Understanding Your Participation

This form is for use in a research study that may involve subjects who may or may not have the capacity to consent to take part in the study. Accordingly, when the subject cannot legally consent to take part, pronouns “you” and “your” should be read as referring to the subject rather than the person (legally authorized representative) who is signing this form for the subject.

If you are the parent or legal guardian of a child who may take part in this study, your permission and the permission of your child will be needed. When “you” appears in this form, it may refer to you or your child.

Lipodystrophy United is working together with PatientCrossroads, AstraZeneca/Bristol-Myers Squibb Diabetes Alliance and the Lipodystrophy (LD) Registry Governance Board to present LD Connect, a registry for lipodystrophy, which will be called LD Connect throughout the rest of this informed consent. We invite you to take part!

Step 1: Create an Account

Create an account today for someone who meets one of the following:

  • A person with a rare form of Lipodystrophy (not HIV-associated lipodystrophy)
  • A family member or medical care giver invited by a person with FPL (familial partial lipodystrophy) or CGL (congenital generalized lipodystrophy) 

Step 2: Review the online informed Consent

Information about LD Connect
Before you agree to participate in LD Connect, it is important that you understand what is involved and what will be done with the information you provide. This form provides information about LD Connect.

Please read this form carefully. Take time to ask the Investigator or study staff as many questions about the study as you would like. The Investigator or study staff can explain words or information that you do not understand. Reading this form and talking to the Investigator or study staff may help you decide whether to take part or not. They may be reached at the email address or telephone number listed above.

Purpose of LD Connect
A registry stores detailed information about people in a single place or database. In this case, LD Connect will store health and other basic information about people with LD or family members of participants with familial partial lipodystrophy (FPL) or congenital generalized lipodystrophy (CGL). A registry keeps information in one place making it easier for researchers to share and study information, while still protecting the privacy of those who take part. This research is being done to better understand LD, and to answer questions such as how LD is treated, and what can be done to improve care for people with LD.

What are the potential risks of participating?
The risks of taking part in LD Connect are low. If you are not comfortable answering or do not want to answer a question in the LD Connect, you do not have to answer. By participating in LD Connect and looking at the data from all other members, you may learn information that is difficult or upsetting to you. Loss of private or confidential information is also a risk. In the unlikely situation where this happens, you will be notified right away. To keep this risk low, your information will be stored in a secure computer database.

What are the potential benefits of participating?
You may not benefit directly from participating in the Connect. You will be able to see a summary of the answers to survey questions from other people with LD. If you are interested, LD Connect can also give you information about research studies for LD.

The information collected in LD Connect may help researchers gain a better understanding of LD. The result of this research may guide the future treatment of LD.

Alternatives to Participating in LD Connect
Taking part in LD Connect is completely voluntary—it is your choice. You do not have to join this registry. If you decide not to join, you are still a member of the LD community. You can continue to receive health care and other support even if you decide not to join LD Connect.

How will my information be kept private?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protect the privacy and security of individual health information. In compliance with these regulations, LD Connect has multiple levels of security. These safeguards include data elements (e.g., restricted access to fields), user access (e.g., a password is needed to enter LD Connect), application (e.g., role-based access to features, access audit trails), and hosting services (e.g., firewall, secure sockets layer). These safety features help to make sure that private health information is protected from those who should not have access to it.

Researchers and other LD Connect participants will have access to the survey answers and other information in the registry. Your “de-identified” or “de-coded” information will be labeled with a unique code number to protect your privacy. Staff in charge of LD Connect (PatientCrossroads) will have access to your records, but other researchers and participants will not be able to see information which identifies you or tells people who you are.  

Your participation in this research will be kept private to the extent permitted by law. However, it is possible that other people may become aware of your participation in LD Connect. We might have to release your private information in a few specific situations—if it is required by the any of the following:

  • Food and Drug Administration (FDA) or representatives from regulatory agencies in other countries
  • Chesapeake Institutional Review Board
  • Law enforcement officials

Reasonable efforts will be made to keep the personal information in your research record private and confidential, but absolute confidentiality cannot be guaranteed. If you are taking certain medications, you may be asked to provide permission to be contacted for additional information or be asked for permission to contact your health care provider who prescribes the medication(s). If the registry collects data regarding certain medications, with your permission AstraZeneca/Bristol-Myers Squibb Diabetes Alliance, the pharmaceutical companies who are providing funding to support this research, may receive identifying information pertaining to adverse event reporting to comply with regulatory reporting obligations.

