RECs for social sciences and humanities in Italy
There are no ethical guidelines for non-health-related research in Italy that recommend or mandate ethics review. For example, the deontological code for psychologists mentions general principles of informed consent and confidentiality but does not specify whether ethics review is necessary. The same is true for the Code of Ethics of Sociologists. Additionally, there are no national organization policies that recommend or mandate ethics review for research outside the health field.
In Italy, the Research Ethics and Integrity Committee at the National Research Council has approved a Charter of principles for research in the social sciences and humanities (2017), along with a code of conduct containing relevant guidelines in the field. The Charter aims to raise awareness among researchers about the crucial role of ethics in human and social sciences research. It identifies tools for addressing ethical issues while safeguarding the rights of research participants, researchers, and society as a whole (including risk prevention and management). Moreover, the Charter supports researchers in identifying potential ethical concerns during both the planning and execution phases of research, allowing for the development of appropriate solutions from conception to the dissemination of results. It involves all stakeholders, including researchers, research institutions, the scientific community, funders, editors and publishers, and policymakers.
The Charter also seeks to promote self-regulation mechanisms to enhance the quality, legitimacy, and trustworthiness of research by fostering common good practices. It aims to protect research autonomy and encourage responsible interpretation and dissemination of research findings in both the social sphere and public communication.
The Charter outlines several general principles, presented without hierarchical order, including:
- Benefit for society: Research should serve the common good of society, even if the social benefits are not immediate or quantifiable. Benefits include the advancement of knowledge, understanding of social phenomena, and cultural enrichment.
- Integrity: Research must be conducted with integrity in all aspects and phases to uphold the social reputation of science.
- Prudence: Researchers should exercise prudence, demonstrating promptness, conscientiousness, vigilance, and balance in their ethical commitment to research.
- Respect: Research should respect the dignity, autonomy, personal integrity, and private life of subjects, treating them impartially and independently of any influences, with particular attention to the vulnerability of certain subjects (especially minors), and promoting their capacity for discernment and expression of will/preferences.
- Dignity: Research must respect human rights, treating individuals as ends in themselves and avoiding exploitation while preserving their integrity.
In non-biomedical fields, there is a lack of regulatory frameworks governing ethics review. Despite this gap, many universities have established RECs for non-health-related research, particularly in the human and social sciences. These committees have emerged spontaneously, often in response to requirements from journals or grants, especially at the international level. However, there is no standardized or uniform organization of these committees across universities. The composition of these committees varies widely. They often include internal professors representing different disciplines, some of whom may lack experience in research evaluation. In certain cases, committee members may have expertise in biomedical research ethics but not in human and social sciences. Currently, there is a lack of coordination among RECs in the human and social sciences. While some initiatives aim to address this issue, they have yet to be fully developed.
In many universities, scientific research in psychology, pedagogy, sociology, cultural anthropology, and economics is typically reviewed. The issues pertaining to the recruitment of participants, incentives, risk/benefit evaluations (considering physical, psychological, social risks), informed consent, covert research, incidental findings, data protection, and privacy (anonimization, identification, codification), obligation of notification, dissemination receive a high level of scrutiny.
Additionally, there is a debate on whether the evaluation should also include the scientific methodology of the research, given the epistemological differences between hard and soft sciences (qualitative methodologies, emerging evolutive design, statistical samples).
In Italy, the number of committees outside the biomedical field is rising in many universities (almost all). There is no census or list of committees; a spontaneous intention to have a sort of coordination is emerging, but there is no regulation in the field regarding the existence of the committee, its composition, role, and tasks, etc. Some RECs assessing non-health-related research are composed of both internal and external members; some are established within universities and give a general evaluation of every field of research, some others are established in departments or single courses. It is worth noting that RECs with experts in ethics coming from a biomedical background may lack experience in applying ethics to specific fields, such as psychology, pedagogy, or behavioral economics.
For example, at the Libera Università Maria SS. Assunta (LUMSA) University REC for non-health-related research involving humans, there is one internal member, while the remaining members are external, in order to guarantee independence and no conflict of interests. The competencies involved are: forensic medicine, ethics of biology and medicine, psychology. LUMSA University's REC for non-health-related research involving humans is regarded as a university committee rather than being affiliated with a specific department. It holds a symmetrical position with the general committee responsible for evaluating research projects for internal funding. The LUMSA University REC is supported by a single secretariat member, who is an administrative staff member assigned to the research office. REC members typically convene four to five times per year, reviewing nearly 6 research protocols or even more during each meeting. All the protocols pertain to non-health or, more precisely, non-medical research.
The REC at LUMSA receives the protocol, and after the REC meeting, it usually requests resubmission with the necessary modifications within 10 days. After a few days, the REC approves the study, typically within a total timeframe of no more than 15 days.
More awareness on ethics of research in human and social sciences is essential through education of researchers and members of committees. There is a need for dialogue and debate between experts of ethics in biomedicine and beyond biomedicine, exchange of good practices and cases evaluation (registries). Education and discussion should aim at the creation of research ethics committees – in the field of social and human sciences - not as censorship, bureaucratisation, de-responsabilization, legalism, but as space and time for critical reflection, interdisciplinary and pluralist dialogue ‘with’ researchers, increased research awareness and literacy, enhancing responsibility and virtue of researchers, innovation and improvement of research quality, in the context of a better trustworthiness of society in science.
Report contributor and national contact
Laura Palazzani
Chair of the Ethics Committee for Scientific Research in LUMSA University
palazzani@lumsa.it
