The person registering and consenting to take part in this FOP Connection Registry may be the adult individual with FOP (“affected individual”), the family member or guardian consenting on behalf of the affected adult who lacks capacity to consent for himself or herself (the person legally responsible for the care and maintenance of that person), or the parent or guardian of a child.
“You” and “your” in this form generally refer to the affected individual.
If you are the parent or legal guardian of a child who may take part in this Registry and your child can understand what this Registry study is about, please explain it to your child (or have your child read this form if able) and obtain your child’s agreement before enrolling him or her in the Registry. Children who turn 18 years old while in the Registry will be asked to provide consent at that time if they are capable of doing so.
Informed Consent: Understanding Your Participation in the FOP Connection Registry
1. What is the FOP Connection Registry?
The FOP Connection Registry is a global patient registry open to individuals with FOP or, in the case of a minor, a family member or legal guardian of the individual with FOP.
A patient registry is a place where medical information, family history, and other related information from patients is collected and stored for medical research. The Registry is intended to collect and store medical information and other information from individuals with FOP. The goals of the Registry are to help our community prepare for engagement in clinical trials, help our community and researchers learn more about the scope and impact of FOP on individuals and families, and encourage research on FOP and related disorders.
Information collected in the FOP Connection Registry will be used for medical research, to help plan for experimental clinical trials, to better understand FOP and related diseases, and to develop new treatments.
The FOP Connection Registry is sponsored by the International FOP Association (IFOPA).
2. What information will be collected and how will it be used?
If you join the FOP Connection Registry, you will be asked to provide medical information on your disease. The intention of the Registry is to share detailed medical and other information with scientists and other researchers while still protecting your privacy. This is done by hiding the name, address and other “identifying” information from the researchers. We call these records “de-identified” because they have been removed of all personal identifiers. Your personal information, such as your name, address, or other information that identifies you or your family, will be labeled with a code number and stored in a secure place and protected with a password. Only authorized people who work on the Registry will know the code and be able to identify you if needed.
Your identifiable information will not be shared with anyone other than the authorized people who work on the FOP Connection Registry (unless you give your permission to share it).
A subset of your de-identified information (information that has been removed of all identifiers) may be shared with global databases with which the FOP Connection Registry may collaborate in order to develop global knowledge of FOP that may lead to new research studies or clinical trials and improved clinical treatment.
3. How will my information be protected?
The IFOPA is the guardian of the information contained within the FOP Connection Registry. Oversight for the Registry will be provided by the IFOPA board of directors in collaboration with the IFOPA medical and scientific advisory board. A protocol for the Registry has been reviewed by the Chesapeake institutional review board (IRB) to ensure protection of the rights and welfare of participants. An IRB, also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. You can read more about Chesapeake IRB at their website: http://chesapeakeirb.com/
Ensuring patient privacy is a primary responsibility and concern of the IFOPA. Steps have been taken to make sure the FOP Connection Registry participants can provide their information in a secure setting. Their record is protected by user id and password. The Registry data will be hosted by Digital Infuzion, Inc., in a SAS 70 Type II HIPAA compliant infrastructure with dedicated firewalls and advanced intrusion detection to secure patient data. All Registry network transmissions will be encrypted for an added level of protection.
The IFOPA does not rent, sell or share any identifying information in our mailing lists or the FOP Connection Registry.
In the event the IFOPA ceases to exist (this is not likely), all attempts will be made to find another suitable entity to take ownership of the FOP Connection Registry. You will be asked to give your consent to the transfer of your data (this includes identifiable and de-identified information). The data of those not consenting for such a transfer will be destroyed. If all attempts fail to identify a suitable entity, then all data collected by the IFOPA will be destroyed to protect your privacy. You will be contacted and informed of this action.
4. How do I participate in the FOP Connection Registry?
After your registration is accepted, you will be permitted access to the FOP Connection Registry and asked to enter your data into the online Registry surveys, similar to completing any other online questionnaire. You will be asked to update your data in the Registry at least twice per year. The Registry will send you a reminder every six (6) months. If the Registry loses contact with you, your account may become inactive.
5. What are the benefits of participating?
Participating in the FOP Connection Registry is voluntary. You do not have to take part in the Registry.
Participation may not benefit you personally, medically, or financially. However, your participation may help members of your family and others with FOP by increasing the understanding of your disease/condition. Collected data may help speed up research by collecting information scientists can use. Medical professionals may be able to improve how they treat the disease. Participants may receive information about opportunities to participate in research, clinical trials, medical advances and other news from the Registry.
There is no cost to you and you will not be paid for taking part in this Registry.
6. What are the risks of participating?
There is minimal risk in taking part in the FOP Connection Registry. The Registry includes questions that can be sensitive and you may feel uncomfortable answering. You do not have to share any information you do not want to. Another unlikely risk is potential breaches in the computer system. In the event the there is a breach in the Registry’s computer system all participants will be notified.
7. What if I change my mind later and want to discontinue my participation?
Should you change your mind and wish to withdraw your data from the FOP Connection Registry, you will be free to do so without having to provide any explanation. Simply complete the Withdrawal Survey and contact the FOP Connection Registry team. All of your data will be removed from the database. Data shared for a specific study prior to your request for removal cannot be retrieved from researchers that have already accessed it.
You will be told about any new information that may affect whether you want to continue to take part in the Registry.
8. I want to be involved in a clinical trial. If I participate in the FOP Connection Registry, is clinical trial participation guaranteed?
Although one of the main goals of the FOP Connection Registry is to make it easier for affected individuals to participate in research, there is no guarantee that those participants will be eligible for a trial. Even if the coordinators of a clinical trial believe that you might be eligible for the trial based on the data about you stored in the Registry, it is still possible that later on it will turn out that you do not meet the trial requirement criteria.
Please also be aware that if we inform you about the existence of a trial, this does not imply that we endorse it. In order to participate in any trial, you will need to discuss the trial with the relevant clinical trial staff members and fill out a separate informed consent form.
9. I don’t want to be involved in a clinical trial. Should I still participate in the FOP Connection Registry?
Yes. We hope that you will still be willing to participate in the FOP Connection Registry, even if you don’t want to take part in a trial. Your information may still be useful to researchers who are trying to learn more about patients with FOP.
10. What are my options if I do not want to be in the FOP Connection Registry?
You do not have to join the FOP Connection Registry. Participation is voluntary. You do not need to participate in this Registry to become or remain a member of the IFOPA. Your decision to participate in the Registry will not affect your healthcare.
11. What if I have more questions or need additional information?
You can ask questions about the FOP Connection Registry any time. Please contact the IFOPA if you have any questions, concerns, or complaints:
- International FOP Association
- 101 Sunnytown Road, Suite 208
- Casselberry, FL 32707
- Website: www.ifopa.org
- Phone: +1 (407) 365-4194
- Email: email@example.com
You may also contact Chesapeake IRB if you have questions about your rights as a participant in the FOP Connection Registry:
• By mail
- Attention: Study Subject Adviser
- Chesapeake IRB
- 6940 Columbia Gateway Drive, Suite 110
- Columbia, MD 21406
• or call toll free: 877-992-4724
• or by email: firstname.lastname@example.org
Please reference the following protocol number when contacting the Study Subject Adviser: Pro00008719.