J. What if you have more questions?
For questions about the study or a research-related injury, contact the researcher, Dr. Dawn Siegel, or her research team at (414) 955-2817.
If additional questions arise, you can ask your doctor. Also, the research study has been reviewed and approved by the Institutional Review Board, whose purpose is to see that the rights and welfare of research participants are adequately protected, and that risks are balanced by potential benefits. A member of this committee is available to speak to you if you have any questions or complaints at (414) 266-7454.
You will get a copy of this form. A copy of the signed consent, assent (if applicable) and HIPAA Authorization will be kept in your medical record.
K. Research data in medical record
A copy of the signed consent, assent (if applicable) and HIPAA Authorization will be kept in your medical record if you are a patient at Children's Wisconsin.
L. Will information be confidential?
Children's Wisconsin / Children's Health System, its researchers and their designees will maintain the privacy and confidentiality of your personal and health information to the extent permitted by law. Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Also, scientific data from this study, without identifiable information, may be presented at meetings and published so that it may be useful to others, as long as it is not identifiable with you. Some organizations that may inspect and/or copy your research records for purposes of quality assurance and data analysis include groups such as: Institutional Review Board of Children's.
Your DNA samples may be shared with other groups whom we collaborate with to obtain genetic testing or analysis of data, including the Centers for Mendelian Genetics. The samples that are sent will be de-identified and only the study team at CHW will be able to link them to you.
A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
- Health insurance companies and group health plans may not request your genetic information that we get from this research.
- Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
- Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
Be aware that this Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Because National Institutes of Health funding has been secured, then we will put your genetic information into other public databases, such as the Database of Genotypes and Phenotypes (known as dbGaP). The National Institutes of Health also controls the dbGaP, and requires funded studies to enter information into this database. The data in this database will be stored permanently. Other researchers must get permission from a Data Access Committee to be able to use the database. We will not put your name on any research data sent to these public databases. Instead, we will label your information with a study number. The master list that links a person's name to their study number is stored in a locked cabinet or on a secure computer file.
Before you sign this form, if you would like to discuss any part of this document with the researchers please contact us.