting with your Partner Participant.
- Each video will be approximately 30 seconds in length.
Video Upload (1-2 minutes):
You will be provided with instructions to upload the video to Research Company.
WHERE WILL THIS STUDY TAKE PLACE? You can record the video in any setting in which you feel comfortable, and where you can make sure that the video only captures images of you and your Partner Participant, and no one else, per the directions you receive. You should ensure that you do not capture any images of any other individuals other than yourself and your Partner Participant. You should also information about yourself or your Partner Participant is captured on the video: (i) ensure that your chosen setting does not include items that could directly identify you or the Partner Participant (e.g. readable address or name, photographs of family on walls, prescripton medication bottles) and (ii) take care to remove any personal items from plain view that you do not want recorded (e.g. sensitive photographs).
HOW MANY PEOPLE WILL PARTICIPATE IN THIS STUDY?
The overall study is targeting enrollment of approximately 1,000 participants.
HOW LONG WILL MY PARTICIPATION IN THIS STUDY TAKE? The actual video capture you will be asked to undertake for the study will take between 1 and 2 minutes, but the entire time required for you to capture the images may take ten (10) minutes or so, depending on how long it takes you to setup to take the video and how many videos you choose to contribute.
WHAT DATA WILL BE COLLECTED? As part of this Study, certain information will be collected from you (we call this “Study Data”) and used as described in this Consent. Study Data includes the following:
- Contact Information: <<Lionbridge AI, email@example.com>>)
- Video/Photo: Full video of your body, including your face (with or without face-coverings / sun-glasses / sports balls) performing the actions listed above. . The Study Sponsor will receive these images but will not use the images of your face to identify you or to develop algorithms to identify you or others. Additionally, while your video may capture incidental audio, the Research Company will remove the audio portion prior to storing the Video images.
- Biometric Data: As stated above, the video you capture will include images of your face, and in certain circumstances, there is the slight possibility that the video images you collect could incidentally include images of your fingerprints. The Study Sponsor does not intend for the fingerprint images to be collected and will not use your face images or those of your fingerprints to identify you or to develop algorithms to identify you or others. Additionally, the Research Company is required to try and blur any fingerprint images that they see on the video you submit.
- Demographic Data: city, state, country, Race/Ethnicity and Skin type (which will be assigned by the Study staff based on the Fitzpatrick scale)
How will my Study Data be kept confidential? Who will have access to my Study Data?
Your Study Data will be kept confidential except if disclosure is required by law or as described in this Consent.
Your Contact Information will be held securely by the staff of Research Company that is conducting the study (“Study Staff”) and access to it will be limited to those Study Staff who need access in order to administer and conduct the study. Your Contact Information and other directly identifying information, if any, will be separated and maintained securely apart 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 (we call this “Coded Study Data”).
The Study Sponsor will receive the Coded Study Data and will not have access to any of your Contact Information or other Study Data that may directly identify you, except as stated below.
Although all Study Data that identifies you will be protected and treated as confidential, total confidentiality cannot be guaranteed. It is possible that members of the Study Sponsor could identify you just from your Coded Study Data (for instance if the Coded Study Data includes video images of you), or there could be unauthorized access to, or security breaches of, the systems used to store your Study Data. If you are in multiple studies, your Study Data may be combined and there is a risk that you may be identifiable. There may be other privacy risks that we have not foreseen.
For more information on how Study Data will be kept secure and confidential, please contact the Study Lead listed above.
USE, DISCLOSURE, AND DELETION: In addition to the Study Staff of Research Company and the Study Sponsor, your Coded Study Data may also be reviewed or used by:
- Third-party service providers of Research Company where such service providers have signed appropriate contracts to protect the study data and use it only for the purposes of the Study Sponsor;
- Affiliates and third-party service providers of the Study Sponsor, where such service providers have signed appropriate contracts to protect the study data and use it only for the purposes of the Study Sponsor.
When required by law, legal process, or litigation, Study Data in identifiable form may also be made available to the Study Sponsor or government authorities, including law enforcement.
How may my Study Data be used?
