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Decree Law No. 80/2018


Publication: Republic Diary No. 198/2018, Series I of 2018-10-15
  • Issuer: Presidency of the Council of Ministers
  • Diploma Type: Decree Law
  • Number: 80/2018
  • Pages: 4965 - 4970

Summary in plain english

What is it?

This decree-law sets the new rules for the ethics committees for health.

These ethics committees seek to ensure that the ethical standards in the area of health are met, and that the human dignity and integrity are respected, both during treatments and during scientific research.

What will change?

There are new rules of organization and harmonization of the ethics committees that operate in locations where:

    • health care is provided (health centres and hospitals, for example)
    • clinical research is done (health care institutions, higher education institutions and centers of biomedical research).
The clinical research shall be covered by these rules

Up to now, only the ethics committees that operated in health institutions were covered by these rules. From now on, these rules also apply to the ethics committees of the higher education institutions and centres of biomedical research, as long as these perform clinical research.

It is considered clinical research the research done on people or with material of human origin.

The functioning of ethics committees is harmonized

These committees have technical and scientific independence and provide advice about ethical issues related to the activity of the institution they are part of.

New principles and clearer rules are defined on what respects to:

    • its constitution
    • its skills
    • its composition
    • its functioning.
1. Constitution

The ethics committees are mandatory in:

    • public, private and social health institutions
    • higher education institutions where clinical research is performed
    • biomedical research centres where clinical research is performed.

The health and higher education institutions and biomedical centres can create a single ethics committee when it facilitates their work, especially if these are part of clinical academic centres.

2. Competences

The ethics committees will, for example:

    • ensure the compliance with the ethics standards within the institution
    • make assessments, reports, recommendations, and other documents, at its own initiative or upon request
    • prepare discussion papers on issues of bioethics
    • collaborate, at regional, national and international levels, with other entities in the area of ethics and bioethics, in order to share knowledge
    • promote training on ethics and bioethics in the institution.
3. Composition

Each ethics committee can have between 5 and 11 members and should have people from different areas, for example:

    • medicine
    • law
    • philosophy/ethics
    • theology
    • nursing
    • pharmacy.

The members of the committees are appointed by the governing body of the institution which they are part of and fulfill these duties during four years (or a maximum of eight years, if re-appointed). The president and the vice-president are elected from among the members of the ethics committee, by the members themselves.

4. Operation

The ethics committees should meet at least once per month and whenever it is necessary.

Within a committee, specialised committees may be created when the topic requires it.

What advantages does it bring?

This decree-law intendeds to:

    • to create a common structure of organization for the ethics committees
    • give ethics committees the ability to support and encourage reflections on ethical questions, promoting the information about ethics and bioethics
    • to promote the integrity, honesty, accuracy and transparency of the ethics committees, increasing trust, reliability, security and integrity of all procedures in the area of health
    • strengthen the role of ethics committees in the institutions where they operate.
When does it come into effect?

This decree-law shall come into effect 60 days after its publication.

The current members of the ethics committees for health continue to fulfill their duties until they are replaced, independent from the coming into effect of the new rules.

Original Version

LEGAL TRANSLATOR

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CONSOLIDATED LEGISLATION

Legislative consolidation integrates the various amendments and rectifications made into an original legal diploma in order to make its consultation more accessible to the citizen.