Abstract
Keywords
Introduction
The increasing complexity of modern biomedical research has highlighted the growing need for robust mechanisms to address ethical challenges effectively. As research advances in complexity, ensuring compliance with ethical standards and protecting research integrity has become increasingly difficult. These challenges are particularly evident in areas such as participant recruitment, informed consent, and data confidentiality, which demand careful consideration and ethical oversight (McCormick et al., 2013).
In many parts of the world, Research Ethics Consultation Services (RECS) have emerged as a critical resource to meet these challenges (McCormick et al., 2013). By offering structured support, RECS ensures adherence to ethical principles and facilitates ethical planning, enabling researchers to anticipate and address potential challenges early in the research process (Taylor et al., 2021).
However, in Malaysia, research ethics governance faces significant systemic challenges. Limited awareness of ethical standards among researchers, a lack of standardised practices across institutions, and insufficient training programmes for ethics oversight have hindered the development of a cohesive ethical governance framework (See et al., 2021). Furthermore, the lack of RECS in Malaysian institutions has created a critical gap in ethical consultation, particularly in high-stakes and rapidly evolving fields such as artificial intelligence and advanced biomedical technologies (Tackett et al., 2024).
Given these challenges, integrating RECS into the Malaysian research governance framework could help improve the country’s research ethics ecosystem. By offering structured ethical guidance and fostering accountability, RECS can help bridge the existing gaps in ethical oversight and support researchers in navigating the increasingly complex ethical landscape of modern biomedical research. Moreover, RECS could significantly improve stakeholder engagement, allowing for the incorporation of diverse perspectives into the ethical review process. This inclusion is essential for protecting the rights of research participants and enhancing the overall quality and integrity of health research conducted in the country (Tackett et al., 2024).
This paper aims to identify the gaps in Malaysia’s current research ethics governance and explore the role of Research Ethics Consultation Services (RECS) in addressing contemporary ethical challenges in research that could help bridge the gaps. Several models of Research Ethics Consultation Services (RECS) have been reviewed and compared with our own departmental model to identify practical strategies and structures that can strengthen the development, implementation, and sustainability of a contextually relevant RECS in Malaysia.
Methods
Literature search strategy
A narrative review was selected as the methodology for this paper to explore the evolving role of RECS, with a focus on various models and their relevance to the Malaysian research ethics landscape. Although narrative reviews are not bound by the strict protocols of systematic reviews, a structured and transparent approach was adopted to enhance the review’s validity.
The literature search was conducted across PubMed, Scopus, and Google Scholar using combinations of the keywords: ‘Research Ethics Consultation Services’, ‘Research Ethics’, ‘Governance’, and ‘Malaysia’. Articles published in English or Malay were included, with no restrictions on publication year, to ensure comprehensive coverage of both foundational and recent developments related to RECS.
Inclusion and exclusion criteria
The inclusion criteria were:
Peer-reviewed journal articles, review papers, case studies, guidelines, and institutional or policy reports.
Articles that discussed the establishment, implementation, structure, competencies, and impact of RECS either globally or within Malaysia.
Both empirical and theoretical pieces relevant to the objectives of the paper.
Articles were excluded if:
They did not address RECS directly (e.g. focussed solely on general research ethics principles or IRB mechanisms).
The full text was not available.
From this process, a total of 12 articles were included in the final analysis (see Supplemental File for detail). These articles formed the core foundation of this review.
Data extraction and thematic analysis
Data from the reviewed literature were organised to extract similar codes which later created key themes that align with the objectives of this paper. These themes included the gaps in the current research ethics governance, the role of Research Ethics Consultation Services (RECS) in addressing contemporary ethical challenges in research, their integration into institutional frameworks, and their effectiveness in promoting ethical research practices. Particular focus was placed on global RECS models, such as the Clinical and Translational Science Awards (CTSA) in the United States and the Research Bioethics Consultation Services in Japan, to evaluate their potential as foundational examples for implementing RECS in Malaysia.
