Scientific review of research proposals to Australian Defence Human Research Ethics Committee (2005 – 2007)
The responsibility for the institutional review of research projects rests ultimately with the institutional Human Research Ethics Committee (HREC). HRECs in Australia are established in accordance with the principles and guidelines defined by the National Health and Medical Research Council (NHMRC). Requirements are set out for: • institutions or organisations in establishing HRECs; • researchers in submitting research proposals to HRECs; and
• HRECs in considering and reaching decisions regarding those proposals and in monitoring the conduct of approved research.
Institutions through the relevant HREC need to satisfy themselves of the scientific validity, scientific relevance, and ethical conduct of a research proposal before giving approval to proceed. With the growing number and complexity of research submissions in recent years, most Australian HRECs have found it necessary to establish some mechanism for the review of scientific content of research projects. This has included referring submissions for expert scientific
opinion, or the establishment of HREC subcommittees to review scientific content or specific content related to the use of therapeutic substances or devices.
The Australian Defence Human Research Ethics Committee (ADHREC) was established by DHS in 1987 in accordance with the National Statement on Ethical Conduct in Research Involving Humans (latest version: NHMRC 2007). In 2005 it was recognized that there was a need for some form of scientific review of research projects. Two reserve health service officers were requested to review the scientific content of research submissions as required prior to approval by ADHREC. Both officers are professional research scientists holding higher qualifications, as
well as adjunct professorial appointments, and bring considerable (more than 30 years each) of research experience to the task.
Submissions have been reviewed for a number of factors including – • Scientific Design – including stated aims, schedule of assessments, statistical analysis plan, and power calculation • Benefits to Defence • Significance and Innovation The scientific standard of submissions reviewed has been generally very good. However, a number of
deficiencies have been identified, including – • Lack of clear aim • Unnecessary assessments, or assessments
inadequate to elicit the stated objective of the proposal, • Inadequate or non-existent sample size estimate
• Work that has already been conducted • Work that represents no benefit to defence. This presentation will focus on the specific deficiencies identified over the past two years, especially those that occur on a frequent basis.
