Health research that involves human participants must—
| (a) |
comply with the Department of Health national ethical guidelines for research with human participants at a minimum; |
| (b) |
be responsive to health needs or priorities of the population, participating community or proposed participants; |
| (c) |
have a valid scientific methodology and be likely to provide answers for the specific research questions that are posed; |
| (d) |
include a favourable risk-benefit analysis; |
| (e) |
ensure that the recruitment and selection process is just and fair; |
| (f ) |
be undertaken with appropriate consent processes; |
| (g) |
undergo independent review by a registered health research ethics committee; |
| (h) |
respect participants' rights, including but not limited to rights to dignity, privacy, bodily integrity and equality; |
| (i) |
make provision for compensation for research-related injury, for more than minimal risk research; and |
| (j) |
be managed by a lead researcher, or person with similar standing or title, with suitable experience and qualifications. |
Copyright Act, 1978