The analysis also emphasised identifying gaps in Malaysia’s current research ethics governance and assessing how the establishment of RECS could address these shortcomings. Additionally, the review highlighted our department’s practice in establishing a tailored RECS, comparing and contrasting it with current practices available in other countries to identify key areas for improvement and opportunities to enhance its effectiveness in addressing ethical oversight and supporting researchers in navigating complex ethical landscapes.
The Supplemental Table summarises the key details of each article, including the author(s), year of publication, article type, focus, and relevance to the objectives of this paper.
The role of Research Ethics Consultation Services (RECS)
RECS are specialised services designed to provide researchers with guidance and support in addressing ethical dilemmas before, during and after the research process. These services offer expert advice to ensure compliance with ethical standards and foster a culture of accountability within research institutions (Taylor et al., 2021). By collaborating with RECS at the outset of research planning, researchers can proactively identify and address ethical risks, elevating the quality, and credibility of their work to new heights (Porter et al., 2018a).
Research Ethics Consultation in the United States of America and Japan
While RECS are emerging globally, the United States remains one of the few countries with a well-established and widespread model. Additionally, the availability of documented practices, research and institutionalised frameworks in the U.S. allows for a more detailed analysis, offering insights that may inform the development of similar services in other regions.
RECS have been established in academic medical centres and research institutions to address the ethical complexities of modern biomedical research. The Clinical and Translational Science Awards (CTSA) network in the United States is a prominent example. Established by the National Institutes of Health (NIH), the CTSA programme institutionalised RECS to foster communication between researchers and oversight bodies and ensure ethical compliance. The CTSA ‘Moral Community’ model emphasises collaboration and structured consultation processes, significantly enhancing ethical decision-making within research institutions (Cho et al., 2015; Taylor and Kass, 2009). However, variability in the availability and expertise of personnel remains a challenge, potentially leading to inconsistencies in the quality of guidance provided (Taylor and Kass, 2009).
Similarly, the Research Bioethics Consultation Service at the Institute of Translational Health Sciences (ITHS) offers tailored ethical guidance to researchers. This model emphasises early engagement with researchers and collaborative oversight, ensuring that ethical principles are integrated into all stages of research (ITHS, n.d). The University of Chicago’s MacLean Center for Clinical Medical Ethics also exemplifies the effectiveness of RECS in addressing complex ethical issues. Their work in guiding ethically complex procedures, such as living donor transplants, demonstrates the value of case-specific ethical consultations in advancing medical science (MacLean Center for Clinical Medical Ethics, 2024).
Additionally, in Japan, the University of Tokyo provides research ethics consultation services by offering both partial and comprehensive support to researchers. This includes assisting with the preparation of materials for ethical applications, ensuring compliance with guidelines, and selecting the appropriate ethics review board. Researchers receive guidance on drafting research protocols, consent forms, contracts, and other essential documents, as well as support in preparing presentations and responding to inquiries from the ethics review board. In addition to procedural support, the university also provides comprehensive consultation by helping establish internal systems, manuals, and training programmes to strengthen ethical research practices. Through these efforts, the University of Tokyo plays a key role in fostering a structured and well supported research ethics environment (OHRS Office for Human Research Studies, 2023).
Similarly, Tokushima University Hospital provides research ethics consultation services through its Clinical Trial Centre for Developmental Therapeutics (CTCDT), which was initially established in 1999 to support registration trials and ensure compliance with Good Clinical Practice (GCP) guidelines. Following the introduction of government ethics guidelines, the centre expanded its role to meet broader ethical requirements, leading to the establishment of the Academic Office of the Ethics Committee in 2002. This office, staffed by a medical doctor and two scientists, began offering advisory services and document pre-checks for investigators. In 2012, these activities evolved into a structured research ethics consultation service, focussing on ethical issues faced by researchers, compliance with regulations and application processes for ethics review. Consultations related solely to procedural matters and application documents were excluded from their service. The hospital systematically recorded and analysed consultation data to improve its research ethics support framework (Yanagawa et al., 2018).