By signing this Consent, you agree to allow the Research Company and Study Staff and third parties identified in this Consent to collect, use, store, analyze, disclose, and otherwise process your Study Data, including Coded Study Data, for the following purposes:
- To support and carry out the study.
- To verify that the study is done properly.
- For Research Company to contact you about future studies sponsored by Study Sponsor, if you agree to be contacted for such future studies.
In addition, the Study Sponsor may collect, use, store, analyze, disclose, and otherwise process your Coded Study Data for the following purposes:
- To analyze the Coded Study Data and publish aggregated results
- To design or improve future studies.
- To combine the results of this study with the results of other studies.
- For the Study Sponsor’s development, design, approval (including regulatory approval), improvement, production, publication, and/or support of products, technologies, processes, and services, including algorithm development for these purposes.
As stated above, when required by law, legal process, or litigation, Study Sponsor may also have access to Study Data in identifiable form.
INTERNATIONAL TRANSFER OF STUDY DATA.
Your Consent to Transfer. Study Sponsor is a global company with affiliates in many countries undertaking research and development. As a result, your Study Data (in the limited situations described above) and your Coded Study Data, may be transferred to Study Sponsor in the United States and other Study Sponsor related entities and third parties designated by Study Sponsor in other countries. These other countries may not have laws as protective as the data protection laws in the country where you reside. It is also possible that the country to which your Study Data or Coded Study Data is sent will have laws that permit the government to request access to data held by private companies, such as Study Sponsor; however, we do not anticipate such requests for your Study Data or your Coded Study Data. Regardless of the country where your Study Data and Coded Study Data are used and maintained by Study Sponsor, its affiliates, and its contracted third parties, it will be used and maintained only for the purposes described in this Consent and it will be protected as described in this Consent. If you do not want to permit your Study Data or Coded Study Data to be transferred internationally, you should not sign this Consent. However, you must sign this Consent to participate in the Study.
Other Data Transfer Mechanisms. In addition to your consent to transfer, the Study Sponsor also abides by the Asia-Pacific Economic Cooperation (APEC)’s Cross Border Privacy Rules (CBPR) System to protect personal data, including Study Data and Coded Study Data, transferred among participating APEC economies.
How long will my Study Data be retained?
Your Study Data, including your Contact Information and Video images, will be retained for up to 10 years from the date of this Consent by the Research Company. Your Coded Study Data, including you Video images, will be retained for up to 10 years from the date of this Consent by the Study Sponsor. Coded Study Data that does not contain Contact Information and for which Video images of your face have been blurred or similarly obscured or removed, may be retained by the Study Sponsor for as long as needed for the purposes and uses stated in this Consent.
CONTACTING YOU ABOUT FUTURE STUDIES: As mentioned above, Research Company may contact you immediately upon completion of this Study to see if you are interested in a similar companion Study. Additionally, the Research Company will maintain your Contact Information for use only by Research Company on behalf of Study Sponsor to contact you about this or future Study Sponsor studies. Research Company will not provide your Contact Information, or this signed Consent, to the Study Sponsor, except where legally required as stated above.
WHAT RISKS OR DISCOMFORTS SHOULD I EXPECT FROM PARTICIPATING IN THIS STUDY? No significant risks to you are anticipated by your participation in this study. However, you may experience some discomfort associated with stretching and manipulating your hands. There may additionally be some unknown and unforeseeable risks. If you feel uncomfortable at any time, contact the Study Lead. There could be privacy risk as set forth above in “How will my Study Data be kept confidential?”
WHAT DATA RIGHTS DO I HAVE?
If you decide to participate in this Study, you have the right to request access to any personal data collected about you as part of this Study and the right to request that any such personal data be corrected, amended, blocked, or deleted. In some circumstances, we may not be able to complete the actions you request (for instance, if your Coded Study Data has been de-linked from, or we do not have access to, your Contact Information, or where applicable law would permit or require us to continue processing certain of your personal data). You also have the right to object to the collection of any data and withdraw from this Study at any time. Information on how to withdraw is included in “How Can I Withdraw from this Study?” section below. You also have the right to contact Apple’s Data Protection Officer at firstname.lastname@example.org.
