No. To participate in a clinical research, it is necessary that you read, understand, clarify all your doubts and then, if you agree with the conditions for participation, sign the consent form. “Guinea pig” is a term used when one does not have the right to decide on participation in a study or test, and is currently used to refer to animals used in laboratory research.
By agreeing to participate in the clinical research, you will receive a refund or advance provision, with an amount agreed in advance, to pay the costs of transportation and food. This is a right guaranteed by law for the clinical research participant. But there will be no financial compensation for your participation.
In the same way that you do not receive any compensation, you will not be charged for your participation in any clinical research. The investigator must guarantee access to the research resources at no additional cost.
When you are invited to participate in clinical research, it means that your doctor thinks that your participation could be positive for you or for science – a treatment option or your health information may increase scientific knowledge (when it’s a study aimed at collecting health data). But you have every right not to agree to participate, and even so, continue to be treated in the same way and by the same doctor.
No. You have the right to participate until it is interesting for you, and you can withdraw at any time or when the doctor deems it is no longer beneficial for you to continue.
Placebo is a substance with no pharmacological effect, administered to the participant with the aim of masking or comparing its effects to those of an active substance. Placebo is only used when there is no other means of comparison, and its use must be duly justified.
We highlight below the main rights of the clinical research participant: To be aware of the possibility of withdrawing consent at any time, without any prejudice to the follow-up and/or treatment, even having signed the Free and Informed Consent Form; Be informed about any procedure that will be performed during the study, as well as clarify doubts regarding these procedures; Receive assistance, at no cost, in the event of damages foreseen or not in the Free and Informed Consent Form; Receive assistance from the researcher and his/her team and from the sponsor involved in the clinical research in case of complications resulting from participation in the research; Not be charged for any procedure, exam and/or medication used and performed during the study; Have decision-making autonomy about participation in the research; Have the right to access study results; Have the security that your data collected for the purpose of the research must be confidential; and Have the ability to contact and freely access the researcher and the Research Ethics Committee (REC).
We highlight below the main duties of the clinical research participant: Follow the study schedule, performing the exams, procedures and taking the medications according to the orientation and previous scheduling by the research team; Report any change in health status, as well as any medication used during the study period; and Report to the researcher, as soon as possible, any unexpected effects experienced.
Your data will only be shared with the researcher, the team assigned to this role and the study sponsor (in the latter case, only when applicable). It is important to emphasize that all your personal and sensitive data will be treated in such a way that, at no time, there is a breach of confidentiality of this data. At no time will you be identified by name or any information that could lead to your identification.
No. If you choose to continue the follow-up with your treating physician, you may even share with him all the tests that show your response to the treatment offered, in case of interventional protocols (which require medical intervention).
To find information about clinical trials happening around the world, simply visit www.ClinicalTrials.gov. Brazil also has its own public platform for publishing clinical trials at www.ensaiosclinicos.gov.br.