Regulatory frameworks and guidelines on research ethics and scientific integrity

This theme emerged from the need to clarify participants’ pre-existing understanding of research ethics and scientific integrity guidelines, enabling reflection on research practice and the identification of potential risks. The analysis revealed recurring patterns concerning the relationship between ethics and regulation, with ethical deliberation often reduced to compliance with established legal requirements, such as National Resolution 8430 of 1993, which governs the scientific, technical, and administrative aspects of health research in Colombia. Participants further noted that this regulatory framework may generate procedural barriers, potentially hindering the development of translational research, as reflected in participants’ accounts:

In this regard, participants indicated that the interpretation and application of regulations vary across institutions and research ethics committees. This variability contributes to the perception that research ethics and scientific integrity processes are shaped by institutional identity and differing levels of procedural stringency. A similar perception extends to intra-team evaluation processes, particularly regarding students, for whom participants emphasized the need for structured mentorship and guided ethical analysis.

In addition to human subject research, participants referred to guidelines governing animal research. Although participants described these guidelines as clearly established, they perceived their enforcement and level rigor as substantially dependent on institutional practices.

Despite general awareness of existing frameworks, participants identified significant challenges in their implementation. As noted in previous sections, some guidelines were perceived to be outdated, insufficiently context-sensitive, or even counterproductive. Within this framing, research ethics and scientific integrity were sometimes construed as constraints, given that scientific progress was described as inherently dynamic and forward moving, whereas regulatory frameworks were perceived as restrictive. Consequently, participants underscored the urgent need for bioethics training at all academic levels to foster a more constructive understanding of ethics and to promote responsible research practices. Insufficient preparation in this domain may unintentionally contribute to inappropriate conduct, as expressed by this participant:

Finally, several participants highlighted the role of research ethics committees in ethical deliberation processes. Beyond acknowledging their formal responsibilities, participants questioned the extent of committee members’ training and technical expertise in translational research within the national context, as one participant explained: “How many people who are able to see both sides of the coin are actually present and available in the labor market to serve on ethics committees, where they can provide an objective assessment of those projects?” (P1-Senior Researcher)

Within this thematic axis, the perspectives of research leaders, investigators, and trainees primarily centered on research ethics guidelines, whereas issues explicitly associated with scientific integrity were comparatively less emphasized. Notably, although ethics committees were not explicitly foregrounded in the interview guide, they received substantial attention in participants’ accounts, underscoring their perceived centrality in ethical oversight and deliberative processes.

Needs and practices in research ethics

This section explores the challenges, uncertainties, and tensions that emerge in relation to research ethics. These issues concern the foundational principles and conditions guiding research involving human participants and animals, with the aim of safeguarding their rights, dignity, and welfare. Across discussions, the most salient topics were risks, incidental findings, informed consent, and animal research.

As shown in Table 1, risks constituted one of the most extensively discussed subthemes. This prominence reflects not only perceived risks but also the uncertainties and ethical tensions inherent to translational research, which is characterized by iterative processes and continuous discovery that may directly affect patients or research participants.

Notably, the identification of risks was predominantly framed from a technical perspective. Such an approach may constrain ethical deliberation by limiting attention to non-physical risks, including psychological, social, or informational harms that participants may also encounter. Within this context, participants raised concerns regarding emerging procedures associated with advances in molecular biology. Data anonymization was described as a potentially vulnerable aspect of research practice, especially when collaboration with external institutions involves ethical standards and governance structures that are not fully known to local investigators.

Participants also reflected on risks to methodological rigor arising from the experimental process itself. Among these, low participant recruitment was identified as a significant challenge. In such cases, protocol modifications may be introduced to address feasibility concerns, potentially undermining the rigor of the study. Time constraints were likewise recognized as limiting factors, restricting opportunities for in-depth ethical reflection and deliberation.

