The SHARE because you CARE ADNP Patient Registry Project
PATIENT CONTACT and BASELINE INFORMATION
Informed Consent
Please read the following information very carefully. Please take your time and ask questions if you have any concerns. Your participation in the SHARE because you CARE ADNP Patient Registry Project will take place in several phases and it is completely voluntary. Should you elect to participate, you will need to fill out and agree to this Informed Consent form.
PATIENT CONTACT and BASELINE INFORMATION
Informed Consent
Please read the following information very carefully. Please take your time and ask questions if you have any concerns. Your participation in the SHARE because you CARE ADNP Patient Registry Project will take place in several phases and it is completely voluntary. Should you elect to participate, you will need to fill out and agree to this Informed Consent form.
Study ID: The SHARE because you CARE ADNP Patient Registry Project - Phase 1 - Contact and Baseline Information
FORM VERSION DATE 10/01/2019
FORM VERSION DATE 10/01/2019
TITLE OF RESEARCH STUDY:
Phase 1 - Informed Consent, Patient Contact and Baseline Information
Phase 1 - Informed Consent, Patient Contact and Baseline Information
PRINCIPAL INVESTIGATOR NAME AND CONTACT INFORMATION:
Name: Sandra Sermone, ADNP Kids Research Foundation
Mailing Address: 24500 NE 132nd Circle, Brush Prairie, WA 98606
Phone: 360-831-3069
Email: [email protected]
Name: Sandra Sermone, ADNP Kids Research Foundation
Mailing Address: 24500 NE 132nd Circle, Brush Prairie, WA 98606
Phone: 360-831-3069
Email: [email protected]
WHAT IS A RESEARCH STUDY?:
The purpose of a research study is to collect information for research. This is to gather the basic contact and baseline data on ADNP patients. Additional phases will follow to develop a complete international patient registry and natural history study data.
PURPOSE OF THIS FULL STUDY:
The purpose of this study is to collect contact information and baseline information from families who have children with an ADNP mutation, alteration or deletion to better understand the affects of the syndrome. The information will be used for research to develop a usable global patient contact database and gather baseline information on ADNP patients which can be used for future clinical studies, drug trials and/or additional research projects such as well a Natural History Study of ADNP syndrome.
Your child may qualify for participation in this study because he or she has been diagnosed with a mutation, alteration or partial deletion of their ADNP gene..
There is no monetary compensation for participating in this study.
*Throughout this document “child” refers to a minor or a legally incapable adult. “You” refers to any individual who may legally act on the minor’s behalf (e.g. parent or legal guardian)
DESCRIPTION OF WHAT’S INVOLVED:
If you agree to participate in this research study, the following information describes what may be involved.
INFORMATION:
We would like to collect contact and general syndrome related information about your child with ADNP syndrome. WE DO NOT WANT TO COLLECT MEDICAL RECORDS OR DOCUMENTS in this phase. We would like to do this by having you fill out the active ADNP Kids Research Foundation CARE because you CARE - ADNP Patient Registry Project Patient Contact and Baseline Information Questionnaire about your child.
We would like to store information that will be obtained from you during this current research study. We need to ask your permission to store this information. This information will be stored in a password protected system, backed up on a separate hard-drive and kept in locked equipment in a locked facility. For privacy purposes, the use of any of the information collected will be DE-IDENTIFIED and will NOT INCLUDE ANY IDENTIFYING INFORMATION ON YOU OR YOUR CHILD. such as name, address, email or phone number. Date of Birth will be shared to categorize ages of children for natural history study and clinical trial study separation. Date of Birth will never be linked to you or your child's name, address, email or phone number. Country of Origin will be shared in order to identify where the children are located for information, research and clinical trial purposes. Again, Country of Origin will never be linked to you or your child's name, address, email or phone number.
MEDICAL RECORDS:
At this time, we are requesting NO FORMAL MEDICAL RECORDS. If copies of formal medical records are needed, a separate informed consent will be created under a separate project name. This project will be patient reported medical information only, with no formal documents.
RESPONSIBILITIES FOR PARTICIPATING IN THIS STUDY:
If you decide to permit your child to take part in this study, you would be responsible for answering general patient information and baseline information questions honestly. Some questions will be mandatory. If you do not feel comfortable answering those questions then you do not need to participate in the registry.