Research Ethics Consultation Services (RECS) are grounded in core ethical principles such as autonomy, justice, and beneficence, which not only shape the philosophical foundation of ethical guidance but also inform the practical procedures used during consultations. The success of a RECS is not measured solely by operational efficiency, such as the number of consultations conducted, but by how well it upholds and applies these ethical principles in real research scenarios, ensuring that the guidance provided promotes ethically sound and socially responsible research. In the United States, for example, the Clinical and Translational Science Awards (CTSA) network demonstrates success through the integration of RECS into institutional governance structures, particularly by embedding ethical consultation early in the research lifecycle and coordinating with Institutional Review Boards (IRBs). This integration leads to improved protocol quality, reduced revision rates, and greater efficiency in ethical review. Additional markers of success include increased researcher engagement, strengthened ethical literacy, and enhanced confidence in addressing complex ethical dilemmas. Similarly, in Japan, institutions such as the University of Tokyo and Tokushima University have shown that success in RECS also includes the development of supportive infrastructure, such as internal manuals, ethics training programmes, and dedicated consultation units. These services have successfully facilitated researchers’ navigation of complex ethical and regulatory requirements, particularly in high-stakes clinical and biomedical research. At Tokushima University, systematic documentation and analysis of consultation data have further contributed to iterative service improvement, ensuring that ethical guidance remains responsive to researchers’ evolving needs. In both contexts, success is not merely measured by procedural efficiency but by the extent to which RECS promotes a culture of ethical responsibility, strengthens institutional support for research integrity, and enhances the overall quality of ethical oversight. In this paper, the term global refers to internationally documented models of RECS, such as those in the United States and Japan, that, while grounded in shared ethical principles, exemplify context-sensitive implementation strategies that align with local institutional needs and cultural expectations, offering adaptable frameworks for promoting ethical integrity in research.
Challenges in Malaysia’s Research Ethics Governance
In Malaysia, research ethics governance faces several systemic issues that hinder the consistent application of ethical standards. These include a lack of standardised practices across institutions, inadequate ethics training programmes, and limited awareness of ethical principles among researchers (See et al., 2021). While tasked with regulatory oversight, Institutional Review Boards (IRBs) often lack the resources to address complex, case-specific ethical dilemmas proactively (See et al., 2021). Since it is difficult to regulate ethical compliance post hoc, ensuring compliance from the outset of research planning is crucial. Perhaps, this is where RECS could play a pivotal role, providing researchers with the tools and guidance necessary to align their studies with ethical requirements from the beginning (Tackett et al., 2024). While RECS may not resolve every challenge, it has the potential to elevate ethical oversight, diminish risks, and forge a path to address the obstacles.
The potential of RECS in Malaysia
The lack of formal establishment of RECS in Malaysian research institutions indicates a lack of awareness regarding the importance of RECs in enhancing ethical oversight. Establishing Research Ethics Committees (RECs) could improve compliance with ethical standards and enhance the quality of research. These services would be particularly beneficial in high-stakes areas like artificial intelligence and emerging biomedical technologies, where current regulations may be inadequate (Reuters, 2024). By incorporating RECS into research institutions, Malaysia can develop a cohesive governance structure that aligns with best practices while addressing local concerns.
Bridging the gap: Introducing a tailored RECS for Malaysia
While models such as the Clinical and Translational Science Awards (CTSA) network and the Research Bioethics Consultation Service have demonstrated the effectiveness of RECS in addressing ethical issues, the lack of RECS in Malaysia underscores a critical gap in research ethics governance. Despite the systemic constraints faced by Malaysian institutions, there is considerable potential to adapt and implement RECS that are tailored to the local context. Recognising this need, the Department of Medical Ethics and Law in the Faculty of Medicine, Universiti Teknologi MARA (UiTM) initiated establishing a Research Ethics Consultation Service (RECS) in 2022 in reflection to the positive establishment of Clinical Ethics Consultation Service (CECS) in 2020 to support clinicians in the hospital.
