RESEARCH ETHICS

Nursing research ethics, guidance

and application in practice
Owen Doody and Maria Noonan

E
thics is rooted in ancient Greek philosophical inquiry
of moral life and relates to a system of principles that ABSTRACT
can considerably change previous thoughts, actions and Ethics is fundamental to good research practice and the protection of society.
decisions (Johnstone, 2009).Within research, ethics is From a historical point of view, research ethics has had a chequered past
an essential measure to protect society, and the earliest and without due cognisance there is always the potential for research to do
research ethics code emerged in 19th-century Prussia (Vollmann harm. Research ethics is fundamental to research practice, nurse education
and Winau, 1996).While ethics codes have developed over time, and the development of evidence. In conducting research, it is important to
the question remains: can unethical research practice still arise plan for and anticipate any potential or actual risks. To engage in research,
today? The harsh truth is that without due attention, application researchers need to develop an understanding and knowledge of research
and awareness, it may. Unethical research always has the potential ethics and carefully plan how to address ethics within their research. This
to occur, as the principles on which ethical research are based article aims to enhance students’ and novice researchers’ research ethics
are attributed to the beliefs of that era and can change over time. understanding and its application to nursing research.
For research to be conducted, ethical approval is required from Key words: Ethics ■ Nursing ■ Research ■ Students ■ Understanding
a research ethics committee or institutional review board in
order to protect the rights, safety and wellbeing of participants.
This article aims to enhance students’ and novice researchers’ need to be viewed in light of the fact that health research has a
knowledge and understanding of nursing research ethics and its history of abuse, where the interests of participants have often
application through the core principles identified by the Nursing being sacrificed for scientific or state gain. These violations of
and Midwifery Board of Ireland (NMBI) (2015): autonomy, human rights within research are among the darkest events in
beneficence, non-maleficence, justice, veracity, fidelity and history and span the 20th century (Box 1).
confidentiality. In recognition of the importance of ethical research, and to
protect all involved in the research process, international nursing
Development of ethics codes regulatory boards have developed and provide guidance for nurses
Since the 19th century, ethics codes have been developed to (Canadian Nurses Association, 2008; Royal College of Nursing,
protect research participants, often in response to poor practice 2009; American Nurses Association, 2010; Australian Nursing
(Nuremberg Code, 1947; Declaration of Helsinki, 1964, 2013; Federation, 2012; International Council of Nurses (ICN), 2012;
Belmont Report, 1979; International Ethical Guidelines for NMBI, 2015). Good ethical nursing research conduct implies
Biomedical Research Involving Human Subjects, 2002; European adherence to ethical standards where research studies are:
Union directive/regulation on the conduct of clinical trials, ■■ Subject to scrutiny by an independent ethics committee/
2014). These codes protect participants through voluntary board
consent, freedom from coercion, appropriate risk–benefit ratio, ■■ Scientifically sound
respect for autonomy, justice and fair selection. Within these ■■ Conducted by researchers who are supervised or have
codes, vulnerability is acknowledged where capacity issues are adequate expertise; and
present. However, capacity can be addressed through the process ■■ Adhere to ethical principles throughout the research process
of an independent review committee, informed rather than (Richards and Schwartz, 2002).
voluntary consent, and appointment of legal guardians. While While diversity in principles exists across the literature, this
the developments of ethical codes have been progressive, they article focuses on the application of the core principles identified
by NMBI (2015), as these principles ensure that the full spectrum
of ethical issues are addressed. While there may be an overlap
Owen Doody, Lecturer, Department of Nursing and Midwifery, between principles, it is useful for students and novice researchers
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University of Limerick, Ireland to consider each in isolation.

