Research and Ethics

Practical application of ethics submissions in Defence Health Research

Submission of research protocols to a Human Research ethics Committee (HREC) for approval requires the provision of a considerable amount of supporting documentation and information. Commonly, one is required to provide the research protocol, subject consent form, background summary, and details of any elaborate research tools or techniques to be employed. Over the years HRECS have developed ad hoc submission documents in the form of
questionnaires or aide memoirs designed to facilitate not only the submission by the researcher but the review process by the HREC.

HRECs in Australia are established in accordance with the principles and guidelines defined by the National Health and Medical Research Council (NHMRC) – principles which cover areas such as composition of members and the information which an HREC should consider when deciding whether to approve a research proposal in human health. Defence Health Services (DHS) established its HREC in 1987. The Australian Defence Medical Ethics Committee, since renamed the Australian Defence Human Research Ethics Committee (ADHREC) is constituted in accordance
with the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999). The new National Statement on Ethical Conduct in Human Research (NHMRC 2007) states that it must also ensure human research in Defence is in accordance with the Australian Code for the Responsible Conduct of Research (NHMRC, Australian Vice Chancellors’ Committee), the revision of the 1997 document, which has not yet been published.

HRECs in Australia have, over the past 20 years, developed a number of formats where research submissions to several different committees were in very different formats. In addition, the current ADHREC Submission Form (as outlined in ADFP 1.2.5.3) was introduced in 2001, and in recent years the nature and complexity of research projects has changed considerably. In 2005 the NHMRC began the NEAF (National Ethics Application Form) project, designed to standardize the format and information required for HREC submissions and simplify the process of both submission by researchers and review by committee members.

Work is currently underway to develop a revised ADHREC submission form and incorporate the changes proposed by the NEAF and incorporated by a number of Area Health Services throughout Australia. The format will be designed to facilitate submission in a clear, logical format that is both easy to complete and straight-forward to review. Internal checks and checklists will be included. Provision will also be made to handle future likely areas of research for Defence.