The Certificate cannot be used to resist a demand for information from personnel of the United States federal or state government agency sponsoring the project and that will be used for auditing or program evaluation of agency funded projects. You should understand that a Certificate of Confidentiality 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, medical care provider, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information.
The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of child abuse or neglect, elder abuse or neglect, or imminent physical harm to self or others that requires our study team to protect your health or safety.
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.
Costs
There are no costs for participating in this study.
Payment
If you participate in study parts A, B, and/or D, you will be paid $20 for each. If you participate in study part C, you will be paid $25 for the first assessment and $35 for the second assessment (6 weeks later). All payments will be either cash, a check, or an electronic gift card (such as from amazon.com) sent to your smartphone. Payments will be given immediately after your participation for parts A, B, and/or D, and at the end of your participation (6 weeks) for part C.
The total you can receive in this study is $110 ($20 each for parts A, B and D; and $60 for part C).
Research-Related Injury
As mentioned above, the assessments we will conduct are widely used and rarely if ever have negative impact. Also, the phone apps in this study are designed to be calming. Nevertheless, every effort will be made to prevent any adverse reactions from occurring in the study. If you should experience any adverse reactions or injuries directly resulting from this research, we will do everything we can to manage the situation, in a timely manner, with the best possible care. If, during your assessment you have an adverse reaction (for example, becoming so upset that you are not safe), a trained clinician from our study team will intervene to protect your safety. This may include: arranging transport to a local emergency room for evaluation, contacting your individual clinician or psychopharmacologist, and/or talking with you to help you decide on the best plan of action. Please be aware, however, that there are no plans to provide medical care or financial compensation for any research-related or non-research-related medical injuries or adverse reactions.
In summary, if you become ill, injured or harmed during or as a result of taking part in this study, you will be referred to care. However, you will be responsible for the cost of this care. Signing this consent form does not waive your legal rights nor does it relieve the investigators, sponsors or involved institutions from their legal and professional responsibilities. You do not give up any of your legal rights by signing this consent form.