Question Title

* 1. Please read this paragraph for CONSENT, then provide open-ended feedback to let us know if the paragraph was understandable and easy to be read.  If not, please state why.  

RESEARCH CONSENT SUMMARY
This study enrolls participants who may be unable to provide informed consent due to their age. The person providing permission for a child to participate in this study must be a parent or legal guardian. The terms “you” and “your” in this form refer to the parent or legal guardian. For participants of legal age to consent, and participants who become a legal adultduring the course of the study and are now reviewing this consent form, “your child” should be read as “you” throughout this consent document. For older adolescent participants reviewing this form for purposes of assenting to participate in this study, “your child” should be read as “you” throughout this form as well. We are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. We are asking permission for your child to participate in this research study because your child is currently receiving, as part of his/her standard medical care, at least one of the drugs we are studying. If you agree to allow your child to participate in this study, your child will be in this study for up to 90 days from the time of signing this consent/permission form. We will collect blood samples from your child. We will also collect certain information about your child’s health from their medical records. The risks of this study include the pain, potential bruising, risk of infection, and bleeding problems that could happen with drawing blood. There is also a potential risk of loss of confidentiality. What we learn in this study will be put in a database run by the National Institutes of Health (NIH) to be shared for future research. This information will not include anything that identifies your child.

Question Title

* 2. Please read this paragraph for CONSENT, then provide open-ended feedback to let us know if the paragraph was understandable and easy to be read. If not, please state why.

DETAILED RESEARCH CONSENT
You are being asked for your permission to allow your child to take part in a research study. A person who takes part in a study is called a “research participant.” The term “parent” could also refer to the legal guardian of a child. “Site staff” means any person at the site investigator’s location. The “study team” includes people involved with the study at the National Institute of Child Health and Human Development (NICHD), the Sponsor (the person in charge of the study overall), Duke University, and The Emmes Company, LLC.

Question Title

* 3. Please read this paragraph for CONSENT, then provide open-ended feedback to let us know if the paragraph was understandable and easy to be read. If not, please state why.

WHAT SHOULD I KNOW ABOUT THIS STUDY?
• Site staff will explain this study to you. This form sums up that explanation. You may take a copy of this form home to review before making your decision.
• Taking part in this study is voluntary. Whether you allow your child to take part is up to you.
• Your decision to not allow your child to participate or to stop participation at any time will not be used against you or your child. It will not affect your child’s access to health care at [insert site name] or other benefits that they would normally receive.
• If you don’t understand, ask questions. Ask all the questions you want before you decide and any time during the study.
• We encourage you to talk about this study with your child’s health care provider, your family, and your friends.
• We will tell you about any new information that may affect your child’s health, welfare, or your choice to have your child stay in this study.
• About 5,000 participants will take part in this study.

WHY IS THIS STUDY BEING DONE?
The purpose of this study is to learn more about how certain drugs given by your child’s regular health care provider, as part of your child’s routine medical care, act in the bodies of children and young adults, and to share what we learn with other researchers.This is important because we currently do not have enough information to know if the given doses are safe or effective. While drugs selected in this study may be used to treat children with various medical conditions, the U.S. Food and Drug Administration (FDA) has not approved use of some of the drugs in children/young adults or the best dose is not fully understood.

WHAT IS INVOLVED IN THIS STUDY?
How long will my child be in the study?
We expect that your child’s participation in this study will last up to 90 days from the date of consent/permission. If your child is given different drugs that we are studying by their health care provider in the future (more than 90 days from signing this consent/permission form), you may be asked about allowing your child to be in this study again. If your child has a reaction where the blood is drawn at the time of the blood draw, he/she will be followed for up to an additional hour. If your child has a reaction to the drug we are studying, he/she will be followed for up to an additional 7 days.