Since its inception, the service has grown consistently, starting with a single consultation in 2022 and expanding to 15 consultations in 2023 and 14 in 2024 (Figure 1). Out of these consultations, 21 were requested by students, primarily postgraduate students, while nine were initiated by staff members (Figure 2). This consistent increase in uptake underscores the growing need for customised ethical guidance among researchers at UiTM.
Line graph showing the number of research ethics consultations from 2022 to 2024.
Distribution of research ethics consultations by staff and students.
At UiTM, research ethics consultants primarily serve as a resource for researchers seeking guidance on the ethical aspects of their studies. Our role is to provide advice and expert opinion when researchers are uncertain about the ethical components of their research design. Researchers are advised to engage with us during the planning phase to confirm that their methodology is both scientifically rigorous and ethically sound. This collaborative approach allows for the identification of potential ethical issues and the development of strategies to mitigate associated risks prior to the submission of their proposals for review by the ethics committee. In some cases, when proposals are reviewed by the Research Ethics Committee (REC) and found to be lacking in ethical clarity or justification, the committee refers the researchers to our service for consultation. We then work with them to strengthen their proposals and help them meet the necessary ethical standards for approval. Beyond one-on-one consultations, we also contribute to capacity building by conducting training sessions and organising an annual Research Ethics Workshop. These initiatives are open to researchers from the Faculty of Medicine, other faculties within UiTM, as well as members of the public. Through these efforts, we aim to foster a stronger culture of research integrity and ethical awareness within the academic and research community. At present, there is limited information available on whether similar research ethics consultation services exist in other Malaysian universities or institutions. As such, our report focuses on our department’s experience and practice, which may represent one of the first formalised RECS models in the country. We hope this contribution will encourage further sharing of best practices and stimulate interest in expanding such services nationally.
By drawing on international practices, particularly in how RECS are structured and implemented, and adapting them to local needs, our department’s RECS has been able to fill a critical gap in ethical oversight. This includes modifying consultation procedures, training approaches, and outreach efforts to fit the Malaysian context. We recognise that ethical decision-making in Malaysia often values family input, respect for hierarchy, and community harmony, elements that differ from the Western emphasis on individual autonomy. Therefore, our RECS does not apply global principles rigidly but instead adapts them to align with local cultural and institutional values. At UiTM, the RECS regularly receives consultations from researchers, most of which involve ensuring that their study proposals meet the ethical requirements of the Research Ethics Committee (REC). Common queries include how to address ethical concerns clearly and how to meet submission standards.
Many discussions revolve around the complexities related to research methods, with researchers examining the ethical implications of addressing sensitive topics, the suitability of questionnaires, and the need to adapt tools for different cultural contexts, including translating questionnaires into
Some consultations delve into more complex scenarios, such as addressing ethical questions regarding clinical trials involving herbal products, understanding insurance requirements, and ensuring compliance with institutional policies. Furthermore, researchers often seek guidance on sample size calculations and statistical analyses to validate and strengthen their studies. While the RECS provides initial ethical guidance on these matters, questions related to statistics are referred to the Biostatistics Consultancy Service for specialised support.
Consultant staffing
Our RECS is composed of six active members from the Department of Medical Ethics and Law, all of whom have medical backgrounds and specialised training in medical ethics and law. Although this service is voluntary and involves no additional compensation, the consultants commit their time as part of their wider academic responsibilities, ensuring that this service is effectively integrated into institutional research governance.
Funding
Unlike many globally established RECS, our service operates without dedicated funding. It is sustained as a departmental initiative, with consultants volunteering their time and expertise. While the absence of financial support limits the expansion of activities, it also underscores the department’s commitment to providing ethical guidance as an integral part of its mission. The service remains accessible to researchers without additional costs, promoting equitable access to ethical support.
