Guest Editorial

Obtaining ethical clearance to conduct research: can the current situation be changed?

Kim Usher
School of Nursing, Midwifery and Nutrition, James Cook University, Cairns QLD

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Article Text

We are witnessing an exponential increase in the number of nurses undertaking and publishing research in Australia today. This journal, as many others, is now allocating more space to the publication of research articles. Therefore, with the beginning of the new millennium it would seem timely to revisit some of the ethical issues which face nurse researchers today. In particular, I would like to examine the issue of obtaining ethical clearance to conduct a research study. Although one may consider this an area on which much has been written, I would argue that it is an important issue that remains a source of confusion to many researchers. Challenging and overcoming this ethical issue offers an opportunity for nursing to lead the way forward in research in the new century.

The ethical problems that face researchers today first received attention after World War II. Those concerns led to the development of a code of ethics for research (The Nuremburg Code). The developed code requires informed consent in all cases. Since then other international standards have followed, for example, the Declaration of Helsinki which was adopted in 1964. In Australia, guidelines for the ethical conduct of research involving humans and animals have been developed by the National Health and Medical Research Council (NHMRC) which recently released a new National Statement on Ethical Conduct on Research Involving Humans (1999). All Human Ethics Research Committees in Australia require research projects to adhere to these guidelines. Whilst the maintenance of high ethical standards in research is clearly desirable, and these codes and guidelines assist both ethics committees and researchers (While 1996), it appears that some degree of confusion about the ethical requirements of research involving human subjects still exists.

My recent experience as a member of a Human Ethics Research Committee has caused me some concern because of this apparent confusion. Members of such committees seem to be constantly faced with researchers who either fail to recognise the need for ethical clearance prior to undertaking research, or alternatively, fail to adequately identify and overcome the issues of informed consent inherent in their study. Further, I have often heard nurse researchers say, "Oh this is just an action research project so we do not need any clearance!" In undergraduate nursing education courses we teach students to identify ethical issues when they critique research articles. Although they are advised that space constraints in journals often precludes the inclusion of lengthy details regarding ethical concerns and the clearances obtained, we do advise students to expect some explanation of how this aspect of a research study was managed. After all, researchers who publish their results are putting their work into the public arena for scrutiny as well as recognition and they are often held in high esteem by their colleagues because of their publishing success. In addition, students hold academics and clinicians who publish in high regard. So how can we ensure that researchers are obtaining ethical clearance to conduct their studies from the appropriate committees? Further, should studies be published if they do not provide adequate details of ethical clearance and informed consent to the editors of journals?

Ethics committees have been charged with safeguarding the rights of human subjects (Usher & Holmes 1997). Part of their role is to ensure that the principles of informed consent are adhered to by those conducting research involving human subjects. Surely then it is reasonable to expect that journals not only provide potential authors with guidelines for preparing their paper, but also include ethical guidelines which outline the necessity of sighting evidence of ethical clearance to conduct the study prior to acceptance of research for publication.

Obviously this is not currently the case for some medical journals which led to a recent editorial in the British Medical Journal (Smith 1997) which asked readers to consider whether studies should be rejected if they fail to provide evidence of informed consent. This request arose because of the submission of two papers describing research in which the informed consent of the participants was not obtained. As a result, the editors and the reviewers found themselves in a state of confusion and conflict regarding whether or not these papers should be published. A survey of the published instructions to authors in 102 major English language biomedical journals revealed that a quarter of these did not give authors any guidance on human research ethics, and only half stated they required evidence of approval to conduct the study from an ethics committee or institutional review board before publication (Amdur & Biddle 1997). A further study by Rennie and Yank (1997), that examined a total of 53 consecutive research articles from five medical journals, found 47 percent did not record approval from an ethics committee. Alarmingly, of the 53 studies reviewed, 25 percent were rated by the authors as having convincing reasons for obtaining safeguards.

Disturbingly, it appears that similar practices exist in nursing journals. Recently I informally reviewed six well respected Australian and international nursing journals. I discovered that they not only failed to present clear guidance regarding adherence to ethical principles, but also failed to give any indication that evidence of ethical clearance to conduct the study was necessary. As more clinicians and students are encouraged to undertake research it seems essential that ethical principles are seen to be upheld. I suggest that one way we can begin to ensure this happens in nursing is for journal editors to insist on sighting evidence of ethical clearance before publishing a research study, and for researchers to support those journals that insist on this standard. Journals requiring evidence of ethical clearance would give authors a clear message that they uphold ethical principals and expect high ethical standards. This is a message that nursing could send to the rest of the health-care world. Whilst ethical issues are never easily resolved, I believe we cannot afford to ignore this issue and that we must now take a stand to ensure that in the future, nursing is seen to be leading the way.

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