HUMAN RESEARCH ETHICS

HUMAN RESEARCH ETHICS: JUSTICE

PART A:
What are the ethical features of justice?

The essential nature of the ethical value of justice is stated in the National Statement in the following words (page 11):

At a profound level, justice involves a regard for the human sameness that each person shares with every other. Human beings have a deep need to be treated in accordance with such justice, which includes distributive justice and procedural justice. In the research context, distributive justice will be expressed in the fair distribution of the benefits and burdens of research, and procedural justice in 'fair treatment' in the recruitment of participants and the review of research. While benefit to humankind is an important result of research, it also matters that benefits of research are achieved through just means, are distributed fairly, and involve no unjust burdens.

Even this short passage reveals the range of meanings that can be given to the concept of justice and seeks, among those, to identify the meanings that are relevant in human research ethics.

Although there is mention in the passage of the application of procedural justice in the review of research, the list of matters set out in the principle at paragraph 1.4 of the National Statement does not include this element.

Read more about justice in the Belmont Report...

An authoritative account of justice in human research ethics can be found in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, to which you were referred in Module One of this course. The passage on justice makes clear that it is the impact on participants of the research design and conduct that is the appropriate focus of justice.

The immediate background to the Commission's work of the Tuskegee syphilis study and the more distant experiences of prisoners in Nazi concentration camps are identified as stark examples of injustice in research. In these cases, the burden of participation was imposed on populations because they were conveniently accessible: there was no attempt to recruit from a broader population base. However, there is a relevant difference between the examples. In the syphilis study, there was a scientific reason for choosing this population: they had contracted syphilis, the disease being studied. In the Nazi case, there was no scientific basis for the selection: they were merely convenient and so doubly unjust.

The National Statement in paragraph 1.4(a) relates this principle of justice to recruitment of research participants in the following words:

In research that is just:
(a) taking into account the scope and objectives of the proposed research, the selection, exclusion and inclusion of categories of research participants is fair, and is accurately described in the results of the research;

Subsequent sub-paragraphs recognise differing situations of injustice in recruitment.

Recruitment without research relevance

It will thus be unjust to recruit a population of participants for research for no reason other than their convenience to the researcher. Using only populations in, for example, schools or hospitals for research that is irrelevant to the population can be unjust on its face: it treats those populations unequally. The National Statement recognises this kind of injustice in both paragraphs 1.4(b) and 1.4(e).

There can be an exacerbated situation where a particular population already endures a recognisable burden or where particular populations are repeatedly chosen, so that recruitment adds to existing burdens. The National Statement recognises this kind of injustice in both paragraphs 1.4(c).

Recruitment with research relevance

The selection of populations, such as those in schools or hospitals, is relevant to the purpose of the study where, for example, they are of the appropriate age for an educational study or have a disease to be studied. However, their recruitment can also be unjust if, as was the case in the Tuskegee study, those populations would not share in the benefits of the study. Here, the injustice can be the unfairness of one or both of two kinds. First, within the population of research participants, the unfairness of bearing burdens but receiving no benefits. Second, among a wider relevant population, the unfairness of being, compared with that wider population who could have been recruited, the few who bear the burdens even if they are among those who receive benefits. The National Statement recognises these kinds of injustice in both paragraphs 1.4(c) and 1.4(d).

Read more about justice and vulnerable populations...

The Belmont Report, in the passage that addresses selection of subjects, recognises the examples of injustice described above and suggests that justice would support an order of preference for recruitment. Finally, the Commissioners draw attention to categories of vulnerable populations.

Vulnerable populations

As the Belmont Report passage shows, the identification of some potential research participant populations as "vulnerable" had become a common practice at that time. The Report indicates that the injustice involved repeated inclusion in research - a specific example of research adding a burden to those already being experienced. Their vulnerability lies in their dependent status and their frequently compromised capacity or giving free consent.

The concept of vulnerability came to be applied too readily and in recent decades here has been extensive re-considerations of the use of the term as the attached article and the On-Line Ethics website describe.

The National Statement uses the term mainly in referring to categories of participants who are otherwise readily identified, e.g. children (Chapter 4.2), people in dependent relationships (Chapter 4.3), some of the categories of participants highly dependent on medical care (Chapter 4.4) and people with cognitive, intellectual or mental impairments (Chapter 4.5)

Relationship with the other Research Ethics Values in the National Statement

Research that is unjust usually also offends one or more of the other three values used in the National Statement. As a result, the injustice that is involved can receive less attention than the absence of respect and beneficence. However, justice needs to be recognized as having a distinct role.

The concept of fairness is perhaps the most useful to reveal the function of justice in the ethical design and review of human research. Research can have sufficient merit in its design, but is it fair to recruit the participants that have been selected? For example, studies of the experiences of women experiencing motherhood for the first time may be well designed but repeated recruitment from one maternity ward may be unfair. Research can be beneficent, that is the risks or participation are justified by the intended benefits, but is it fair to select these participants when others are available? Research can respect participants by seeking their consent, but is it fair to ask these participants to do so?