What will happen in the study?
We will record your child’s sex, date of birth, race, ethnicity, other birth information, and information on how to contact you. Depending on the hospital you are doing the study at, we may create a code for the rural versus urban area where your child lives most often. Only this code will be recorded in the study records. Your child cannot be personally identified by this code. We will also record information from your child’s medical record at this location. If your child is seen at another location, we may ask you to sign a form to allow us to get those records. Examples include medical history, Consent/Permission, physical exam, recent laboratory values, and evaluations over the course of your child’s hospitalization or clinic visits. If these evaluations are not already noted in the medical record, they may be performed for this study and will be recorded as study data.

Question Title

* 4. Please read this paragraph for CONSENT, then provide open-ended feedback to let us know if the paragraph was understandable and easy to read.  If not, please state why.  

Blood Collection and Testing
Blood will be collected from a heel stick, finger, hand or arm sticks, or from a line that is already present and used to draw blood. To reduce the number of blood draws or “sticks,” we will make every effort to collect study specific blood samples at the same time as your child’s routine blood draws; however, this may not always be possible. Blood samples will be collected up to 10 times from your child during the 90-day period of participation. The amount of blood collected per sample will be as follows:
• For children (less than 12 months of age) each blood sample will be about 1/10th of a teaspoon (0.5 mL). The total amount of blood collected for study testing will be up to approximately 1 teaspoon (5 mL) per the 90-day period.
• For children/young adults (12 months of age or older), each blood sample may be a little more than 1⁄2 teaspoon (3 mL). The total amount of blood collected for study testing will be up to approximately 2 tablespoons 30 mL) per the 90-day period.
If your child is an inpatient, no more than 3 needle sticks specifically for this study will happen in any day (24-hour period). If your child is an outpatient, no more than 6 needle sticks specifically for this study will happen per the 90-day period. The samples that we collect will be used to measure the amount of drug in your child’s blood. This information helps researchers understand what dose of the drug to give and how often it should be given. Based on which drug your child is receiving; we may test for certain biomarkers in your child’s blood. Biomarker tests can help us better understand the body’s response to certain drugs.

Leftover samples:
We may also collect “leftover” blood that has already been obtained as part of your child’s routine medical care and is being stored in the laboratory prior to being thrown away. Leftover samples used for this study may have been obtained before you signed this consent form and through the 90-day study period. We will only collect leftover samples after you have signed this consent form.

Question Title

* 5. Please read this paragraph for CONSENT, then provide open-ended feedback to let us know if the paragraph was understandable and easy to read.  If not, please state why. 

OPTIONAL: Genetic Tests
Researchers are studying how differences in people’s genes affect health. A gene contains information that determines traits (for example, eye color, height, or disease risk). We are interested in understanding if and how differences in genes impact drug dosing. At the end of this consent form you will have the chance to tell us whether you will allow us to use one of the blood samples we collect for the purpose of genetic testing. This information will help the researchers better understand the disease process and the
body’s response to the drugs.

We will not conduct whole genome sequencing (WGS) as part of this study. WGS provides complete genetic information which is unique to your child.
The genetic test(s) will not provide you with any medical information about your child’s present condition or any other disease or illness. The site staff will not put information about your child’s genetic test(s) results in your child’s medical records, and you/your child will not receive results from these tests.

A U.S. law called the Genetic Information Nondiscrimination Act (GINA)
• Protects against genetic discrimination (the use of genetic information to deny things such as employment or getting insurance) by employers and health insurers.
• Does not protect against genetic discrimination by companies
1.) that sell life insurance, disability insurance, or long-term care insurance.
2.) based on an already-diagnosed genetic condition or disease.

ARE THERE BENEFITS TO TAKING PART IN THIS STUDY?
There are no direct medical benefits to your child from taking part in this study. We hope the information learned from this study will benefit children in the future.

Question Title

* 6. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read.  If not, please share why.  

