In Finland this week, a ceremony was held to celebrate the 50th Anniversary of the Declaration of Helsinki.
The Declaration is one of the most important documents in the history of human research ethics and is widely considered the landmark document governing the conduct of clinical research.
Most of the practices that were of grave concern in 1964 are happily rare today. However, researchers and participants now face new ethical dilemmas with the development of new technologies and advances in biomedicine.
For instance, genomic research has brought with it ethical considerations such as consent, privacy and the collection, storage and release of genomic data. Our increasing store of biological material for access and use by researchers raises similar considerations.
The National Health and Medical Research Council (NHMRC) and its Australian Health Ethics Committee have a role in responding to these matters, as the nation’s vanguard of health and medical research ethics.
At NHMRC, we are proud of our history as Australia’s leading body on health and research ethics.
Following the Declaration of Helsinki in 1964, the National Health and Medical Research Council issued its Statement on Human Experimentation in 1966.
It reflected much of the Declaration, and ensured that its ethical concepts were instilled in the Australian research community and a core part of our research landscape.
In 1976 NHMRC mandated the need for NHMRC-funded research to be reviewed by an institutional Human Research Ethics Committee. In 1992, the Australian Health Ethics Committee (AHEC) was established under the NHMRC Act, replacing the Medical Research Ethics Committee and the National Bioethics Consultative Committee.
AHEC is the only national body in Australia with statutory responsibilities for providing advice on ethical issues related to health and for developing human research guidelines. In 1999, AHEC released the National Statement on Ethical Conduct in Research Involving Humans, which in 2007 was replaced by the National Statement on Ethical Conduct in Human Research, and in the same year released the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research, 2007.
Under the NHMRC funding agreement, all NHMRC-funded researchers are required to comply with the National Statement, as well as NHMRC’s Australian Code for the Responsible Conduct of Research, 2007, which, in accordance with the Declaration of Helsinki, sets out guidance on the dissemination of data from research.
Medical research continues to develop and change and this brings new ethical issues to address. We must never rest on our laurels.
In addition to conducting a rolling review of the National Statement, NHMRC’s AHEC is in the process of determining the type of ethical guidance that is needed around the provision of results to participants from genetic/genomic research. AHEC will also soon be reviewing two research ethics guidelines pertaining to Indigenous health research: Keeping research on track: a guide for Aboriginal and Torres Strait Islander peoples about health research ethics, 2005 and Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research, 2003.
NHMRC’s broader scope of work in the ethics space also encompasses animal research ethics – including native mammals, non-human primates, the Australian code for the care and use of animals for scientific purposes 8th edition (2013) and more.
I am convinced that NHMRC’s role, in ensuring Australian research is guided by the highest possible standards, remains as relevant as ever.
There have been many hundreds of people (researchers, ethicists, consumers, researchers and community representatives) who have given their time to ensure research in Australia is conducted in the most ethical way.
I would like to thank those who have contributed so much already, and those who we will no doubt draw upon in future, as technology continues to advance and we gain even greater insight into diseases and the human body.
Professor Warwick Anderson AM
Chief Executive Officer, NHMRC