We Are Recruiting Study Subjects!
STUDY TITLE: The development of computer vision algorithms to detect and measure alcohol consumption by analyzing characteristics of the eye
STUDY INVESTIGATOR: LaVonda Brown, MBA, PhD
STUDY SITE: EyeGage, Inc.
640 North Ave NW, Suite 200
Atlanta, GA 30318
TELEPHONE: 404-452-3774 (24 hours)
SPONSOR: EyeGage Inc.
You are being asked to participate in a research study. Your participation in this research study is strictly voluntary, meaning that you may or may not choose to take part. To decide whether or not you want to be part of this research, the risks and possible benefits of the study are described in the consent form so that you can make an informed decision.
You may have a copy of the consent form to review at your leisure or to ask advice from others. The study doctor or study staff will answer any questions you may have about the consent form or about the study. Please read this document carefully and do not hesitate to ask anything about this information. After reading the consent form, if you would like to participate, you will be asked to sign the consent form in-person. You will be given a signed copy of your consent form to take home and keep for your records.
Things you should know:
The purpose of the study is to better understand how alcohol consumption affects characteristics of the eyes such as pupil size, eye color, and reaction time.
If you choose to participate, you will be asked to consume alcohol while at the study site and have measurements and pictures/videos of your eyes taken every 15 minutes.
Risks or discomforts from this research include those associated with drinking alcohol such as vision changes, slurred speech, difficulty walking, short-term memory loss, a slowed reaction time and changes in mood and emotion.
There is no direct benefit to you from participating in this study.
Current alcohol-screening measurements include Blood Alcohol Test (BAC), Breath Alcohol Concentration (BrAC), Urine test for Ethyl Glucuronide (EtG), and a Standardized Field Sobriety Test (SFST). Blood tests are the most accurate but require a blood draw and results are not immediate. The Breath test using a breathalyzer is readily available to law enforcement and individuals to use but can be inaccurate in certain situations. The urine test requires a laboratory analysis and results are not immediate. The sobriety test can have inaccuracies and may not be performed accurately.
For these reasons, EyeGage, Inc. is conducting this study to develop an algorithm using eye images that may lead to the development of alcohol screening technology that is non-invasive and can provide results quickly.
The purpose of this study is to better understand how alcohol consumption affects characteristics of the eyes such as pupil size, eye color, and reaction time.
Approximately 500 men and women age 21 to 45, inclusive, will participate in this study.
Before any study related procedures are performed you will be asked to read and sign the consent form.
You will be required to have your temperature taken and complete a COVID-19 survey before entering the study facility. You will be required to wear a mask while at the study facility. It may be removed temporarily when you are consuming alcohol. During the study visit, the study staff will take images and videos of your eyes before and after you have consumed alcohol. The amount of alcohol consumed will be based on your weight, sex, height, and age. Your blood alcohol content (BAC) will be estimated from a breathalyzer test and you will complete a standardized field sobriety test (SFST) before consuming alcohol as a baseline measurement. The breathalyzer and sobriety test will be repeated in 15-30 minute intervals until your BAC is at an acceptable level. There will be an optional blood test to measure BAC at the end of the study.
Transportation will be provided to get you to and from the facility. You will remain at the facility until your BAC is 0.04. If you choose to drive, you will not be permitted to leave the facility until your BAC is 0.00. Testing will last no more than 8 hours. Two final breathalyzer measurements will be taken before you can leave the facility.
Alcohol poisoning is a known risk of binge drinking. An EMT will be present in the event that you become ill.
When you consume alcohol in this study it is expected to impair your cognitive function. You may experience vision changes, slurred speech, difficulty walking, short-term memory loss, a slowed reaction time and changes in mood and emotion. There are many health risks associated with alcohol use including liver disease, cancer and gastrointestinal problem.
There may be risks from participating in this study that are not yet known.
You will not benefit directly from the study. However, this research will be a building block for further development of a non-invasive indicator for alcohol screening. This technology will allow individuals to assess alcohol levels before deciding to operate vehicles and/or heavy equipment.
COMPENSATION AND COSTS TO YOU:
There will be no compensation or costs for participation in the study. There are no financial obligations required for you to participate in the study.
VOLUNTARY PARTICIPATION AND WITHDRAWAL:
Participation in this study is voluntary. You do not have to be in this study. If you change your mind, you have the right to stop your participation at any time. You may not leave the study facility until your BAC is 0.04 or 0.00, depending on whether you are being transported home or driving yourself.
Your records will be kept private to the extent allowed by law. Only Dr. Brown and the research team will have access to the information you provide. To protect your privacy, records will be kept under a code number rather than name. Your name and any facts that may identify you will not appear when the study results are presented or published. The results will be summarized and reported in group form. You will not be identified personally. Information that identifies you may be shared Sterling Institutional Review Board (IRB) or government agencies who make sure the study is done correctly.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
The photos/videos taken by the study staff for the study will be kept securely with your study data and will not be used in any presentation or publication. You may be able to be identified from your photos/videos if someone who is not part of the study got access to these images.
Will my information be used for future research or shared with others?
We may use or share your research information for future research studies. If we share your information with other researchers it will be de-identified, which means that it will not contain your name or other information that can directly identify you. This research may be similar to this study or completely different. We will not ask for your additional informed consent for these studies.
Certificate of Confidentiality
To help us protect your privacy, a Certificate of Confidentiality has been issued from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.
Exceptions: A Certificate of Confidentiality does not prevent researchers from voluntarily disclosing information about you without your consent. For example, we will voluntarily disclose information about incidents such as child abuse or intent to hurt yourself or others. In addition, the Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. Finally, the Certificate may not be used to withhold information from the federal government needed for auditing or evaluating federally funded projects or information needed by the FDA.
IN CASE OF INJURY/HARM:
If you are injured as a result of being in this study, please contact Dr. L. Brown at (404) 452-3774. Neither the Study Investigator nor the Sponsor has made provision for payment of costs associated with any injury resulting from participation in this study. You do not waive any of your legal rights or release anyone from liability for negligence by signing this document.
Your participation in this study is voluntary. You do not have to be in this study if you do not want to be.
You have the right to change your mind and leave the study at any time without giving any reason, and without penalty.
Any new information that may make you change your mind about being in this study will be given to you.
You will be given a copy of the consent form to keep.
You do not waive any of your legal rights by signing the consent form.
QUESTIONS ABOUT THE STUDY OR YOUR RIGHTS AS A RESEARCH PARTICIPANT:
Should you have any questions or desire further information, please call or email Dr. LaVonda Brown at 404-452-3774 and firstname.lastname@example.org.
If you have any questions about your rights as a research subject, you may contact Sterling IRB by phone at 888-636-1062 or email@example.com.