Introduction to research ethics

Introduction

Research ethics encompasses norms, principles and values that contribute to the regulation of scientific activities. The norms have been developed over time and are rooted in the international research community. In Norway, the concept of research ethics is understood broadly. This means that research ethics includes norms to ensure quality and reliability; norms that regulate the research community; norms concerning the relationship between researchers and individuals or groups involved in or affected by research; and norms regarding the use and consequences of research.

In many cases, the norms can be traced back to principles, which are often more overarching. In bioethics, for example, the principles of autonomy, non-maleficence, beneficence, and justice are central (Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics). Values express a desired state, and in research ethics, trust and quality are values that norms and principles aim to promote.

Parts of research ethics can be derived from general morality, i.e. the norms, values and principles that are broadly accepted in our culture (Tranøy 2005). Other research ethical principles, values, and norms are more closely tied to the nature and purpose of research itself, such as those formulated as the ethos of science (Merton, 1942). Research is a special form of knowledge production aimed at expanding our understanding, and the knowledge produced must be reliable and verifiable. Norms intended to help maintain research as a special form of knowledge production are common across all disciplines, although they may have different formulations, adapted to specific fields.

Research ethics cannot be reduced to a single ethical theory. It is pluralistic (see fact box). Many believe that research should be judged based on the effects it has, such as whether it will benefit society. At the same time, most people believe that there are absolute limits to what research can allow, regardless of its usefulness, partly because researchers have an obligation to respect human dignity and because research must safeguard fundamental principles such as the search for truth. Therefore, research ethics requires reflection, not just compliance with rules.

Descriptive and normative ethics

Descriptive ethics explains, among other things, the rights and obligations of researchers, for example regarding individuals who participate in research, such as the norm of informed consent.

Normative ethics, on the other hand, focuses more on ideals and describes the desired practices. In normative ethical theory, there are distinctions between consequentialism, deontology, and virtue ethics. In consequentialism, human behaviour is assessed based on the effects it has. Deontological ethics emphasizes the importance of absolute principles or rules, regardless of consequences. Virtue ethics focuses on virtues, i.e., traits or attitudes, and the character of the agent.

Key norms

The truth norm is indispensable to all scientific activity. The search for truth, commitment to truth, integrity, and honesty are preconditions for quality and reliability in research. The truth norm is linked to overarching methodological norms, such as factuality, accuracy, transparency, and accountability. These norms are intended to ensure that scientific methods are followed in a professionally sound manner. Furthermore, research is regulated by institutional norms, which are intended to contribute to research being open, collective, independent and critical (known as the "ethos of science"). All these norms constitute and regulate good scientific practice and aim to ensure the integrity of research.

Perhaps the most fundamental moral value in research ethics is human dignity, which is upheld through three principles: respect for equality, freedom and autonomy, protection from the risk of significant harm and unreasonable burdens, and justice in procedures and the distribution of benefits and burdens (as stated in The Belmont Report, 1979). These obligations aim to ensure responsible research. 

According to the UN Universal Declaration of Human Rights, everyone has the right to share in scientific advancement and its benefits (Art. 27 (2)). Research dissemination is therefore an important part of research ethics. Researchers should be open about risks and scientific uncertainty, and they must take the necessary precautions to avoid research causing harm to people, society, nature and the environment.

Research ethics evolves as research and society change. In recent years, there has been a strong focus in research policy on research contributing to solving major societal challenges and interacting with business, public administration and users. This development may largely be in line with current norms of research ethics, but it also puts norms under pressure and can increase the need to ensure the independence of research.

Research ethics has developed close to the individual discipline and in line with the challenges researchers face in various fields. The fact that research ethics is designed according to specific characteristics within a discipline, institution and nation can make it more user-friendly. At the same time, a cross-disciplinary and global dialogue on research ethics is desirable.

Guidelines for research ethics

Recognised norms of research ethics are developed both internationally and nationally. In Norway, research ethics is enshrined in guidelines drawn up by national research ethics committees. Research ethics guidelines and assessments are advisory.

