HUMAN RESEARCH ETHICS

RESEARCH MERIT AND INTEGRITY

PART A:
What are the ethical features of research merit?

The essential nature of the ethical value of research merit and integrity is stated in the National Statement in the following words (page 11):

Research merit and integrity are discussed first. Unless proposed research has merit, and the researchers who live to carry out the research has integrity, the involvement of human participants in the research cannot be ethically justifiable.

The ethical issue that is at stake is sometimes, colloquially described as "bad science means bad ethics". A better explanation is that there need to be good reasons for participants to be involved in human research. Because participation is not compulsory or required, people who are invited to participate need to be given good reasons for agreeing to do so.

Important among the good reasons that need to be given are that the research has value, that is, it will provide benefits to the community, to the participants or to both. Paragraph 1.1(a) of the National Statement identifies those benefits to include new knowledge or understanding, improved practices or procedures or even better trained researchers.

However, for any research to be beneficial in these ways - to have value - it must be designed so that the results it generates are recognized as being true or meaningful. Another way of describing this quality is to say that research must have validity. The criteria for validity in research are the product of scientific, academic and disciplinary traditions. Accordingly, researchers need to know and abide by the criteria for validity of the relevant discipline in designing and conducting research and need to show members of ethical review bodies that the proposed research conforms to them.

Involving people in research that has no value or validity is unethical because those people give their time and expose themselves to the risks of participation for no good reason. Their consent to participation would not overcome this deficiency where the process of seeking consent to participation in research that lacks value or validity or both involves misrepresentation of the research.

The roles of ethical review bodies

It is important to recognize that ethical review bodies are not established as scientific review bodies: their functions do not include the task of judging the value and validity of human research. However, they do need to be satisfied that research that they review and approve has both.

There is an important distinction between judging that value and validity are present and being satisfied that research has value and validity. Although this is frequently misunderstood, it needs to be maintained.

Where the bodies or processes that are used to judge value and validity are different from those used to determine whether human research is ethically acceptable, the distinction can be more readily maintained. This occurs when formal scientific or disciplinary peer review processes are relied on as elements of competitive research grant processes, at national, state, regional or institutional levels, or elements of institutional research governance procedures. When human research proposals are approved by any of these procedures, the function of human research ethics review bodies proceeds on the premise that the research has merit - that is, has value and validity. National Statement 1.2

Where there is no formal peer review process, ethical review bodies are confronted with the need for advice or assurance that research has merit - that is, has value and validity. One source of such advice is the body's membership. Paragraph 5.1.30(f) of the National Statement requires that the minimum membership of HRECs include:

"at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise."

Read more about functions of ethics review bodies...

One function of these members is to assure researchers who submit proposals for ethical review that the review body has sufficient relevant knowledge of the type of research involved and that those members can understand and explain the disciplinary basis for the research design. As noted above, the primary responsibility for showing that research has merit lies on the researcher.

The National Statement directs institutions to ensure that HRECS have access to necessary expertise and authorises HRECs to seek additional expertise. Accordingly, if an HREC's membership does not include sufficient relevant expertise, it should seek that from sources beyond its membership.

Once an ethical review body is satisfied that research has merit, questions arise about the ethical consequences of that research design. It will always be necessary to decide whether the proposed benefits, which constitute an important part of the research merit, are sufficient to justify the risks to which participants will be exposed. This is the determination of the ethical value of beneficence, rather than research merit, and is an essential judgment for every research proposal. Where a review body determines that the benefits of the research do not justify the risks of participation, it may not only inform the researcher of that view but also suggest that an adjustment is made in the research process so as to reduce the risk to justifiable levels. Sometimes these requests are seen by researchers as questioning their methodology and are criticised as being beyond the scope of an ethics review body. However, these criticisms arise from a failure of the review body to explain fully why it is making the request, that is, that although it accepts that the research has merit, it is not satisfied that the research meets the test of beneficence, that is, that the proposed benefits justify the risks.

What Is Research Merit?

The National Statement sets out, in six paragraphs, the elements of research merit. These can be summarised as:

  • Benefit in knowledge, understanding, improved welfare or wellbeing or research skill;

  • Use of appropriate methods;
    - the goals of the research, informed by disciplinary and academic traditions, usually determine the proposed research methods;
    - it is important to be satisfied that the methods will lead to the intended outcomes

  • A basis in current literature or prior research;
    - the current literature of the relevant discipline is the likely source for determining whether the research question proposed to be answered by the research proposal is recognised as both worth asking and not yet answered

  • Uncompromised respect for participants;
    - while the research design needs to have value and validity, it must also maintain respect for the participants: the likely benefits of the research cannot be used as a basis for denying respect for the participants, it is respect that is the central value;

  • Appropriately qualified and competent researchers; and
    - some evidence of qualifications and experience need to be provided and can be formal qualifications or experience or both
    - relevant competence of researchers is to undertake the research methods proposed

  • Use of appropriate facilities and resources
    - facilities need to be appropriate not only to the research methods but also for the protection of the interest and welfare of participants;
    - resources need to be sufficient to complete the intended research.

What are the ethical features of Researcher Integrity?

The National Statement sets out the elements of integrity in the following four paragraphs:

Research that is conducted with integrity is carried out by researchers with a commitment to:

  1. searching for knowledge and understanding;

  2. following recognised principles of research conduct;

  3. conducting research honestly; and

  4. disseminating and communicating results, whether favourable or unfavourable, in ways that permit scrutiny and contribute to public knowledge and understanding.

Searching for Knowledge and Understanding

Broadly stated, the common goals of research are to discover new knowledge or understanding and it is motivation to these ends that shows that researchers have integrity. Where, by contrast, researchers are solely motivated by personal advancement, financial rewards or competitive advantage, they are likely to lack that integrity.

Accordingly, because it will often be the manner in research is funded that can raise questions about researcher integrity, the National Statement imposes responsibilities on researchers to disclose to ethics review bodies information about funding and resources.

Conflicts of Interest

The other common sources of motivations that erode or eliminate researcher integrity are their conflicts of interest. Where researchers have interests or commitments that compete or threaten to compete with their commitment to the search for knowledge and understanding, their integrity can be compromised.

Read more about conflicts of interest...

An account of the contexts that do and can involve conflicts of interest would extend well beyond the needs of this module and this course. The subject is dealt with in both the National Statement and in Section 7 of the Australian Code for the Responsible Conduct of Research, the guidelines issued by the National Health and Medical Research Council, Australian Research Council and Universities Australia that applies generally to the conduct of any research, including human research.

Some indication of the nature of what can constitute an interest that competes with a researcher's commitment to research integrity is provided by the NHMRC discussion paper.

Following recognised principles of research conduct

The Australian Code provides an authoritative guide to these principles.

Conducting research honestly

This responsibility is referred to in the Australian Code as the obligation to "foster and maintain a research environment of intellectual honesty and integrity, and scholarly and scientific rigour." At the time of prior review of proposed human research, ethics review bodies cannot identify or expose the blatant dishonesty involved in falsification, fabrication or plagiarism that have been the common examples of failures to conduct research honestly. Rather, they will need to rely on information about the researcher's track record that she has a responsibility to provide.

Disseminating and communicating results

Again, as with conducting research honestly, an ethics review body will need to rely on the researcher's track record and particularly the plan for disseminating the results of the proposed research. Limitations on the publication of unfavourable results or on access to professional scrutiny can signal possible failures to meet this obligation. They can also arise from the influence of sponsors of research who may wish to exercise their vested interest in publishing only favourable results.