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
You and your child will not be paid for participating in this study. Being in this study will not lead to extra costs to you and you will not be reimbursed for any costs. You will not be reimbursed for your or your child’s time that may be required to participate as described above (time filling out questionnaires, etc)
POSSIBLE BENEFITS:
You and/or your child are not expected to get any specific or direct benefit from taking part in this study. However, there may be some indirect benefit to you in that the de-identified information collected may be used to develop drug trial design, de-identified information shared with our research teams and published in summaries from the study, which may include informative syndrome descriptions, may help increase your knowledge about ADNP syndrome.
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS:
Participation will consist of your personal time in answering survey questions and possible follow up calls or email from the primary investigator or member of the research team.
PRIVACY:
We will never release the information about you or your family unless in the rare event that you authorize us to do so. We may publish de-identified results of this research study on our website and/or in medical literature. When we publish results, we do NOT use names, addresses, email or phone numbers of patients or parents/caregivers.
As an added layer of protection, the investigator/foundation will keep your name, address and contact information separate from the registry database. The information that you send will be assigned an ID number and names will never be shared unless you authorize us to do so. We will keep linking information, including name, address, email and phone number attached to assigned ID number under lock and key and confidential to the extent permitted by law.
There always exists the potential for loss of private information; however, these risks are extremely low and there are procedures in place to minimize this risk.
KNOWN RISKS DISCLOSURE:
We are required by law to inform you of any possible known risk scenario.
Your name and/or your child’s name and other information that could identify you will never be placed into a scientific database. Your child’s genetic information is unique to them, based on their unique sequence, therefore any prior publications with identifying information or information that ‘you, those you know personally or professionally have shared publicly’, can pose a risk. In the rare case that there is a break in security, this may also pose a risk of revealing information about your family having a child with ADNP syndrome and related health concerns. The risk of this happening is very small, but we are required by law to inform you of any possible known risks. as stated above, we have a layered plan of protection to protect your information as best as possible.
There is a US Federal law called the Genetic Information Nondiscrimination Act (GINA). Please review http://www.ginahelp.org for a full description.
OTHER POSSIBLE OPTIONS TO CONSIDER:
You may decide NOT to permit your child to take part in this research study without any penalty. The choice is totally up to you.
ENDING PARTICIPATION IN THE RESEARCH STUDY:
You may decide to STOP your child’s participation in this research study at any time without any penalty. If you decide to stop your child’s participation in the research study, please contact the Principal Investigator.
If you decide to stop your child’s participation in the research study, already collected information may not be removed from the research study database and will continue to be used to complete the research analysis.
If you decide to withdraw your permission for the use and disclosure of your child’s protected information for research, you must do so in writing to the Principal Investigator at the address on the this document. Even if you withdraw your authorization, the Principal Investigator for the research study may still use the information that was already collected if that information is necessary to complete and ongoing research study.
Please remember, at this time this project will not be collecting copies of any personal medical records at this time. If copied or electronic medical records are needed, a new informed consent will will be sent and your participation is optional.
Withdrawal without your consent or permission: The study team or the Principal Investigator may stop your child’s involvement in this research study at any time without your consent or permission. This may be because the research study is being stopped, the investigator believes it is in your child’s best interest, or for any other reason. If data has been stored as part of the research study, they too can be destroyed without your permission.
CONTACT PERSON:
If you have any questions, concerns, or complaints at any time about this research, please contact the Principal Investigator at email address [email protected] or phone number 360-831-3069.
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
In maintaining confidentiality, we are asking your permission consistent with the Federal Health Insurance Portability and Accountability Act (HIPAA).
What protected health information is collected and used in this study, and might also be disclosed (shared) with others?
As part of this research project, the researchers will collect your child’s name, address, telephone number, dates directly related to the child (birth, death, diagnosis), mutation, and photographic images. This information will be-identified and your child will be given a linked identification number and this linked personal information will be kept under lock and key, on a password protected database, and will never be linked to the registry database or shared without your prior written consent.
During the study the researchers will gather information by:
Why is your child’s protected health information being used?
Your personal contact information, and that of your child, is important to be able to contact you during the study. Your child’s health information being collected as part of this research study will be used for the purpose of this study as explained earlier in this consent form. The results of this study could be published or presented at scientific meetings, lectures, or other events, but would NOT include any information that would let others know who your child is, unless you give separate permission to do so.