The national guidelines for research ethics in Norway have been developed by researchers, in collaboration with researchers and to help researchers. The guidelines are a codification of the research community's own values and norms, and they seek to ensure academic freedom, responsibility and integrity in research. They have been developed over time, and they are based on experiences with new challenges and input from various stakeholders.

The guidelines for research ethics are intended to provide students, researchers and the research community, including the higher education sector, research institute sector, health trusts and industry, with an understanding of recognised research ethical norms. The guidelines are also intended as a knowledge base document for research funding bodies, public administrators, public and private partners in collaborations, politicians, and the general public. They can be useful tools in discussions about role clarification, clarification of conflicts of interest, and demarcation between research and politics. The research ethics guidelines apply regardless of how the research is organized and funded. The guidelines are also relevant for other research-related activities, such as innovation and development. 

The guidelines are advisory and intended to promote good scientific practice and develop research ethical judgment and reflection, clarify ethical dilemmas, promote responsible research and prevent misconduct. They account for various considerations and obligations, and they elaborate on the responsibilities of researchers, research institutions and other research actors. They can be of assistance in addressing specific challenges, in the planning of a research project, or in the reporting and publication of findings and results.

In research ethics judgements, researchers must often weigh different concerns against each other. At times, different norms are intimately linked; for example, accountability is a precondition for verifiability. In other cases, different parts of the guidelines may conflict with each other; for example, when one considers societal benefits against the risk of harm or disadvantage to singular individuals. During the research process, ethical questions may also arise that are not accounted for in the guidelines. Researchers must identify and consider ethical dilemmas and exhibit reflective and articulated judgement.

Basic norms apply across disciplines, while other norms may be partly discipline-specific and help to define and regulate research within the respective field. In interdisciplinary projects, it is recommended that the research ethics guidelines for the various disciplines are followed.  

Medicine and health sciences

In medical and health research, research ethics is based on international guidelines, especially developed as a response to unethical medical experiments during World War II. The most central one being the Declaration of Helsinki, which is given by the World Medical Association but now regarded as a guiding document for research in medicine and health. This affirms that individual-focused ethics is fundamental, by stating that the goal of generating new knowledge can never take precedence over the rights and interests of individual research subjects (section 8). The Biomedicine Convention is another central document intended to ensure the protection of human rights in the application of biology and medicine.

In Norway, the Declaration of Helsinki is central to the Health Research Act, which regulates all medical and health research. According to this law, medical and health research must have prior approval before it can be initiated. The approval is granted by the Regional Committees for Medical and Health Research Ethics (REK), and decisions can be appealed to the National Committee for Medical and Health Research Ethics (NEM). NEM is also responsible for the professional coordination of the committees in REK.

The purpose of the Health Research Act is «to promote good and ethically sound medical and health research» [unofficial translation by the University of Oslo]. Medical and health research is defined in the Act as «activity conducted using scientific methods to generate new knowledge about health and disease».

NEM has developed several specific guidelines for medical and health research. These are intended to provide guidance to researchers in fields where research ethics dilemmas arise in particular:

Medical and health research in low- and middle-income countries (2021) has been developed to uphold fundamental ethical principles in medical and health research conducted in a low- or middle-income country.  

The factual scope of the Health Research Act (2021, in Norwegian only) is an assessment and clarification of the purpose and scope of the Health Research Act and is primarily intended to assist discussions of the RECs, but researchers and the research community may also benefit from it.

Guidelines for the use of genetic testing of humans in medical and health research (2016, in Norwegian only) have been prepared to contribute to predictable and uniform practice in the REC system and to contribute to ethically and legally justifiable treatment of research projects that include genetic testing. 

Payment to participants in medical or health research (2009, in Norwegian only) deals with the dilemmas that may arise and the ethical considerations that must be taken into account when assessing the payment of research participants. 

The Guidelines for Research Ethics and Scientific Assessment of Qualitative Research Projects in Medicine and Health Sciences (2010, in Norwegian only) have been prepared to help meet a need for clear criteria for the assessment of qualitative studies in the REC system.

Clinical trials of drugs (2005, in Norwegian only) are guidelines for the assessment of post-marketing studies.

The Guidelines for the Inclusion of Women in Medical Research (2001, in Norwegian only) discusses the importance of including both genders in all medical research.

