What happens to the information collected for this research?
Confidentiality and Data Protection
Your privacy is very important to the Sponsor and the study researchers, and they will expend every reasonable effort to protect your privacy in accordance with applicable law. During the study, the study Investigator and study team will collect and record in your study record sensitive information about you such as: birthdate, gender, ethnicity, self- reported medical history, your physiological data collected while performing study tasks, video and voice recordings, behavioral and other results of study procedures as described in this informed consent form. Except as required by law, your study data and study records will not include your name or other direct personal identifiers. Rather, your study samples and records will be identified by an assigned code number (the “Subject ID Code”). This code can only be tracked back to you via a master list linking the code numbers to names, which will be held by the sponsor and kept separate from the study data and study records. Although procedures are in place to protect your privacy, absolute confidentiality cannot be guaranteed.
The coded data held by the Sponsor and its service providers will be stored, processed and compiled, including by manual and electronic methods. Electronic forms will be utilized in the study, called case report forms (CRFs), where your personal and sensitive information like demographics, gender, self-reported medical history etc., and other study tasks data will be recorded. These electronic forms will be stored on sponsor provided personal computers or cloud based digital repositories/storage systems (for example, Amazon Web Services, Google Drive) protected by passwords accessible only to the Investigator(s).
Data recordings from the computer (including keyboard, mouse, microphone, and camera), as well as from the physiological sensors used in this study will be captured and stored without your personal identifiers on sponsor provided personal computers or cloud based digital repositories/storage systems (for example, Amazon Web Services, Google Drive), and/or on the device or cloud associated with the commercial device data collection format.
The coded data and your study records may be transferred within the United States and to other countries. The coded data from this study may be used by or for Sponsor to carry out the study and future research, maybe shared with collaborators or other investigators to further this kind of research, for development of future therapy, to meet legal obligations and requirements in connection with the study and to make publications or presentations. Your name and identity will not be included in any such publications or presentations. By signing this informed consent form you are agreeing that your coded data and results may be used and disclosed as described in this informed consent form. Coded data collected in this research might be used for future research or distributed to collaborator or another investigator for future research without your consent.
Your medical records and other personal information will be protected in accordance with U.S. law and any other applicable data protection laws. Your study records, data and results will likewise be stored and kept according to applicable legal requirements.
Your private information and your medical record will be shared with individuals and organizations that conduct or watch over this research, including:
- The study investigator, study team and those working for or with them
- The research Sponsor
- People who work with the research sponsor, its affiliates, persons and organizations working with sponsor and its affiliates
- Government agencies, such as United States Food and Drug Administration (FDA)
- A human research oversight authority, the Institutional Review Board (IRB), that reviewed this research
By signing this consent form, you authorize the above organizations and individuals to access your study records and self- reported medical records for the purposes provided in this informed consent form and further agree that the IRB and regulatory authorities may make copies of such records, including those with your name on them.
The Sponsor may publish the results of this research. However, your name and other identifying information will be kept confidential.
The Sponsor will protect your information from disclosure to others to the extent required by law. The Sponsor cannot promise complete confidentiality.
Whom to contact about this study?
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:
- Whom to contact in the case of a research-related injury or illness;
- Payment or compensation for being in the study, if any;
- Your responsibilities as a research subject;
- Eligibility to participate in the study;
- The Investigator’s or study site’s decision to withdraw you from participation;
- Results of tests and/or procedures;
Please contact the Investigator at the telephone number listed on the first page of this consent document.
If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, contact:
- By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
- or call toll free: 877-992-4724
- or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser: Pro00073795.
What if I am injured because of taking part in this research?
If you are injured or get sick because of being in this research, you need to seek medical attention immediately, as you normally would. Your insurance may be billed for this treatment. The sponsor will pay any charges that are not covered by insurance policy or the government, provided the injury was not due to an underlying illness or condition and was not caused by you or some other third party. No other payment is routinely available from the study Investigator or sponsor. If you are injured as a result of this study, you do not give up your right to pursue a claim through the legal system.
To pay medical expenses, the sponsor will need to know some information about you like your name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.
Can I be removed from this research without my approval?
The person in charge of this research can remove you from this research without your approval. Possible reasons for removal include:
- It is in your best interest
- You have a side effect that requires stopping the research
- You are unable or unwilling to comply with placement of physiological sensors
- You are unable or unwilling to view potentially aversive and distressing video content
- You are unable to remain relatively still in a seated position for up to one hour throughout data collection
- The research is canceled by a government agency with human clinical research oversight authority or the sponsor
- You are unable to keep your scheduled appointments
We will tell you about any new information that may affect your health, welfare, or choice to stay in this research.
What happens if I agree to be in this research, but I change my mind later?
You may decide at any time to leave the study. Simply contact the study team and asked to be withdrawn. Your research data will continue to be used up to the date of withdrawal.
There is no penalty to you for withdrawing from the study.
Will I be paid for taking part in this research?
You will be paid for taking part in this research.
You will earn a total of $50 for completing the in-person session, which is expected to last about 1-2 hours. You will earn $100 for remotely completing the electronic diary entries as instructed for the full 7 days following your in-person study session. You will be paid at the end of your participation in the research study after your diary has been reviewed for completeness.
If you choose to stop participating during your in-person visit, you will be paid $20 per hour for your time spent prior to stopping (in 15 minute increments). If you choose to stop participating after completing your in-person session, but before completing the full 7 days of diary entries, you will be paid $50. If you successfully complete both the in-person study session and the full 7 days of diary entries, you will be paid the full $150.
Participants invited to complete only the in-person session will not be asked to complete the electronic diary and will receive compensation only for the in-person session.
As appropriate, you may also be given a payment code for a ride sharing service or have your reasonable travel costs associated with participating in the study reimbursed in addition to your payment for participation.
Payment will be provided electronically (for example, Zelle, PayPal) using your recorded email address in one lump sum after electronic diary entries have been reviewed for completeness.