Who, outside the ADNP Kids Research Foundation, might receive your child’s protected health information?
As part of the study, the Principal Investigator and the ADNP Kids Research Foundation may disclose protected health information, including the results of the research study to the following organizations: This will be done according to all HIPAA laws. (It is possible that there may be changes to this list during this research study; you may request an up-to-date list at any time by contacting the Principal Investigator.)
In all disclosures outside of the ADNP Kids Research Foundation, your child will not be identified by name, address, phone number or any other direct identifier unless discloser of direct identifier is required by law. Some records and information disclosed may be identified with a unique code number. The Principal Investigator will ensure that the records liked to the ID code will be kept securely stored electronically on a separate hard drive and printed together in a locked file. The code will not be used to link the information back to your child without your permission, unless the law requires it, or rarely if the Instructional Review Board allows it after determining that there would be minimal risk to your child’s privacy. It is possible that a sponsor or their representatives, a data coordinating office, a contract research organization, may come to inspect your child’s records. Even if those records are identifiable when inspected, the information leaving will be stripped of direct identifiers. OHRP and FDA are authorized to remove information with identifiers if necessary to complete their tasks. By signing this document you are authorizing this access.
For how long will the ADNP Kids Research Foundation be able to use or disclose your child’s protected health information?
Your authorization for your child’s protected health information for this specific study does not expire. However, you can request to remove your child from the study at anytime as noted above.
Will you be able to access your child’s records?
During participation in this study, you will have access to your child’s records and any study information that is part of that record. The investigator is not required to release information that is not part of your child’s medical record to you. A request in writing is required describing your desired access to the address of the Primary Investigator.
Do you need to give us permission to obtain, use or share you or your child health information?
NO! If you decide not to let us obtain, use or share your child’s health information you should NOT sign this form, and your child will not be included in the research study. If you do not sign, it will not affect eligibility or enrollment of other future studies.
If as part of this research project your child’s medical records are being reviewed or when your child’s medical history is being take, it is possible that HIV-related information may be revealed to the researchers. If that is the case, the following information concerns you.
The purpose of a research study is to collect information for research. This is to gather the basic contact and baseline data on ADNP patients. Additional phases will follow to develop a complete international patient registry and natural history study data.
PURPOSE OF THIS FULL STUDY:
The purpose of this study is to collect contact information and baseline information from families who have children with an ADNP mutation, alteration or deletion to better understand the affects of the syndrome. The information will be used for research to develop a usable global patient contact database and gather baseline information on ADNP patients which can be used for future clinical studies, drug trials and/or additional research projects such as well a Natural History Study of ADNP syndrome.
Your child may qualify for participation in this study because he or she has been diagnosed with a mutation, alteration or partial deletion of their ADNP gene..
There is no monetary compensation for participating in this study.
*Throughout this document “child” refers to a minor or a legally incapable adult. “You” refers to any individual who may legally act on the minor’s behalf (e.g. parent or legal guardian)
DESCRIPTION OF WHAT’S INVOLVED:
If you agree to participate in this research study, the following information describes what may be involved.
INFORMATION:
We would like to collect contact and general syndrome related information about your child with ADNP syndrome. WE DO NOT WANT TO COLLECT MEDICAL RECORDS OR DOCUMENTS in this phase. We would like to do this by having you fill out the active ADNP Kids Research Foundation CARE because you CARE - ADNP Patient Registry Project Patient Contact and Baseline Information Questionnaire about your child.
We would like to store information that will be obtained from you during this current research study. We need to ask your permission to store this information. This information will be stored in a password protected system, backed up on a separate hard-drive and kept in locked equipment in a locked facility. For privacy purposes, the use of any of the information collected will be DE-IDENTIFIED and will NOT INCLUDE ANY IDENTIFYING INFORMATION ON YOU OR YOUR CHILD. such as name, address, email or phone number. Date of Birth will be shared to categorize ages of children for natural history study and clinical trial study separation. Date of Birth will never be linked to you or your child's name, address, email or phone number. Country of Origin will be shared in order to identify where the children are located for information, research and clinical trial purposes. Again, Country of Origin will never be linked to you or your child's name, address, email or phone number.