Science and technology

In the field of science and technology, research ethics norms are specified in the Guidelines for Research Ethics in Science and Technology, prepared by the National Committee for Research Ethics in Science and Technology (NENT). NENT has also drawn up ethical guidelines for the use of animals in research. 

The Guidelines for Research Ethics in Science and Technology are divided into ten areas:

The role of research in society. Research has value in itself as a basis for new knowledge. This knowledge can be useful in various ways, in the short and long term. The guidelines that concern the obligations of research to society are about the responsibility of researchers and research performing organisations. This responsibility includes ensuring the knowledge base for sustainable development, contributing to public discourse, preventing the unintended use of research with negative consequences for people, society, and nature (including animals and the environment) and complying with recognised international conventions relevant to research ethics.

Scientific integrity, accountability, and openness. The search for reliable, comprehensive, and relevant knowledge is fundamental to research. For research to be reliable and legitimate, researchers must follow good scientific practice, which is regulated by the research community itself.

Academic freedom and the independence of research are necessary bases for the development of trustworthy knowledge. To ensure its integrity, research must be free and independent. Academic freedom presupposes responsible self-regulation and good scientific practice.

Uncertainty, risk and the precautionary principle. Research and technology development may have far-reaching consequences for health, society, and the environment. Concerns about the destructive impact of human activity on the environment led to the development of the precautionary principle. This, in turn, led to an increased awareness that scientific methods are not always sufficient for determining whether an intervention will have negative consequences.

It is important that researchers assess and communicate uncertainty and risk in connection with their research and that decision-makers who use scientific knowledge have a thorough understanding of the validity and the context of this knowledge. Uncertainty and risk are also relevant to research ethics in cases in which they cannot be quantified. While uncertainty generally is a neutral characterization, risk denotes something negative or an undesirable consequence.

Conflicts of interest and impartiality. The independence and transparency of research affect society’s trust in it. Trust in research may be tested if doubts are raised about the circumstances that have influenced the research. Such circumstances may concern the interests of researchers and research performing organisations, or influence from authorities, funders or partners in collaborations. To counteract illegitimate influence and the weakening of trust in research, it is important to be transparent about the role of the researcher, the research, and its funding. This applies to all research but may require more attention in commissioned research in which the varying interests of the collaborating parties may put the research under more pressure.

Protection of persons. Research involving human subjects raises specific demands related to respect for their inviolability and safety. This includes researchers’ responsibility to obtain consent, provide adequate information and ensure privacy. These requirements may be more stringent in research involving vulnerable groups or children. Researchers must also take into account others who are affected by the research, such as relatives, guardians, owners of animals being researched, and people who contribute with observations, photos, and the like. 

Protection of animals used in research. Some research involves animals, either as model organisms or through direct animal-related research. Animals are sentient beings with the capacity to feel pain. The interests of the animals and good animal welfare must be included in ethical considerations concerning harm and benefits to humans, animals, and the environment. 

Other bearers of knowledge and forms of knowledge. All societies have a range of types of knowledge. Researchers, professionals, and laypeople have different kinds of experience-based knowledge. Individuals and local communities may possess specific local knowledge. Traditional knowledge refers to a cumulative body of knowledge, know-how, practices, and representations maintained and developed through experience, often over generations. These types of knowledge and their bearers should be treated with due respect and protected against unreasonable exploitation. 

Commissioned research, collaboration and participation. Research and innovation are often carried out in collaboration with external partners or on behalf of external research clients. When external actors influence design and thematic delimitations to a greater or lesser extent, the difference in expectation and interest might place research ethical norms under increased pressure.

Whistleblowing. Whistleblowing occurs when employees report issues of concern at their own institution or elsewhere. In addition to whistleblowing as defined under the Working Environment Act, whistleblowing may concern internal matters in research connected to scientific misconduct, or it may concern broader research ethical issues with other types of social or environmental impact. It is in this broader sense that the term whistleblowing is used here.

Institutions must handle whistleblowing cases in an appropriate manner in accordance with applicable procedures and regulations. Institutions must ensure that the legal protection and reputation of those involved are not jeopardised.

