PATIENT RIGHTS
Your safety, autonomy and well-being are priorities at all stages of clinical research
In Brazil, the protection and rights of clinical research participants are ensured by national and international legislation and guidelines, such as the Good Clinical Practice Document of the Americas, Resolution CNS No. 466/2012 (which replaced Resolution 196/1996) of the National Health Council and Resolution RDC No. 39/2008 of ANVISA. Every study involving human beings in the country must follow these references and be conducted in accordance with Good Clinical Practice (GCP).
One of the central principles of these standards is the mandatory obtaining of the Informed Consent Form (ICF), a document that formalizes voluntary participation. This form must be presented and discussed with each potential participant before the beginning of any research activity. If the person does not have legal capacity to consent, authorization must be given by a legally authorized representative, always in accordance with current legislation. The ICF must be signed, dated and delivered in copy to the participant, constituting the main tool for ethical and legal protection of the volunteer.
Informed Consent Form
Informed consent is based on the principle that every competent individual has the right to decide, consciously and autonomously, whether or not they wish to participate in a research study. This process guarantees respect for individual freedom and human dignity.
The ICF must be obtained before any study procedure, including screening exams or tests performed only to verify participant eligibility. The decision to participate must be voluntary, based on free will and without any form of pressure. The signature of the form transforms the individual into a “research subject,” but consent is understood as a continuous process: it begins at the first contact with the team and must be renewed, reinforced and clarified throughout the entire study.
Each volunteer must have sufficient time to reflect, discuss with family members or trusted persons, and clarify all doubts before deciding. The researcher must provide adequate conditions for this process, ensuring that the decision is made with full understanding. In addition, the ICF must clearly present:
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the possible risks and discomforts associated with participation, including for embryo, fetus or infant, when applicable;
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the potential benefits for the participant or for society;
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the indication of when there is no expected direct clinical benefit;
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the alternative procedures or available treatments, with their respective risks and advantages.
It is important to emphasize that the researcher cannot offer unrealistic guarantees about results or benefits, nor allow family members or community leaders to exert undue influence on the participant’s decision. The ethical commitment is to ensure that the choice is, in fact, free, conscious and well informed.
Frequently Asked Questions
Can the research subject leave the study after signing the ICF?
If it is the research subject’s wish to leave the study, they can do so at any time after signing the ICF. This decision will have no repercussion on their participation in other clinical studies and will not result in any punishment or loss of benefits to which you are entitled.
Can the research subject be remunerated to participate in a study?
According to Brazilian legislation, payment of research subjects to participate in the study is prohibited. Only reimbursement of transportation and meals to the research subject is acceptable. The reimbursement must be defined before the beginning of the study and must be described in the Informed Consent Form.
Can the ICF be obtained more than once during the conduct of the study?
When there are substantial changes in the conditions and procedures of a study, and also periodically in long-term studies, the researcher must once again seek the informed consent of the subjects.
How can the research subject learn about a clinical study that will recruit or is recruiting patients?
Research subjects learn about the conduct of studies through publication in the media and at the research center, which may be the hospital or clinic itself where the subject is receiving treatment. All such advertisements must have prior approval by the Research Ethics Committee. In addition, the research subject can talk to their physician so that they can provide guidance on possible research studies in which they may participate. In Brazil there is the Brazilian Clinical Trials Registry (ReBEC), which is a platform where research subjects can search for possible studies in which they may be potential participants. To learn about some of the clinical trials being conducted in Brazil, you can access the link: http://www.ensaiosclinicos.gov.br/
Can the study physician remove the research subject from the study for safety reasons?
The physician, according to their clinical evaluation, may discontinue treatment to safeguard patient safety. Depending on what was planned in the schedule, it is not possible to perform other procedures planned in the research, as it may affect the health and test results.