The purpose of the Neonatal Biorepository is to establish a data and biological specimen bank (i.e., blood, saliva, fecal matter, or urine) that allows scientists to study diseases of pregnancy and the newborn. 

Approximately 9,000 people will take part in this study. 

There are no direct benefits or costs by taking part in this study, but in the future it may have benefits for others based on research findings. 

Discarded or leftover blood samples will be obtained if available. There are no associated risks with obtaining leftover blood samples. In some cases, a blood draw may be necessary, which can cause pain or bruising at the site of the draw, or rarely an infection. A saliva sample may cause dryness of the mouth for a short amount of time. Discarded fecal matter or urine may be collected, but will not require any effort or time. 

In addition to biological sampling, clinical data such as patient demographics, medical, developmental (both physical and intellectual), pregnancy, and family medical history may be obtained. This data may be collected by review of your child's and your own University of Iowa Health Care medical records. 

By enrolling, you will be a part of ongoing health research conducted by researchers at the University of Iowa and their collaborators. Any health or sample information, such as genetic materials (i.e., DNA, RNA, proteins, or other metabolic information) collected may be stored indefinitely in Dr. Momany's laboratory and may also be shared with researchers. Subjects retain the right to leave the study at any time by contacting Dr. Allison Momany, PhD, at (319) 678- 3034.

At some point, it is possible that your sample, information, and/or data may be added to other repositories. It will be stripped of identifiers if placed in a central repository or other national repositories sponsored by the National Institutes of Health or other Federal agencies. Other qualified researchers who obtain proper permission may gain access to your sample and/or data for use in approved research. 

There is a risk of disclosure of confidential health information. We will keep your participation in this research study confidential to the extent permitted by law. Security measures such as password-protected logins, de-identification of samples using codes, and locked physical files will be utilized to prevent this from taking place. Access to computer systems housing sensitive information will be strictly regulated and credentials giving access to said systems will be given only to people in the lab that work on this project. Additionally, researchers have obtained a Certification of Confidentiality from the Department of Health and Human Services (DHHS), which means researchers cannot be forced to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding. A copy of this certificate is available upon request.

Subjects are unable to participate in this study unless you permit us to use your protected health information. If you choose not to allow us to use this information, we will discuss any non-research alternatives with you. Your decision will not affect your right to medical care that is not research-related. 

Any genetic findings based on sequencing and genotyping will not be added to medical health records and no one else (like a relative, boss, or insurance company) will be given test results. The federal law Genetic Information Nondiscrimination Act also makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information.  

Any publications or reports using your data will be done in a way that prevents direct identification.

After enrolling in this study it is possible that you will be contacted to participate in new research studies that would require additional participation and consent. Agreeing to this study does not obligate you to participate in any future studies. 

We encourage you to ask any questions that arise. You can do so by contacting Dr. Allison Momany at the number stated above.

Click the links to view the full Informed Consent Document or Consent Summary.

If you feel as if you and your infant are eligible participants and would like to find out more, feel free to contact us at (319) 335-9632 or email us at Neonatal-Biorep@uiowa.edu.