INFORMED CONSENT AND RELEASE
Study Title: <<Hand Movements II>>
Study Lead Researcher: << Hasan Shibly>>, <<AIDATACOLLECTION@lionbridge.com >>
This is a voluntary study undertaken by Lionbridge (“Research Company”) on behalf a consumer technology company (“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.
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 18 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, gloves, etc. 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. You will be asked to avoid capturing your face on video. Please perform any actions as naturally as possible.
- You may be asked to capture the video 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, or 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 no directly identifying features of yourself and the Partner Participant (such as images of faces), and no other images of any other people at all, appears or is included in the video. The Research Company will remove the audio portion of your video capture prior to storing the video and including it in the Study Data. You should also : (i) ensure that your chosen setting does not include items that could identify you or the Partner Participant (e.g. readable address or name, photographs of you or 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 1,250 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: <<name, email>>
- Video/Photo: Video of your hands, arms, feet, upper body. The video may also include images of your face, if you weren’t successful in avoiding it or you didn’t realize your face was captured. The Study Sponsor will receive these images but will not use these 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: in certain circumstances, there is the slight possibility that the video images you collect could incidentally include images of your fingerprints. The Study Sponsor did not intend for these images to be collected and will not use these images to identify you or to develop algorithms to identify you or others and the Research Company is required to try and blur these images when they see them on the video.
- 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.
How long will my Study Data be retained?
Your Study Data, including your Contact Information (which may include unblurred video images of your face if you captured it incidentally), will be retained for up to 10 years from the date of this Consent by the Research Company. Your Coded Study Data (which may include unblurred video images of your face if you captured it incidentally), will be retained for up to 10 years from the data 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 Companywill 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? You may contact the Study Lead at any time to request deletion of your personal information associated with your Study Data. In some circumstances, deletion of your personal information may not be feasible (for instance, if your Coded Study Data has been de-linked from your Contact Information). However, reasonable efforts will be made to delete identifiable data within a reasonable amount of time of your request. You may also withdraw from the Study at any time – see “How Can I Withdraw From This Study” section below.
However, if you are a resident of the state of California, the following applies to you:
- If you decide to take part in the Study, you have the right to request access to personal information collected about you as part of this Study, and the right to request that such personal information be deleted. You may freely exercise these rights without discrimination.
- If you request deletion of your information, reasonable efforts will be made to delete identifiable personal information included within your Study Data within a reasonable amount of time. However, we may be permitted or required to retain all or part of your personal information for certain purposes, such as to comply with regulatory requirements. Also, it may not be possible to delete your personal information if your Coded Study Data has been de-linked from your Contact Information.
- You can exercise the above rights by contacting the Study Lead. You also have the right to withdraw from this study at any time. To withdraw, see the section below “How Can I Withdraw from this Study.”
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 $[45] if you complete [10] videos of sufficient quality. If you withdraw or are withdrawn from the study, or if you provide less than [10] 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
LEGAL RIGHTS
You will not lose any of your legal rights to which you are otherwise entitled by signing and dating this Consent.
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.
- I am at least 18 years old or older.
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.