CDH Subscriber Details

General Information
Study Title: CDH Patient Registry
Participation Duration: Ongoing
Anticipated Number of Subjects: Continued Enrollment

Research Purpose: The primary purpose of this database is to collect, collate, and make available to partnered researchers the natural history of individuals with a congenital diaphragmatic defect. This collection will help researchers investigate the cause(s) of CDH and develop standard of care practices.

Information on Research

Introduction

The purpose of this form is to give you information to help you decide if you want to take part in a research study and to give your permission to the research team to obtain and use your patient information. This consent and HIPAA authorization form includes information about:
• why the study is being done;
• the things that you will be asked to do if you are in the study;
• any known risks involved;
• any potential benefit;
• options, other than taking part in this study, that you have; and
• the way your health information will be used and shared for research purposes.

A research coordinator is available to discuss the study with you. If at any time you have questions about the study, please ask a member of the CDH International Research Team. Take all the time you need to decide whether you want to take part in this research study.

This document is also used for parents to provide permission to the research team to obtain the patient information of their minor children, and for legally authorized representatives of subjects (such as an appropriate family member) to provide permission to the research team to obtain patient information of individuals who are not capable themselves of providing permission. In such cases, the terms “you” and “your patient information” refer to the subject rather than the person providing permission.

A minor’s signature is required to release the following information about the minor: 1. Age 14 and older – information relating to reproductive care, including but not limited, to birth control and pregnancy-related services and sexually-transmitted diseases, including HIV/AIDS and 2. Age 13 and older – substance abuse diagnosis or treatment, and mental health information.

Study Purpose

You are invited to participate in CDH International’s Natural History Database. Since 1995, CDH International has collected the natural history information from CDH patients with over 5,000 participants. This survey collects data not normally obtained by specialists and emergency care physicians. We hope to use this database alongside medical researchers to reveal any potential root causes, mitigating or aggravating factors involved in occurrence and mortality, and up-todate risk assessments.

This database’s enrollment is on-going, and you are being invited to participate because you are either the patient, or the surviving or non-surviving patient’s primary care giver. Participants are members of CDH International and have been administratively approved to ensure the integrity of our data. If you would like to participate but are not a member, please reach out to CDH International’s Support Team.

Study Procedures

If you have been invited to participate you will receive and email with a link to this document and a link to the survey. Please download this document, sign it, and upload it on the first page that asks for your Informed Consent.

The survey consists of yes/no questions, multiple choice, checkboxes, and open-ended questions. Please fill out the forms to the best of your ability. Please do not guess if you are not certain. If the question does not fit your situation, please skip it without answering. You may refer to any resource you may have been given to answer your questions. If there are questions or answers that do not make sense, please reach out to the CDH International Research Team.

Risks

What are the risks of the study?

There are no physical risks associated with participating in the study.

Additional Information

Sharing of de-identified natural history data

The natural history data generated through the research study will be de-identified and made available to clinical and genetic researchers who partner with CDH International. These data may be used by other researchers who have permission granted to access the information. The natural history data submitted will be de-identified and only the principal investigator of the CDH International study will be able to link back the natural history data to the participant. No one else will learn your identity. The sharing of these samples and data will aid in the advancement of CDH research.

Benefits

Your child will not benefit personally from this study. Your child will not receive immediate medical benefit from participation. Benefits to society may include further understanding of the genetic basis of disease. Ultimately this understanding can lead to significant improvements in the prevention and treatment of human disease.

Alternative Procedures

There are no alternative procedures. Your decision to either participate in this study or not participate will have no effect on the patient's medical care or outcome.

Compensation

There will be no compensation for your participation.

Additional Costs

There will be no additional costs to you or the patient

Patient Information Use

The patient information that will be obtained and used “Patient information” means the health information in your medical or other healthcare records. It also includes information in your records that can identify you. For example, it can include your name, address, phone number, birthdate, and medical record number.