Could I be withdrawn from this study?
The Study Staff or the Study Sponsor may, at any time, withdraw you from the study and stop your participation for any of the following reasons:
- If you fail to follow directions for participating in the study;
- If it is discovered that you do not meet the study requirements;
- If the Study Staff finds that it is not in your best interest to continue taking part in the study; or
- If the study is cancelled.
Can I withdraw from this study?
Your decision to participate in this study is voluntary. You may choose to not participate, or you may withdraw from the study for any reason, without penalty or loss of benefits to which you are otherwise entitled. If you want to withdraw, please notify the Study Staff and/or study lead using the information at the top of this Consent.
If you withdraw or are withdrawn from the study, any Coded Study Data previously collected and shared with the Study Sponsor may continue to be used and disclosed by the Study Sponsor and used and shared with others as described in this Consent, unless you request that it be deleted, in which case it will be deleted where feasible as stated above in “What Data Rights Do I Have” section.
WILL I RECEIVE COMPENSATION FOR PARTICIPATING?
You will be paid $10 if you complete 2 videos of sufficient quality. If you withdraw or are withdrawn from the study, or if you provide less than 2 videos, you will be paid only for the videos of sufficient quality that you provide.
WILL I RECEIVE OTHER BENEFITS?
This study is for research and development purposes as described in this Consent. There is no direct benefit to you from your participation in the study.
COMMERCIAL GAIN BY STUDY SPONSOR.
This study is part of the development of consumer-available devices. Your information collected during this study may be used for the development, design, possible approval (including marketing approval), production, and support of products, technologies, processes, and/or services for commercial sale. The Study Sponsor has no plans to offer you financial compensation or share any profits from the commercialization of any products, technologies, processes, or services developed from your information. You will not, however, lose any legal rights to which you are entitled by signing and dating this consent document.
WHAT ARE MY CONFIDENTIALITY OBLIGATIONS? If you agree to participate in the study, you must also agree to not disclose any information from or about the study with anyone, without first obtaining approval from the Study Lead.
WHAT IS CONSIDERED CONFIDENTIAL? The fact that Company and the Study Sponsor are conducting this study, the types and methods of data collection, and any other detail about the study or how it is conducted are confidential. Any information that you learn about the study, including technical information and any other information identified as non-public information is considered confidential and proprietary information that belongs to the Study Sponsor and must not be disclosed by you.
WHO NEEDS TO KNOW? Do not assume that anyone knows information about the study. Do not talk to anyone about the study unless you are authorized to do so by the Study Lead.
NO DISCLOSURES, PHOTOS, VIDEOS OR SOCIAL MEDIA. It is of utmost importance that no confidential information be communicated to anyone outside of the Study Staff, including friends, family members, and professional colleagues. You will not be permitted to take any photographs or videotape anything related to the research study.
Failure to maintain the confidentiality of information may seriously harm the research study. If you become aware of any unauthorized disclosure of confidential information, please report it to a Study Staff or the Study Lead immediately.
If you have any questions that are not addressed here, please discuss with a Study Staff or the Study Lead.
WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY? If a study-related problem should occur, or if you have any questions about the study at any time, please contact the Study Lead as set forth at the top of this Consent
You will not lose any of your legal rights to which you are otherwise entitled by signing and dating this Consent.
By signing this Consent, I acknowledge and agree:
- I have read and understand this Consent and have had an opportunity to ask questions and have received answers to my questions and agree to all of its terms.
- I am voluntarily signing this Consent indicating that I consent to participate in this study.
- I agree that I will keep confidential all information disclosed to me during the study.
- I grant the Study Staff and Sponsor and other entities as stated in this Consent the right to collect, use, process, store, and disclose my Study Data, including my Coded Study Data, as described in this Consent.
- I understand that I will receive a copy of this Consent form after I sign it.
- I have read this information, which is printed in English. This is a language that I read and understand.
If this is an electronic consent, I understand that by clicking accept or typing my name and the date below I am providing my consent electronically and that it has the same force and effect as if I was signing in person on paper.