From the Senate Agency | 01/15/2024, 8:33 pm
Source: Senado Agency
The project that establishes rules for clinical research with human beings and the control of good clinical practices through research ethics committees (CEPs) is back in the Senate. PL 6.007/2023 is a substitute (alternative text) from the Chamber of Deputies to PLS 200/2015, by former senators Ana Amélia, Waldemir Moka, and Walter Pinheiro. The authors’ intention was to accelerate the approval of clinical research in Brazil.
Approved by the Senate in 2017, the project was analyzed by the deputies, who presented a new text to replace that of the senators, with more articles and definitions related to research. Approved in December, the substitute will now be analyzed by the Senate. The text, by Deputy Pedro Westphalen (PP-RS), establishes rights for the voluntary participants in the research and duties for the researchers, sponsors, and entities involved.
The substitute includes 54 definitions of terms related to research, as well as ethical and scientific requirements for conducting research with human subjects. It also establishes the National System of Ethics in Clinical Research with Human Subjects and creates rules for the manufacturing, use, import, and export of goods or products for this type of research. Rules for the storage and use of data and human biological material are also provided.
One of the innovations compared to the Senate’s text is the 90-day deadline for the National Health Surveillance Agency (Anvisa) to analyze primary petitions for clinical trials with human beings for the purpose of product registration. The exception will be for complex products, which will have a deadline of 120 days. These deadlines were not included in the original text. If the deadlines are not met, clinical development may be initiated as long as the relevant ethical approvals are in place.
According to the text, research must meet ethical and scientific requirements, such as a favorable risk-benefit ratio for the participant, respect for their rights, safety, and well-being, as well as respect for their privacy and confidentiality of their identity.
For research involving human subjects, whether it is a clinical trial of an existing or similar drug or experimental therapies, the researcher must submit the research protocol to the ethics committee associated with the institution conducting the research. The committee will be composed of a multidisciplinary team in the medical, scientific, and non-scientific fields and will include a representative of the research participants.
If the research involves a special group, a representative of that group may participate as an ad hoc member, and if necessary, a consultant familiar with the language, customs, and traditions of the community (such as indigenous people) may also participate. This invited member does not participate in the deliberations, which are the sole responsibility of the regular members.
The committees have a deadline of 30 days to analyze the research protocols submitted to them with the necessary information, with the possibility of requesting additional documents from the researcher. The committee’s opinion will be for the approval of the research, non-approval, approval with pending corrections, or suspension if the approved research in progress needs to be halted for safety reasons. This decision can be appealed to the committee itself.
When the research is of strategic interest to the Unified Health System (defined by the Ministry of Health), it will have priority in ethics review and will follow special analysis procedures as determined by regulations.
Participation in the studies is voluntary and unpaid, but participants may receive some form of payment if the research involves phase 1 clinical trials or bioequivalence studies, such as those conducted to assess the functionality of vaccines or the effectiveness of generic medications.
To be eligible, interested individuals must be part of the National Registry of Volunteers in Bioequivalence Studies, not participate in more than one study at the same time, and, in the case of maximum tolerated dose evaluation or assessment of bioavailability and bioequivalence, wait six months between one study and another.
Participation in any research will depend on a signed informed consent form (ICF) by the participant or their legal representative. This form must be written clearly and legibly with the necessary information for a complete understanding of the research. The participant may withdraw from the study at any time, without cost or damage, and will be entitled to reimbursement of expenses such as transportation and meals, even those involving their companions.
After the participant’s involvement in the clinical trial, the project stipulates that the researcher must assess the need for continued supply of the experimental medication. Unlike the current provisions in infralegal regulations, the supply of the researched medication may be interrupted in certain situations.
One such situation is after five years of the medication’s commercial availability in the country. The Senate project originally proposed a two-year period. Another hypothesis included in the substitute is when the experimental medication is available in the Unified Health System (SUS).
Among the reasons that authorize interruptions are the participant’s decision, disease cure, worsened health condition, introduction of satisfactory alternative therapy, lack of continued benefit (considering the cost/benefit ratio), adverse reactions that make continuation impossible, inability to obtain or manufacture the medication due to technical or safety issues.
In the informed consent form, the participant must authorize or not authorize the storage of their biological material for other research purposes, free of charge. To do so, they have the right to be informed about potential benefits and inherent risks associated with the use of their biological material. They will also have access to information associated with their material, particularly regarding research findings that reveal potential harm to their health, and be informed about the transfer, loss, alteration, or disposal of the material. Participant consent can be withdrawn at any time.
The project stipulates that biological material and research data will be used exclusively for the purpose of the respective project, except if the informed consent form explicitly authorizes its use in future research. The committee may authorize the waiver of this prior consent if the research is of significant social value and is not feasible without such waiver.
Additionally, through a transfer agreement, biological material may be sent to other researchers, including those abroad.
The proposal also mandates compensation for any damages suffered by participants during the research. In such cases, they must receive the necessary healthcare assistance to address these damages. The sponsor will be responsible for paying the compensation and providing assistance.
In the case of research sponsored by governments, national or international governmental agencies, or non-profit institutions, the Brazilian research institution may assume the responsibilities for compensation, exempting the sponsors from this obligation. This exception was included in the text by the Chamber.
With information from the Chamber of Deputies Agency.