Ethical Principles in Healthcare Research

© Springer International Publishing AG 2017
P. Anne Scott (ed.)Key Concepts and Issues in Nursing Ethics10.1007/978-3-319-49250-6_14

14. Ethical Principles in Healthcare Research

P. Anne Scott 

National University of Ireland Galway, Galway, Ireland



P. Anne Scott


Ethical issues permeate the entire research process from the identification of the research question and selection of research participants, to dissemination of findings. This chapter identifies some of the historical influences informing the development of research ethics frameworks internationally. The author then moves to highlight some of the key ethical issues that need to be considered throughout the various elements of the research process. Some of the important principles underlying research ethics frameworks are identified and interpreted within the context of the research process.

Nursing researchResearch ethicsRespect for personsAutonomyBeneficenceInformed consent

The original version of this chapter was published in Curtis EA, Drennan J (2013) Quantitative health research: issues and methods. Open University Press. © Reproduced with the kind permission of Open University Press. All rights reserved.


Recognition of the need to regulate research on human beings can be traced back to reactions against the abuses associated with German and Japanese research during World War II. However as the twentieth century rolled out it was increasingly recognised that a number of abuses, in terms of research on human subjects, continued into the post-war period in both democratic and communist countries (Mason and McCall Smith 2010). Revelations during the Nuremburg Trails, for example, of the atrocities committed in the name of medical experimentation during World War II, combined with other twentieth century medical research scandals such as the Tuskegee Syphilis Study 1932–1927 (Adams 1996), the Willowbrook hepatitis studies (Krugman 1986) and the New Zealand cervical cancer inquiry (Cartwright 1988; Paterson 2010) has helped develop widespread resolve regarding the need to protect participants in human research projects and the need to continue to monitor the conduct of such research internationally. The first internationally accepted set of ethical guidelines with regard to these issues was the Nuremburg Code published in 1947 (for further comment see Annas and Grodin 1992). The World Medical Association (WMA) publicly endorsed the principles expressed in the Nuremburg Code by drawing up the Declaration of Helsinki in 1964 (WMA 1964). This Declaration has been revised a number of times since its first publication.

The past 30 years has seen a number of countries and organisations highlight issues surrounding the ethics of research on human subjects: for example the Belmont Principles (The Belmont Report 1979), the Irish Council for Bioethics (2004). In the nursing arena NMBI (the Nursing and Midwifery Board of Ireland) (2015) the Royal College of Nurses (RCN 2011) the International Council of Nurses (ICN 1996) and the Nordic Nurses Association (1995) all published new or revised guidelines for nursing research. Issues regarding the human rights of research participants have also been underlined by the Council of Europe (Council of Europe 1997).

Guided by international instruments (such as the Nuremberg Code, the United Nations Declaration on Human Rights (1948) the United Nations Convention on the Rights of the Child (1989), the Belmont Report (1979), and the Declaration of Helsinki (WMA 2008)), in addition to various ethical theories that have become influential in health care ethics in general, such as Kantian ethics and the principle-based framework of Beauchamp and Childress (2013), a conceptualisation of appropriate ways to treat and protect human beings, both the fully functioning adult and vulnerable human beings such as children, the older person, the terminally ill, has emerged and continues to be modified over time.

However as we move towards the end of the second decade of the twenty first century there are certain ethical principles that are seen as fundamental to the framework of ethics that guides decisions regarding the morally appropriate consideration and treatment of human being during research activities. For example the Irish Council of Bioethics in 2004 commented as follows:

Research involving human participants should be based on a fundamental moral commitment to the individuals concerned and to advancing human welfare, knowledge and understanding. A number of guiding moral principles govern the ethical review of research proposals. These principles aim to protect the well-being and rights of research participants/volunteers. (p. 6).

Some Important Considerations

Human beings are deserving of respect and protection as inalienable rights (UNDHR 1948). This is equally the case during research activities as it is in any other circumstances. Based on the work of the philosopher Immanuel Kant1 such values are expressed in the principle of respect for persons, sometimes translated as respect for autonomy. Such expressions of course raise questions of the definition of person and autonomy and when and in what set of circumstances such concepts are and are not applicable.2 However for the purposes of this chapter we will take it that respect is applicable to all human participants in nursing and health care research. The question then arises regarding what this actually means in the case of individual participants in a particular research project. At a minimum, the considerations explored below are relevant.

Respect for the Human Person

Within the context of research activity the principle of respect for persons is frequently articulated in terms of rights – both rights to autonomous participation and welfare rights (welfare rights refer to the right to have one’s support and protection needs respected). Some such rights are the following:

  • The right not to be injured or mistreated.

  • The right to give informed, un-coerced consent to participate in the particular piece of research.

  • The right to privacy, confidentiality and/or anonymity.

In terms of protecting the participant’s right not to be injured or mistreated, it is normally the duty of the research team not to expose the research participant to significantly burdensome, unreasonable, known or predictable risk. On occasion however, when significant burden or predictable material risk is unavoidable, it is the duty of the research team to provide appropriate information on the likely burden and /or risk involved, so that the participant can determine if they fully understand and accept such burden or risk. Thus, for example, in drug trials and trials involving medical devices, the trials are phased and normally commence with non-human (laboratory and animal) trials. Such measures help to provide insight into likely effects of the particular drug or device – at least on non-human subjects. Thus by the time clinical trials (trials using human participants) commence, previous phases give insight into the actions of the agent (drug or device for example). This provides a certain level of confidence that the agent will either not cause significant physical risk to the trial participants or that any such risks, which will be explained to the participant prior to participation, can and will be managed and /or mitigated by the research team. Where discomfort, burden and/or risk cannot be avoided such discomfort, burden and/or risk must be proportionate to the anticipated gain, either directly to the individual participant and/or to humanity or society. Such considerations are directly linked to the discussion of the principles of beneficence and non-maleficence below.

