INFORMED CONSENT DOCUMENT

Project Title:	NICU and Pediatric Repository

Principal Investigator:	Allison Momany, PhD

Research Team Contact:	Nancy Weathers, nancy-weathers@uiowa.edu

•	If you are the parent/guardian of a child under 18 years old who is being invited to be in this study, the word “you” in this document refers to your child.  You will be asked to read and sign this document to give permission for your child to participate.  
•	If you are a teenager reading this document because you are being invited to be in this study, the word “you” in this document refers to you.  You will be asked to read and sign this document to indicate your willingness to participate.

This consent form describes the research study to help you decide if you want to participate.  This form provides important information about what you will be asked to do during the study, about the risks and benefits of the study, and about your rights as a research subject.  
•	If you have any questions about or do not understand something in this form, you should ask the research team for more information.  
•	You should discuss your participation with anyone you choose such as family or friends.  
•	Do not agree to participate in this study unless the research team has answered your questions and you decide that you want to be part of this study. 

WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study.  We are inviting you to participate in this research study because your child (or children, if multiples) was seen, born at or transferred to the University of Iowa Hospitals and Clinics.

The purpose of this research study is to establish a data and specimen bank (Repository) that allows scientists to study diseases of pregnancy and the newborn such as prematurity, gestational diabetes, respiratory distress, infections or birth defects, or other diseases or conditions that can occur later in life not related to newborn status.  Research using samples as part of this data bank may involve studies done on genetic materials such as DNA, RNA, proteins or other metabolic information.  We are inviting children who have an illness or birth defect as well as children who are healthy, along with their parents to become part of this data bank.  Information and samples collected as part of the data bank will be stored indefinitely, and may be shared with other researchers working on these problems.

HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 9,000 people will take part in this study conducted by investigators at the University of Iowa.  

HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, your involvement today will last for one-half hour.  On occasion, we may re-contact you for more information about yourself and your family members. By enrolling, you will be part of ongoing health research conducted by researchers at the University of Iowa and their collaborators. Your sample and health information may be used indefinitely by many different researchers for many different studies, now and in the future. However, you have the right to leave the NICU and Pediatric Repository at any time.
   
WHAT WILL HAPPEN DURING THIS STUDY?
Biological sampling:  For children we make every attempt to collect your child’s blood sample using samples that are already available. This includes using blood that is routinely drawn from the umbilical cord at birth, or blood left over from tests done in the hospital laboratory, which may have been collected before consent is signed.  If we are unable to use existing blood samples we will use an alternative procedure, such as collection of saliva into a small bottle or on cheek swabs.  In rare cases we may ask you if we can obtain a blood sample.  We would try to collect blood at the same time that blood is drawn for other tests ordered by your child’s doctor. Blood samples are obtained by either venipuncture or a smaller blood sample through the use of an autolet (heel stick) device.  In the case of venipuncture we collect about 1-2 teaspoons of blood (1ml per kg up to 10 ml). A sample of your child’s stool may also be collected. Meconium is the first bowel movement a newborn baby has, and either it or later bowel movements can be used to get genetic material and to look at normal body chemicals, proteins and toxins.  For adults, if possible, we will use blood that is leftover from a laboratory study, which may have been collected before you sign the consent. In the event that a leftover blood sample is not available, we will use an alternative procedure, such as collection of saliva into a small bottle or on cheek swabs.

If required saliva collection will take about 15 minutes of your time. Discarded blood may also be collected but will not require any effort or time from you. Discarded fecal matter or urine may be collected from your child but will not require any effort or time from you.

Biological specimens such as blood, saliva, fecal matter or urine are collected for the purpose of extracting DNA, RNA, proteins or other metabolic information.  The samples will be stored in Dr. Momany’s laboratory indefinitely. If you choose not to participate in this study, the samples we may have collected will be destroyed.

Clinical data collection:  Clinical data used for research may include the following information; demographic, medical, developmental (both physical and intellectual), pregnancy history and family medical history.  This data may be collected by a review of your child’s and your own University of Iowa Health Care medical record.  We may access all past, present and future parts of the medical record, including newborn screening test values available from the State of Iowa Hygienic Lab. Since all predictors of conditions such as premature birth have not been identified, clinical data may be accessed in the future for questions unknown at this time. For samples shared with qualified investigators, clinical and biologic data collected by them will be shared back with the NICU Pediatric Repository to supplement existing data, and will be available for use by other investigators using the repository.

