The National Health and Medical Research Council (NHMRC) is Australia's leading expert body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research. As part of its work to support a nationally consistent approach to the way human research (including clinical trials) is conducted and overseen, NHMRC is piloting National Scientific Committees to provide advice to Human Research Ethics Committees (HRECs), sponsors and researchers on complex genetic research, clinical trials involving medical devices and early phase clinical trials and first-in-human studies.
The National Scientific Committees (NSCs) will provide advice to HRECs, sponsors and investigators on the scientific merit and integrity of a research protocol. The committees will not provide ethics approval for human research and positive advice from a committee does not constitute an approval to commence a research project.
Under this pilot, Bellberry Limited (Bellberry), a national private not-for-profit company, will provide secretariat and administrative support to the committees.
While the Terms of Reference, Standard Operating Procedures and the membership of the committees have been approved by NHMRC, Bellberry will be responsible for the day-to-day management of the committees. NHMRC has provided funding to Bellberry to cover the costs associated with the pilot project.