Informed Consent

Respect for the individual’s right to make decisions about themselves and their life (respect for autonomy) requires that research participants are adequately and properly informed regarding the nature of the research project. For example, potential participants must be informed with regards to what will be required of the individual participant, including the approximate time requirement, any procedures that will be performed on him/her, any known or predictable risks or side effects, the nature of the trial (where a clinical trial is part of the research design), whether a placebo is being used, whether the trial is blinded and so forth. Such information enables the potential research participant to give informed consent to participate in the particular research activity or project.

There are two other crucial elements that must be in play in order to ensure that consent is not only informed but also voluntary – and thus autonomously exercised. These elements are:

  • The participant must have the capacity to both understand the information being provided regarding the particular piece of research, including the implications of participation for the individual, and the (cognitive) ability to exercise consent.

  • The participant must be free from coercion. Thus the participant must be assured and accept, for example, that refusal to consent will not affect her/his current care and treatment if the individual is being cared for by any member of a health care team; either in hospital or in the community. The individual should also be free from any other form of duress related to the research in question – from the research or health care team or from relatives or significant others (see Doyal and Tobias (2001) for a detailed discussion of the principal requirements of informed consent).

In instances where the potential research participant is a patient, practitioners should be aware of the profound influence that they may have on patients to whom they suggest participating in research. For example Kass et al. (1996), in a study on participant consent to involvement in cancer clinical trials, express it thus:

Clinicians should be mindful of the tremendous influence they have over their patients, given that the mere suggestion of enrolment in research by a patient’s personal physician was interpreted by many patients to be endorsement.

Some research, within the context of health and developing the appropriate evidence base for health care provision, will require the participation of individuals who are incompetent or temporarily not competent to give consent to participate in the research activity. Such people should only be involved in research under very clearly articulated and strictly monitored conditions. If it is impossible to carry out the particular research project with competent participants (or for example to wait for the unconscious person to regain consciousness, or where such would invalidate the study) consent must be sought from the legally authorised guardian of the individual involved. As a general rule of thumb incompetent individuals, or members of other vulnerable groups, should only be involved in research when it is reasonable to expect that the individual, or the group of which she /he is a member, will ultimately benefit from the research in question; and where the potential participant is exposed to minimal risk and burden. This is part of protecting the welfare of such individuals. However it is also important, from an ethics point of view, that people with these kind of disabilities are involved in high quality research that is relevant to their care and treatment – in order to develop a relevant evidence base for this care and treatment.

Should the potential participant, identified as incompetent to consent, be able to give assent to participation in research, such assent should be sought – in addition to the consent of the legal guardian described above. In such circumstances a decision to withhold assent should be acknowledged and respected; thus this individual should not be included in the research project in question.

A corollary of informed consent is that the individual should be assured that her/his participation, responses, tissue samples and so forth are being used for the purposes of the identified research project only. Personal information and/or donated material, such as tissues samples, will then be destroyed under properly regulated mechanisms that are fully protective of the autonomy and privacy of the participant. If this is not the case the potential participant should be made aware, explicitly, that it is intended to use such material for another, future study or studies. This enables the potential participant to knowingly consent, or withhold consent, to any potential future study. It clearly protects against a recurrence of cases, such as those reported in the past in both Ireland and the UK (The Royal Liverpool Children’s Inquiry Report 2001; The Dunn Inquiry 2005; Government of Ireland 2006), where human organs were retained, post mortem, for potential use in current or future research projects.

In some, perhaps many, nursing research projects private, intimate information may be sought from the research participant during data collection; for example, information on previous medical history, information on personal behaviours and habits or information on the participant’s children, siblings and so forth. Intimate, personally significant information may also be discovered as a result of interventions designed into the particular research initiative –i.e. genetic screening, chromosome studies, screening for risk of cancer and cardiac disease, alcohol use, sexual activity, patient satisfaction surveys and so forth. Research participants, in order to be properly protected from unwarranted risk of such personal information becoming available publically, and thus potentially being used to the detriment of the research participant, (and to enable the participant to feel safe to participate in the particular study) should be assured that such personal information will be kept private and confidential. Where strict confidentiality cannot be assured appropriate mechanisms should be designed into the study to protect participants. Participants can thus be assured that their identity will not be divulged – i.e. the data collection, handling and storage processes protects anonymity. In this latter case, for example, participants are normally not asked to divulge their names on self-completed questionnaires– such as when completing patient satisfaction questionnaires or when a staff member completes a staff survey.

Beneficence and Non-maleficence

Two of the internationally accepted, fundamental core principles underpinning both nursing practice and research are the principle of beneficence (do good) and the mirror principle of non-maleficence (do not harm). Thus one should do good to and should not harm one’s patients, clients or research participants. Clearly some interventions (for diagnostic, therapeutic and/or research purposes) may be uncomfortable, burdensome or painful. Some may cause a degree of harm – for example surgical intervention, dressing of wounds and burns and so forth. However, the basic stance is that the core function of the health care professional is to work for the benefit of the patient or client from a health perspective. Thus the practitioner or the researcher must not cause unnecessary or avoidable harm or distress to one’s patients, clients or research participants. Article 6 of the Declaration of Helsinki states this position with particular clarity: “In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests” (WMA 2008).

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Nov 28, 2017 | Posted by in NURSING | Comments Off on Ethical Principles in Healthcare Research
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