Research ethics – A to Z series 

Here at the National Office, our role is to support innovative health research while ensuring the safety, dignity and well-being of research participants are safeguarded – and we do that by contributing to the system that ensures research ethics is an integral part of how health research is carried out in Ireland.  

But what exactly does it mean to conduct research ethically? And how do bodies like research ethics committees (RECs) help ensure this happens?  

Research ethics is a complex area, bringing together a diversity of disciplines such as for example, medicine, governance, artificial intelligence, law, and statistics. In a new series of feature articles, we want to shed light on some of the key concepts and topical issues in the field, with the help of experts from across Ireland’s research ethics community.   

To kick things off, we asked our team to put together a ‘rapid round’ A-Z that can give a flavour of the world of research ethics, the work of a REC and the role of the National Office.   



Anonymity, data protection and confidentiality are interlinked cornerstone principles when it comes to protecting the fundamental rights, freedoms and dignity of research participants. When submitting a study proposal to a REC, a research team must outline how they plan to safeguard personal data and ensure anonymity is preserved. This is then carefully reviewed from an ethical perspective by the committee, giving regard to national and international legislation such as the Health Research Regulations and the EU General Data Protection Regulations (GDPR).  

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One area of health research that presents new ethical considerations is the growing research field of biobanking and biobank infrastructure – collections of human biological samples together with their associated data, for use in (future) research. Knotty issues for RECs range from the use of biobank materials for unknown future uses, to difficulties in valid informed consent in certain socioeconomic or cultural contexts, to access rights and governance. The establishment of the National Irish COVID-19 Biobank has been a landmark development in biobanking here in Ireland – and in 2022, the National Office established a new dedicated REC to oversee ethical governance of this new research resource.
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Clinical trials

In Ireland, clinical trials of investigational medicinal products are one of the regulated areas of research where studies must undergo an ethics review by a National Research Ethics Committee (NREC). The members of these NRECs for Clinical Trials review applications and provide a ‘single national opinion’ on the ethics of proposed trials, in line with the requirements of the EU Clinical Trials Regulation. Without a favourable opinion, the clinical trial cannot proceed. 


Diversity – in gender, ethnicity, or socioeconomic background, for example – is important for the practice of research ethics in a number of ways. On the one hand, RECs look at diversity in the prospective study participants: to make sure that research is equitable and just, between different groups of society, are not only being recruited from particular social groups, for instance, unless this is justified by the health condition under investigation. On the other hand, it is important that the composition of the REC itself reflects society more broadly, as a robust ethics review requires diversity in viewpoints and lived experience.  

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A typical dictionary definition would define ethics as a set of moral values – perceptions held by an individual or society about what is morally the ‘right’ thing to do in a given situation. Research ethics is about applying those values to research activities: the design and conduct of research, the relationship between researchers, research participants and society more broadly, and balancing risks and benefits for all involved.
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The concept of fairness is important in determining whether research is ethical. There are questions of fairness involved in how research participants are selected, for example: are they being chosen from particular groups, and if so is this justified? Fairness also comes into play when considering how the benefits and potential harms of research are shared between participants.
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The emerging field of genomics presents new ethical questions. While genome sequencing offers immense potential for diagnosis and treatment of certain conditions, it also raises the issue of how to handle information uncovered by sequencing that is unrelated to the original investigation. Should a clinician inform a patient being treated for haemophilia that their genome indicates an outsized risk of developing lung cancer? The ethical dilemmas presented are prompting intense reflection and discussion as the research and clinical field evolves. 

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History of ethics

The origins of today’s principles of health research ethics can be traced back to the darkest episodes in human history. The horrific abuse of research subjects in Nazi Germany informed the Nuremberg Code, a 10-point statement drafted in 1947 with the aim of preventing future atrocities. This fed into the 1964 Declaration of Helsinki, which focused on clinical research and remains the global international statement for medical research ethics today. Likewise, prompted by the reaction to unethical research on African-Americans in the Tuskegee Syphilis Study, the 1979 Belmont Report has become another foundational text, defining ‘respect for persons, beneficence and justice’ as cornerstone ethical principles in health research.
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Informed Consent

Informed consent is one of the most important ethical principles and legal rights in health research (and medical care and treatment). It refers to the imperative for individuals to give informed, explicit agreement to participate in a research study with the assurance their fundamental rights and freedoms are not compromised. The prospective participant should understand the purpose of the research and what they are agreeing to, by participating and their consent must be deliberate, freely given and unambiguous and recorded.
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Along with respect for persons, autonomy, beneficence, non-maleficence, justice is one of the central principles of research ethics. Justice refers to striking a fair balance as to who benefits from research and who bears the risks – in particular ensuring that research does not exploit those who cannot protect their own interests, meaning it is closely linked to the concept of vulnerability.  

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To evaluate whether a research proposal meets ethical standards, many different types of knowledge are needed – which is why RECs are made up of members with diverse professional and personal backgrounds. Depending on the topic of research, the review may require a medical opinion, specialist knowledge on the workings of technology, or detailed understanding of the finer points of legislation. Equally essential is the knowledge gained through lived experience as a patient or research participant, making PPI representation vital to effective a robust REC review.  


Some research ethics committees are governed by a framework of national and international legislation. In the Irish context, key statutes include the Health Research Regulations of 2018 and EU legislation the Clinical Trials Regulation (replacing the Clinical Trials Directive), the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices  Regulation 

Medical devices

Clinical investigations and post-market studies on medical devices are another area of health research in Ireland where studies must receive ethics approval from an NREC in line with EU regulations. Medical devices are defined by the European Medicines Agency as “products or equipment intended for a medical purpose” – these can be physical items ranging from pacemakers to stents, contact lenses to CT scanners, or any software that drives or influences the use of a device. The advent of artificial intelligence (AI) presents new ethical challenges in this context – see ‘Technology’ below.


