Consent Form for Participation in a Research Study
Study Title: The MS-SUPPORT Study
You are being asked for your consent to take part in a research study. This paragraph provides a summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research.
What should I know about this research?
- We are testing a new online doctor-patient tool for adults with Multiple Sclerosis (MS).
- You may be given access to the new online doctor-patient tool.
- The tool will ask you questions about how you manage your MS, how MS affects your life, and what matters to you. It gives you personalized feedback. It creates a short summary to help you talk with your medical team. We will suggest you share that summary with your healthcare provider.
- Participants are limited to people with a relapsing form of MS who have a scheduled appointment within the next 12 weeks with their healthcare provider. This includes Relapsing Remitting MS (RRMS or RMS), secondary progressive MS (SPMS) with relapses, or CIS (Clinically Isolated Syndrome).
- You will be asked to complete six online surveys over the next year regarding your MS and use of disease modifying therapies (DMT), if any. The initial survey will take about 30 minutes, the remaining surveys will take between 5 and 15 minutes.
- Taking part in this research is voluntary. Whether you take part is up to you. If you don’t take part, it won’t be held against you. You can take part now and later drop out, and it won’t be held against you.
- This study is sponsored by Shared Decision Making Resources under a Scientific Research with Agreement EMD Serono in partnership with the Multiple Sclerosis Association of America (MSAA).
Detailed Consent
Why is this research being done?
Decisions about MS are difficult. This study tests a new way to manage your MS with your healthcare provider. We developed a new online doctor-patient tool called MS-SUPPORT designed to help people with MS make better treatment decisions with their healthcare provider. We want to know if MS SUPPORT affects the use of disease modifying treatments (DMTs), patient-provider communication, quality of care, and quality of life.
How long will I be in this research?
We expect that taking part in this research will last one year.
What happens to me if I agree to take part in this research?
- You will be asked to complete an online survey about yourself and your MS.
- You will be randomly selected (by chance) to receive the new online doctor-patient tool for people with MS.
- The doctor-patient tool, MS-SUPPORT, will take about 30 minutes to complete. You don’t have to complete it all at once.
- The tool will ask you questions about how you manage your MS, how MS affects your life, and what matters to you. It gives you personalized feedback. It creates a short summary to help you talk with your medical team. We suggest you share that summary with your provider.
- You will be asked to complete a total of six (6) online surveys over the next year regarding your MS and use of disease modifying therapy (DMT), if any. The initial survey will take about 30 minutes, the remaining surveys will take between 5 and 15 minutes.
- Your next online evaluation will be after your upcoming visit with your MS provider. That survey will ask about your MS and ask you to rate the quality of the conversation you had with your MS provider.
Could being in this research hurt me or pose a risk?
We believe there are no known risks associated with this research study; however, as with any online related activity the risk of a breach of confidentiality is always possible. To the best of our ability your answers in this study will remain confidential. We will minimize any risks by encrypting data, using the most secure software, restricting access to the data to only the study investigators, replacing personal identifiers from stored data with a study ID, and keeping the list linking study ID to consented patients in a locked file, separate from the rest of the study data.
No identifying information will be connected to your survey answers. The survey is therefore anonymous. However, your participation in the research is considered confidential because your email will be associated with your survey response in order to pay you.
After you have consented to be in this study, if you report either a serious side-effect from a DMT or a pregnancy while taking a DMT and have not reported this to your healthcare provider, we will be required to report it to the FDA. We will not include your name or any personal identifiers in this reporting. This will help the FDA to monitor the safety of drugs. It is important to report serious side effects from any medical product to your health care provider (HCP).
Who will have access to my study information?
Records of your participation in this study will be held confidential so far as permitted by law. However, the study principal investigator and study coordinators and, under certain circumstances, the Department of Health and Human Services, the Food and Drug Administration and New England Independent Review Board (IRB) will be able to inspect and have access to confidential data that identifies you by name. Any publication or presentation of the data will not identify you.
Will being in this research benefit me?
It is not expected that you will personally benefit from this research. However, your participation will help us test a new approach to managing MS with your healthcare provider that may improve decision-making about MS treatments for you and others. Once the study is completed, we will send you the results and access to the final version of the MS-SUPPORT tool.
What other options are available?
You may choose not to participate in this study without penalty.
Will it cost me anything to participate in this study?
We do not expect that you will incur any expenses. We do offer a small compensation for your effort in participating (see below).
Will I be paid for being in this study?
You will be paid for your time and effort with online Amazon gift cards. Upon completion of the survey that follows your next MS appointment, you will receive a $15 card. After completing the next 3 short surveys completed, you will receive a $5 card per survey. For the final survey you will receive a $20 card, for a maximum total of $50 in gift cards.
Am I required to participate in this study?
Your participation in this study is completely voluntary and you can withdraw at any time. Your refusal to participate or your withdrawal from the study will involve no penalty or loss of benefits to which you are entitled. You may stop your participation at any time without affecting your ongoing medical care.
Can I be removed from the study without my permission?
We may end your participation in this study for any of the following reasons:
- If you are unable to keep your scheduled appointment within the allowed timeframe;
- If the study is cancelled by the sponsor or the New England Independent Review Board; or
- For administrative reasons.
Who do I contact if I have questions about the study?
If you have questions or concerns about this study, you may contact Dr. Nananda Col at (207) 272-9829 or via email at MSstudy@SDMR.US. If you have questions about your rights as a research subject, or other concerns about this research, you can contact the New England Independent Review Board at 1-800-232- 9570 or at info@neirb.com.
Statement of consent
I have read the above consent form and agree to participate in this study and I am over 18 years of age.