Access and utilisation
The Research Ethics Consultation Service (RECS) at UiTM is accessible to all members of the Faculty of Medicine, including academic staff, researchers, and students. Postgraduate students represent the majority of those seeking consultations, often reaching out at the research planning stage or upon receiving feedback from the Research Ethics Committee (REC).
It is important to note that RECS serves a different function from the university’s REC. While the REC is a formal regulatory body responsible for reviewing, approving, or rejecting research proposals based on ethical criteria, RECS offers informal, nonbinding consultation. The service is designed to support researchers in refining their ethical approach prior to submission and to provide interpretative assistance when REC feedback highlights ethical shortcomings. In this way, RECS complements the work of the REC by helping researchers anticipate potential ethical concerns and improve the quality of their submissions.
Besides that, participants of the Research Ethics Workshop also receive free consultations during the event and are introduced to both the theoretical and practical dimensions of ethical research practices. These efforts aim to build a culture of ethical sensitivity and improve the overall quality of research conducted within and beyond the institution.
Communication, tracking, and evaluation
Consultation requests are initiated via a Google Form, managed by the department’s administrative staff. The staff forwards the request to the appropriate consultant, who arranges a face-to-face or virtual meeting with the requester. At present, there is no written feedback offered to requesters following consultations, which points to a potential area for improvement. Implementing formal documentation of recommendations could facilitate the incorporation of ethical adjustments and provide a valuable reference for researchers and also consultants. Additionally, the current efforts to systematically track consultation outcomes and assess service effectiveness are limited, indicating opportunities for further development.
Relationships with other institutional entities
Five out of six RECS members concurrently serve on IRBs, either at the faculty or university level, while two members hold positions on Malaysia’s National Research Ethics Committee governed by the Ministry of Health Malaysia. The current participations strengthen the alignment between ethical consultation and regulatory oversight, bridging theoretical principles with practical governance. Additionally, the RECS collaborates informally with the faculty’s Biostatistics Consultancy Service, referring requests primarily involving statistical analysis. All RECS consultants are also involved in the Clinical Ethics Consultation Service (CECS), although no crossover referrals have occurred to date, reflecting the distinct operational domains of the two services.
Confidentiality and privacy
No formal confidentiality policies currently exist in our RECS. Consultations are conducted based on mutual trust and professional responsibility without standardised documentation of confidentiality agreements. Introducing formal protocols for confidentiality could enhance the service’s credibility and align it with global best practices, particularly in cases involving sensitive ethical dilemmas.
Discussion
The establishment of our RECS addresses a significant gap in Malaysia’s research ethics governance. It provides researchers with essential ethical guidance in an environment where systemic gaps, such as limited awareness of ethical standards and the lack of standardised practices, persist. One of our RECS’s unique strengths lies in its consultants’ expertise, many of whom serve on institutional or national IRBs. This dual involvement allows the service to align closely with regulatory frameworks while addressing ethical oversight that enhances ethical oversight, such as issues involving secondary data, vulnerable populations, and methodological dilemmas. Additionally, our RECS consultants are actively involved in Clinical Ethics Consultation Services (CECS) provided by our academic medical centres. In line with the call for open communication between RECS and CECS proposed by Cho et al. (2018) and Porter et al. (2018b), our service has implemented collaborative practices that extend beyond mere communication. This integrated partnership fosters greater effectiveness and broader benefits in addressing complex ethical issues in research ethics consultation services. However, the absence of dedicated funding remains a significant limitation, restricting the service’s capacity for expansion and sustainability. Institutional recognition and financial support could provide the resources needed to address these gaps effectively.
Despite its achievements, the service has areas for improvement. For instance, the lack of formal feedback mechanisms for requesters and standardised tracking of consultation outcomes limits its ability to systematically measure and enhance its effectiveness. Introducing written recommendations, post-consultation could serve as both a reference for researchers and a tool for service evaluation. Similarly, developing confidentiality policies and protocols would align the service with global standards, fostering trust and ensuring ethical rigour.
