The University of Arizona Consent to Participate in Research
Questionnaire Consent
Study Title: Insight into Subcutaneous Adipose Tissue Disorders
Principal Investigator: Karen L. Herbst, PhD, MD
Sponsor: Lipedema Foundation
This is a form for your consent to participate in a research project. It contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to discuss the study with your friends and family and to ask questions before making your decision whether or not to participate.
1. Why is this study being done?
This research study is being done by Dr. Karen Herbst and her colleagues to better understand lipedema, Dercum's Disease (DD) and other subcutaneous adipose tissue (SAT) disorders where the fat is lumpy and/or painful. Not much is known about these diseases. This study will help advance our understandings of these diseases. This study will also enroll people without lipedema and Dercum's disease, so we can understand how people without SAT disorders are different from people with SAT disorders. You are being asked to participate in the study because you are interested in contributing to the research for these disorders.
2. What will happen if I take part in this study?
If you decide to take part in this research study, you will need to sign a consent form before participating. We then will ask you to fill out a questionnaire that will also allow you to upload your genetic data. We will first look at all genetic markers to determine if any are more common in individuals with SAT disorders, compared to those without SAT disorders. We will also analyze specific markers that have previously been linked to SAT disorders and/or body composition and fat distribution and examine whether these are more common in those with SAT disorders. We will not examine markers having to do with other diseases or conditions that are unrelated to SAT disorders. Analyses of genetic data will be conducted in the absence of your name or other identifying information.
Consent: You will complete this consent as part of a HIPAA compliant secure survey program called RED Cap which is a secure data base used by the University of Arizona. If you have any questions you may contact the study office by phone or email (see below).
Questionnaires: This consent form is followed by a set of questions on your medical, social and family history and quality of life, body shape, and pain.
Genetic Information: If you have a SAT disorder, it may be helpful to study the DNA from members of your family. Family members may also participate in this study. Your relatives will not be contacted without your permission. You will need to provide our contact information to your family member who will need to contact us, if interested. Your family will be asked to read and sign a consent form, provide a sample of their DNA, medical history, and a physical exam if they are in the area.
There is also a risk to confidentiality from the collection of DNA and RNA that can lead to identification of patients. A federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information.
A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:
• Health insurance companies and group health plans may not request your genetic information that we get from this research.
• Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
• Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.
All employers with 15 or more employees must follow this law as of November 21, 2009.
Be aware that this new Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
3. How long will I be in the study?
Your answers to the questionnaires will be used and stored indefinitely. There is no limit to the length of time your information will be stored for future research. Once samples are in the questionnaire database they cannot be withdrawn or destroyed. You can choose to not participate in future studies.
4. Can I stop being in the study?
Your participation is voluntary. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your usual benefits. Your decision will not affect your future relationship with The University of Arizona. If you are a student or employee at the University of Arizona, your decision will not affect your grades or employment status.
5. What risks can I expect from being in this study?
Some of the questions on the questionnaires may be embarrassing to you. You may refuse to answer any of the questions. The main risks for participation in the study are those typically associated with providing samples for storage for DNA and body fluid collections, including the loss of confidentiality and break of security of data related to your sample. The investigators seek to minimize these risks by giving a random code to all samples and will place the samples in an independent database free of your personal clinical information.
If you are Native American and agree to participate in this study there may be risks associated with the research that impact your community. Health information, especially genetic information, can be applied to more than just you. Genetic analysis may be able to provide information about a person's parents, siblings, children, or others. Some genetic research can produce new information about entire subpopulations and individual racial or ethnic groups. It is unknown exactly what the researchers will discover, because this study involves unspecific future research. Risks may include legal, financial, social, or physical harm. Information may be published that conflicts with your communities' culture, traditions, mythologies, or spiritual beliefs.
6. What are the benefits of participating?
There will be no direct benefit to you from participating in this study. However, this study will help doctors learn more about SAT disorders such as lipedema and those that look similar to lipedema including Dercum's disease and familial lipomatosis and it is hoped that this information will help in the treatment of future patients with difficult to lose fat.
7. What other choices do I have if I do not take part in the study?
You may choose not to participate in this study without penalty or loss of benefits to which you are otherwise entitled. This study is not designed to provide treatment and is not intended to substitute for any medical care that you are otherwise entitled to receive.
8. Will my study-related information be kept confidential?
Only the investigator and their designated staff will have access to research records, databases and the link between the consent and your questionnaire. Data describing clinical cases may be included in publications but no patient identifying information data will be revealed. All the results obtained from this study and participant records associated with this study will be kept in a secure file folder in Dr. Karen Herbst's office. This room is locked when the room is empty. Research records on the computer are only accessible to Dr. Karen Herbst or the Research Coordinator. If specimens and data are shared with other investigators, through approved appropriate UA approvals and documentation, they will be identified only by code.
Efforts will be made to keep your study-related information confidential. However, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law.
Also, your records may be reviewed by the following groups:
• Office for Human Research Protections or other federal, state, or international regulatory agencies.
• The University of Arizona Institutional Review Board
Participation in research involves some loss of privacy. Your personal information may be given out if required by law.
9. Will there be any costs to me?
There are no costs to you or your insurance for study participation. This study only involves completing a questionnaire online and uploading data if you have it.
10. Will I be paid for taking part in this study?
Participation will be voluntary.
11. What are my rights if I take part in this study?
By signing this form, you do not give up any legal rights.
12. Who can answer my questions about the study?
For questions, concerns, or complaints about the study you may contact Dr. Karen Herbst (520-626-7689) or Bonnie McCutcheon (520-626-7689) or send an email to: treatprogram@deptofmed.arizona.edu.
For questions about your rights as a participant in this study or to discuss other study related concerns or complaints with someone who is not part of the research team, you may contact the Human Subjects Protection Program at 520-626-6721 or online at http://rgw.arizona.edu/compliance/human-subjects-protection-program.
If you are injured as a result of participating in this study or for questions about study related injury, you may contact Dr. Karen Herbst (520-626-7689).
An Institutional Review Board responsible for human subjects research at the University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare participants in research.
