Chapter 30: Ethical principles and consent

 

What is consent?

In research, consent means that human participants enter research freely, with all information provided about the research, and that consent is given before entering the research.¹ The principle of informed consent is formalised to ensure that relationships between the researcher and those participating in the research are based on trust and integrity and to safeguard people’s freedom to decide whether or not to participate in research.¹ There are 4 ethical principles that researchers must adhere to in health and social care research: (1) autonomy, (2) beneficence, (3) non-maleficence and (4) justice.² Consent needs to cover each of these elements.

The origins of consent

After the Second World War, when it was discovered that doctors had conducted pseudoscientific medical experiments on prisoners in Nazi Concentration Camps, the Nuremberg Code for research on human subjects was established. The Code is composed of 10 principles, centred on the consent and autonomy of research participants, rather than researchers’ objectives. The first principle of the Nuremberg Code is that “the voluntary consent of the human subject is absolutely essential”³.

History is fraught with problems involving consent. One of the best-known studies is the Syphilis Study at Tuskegee.⁴ In 1932, the United States (US) Public Health Service began a study in Tuskegee, Alabama to record the natural history of syphilis in a socioeconomically deprived area known to have the highest rate of syphilis in the US at that time. The study initially recruited 600 Black men. Participants were not given the opportunity for informed consent; In fact, the researchers misled participants by telling the men that they were being treated for ‘bad blood’. The researchers persuaded the men to participate in exchange for free medical treatment, free meals and burial insurance. By 1943, when penicillin was discovered as an effective treatment for syphilis, participants in the study were not told about or offered this treatment. Seven men in the study died directly as a result of syphilis, and more than 100 are thought to have died from syphilis-related complications.⁴

Today, consent is one of the most important considerations when recruiting participants for health and social care research. The consent requirement serves the important function of safeguarding participants from harmful interventions, and the provision of information is considered a prerequisite for potential participants to make rational decisions concerning their involvement in research.⁵

Autonomy

Autonomy means that all persons have intrinsic and unconditional worth, and therefore should have the power to make rational decisions and moral choices. Autonomy enshrines individual participants’ rights for self-determination. To maintain research participants’ autonomy, researchers must ensure that consent is informed. This means that prospective participants must be provided with detailed information about what their participation will entail, with no undue influence.²

Informed consent

According to the Declaration of Helsinki,⁶ developed by the World Medical Association as a statement of ethical principles for medical research involving human participants, adequate information for informed consent must be comprehensible and meet the following criteria:

• The information should be given both verbally and in writing.
• The purpose and design of the research, what it means to participate, the advantages and disadvantages of participation, plans for the broader study overall, voluntary participation, and the unimpeded opportunity to withdraw, must be outlined to every participant.⁷

The term ‘informed consent’ infers the past tense, or a completed process. This suggests that all information is known and described at the onset of the study, which is a much clearer process in quantitative research than in qualitative research. This is because, as discussed in the data collection and analysis sections of this textbook (section 3 and section 4), qualitative research is often iterative and evolves as the research progresses. Some information about the research may therefore not be known at the start of the study.⁸ To ensure that participants are provided with adequate opportunity to make autonomous and informed decisions about their participation, the researcher can, for example, send the participant a list of questions before the data collection takes place. Prospective participants can consider the tangential topics that might ensue during the course of the study, and make an informed decision about their participation.

In her article, ‘The concept of informed consent in qualitative research’,⁹ Dr Byrne describes semi-structured interviews regarding compliance with antihypertensive medication. After a few interviews, the researcher identified the need to investigate participants’ sexual function, as sexual dysfunction is a common side effect of these medications that can contribute to non-compliance. The researcher had not included the subject matter of sexual dysfunction in the consent form initially provided to prospective participants but had they known this private topic would arise, they may not have opted to consent. This study exemplifies the dynamic aspects of qualitative research that require researchers’ continuing consideration of informed consent, in order to protect research participants. No participants withdrew from the study, but the researcher reflected on the unforeseen discomfort caused to participants, in contradiction to the principle of non-maleficence.