MEDICAL RECORDS:
At this time, we are requesting NO FORMAL MEDICAL RECORDS. If copies of formal medical records are needed, a separate informed consent will be created under a separate project name. This project will be patient reported medical information only, with no formal documents.
RESPONSIBILITIES FOR PARTICIPATING IN THIS STUDY:
If you decide to permit your child to take part in this study, you would be responsible for answering general patient information and baseline information questions honestly. Some questions will be mandatory. If you do not feel comfortable answering those questions then you do not need to participate in the registry.
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
You and your child will not be paid for participating in this study. Being in this study will not lead to extra costs to you and you will not be reimbursed for any costs. You will not be reimbursed for your or your child’s time that may be required to participate as described above (time filling out questionnaires, etc)
POSSIBLE BENEFITS:
You and/or your child are not expected to get any specific or direct benefit from taking part in this study. However, there may be some indirect benefit to you in that the de-identified information collected may be used to develop drug trial design, de-identified information shared with our research teams and published in summaries from the study, which may include informative syndrome descriptions, may help increase your knowledge about ADNP syndrome.
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS:
Participation will consist of your personal time in answering survey questions and possible follow up calls or email from the primary investigator or member of the research team.
PRIVACY:
We will never release the information about you or your family unless in the rare event that you authorize us to do so. We may publish de-identified results of this research study on our website and/or in medical literature. When we publish results, we do NOT use names, addresses, email or phone numbers of patients or parents/caregivers.
As an added layer of protection, the investigator/foundation will keep your name, address and contact information separate from the registry database. The information that you send will be assigned an ID number and names will never be shared unless you authorize us to do so. We will keep linking information, including name, address, email and phone number attached to assigned ID number under lock and key and confidential to the extent permitted by law.
There always exists the potential for loss of private information; however, these risks are extremely low and there are procedures in place to minimize this risk.
KNOWN RISKS DISCLOSURE:
We are required by law to inform you of any possible known risk scenario.
Your name and/or your child’s name and other information that could identify you will never be placed into a scientific database. Your child’s genetic information is unique to them, based on their unique sequence, therefore any prior publications with identifying information or information that ‘you, those you know personally or professionally have shared publicly’, can pose a risk. In the rare case that there is a break in security, this may also pose a risk of revealing information about your family having a child with ADNP syndrome and related health concerns. The risk of this happening is very small, but we are required by law to inform you of any possible known risks. as stated above, we have a layered plan of protection to protect your information as best as possible.
There is a US Federal law called the Genetic Information Nondiscrimination Act (GINA). Please review http://www.ginahelp.org for a full description.
OTHER POSSIBLE OPTIONS TO CONSIDER:
You may decide NOT to permit your child to take part in this research study without any penalty. The choice is totally up to you.
ENDING PARTICIPATION IN THE RESEARCH STUDY:
You may decide to STOP your child’s participation in this research study at any time without any penalty. If you decide to stop your child’s participation in the research study, please contact the Principal Investigator.
If you decide to stop your child’s participation in the research study, already collected information may not be removed from the research study database and will continue to be used to complete the research analysis.
If you decide to withdraw your permission for the use and disclosure of your child’s protected information for research, you must do so in writing to the Principal Investigator at the address on the this document. Even if you withdraw your authorization, the Principal Investigator for the research study may still use the information that was already collected if that information is necessary to complete and ongoing research study.
Please remember, at this time this project will not be collecting copies of any personal medical records at this time. If copied or electronic medical records are needed, a new informed consent will will be sent and your participation is optional.
Withdrawal without your consent or permission: The study team or the Principal Investigator may stop your child’s involvement in this research study at any time without your consent or permission. This may be because the research study is being stopped, the investigator believes it is in your child’s best interest, or for any other reason. If data has been stored as part of the research study, they too can be destroyed without your permission.
CONTACT PERSON:
If you have any questions, concerns, or complaints at any time about this research, please contact the Principal Investigator at email address [email protected] or phone number 360-831-3069.
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
In maintaining confidentiality, we are asking your permission consistent with the Federal Health Insurance Portability and Accountability Act (HIPAA).
What protected health information is collected and used in this study, and might also be disclosed (shared) with others?
