What is a registry?
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 purpose of this Registry is to collect and store medical information and other information from individuals with the same disease or similar diseases. This information will be helpful in better understanding what preeclampsia is and how preeclampsia affects people during pregnancy and also long-term.
Whose information are you collecting in The Preeclampsia Registry?
We are collecting data from:
- Women who were medically diagnosed with preeclampsia or a related hypertensive disorder of pregnancy (HDP) such as eclampsia or HELLP syndrome
- Female relatives of affected women
- Women who have never had preeclampsia or hypertensive disorders of pregnancy, but would like to serve as "controls" in research studies about preeclampsia.
What if I had another form of preeclampsia?
Throughout this Registry, the term “preeclampsia” is used to include all hypertensive disorders of pregnancy such as preeclampsia, eclampsia, HELLP syndrome and gestational hypertension.
Can I enroll a mother who died or is disabled as a result of preeclampsia?
Yes. In the My Registry section, after logging in to the website, select “Enroll on behalf of someone who had preeclampsia but died or is disabled”.
Can I participate if I live outside the United States?
Yes. The Registry is available to participants anywhere in the world.
Can I participate if I am under the age of 18?
Yes. A parent or guardian will need to review the consent form with you. Both you and your parent or guardian will need to agree for you to participate. You will also need to provide your assent. Please ask the registry staff any question before agreeing to take part.
Who do I call if I have questions about the Registry?
Call the Research Coordinator at the Preeclampsia Foundation, Alina Brewer, at 801-994-4103 or email at email@example.com.
Who is paying for the Registry?
The sponsor of the Registry is the Preeclampsia Foundation. There is no cost to be a participant of the Registry. All costs are paid for by the Foundation. As a 501(c)(3) non-profit organization, the Foundation's mission is made possible through individual and corporate donations. If you would like to support this and/or other initiatives, please consider a gift to the Foundation in honor or memory of a loved one, or just as am outright donation. Please contact our Director of Development to discuss corporate or major gift support support.
Will you collect any blood or other biological samples for research (such as genetic testing)?
Sometimes a registry may also be linked to a biobank which is a place that stores tissue, blood or other samples from patients. The Preeclampsia Registry has developed a biobank where some Registry participants have been invited to provide a saliva sample from which we will extract DNA. When first enrolling in The Preeclampsia Registry, there will be a section on the consent form where you can give your permission for us to contact you about donating a biological specimen for research. If you are invited to participate in the biobank, you will need to agree to a separate consent form before enrolling in the biobank.
Will anyone else know my name?
Your personal information such as your name, address, or other information that identifies you or your family will be labeled with a code number, encrypted, stored in a secure place and protected with a password. Only authorized people who work in the Registry will have access to the code and be able to identify you, if needed.
Your identifiable information will not be shared with anyone outside the Registry. Approved scientists, researchers, and clinicians, will be given only the de-identified information and may search the de-identified data for patients for their studies. We call this information “de-identified” because all personal identifiers have been removed.
All other information (such as hard copies of records) will be stored in locked files and destroyed in accordance to the standards established by the HIPAA Privacy Act. To review the entire HIPAA Privacy Act, and for information about how it applies to patients, see the Office for Civil Rights website: http://www.hhs.gov/ocr/hipaa.
Can insurance companies access my medical information and/or my participation in this study?
Insurance companies are not permitted access to research records, and participants do not have to tell their health insurance companies that they have participated in a research project. Research is different from clinical care. Research records are not a part of a person’s medical record.
The Genetic Information Nondiscrimination Act (GINA) of 2008 is intendedto prohibit the improper use of genetic information. GINA providescomprehensive protection to individuals so that they may availthemselves of genetic diagnostic tests for the advancement of theirindividualized medical care without the threat of discrimination frominsurance companies based on their personal genetic makeup. To reviewthe entire Genetic Information Nondiscrimination Act of 2008 and otherhelpful information regarding GINA, go to http://www.genome.gov/11510239.
Is there any compensation for participating?
There is no cost to you to participate and you will not receive compensation for participation.
I want to be involved in a clinical trial. If I register, is this guaranteed?
Although one of the main goals of the 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. Please note that even if the coordinators of the 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 after all. 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 its research staff about the trial and fill out a separate consent form.
I don’t want to be involved in a clinical trial. Should I still register?
Absolutely. We hope that you will still be willing to register, 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 individuals who had preeclampsia.
I don’t have much time. What exactly is involved?
- Click “Enroll Now” button on the home page. Provide your contact information and then check your email to get your unique username and password.
- Return to the website to login, read and approve the consent form, and complete the online registry questionnaire. This can take up to an hour of your time, but may be completed in more than one sitting.
- Using “My Registry”, available on the home page after you login, you can upload your medical records, provide updates on your health and your child’s health, and submit your own research ideas.
- In the future, you may be asked to sign a medical records release form to allow The Preeclampsia Registry Administrator to request your medical records
What else will be expected from me?
After enrollment in the registry, and with your permission, you can expect the following:
- To be contacted by email or phone at least once a year to update your information.
- Answer new questions as we or outside researchers have new ideas to explore.
- Your information will be combined with others’ and shared with researchers, but your identity will not be shared. Your privacy remains our top priority.
- You may be contacted about other clinical trials being conducted that you may qualify for.
- You may be contacted about donating a sample of blood, tissue, or other biological specimen. (If you decide to donate a sample, you will need to provide separate consent)
Why do you need to look at my medical records?
By reviewing your medical records pertaining to preeclampsia we are able to verify the information you are entering into the registry. This is very important to some research studies. The Registry will remove your personal identifying information (name, date of birth, etc.) from your medical records and replace it with a code before your records are ever shared with other researchers, databases, or registries.
What are the risks?
There is minimal risk in being a Participant of the Registry. The Registry questionnaire 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. Almost every question has an “I Don’t Know” option. Other possible risks to you may include fatigue and concern about answering personal questions. You may take as much time as you need to complete the questionnaire and may skip questions that you feel are too personal.
What if I decide I do not want to participate after finishing The Registry questionnaire?
Should you change your mind and wish to withdraw your data from The Preeclampsia Registry, you will be free to do so without providing any explanation. However, information accessed prior to the request for removal cannot be retrieved from researchers that have already accessed it. You may withdraw your participation by writing an email to Registry@preeclampsia.org or by writing a letter to:
6905 N Wickham Road
Melbourne, FL 32940
What if I made a mistake when completing my questionnaire? Why can't I make changes to the answers I provided?
Your questionnaire is locked to any changes after you click "submit" in order for us to protect the quality of the information we gather. If you think you've made a mistake or recently learned of new information that would have impacted your responses, simply email the Research Coordinator at firstname.lastname@example.org for assistance.
How can I provide the Registry with an update on my/my child's health or a new pregnancy?
The Registry is most valuable when your information is kept up-to-date. Log-in to The Preeclampsia Registry and select "Provide an Update" from your MyRegistry page. From there you have the option to provide a health update for you or your child and add a new pregnancy.
How can I retrieve my username or password to log-in to The Preeclampsia Registry?
Send an email the Research Coordinator at email@example.com to let her know that you have lost your log-in information. She will respond to you withing one business day with your username and a temporary password. When you log back in, you will be prompted to change your password.