MODULE FIVE: RESPECT
What are the ethical features of respect in human research ethics?
What is meant by respect for human beings?
The ethical value of respect is described in the National Statement in the following words (page 11):
Among these values, respect is central. It involves recognising that each human being has value in himself or herself, and that this value must inform all interaction between people. Such respect includes recognising the value of human autonomy - the capacity to determine one's own life and make one's own decisions. But respect goes further than this. It also involves providing for the protection of those with diminished or no autonomy, as well as empowering them where possible and protecting and helping people wherever it would be wrong not to do so.
And on page 12:
Respect for human beings is the common thread through all the discussions of ethical values. Turning to it as the final value is a reminder that it draws together all of the ethical deliberation that has preceded it.
As the National Statement states, the value of respect for human beings is central to human research ethics and to the other values already considered in this course: research merit and integrity, justice and beneficence. Fulfilling the other three values is part of the value of respect (NS paragraph 1.10) and the infamous examples of unethical research illustrate this.Read more on historical examples...
Taking the Tuskegee research study as an example, the study lacked scientific merit, it was plainly unjust to rely only on the selected population of disadvantaged participants, the risks were not justified by the intended benefits, and, given the deficient research design, probably could never have been, and it was profoundly disrespectful to the participants who were never told they were in a research study, were deceived as to the "treatment" and were deliberately deprived of effective treatment when it became available.
The Auckland Women's Hospital study of cervical cancer is another recent example. The absence of consent and the unjustified risks to which women were exposed were clearly unethical, but it was equally unfair to only select those women.
These examples also serve to emphasise the breadth of the value of respect as it is used in the National Statement. This differs from the account of the same value in the Belmont Report. There, the value is said to express two moral requirements, to treat individuals as autonomous agents and to protect those with diminished autonomy. While both these requirements are included in the National Statement account, and will be examined below, its treatment is wider. Respect is more than respecting autonomy or those with diminished autonomy: it is about a fundamental respect for humanity. Whether a person is autonomous or not, it is respect for his or her nature as a human being with beliefs and cultural heritage that expresses this value. So, in relation to research participants who lack the capacity to give their own consent because of intellectual impairment, there remains an obligation to explain to them what the research is about and what participation involves.
Interacting respectfully with people from different cultures requires recognition of that background in the ways that we communicate and relate. The chapters in the National Statement that address research with Aboriginal and Torres Strait Islander Peoples and with populations overseas provide examples of this dimension of respect. These matters and the fact that respect involves more than respect of autonomy and protection of those with impaired autonomy are clearly recognised in the National Statement paragraph 1.10:
1.10 Respect for human beings is a recognition of their intrinsic value. In human research, this recognition includes abiding by the values of research merit and integrity, justice and beneficence. Respect also requires having due regard for the welfare, beliefs, perceptions, customs and cultural heritage, both individual and collective, of those involved in research.
Confidentiality and privacy
Furthermore, this value includes respect for confidentiality and privacy and cultural sensitivities of participants, again regardless of their level of autonomy. To treat people as they uniquely are and as they wish to be represented to others expresses the central element of this value. Paragraph 1.11 of the National Statement makes this clear:
1.11 Researchers and their institutions should respect the privacy, confidentiality and cultural sensitivities of the participants and, where relevant, of their communities. Any specific agreements made with the participants or the community should be fulfilled.
Respect and Consent
The usual focus for this value is the respect that it requires for potential participant's choice about participation, usually called the requirement for consent. This essential element is described in paragraph 1.12 and discussed in more detail below:
1.12 Respect for human beings involves giving due scope, throughout the research process, to the capacity of human beings to make their own decisions.
This paragraph importantly recognises that capacity can vary infinitely and that respect is required and can be expressed at any of these levels, not merely when there is full capacity.
Protecting those with impaired or diminished autonomy is recognised in paragraph 1.13:
1.13 Where participants are unable to make their own decisions or have diminished capacity to do so, respect for them involves empowering them where possible and providing for their protection as necessary.
Protection can take many forms, from securing consent to their participation from suitably qualified decision makers to ensuring a constant vigilance over their participation. Excluding them from participation can be justified as another means of protection, but such a step will need to be shown not to be unjust.
The most common and widespread expression of the value of respect is in the requirement for consent, that is, that research participants give their consent to participation. This has always been a central ethical feature of human research, was emphasised as the first clause of the Nuremberg Code (referred to in Module one of this course) and is addressed in philosophical analyses of ethical issues of human research. The fundamental premise is that because participation is not required, people must choose to participate.
The requirement is first recognized in paragraph 1.12 of the National Statement but its importance as an ethical issue is reflected in the National Statement's devotion of a chapter to the elements of consent and a second chapter to qualifying for waving conditions for consent. This essential ethical requirement is clearly stated in paragraph 2.2.1:
2.2.1 The guiding principle for researchers is that a person's decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it. For qualifications of this principle, see Chapter 2.3: Qualifying or waiving conditions for consent, page 23.
This paragraph distinguishes three characteristics of consent:
- that it is voluntary,
- that it is based on sufficient information, and
- that it is based on an adequate understanding.
The next three paragraphs of the National Statement address the element of adequate understanding, firstly by describing the subject matter of the required understanding (2.2.2), secondly by requiring that information about those subjects must be presented in suitable ways (2.2.3) and, lastly, by strongly emphasizing that the consent process should be designed to achieve mutual understanding between researchers and participants (2.2.4). This last paragraph reflects the broader conception of respect identified earlier in the National Statement.Read more on the National Statement and understanding...
