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Consent and Parental Permission to Participate in Research
Title of Research: Rare Epilepsy Network (REN) Registry
Introduction
You are being asked to participate in a research study for yourself and the person with a rare epilepsy.
Throughout this form we will use the term “affected person” to refer to the person with a diagnosis of a rare
epilepsy. The affected person may be your minor child or an adult for whom you are the legal guardian.
Before you decide about participation, please read this form so that you understand the study’s purpose and
what you will be asked to do if you decide to enroll yourself and the affected person in the study. This form is
for parents (or legal guardians) to consider (1) their own participation and (2) permitting the affected person to
participate. This form tells you who can be in the study, the risks and benefits of participation, how we will
protect information, and who you can contact if you have questions.
Purpose
The Rare Epilepsy Network (REN) registry is being created to conduct research on a group of syndromes or
disorders that are both rare and may be associated with epilepsy (another word for seizures). REN includes the
Epilepsy Foundation, RTI International, Columbia University, and several rare disease organizations that
advocate for patients with rare epilepsy.
The REN study described here is being conducted by the Epilepsy Foundation, RTI International, a research
organization located in North Carolina, and Columbia University in New York. The purpose of this study is to
develop a registry of people with rare epilepsies in order to: (1) understand what these disorders have in
common and how they change over time; and (2) share information on new studies in which patients may be
eligible. The study intends to enroll approximately 3000 individuals living in the United States, including 1500
affected persons with a rare epilepsy and 1500 parents or legal guardians.
You may have found out about the REN registry through one of the rare epilepsy organizations or the Epilepsy
Foundation, a description of the registry sent by email, or an announcement on social media. You may follow
the progress of the REN and this study through the website at http://REN.rti.org.
Procedures
Participation would include the activities described below, all completed through a secure website which you
can access at any time. Once you complete the initial activities, we will send you emails 2-3 times a year
asking you to update the initial survey by answering questions about any changes that may have occurred. We
plan to collect information from you over several years. However, any time we contact you in the future, you
will be free to refuse to further participate. If you agree, we will also send you an email if we know of a study
by another researcher that you or the affected person may be eligible for, so you can decide whether to contact
the researcher to ask questions or to indicate interest in participating.
The first activities after you agree to participate will ask you to:


Provide your contact information
Provide the name, date of birth and social security number of the affected person. Providing the social
security number of the affected person is optional.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 1 of 10

Complete a survey about (1) the affected person’s demographics, medical history, current health,
mental health, growth and development, treatment, genetic testing, imaging studies, and changes in
disease severity over time and (2) because we are also interested in how seizures and epilepsy has
affected your life, we will ask you survey questions about your quality of life, any financial burden
you have experienced as a result of caring for the affected person, and other impacts of epilepsy on
your life. This survey will take about 45 minutes to complete.
You have a choice about whether you want to do these activities.

Upload the affected person’s most recent EEG report, MRI report, and genetic testing results that you
have in your personal files. The study team will provide instructions for how to upload these
documents. These documents will be part of the affected person’s study data and will be reviewed by a
study physician to evaluate the affected person’s condition for the purposes of the study.

Permit the research team to share your name and email address, and the name of the affected person
with the patient advocacy organization that is related to the affected person’s condition. The patient
organization may use this information to establish a membership list or to contact you about future
events, such as family conferences.

Permit the research team to share de-identified survey information with investigators inside and
outside the registry and network who are interested in studying issues related to rare epilepsy. The
research team will approve access to de-identified data only after they consider the investigator’s
qualifications. De-identifying the data prevents your identity from being connected to your answers to
study questions. De-identified information will not contain any identifiers or personal information that
could identify you or the affected person, but does include all survey responses about the affected
person, including information regarding their medical history and genetic testing. Any medical
records you have uploaded at the web site and any information about your quality of life would not be
shared. You will be asked about whether your de-identified survey responses can be shared with other
investigators after each survey or survey section has been completed.

