INTRODUCTION
The International FOP Association (IFOPA) is conducting an observational research study using existing medical data (e.g. electronic medical records, insurance claims data, etc) to better understand the natural history of FOP. This agreement form tells you about the study.
We are aware that your family member with FOP has passed. However, there is now an optional FOP research study that is collecting existing medical data. It would provide your family member with FOP an opportunity to continue participating in FOP research. We are contacting you as next of kin for your authorization to collect data on your FOP patient, as part of this optional research study.
If you agree to participate and share your FOP patient's information, you will be asked to provide your signature and your FOP patient's information at the bottom of this agreement form, as part of standard electronic agreement procedures. No one can force you to take part in this study.
PURPOSE OF THIS STUDY
Currently, there is limited information on the progression and long-term effects of FOP. Understanding data on clinical outcomes within the FOP population will provide information to researchers on the natural history of the disease that will be informative to patients, caregivers, treating physicians and researchers. Existing medical data (e.g. electronic medical records, insurance claims data, etc) is a commonly used way to track clinical outcomes.
The IFOPA is conducting a study to use existing medical data to learn more about the progression and long-term effects of FOP. Accessing the existing medical records of known FOP patients is the best way to ensure that this study has accurate information on the clinical outcomes of FOP patients. The IFOPA United States membership database is the source of participants who are invited to take part in this study.
If you agree to participate in this study, the IFOPA will collect basic contact information from you about your FOP patient. FOP researchers interested in using existing medical data of FOP patients to study the natural history of the disease will then request a license from the IFOPA to use the information you have shared on your FOP patient. In order to ensure your FOP patient's anonymity during this study, the IFOPA will not share your FOP patient's personal information with the FOP researcher, but with a software company that is contracted to use existing software tools to create a unique de-identified code (token). Your FOP patient's unique code, along with the individually unique codes of other FOP patients who have opted in to this study, will be run against a large medical record database to capture your FOP patient's, and other FOP patients', existing medical data. The creation of this code ensures the protection of your FOP patient's privacy while still allowing their contribution to this study. Neither the FOP researchers nor the software companies contracted to pull this medical information can ever trace this code back to your FOP patient. Data from the large medical record database will only be shared with FOP researchers in a summarized format (no identifiable patient-level data will be shared).
PROCEDURES
If you wish for your FOP patient to be included in this study and allow for the creation of a code that is unique to your FOP patient and that will be used to access their existing medical data, the only action you need to take is to opt-in by selecting the opt-in box at the bottom of this form and providing your electronic signature (e-signature) and your FOP patient's full name, date of birth, gender and last zip code and street address. You can opt-out of participation by marking the opt-out box and providing your e-signature below. No response to this request will be considered opting out of participation.
RISKS
There is minimal risk in taking part in this study. One unlikely risk is potential breaches in the computer system. In the event there is a breach in the FOP researchers’, software companies', or the IFOPA’s computer system, all participants who have opted in to the study will be notified.
BENEFITS
Participating in this study is voluntary. You do not have to opt-in to this study on behalf of your FOP patient, and your decision will not affect their ability to be invited to participate in future applicable research studies.
Participation may not benefit you personally, medically or financially. However, the participation of your FOP patient may help members of your family and others with FOP by increasing the understanding of the condition.
DATA PRIVACY RIGHTS
Your Data Privacy Rights are listed here:
- The right to be informed (how the data will be used)
- The right to request information about the handling of your FOP patient's data
AUTHORIZATION TO USE AND DISCLOSE RECORDS
The authorization part of the agreement gives more detailed information about how your FOP patient's personal identifying information may be used and disclosed by FOP researchers or the IFOPA.
This study requests the following personal identifying information which will be used to generate the unique code:
- First name
- Last name
- Date of birth
- Gender
- Last zip code where FOP patient lived
- Last street address where FOP patient lived
CONTACT INFORMATION
You can ask questions about the IFOPA and the involvement in this study at any time. Please contact the IFOPA if you have any questions, concerns or complaints:
International FOP Association
1520 Clay St, Ste H2
North Kansas City, MO 64116
Website: ifopa.org
Phone: 720-341-6999
Email: sammi.kile@ifopa.org