WHAT ARE THE DISCOMFORTS OR RISKS OF THE STUDY?
Please note: Your child is not receiving study drug as part of this study. Your child’s health care provider will review with you any side effects of the drug(s) they are prescribing for your child. You may also request information from the site investigator.
Risks of Blood Drawing:
There are small risks to having blood drawn. These risks may include some pain, discomfort, or bruising where the blood is drawn. There is a small chance of infection and bleeding problems.
Risk of Genetic Testing:
Test results will be kept confidential, but complete confidentiality cannot be guaranteed. Because some genetic conditions are very rare, it may be possible to identify test results to the person who gave the sample.
Unforeseen Risks:
There may be other risks to the participant from this research that are not known or foreseeable at this time.
Risk of Loss of Confidentiality:
There is a risk of loss of confidentiality. Every effort will be made to protect your child’s information, but this cannot be guaranteed.
WHAT OTHER CHOICES ARE THERE BESIDES TAKING PART IN THIS STUDY?
This study is not designed to diagnose, treat, or prevent any disease. Your child’s alternative is to not take part in the study. Even if you don’t allow your child to participate, he/she will have access to standard medical care at [the study site].
WILL I BE PAID FOR TAKING PART IN THIS STUDY?
There will be no money paid to you or your child for being in this study.
OR You will be reimbursed for time and travel, up to $100 in the form of a debit card for participating in study visits and sample collection(s).
Your child’s study data and/or samples will not be sold to anyone. However, the use of study data and/or samples may result in commercial profit. You will not receive any payment if there is commercial profit.
WILL I HAVE TO PAY TO TAKE PART IN THIS STUDY?
There will be no additional costs to you or your child as a result of being in this study. Any study specific procedures or study specific tests will be provided to your child free of charge. However, you or your insurance company will be charged for the standard medical care your child would receive whether or not your child participates in this study. You may wish to contact your child’s insurance company to talk about this further.
WHAT IF MY CHILD IS INJURED BECAUSE OF TAKING PART IN THIS STUDY?
If your child is injured or gets sick because of being in this study, call the site
investigator named on the first page of this form immediately. The investigator will provide your child with treatment or refer your child for treatment; you and/or your insurance will be billed for this.
Who will pay if my child is injured?
There is no plan by the study site to provide free medical care or money for injuries to participants in this study. There is no plan by the National Institute of Child Health and Human Development (NICHD), Duke University, or Duke University Health System to provide any reimbursement or payment for any study-related injury costs. You are not giving up any of your legal rights by signing this consent/permission form.

Question Title

* 7. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read. If not, please share why.

CONFIDENTIALITY What happens to my child’s study data and samples? 

The data we record as part of this study will be stored in a secure database. All study data in the database and samples will be given a unique code number and will not be labeled with your child’s name or initials, social security number, address or telephone number. Only the site staff conducting this study at [insert site name] can match your child’s name to this code number, if it is necessary to do so. The Emmes Company, LLC may review information that may identify your child, as part of their effort to monitor the study. All study team members who see your child’s personal information will keep it confidential. 

After the study is completed, all data and samples are de-identified, meaning anything that could be used to identify your child will be removed from the samples and data. All de-identified study data will be submitted to the NICHD data storage location called the Data and Specimen Hub or DASH (https://dash.nichd.nih.gov). Leftover de-identified study samples will be submitted to an NICHD sample storage location. With NICHD approval, these data and samples may be used by other researchers in the future. The purpose of sharing this information is to make more research possible that may improve children’s health. This will be done without obtaining additional permission from you. 

Other researchers may conduct WGS in the future. By doing WGS, the other researchers may have information that is unique to your child. 

The data and samples collected in this study may be kept forever. We may publish the results of this study. However, we will not include you or your child’s name or any other identifying information. This study is covered by a Certificate of Confidentiality (CoC) from the National Institutes of Health (NIH). The CoC further protects you and your child’s privacy. It keeps the courts and other agencies from forcing the U.S. study team to share information or body fluid samples that may identify your child during a legal proceeding unless you agree to this. If you want your study information shared with insurers, medical providers, or others not connected with this research, you must ask the investigator to release it.