Beneficence

Beneficence means that researchers must act in the best interests of their participants – to their benefit. It supports several moral rules to protect and defend the rights of participants, and to remove conditions that will cause harm.² The language of beneficence is positive; the principle calls for more than the avoidance of harm: to purposely benefit research participants and to promote their welfare. Researchers consider beneficence by:

• Assessing the risks of harm and the potential benefits of research to participants and to the wider community.
• Being sensitive to the welfare and interests of participants involved in their research.
• Reflecting on the social and cultural implications of their work.

Non-maleficence

Non-maleficence demonstrates the ethical tenet to do no harm to participants.² The practical application of non-maleficence is for the researcher to weigh up the potential benefits of the research versus the potential burden on participants, to ensure that this balance is appropriate and to choose the best research design and level of involvement for participants.

Until the 21st century, the concept of ‘do no harm’ was primarily discussed among quantitative researchers following experiments conducted on humans and the risk of unforeseen physical and psychological harm. In contrast, the harms appear to be minimal in qualitative research when researchers are talking to participants, as opposed to executing an intervention. However, while the risk of physical harm is less prominent in qualitative research, the risk of psychological discomfort is indeed present.¹⁰ Some qualitative research is also interventional (see Chapter 7 on Action Research), and therefore non-maleficence must also be considered in this context.

Justice

In general, justice is interpreted as the fair, equitable and appropriate treatment of research participants.² Research that is just considers that:

• The scope and objectives of the proposed research, the selection, exclusion and inclusion of participants are fair.
• The process of recruiting participants is fair.
• There is no unfair burden on research participants.
• There is fair distribution of the benefits of participation in research.
• There is no exploitation of participants in the conduct of research.
• There is fair access to the benefits of research.

Informed consent in qualitative research

Houghton and colleagues have outlined 5 ethical challenges within the 4 principles of consent, specific to qualitative research: (1) informed consent processes, (2) the participant–researcher relationship, (3) continuously monitoring the risk-benefit ratio of the research, (4) confidentiality and (5) the dual role of the clinician-researcher.¹¹

Informed consent processes

As described earlier in this chapter, the traditional, one-off process of informed consent is not always feasible in qualitative research, since the researchers may not be able to predict the direction of an interview or focus group, based on the interpretivist nature of this approach. If previously unanticipated information is discussed in the process of collecting data, the researcher should reiterate that the participant has the right to withdraw from the study at any time. By reminding participants of this right, the researcher is bringing the voluntary nature of autonomy and informed consent to the forefront and enshrining participants’ right to informed consent.

It can be challenging for researchers to know from whom consent is required. For example, ethnographic studies (Chapter 9) often involve participant observation (Chapter 15). The question is whether the researcher needs to gain consent from everyone being observed. What about people who are observed incidentally but are not part of the study? In her ethnographic study, Ethical conduct and the nurse ethnographer: consideration of an ethic of care,¹² Pauline Griffiths initially attempted to obtain written informed consent from hospital patients while they were acutely unwell. Upon being approached patients were apprehensive and concerned that they were about to experience additional medical intervention. It was subsequently decided (in conjunction with the university and hospital human research ethic boards) to seek verbal informed consent from certain patients who were not as unwell as others. This decision was based on the principle of beneficence, and the fact that the researchers believed that written consent was causing some participants needless anxiety.

