Describe all procedures in lay language, using simple terms and short sentences (refer to Study Procedures posted under the IRB section of PINE for approved language). Provide a lay description of the randomization procedure, if applicable, and describe the chances of being assigned to any one group (for two groups use a coin,’ for ‘flipping more than two groups use drawing numbers from a hat’. ‘like If you are drawing blood, you must list the amount (use teaspoons, tablespoons, ounces, etc.) per procedure and the reason for the blood draw (for example, cholesterol or fasting plasma glucose). If the study includes genetic testing, include the following: The Genetic Information Nondiscrimination Act (GINA) may help protect your child from health insurance or health-related employment discrimination based on genetic information. The law provides that health insurance companies and group health plans may not ask for genetic information from this research and may not use genetic information when making decision about eligibility or premiums The law will not stop health insurance companies from using genetic information to decide whether to pay claims. The law does not apply to other types of insurance (such as life, disability or long-term care). Despite the GINA protections and the best efforts of the research team to protect your child’s information, your child may still be at risk if information about your child were to become known to people outside of this study. 6- Biospecimens for Future Research If the study includes collection of biospecimens for future research, include the following (if you are not storing biospecimens for future research, delete this section and renumber the following sections): You are being asked to allow some of your child’s list biospecimen(s) being stored to be stored and used for research at a later time. These bodily materials are called biospecimens. If biospecimens for future research is optional, include the following: The donation of biospecimens in this study is optional. No matter what you decide to do, it will not affect your child’s study participation. Your child will still be allowed to take part in the study even if you don't want your child’s specimens to be collected and used for future research.
Describe all procedures in lay language, using simple terms and short sentences (refer to Study Procedures posted under the IRB section of PINE for approved language). Provide a lay description of the randomization procedure, if applicable, and describe the chances of being assigned to any one group (for two groups use ‘flipping a coin,’ for more than two groups use ‘like drawing numbers from a hat’. If you are drawing blood, you must list the amount (use teaspoons, tablespoons, ounces, etc.) per procedure and the reason for the blood draw (for example, cholesterol or fasting plasma glucose). If the study includes genetic testing, include the following: The Genetic Information Nondiscrimination Act (GINA) may help protect your child from health insurance or health-related employment discrimination based on genetic information. The law provides that health insurance companies and group health plans may not ask for genetic information from this research and may not use genetic information when making decision about eligibility or premiums The law will not stop health insurance companies from using genetic information to decide whether to pay claims. The law does not apply to other types of insurance (such as life, disability or long-term care). Despite the GINA protections and the best efforts of the research team to protect your child’s information, your child may still be at risk if information about your child were to become known to people outside of this study. 6- Biospecimens for Future Research If the study includes collection of biospecimens for future research, include the following (if you are not storing biospecimens for future research, delete this section and renumber the following sections): You are being asked to allow some of your child’s list biospecimen(s) being stored to be stored and used for research at a later time. These bodily materials are called biospecimens. If biospecimens for future research is optional, include the following: The donation of biospecimens in this study is optional. No matter what you decide to do, it will not affect your child’s study participation. Your child will still be allowed to take part in the study even if you don't want your child’s specimens to be collected and used for future research.
InformedConsentforMinors2015-12-1.docx