Questionnaire data collection: Family prematurity history, pregnancy history, and health habits such as diet and smoking before and during pregnancy may be collected through the use of questionnaires by the person obtaining this consent. You are not required to answer these questions and may skip any that you do not want to answer.  

Tissue/Blood/Data Storage for Future Use
As part of this study, we are obtaining biological samples (i.e., blood, saliva, child - fecal matter or urine) from you and your child. The tests we might want to use to study your biological samples may not even exist at this time.  Therefore, we are asking for your permission to store your biological samples indefinitely so that we can study them in the future.  These future studies may provide additional information that will be helpful in understanding medical conditions of pregnancy, conditions of the newborn or conditions unrelated to the newborn, but it is unlikely that what we learn from these studies will have a direct benefit to you.  It is possible that your biological samples might be used to develop products or tests that could be patented and licensed.  There are no plans to provide financial compensation to you should this occur.  

Blood cells removed from the blood samples may be used to conduct whole genome sequencing. The genome sequencing results will be available to researchers trying to learn more about the medical conditions of pregnancy, conditions of the newborn or conditions unrelated to the newborn.

Each of the cells in one’s body contains DNA. DNA is the instruction manual that determines the appearance in things like eye color or how tall someone can be. DNA may also lead to higher or lower risk of certain diseases. One’s environment will also determine some of a person’s disease risk.

DNA is a string of four building blocks, called “bases”. These bases are represented by the letters G, A, T and C. There are billions of these letters strung together in every human’s DNA and they are arranged in packages like words. Each of the “words” have specific jobs in the body. Most of the time the letters are the same in everyone. But about 1% of the population might have an “A” where someone else has a “G”. This difference can explain why some people have blue eyes and others brown eyes, or why some have a high risk for a certain cancer and others a low risk. All these letters come together to create your “genome sequence”, a kind of book of your genetics. It is now possible to read off each of these letters and read your complete genome sequence. Your DNA sequence is unique to you. You inherit your DNA in almost equal parts from each of your parents. In very rare cases, your genome can also change through “mutations”. A mutation is like if you tried to copy a page from a book but misspelled some words. Mutations usually result from copying errors that occur in certain letters when being passed from parent to child. 

When we use a sample of blood for this study, it will go to a lab to read off those letters and give us a report on the genome. This information will then be compared to other genomes to see how they may be the same or different. It is our hope this will help us to better understand how the human body works and/or what causes it to not work well, as when someone has a disease. 

If you agree now to future use of your biological samples, but decide in the future that you would like to have it removed from future research, you should contact Dr. Allison Momany, PhD, at (319) 678-3054.  However, if some research with your biological samples has already been completed, the information from that research may still be used. 

Your sample, information, and/or data may be added to other repositories. It will be stripped of identifiers (such as name, date of birth, address, etc.) 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 studies that may or may not be related to in the purpose of this study.

You may be contacted via mail or during a follow-up clinic visit by a research team member requesting more sample. This sample would be a saliva sample and you may refuse providing a sample if you wish.

You may be contacted to participate in new research studies that would require additional participation and consent. Your name, address and phone number will be kept in a secure database for possible future contact. Agreeing to be in this study does not obligate you to participate in any future studies. A separate Consent Document would be signed for future studies.

WILL I BE NOTIFIED IF MY OR MY CHILD’S BIOSPECIMENS RESULT IN AN UNEXPECTED FINDING?

The results from the biospecimens we collect in this research study are not the same quality as what you or your child would receive as part of you or your child’s routine health care. The biospecimen results will not be reviewed by a physician who normally reads such results. Due to this, you or your child will not be informed of any unexpected findings. The results of your or your child’s biospecimens will not be placed in your or your child’s medical record with you or your child’s primary care physician or otherwise. If you or your child believe you or your child are having symptoms that may requires care, you should contact you or your child’s primary care physician. 

Genetic Research
One purpose of this study is to look at genes (DNA) and how they affect health and disease. Genes are the instruction manual for the body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person’s risk for certain diseases and how they will respond to treatment. 

You and your child are being asked to give biological samples (i.e., blood, saliva, child - fecal matter or urine) for genetic research. What we learn about you from this sample will not be put in your health record. Your test results will not be shared with you or your doctor. No one else (like a relative, boss, or insurance company) will be given your test results. Biologic samples and data will be made available to researchers trying to learn more about the cause of diseases. 

Genetic Information Nondiscrimination Act (GINA)
A new federal law called the Genetic Information Nondiscrimination Act (GINA) generally 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. Based on this new law, health insurance companies and group health plans are prohibited from requesting your genetic information that we get from this research. This means that they may not use your genetic information when making decisions regarding your eligibility for insurance coverage or the amount of your insurance premiums. Be aware that this new federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. The law also does not prohibit discrimination if you already have a manifest genetic disease or disorder.

WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study. 

The possible risks associated with participating in this research project include:  Obtaining leftover blood samples has no associated risks. A blood draw may cause pain or bruising at the site, or rarely an infection. Collecting a saliva sample may make your mouth dry for a short time.  

Participation in this study may indicate that you are a carrier of a specific gene under study.  The results of the genetic analysis performed for purposes of this research study will not appear in your medical record.  We will not release your personal information unless authorized by you to do so or unless we are required to do so by law.  There is a risk of loss of confidentiality. De-identified research data may contain sensitive information regarding individual traits and/or the risk of developing a disease. Electronic research networks utilize multiple levels of data security. However, there is a risk of involuntary disclosure of confidential information.

Genetic Research
One risk of giving samples for this research may be the release of your name that could link you to the stored samples and/or the results of the tests run on your samples. To prevent this, these samples will be given a code. Only the study staff will know the code. The name that belongs to the code will be kept in a locked file or in a computer with a password. Only Dr. Allison Momany and approved research team members will have access to your name.

WHAT ARE THE BENEFITS OF THIS STUDY?
You will not benefit from being in this study. However, we hope that, in the future, other people might benefit from this study because we may be able to identify the causes and risk factors associated with diseases that affect mothers and their children.  

WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.

WILL I BE PAID FOR PARTICIPATING?
You will not be paid for being in this research study.  

WHO IS FUNDING THIS STUDY?
Departmental funds are funding research activities using these samples.  This means that the University of Iowa is receiving payments internally to support the activities that are required to conduct the research.  

WHAT IF I AM INJURED AS A RESULT OF THIS STUDY?
•	If you are injured or become ill from taking part in this study, medical treatment is available at the University of Iowa Hospitals and Clinics.
•	The University of Iowa does not plan to provide free medical care or payment for treatment of any illness or injury resulting from this study unless it is the direct result of proven negligence by a University employee. 
•	If you experience a research-related illness or injury, you and/or your medical or hospital insurance carrier will be responsible for the cost of treatment.

WHAT ABOUT CONFIDENTIALITY?:
We will keep your participation in this research study confidential to the extent permitted by law.  However, it is possible that other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research.  Some of these records could contain information that personally identifies you. 
•	federal government regulatory agencies, 
•	auditing departments of the University of Iowa, and 
•	the University of Iowa Institutional Review Board (a committee that reviews and approves research studies) 

In the future, the National Institutes of Health (NIH) and March of Dimes Foundation (MOD) may continue to use your health information that is collected as part of this study. For example, the NIH and MOD may combine information from this study with the results of other studies to re-analyze the safety and effectiveness of the study of premature birth, to evaluate other products or therapies, to develop a better understanding of a disease, or to improve the design of future research studies. The NIH and MOD may also share information from the study with regulatory agencies in foreign countries.

To help protect your confidentiality, we will use coded files to distance your research records from your name and identifiers, locked storage areas, and password-protected computer files. Access to computer systems housing sensitive information will be strictly regulated. Credentials giving access to said systems will be given only to people in the lab who work on this project. All systems are secured from a break in from the outside through the use of hardware and software firewalls and are updated with necessary security patches as they become available. Related hardware and backup media are kept in a secure place and only essential personnel have physical access. Limited remote access to our computers is available to qualified people only over encrypted channels.

The University of Iowa Hospitals and Clinics generally requires that we document your participation in research occurring in a University of Iowa Health Care facility.  This documentation will be in either your medical record or a database maintained on behalf of the institution reflecting that you are participating in this study. The information included in the medical record will provide contact information for the research team as well as information about the risks associated with this study. We will keep this Informed Consent Document in our research files; it will not be placed in your medical record chart.

If we write a report or article about this study or share the study data set with others, we will do so in such a way that you cannot be directly identified.

Certificate of Confidentiality
To further protect your privacy, the researchers have obtained a Certificate of Confidentiality from the Department of Health and Human Services (DHHS).  This Certificate means that the researchers cannot be forced (for example by court subpoena) to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding.  However, a Certificate of Confidentiality does not prohibit the researcher from disclosing information about you or your involvement in this research that you have agreed to disclose or make available.  For example, if you or your legally authorized representative request in writing that information about you or your participation in the research be released to an insurance company, the researcher may not use the Certificate of Confidentiality to withhold this information.  This means that you and your family should actively protect your own privacy.  Finally, the researcher is not prevented from taking steps, including reporting to appropriate authorities, to prevent serious harm to yourself or others.  You may receive a copy of the Certificate of Confidentiality upon request.

