| Title |
Disease Burden and Unmet Needs in Lambert-Eaton Myasthenic Syndrome (LEMS) |
| Protocol No. |
CAT-2606-01
WCG IRB Protocol #20263593 |
| Sponsor |
MedPanel, Inc. |
| Investigator |
Janet Bernard
29B Legacy Ln., Groton MA 01450
|
| STUDY-RELATED PHONE NUMBER(S) |
(978) 505-5871 |
About this research
You are being invited to take part in a research study about the experiences of people living with Lambert-Eaton Myasthenic Syndrome (LEMS).
MedPanel, an independent healthcare consulting firm, is conducting this research. The purpose of the study is to better understand the experiences of people living with LEMS, including diagnosis, symptoms, healthcare and treatment experiences, and the impact of LEMS on day-to-day life.
This research is being conducted for research and market-analysis purposes only. No sales or promotional activities will result from your participation.
What will happen if I participate?
First, you will be asked a few questions to determine whether you qualify for the study. These questions will take approximately 3–5 minutes.
If you qualify and choose to participate, you will be invited to take part in an individual telephone interview lasting approximately 60 minutes.
During the interview, you will be asked questions about your experience living with LEMS, which may include your diagnosis, symptoms, healthcare and treatment experiences, and the ways LEMS affects your daily life.
The interview will be audio recorded and transcribed so that the research team can accurately review and analyze the discussion.
Recording and transcription
If you participate in the interview, your interview will be audio recorded and a written transcript will be prepared.
The transcript will be de-identified by removing your name and other information that could readily identify you before it is provided to the study sponsor or used for research analysis.
The recordings and transcripts will be used only for purposes related to this research.
What are the possible risks or discomforts?
There are no expected physical risks from taking part in this study.
Some questions may ask about your health, diagnosis, symptoms, treatment experiences, or the impact LEMS has had on your life. You may find some of these questions personal, sensitive, or uncomfortable.
You do not have to answer any question you do not wish to answer, and you may stop the interview at any time.
As with any research involving personal information or recorded interviews, there is a small risk that information about you could be unintentionally disclosed. Reasonable measures will be taken to protect the privacy and confidentiality of the information you provide.
Are there any benefits to participating?
There is no direct medical benefit to you from taking part in this study.
Information learned from this research may help researchers better understand the experiences, disease burden, and unmet needs of people living with LEMS.
Participation in this research will not provide medical advice, diagnosis, or treatment and is not a substitute for care from your healthcare provider.
Will I be compensated?
If you qualify and complete the 60-minute interview, you will receive $150 USD as compensation for your time.
Compensation is provided for your time and participation and should not be considered a medical or other benefit of the research.
How will my information be protected?
MedPanel will collect contact information, such as your name, telephone number, and email address, as necessary to determine eligibility, schedule the interview, and administer the research.
Your contact information will be kept separate from the research findings and will not be included in reports or publications resulting from the study.
Research findings may be analyzed and reported in aggregate and may be used in research reports, presentations, publications, or public-relations materials. You will not be identified by name in these materials.
Reasonable measures will be taken to protect your information, but complete confidentiality cannot be guaranteed.
Do I have to participate?
No. Taking part in this research is entirely voluntary.
You may choose not to participate. If you participate, you may decline to answer any question and may stop participating at any time without penalty or loss of benefits to which you are otherwise entitled.
Your decision about whether to participate will not affect your medical care or your relationship with your doctor, healthcare providers, MedPanel, or any patient organization through which you may have learned about the study.
If you choose not to participate, there are no consequences to you. The alternative to participating in this research is simply not to take part.
Who can I contact if I have questions?
If you have questions about this research, please contact:
Amanda Muniz
MedPanel
Email: aMichaels@medpanel.com
Telephone: 978.290.7185
If you have questions about your rights as a research participant, concerns about the research, or would like to speak with someone independent of the research team, please contact:
WCG IRB
Email: clientcare@wcgclinical.com
Telephone: 855-818-2289
Agreement to participate
By selecting "Yes" below, you confirm that:
- You have read and understood the information above.
- You have had the opportunity to consider whether you want to participate.
- You understand that participation is voluntary.
- You understand that, if you qualify for the interview, the interview will be audio recorded and transcribed as described above.
- You voluntarily agree to participate in this research.