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What is a research study?
Each research study is created to find an answer to a specific problem. In the Interventional Cardiology Research program, our studies are created with many different intents. Some of these reasons are to help learn more about cardiology diseases, more quickly identified these diseases in patients before they progress, more effectively treat these diseases or better prevent someone from experiencing these diseases.
A clinical trial is a specific type of research study. Clinical trials help the medical community decide whether a treatment or device should be approved for the general population. A clinical trial investigates the safety and effects of a wide range of medical treatments, from medication to interventional devices.
Why should I participate in a study?
You may not benefit personally from taking part in a research study, but your participation may help other patients in the future benefit from what we learn in the study. In some cases, patients may personally benefit from participating in a study by receiving access to care they might not have had access to without participating.
Is it safe to participate in a research study?
Yes. Participants in a research study will follow up with their doctor and study team regularly throughout the course of the study. While each study protocol is different and therefore calls for varied forms of intervention and follow up, the study care team for each trial will monitor your health closely to ensure your safety. Prior to consenting to a study, the study team will discuss with you what your care schedule will look like and what potential risks or concerns there might be. If at any point, the doctor is concerned about your safety, he or she may take you out of the study and help you find the appropriate care.
How long will the research study last? How often will I need to see a doctor?
Each study varies in length and number of visits. Prior to consenting to a study, you will review the study length and the visit expectations with the study staff.
Will my samples or health information be shared with anyone outside of the study? How will Mass General protect my privacy?
The information we collect in this study may help advance other research. If you join this study, we may remove all information that identifies you (for example, your name, medical record number, and date of birth) and use these de-identified samples and data in other research. It won’t be possible to link the information or samples back to you. Information and/or samples may be shared with investigators at our hospitals, at other academic institutions or at for-profit, commercial entities. You will not be asked to provide additional informed consent for these uses.
Federal law requires us to protect the privacy of heath information and related information that identifies you. We refer to this information as “identifiable information." If identifiable information must be shared, we take safety steps to protect the privacy of this information. The study team will discuss these possible scenarios with you before you sign consent. If you withdraw your research consent at any time, you have the right to withdraw your permission for us to use or share your identifiable information. You also have the right to see and get a copy of your identifiable information that is used or shared for treatment or for payment.
Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop using or sharing your identifiable information. Your permission to use and share your identifiable information does not expire. The results of this research study may be published in a medical book or journal or used to teach others. However, your name or other identifiable information will not be used for these purposes without your specific permission.
What happens if I want to stop participating in a study I have already started?
If you take part in a research study, and want to drop out, you should tell us. We will make sure that you stop the study safely. We will also talk to you about follow-up care, if needed. Also, it is possible that we will have to ask you to drop out of the study before you finish it. If this happens, we will tell you why. We will also help arrange other care for you, if needed.
Taking part in a research study is up to you. You can decide not to take part. If you decide to take part now, you can change your mind and drop out later. Your decision won’t change the medical care you get within Mass General Brigham now or in the future.
Will I receive any monetary benefits from taking part in a study?
Monetary compensation varies from one trial to another. Some trials offer remuneration, some offer travel reimbursements, some offer to cover cost of care, and some do not offer any monetary benefit. Before signing consent, the study staff will discuss whether or not you can expect to receive any monetary benefit.
Will taking part in a research study cost me any money?
The amount of study coverage provided varies from one trial to another. In general, study funds will pay for certain study-related items and services. We may bill your health insurer for, among other things, routine items and services you would have received even if you did not take part in the research. You will be responsible for payment of any deductibles and co-payments required by your insurer for this routine care or other billed care. If you have any questions about costs to you that may result from taking part in research, please speak with study doctors and study staff. If necessary, we will arrange for you to speak with someone in Patient Financial Services about any potential costs.
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