HUMAN RESEARCH ETHICS

HUMAN RESEARCH ETHICS: BENEFICENCE

PART A:
What are the ethical features of beneficence?

The ethical value of beneficence is described in the National Statement in the following words (page 11):

Researchers exercise beneficence in several ways: in assessing and taking account of the risks of harm and the potential benefits of research to participants and to the wider community; in being sensitive to the welfare and interests of people involved in their research; and in reflecting on the social and cultural implications of their work.

This description indicates that there are several elements to beneficence. It has been given a similarly broad range of meanings in other authoritative sources, such as the Belmont Report.

One reason for this range of meanings is that the concept has a long history in medical ethics, where it characteristically means to do good and is often used in conjunction with its companion value of non-maleficence or “do no harm”. This is an injunction that has an even longer history in medical ethics dating back to the Hippocratic oath.

However, it is the application of beneficence in human research that is important. Doing good in research would commonly mean conducting research that is beneficial or at least likely to be so. However, it is the nature of research that requires human beings as participants that they will be exposed to some unknown effects and therefore to some risk of harm, whether physical, psychological or emotional. As a result, the simpler meaning of the value, doing good, needs to be revised. The Belmont Report indicates that this revision involves accepting that risks will be involved when conducting beneficial research and, as a result, asking whether that research can be justified despite the risks or whether the benefit should be foregone because of the risks. Acting beneficently in human research thus requires some assessment of both the intended benefits of the research and of the risks to which participants will be exposed.

These assessments are sometimes referred to as balancing the risks and benefits or finding a favourable risk-benefit ratio. However, both the Belmont Report and the National Statement prefer the language of justification. Instead of expressing the value in terms of whether there is an acceptable balance between the intended benefits and the risks, or that there is an acceptable risk-benefit ratio, the National Statement requires the risks of a research project to be justified by its intended benefits, or that the intended benefits justify the risks.

The National Statement uses these terms in describing beneficence as a principle:

1.6 The likely benefit of the research must justify any risks of harm or discomfort to participants. The likely benefit may be to the participants, to the wider community, or to both.

Accordingly, to be satisfied that human research meets this value and principle, there will need to be an assessment of both the intended benefits and of the risks.

The relevance of benefits in human research ethics

The benefit of human research is relevant to all the values used in the National Statement that have been already considered in this course. To be worth conducting at all, regardless of the risks involved, human research must be intended to have potential benefits. Identifying that benefit is thus an essential matter in being satisfied the value of research merit is fulfilled. Benefits that give research merit can be to knowledge and understanding, improved social welfare and individual well-being or to the skill and expertise of researchers. (National Statement 1.1 (a)).

Read more on benefits...

The extent to which participants receive benefits is relevant in considering the justice or fairness of their being selected to have the opportunity to participate, a matter relevant to satisfying the value of justice.

When human research has a benefit and where the selection of participants is fair, given the extent to which they will share in that benefit, the values of research merit and justice will usually have been satisfied. However the beneficence question remains: do the benefits, whether they are enjoyed by participants or others, justify the risks to which participants will be exposed? As paragraph 1.6 (quoted above) shows, that benefits can be to participants or to the wider community is explicitly recognized in the National Statement as part of the value of beneficence.

One means of promoting positive answers to the beneficence question is to use the value of beneficence as a requirement that investigators maximize the benefits and minimize the risks of human research. This approach is suggested in the Belmont Report but is not adopted in the National Statement, which requires the presence of sufficient benefit as part of satisfying the value of research merit. Instead, the National Statement, in paragraph 1.7(a) requires investigators to minimize the risks of harm or discomfort to participants:

1.7 Researchers are responsible for:

  • designing the research to minimize the risks of harm or discomfort to participants;

  • clarifying for participants the potential benefits and risks of the research; and

  • the welfare of the participants in the research context.

It is notable that subparagraph (c) of this paragraph echoes the element of doing good that is a part of the traditional meaning of the value of beneficence.

