Copy of LFR Informed Consent

This is a copy of the Informed Consent for convenience only; please click the blue GO TO REGISTRY button if you wish to complete the Consent and participate in the Registry.


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Your Consent to Join the Lipedema Foundation Registry

The Lipedema Foundation Registry (LFR) is a private and confidential online registry established by the Lipedema Foundation to help the Lipedema community, including affected individuals, families, clinicians and researchers. Its goals are to learn more about Lipedema; understand barriers to diagnosis; better manage symptoms; assess quality of life impact; and develop new treatment approaches.

The Lipedema Foundation (LF) governs the Lipedema Foundation Registry (LFR) and the information that you provide.

This consent document, which includes the FAQ, explains the potential benefits and risks of joining the LFR and what you can expect as a result of your participation. Please read the information carefully and take as much time as you need before making a decision about whether to participate. After you have read the consent document, you can decide whether you wish to participate in the LFR.

Please read the FAQ (Frequently Asked Questions) www.lipedema.org/faqs

If you have any questions about the registry, please feel free to:

(1)   Visit our webpages

(2)   Email registry@lipedema.org

(3)   Leave a voicemail message at +1-800-407-5241 or +1-203-489-2989

 

The Lipedema Foundation is focused on collecting information about people with Lipedema and advancing research into Lipedema. Please note that while we care deeply about the well-being of members of the Lipedema community, our staff does not include medical or mental health professionals or social workers. As a result, we cannot provide any advice or assistance with medical, mental health, or social welfare questions. We encourage members of the community to reach out to their healthcare providers for assistance with any such issues or consult the resources identified on our Resources webpage www.lipedema.org/resources.

1)    Who Can Join the LFR?

This registry is for:

  • People with Lipedema

  • People who think they might have Lipedema

  • People who do not have Lipedema (to use as comparison groups)

Participants under 18 must be enrolled in the registry by an adult. The adult must:

  • Be 18 years of age or older

  • Be the parent, legal guardian, or other legally authorized representative of the participant

  • Be willing and able to provide consent for the child under 18

  • Obtain assent (agreement) from the minor participant if they are between 13-17 years of age and are able to assent. Children under 13 are able to participate, although assent is not required.

Once the participant turns 18, we will contact the family and request that the participant provide his/her own consent to stay in the LFR.

Individuals from any country are welcome to participate in the LFR. Currently, the LFR is only available in English and participants must be able to read the consent and answer the surveys in English.

2)    Joining Is Your Choice

Participation in the LFR is your choice. Please consider joining because your data is important to help us better understand Lipedema and improve management of the condition. If you choose not to participate, it will not affect your relationship with the Lipedema Foundation or any healthcare that you receive.

You may stop participating in the LFR for any reason and at any time. If you decide to withdraw from the LFR, we will not penalize you or request an explanation. We may, however, ask for your feedback so that we can continue to improve the LFR.

If you decide to participate now but later wish to withdraw, you will need to contact the LFR to withdraw by emailing us at registry@lipedema.org or by leaving a voicemail at +1-800-407-5241 or +1-203-489-2989. Please see question “What If I Decide to Withdraw from the Registry?” for more information.

3)    Purpose of this Registry

The goal of the LFR is to collect and analyze information about three types of people: (1) people with Lipedema, (2) people who think they might have Lipedema, and (3) people who do not have Lipedema (to use as comparison groups). We hope to collect information from as many people in these categories as possible.

The information that we collect will be used for research, such as to better understand the symptoms of people with Lipedema compared to people without Lipedema. The information will also be used to understand the needs of the Lipedema community and to identify research topics that might be funded by the Lipedema Foundation or other groups. In addition, the information may be used to help support other research studies; for example, to find out if there are enough people who are experiencing certain symptoms to make a research study possible.

A very important part of the LFR is sharing information with other researchers and partner organizations. At the end of the consent document you can choose how the Lipedema Foundation can share your information with other researchers and organizations.

4)    We Take Your Privacy Seriously

The information you share with us, including information about your identity, your health, and your experiences will be stored securely in a registry powered by REDCap Cloud’s products REDCap Cloud MyHealth and REDCap Cloud EDC. According to REDCap Cloud, these information management systems are ISO 27001 certified and are hosted on a secure cloud environment used in many clinical trials. To learn more visit www.redcapcloud.com.