Maria Noonan, Lecturer, Department of Nursing and Midwifery,
University of Limerick, Ireland Autonomy
Accepted for publication: July 2016 Autonomy considers participants as independent people able to
make their own choices and manage their concerns.Therefore,

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 Box 1. Studies highlighting historical abuse/violations of human rights
manipulation or coercion (Newell and Burnard, 2011; Polit and
Beck, 2013). Full autonomy requires participants to understand
■■ World War II Nazi experiments: one example aimed to learn how to treat hypothermia. fully what is being asked of them and the effect participation will
Participants had to endure ice-water tanks or stand naked in below-freezing temperatures
have on them; to be afforded the opportunity to ask questions
for several hours so different ways of warming survivors could be assessed (Berger,
1990; Bogod, 2004) before/during/after the study; and to comprehend that it is
■■ Tuskegee syphilis study, 1932–72: researchers purposely withheld treatment from 399 their choice to participate.
African-American syphilis suffers to study the long-term effects of the disease (Brandt, Essential components within a valid informed consent process
1978). Bill Clinton, as president, made a public apology to the participants on behalf of are: disclosure of information, comprehension, competency and
the nation in 1997
voluntariness (Beauchamp and Childress, 2012). In addition,
■■ Lying-In Hospital, University of Chicago, 1950–52: an experiment started whereby 1000
pregnant women were administered diethylstilbestrol to prevent miscarriages (United Gillon (1985) identified three types of autonomy: autonomy
States District Court, 1978). These women were engaged in a double-blind study of thought (choice) or thinking for oneself; autonomy of will
without consent and 20 years later their children had high rates of cancer and other (capacity) or freedom to do something based on one’s own
abnormalities deliberations; and autonomy of action (sovereignty: governing
■■ In the 1950s, mind-control research was conducted at the McGill University, Montreal,
oneself) or freedom to act as one wishes. To help researchers
Canada. Psychedelic drugs were administered to 52 unknowing patients to conduct
brainwashing experiments for the CIA (Rauh and Turner, 2016) uphold these components, the authors recommend essential
■■ Jewish Chronic Disease Hospital, 1963: 22 elderly patients were injected with live cancer elements be addressed (Box 2).
cells to discover how healthy bodies fight the invasion of malignant cells (Katz et al,
1972) Beneficence
■■ Willowbrook Study, 1963–66: children with disability were intentionally infected with
Beneficence seeks to do good or to benefit participants, so
hepatitis to investigate the course of the disease and to test a potential immunisation
vaccine. Most striking is the fact that some individuals were fed faecal matter in order for research should help/benefit individual participants and society
them to become infected (Rothman and Rothman, 1984) as a whole (Beauchamp and Childress, 2012; Parahoo, 2014).
■■ National Women’s Hospital Auckland Study, 1966: a doctor conducted a study over Beneficence requires researchers to take actions to benefit and
20 years whereby he withheld treatment to 160 women with abnormal cervical smears promote the welfare of participants (Butts and Rich, 2013).
in order to prove cervical abnormalities would not lead to cervical cancer. Women were
To ensure this, a risk–benefit assessment should be conducted,
enrolled without their knowledge or consent (McIndoe et al, 1984)
■■ Stanford University, 1971: a social study ended prematurely due to abusive behaviours considering all potential and perceived benefits. For example, a
generated among participants assigned the role of ‘guards’ towards participants assigned participant may overestimate the benefits of taking part in an
the role of ‘prisoners’ (Haney et al, 1973) experimental treatment in a chance to gain access (Wertheimer,
■■ Los Angeles, 1989–91: over 700 babies and 1500 6-month-old children were given an 2013).While it is common in qualitative research that participants
experimental measles vaccine called EZ. Parents were not informed of the experiment or
may not directly benefit from their involvement in a research
that the vaccine was unlicensed (Awadu, 1996)
■■ Bristol Royal Infirmary, 1991–95: 30–35 children underwent heart surgery as study, it is also worth noting that participants often experience a
experimental subjects and died unnecessarily because surgeons operated despite poor cathartic effect from telling and having their story heard (Davies
survival rates and introduced new techniques (Bristol Royal Infirmary Inquiry, 2001) and Gannon, 2006; Elmir et al, 2011; Rossetto 2014). Beneficence
■■ Amnesty International has documentation of cases where prisoners have been used as of any action can be extremely personal and may differ between
experimental subjects and BBC News reported that prisoners in Iraq were used to test
individuals, where what benefits one person might not benefit
chemical weapons (BBC News, 1998, 2002; Amnesty International, 2006)
another. Researchers should consider what benefit will occur
for those being invited to participate and society at large. Often,
when deciding to become involved in a study, participants benefit is interpreted in the broadest sense and not always as
should be able to make a free, independent and informed choice the direct benefit of participating in the research; therefore,
without coercion (Newell and Burnard, 2011). Participants it is common and acceptable for researchers to offer greater
should be able to express personal decisions, free of outside potential benefit to society rather than individual participants.
interference and to have those decisions honoured (Butts Where incentives are being offered for participation, they need
and Rich, 2013). Researchers must ensure participants have to be considered in terms of risk–benefit analysis, as incentives
the right to self-determination (i.e. choose whether or not may affect the participant’s ability to make a truly autonomous
to participate). To ensure this, participants must receive full decision to partake in the research. Often, although research
disclosure of information outlining the nature of the study, their may be of benefit, it has to be balanced against the vulnerability
right to withdraw at any time without consequence, and an of the participants (intellectual disability, advanced age) and the
identification of the risks/benefits to allow an informed choice research needs to address how they can support the participant
(Polit and Beck, 2013). However, the participants’ ability to before (easy-read format), during (familiar person present) and
withdraw may not always be possible, such as after analysis and after (availability, counselling).
publication, or if they responded to an anonymous questionnaire.
In some cases, people may have diminished levels of autonomy Non-maleficence
(e.g. babies, those with dementia, or intellectual disability) ‘Non-maleficence’ means seeking to do no harm. Researchers have
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and need additional protection due to their ability to give a responsibility to balance potential benefits against potential risks
informed consent. Special safeguards to protect their autonomy to reduce possible risk and safeguard the protection of participants
are therefore required, as ‘autonomy’ considers the capacity to (Parahoo, 2014). In research, no excessive physical, emotional or
be one’s own person, and to make one’s own decisions freely, psychological demands should be placed on participants (Polit and
based on personal reasons and motives, and not because of Beck, 2013). While physical harm may be easily recognised and

