Academy of Social Sciences in Australia

Ethical Conduct in Research Involving Humans

Commentary and proposed amendments to the National Statement on Ethical Conduct in Research Involving Humans

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February 2005

Preamble

The new draft NS is a welcome attempt to produce a policy on research ethics which transcends the origins of the former NS in the ethical regulation of medical and biomedical research. The drafting committee has undertaken a formidable task, because expanding the scope of the policy from medical and bio-medical research to all forms of research involving humans has vastly increased the range of research methods and contexts which are to be addressed. The new document must speak to all researchers in terms that make sense within their discipline, as well as giving clear guidance to HRECs in dealing with research projects in fields with which they may not be familiar.

We recognize the careful thought and effort which has gone into the preparation of this draft, and we note many improvements over the 1999 National Statement, including but not only the provisions to avoid the waste of resources caused by multiple review of the same project. We find nonetheless that there are a number of areas in which it does not fully achieve these goals. We make the following comments and suggestions as a contribution to achieving a document which will speak clearly to and deal responsibly with all researchers in Australia, irrespective of discipline, and which will contribute to strengthening a culture of ethical research practice in Australian institutions.

We have identified a number of places in the new NS where the ethical issues relevant to research in the social sciences and humanities have not been satisfactorily dealt with and where HRECs are left with insufficient guidance in their responses to projects in these fields. Perhaps the clearest lesson from the experience of the five years since the original National Statement was issued is that HRECs need clear guidelines if they are to deal fairly with all disciplines and if there is to be consistency across the Australian research community as a whole. We identify the following major issues which need attention if the new National Statement is to work appropriately and effectively in the interests of research, of participants and of the community:

  1. The document should give better recognition to the complexity of ethical issues and to the likelihood that researchers will face ethical dilemmas.
  2. The document should give greater recognition to the responsibility of the individual researcher to make ethical decisions.
  3. The document should provide a definition of research which is appropriate to the needs of ethical review, rather than to assessment of research impact.
  4. The document should not require HRECs to judge the lawfulness of research projects.
  5. The document should not require HRECs to judge the research merit of projects.
  6. The document should pay more careful attention to the issue of risk.
  7. The document should pay attention to the issue of accountability.
  8. The document should pay more careful attention to the issue of informed consent.
  9. The document should encourage the use of discipline or field-specific subcommittees by HRECs

At each point we have carefully explained our objections to the present wording and we have offered an alternative wording which we feel is appropriate. We ask that you take our suggestions seriously and we hope that you will consult us directly if you require clarification on any matter or if you wish to explain why you cannot accept our suggestions. We are aware that some of the changes which we suggest have no bearing at all on medical research, but we argue strongly that there is a place these issues in the National Statement, just as there is a place for those parts of the current draft have no bearing on social science or humanities research.

The task of revising the current NA is immensely important. If it can be carried out effectively, it will make a valuable contribution to the management of research ethics, not only in Australia but also globally.


Academy of the Social Sciences

February 2005