Within this thematic domain, risks to participants was the most salient topic. Discussions focused particularly on the immediate consequences of interventions and experimental outcomes, especially in situations where the appropriate course of action for researchers is not clearly defined, as one participant described:

Incidental findings were another central area of discussion. In translational research, incidental findings are defined as unanticipated clinical, genetic, or experimental information identified during a study and not directly related to the research question. Although such findings may influence the course of the study, participants emphasized their implications for individuals, particularly regarding diagnosis, prognosis, or risk status. Researchers described uncertainty about their ethical obligations in these circumstances and, in some cases, acknowledged personal distress associated with not knowing how to respond appropriately. Despite this uncertainty, some investigators, drawing on prior experience and institutional requirements, highlighted the importance of informing participants about the possibility of incidental findings during the consent process and ensuring appropriate clinical guidance for timely and responsible disclosure:

Informed consent emerged as one of the most prominent subthemes in terms of frequency and depth of discussion. Participants underscored the practical and ethical challenges of designing consent processes that meet participants’ expectations and ensure meaningful understanding of study procedures and potential implications. A critical issue concerned therapeutic expectations, particularly in projects involving patients with severe or difficult-to-treat conditions. Researchers recognized participants as potentially vulnerable, often with limited capacity to fully assess risks and benefits, thereby framing informed consent as a process requiring careful ethical reflection rather than mere procedural compliance. Participants also proposed improvements to strengthen consent practices, including structured feedback mechanisms for patients. As participants indicated: “…that is difficult, but any clinical study should try to provide feedback to patients once the study is completed… However, patients are often given little consideration” (P5-Leader of Research Center).

Finally, although fewer participants reported direct experience with animal models, the discussion of animal research revealed divergent perceptions. Some considered regulatory frameworks overly rigid, potentially introducing procedural constraints or unintended bias in results. Others perceived excessive flexibility and the persistence of suboptimal practices. These tensions were linked to concerns about uneven regulatory oversight and insufficient recognition of institutional mechanisms such as Institutional Animal Care and Use Committees and established standards for animal welfare and good laboratory practice.

Needs and practices in scientific integrity

This section examines accepted standards, professional values, and practices within the scientific community aimed at ensuring objectivity, transparency, utility, and rigor in scientific evaluation. These principles are fundamental to preventing bias, fabrication data, plagiarism, undue external influence, and forms of censorship that may compromise the quality and reliability of research outputs. Although the number of references to this theme was generally lower than to others, discussions nevertheless emerged around issues such as publications, conflicts of interest, bias, and the management of personal data.

Publications were addressed primarily from the perspective of access to high-impact journals. According to participants, this opportunity is directly linked to funding prospects and to the strengthening of translational research groups. In this same vein, the discussion extended to data publication, particularly in projects funded with public resources. From the researchers’ perspective, this practice not only promotes transparency but also reinforces good research practices:

Within this discussion, participants also raised questions regarding the dual role a researcher may assume when simultaneously acting as a treating physician. This issue is especially relevant in translational research, as it may influence clinical practice in ways that directly benefit the patient, thereby generating tensions when overlapping with research interests. As one participant expressed, there is a fine line between the actual standard of medical care and the subjectivity that may be introduced when acting concurrently as a researcher:

As noted in previous sections, number and quality of publications, research group rankings according to national scientific evaluation systems, and other performance indicators are key elements for accessing funding and ensuring project continuity. In addition, participants emphasized the need to establish strategic alliances, particularly with institutions in the Global North, to support and strengthen local scientific production.

Participants also highlighted two aspects related to funding biases. First, they noted that timelines established by funding agencies are often shorter than those required for translational research processes. This renders translational research a long-term endeavor that demands sustained support from multiple funding sources to maintain a single project and achieve meaningful impact on society and public health.

Second, in response to time constraints and pressure to deliver results, some researchers mentioned the option of publishing partial findings. Although this practice may alleviate pressures related to deadlines and project continuity, it poses both methodological and ethical challenges. In this regard, participants also examined the influence of bias and the political instrumentalization of science in analytical processes. This issue is particularly significant, given that state support is essential not only for research sustainability but also for access to resources that strengthen scientific work. However, one participant warned that, in practice, such processes frequently lack the necessary objectivity and impartiality.

Finally, issues of particular concern to researchers emerged in the discussion, among which the management of personal data was especially prominent. Some participants indicated that assigning responsibility or custodianship to a specific researcher typically the principal investigator served as a strategy to ensure greater control over information. Nevertheless, other researchers stressed the importance of advancing toward more mature processes and adopting improved data protection practices. In this sense, international models regulated by law were highlighted as offering stronger guarantees of data security and anonymization, as one participant described:

Although scientific integrity was not explicitly identified through the review of formal guidelines or codes of good research practice, the analysis revealed several issues that directly affect its development. This category was constructed primarily from contributions of the investigator group and the student interview, which pointed to significant biases that constrain the development of translational research and the dissemination of results. Within this domain, personal data governance practices (including data access, storage and protection measures) stand out as requiring strengthening practices to ensure responsible and secure management.