Portugal - RECs and Medical Research
History
There are 3 levels of control for medical research in Portugal - National Council of Ethics for Life Sciences, Centres of Reflection and Health Ethics Committees. The National Council of Ethics for Life Sciences was created in 1990 and acts as a consultative body alongside the Council of Ministers. The Centres of Reflection consider bioethical issues and produce guidance on these issues for other bodies to consult
An Administrative Rule of the Minister of Health created another level of review with the Ethics Committee for Clinical Research (CEIC). Law 46/2004, which implements Directive 2001/20/EC requires that the CEIC issues a favourable opinion for clinical trials to proceed but in practice they can appoint a Health Ethic Committee to review the trial. The CEIC is responsible for monitoring Health Ethics Committees, receiving all applications for ethical review and is answerable to the Minister of Health. Decree Law 97/95 created Health Ethics Committees to review biomedical research and sets out their composition, operation and powers.
In the case of clinical trials, authorisation is required from the director and/or the administrative council of the hospital where the trial is to be carried out. Law 46/2004 states that authorisation from the National Institute of Pharmacy and Medicines (INFARMED) is also required for a trial to go ahead.
Summary of Portuguese RECs
| Type of REC | Ethics Committee for Clinical Research (CEIC) | Health Ethics Committees -Institutional Review Boards |
| Where situated? | Centrally | Health Establishments |
| Who applies to them? | Researchers | CEIC |
| Formal/Informal | Formal | Formal |
| National/Regional | National | Regional |
| Laws Involved |
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| Guidance Involved |
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| Membership requirements | Multidisciplinary | |
| Responsible/accountable to whom? | Minister of Health | Clinical Director of Specific Institution |
| Approval or Advisory powers | Approval | Approval in case of clinical trials, otherwise advisory |
Not submitting research or failing to follow review
There is professional liability in the case of Doctors infringing their Code of Practice, the Medical Association Statute (Decree-law 282/77) or the Doctors' Statute (Decree-law 373/79). Punishment could take the form of a fine, suspension or expulsion. There could also be a case under the Protection of Personal Data Law 67/98.
Which body, if not the REC itself takes this action, and how do they proceed?
Breach of the Code of practice is
dealt with by the Medical Association, other infringements of law are
dealt with by the courts, either civil or criminal.
Impact of Directive 2001/20 EC
Law 46/2004 (19th August) implements this Directive. It has introduced several changes in the system of ethical review. An opinion is now required from the newly created central ethics committee, although they can ask a local committee to undertake this task and an opinion must be issued within 60 days of receiving the application.
Legal action that can be taken against RECs
No legal action can be taken against RECs.
Links section
- National Consultative Committee of Ethics (in Portuguese)
- Portuguese Medical Association (in Portuguese)
- Clinical
Trials Law - University of Coimbra, Centre for Biomedical Law (English
& Portugese)
Attorney General's office (in Portuguese, English & French) - National Institute of Pharmacy and Medicines (INFARMED) (in English & Portugese)
See the REC bibliography section for more links and papers