As part of this research project, the researchers will collect your child’s name, address, telephone number, dates directly related to the child (birth, death, diagnosis), mutation, and photographic images. This information will be-identified and your child will be given a linked identification number and this linked personal information will be kept under lock and key, on a password protected database, and will never be linked to the registry database or shared without your prior written consent.
During the study the researchers will gather information by:
- Asking you to fill out a questionnaire containing medical history (including current and past medications or therapies, illnesses, conditions or symptoms, family history, allergies, etc.)
- Completing the procedures, questionnaires and interviews explained in the description section of this consent
- Reviewing any other information provided by you.
Why is your child’s protected health information being used?
Your personal contact information, and that of your child, is important to be able to contact you during the study. Your child’s health information being collected as part of this research study will be used for the purpose of this study as explained earlier in this consent form. The results of this study could be published or presented at scientific meetings, lectures, or other events, but would NOT include any information that would let others know who your child is, unless you give separate permission to do so.
Who, outside the ADNP Kids Research Foundation, might receive your child’s protected health information?
As part of the study, the Principal Investigator and the ADNP Kids Research Foundation may disclose protected health information, including the results of the research study to the following organizations: This will be done according to all HIPAA laws. (It is possible that there may be changes to this list during this research study; you may request an up-to-date list at any time by contacting the Principal Investigator.)
- Other collaborating research center(s) and their associated research/clinical staff who are working with the Investigators of this project:
- Seaver Autism Center at the Icahn School of Medicine at Mount Sinai, New York
- Tel Aviv University, Israel
- University of Washington, Washingon
- University of Antwerp, Belgium
- Greenwood Genetics, South Carolina.
- The National Institute of Health (NIH).
In all disclosures outside of the ADNP Kids Research Foundation, your child will not be identified by name, address, phone number or any other direct identifier unless discloser of direct identifier is required by law. Some records and information disclosed may be identified with a unique code number. The Principal Investigator will ensure that the records liked to the ID code will be kept securely stored electronically on a separate hard drive and printed together in a locked file. The code will not be used to link the information back to your child without your permission, unless the law requires it, or rarely if the Instructional Review Board allows it after determining that there would be minimal risk to your child’s privacy. It is possible that a sponsor or their representatives, a data coordinating office, a contract research organization, may come to inspect your child’s records. Even if those records are identifiable when inspected, the information leaving will be stripped of direct identifiers. OHRP and FDA are authorized to remove information with identifiers if necessary to complete their tasks. By signing this document you are authorizing this access.
For how long will the ADNP Kids Research Foundation be able to use or disclose your child’s protected health information?
Your authorization for your child’s protected health information for this specific study does not expire. However, you can request to remove your child from the study at anytime as noted above.
Will you be able to access your child’s records?
During participation in this study, you will have access to your child’s records and any study information that is part of that record. The investigator is not required to release information that is not part of your child’s medical record to you. A request in writing is required describing your desired access to the address of the Primary Investigator.
Do you need to give us permission to obtain, use or share you or your child health information?
NO! If you decide not to let us obtain, use or share your child’s health information you should NOT sign this form, and your child will not be included in the research study. If you do not sign, it will not affect eligibility or enrollment of other future studies.
If as part of this research project your child’s medical records are being reviewed or when your child’s medical history is being take, it is possible that HIV-related information may be revealed to the researchers. If that is the case, the following information concerns you.
Notice Concerning HIV-Related Information
If you are authorizing the release of HIV-Information, you should be aware that the recipient(s) is (are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted to do so under federal or state law. You also have a right to request a list of people who may receive or use your child’s HIV-related information without authorization. If you or your child experience discrimination because of the release or disclosure of HIV-related information, you may contact an agency who is responsible for protecting your rights.
ADNP Syndrome description includes any individual who has been diagnosed with a mutation, change or partial deletion on their ADNP gene
If you are authorizing the release of HIV-Information, you should be aware that the recipient(s) is (are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted to do so under federal or state law. You also have a right to request a list of people who may receive or use your child’s HIV-related information without authorization. If you or your child experience discrimination because of the release or disclosure of HIV-related information, you may contact an agency who is responsible for protecting your rights.
ADNP Syndrome description includes any individual who has been diagnosed with a mutation, change or partial deletion on their ADNP gene
photo credit - www.ADNPkids.com