That research has benefit is necessary in order to satisfy the value of research merit. For this purpose, it does not usually matter whether participants receive the benefits directly, e.g. as better treatments for their illnesses or conditions, indirectly, e.g. as recipients of more reflective social welfare policies or at all. However, as paragraph 1.1(a) of the National Statement indicates, there can be exceptions to this, so that

What constitutes potential benefit and whether it justifies research may sometimes require consultation with the relevant communities;

In Australia, it is increasingly recognised that Aboriginal and Torres Strait Islander people are such communities, especially in relation to health and medical research. As a result, the National Statement (Section 4.7) explicitly addresses the matter of the benefits of research to those communities.

Whether the participants receive benefits or not and, if so, directly or indirectly, is a relevant but usually not decisive factor in showing that the research is just.

However, whether participants receive the benefits and in what way will be central to deciding whether the research meets the value and principle of beneficence. This is because it is the risks to these participants that must be justified. Accordingly, the extent to which they receive benefits from the research will be an essential element in the justification of the risks to which the research exposes them. In the National statement clearly recognizes this in paragraph1.8:

1.8 Where there are no likely benefits to participants, the risk to participants should be lower than would be ethically acceptable where there are such likely benefits.

At the time of prior ethical review, it is only intended benefits that can be assessed. However, as a research progresses, assessments of intended benefits - and of predicted risks – can be made more accurately. Where this assessment identifies situations where the risks are no longer justified, usually because the risks are in fact higher than expected or because it is apparent that benefits will be less than intended, research needs to be suspended. This is recognized by the National Statement in paragraph 1.9 and other paragraphs in section 5.5.

The relevance of risk in human research ethics

Because assessing the risks involved in human research, whether to participants or to others, is central to meeting the value and principle of beneficence and is therefore necessary in designing and ethically reviewing every human research project, the National Statement devotes a whole chapter, Chapter 2.1, to this subject.

The National Statement describes risks in human research as meaning the potential for harm, discomfort or inconvenience to participants or to others.

The concept of risk is recognized as consisting of two elements:

  • the likelihood of occurrence and

  • the severity and consequences of occurrence.

In the assessing both these elements, previous history of the use of the same intervention, whether an interview technique, a test of physiological, psychological or emotional factors or a physical intervention such as a drug will be relevant.

The severity of the risk will require an evaluation of what harm research may cause research participants and others. The National Statement contains an account (section 2.1) of the kinds of harms that research can involve.

There are similar characterizations of research risk which may be informative.

Read more on categorization of research risk...

Because of the wide range of possible harms or discomforts that research can cause participants or others, it is common to adopt a categorisation. One common categorization is between research that involves no more than minimal risk and research that involves more than minimal risk. The central concept in this categorization is a that of minimal risk, which is often described as no greater risk and than participants would experience in their own lives. This categorization is adopted by the United States regulations governing human research and a recent examination of the categorisation by the Secretary’s Committee on Human Research Protections is informative.

However, the National Statement adopts a different categorization. It distinguishes harms from discomforts and inconveniences. Research that involves risk of more than discomfort is defined by the National Statement as involving more than low risk. Research that involves no more than discomfort is defined by the National Statement as low risk research (section 2.1) and research that involves no more than inconvenience, is defined as negligible risk research.

These categorisations are used to support a proportional approach to the ethical review of human research. The National Statement requires institutions to subject research which involves more than low risk to review by a human research ethics committee (HREC); research which involves no more than low risk to review by either an HREC or another review body or process subject to specified conditions (section 5.1). The National Statement authorises (section 5.1), institutions to determine that negligible risk research that involves existing collections of non-identifiable data need not be subject to ethical review.

The guidelines contained in chapter 2.1 set out a sequence of steps for arriving at a judgement on the ethical acceptability of the risks of a human research project. The steps are:

  • identifying risks,

  • assessing their likelihood and severity,

  • identifying whom the risks affect,

  • minimizing risks,

  • identifying potential benefits and to whom they will accrue, and

  • managing risks.

Guideline 2.1.5 recognizes that some participant populations to whom benefits of research will accrue may be willing to assume greater risks, a willingness that review bodies may take into account.

The management of risks requires that researchers include in their research proposals mechanisms to manage risks and monitoring procedures (section 5.5) to check that these mechanisms are effective. Monitoring research is also concerned with ensuring that the research is conducted in the manner in which it was approved.