Globally, RECS have demonstrated their value in addressing ethical complexities in biomedical research by integrating structured support into research governance frameworks. Our service mirrors these practices in many ways but has yet to fully realise its potential as a transformative resource for ethical research practices. To achieve this, further efforts are needed to strengthen documentation, expand outreach, and secure funding. By addressing these areas, the RECS can better meet the needs of researchers and contribute to a culture of ethical excellence within the institution.
As research continues to evolve with advancements in artificial intelligence, genomic medicine, and other emerging fields, the role of RECS will become increasingly vital. These services not only provide essential guidance for persistent limitations but also prepare researchers to navigate future ethical complexities. Our department’s experience underscores the importance of embedding RECS into institutional structures and the need for ongoing development to ensure their sustainability and effectiveness in fostering ethical research practices.
Conclusion
RECS are critical in addressing the growing complexities of ethical dilemmas in biomedical research. Globally, these services have been integrated into research governance frameworks, offering researchers structured guidance to ensure ethical compliance, enhance research integrity, and promote accountability. Our department’s RECS has been established to bridge a significant gap in Malaysia’s research ethics governance, addressing regulatory weaknesses such as limited awareness of ethical standards, a lack of standardised practices, and inadequate training programmes. Since its inception, the service has demonstrated its value through steady growth and utilisation, particularly among postgraduate students. Staffed by a team with extensive medical ethics and law expertise, the service has successfully supported researchers in navigating a wide range of ethical dilemmas, from compliance in research planning to addressing complex issues involving vulnerable populations and emerging technologies. Despite its achievements, the absence of dedicated funding, formal feedback mechanisms, and standardised confidentiality protocols presents areas for potential improvement. Institutional support is essential to fully realise the potential of RECS in Malaysia. Securing funding, strengthening outreach efforts, and implementing systematic tracking and evaluation processes are crucial to enhancing the service’s sustainability and effectiveness.
Furthermore, aligning with global best practices by introducing confidentiality protocols and formalising feedback mechanisms will help establish RECS as a cornerstone of ethical research governance in Malaysia. As research continues to evolve with advances in technology and interdisciplinary collaboration, the role of RECS will become increasingly indispensable. By fostering a culture of ethical responsibility and providing tailored support to researchers, RECS can address current ethical responsibility and prepare institutions to navigate the complexities of future research landscapes. Our department’s experience serves as a model for the potential of RECS to contribute to ethical excellence in research, both locally and globally.
Supplemental Material
sj-docx-1-rea-10.1177_17470161251353541 – Supplemental material for The role of Research Ethics Consultation Services in advancing ethical compliance in research: A Malaysian case
Supplemental material, sj-docx-1-rea-10.1177_17470161251353541 for The role of Research Ethics Consultation Services in advancing ethical compliance in research: A Malaysian case by Hazdalila Yais Haji Razali, Aimi Nadia Mohd Yusof, Astrid Sinarti Hassan and Amnah Azahar in Research Ethics
Footnotes
Acknowledgements
The authors thank the Faculty of Medicine, Universiti Teknologi MARA, for their support in establishing the Research Ethics Consultation Service.
Ethical considerations
This article was prepared in accordance with the highest standards of research integrity and ethical scholarship. All analyses and discussions presented in this article are based on departmental census data and publicly available literature. The data used consist solely of aggregate numbers (e.g., the number of research ethics consultations) and do not involve individual-level or identifiable information. Therefore, no new human or animal subjects were directly involved, and specific informed consent was not required. The authors have ensured that all sources are properly acknowledged and have adhered to principles of honesty, transparency, and academic rigor throughout the writing process. Any potential conflicts of interest have been disclosed, and there are no competing interests to declare.
Author contributions
Hazdalila Yais Haji Razali: Initial writing, methodology development, literature review, data analysis and interpretation, thematic analysis, and submission of the article. Aimi Nadia Mohd Yusof: Draft editing and proofreading. Astrid Sinarti Hassan: Draft editing and proofreading. Amnah Azahar: Original idea conception.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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References
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