Research ethics committees operate in different contexts: they may be based at a particular institution (e.g. a hospital or university), at a regional health authority or at a national level. In Ireland, the first National Research Ethics Committees (NRECs) were established in 2020-21, supported by the National Office for Research Ethics Committees. They are tasked with providing ‘single national opinions’ on ethical aspects of research under certain regulated areas. A single national opinion is valid for all sites where a study is conducted.  


At a fundamental level, the concept of openness is vital to research ethics – researchers must be transparent and honest about why and how they are conducting their studies, in order to enable proper oversight. The term ‘open research’ has acquired a specific meaning over time, however, today referring to the practice of making outputs of research freely accessible to maximise re-use. As this can amplify the social benefits of research, best ethical practice should include a commitment to open research – provided all ethical and legal obligations are met, as outlined in the National Office guidance on open research.  The Health Research Board supports open research through its publishing platform 


Patient, public and carer involvement (PPI) refers to active partnership with patients and members of the public along all stages of the research process, so that they can make their voices heard and contribute their own lived experience to the work of health research that impacts everyone in society. PPI members on our own NRECs bring this expertise and perspective to ethics review in Ireland – and describe the benefits of participating in their own words here 


Methodological quality is an essential ethical requirement for any research study. RECs evaluate quality with reference to international standards such as those set out by the International Committee on Harmonisation of Good Clinical Practice (ICH-GCP) Guidelines – a globally recognised ethical and scientific quality standard for designing, conducting, recording and reporting trials.
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Research ethics committees (RECs)

RECs are a group of individuals from various professional and experiential backgrounds, who are tasked with reviewing the ethics of a research study before it can proceed. While their precise composition, legal status and mode of operation will depend on the jurisdiction or institutional setting, their essential function is always the same: to ensure the safety, well-being and dignity of individuals participating in health research.
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The safety of participants in research is paramount to any study and ethics committees play a fundamental role to ensure that participants are not harmed. Any potential harms are offset by robust precautionary actions and should be outweighed by the benefits of the research. Other bodies, such as the Health Products Regulatory Authority in Ireland, also play a role in monitoring the safety of drugs and medical devices that maybe part of a research study. From time to time, the HPRA publishes safety notices relating to the safety and quality of drugs and devices.   


Research involving new technologies often raises new ethical questions, requiring particularly careful deliberation on the part of RECs – both due to lack of precedence and uncertainty over future development. Innovations in emerging areas ranging from artificial intelligence (AI), ‘big data’ processing, remote monitoring, novel neurotechnologies to robotics, are just some of the emerging areas that are posing interesting ethical questions.  

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The fundamental role of an ethics committee is to ensure that the study a participant consents to enrol in, is conducted to the highest ethical standards. An example of an unethical practice is inducement or a means to overtly entice an individual to participate in a study. However, it is also unethical to cause economic harm to a participant such as not being adequately compensated for out-of-pocket expenses that maybe incurred when participating in a study. Inducement versus recompense should be carefully balanced. This is an ethical area that RECs carefully monitor.  

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In the statement of the Declaration of Helsinki (see ‘History’ above), vulnerable groups “may have an increased likelihood of being wronged or of incurring additional harm” and so additional governance and/or ethical safeguards may be required during research to ensure the rights and freedoms of those individuals. In regulated areas of research (see ‘Legislation’) vulnerable groups are clearly defined. Factors that might make a research participant vulnerable include an inability to provide informed consent due to diminished capacity, or being party to a power imbalance that might limit their capacity to choose freely. However, the concept of ‘vulnerability’ can be contentious and is not clearly defined. It is important not to apply assumptions or an overtly paternalistic approach to some cohorts that may be perceived as vulnerable, as they may well be in a position to speak to their own best interests.  

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Approaches to research ethics can vary widely depending on where in the world that research is taking place. It is important for researchers to understand culturally specific understandings of what is meant by ethics, differing conceptualisations of individual rights, and any cultural or political sensitivities that may be in play. Ethical questions around power differentials between the Global North and South may require special attention if, for example, research is conducted by international teams in low-income countries.  



Depending on the research study being proposed, RECs may look at the extent to which participants will be exposed to ionising radiation – such as from x-rays – if the exposure or intervention is experimental or beyond the standard of care. This is part of their duty to safeguard research participants. 

Young research participants

Particular ethical considerations apply to research where the participants include minors – children or young people up to the age of 16 or 18 years of age, depending on the legal framework applied. RECs will always endeavour to ensure the rights of young participant are upheld and core to the research study. Ethical considerations that may arise, for example, are power differentials in children’s interaction with adult researchers, ensuring children’s understanding of the purpose and process of the research, and the involvement of parents or carers in the research process.
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Zoonotic diseases that are transmitted from animals to people have the potential to unleash new and rapidly spreading health threats – with the COVID-19 pandemic providing the ultimate case in point. This presents specific challenges for research ethics, as evaluations must be made in a context where many variables are still unknown and where the facts on the ground are changing constantly. Here in Ireland, the National Office played an integral part in supporting best ethical standards in research during this turbulent time: the establishment of the NREC COVID-19 facilitated an expedited ethics review process for COVID-19 health research – supporting immediate, evidence-based decision-making and contributing to global efforts to counter the pandemic. 

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