For more detailed information on the competencies and functioning of the Ethics Committee of IPC, please consult:
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 IPC, please consult:
Regulations of the Ethics Committee of the IPC
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).
The National Commission for Data Protection (CNPD) has decided to disapply some rules of the national law implementing the General Data Protection Regulation (GDPR) Source: https://www.cnpd.pt/
The CNPD decided to disapply some provisions of Law 58/2019, dated August 8th, as it considers that they manifestly contradict the provisions of the GDPR, which violates the principle of the primacy of the Union, as well as seriously harming the functioning of the consistency mechanism that aims at a uniform application of data protection rules across the EU.
The CNPD’s decision is based on the Portuguese Constitution and the jurisprudence of the Court of Justice of the EU.
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
- Lei n.º 58/2019, de 8 de agosto Assegura a execução, na ordem jurídica nacional, do Regulamento (UE) 2016679
- Investigação Clínica
- Declaração Universal dos Direitos Humanos
- Declaração de Helsínquia da Associação Médica Mundial
- cnecv_utilizacao_de_canabis_para_fins_medicinais
- cnecv_tomada_de_decisao_lei_de_bases_da_saude_principios_e_fundamentos_um_contributo_do_cnecv
- cnecv_relatorio_e_parecer_sobre_proposta_de_declaracao_universal_sobre_igualdade_de_genero
- cnecv_parecer_sobre_integridade_na_investigacao
- cnecv_parecer_sobre_a_proposta_de_lei_n._75_xiii_2_gov
- cnecv_parecer_estatuto_maior_acompanhado
- cnecv_acesso_aos_dados_em_saude
- cnecv_parecer_dispositivos_medicos