Will I be compensated for my time?
You or your parent/guardian will receive $150 per blood draw and $50 per behavioral assessment for participating in this study. If a blood redraw happens, you or your parent/guardian will be provided another $150 for that visit.
Payments for taking part in a research study, including certain reimbursement requests that cannot be confirmed with receipts, may be considered taxable income. If this payment is $600.00 or more in any one calendar year, the amount will be reported to the Internal Revenue Service (IRS). Personal information about you, including your name, date of birth, address and Social Security Number (SSN) or Tax Identification Number (TIN), may be provided to the Sponsor, reimbursement or other vendors engaged by Sponsor, or government authorities for the purpose of payment and for tax reporting to the IRS. The Sponsor or vendor will issue you an IRS form 1099-MISC, Miscellaneous Information, listing your payment as reportable income. Under certain conditions, the Sponsor may also need to issue a 1099 MISC form to you even if you receive less than $600 in one calendar year, such as in cases where if you do not provide a SSN or TIN and have backup withholding. If you do not provide your SSN or TIN, you may be subject to backup withholding at the applicable tax rate under the Internal Revenue Code.
Can I decide later to not be in the study?
Your participation in this study is voluntary. You can decide not to be in the study, and you can change your mind about being in the study at any time. There will be no penalty to you.
Please note: You cannot withdraw your samples and information from studies that have already begun. Sanguine BioSciences, Inc., cannot get back samples or information already given to researchers.
What will be asked of me if I decided to participate?
If you decide to be in this research study, you will be asked to provide blood samples, complete behavioral assessments, and give personal and health information to Sanguine Biosciences, Inc.
You will have a screening phase and study visits that will occur approximately on day 1 (baseline), week 12, week 24, week 36, week 48, week 72, and week 96. These visits will be performed in your home by a phlebotomist who is trained to draw blood. During the screening phase, you will be asked to provide certain personal and health information to see if you qualify for study activities. If you qualify and decide to continue in the study, you will have blood samples collected and complete behavioral assessments for 7 total study visits.
Do I need to have health insurance?
No. You do not need to have health insurance in order to qualify for the study. However, to participate in most studies, you will need to provide proof of your diagnosis. Even if you are not currently seeing a physician, you can still sign an authorization for Medical Record Release from your former physician that can serve as proof of diagnosis.
What are the potential study risks?
Blood Collection. You may feel brief pain or have some bruising from the needle insertion. Infection, light-headedness, and fainting are also possible but unlikely.
Tell the study staff right away if you have any problems with your health or how you feel during the study, even if you think they are not related to the study procedure. In the event of an emergency, dial 911 immediately. If you require emergency care, be sure to tell the emergency care provider about your participation in this study. Contact the study staff as soon as possible.
Blood Collection. You may feel more nervous, fearful, or stressed before, during, and after the blood collection.
Your past, present, and future health records, and any data collected for this study, also known as your Protected Health Information (PHI), will be used as part of your participation in this study. Your privacy and the confidentiality of your data are very important to Sanguine Biosciences, Inc, and we will make every effort to protect information that identifies you. There is a risk that someone could get access to data we have stored about you or identify you from data we provide, and because your genetic and treatment information is unique to you, there is a small chance that someone could trace it back to you. Though the risk of this happening is small, it may change in the future.
If your data identifies you and suggests something serious about your health, it could be misused. For example, it could be used to make it harder for you to get or keep a job or insurance. In the United States, there are laws against this kind of misuse, but they may not give full protection.
The following agencies and affiliates may access your protected health information to make sure the study is conducted properly: the U.S. Food and Drug Administration (FDA), the institutional review board (WCG IRB) overseeing this study for human subject research protections, or other regulatory agencies, here or in other countries.
How will my information be kept confidential?
Your identity will be protected as required by law, and according to any policies, or sponsor may have. We will remove your name and any other information that could directly identify you from your samples before sharing them with researchers. This information will be replaced with a unique study identification number that cannot identify you.
Your study records (which include your signed consent form and other information) may be shared as needed for the study. In some cases, your information in this research study could be reviewed by representatives of the sponsor and its authorized agents, the U.S. Food and Drug Administration (FDA), governmental agencies in other countries where the study drug may be considered for approval, WCG IRB (a group of people who review research studies to protect the rights and welfare of research participants), or government agencies for purposes such as quality control or safety. Not all parties who will have access to your medical information as part of the study are prohibited by federal law from further sharing it, so the information, once received by them, may no longer be protected by federal law.
How will my privacy be protected?
Sanguine Biosciences, Inc. and its partner employees will protect your information to the best of our ability. We have implemented physical, administrative, and technical safeguards to protect your PHI using standards provided by local and federal laws.
We will remove your name and any other information that could directly identify you from your sample and information before sharing it with researchers. We will replace this information with a unique study code. Only approved study staff can link your information with this code and are required by law to keep your information private.
The samples will be kept in locked containers in locked buildings. We will keep health information and research data on secure computers. These computers have many levels of protection. We will not give information that directly identifies you to third parties, like regulatory agencies, without your permission, except as required by law.
Research records are maintained separately from medical records. We will not place any information from this study in your medical record.
Genetic Information Nondiscrimination Act
There is a federal law called the Genetic Information Nondiscrimination Act (GINA). This law makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law will generally protect you in the following ways:
1. Health insurance companies and group health plans may not request your genetic information from this research.
2. If health insurance companies and group health plans do somehow receive your genetic information from this research, they may not use it to make decisions about your eligibility or premiums.
3. Employers with 15 or more employees may not use your genetic information from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
All health insurance companies, and group health plans must have started following this law by May 21, 2010. All employers with 15 or more employees must have started following this law by November 21, 2009.
However, GINA does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Are there costs?
There are no costs to you or your insurance for taking part in the study. However, if you suffer a research-related injury, your medical expenses will be your responsibility or that of your third-party payer, although you are not precluded from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research.
Be aware that your health care payer/insurer might not cover the costs of study-related injuries or illnesses. You do not give up any of your legal rights as a research participant by signing this form.
What are the benefits of the study?
You should not expect to get direct health benefits from this research study because it does not involve treating any condition. Future patients with certain health problems may benefit from research results obtained from samples collected in this study.