LD Connect may share de-identified (no names) information with other databases, such as the National Institute of Health (NIH) Global Rare Diseases Patient Registry (GRDR) and Data Repository, which may help to expand research on LD.

In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search the Web site at any time.

How will new findings be discussed with you?
LD Connect will not give you specific health information. However, it may give you general information about recommended health screenings based on the age of the person with LD. You will also be able to see the de-identified survey answers collected from all members by logging into your account. If you take part in a specific research study as a result of being in LD Connect, the researchers may share results with you. If scientists learn anything interesting about LD, the LD Connect Coordinator may post these results on the LD Connect website.

What if I change my mind about participating in LD Connect?
Taking part in LD Connect is entirely voluntary—it is your choice. You can choose to stop taking part at any time you want—you don’t have to explain why and there will be no penalty or loss of benefits to which you are otherwise entitled.

If you change your mind and no longer want to be part of LD Connect, you may contact the LD Connect Coordinator by e-mail (coordinator@ldconnect.org). Your account will be deleted; however, information which is collected and de-identified before you decide to withdraw from LD Connect cannot be retrieved.

What are the costs of participating in LD Connect?
There are no costs to join the LD Connect. You will not be paid any money for taking part in LD Connect.

Who do I contact if I have any questions?
If you have any questions about LD Connect or about your rights as a participant, you may contact the LD Connect Coordinator by e-mail (coordinator@ldconnect.org) or the Chesapeake Institutional Review Board:

By mail:
Study Subject Adviser
Chesapeake Research Review, Inc.
7063 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
Phone: call collect: 410-884-2900
Email: adviser@irbinfo.com

Please reference the following number when contacting the Study Subject Adviser: CRRI Pro00009092

Who can participate in LD Connect?
LD Connect is for people who have or believe they have LD. It is also for family members of people diagnosed with FPL or CGL who want to provide information about them. Approximately 400 people are expected to participate in LD Connect around the world.

You must be 18 years of age or older to provide consent to participate in LD Connect. If you are younger than 18, your parent or legally authorized representative will need to create your account in order for you to participate.

How long will you be in LD Connect?
If you agree to join LD Connect, you will be asked to complete several surveys over the next 5 years. Each survey will take approximately 5-15 minutes to complete. The information entered will be stored securely in LD Connect for up at least 5 years. Your participation in LD Connect may end early if the registry is cancelled by the Sponsor. 

What do you have to do to participate LD Connect?
You should read this informed consent form carefully and ask any questions you may have. You will be asked to if you agree to participate and you will create an account with a login username and password that you choose. You may then answer the surveys, which do not need to be completed all at once. You can take a break, save your answers and finish at a later time.

Over the next 5 years, additional surveys will be added to LD Connect. You will be sent e-mail notices when there are additional surveys for you to complete. You should log into LD Connect to complete these additional surveys.

Using a medical caregiver to enter your registry information
You may give your permission for your medical caregiver to enter your information into the registry. In this case, please select the relationship to the participant as "medical caregiver".  For more help, view Registration Helpful Hints.

Step 3: Click the appropriate informed consent boxes, enter the security code, and click “Register.”

If you are the parent or legally authorized representative of a person with LD, you may provide informed consent on behalf of the person if you agree to have the person’s information included in LD Connect. The Legally Authorized Representative is the person legally responsible for the care of the person with LD.

  •  I understand the purpose and nature of LD Connect, and I have no additional questions.
  • My participation in this project is entirely my choice. If I change my mind and wish to withdraw my information from LD Connect, I will be free to do so without having to provide any explanation. I understand this.
  • I understand the risks and benefits of participation and I agree to participate in LD Connect.

Consent Options
Please choose the consent option that applies to the person being registered (select one).

I have read the explanation about LD Connect and have been given the opportunity to discuss it and ask questions. I hereby consent, or give permission for myself or the participant to take part in the LD Connect.

  • I am 18 years of age or older and give consent to participate.
  • I am the Legally Authorized Representative of a person who is 18 years of age or older and cannot provide his or her own consent. I give permission to participate.
  • I am the Parent or Legally Authorized Representative of a minor and give permission to participate.

Please choose the assent option that applies to the person being registered (select one):
We request assent if the participant is age 7-17 years and is able to say they want to participate.

  • Yes, the information in the above consent was described to the participant who is 7-17 years and he/she agrees to participate in the LD Connect.
  • Not applicable. The participant is not able to provide assent.
  • Not applicable. The participant is 18 years of age or older and has provided his/her informed consent as above. 

 

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