1. Location of patient information
By signing this form, you are giving permission to the following organization to disclose your patient information for this research.
• CDH International

2. Patient information that will be released for research use
The specific information that will be released and used for this research is described below:

• All records [De-Identified]

How your patient information will be used

1. Who may receive your patient information

• Researchers at CDH International. “CDH International” includes any persons or companies that are working with or for the CDH International, or that are owned by the institution

2. Why your patient information will be used and/or given to others

o To build a repository of CDH patient natural histories for research into best practices, causes, and peripheral patient-centered care datapoints

o To do the research

o To study the results, and

o To see if the research was done right
If the results of this study are made public, information that identifies you will not be used. The researcher will use your patient information only in the ways that are described in the research consent form that you sign and as described in this HIPAA
Authorization.

You can ask questions about what the research team will do with your information and how they will protect it.

The privacy laws do not always require the receiver of your information to keep your information confidential. After your information has been given to others, there is a risk that it could be shared without your permission.

You have the right to obtain your patient information in the CDH Natural History Database. We will provide you with your full record upon request.

Expiration

This permission for the researchers to obtain your patient information: Ends upon the dissolution of CDH International

Confidentiality

Any information obtained during this study and associated with your child will remain strictly confidential. Absolute confidentiality cannot be guaranteed. Despite all our efforts, unanticipated problems, such as a stolen computer may occur, although it is highly unlikely. Access to your health information is required to be part of this study. If you choose to take part in this study, you are giving us the authorization (i.e., your permission) to use the protected health information and information collected during the research that can identify your child. The health information that we may collect and use for this research may include medical history that may be considered sensitive.

Information about your child may be obtained from any hospital, doctor, and other health care provider involved in your child's care that is needed for this research purpose, including the surgeon or physician.

The research information that is shared with people outside of CDH International will not include your name, address, telephone number or any other direct identifier unless disclosure of the information is required by law, or you have authorized the disclosure.

Research findings will not be part of your child's medical record. The patient’s data will be assigned a code number and separated from your child's name or any other information that could identify your child.
The research file that links your child's name to the code number will be kept in an encrypted file, and only the investigators and study staff will be allowed to look at this file. Study information will only be released if ordered by a court of law. Access to names of research program participants and coded samples will be strictly controlled by the Principal Investigator. Your child's identity will not be revealed when research findings are published. Federal regulations give you certain rights related to your child's health information. These include the right to know who will be able to get the information and why they may be able to get it. The investigator for this research study must obtain your authorization (permission) to use or give out any health information that might identify your child. This includes medical and research records, records of telephone calls, records of study visits, records about this study.

By signing this document, you grant permission for medical information about your child, obtained during this study to be made available to:

- The investigators and study staff and other medical professionals who may be evaluating the study

If the results of the study are published or presented at a medical or scientific meeting your child will not be identified. By signing this consent form, you are giving permission to use and give out health information as listed above for the purposes described. If you refuse to give permission, your child cannot participate in this research study.

Your authorization to use and share your child’s health information does not have an expiration (ending) date.

Once your child’s health information has been disclosed to a third party, federal privacy laws may no longer protect it from further disclosure.

You may change your mind and revoke (take back) this consent and authorization at any time and for any reason. To revoke this consent and authorization, you must contact the Research Administrator at research@cdhi.org.

However, if you revoke your consent and authorization, you will not be allowed to continue taking part in the Research.

Voluntary Participation

The patient’s participation in this study is completely voluntary. You can withdraw the patient from the study at any time and such a decision will not affect your/your child's medical now or in the future. The investigator is also free to terminate the study, or your child's participation in it, at any time. Signing this form does not waive any of your child's legal rights.

You do not have to sign this consent form. If you do not, you will not be allowed to join the research study. Your decision to not sign this permission will not affect any other treatment, health care, enrollment in health plans or eligibility for benefits.

If you have any questions, please ask, and we will do our best to answer them. If you have additional questions in the future, you can reach out to the Research Administrator at research@cdhi.org.