Quick questions on Research ethics and the NHMRC: HSC Investigating Science Module 8

The codes are implemented locally through committees.

The Australian system is one of the strongest globally but has limitations:

Following the Nazi medical experiments uncovered at the Nuremberg trials, this established the principle of voluntary informed consent.

The World Medical Association extended the Nuremberg principles to all medical research, distinguishing therapeutic from non-therapeutic research.

US Public Health Service withheld treatment from 600 African-American men with syphilis for 40 years. Exposed in 1972, this led to the 1979 Belmont Report and the modern US system of Institutional Review Boards.

Australia introduced national ethical codes from the 1980s, consolidated in the National Statement of 1999.

Approximately 180 HRECs operate across Australia, accredited by NHMRC. Every research project involving humans must obtain HREC approval before any data collection begins.

Required at every institution using animals. Independent review of every proposed animal study.

Committees include scientists, ethicists, lay members, religious or cultural representatives and lawyers. Diversity is mandated to bring multiple perspectives.

Following Chinese scientist He Jiankui's 2018 announcement of CRISPR-edited human embryos that led to live births, the international scientific community called for a moratorium. Australia's existing law was already restrictive; the NHMRC published clarifying guidance in 2020.

The National Centre for Indigenous Genomics, established at the Australian National University, holds genomic data with strict community consent and benefit-sharing arrangements, modelled on AIATSIS protocols.

During the pandemic, ethics review timelines were compressed (some reviews completed in days rather than months) while maintaining substantive standards. The experience showed that timely review is possible without weakening principles.

Outline the 3Rs of animal research ethics and give one practical example of each. [3 marks]

A university researcher proposes interviewing high-school students about cyberbullying. State three NHMRC requirements before the project can begin. [3 marks]

A clinical trial of a new diabetes drug recruits Aboriginal participants in the Northern Territory. (a) Identify one NHMRC code that applies. (b) Identify one AIATSIS-specific requirement.