Permit us to take steps if we are unable to reach you after trying for one year. We ask permission to
submit the affected person’s name, date of birth and social security number to a national death index to
determine his/her vital status.
There are some follow-up activities that occur after these initials steps that you should consider as well:




Two-three times each year you will be asked to complete a follow-up survey that takes about 30
minutes to complete. It will ask about changes over time in the information you provided at enrollment
on both the affected person and yourself, and other issues that may be related to rare epilepsy. You
will be asked to upload additional medical records in your personal file as well.
If you tell us the affected person has passed away, we will ask you to complete a form about the
person’s death. Participation for you and the affected person will end at that time.
Complete additional surveys about the affected person’s condition or about the impact of epilepsy or
seizures on your life as part of this study.
It is also possible that we may contact you about obtaining a biologic specimen from the affected
person for future research purposes. That aspect of the study will be described in a separate consent
form.
Possible Risks or Discomforts
It is possible that some of the survey questions may make you uncomfortable or upset. You may refuse to
answer any question or you may take a break at any time and return to the website to finish answering the
questions. There is also an unlikely risk for loss of confidentiality but your private data and the affected
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 2 of 10
person’s private data will be kept in the strictest confidence and will be accessible only to investigators
working on this study or others you have specifically given permission to use it.
Benefits
There are no direct benefits to you or the affected person in this study, but your participation may help future
people with a rare epilepsy receive a quicker diagnosis or better treatment. Through the study website, you
may access reports of summary data collected within the different rare epilepsy conditions. There will also be
opportunities for you to participate in other research projects if you wish.
Payment for Participation
You will not be paid to participate in this study.
Confidentiality and Data Security
Many precautions have been taken to protect your and the affected person’s personal and health information.
All personal information like your name, address and telephone number and the affected person’s name and
social security number will be stored separately in a secure database from the answers you provide on the
surveys. All the information you enter through the study website will be labeled only with a special code
number and not any personal information so the information cannot be traced back to you. The information
you enter through the study website is protected by secure socket layer (SSL) technology. This technology
scrambles (encrypts) the data as it is being sent over the internet. Any personal health records that you choose
to upload through the study website will also be kept secure and confidential, separate from your and the
affected person’s identifying information, and with access only to people working on the study.
If the results of this study are presented at meetings or published in scientific journals, no information will be
included that could identify you, the affected person or your answers.
Genetic Information Nondiscrimination Act (GINA)
While it is unlikely that there would be a breach of confidentiality, a special federal statute addresses how
genetic information may be used in certain settings. This study requests information on genetic testing. The
surveys contain questions about genetic testing for the affected person and for family members. Uploaded
medical information may also contain genetic information. Here is information about the statute:
A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for
health insurance companies, group health plans, and most employers to discriminate against you or the
affected person based on your/their genetic information. This law generally will protect you and the affected
person. However, this Federal law does not protect you or the affected person against genetic discrimination
by companies that sell life insurance, disability insurance, or long-term care insurance.
Your Rights
Your decision, to participate in this study and to permit the affected person to participate, is completely
voluntary. You can refuse any part of the study and you can stop participating at any time. You can refuse to
answer any question. If you decide to participate and later change your mind, you will need to notify us by
email at REN@rti.org and you will not be contacted again or asked for further information. If you choose to
stop participating, we will continue to use the information you have already sent us as part of our research
study unless you ask us not to in the email. If you no longer want your information used in our research, we
will delete your survey responses and any records or reports you uploaded. If you permitted us to share
information about you and the affected person with another group, we cannot withdraw that information.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 3 of 10
Your Questions
The Institutional Review Board (IRB) at RTI International has reviewed and approved this research. An IRB
is a group of people who are responsible for assuring that the rights of participants in research are protected.
The IRB may review the records of your participation in this research to assure that proper procedures were
followed.
If you have any questions about the study or your participation, you may email us at REN@rti.org or call the
REN toll free number at 888-886-3745 and someone will get back to you during normal business hours. If you
have any questions about your rights as a study participant, you may call RTI’s Office of Research Protection
at 1-866-214-2043 (a toll-free number) during normal business hours.
[NEW PAGE]
Summary of Consent
Please check how well we have described this study by reviewing the following list of key points:

The purpose of this study is to develop a registry of people with rare epilepsies in order to better
understand these disorders and to share information on new studies.

You will be asked to enter personal information and survey responses through a secure website.

All of your survey responses will be labeled with a code number and kept separate from any
identifying information.

The enrollment survey will take about 45 minutes to complete.