2.2.2 Participation that is voluntary and based on sufficient information requires an adequate understanding of the purpose, methods, demands, risks and potential benefits of the research.
2.2.3 This information must be presented in ways suitable to each participant (see paragraph 5.2.16, page 84).
2.2.4 The process of communicating information to participants and seeking their consent should not be merely a matter of satisfying a formal requirement. The aim is mutual understanding between researchers and participants. This aim requires an opportunity for participants to ask questions and to discuss the information and their decision with others if they wish.
These paragraphs also emphasize the ethical character of the consent process and decision and seek to remind researchers, members of ethical review bodies and research participants that the substance and the process is more important than the form. Consent can be reduced to mere written formality, often in order to meet perceived obligations of providing clear evidence of consent. The risk of this perception is that it leads to the omission of the true ethical feature of consent, namely, a position of understanding between researchers and participants. The same emphasis is apparent in paragraph 2.2.5 that seeks to make clear that the form in which consent is expressed can vary according to the circumstances, provided, as required by paragraph 2.2.7, that each participant's decision to participate is clearly established.
Establishing consent shows that consent is to be regarded as a matter of fact that needs to remain true for the duration of the participation. Circumstances may require that this fact be re-established, for example, where the research has changed or the participation continues for an extended period. (Paragraph 2.2.8) Equally, it is important to recognize that potential participants are as entitled to decline to participate as to agree. Respecting such decisions can also involve attention to the consequences for those declining, a matter recognized in paragraph 2.2.19.
The process of seeking and obtaining consent from participants requires that they be provided with information about the purpose, methods, risks and potential benefits of the research. The National Statement makes clear that disclosing to potential participants information on these matters is essential. Often, other information is needed and paragraph 2.2.6 contains a list of typical examples.
The National Statement recognizes three distinct situations in which the voluntary nature of participants' consent will be impaired. These can be described as coercion: situations in which pressure is brought to bear intentionally or otherwise to cause a person to choose to participate; inducement: situations in which offers of money or other benefits are made to participants to encourage them to participate; and deception: situations in which information is deliberately withheld in part or whole from participants who are then asked to consent. Although the ethical consequence of these three situations is the same, that is, they impair the voluntary character of consent, they arise from quite different practical situations. As a result, different steps are needed to address avoid or overcome their ethical effect.Read more on Coercion, Inducement and Deception...
Respect for human beings is not dependent on their capacity, as paragraph 1.10 of the National Statement makes clear. However, respect is displayed in different ways to people whose capacity to participate in decision-making about research varies.Read more on incapacity...
There are legal standards for capacity that determine when it is necessary that someone else, such as a guardian or other body, make decisions for a person lacking capacity. For example, it is assumed that children lack the requisite capacity so that their parents, as their guardians, are authorised to make decisions for them. Guardians and other authorised decision-makers are required to decide in the best interest of the persons for whom they are deciding.
Paragraph 2.2.12 recognises these matters and draws attention to the fact that capacity is not always static and fluctuating capacity needs to be considered in seeking and gaining consent. Categories of participants whose capacity may be uncertain and in respect of whom researchers may need to show how they will assess capacity include children (chapter 4.2), people highly dependent on medical care (chapter 4.4) and people with a cognitive impairment, an intellectual disability or a mental illness (chapter 4.5).
Future use of data and tissue samples
Conventionally, consent for participation in research was sought only for a specific project and usually stated that the data collected in that project could be used for that project alone. Increasingly, especially in health and medical research, the practice has developed of collecting data that has potential research use in subsequent research projects. This is the case with both information and with samples of human tissue.Read more on consent to future use of data or tissue samples...
There are ethical tensions in continuing to confine consent fro the use of data or samples to only the project for which they are first collected. On the one hand, this confinement maximises respect for individual participants choice but, on the other, it increases the time and cost of further research using those data or samples and, further, having to seek consent for each future use can reduce the data or samples available and so reduce the benefit of that research. In seeking to assist the resolution of these tensions, the National Statement, in paragraphs 2.2.14 to 2.2.18 authorises the use of consent to include research use of data and samples for later projects beyond the project in which they are first collected. It introduces three categorisations of consent: specific, extended and unspecified consent (section 2.2). These paragraphs emphasise the importance of a full explanation of the terms and implications of extended and unspecified consent. Their recognition accepts that such forms of consent can be ethically justifiable but that researchers proposing to use them need to make that justification.
Having decided to participate in a research project, respecting participants includes allowing them to withdraw their consent at any time. Because of this, it is essential, as paragraph 2.2.20 recognises, that at the time they make the decision to participate, they are informed about any consequences of a later withdrawal, for example, whether or not they will be able to withdraw data they have provided. In studies where participants' data is aggregated and non-identified, withdrawing data will not be possible but in projects where data remains identifiable, for example, interview transcripts or test results, that return will usually be possible.
Finally, the National Statement addresses the circumstances in which it can be ethically justifiable to waive the requirement to seek consent. Doing so means that people will participate in human research unknowingly, whether through the use of their information or the observation of their behaviour. Accordingly, waiving the requirement for consent will be exceptional and the conditions imposed by paragraphs 2.3.5 and 2.3.7are strict. The paragraphs distinguish between research designed to expose illegal activity and research not so designed.
The final condition in paragraph 2.3.6 will remind researchers and ethical review body members of the relevance of privacy legislation when the waiver of consent is to the use of personal information that identifies individuals.
The potential impact of research being conducted without consent on the reputation of human research and researchers led to the addition of paragraph 2.3.8, imposing a responsibility on institutions to implement some form of public notice of human research in which the requirement for consent has been waived.