Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos

Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos

2003;17(Supl 1):33-41 | Conselho Nacional de Saúde
The National Health Council (CONAS) approved Resolution 196/96 to establish guidelines and regulatory norms for human research. The resolution is based on international ethical documents, including the Nuremberg Code, Helsinki Declaration, and others, and aligns with Brazilian laws and constitutional principles. It emphasizes four ethical principles: autonomy, non-maleficence, beneficence, and justice. The resolution requires periodic review to adapt to scientific and ethical developments. Key elements include informed consent, which must be voluntary, free from coercion, and based on complete information about the research's nature, risks, and benefits. The Research Ethics Committee (CEP) is responsible for reviewing research protocols, ensuring ethical standards, and protecting participants' rights and dignity. The CEP must include members from various disciplines, including health, social sciences, and ethics, and must be independent and consultative. Research involving humans must be approved by the CEP, which evaluates the protocol's ethical and scientific validity. The CEP must ensure that risks are minimized, benefits are maximized, and vulnerable populations are protected. The CEP must also monitor the research's progress, provide feedback, and ensure that participants' confidentiality and privacy are maintained. The National Ethics Committee for Research (CONEP/MS) oversees the CEPs and ensures that research adheres to national and international ethical standards. It reviews research in specific areas, such as genetics, human reproduction, and new medical technologies, and provides guidelines for ethical research. The resolution also outlines the responsibilities of researchers, sponsors, and institutions, emphasizing the importance of informed consent, participant safety, and ethical oversight. The resolution requires that all research involving humans be documented and reviewed by the CEP, with protocols submitted for approval before research begins. Researchers must maintain records for five years and ensure that research results are published with proper credit. The CEP must also handle complaints and ensure that research is conducted ethically and transparently. The resolution establishes a framework for ethical research, ensuring that participants' rights, dignity, and well-being are protected throughout the research process.The National Health Council (CONAS) approved Resolution 196/96 to establish guidelines and regulatory norms for human research. The resolution is based on international ethical documents, including the Nuremberg Code, Helsinki Declaration, and others, and aligns with Brazilian laws and constitutional principles. It emphasizes four ethical principles: autonomy, non-maleficence, beneficence, and justice. The resolution requires periodic review to adapt to scientific and ethical developments. Key elements include informed consent, which must be voluntary, free from coercion, and based on complete information about the research's nature, risks, and benefits. The Research Ethics Committee (CEP) is responsible for reviewing research protocols, ensuring ethical standards, and protecting participants' rights and dignity. The CEP must include members from various disciplines, including health, social sciences, and ethics, and must be independent and consultative. Research involving humans must be approved by the CEP, which evaluates the protocol's ethical and scientific validity. The CEP must ensure that risks are minimized, benefits are maximized, and vulnerable populations are protected. The CEP must also monitor the research's progress, provide feedback, and ensure that participants' confidentiality and privacy are maintained. The National Ethics Committee for Research (CONEP/MS) oversees the CEPs and ensures that research adheres to national and international ethical standards. It reviews research in specific areas, such as genetics, human reproduction, and new medical technologies, and provides guidelines for ethical research. The resolution also outlines the responsibilities of researchers, sponsors, and institutions, emphasizing the importance of informed consent, participant safety, and ethical oversight. The resolution requires that all research involving humans be documented and reviewed by the CEP, with protocols submitted for approval before research begins. Researchers must maintain records for five years and ensure that research results are published with proper credit. The CEP must also handle complaints and ensure that research is conducted ethically and transparently. The resolution establishes a framework for ethical research, ensuring that participants' rights, dignity, and well-being are protected throughout the research process.
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