Question Title

* 8. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read. If not, please share why.

WHAT INFORMATION WILL BE IN MY CHILD’S RECORDS AT THE STUDY LOCATION? 

Study data entered in your child’s medical records will be kept per [insert study site name] policies. Other study records will be kept until the FDA has completed their review of the results or for a minimum of 2 years after the study has ended, whichever is longer. A copy of this signed form may go into your child’s medical record. This will allow the health care providers caring for your child to know what tests your child is receiving as part of the study and to know how to take care of your child if he/she has other health problems or needs during the study. It is possible that you may not be able to see the information that has become part of your child’s records until the entire study is over. 

AUTHORIZATION FOR THE USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION 

The United States government has a Privacy Rule to protect the privacy rights of patients. The Privacy Rule protects the confidentiality of personal health information that can be linked to a specific individual. The information protected under the Privacy Rule is often referred to as “protected health information” or PHI. This section, called an “Authorization,” explains how your child’s PHI will be used and shared, and it also describes your child’s rights. 

Your child’s PHI, which may include your child’s dosing information and the results of any tests, therapies, or procedures that your child has for his/her medical care will be shared by site staff with individuals and organizations that oversee this study, including: 

• The study team (named on the first page of this form), and their authorized representatives, including laboratories that may be hired to perform tests, 

• Government agencies, such as international health regulatory agencies, the U.S. FDA and NICHD, a part of the NIH, who will obtain information from this study under the data collection authority given to them under U.S. law. 

• The Institutional Review Board (IRB), Ethics Committee(s) (US or global), and/or safety/data oversite committee(s)that review(s) the ethical and / or safety conduct of this study We try to make sure that everyone who sees your child’s PHI keeps it private, but we cannot guarantee this. If your child’s information is shared with anyone outside the study team, it may be further shared by them and may not be covered by federal privacy laws. Except when required by law, we will only use or share information outside the study team in a way that nobody can tell it is your child’s information. 

There is no expiration date for the use of this information as stated in this Authorization, but you have the right to stop this Authorization at any time. 

OR If the study site is in California, Delaware, Indiana, Washington, or Wisconsin: This Authorization will expire on 31Dec2060. If you want your child to be in this study, you must sign/date this form. By agreeing to be in this study, you are giving consent/permission (also called authorization) for us to use and disclose your child’s PHI as described in this form. If you refuse to allow the study team to share your child’s PHI, your child will not be able to be in the study. However, not signing this form will not affect your child’s access to medical care. 

You have the right to stop this Authorization at any time. To stop this Authorization, you should inform the site investigator, as named on the first page of this form, of your decision. Stopping your Authorization will prevent sharing of PHI in the future but will not affect any PHI that has already been shared.

Question Title

* 9. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read. If not, please share why.
WILL I SEE ANY STUDY RESULTS? You may be contacted by the study team conducting this research in the future to be provided with overall study results (summary results from all participants). This means you will not know the results as they relate to your child specifically. You can contact the site staff if you have any questions about study results availability. A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by law. This Web site will not include information that can identify your child. At most, the Web site will include a summary of the results. You can search this Web site at any time. You will not be provided with overall results from studies done with data and specimens submitted to the NIH data repository or storage facility. 

WHO CAN ANSWER MY QUESTIONS ABOUT THIS STUDY?  If you have questions about this study or concerns that your child was harmed as a result of participation, call the site staff at the phone number listed on the first page of this form. This study is being overseen by an IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at [insert appropriate information based on ruling IRB: (800) 562-4789 / help@wirb.com or 360-252-2500 / Help@copernicus.com] if: 

• You have questions, concerns, or complaints that are not being answered by the site staff. 

• You have questions about your child’s rights as a study participant. 

