The Australian Government has established the National Health and Medical Research Council to provide guidelines for the way medical research that involves human beings is carried out in Australia. These guidelines are called the National Statement on Ethical Conduct in Research Involving Humans (the National Statement).

The National Statement sets out the principles of ethical conduct in medical research and requires all medical research to be approved by a Human Research Ethics Committee.

What are the principles of ethical conduct in medical research?

There are four main principles required of those who undertake medical research in Australia:

1. To act with integrity
2. To respect the inherent dignity of those who participate in research
3. To minimise the risks of harm or discomfort to participants (beneficence)
4. To act justly, which includes:
   1. Not imposing an unfair burden on a particular group in the research
   2. Ensuring that the selection, recruitment, exclusion and inclusion of people in research is fair.

To find out more about these principles and how they are understood, there is a commentary on the National Statement available from the National Health and Medical Research Council's website (www.nhmrc.gov.au).

How are these principles enforced?

The National Statement requires that each institution that carries out medical research set up a Human Research Ethics Committee. If an institution fails to comply with the terms of the National Statement it may become ineligible for funding from the National Health and Medical Research Council or the Australian Research Council.

What does a Human Research Ethics Committee do?

The primary role of the Human Research Ethics Committee is, "to protect the welfare and the rights of participants in research" (National Statement para. 2.5). The Committee must approve the medical research prior to the research going ahead.

In deciding whether the research should proceed, the Committee must be satisfied that the research can "produce valid results and can protect the welfare and rights of research participants" (Commentary on the National Statement page C23).

In working this out, the Committee will look at:

• The scientific basis of the research project and whether it is worthwhile
• Who the researchers are, their qualifications, ethical and legal obligations
• Who is funding the research
• Whether any other Committee has approved or failed to approve the research
• How sound the research is in terms of the methods it will employ
• How it will recruit people to be in the research
• The burdens of the research and who will bear there burdens
• Whether there are incentives to people to participate in the research and the effect this may have on the ability of people to withdraw from the research should they want to
• How will people consent to being part of the research
• How can people get of out the research if they want to
• How is information collected by the research protected
• Legal issues involved in the research.

Why don't we exclude such people from research so that they can't be harmed?

If we automatically exclude people who have a disability that affects their ability to make judgments from research, it may be difficult for people to perform research that also benefits this group of people.

It would also be discriminatory to single out people simply because of their disability. However, it is important that people are protected from exploitation where they may be unable to refuse participation or powerless to prevent it. That is why the Committee has an important role to play when approving the participation of people who are vulnerable in a research project.

How are vulnerable people protected from being exploited or abused in medical research?

The Committee is to make sure that vulnerable people only participate in the research if it is appropriate for them to do so. People may be vulnerable for a number of reasons. They could be so sick that they will try anything to get better. They may be unconscious because of an injury they have sustained. They may have a disability that prevents them from making a judgment as to whether they should be part of the research. There may be too afraid to disagree with their doctor.

The Committee is required to think about these groups of people and decide whether the research is appropriate for such people to be involved. The Committee may require the researchers to put special measures in place to ensure that the four principles set out above operate for these groups if they are in the research.

How can people who have a disability participate in research if they cannot make a judgement for themselves?

Victoria passed new laws in 2006 which set out a process to be followed that will allow people who have a disability to participate in medical research. There are four steps to the process.

Step 1 requires that the medical research project is approved by a Committee. If the medical research project is not approved, the patient cannot participate in the research. If the Committee has set out special conditions for participation of people who have a disability, then these must be followed.

Step 2 requires that if the patient is likely to be capable of giving consent to the medical research procedure within a reasonable time, then the procedure cannot be carried out. If the patient will not be capable of giving consent for themselves within a reasonable time, then the person responsible can provide consent for them (see Step 3). If there is no person responsible (or they can't be found), then the patient can still participate in the research so long as the researcher follows the process set out in step 4.

Step 3 allows the person responsible to provide consent to the medical research procedure. The person responsible can only do so where they believe -

1. That the medical research procedure is not contrary to the best interests of the patient; and
2. The consent is consistent with any requirements that may have been set out by the Committee.

Step 4 applies where the patient can't consent and there is no person responsible or that person can't be found despite reasonable efforts to do so. If the medical practitioner goes through the process, then the patient can participate in the medical research.

The process involves the medical practitioner certifying, using Section 42T Certificate of the Guardianship and Administration Act 1986, all of the following:

• The patient is not likely to be capable of giving consent within a reasonable time
• The medical practitioner has taken reasonable steps to find any person responsible but they were not found
• The medical research procedure is not contrary to the patient's best interests
• The medical research procedure is not against the patient's wishes
• The medical practitioner believes that the Committee has approved of persons in the patient's circumstances (that is, unable to consent nor have consent provided by another) being involved in the medical research project
• The medical practitioner believes that the research project is to assess the effectiveness of the therapy and it poses no more risk than is inherent in the patient's condition and alternative treatment
• The medical practitioner believes that the research project is based on valid scientific hypotheses that support a reasonable possibility of benefit for the patient as compared with standard treatment
• The patient will be informed about the research if they regain capacity or, if the person responsible is found they will be informed of the medical research procedure.

The Section 42T Certificate must be kept on the patient's file. A copy must be sent to the Human Research Ethics Committee and the Office of the Public Advocate. If the procedure extends over one month the medical practitioner must provide an updated certificate and forward a copy to those bodies as well.

The Office of the Public Advocate has developed standard forms which may assist practitioners to provide these certificates.