The National Health Council's Resolution 196/96 outlines the guidelines and regulations for research involving human subjects. It is based on international documents such as the Nuremberg Code, the Universal Declaration of Human Rights, the Helsinki Declaration, and others. The resolution emphasizes the principles of bioethics: autonomy, non-maleficence, beneficence, and justice. It requires that research involving human subjects must respect the dignity, autonomy, and vulnerability of participants, and ensure that any risks are minimized and benefits maximized. Key aspects include: 1. **Definition of Terms**: Definitions for terms like "research," "research involving human subjects," "protocol of research," and "ethics committee" are provided. 2. **Ethical Aspects**: Research must adhere to ethical and scientific requirements, including obtaining informed consent, balancing risks and benefits, ensuring confidentiality, and minimizing harm. 3. **Informed Consent**: Participants must give voluntary and clear consent, understanding the purpose, methods, risks, and benefits of the research. 4. **Risks and Benefits**: Research must offer significant benefits to participants and society, and any risks must be justified by the potential benefits. 5. **Ethics Committees (CEP)**: Institutions conducting research involving human subjects must have an ethics committee to review and approve protocols. The committee must be multidisciplinary and independent, with members from various fields. 6. **National Ethics Committee (CONEP/MS)**: CONEP/MS is an independent, consultative body that oversees the ethical aspects of research and can approve or disapprove protocols. It also provides guidance and updates on ethical norms. 7. **Transitional Provisions**: The resolution outlines transitional measures, including the role of the Group Executive Working Team (GET) until CONEP/MS is established. The resolution aims to protect the rights and welfare of human subjects in research while promoting scientific progress and societal benefits.The National Health Council's Resolution 196/96 outlines the guidelines and regulations for research involving human subjects. It is based on international documents such as the Nuremberg Code, the Universal Declaration of Human Rights, the Helsinki Declaration, and others. The resolution emphasizes the principles of bioethics: autonomy, non-maleficence, beneficence, and justice. It requires that research involving human subjects must respect the dignity, autonomy, and vulnerability of participants, and ensure that any risks are minimized and benefits maximized. Key aspects include: 1. **Definition of Terms**: Definitions for terms like "research," "research involving human subjects," "protocol of research," and "ethics committee" are provided. 2. **Ethical Aspects**: Research must adhere to ethical and scientific requirements, including obtaining informed consent, balancing risks and benefits, ensuring confidentiality, and minimizing harm. 3. **Informed Consent**: Participants must give voluntary and clear consent, understanding the purpose, methods, risks, and benefits of the research. 4. **Risks and Benefits**: Research must offer significant benefits to participants and society, and any risks must be justified by the potential benefits. 5. **Ethics Committees (CEP)**: Institutions conducting research involving human subjects must have an ethics committee to review and approve protocols. The committee must be multidisciplinary and independent, with members from various fields. 6. **National Ethics Committee (CONEP/MS)**: CONEP/MS is an independent, consultative body that oversees the ethical aspects of research and can approve or disapprove protocols. It also provides guidance and updates on ethical norms. 7. **Transitional Provisions**: The resolution outlines transitional measures, including the role of the Group Executive Working Team (GET) until CONEP/MS is established. The resolution aims to protect the rights and welfare of human subjects in research while promoting scientific progress and societal benefits.