CEIPC’s competences and functioning
Legal Framework of the CEIPC (Principles and rules applicable to ethics committees operating in health institutions, institutions of higher education and biomedical research centres that develop clinical research).
For more detailed information on the competencies and functioning of the Ethics Committee of PUC, please consult:
Regulation of the Ethics Committee of the PUC
For more detailed information on data protection legislation
Law no. 58/2019, of August 8th
– It ensures the implementation, in the national legal order, of Regulation (EU) 2016/679 of the Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (GDPR).
– Adopts the rules on the processing of personal data for the purposes of prevention, detection, investigation or prosecution of criminal offences or the execution of criminal penalties, transposing Directive (EU) 2016/680 of the European Parliament and of the Council of April 27th, 2016.(13.8.2019).
CNPD Resolution/2019/494
The CNPD deliberated to disapply some rules of Law No. 58/2019, of August 8, as it is understood that these clearly contradict the provisions of the General Data Protection Regulation (GDPR), violating the principle of the primacy of the Union, as well as seriously harming the functioning of the coherence mechanism that aims to ensure a uniform application of data protection rules throughout the EU.
The CNPD’s decision is based on the Portuguese Constitution and the case law of the Court of Justice of the EU.
(Source: https://www.cnpd.pt/)
Exemption from fines for public authorities
The CNPD approved, at its last plenary meeting, an interpretative deliberation on the waiver of the application of fines to public entities, provided for in Article 44(2) and Article 59 of Law 58/2019, dated August 8th, following several requests made in this regard.
The CNPD considers that it is only possible to request this reasoned waiver after an accusation of the practice of an administrative offence. The CNPD’s decision will take into account the concrete case, weighing all interests and rights therein. (9.9.2019)
Access to other legislation, recommendations and supporting documents
For clarifications, documentation and legislation, please send an e-mail requesting access permissions to the shared folder (etica@ipc.pt)
Other Documents: Legislation, Guidelines, Standards and References
- Universal Declaration on Bioethics and Human Rights
- Universal Declaration of Human Rights
- World Medical Association Declaration of Helsinki
- Clinical Research
- CNCEV: opinion on the use of cannabis for medicinal purposes
- CNECV: decision-making on the Health Framework Law - principles and foundations
- CNECV: opinion on the proposed Universal Declaration on Gender Equality
- CNECV: opinion on Bill No. 75_xiii_2_gov on self-determination of gender identity
- CNECV: opinion on the Statute of the Accompanied Adult
- CNECV: opinion on access to health data
- CNECV: opinion on medical devices
- CNECV: opinion on integrity in research