Follow-up surveys may take 30 minutes to complete.

Some survey questions may make you feel uncomfortable or upset.

We will ask you to upload recent EEG, MRI and genetic test results through the secure website.

This study asks for genetic information from the affected person in the survey and in the medical
records.

Your personal information and your survey responses will be kept secure and confidential.

You will not receive any payment or incentive for your participation.

A committee that protects participants in research has approved this study.

You may email us or call one of the phone numbers in the consent to ask questions about the study or
your rights as a research subject.

Your participation in this study is completely voluntary. You may stop participating at any time by
contacting us or by refusing to provide additional information.
Only if you gave your permission will we:
 Tell you about other research studies you may qualify for

Send your name and email address and the affected person’s name to the patient advocacy
organization that is related to the affected person’s condition.

Share your de-identified survey responses about the affected person with other investigators only
when the study team has approved their request. After each survey or survey section you complete, we
will ask you whether your responses to that survey or section may be shared.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 4 of 10

Send the affected person’s name, date of birth and social security number to a national death index.

Contact you if we learn the affected person has passed away.
[NEW PAGE]
The consent form referenced several optional activities. Please indicate whether or not you wish to permit
these additional study activities.
PLEASE CHECK THE APPROPRIATE BOX BESIDE EACH STATEMENT INDICATING
WHETHER YOU AGREE OR DISAGREE:
YES NO I agree that the study may send me information to review about other research studies in the
future that the affected person or I may qualify for. If I check YES, I am not consenting to participation in
these studies. I understand I will be provided with contact information for the study investigator and/or an
additional consent to review and make a decision whether to participate or not.
YES NO I agree that my name and email address and the affected person’s name may be sent to the
patient advocacy organization that is related to the affected person’s condition. The patient organization may
use this information to establish a membership list or to contact me about future events.
YES NO I agree that the affected person’s name, date of birth, and social security number may be sent
to a national death index to determine his/her vital status if the study is unable to contact me by email, phone
or mail after trying for one year.
YES NO I agree to be contacted by the study if the national death index indicates the affected person
has died in order to find out more information about the death.
Please complete the section below if you wish to participate.
Please indicate your relationship to the affected person (check one box).
I am the parent of an affected person that is less than 18 years old
I am the legal guardian of an affected person that is at least 18 years old (an adult). A legal guardian is an
individual who is authorized under applicable State or local law to consent on behalf of a child or
incompetent adult to general medical care.
By checking the box below, you indicate that you have read the study consent form and the summary, you
have received answers to your questions, and you have freely decided to participate in this research.
I consent to participate in this research and I have the legal authority to give permission for the affected
person to participate.
Name of affected person ___________________________________________
Name of person providing consent ___________________________________
PLEASE DOWNLOAD A COPY OF THIS CONSENT FORM TO KEEP.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 5 of 10
Consent to Participate in Research
Title of Research: Rare Epilepsy Network (REN) Registry
Introduction
You are being asked to participate in a research study. Before you decide about participation, please read this
form so that you understand the study’s purpose and what you will be asked to do if you decide to enroll in the
study. This form also tells you who can be in the study, the risks and benefits of participation, how we will
protect information, and who you can contact if you have questions.
Purpose
The Rare Epilepsy Network (REN) registry is being created to conduct research on a group of syndromes or
disorders that are both rare and may be associated with epilepsy (another word for seizures). REN includes the
Epilepsy Foundation, RTI International, Columbia University, and several rare disease organizations that
advocate for patients with rare epilepsy.
The REN study described here is being conducted by the Epilepsy Foundation, RTI International, a research
organization located in North Carolina, and Columbia University in New York. The purpose of this study is to
develop a registry of people with rare epilepsies in order to: (1) understand what these disorders have in
common and how they change over time; and (2) share information on new studies in which patients may be
eligible. The study intends to enroll approximately 3000 individuals living in the United States, including 1500
affected persons with a rare epilepsy and 1500 parents or legal guardians of patients that are not able to
consent for themselves.
You may have found out about the REN registry through one of the rare epilepsy organizations or the Epilepsy
Foundation, a description of the registry sent by email, or an announcement on social media. You may follow
the progress of the REN and this study through the website at http://REN.rti.org.
Procedures
Participation would include the activities described below, all completed through a secure website which you
can access at any time. Once you complete the initial activities, we will send you emails 2-3 times a year
asking you to update the initial survey by answering questions about any changes that may have occurred. We
plan to collect information from you over several years. However, any time we contact you in the future, you
will be free to refuse to further participate. If you agree, we will also send you an email if we know of a study
by another researcher that you may be eligible for, so you can decide whether to contact the researcher to ask
questions or to indicate interest in participating.
The first activities after you agree to participate will ask you to:
 Provide your contact information
 Provide your name, date of birth and social security number. Providing your social security number is
optional.
 Complete a survey about your demographics, medical history, current health, mental health, growth
and development, treatment, genetic testing, imaging studies, changes in disease severity over time,
quality of life, any financial burden you have experienced as a result of having epilepsy, and other
impacts of epilepsy on your life. This survey will take about 45 minutes to complete.
You have a choice about whether you want to do these activities.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 6 of 10