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 RESEARCH ETHICS

therefore avoided or diminished, emotional, social or economic Box 2. Elements participants must be aware of to give informed consent
factors may be less apparent. Ensuring that support mechanisms
(e.g. counselling, employee assistance programme) are in place for ■■ Title of study
■■ Name, place of work, qualifications and contact details of researcher(s)
participants who become distressed during or after data collection
■■ Study population
is important, especially when there is potential to highlight sensitive ■■ Purpose of study
information, past experiences, or when it is difficult to anticipate ■■ Study procedures and steps for data collection
the direction of data to be collected. ■■ Potential risks

Participants should not be compromised by the demands of the ■■ Potential benefits

■■ How anonymity or confidentiality will be upheld
study, and if a participant becomes upset or uncomfortable, the
■■ How data will be collected
researcher should offer the participant the opportunity to cease ■■ Who will collect data
and only reconvene at their discretion. Participants should also be ■■ How data will be stored
afforded a choice of venues in order to reduce inconvenience and ■■ Who will have access to data

opportune costs imposed, such as travel or allowing the researcher ■■ Participation is voluntary
■■ Participant has the right to refuse to participate or withdraw at any time
into their home (Burns and Grove, 2013). Researchers must
■■ Participant can choose not to answer any question, stop or cease their involvement
also be mindful of the possibility that misconduct or unethical at any stage
practices could be disclosed, and be familiar with the health ■■ Opportunity to ask the researcher questions related to the study
organisations, ethics review board and governing body’s policy ■■ How participant can obtain the results of the study

guidelines in these situations. ■■ Both parties will receive a signed and dated consent form