Dissemination of research. Disseminating research to a broader audience beyond the research community is a social responsibility. Research dissemination is one of the core tasks of researchers; therefore, individual researchers should give this a high priority.

Institutions must enable researchers to contribute to this dissemination. The dissemination of research and participation in relevant public debates should be routine parts of research activity.

Social sciences and humanities

The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) has developed guidelines for research in the social sciences and humanities in a broad sense, including disciplines such as law, theology, educational sciences, psychology and public health. They can be applied in artistic development work and museum practice, and they can be relevant to other disciplines and interdisciplinary collaborations.  

NESH's guidelines outline key research ethics obligations within social sciences and humanities, summarised in five parts:

A)  The research community: Researchers have a shared responsibility towards each other within the research community. They should behave truthfully, treat each other with respect, and recognise each other’s contributions in projects and publications. Researchers have a collective responsibility for promoting the values and norms of research ethics in their teaching, supervision, dissemination, and publication.

B)  Research participants: Researchers have responsibilities towards everyone who is involved in or participates in research. Researchers must respect their human dignity and safeguard their personal integrity, safety, and well-being. As a main rule, researchers should both provide information and obtain consent from those who are involved in or participates in research.

C)  Groups and institutions: Disadvantaged and vulnerable groups have a particular need for protection Specific attention may be required in research across cultures or on cultural heritage. Public offices and private organisations have a joint responsibility to ensure that their participation in research is in accordance with recognised norms of research ethics.

D)  Commissioners, funders, and collaborators: Researchers and research institutions have obligations towards commissioners, funders, and collaborators. Similarly, other research actors have obligations towards researchers and research institutions. Research ethics balance the norms of openness and independence against demands for social utility and relevance.

E)  Dissemination of research: Researchers and research institutions have a responsibility to disseminate scientific results, methods, and attitudes from their own and others’ research to the society at large. Dissemination of research includes dialogue across disciplines, interaction with different actors in society, and participation in public debates.

Human remains

Norway has its own committee, the National Committee for Research Ethics on Human Remains (the Human Remains Committee), which gives advice and guidance for research on (ancient) human remains.

Ancient human remains encompass multiple and often overlapping identities that can give rise to a wide range of ethical dilemmas. The remains (i) are from individuals who deserve respectful treatment; (ii) represent ethnic or other groups whose history and culture also deserve respectful treatment; (iii) serve as scientific sources for better understanding past societies and peoples; and (iv) may, based on their cultural or archaeological context, be defined as unique or rare. Examples may be the remains of individuals from historically oppressed groups, remains with few existing cultural or archaeological parallels, or remains without a clear discovery context or origin.

The dilemmas are specific to this field of research. Therefore, the Human Remains Committee has focused on establishing specific guidelines for research on ancient human remains based on recognised norms and standards within the research community.

Guidelines for Ethical Research on Human Remains (2022) consists of 11 points divided into two parts: «Part A: Recognition, Consideration and Context» and «Part B: Analyses, Results, Dissemination and Repatriation». Part A includes consideration for the individual (1), living descendants (2), contextually unique human remains (3), discovery context, origin and ownership history (4) and affected groups (5). Part B includes considerations of the quality and feasibility of the research project (6), unintended consequences (7), destructive methods and verifiability (8), data management (9), repatriation (10) and visual dissemination (11). 

Further Reading

Research ethics guidelines from the various committees can be found here.  

If you want to read more about various research ethics topics, go to the Research Ethics Library, a collection of articles particularly suitable for teaching and written by various experts.

If you want suggestions for teaching, you can see this page, or the overview of external resources. You will also find journalistic content on research ethics in the Research Ethics Magazine, an independent journal published by the National Research Ethics Committees. 

References

Beauchamp, T.L. and Childress, J.F., 2001. Principles of biomedical ethics. Oxford University Press, USA.

Merton R.K. 1942. The Ethos of Science, J. Legal and Political Sociology 1: 115‐126. Gjengitt i: Merton R.K, Sztomka P. (ed.), Social structure and science, 1996. University of Chicago Press, Chicago.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Tranøy, K. E., 2005. Medisinsk etikk i vår tid. Fagbokforlaget