Generally speaking, data can be treated in two ways.

Identifiable data is information that can be used to identify a person either directly or indirectly, such as your name, date of birth, location (street address and postal code), email address, and phone number.

De-identified data means that the identifiable portions (such as your name and address) of the information you provided have been removed, anonymized, and/or encrypted, but your other data remain. For example, consider knowing a research participant’s height. Many people may be the same height, but knowing a given research participant’s height does not tell someone who you are.

Your identifiable data and de-identified data will be accessible to the Lipedema Foundation’s registry staff, the REDCap Cloud technical team, and partner organizations who analyze LFR data for LF (such as hired biostatisticians).

You can choose to share your identifiable data and de-identified data with other groups in this consent.

In order to make our research plans as flexible as possible, you will be given options now for how your data will be used in the future.

At the end of this consent document, you will find options for you to choose:

  • Whether we may share your de-identified data with nonprofit organizations, such as universities

  • Whether we may share your de-identified data with for-profit organizations (see for-profit question #11)

  • Whether we may share your identifiable data with nonprofit organizations, such as universities

  • Whether we may share your identifiable data with for-profit organizations (see for-profit question #11)

5)    How Will Joining the Registry Affect Me?

If you choose to join the LFR, you will be asked to provide information through an online Initial Survey. This survey will ask you to provide medical and family history information. You will also be asked to answer questions about symptoms or effects on your life. You will be asked to provide important measurements, such as your lower leg circumference. We will give you directions on how to get this information. We also request photographs of different parts of your body. You can choose whether you want to provide each of these types of information.

If you join the Registry, the LF team will contact you to update your information and to answer new surveys or survey questions. Answering these questions will be your choice. Up-to-date information is crucial to the LFR's ability to answer important research questions, to assess the feasibility of different types of research, and to identify who may qualify for particular studies.

We will also send you information about other types of research studies.

There is no cost to participate. You will not be paid to participate.

6)    What If I Decide to Join the Registry?

The goal of the LFR is to make the information you provide widely usable while protecting your privacy. Your identifiable data and de-identified data will be accessible to the Lipedema Foundation’s registry staff, the REDCap Cloud technical team, and partner organizations who analyze LFR data for LF (such as hired biostatisticians), unless you choose to have us share that information more broadly.

If you decide to join the LFR, this is what you consent to do:

1.      Give the Foundation your information by answering surveys. The information can be used for research, planning, and educational purposes. The Foundation will use your information indefinitely (meaning there is no planned end date) to support, among other things, longitudinal (long-term) and genetics studies. After consenting and taking the Initial Survey, we will periodically ask you to update your information and fill out new surveys.

2.      Agree to learn about research studies and projects by other organizations and researchers. It will be your choice whether to participate. The Foundation will send you information about these other studies and projects indefinitely (meaning there is no planned end date).

3.     At the end of this consent form, you have the choice for how your information may be shared. The choice you make will be indefinite (meaning there is no planned end date).

You can contact us at any time and change your choices or withdraw from the LFR.

7)    What If I Decide to Withdraw from the Registry?

You may stop participating in the LFR for any reason and at any time. If you decide to withdraw from the LFR, we will not penalize you or request an explanation. Withdrawing from the LFR will not affect your relationship with the Lipedema Foundation. We may, however, ask for your feedback so that we can continue to improve the LFR.

If you decide to participate now but later wish to withdraw, you will need to contact LF to withdraw by emailing us at registry@lipedema.org or by calling +1-203-489-2989.

You will be able to choose whether the LFR can continue to use your de-identified data that is already in our database, or whether you want us to remove all of your information from our database. No matter which option you choose, we cannot get back data that has already been used in research and/or provided to other organizations.

8)    Possible Risks of Participating

There is a chance that answering questions about your experience with Lipedema might make you upset, angry, or worried. You are not required to answer these questions.

Participating in a registry and registry research comes with a small risk that information about you will be discovered by someone who is not authorized to see or have it. The LFR team has taken steps to reduce this risk and protect your information. The LFR is hosted by REDCap Cloud, which is a secure clinical trial platform. Specifically, REDCap Cloud provides a data storage environment that is designed to securely protect participant data in research. But of course, no data storage system is 100 percent secure.