Upload the most recent EEG report, MRI report, and genetic testing results that you have in your
personal files. The study team will provide instructions for how to upload these documents. These
documents will be part of your study data and will be reviewed by a study physician to evaluate your
condition for the purposes of the study.

Permit the research team to share your name and email address with the patient advocacy organization
that is related to your condition. The patient organization may use this information to establish a
membership list or to contact you about future events, such as family conferences.

Permit the research team to share de-identified survey information with investigators inside and
outside the registry and network who are interested in studying issues related to rare epilepsy. The
research team will approve access to de-identified data only after they consider the investigator’s
qualifications. De-identifying the data prevents your identity from being connected to your answers to
study questions. De-identified information will not contain any identifiers or personal information that
could identify you, but does include survey responses about you, including information regarding your
medical history and genetic testing. Any medical records you have uploaded at the web site would not
be shared. You will be asked about whether your de-identified survey responses can be shared with
other investigators after each survey or survey section has been completed.

Permit us to take steps if we are unable to reach you after trying for one year. We ask permission to
submit your name, date of birth and social security number to a national death index to determine your
vital status.
There are some follow-up activities that occur after these initials steps that you should consider as well:



Two-three times each year you will be asked to complete a follow-up survey that takes about 30
minutes to complete. It will ask about changes over time in the information you provided at enrollment
and other issues that may be related to rare epilepsy. You will be asked to upload additional medical
records in your personal file as well.
Complete additional surveys about your condition or about the impact of epilepsy or seizures on your
life as part of this study.
It is also possible that we may contact you about obtaining a biologic specimen for future research
purposes. That aspect of the study will be described in a separate consent form.
Possible Risks or Discomforts
It is possible that some of the survey questions may make you uncomfortable or upset. You may refuse to
answer any question or you may take a break at any time and return to the website to finish answering the
questions. There is also an unlikely risk for loss of confidentiality but your private data will be kept in the
strictest confidence and will be accessible only to investigators working on this study or others you have
specifically given permission to use it.
Benefits
There are no direct benefits to you in this study, but your participation may help future people with a rare
epilepsy receive a quicker diagnosis or better treatment. Through the study website, you may access reports of
summary data collected within the different rare epilepsy conditions. There will also be opportunities for you
to participate in other research projects if you wish.
Payment for Participation
You will not be paid to participate in this study.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 7 of 10
Confidentiality and Data Security
Many precautions have been taken to protect your personal and health information. All personal information
like your name, address, telephone number, and social security number will be stored separately in a secure
database from the answers you provide on the surveys. All the information you enter through the study website
will be labeled only with a special code number and not any personal information so the information cannot be
traced back to you. The information you enter through the study website is protected by secure socket layer
(SSL) technology. This technology scrambles (encrypts) the data as it is being sent over the internet. Any
personal health records that you choose to upload through the study website will also be kept secure and
confidential, separate from your identifying information, and with access only to people working on the study.
If the results of this study are presented at meetings or published in scientific journals, no information will be
included that could identify you or your answers.
Genetic Information Nondiscrimination Act (GINA)
While it is unlikely that there would be a breach of confidentiality, a special federal statute addresses how
genetic information may be used in certain settings. This study requests information on genetic testing. The
surveys contain questions about genetic testing for you and for family members. Uploaded medical
information may also contain genetic information. Here is information about the statute:
A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for
health insurance companies, group health plans, and most employers to discriminate against you based on your
genetic information. This law generally will protect you. However, this Federal law does not protect you
against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care
insurance.
Your Rights
Your decision, to participate in this study is completely voluntary. You can refuse any part of the study and
you can stop participating at any time. You can refuse to answer any question. If you decide to participate and
later change your mind, you will need to notify us by email at REN@rti.org and you will not be contacted
again or asked for further information. If you choose to stop participating, we will continue to use the
information you have already sent us as part of our research study unless you ask us not to in the email. If you
no longer want your information used in our research, we will delete your survey responses and any records or
reports you uploaded. If you permitted us to share information about you with another group, we cannot
withdraw that information.
Your Questions
The Institutional Review Board (IRB) at RTI International has reviewed and approved this research. An IRB
is a group of people who are responsible for assuring that the rights of participants in research are protected.
The IRB may review the records of your participation in this research to assure that proper procedures were
followed.
If you have any questions about the study or your participation, you may email us at REN@rti.org or call the
REN toll free number at 888-886-3745 and someone will get back to you during normal business hours. If you
have any questions about your rights as a study participant, you may call RTI’s Office of Research Protection
at 1-866-214-2043 (a toll-free number) during normal business hours.
[NEW PAGE]
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 8 of 10
Summary of Consent
Please check how well we have described this study by reviewing the following list of key points:

The purpose of this study is to develop a registry of people with rare epilepsies in order to better
understand these disorders and to share information on new studies.

You will be asked to enter personal information and survey responses through a secure website.

All of your survey responses will be labeled with a code number and kept separate from any
identifying information.

The enrollment survey will take about 45 minutes to complete.

Follow-up surveys may take 30 minutes to complete.

Some survey questions may make you feel uncomfortable or upset.

We will ask you to upload recent EEG, MRI and genetic test results through the secure website.

This study asks for genetic information in the survey and in the medical records.

Your personal information and your survey responses will be kept secure and confidential.

You will not receive any payment or incentive for your participation.

A committee that protects participants in research has approved this study.

You may email us or call one of the phone numbers in the consent to ask questions about the study or
your rights as a research subject.

Your participation in this study is completely voluntary. You may stop participating at any time by
contacting us or by refusing to provide additional information.
Only if you gave your permission will we:
 Tell you about other research studies you may qualify for

Send your name and email address to the patient advocacy organization that is related to your
condition.

Share your de-identified survey responses with other investigators only when the study team has
approved their request. After each survey or survey section you complete, we will ask you whether
your responses to that survey or section may be shared.

Send your name, date of birth and social security number to a national death index.
[NEW PAGE]
The consent form referenced several optional activities. Please indicate whether or not you wish to permit
these additional study activities.
PLEASE CHECK THE APPROPRIATE BOX BESIDE EACH STATEMENT INDICATING
WHETHER YOU AGREE OR DISAGREE:
YES NO I agree that the study may send me information to review about other research studies in the
future that I may qualify for. If I check YES, I am not consenting to participation in these studies. I understand
I will be provided with contact information for the study investigator and/or an additional consent to review
and make a decision whether to participate or not.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 9 of 10
YES NO I agree that my name and email address may be sent to the patient advocacy organization that
is related to my condition. The patient organization may use this information to establish a membership list or
to contact me about future events.
YES NO I agree that my name, date of birth, and social security number may be sent to a national death
index to determine my vital status if the study is unable to contact me by email, phone or mail after trying for
one year.
Please complete the section below if you wish to participate.
By checking the box below, you indicate that you have read the study consent form and the summary, you
have received answers to your questions, and you have freely decided to participate in this research.
I consent to participate in this research and I am at least 18 years of age
Name of person providing consent ___________________________________
PLEASE DOWNLOAD A COPY OF THIS CONSENT FORM TO KEEP.
Consent Version: [insert consent revision date]AMD EDITS!
RTI IRB ID: [insert IRB ID number – obtain from IRB office]
RTI IRB Approval Date: [insert date of IRB approval – obtain from IRB office]
page 10 of 10