WILL MY HEALTH INFORMATION BE USED DURING THIS STUDY?
The Federal Health Insurance Portability and Accountability Act (HIPAA) requires University of Iowa Health Care to obtain your permission for the research team to access or create “protected health information” about you for purposes of this research study.  Protected health information is information that personally identifies you and relates to your past, present, or future physical or mental health condition or care.  We will access or create health information about you, as described in this document, for purposes of this research. Once University of Iowa Health Care has disclosed your protected health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but we will continue to protect your confidentiality as described under “Confidentiality.”

We may share your health information related to this study with other parties including federal government regulatory agencies, the University of Iowa Institutional Review Boards and support staff, and other University of Iowa researchers.

You cannot participate in this study unless you permit us to use your protected health information.  If you choose not to allow us to use your protected health information, we will discuss any non-research alternatives available to you.  Your decision will not affect your right to medical care that is not research-related.  Your signature on this Consent Document authorizes University of Iowa Health Care to give us permission to use or create health information about you.

Although you may not be allowed to see study information until after this study is over, you may be given access to your health care records by contacting your health care provider. Your permission for us to access or create protected health information about you for purposes of this study has no expiration date. You may withdraw your permission for us to use your health information for this research study by sending a written notice to Allison Momany, PhD, 100 Hawkins Drive, 363 CDD, Iowa City, IA 52242.   However, we may still use your health information that was collected before withdrawing your permission.  Also, if we have sent your health information to a third party, such as the study sponsor or collaborator, or we have removed your identifying information, it may not be possible to prevent its future use.  You will receive a copy of this signed document.

IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If you decide to be in this study, you may stop participating at any time.  If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you otherwise qualify.

WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions.  If you have any questions about the research study itself, please contact: Allison Momany, PhD, University of Iowa; (319) 678-3054. If you experience a research-related injury, please contact: Human Subjects Office, 105 Hardin Library for Health Sciences, 600 Newton Road, The University of Iowa, Iowa City, Iowa, 52242-1098, (319) 335-6564, or e-mail irb@uiowa.edu. 

If you have questions, concerns, or complaints about  your rights as a research subject or about research related injury, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 600 Newton Rd, The University of Iowa, Iowa City, IA  52242-1098, (319) 335-6564, or e-mail irb@uiowa.edu.  General information about being a research subject can be found by clicking “Info for Public” on the Human Subjects Office web site, http://hso.research.uiowa.edu/. To offer input about your experiences as a research subject or to speak to someone other than the research staff, call the Human Subjects Office at the number above.

								Family ID: _________________________
This Informed Consent Document is not a contract. It is a written explanation of what will happen during the study if you decide to participate. You are not waiving any legal rights by signing this Informed Consent Document. Your signature indicates that this research study has been explained to you, that your questions have been answered, and that you agree to take part in this study.  You will receive a copy of this form.

1)  ____________________________     ________________________________________   ________
            (Print Parent’s Name)                                (Signature of parent which authorizes consent for self to participate)    (Date)
                                                                     
 2)  ___________________________    _________________________________________   ________ 
            (Print Parent’s Name)                               (Signature of parent which authorizes consent for self to participate)     (Date)

3)________________________ 4)___________________________ 5)___________________________
        (Print Child Subject’s Name)                        (Print Child Subject’s Name)                            (Print Child Subject’s Name)

__________________________    										     Signature of child (only if age 13 to 17)         Signature of child (only if age 13 to 17)              Signature of child (only if age 13 to 17)

       (Print Parent/Guardian Name)                 			     (Relationship to Child)  

___________________________________________________						
(Signature of Parent/Guardian which authorizes consent for child/children to participate)   (Date)

________________________________________________________________________________________________________________  

Check the method by which consent is being obtained:
□ Consent is being obtained by mail without a discussion between a research team member and the subject.  (Research team member does not sign this document)

□ Consent is being obtained in person or by mail after a discussion between a research team member and the subject. (Research team member signs below.)

Statement of Person Who Obtained Consent  
(This line is only to be signed by a research team member after discussion with subject.) 

I have discussed the above points with the subject or, where appropriate, with the subject’s legally authorized representative.  It is my opinion that the subject understands the risks, benefits, and procedures involved with participation in this research study.

__________________________________________            _______________________
(Signature of Person Who Obtained Consent)                                    (Date)