9)    Benefits to Participating

Your participation will help promote Lipedema research and discovery by:

  • Helping to speed research in Lipedema by sharing your data

  • Advancing analysis and understanding of the condition across the affected community

  • Providing an opportunity to learn about and participate in studies that assess the impact of Lipedema symptoms and help to develop new treatments

  • Receiving notifications of research studies that may be of interest to you

10)  How is the Registry Financially Supported?

The Lipedema Foundation Registry is supported by the Lipedema Foundation.

11)  Why would LF consider sharing your data with for-profit organizations?

We take your privacy seriously. Sharing your data with for-profit organizations is a serious consideration that LF would only undertake if access to the data would lead to better health and treatment outcomes for the Lipedema patient community.

We are aware of a few for-profit companies whose products are in line with our mission to define, diagnose, and development treatments for Lipedema.

One example is a company that could possibly make an app to diagnose Lipedema. We believe it could be beneficial to people with Lipedema for LF to provide financial support for the development of such an app. Allowing that company access to LFR data could speed up the development of the app, and make it better.

12)  My Consent

Section A

You must select 'Agree' on all four statements in Section A below, meaning you confirm that you are making those statements to us, in order to register.

1.      I have reviewed the consent information. I understand it, and I do not have any questions. * 

Agree

2.      I agree to have my data collected and used by the Lipedema Foundation. I understand that access to my information will be limited to the Lipedema Foundation, REDCap Cloud, and partner organizations who analyze data for the Lipedema Foundation, unless I provide my consent for the Lipedema Foundation to share my information. I understand that I may be asked to update the information I have provided and answer new surveys. I agree to receive information about other studies and projects. Joining any of those extra studies or projects will be my choice. *

Agree

 

3.     I understand that my participation in the Registry is voluntary. I can change my mind and withdraw from the Registry at any time.*     

Agree

4.     I acknowledge that the LFR runs on REDCap Cloud products and that LF has no control over REDCap Cloud’s user interfaces, product features, products, security or security breaches, business model, funding, or defects (‘bugs’) currently in their products or that may be introduced to their products, nor the resolution or changes thereof. 

Agree

 

Section B

Your answers to the following questions do not affect your ability to participate in the LFR. We want to make the most of your valuable data and speed up research on Lipedema. To try to do this, we want to give you the choice to have your data used in other important ways.

1.      Allow sharing of your de-identified data with non-profit organizations, such as universities.

Yes

No

2.      Allow sharing of your de-identified data with for-profit organizations and companies.

Yes

No

3.      Allow sharing of your identifiable data with non-profit organizations, such as universities, which could be researchers who receive your de-identified data when you participate in the LFR.

Yes

No

4.      Allow sharing of your identifiable data with for-profit organizations.

Yes

No

My Consent Information

Please type your first name:

Please type your last name:

Please type your email address:

Please enter today’s date:

 

Are you registering a minor participant?:

The minor I am registering is between 13-17 years of age and has given me his/her assent (agreement) to include his/her information in the Lipedema Registry; OR the minor I am registering is between 13-17 years of age and is not able to understand the idea of participating in a registry and I am making the choice for him/her; OR the minor is under 13 years of age. I am 18 years of age or older. I am the parent, legal guardian, or other legally authorized representative of the participant. I am willing and able to provide consent for the child under 18. I have obtained assent (agreement) from the minor participant if they are between 13-17 years of age and are able to assent.

Yes, I am registering a minor

No, I am not registering a minor

 

Name of person giving consent (please type):

Please enter today’s date:

 

Thank you for carefully reading the consent.

If you have any questions about the registry, please feel free to:

(1)   Visit our webpages

(2)   Join our Facebook group “Lipedema Foundation” www.facebook.com/Lipedema

(3)   Email registry@lipedema.org

(4)   Leave a voicemail at +1-800-407-5241 or +1-203-489-2989

 

Please note that while we care deeply about the well-being of members of the Lipedema community, our staff does not include medical or mental health professionals or social workers. As a result, we cannot provide any advice or assistance with medical, mental health, or social welfare questions. We encourage members of the community to reach out to their healthcare providers for assistance with any such issues or consult the resources identified on our Resources webpage www.lipedema.org/resources.

 

Lipedema Foundation

registry@lipedema.org

+1-800-407-5241 or +1-203-489-2989

 

Contact information for our Data Protection Officer: Felicitie Daftuar, felicitie@lipedema.org

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