NMBI (2015) has highlighted that the researcher should have

a clear reason for the disclosure and seek support from their possible power relationship between them and the researchers
supervisor, ethics committee and other relevant people, and that all (Riley et al, 2003; Karnieli-Miller et al, 2009). Also, researchers
decisions are clearly documented. Often overlooked in the process should consider participants’ involvement and reimburse them
is the risk to the researchers themselves, as they often engage for any costs they might incur.
in the research process as a lone worker. Here, the researcher
should adhere to their local health authority lone worker policy Veracity
and maintain a visit proforma that is accessible to colleagues/ Veracity involves the responsibility of the researcher to tell the
supervisors monitoring the visits. In circumstances where truth about the study and the absence of deception. Individuals
researchers do not work within a health authority, they should have the right to be told the truth and not to be deceived about
check guidance from the ethics review committee/institutional any aspect of the study (Parahoo, 2014). All aspects of a research
review board, seek out and consult with their supervisors/ project require description and clarification by the researcher
colleagues, and maintain a visit proforma monitoring the visits. who must make every effort to ensure participants understand
all aspects of the study. Participants should be aware of the
Justice expected involvement, duration (i.e. time commitment), what
According to the principle of justice, researchers are obliged to happens to their information, and who will have access to their
treat participants fairly and equitably throughout the research study. information.The principle of veracity is often linked with respect
Justice should also be applied when providing the opportunity for autonomy and is grounded in respect for persons.
to partake in research and ensure anonymity, privacy and fair For a person to make a choice, they must have the relevant
treatment (Dempsey and Dempsey, 2000).Within the principle information to make their decision. Moreover, this information
of justice, the researcher is obliged to distribute benefits and risks must be clear, logical and truthful. To present clear and logical
equally, without prejudice, and certain individuals, groups or information, the researcher should avoid cloaking information
communities should neither bear an unfair share of the burden in jargon or language that fails to express information in a way
nor be unfairly omitted/excluded from the potential benefits of that can be understood by the participant. Truth-telling can be
participation.Alperovitch et al (2009) described two elements of dishonoured in at least two ways: first, by the act of lying, or the
the principle of justice, namely equality and equity, which require deliberate exchange of inaccurate information; and, second, by
research participants to be justly chosen based on the purpose omission or the deliberate withholding of information.
and expected outcome of the research—including thought for
the participant as an individual and as a member of society. Fidelity
Research participants in studies should be similar to those who Fidelity is where trust is given and obtained between the
may benefit from the outcome of that research, and be selected researcher and participants, and involves the researcher
for reasons related to the phenomenon being investigated, rather maintaining confidentiality (Macnee and McCabe, 2008; ICN,
than for convenience (Pratt and Loff, 2011).This principle often 2012). Participants place trust in researchers and this creates an
proves challenging for researchers in ensuring that all groups in obligation to safeguard them. The researcher must ensure that
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society, regardless of perceived vulnerability, are able to benefit participants have an understanding of the risks and foster a trusting
from being involved in research. Avoiding including, or making relationship to safeguard the rights of the participants (Parahoo,
it difficult to include, any group in research based on perceived 2014). On agreeing to participate in a research project, participants
vulnerability could be described as ‘unjust’, as it could be argued are entrusting themselves to the researcher, and it is essential
that all participants in research are vulnerable because of the that researchers be open and honest so participants can make

