HCM Research...A quest for answers
Why do we need additional research in HCM and what can you do to help. A research study is a way to find answers to difficult scientific or health questions in order to find better ways to treat and or cure a disease. Some studies require patients to test new treatments however some studies just require information from a patients medical records.
Why should I participate in a research study?
Participation in a research study helps to:
Will being in a study help me or my child?
- Find treatments for existing diseases to improve the health of both children and adults.
- Identify the best dose of medicines to prevent harmful effects or under-treatment.
- Identify the most likely people to benefit from devices, interventions and therapies.
It is very important to understand that research is done to gain information about HCM, condition, drug or treatment that will benefit people in the future. Although, your family might not be able to benefit from the results of the study, your participation will certainly help the greater community affected with HCM. It is different from regular medical treatment that is given to help a specific person. However, there are benefits to being in a study.
What are the benefits of participating in a study?
There are several benefits to participating in a research study. These include:
What should I know before making my decision?
- Researchers test new drugs (or new to use in HCM) and treatments because they have reason to believe they might work better or be safer than the standard care. In a study, you or your child may have access to something that is not available yet. If the drug or treatment is found to be helpful, your child may be among the first to benefit.
- Sometimes enrolling in a study can give you or your child a chance to see extra doctors or find out more facts about you or your child’s condition. A study may be able to put you in touch with families going through what you are going through.
- A clinical study may offer closer monitoring or additional testing for you or your child, which may not be part of regular care. Sometimes a study asks patients to keep a diary or to be seen more often. Everyone in a study will be watched closely for side effects and to understand how the treatment is working.
Choosing to participate in a research study is an important personal decision. Here is some information to help you make that decision.
The United States government has strict guidelines and safeguards to protect people who choose to participate in research studies. Each study that uses human subjects must be approved and monitored by the Institutional Review Board (IRB) where the research is to be conducted. The IRB’s job is to make sure the risks are as low as possible, the studies are worth any potential risks, and that these risks and benefits are explained in a simple and clear manner for the participants to make an informed decision. Every study promoted by the HCMA must have prior IRB approval.
Before you are allowed to participate in a study, you will be asked to sign an “informed consent.” “Informed consent” is the process of learning the key facts about a study before you decide whether or not to participate. While some people may see this as a simple administrative step we caution you to read, question and carefully review these documents. It is also important to remember declining participation will not have adverse consequences on your care with your treating doctor.
These facts include:
- Why the research is being done?
- What the researchers want to accomplish?
- What will be done during the study and for how long?
- What risks are involved in the study?
- What benefits can be expected from the study?
- Can I decline participation in the study at any time?
If you wish to participate in a study, the research staff will give you informed consent documents that describe the study, the guidelines of the study. You should ask the research team any questions you have before you make a decision, during the study and after the study.
Some other questions you might want to ask are:
- Will I benefit from the results of this study or will others?
- Will I have access to the results of this study?
- Will my samples or records be destroyed or returned in a reasonable amount of time?
- Are there any inconveniences such as expenses, time, medications associated with the study?
- Who will have access to my medical information?
- Is this study suitable for children?
- Is there a written guarantee of privacy?
- Will there be pain – physical or emotional – associated with the study?
- Who is sponsoring the study?
- Is this study repetitive?
Plan ahead and write down the questions you want to ask. You should not incur any expenses due to participation in a study. It is also a good idea to discuss the consent documents with your friends and family members. Participating in research studies does not entitle you to free medical care from the research investigators unless explicitly stated in the consent form. If you decide to participate, always obtain a copy of your signed consent form.