CAN MY CHILD BE REMOVED FROM THIS STUDY WITHOUT MY APPROVAL? 
Your child may be removed from this study without your approval. Possible reasons for removal include: 
• Your child’s condition changes, and the study is no longer in your child’s best interest 

• The entire study is stopped by the FDA, NICHD, or the IND sponsor 

• The investigator is no longer participating in the study 

• Your child does not follow the study rules 

While your child will not be removed from the study if she becomes pregnant, we request that you let us know and inform her doctor. 

WHAT HAPPENS IF I AGREE TO HAVE MY CHILD PARTICIPATE IN THIS STUDY, BUT I CHANGE MY MIND LATER? If you decide you no longer want your child to participate in this study, call the site staff at the phone number listed on the first page of this form. No additional samples will be collected and no new information about your child will be collected for study purposes unless your child has a side effect related to being in this  study. If a side effect occurs, the site staff may need to contact you or review your child’s medical records. 

Any information and study samples collected before your child’s withdrawal will remain a part of the study records.

Question Title

* 10. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read. If not, please share why.

THE INFORMATION BELOW CAN ONLY BE COMPLETED BY A PARTICIPANT OF LEGAL AGE, OR THEIR PARENT OR LEGAL GUARDIAN Decision to Include Blood Sample For Genetic Testing 

Please initial (or otherwise mark) the appropriate line to indicate whether or not you agree to provide a blood sample for genetic testing. 

______Yes, I give study staff permission to collect a blood sample for genetic testing. 

______No, I do not give study staff permission to collect a blood sample for genetic testing. I understand that I [my child] may still participate in this study without providing a blood sample for genetic testing. 



Question Title

* 11. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read. If not, please share why.

STATEMENT OF PARENTAL PERMISSION/STUDY CONSENT: 

Participants of legal age should consent for themselves to be in the study. 

STUDY STATEMENT OF PARENTAL PERMISSION/STUDY CONSENT 

By signing this form, I confirm that: 

• I have read this consent/permission form and was given enough time to consider the decision for myself/my child to participate in this study. 

• The purpose of this study, procedures to be followed, risks, and benefits have been explained to me. 

• I have been encouraged to ask questions, and my questions have been answered to my satisfaction. 

• I have been told whom to contact if I have questions, to talk about problems, concerns, or suggestions related to this study. 

• I have read this form and agree to give my consent/permission for myself/my child’s participation in this study. 

• I understand that participation in this study is voluntary, and I may withdraw myself/my child from the study at any time without affecting my/my child’s future medical care. 

• I have been told that I will be given a signed and dated copy of this consent/permission form. [as well as a signed and dated copy of the Experimental Subject’s Bill of Rights. ***For CA Sites Only***] 

Printed Name of Participant (if not signing the consent) 

The information below can only be completed by a Participant of legal age, a Parent or a Legal Guardian capable of providing permission. 

For Parents or Legal Guardians: By signing below, I certify that I am the parent or legal guardian of the participant named above. I am permitted under state law to sign this form on behalf of the participant. 


Printed Name of Parent or Legal Guardian (or Printed Name of Participant of legal age) 

Relationship to participant, if applicable (check one) 

Mother Father 

Legal Guardian 



Question Title

* 12. Please read this paragraph for CONSENT, then provide open-ended feedback about the paragraph if it is understandable and easy to read. If not, please share why.

STUDY STATEMENT OF PERSON OBTAINING CONSENT/PARENTAL/LEGAL GUARDIAN PERMISSION AND/OR ASSENT (As applicable) 

My signature below documents that: I have fully explained the study described by this form in a language the person(s) signing this form understood or via translation. I have answered their questions and will answer any future questions to the best of my ability. I will tell the person(s) signing this form of any changes in procedures or in the possible harms/possible benefits of the study that may affect their willingness to provide consent/permission/assent to stay in the study. Consent/Permission/Assent was freely given, and I will provide the person(s) signing this form with a signed copy of this form. 

The information below can only be completed by the person obtaining consent/permission/assent. 

Printed Name of Person Obtaining Consent/Permission/Assent 

Signature of Person Obtaining Consent/Permission/Assent



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