In addition to the participants who are intended to be observed, conducting observational studies in a public setting can pose other ethical challenges. There may be other people, such as visitors, who become part of the observations, even if the intention is to only observe specific participants in the research. The challenge lies in deciding from whom to obtain informed consent and by what means.¹¹

The relationship between the researcher and the participant

The relationship between the researcher and the participant is not as clear-cut in some qualitative research settings as it is in quantitative research. When data is collected over a period of time, there is the opportunity for participants and researchers to build a relationship. As the research progresses and relationships grow, researchers must remain aware of the presence and nature of power, particularly power imbalances between themselves and participants (and the potential effect of this on the participant), in accordance with the principle of justice. Xu and colleagues, have reflected on this in an article examining their experiences of obtaining informed consent in qualitative research.¹³ They identified that the researcher–participant relationship should be discussed as part of the process of informed consent in long-term qualitative studies, so that the researcher and the participant can decide together on a mutual assessment of suitability for research participation.¹³

Risk-benefit ratio

Adhering to the principles of beneficence and non-maleficence involves calculating the level and extent of risk, balanced with the potential benefits of research participation. It is important for researchers to convey these principles to participants. That way, if unexpected topics arise within an interview or focus group discussion, participants and researchers can have a conversation about whether this may cause harm or distress, or whether the benefits of participation outweigh the potential harm.¹¹ In essence, it is important that the researcher is mindful of the effects of the research on the participant and should take appropriate steps to minimise associated risks.

Confidentiality

There are two main considerations for confidentiality in the context of qualitative research: when there are multiple participants in a focus group, and when detailed descriptions are used to report participant characteristics within a study.¹⁴ With regard to participant characteristics, researchers may need to use pseudonyms and to be selective when describing defining characteristics of participants that could reveal their identities. With regard to focus group confidentiality, the researcher should direct participants not to discuss the focus group (including other participants and topics discussed) outside of the data collection setting. At the same time, the researcher must stress that it is impossible to guarantee focus group anonymity.

When it is difficult to gain informed consent

Up to this point, informed consent has been discussed in the context of potential participants who are cognitively intact. However, many people who participate in research are from groups considered vulnerable, or who may not have the capacity to provide informed consent. Some examples include, but are not limited to¹⁵:

• Pregnant people
• People with cognitive impairment, intellectual disability, or mental illness such as dementia or schizophrenia
• People with impaired capacity for communication, including children
• People who are in hospital or reliant on others for care
• People who are incarcerated, or people on parole
• Children living in out-of-home care or foster care.

These populations should not be excluded from research based on their potentially limited capacity to provide consent. Researchers have designed consent frameworks and checklists to facilitate participation for these population groups. Following is an example of older people living with dementia.

Informed consent for people living with dementia

Dewing’s consent framework for older people living with dementia¹⁶ prompts researchers to be mindful during qualitative data collection of possible expressions of verbal, non-verbal and behavioural discontent, disengagement and discomfort. This framework emphasises consent as well as the concept of assent, which describes the ability to indicate a meaningful choice and a minimal level of understanding by those who lack the capacity to provide obvious verbal or written consent.

Table 30.1: Dewing's process consent framework

Stage	What is involved?
Preparation and background	• Gaining permission to access the person if they are in a location where this is necessary • Finding out about the person • Establishing a basis for consent and understanding the person’s ability to provide consent
Initial consent	• Considering consent and assent • Using a range of written or verbal prompts to enhance understanding • Maintaining notes as evidence
Ongoing consent	• Monitoring • Revisiting consent
Feedback and support	• Providing feedback to the person, staff or family following data collection • Assisting the person transition back to their usual environment

Data derived from Process Consent and Research with Older Persons Living with Dementia¹⁶. Not available for reuse under CC BY NC.

Emerging challenges

Emerging data collection methods in qualitative research do not involve clear-cut participant involvement. Examples include participant observation (Chapter 15) and social media research (Chapter 16), as well as challenges that arise when working with vulnerable and hard-to-reach populations (Chapter 33). A group of researchers aiming to identify considerations for making informed choices about engaging in qualitative research in underrepresented populations identified 9 core values to consider.¹⁷

Conclusion

The 4 ethical principles of research are autonomy, beneficence, non-maleficence and justice. Informed consent must be included in each of these principles. Consent can be complex in qualitative research; researchers must consider their relationship with the participant, the risk-benefit ratio and the processes of continuous consent. Emerging populations and research designs have also given rise to new methods of consent, which require consideration prior to conducting research.

References

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