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 an informed decision. As part of this process, participants should Participants have the right to exclude themselves, or their
know they can withdraw from the research at any time (where information, and thus express themselves selectively.This tendency
possible, acknowledging limits expressed in the autonomy section varies among cultures and individuals. In research, the use of
above) and that doing so will have no consequences.This trusting interviews can pose difficulties, as the direction of questions
relationship is a two-way process, with researchers needing to cannot always be anticipated, and probing questions are used to
trust research participants—for example, about being honest obtain meaningful information about the phenomenon under
in their descriptions of their experiences or taking medicine investigation (Richards and Schwartz, 2002; Parahoo, 2014).
according to the study protocol. Where a trusting relationship Therefore, participants may reveal intimate and personal details,
develops, participants are more likely to remain in the study and and researchers should reassure participants that the information
are not surprised by the burden of participation (Coghlan and they disclose is confidential.
Brydon-Miller, 2014). To uphold confidentiality, consideration must be given to
access and storage of data, and the researcher should assign
Confidentiality each participant an identification code/number that only the
The researcher is responsible for guaranteeing confidentiality researchers has access to. Data should be stored in a locked facility
of participants and their data. Personal information obtained and all electronic data should be password-protected. Participants
must not lead to identification of participants and should not should also be aware of where their data will be stored, for how
be made available to others without participants’ consent and long (duration stipulated by ethics boards is often 5–7 years), and
prior knowledge. There are extraordinary circumstances where how data will be destroyed after this time.
information may have to be revealed without the permission of
participants, thus breaking confidentiality.These situations include Conclusion
public interest and safety, or when the researcher believes that Ethical issues are concerned with the rules and principles of
there may be a danger in non-disclosure (NMBI, 2015). Here, human behaviour. It is the responsibility of the researcher to
the researcher must have a strong reason for the disclosure of safeguard the participants’ rights throughout all stages of the
information and should seek advice and assistance from the research (Holloway and Wheeler, 2010; Nieswiadomy, 2012).
research supervisor, ethics committee and other relevant persons, Research ethics is fundamentally concerned with the safeguarding
with all decisions clearly documented (NMBI, 2015). of research participants from harm and limiting risk of harm.
Researchers can ensure that confidentiality is upheld Traditionally, ethical approval of research has been seen
by allocating an identification number or pseudo-name to as an issue for medical/clinical research. However, it is now
participants, so that identifiable information is successfully recognised that it applies to all research projects and a research
secured and that identifying information is not entered into a ethics committee/institutional review board is charged with
computer system or other potentially accessible database (Polit considering the ethics of proposed research projects, and agreeing
and Beck, 2013). Where small samples and/or quotes are used, as to whether the projected research is ethical—thereby protecting
there is the potential for participants to be identified, so when participants’ rights, safety and wellbeing by reviewing all aspects
transcribing, analysing data and writing up findings, researchers of the study and approving its start-up.
should exclude individual expressions or language nuance, and A key component of research is informed consent (Shaw et
only include information in fitting with the findings. This can al, 2011). It is the responsibility of the researcher to demonstrate
be achieved by the masking of quotations in the presentation that they have taken the necessary steps to guarantee that the
of results, whereby specific sayings, expressive mannerisms or participant whose consent is being sought has been given the
details can be masked by using […] to protect the identity of necessary information in an understandable manner. Research
the participant or other parties. results must always preserve participants’ anonymity unless
Raw data should comprise the name and/or identifiers (code, permission has been given by the participant to use his/her
pseudonyms) that can be used to connect the participant’s data name. All research can in theory be harmful to participants and
to their name.While researchers have access to this information, researchers (Long and Johnson, 2007) and research should be seen
it should not be contained in the final report, nor should anyone as a privilege, not a right (McHaffie, 2000). Confidentiality is a
other than those stated in the consent form have access to the considerable risk in research, as sensitive data are often collected
data (Dempsey and Dempsey, 2000). Confidentiality should not and analysed (Polit and Beck, 2013). As a nurse researcher, it can
be confused with anonymity, which refers to people being fully be difficult to balance one’s role as researcher with the caring
anonymous, and as participants become known to the researchers, responsibilities inherent in the profession (Eide and Kahn, 2008;
true anonymity is not achievable (Scott, 2005).Therefore, when Judkins-Cohen et al, 2013). BJN
participants engage in face-to-face contact with the researcher,
it is considered unrealistic to promise anonymity and more Declaration of interests: none
appropriate to promise confidentiality. The terms ‘anonymity’
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 RESEARCH ETHICS

world’s human rights. Amnesty International, London

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