Ethics Committees in Healthcare and Research: A Comprehensive Guide
Ethics Committees
Ethics committees lay the groundwork for ethical considerations in healthcare and research. They serve as forums for ethical reflection and act as social regulators, guiding moral considerations in scientific advancements. These committees help clarify action limits and protect the fundamental rights of individuals involved.
Ethics committees apply the principles outlined in the Universal Declaration on Bioethics and Human Rights (UNESCO, October 2005). This declaration addresses ethical issues related to medicine, life sciences, and technologies applied to humans, considering social, legal, and environmental aspects. It emphasizes respect for human dignity, autonomy, social responsibility, consent, vulnerability, and personal integrity. The declaration advocates for protecting individuals and future generations.
Types of Ethics Committees
Research Ethics Committees (RECs)
RECs ensure the ethical and legal soundness of research involving human participants or biological samples. They operate in research centers and evaluate:
- Methodological rigor
- Ethical considerations
- Legal compliance
Accreditation requirements for RECs include:
- Independence and Impartiality: Members must remain independent from researchers and sponsors.
- Interdisciplinary Composition: Committees should include experts from various fields.
A favorable report from the REC is mandatory before conducting research. These committees complement the work of Clinical Research Ethics Committees (CRECs), focusing on clinical drug trials. RECs ensure the protection of fundamental rights in research involving human subjects and biological samples.
Clinical Research Ethics Committees (CRECs)
CRECs are independent bodies composed of healthcare professionals and non-healthcare members, reflecting a multidisciplinary approach. They evaluate clinical drug trials and ensure ethical conduct. Their functions include:
- Evaluating the scientific design of studies
- Assessing researcher competence
- Reviewing informed consent procedures
- Evaluating subject selection processes
- Assessing benefit/risk ratios
- Providing compensation for potential harm
Legislation mandates that all clinical trials receive a favorable report from a CREC before initiation. These committees operate independently of promoters, researchers, and health authorities. The establishment of a Community code on human medicines harmonizes the laws of Member States in this field.
Healthcare Ethics Committees (HECs)
HECs provide ethical guidance within healthcare institutions. They assist in decision-making, particularly in complex cases, and develop protocols for ethical practices. The composition of these committees is multidisciplinary, and their role extends beyond the committee members to influence the entire institution.
While initially voluntary, recent regional regulations have made the formation of HECs mandatory in some cases. Legislation often requires the participation of an HEC member in CREC deliberations, establishing a collaborative relationship between the two committees.
The Bioethics Committee of Spain
:
It is created by the Biomedical Research Act.
It is considered the appropriate body for consultation on all aspects with ethical and social implications of the field of medicine and biology and is called to set the guidelines and general principles for the development of codes of practice of scientific research to develop the Committees Research Ethics.
With regard to the composition will be of a certain number of members elected from among qualified persons authorized the scientific, legal and ethical. The composition should be sought balanced representation of different disciplines involved in bioethical reflections
As for the functions:
-Issue reports, proposals and recommendations to the government.
-Establish general principles for the development of codes of practice of scientific research to be developed by the Committees for Research Ethics.
-Representing Spain in international forums
-Balanced presence of all disciplines involved in bioethical reflections
Also important to mention that the Law estab1ece collaboration of Figures
Autonomous.