Australia NHMRC National Statement on Ethical Conduct in Human Research

Apply additional ethical considerations for research involving women who are pregnant and the human fetus.

• Additional risk assessment for pregnancy/fetus
• Specific consent considerations
• Review-body attention to this group

• Group-specific risks not assessed
• Consent considerations omitted

Apply additional ethical considerations for research involving children and young people, including capacity and parental/guardian consent.

• Assessment of child capacity/assent
• Parental/guardian consent
• Age-appropriate information

• Assent/capacity not assessed
• No parental consent where required

Apply additional considerations where participants are in dependent or unequal relationships with researchers or recruiters.

• Identification of dependent relationships
• Measures to avoid coercion
• Independent recruitment where needed

• Coercion risk unmanaged
• Dependency not identified

Apply additional considerations for research involving people highly dependent on medical care who may be unable to give consent.

• Substitute decision-maker consent
• Justification for involving this group
• Welfare safeguards

• Consent basis unclear
• No substitute decision-maker process

Apply additional considerations for research involving people with cognitive impairment, intellectual disability or mental illness.

• Capacity assessment
• Consent/substitute consent process
• Safeguards against exploitation

• Capacity not assessed
• No appropriate consent process

Apply additional considerations for research involving people who may be involved in illegal activities, including confidentiality and legal risk.

• Confidentiality protections
• Management of legal risk to participants
• Data protection from disclosure

• Confidentiality not protected
• Legal risk to participants unmanaged

Apply the ethical considerations and values for research with Aboriginal and Torres Strait Islander Peoples, including community engagement and benefit.

• Community engagement and agreement
• Alignment with AIATSIS/NHMRC Indigenous research values
• Benefit to the community

• No community engagement
• Indigenous research values not applied
• No community benefit

Apply additional considerations for research conducted in other countries, respecting local context, laws and review.

• Local ethical review and approval
• Respect for local laws and culture
• Equitable benefit to host community

• No local review
• Local context/laws not respected

Address the seven common elements of research (research scope and design; recruitment; consent; collection, use and management of data and information; communication of results; etc.) ethically.

• Protocol covering the research elements
• Data and information management plan
• Plan for communicating results

• Elements not addressed in design
• No data management plan
• Results not communicated to participants/community

Apply ethical requirements specific to the collection, storage, use and disposal of human biospecimens in laboratory-based research.

• Consent and governance for biospecimen use
• Storage, tracking and disposal procedures
• Ethical approval for biospecimen research

• Biospecimens used without specific consent
• No storage/disposal governance
• Approval not obtained

Apply ethical requirements specific to genomic research, including management of genomic information and findings.

• Governance for genomic data and findings
• Consent addressing genomic implications
• Management of incidental/secondary findings

• Genomic data ungoverned
• Consent silent on genomic implications
• Findings management undefined

Apply ethical requirements specific to animal-to-human xenotransplantation research.

• Specialised ethical approval
• Risk management for xenotransplantation
• Long-term participant monitoring

• No specialised approval
• Risks not specifically managed
• No long-term monitoring

Institutions establish and maintain research governance, including risk-based review pathways, resourcing and oversight of research conduct.

• Research governance framework and policies
• Risk-based review pathways (Chapter 5.1)
• Institutional oversight of research

• No governance framework
• Review pathways undefined
• No institutional oversight

Human Research Ethics Committees and other review bodies are properly constituted and review research against the National Statement.

• HREC composition meeting minimum membership
• Review records against the National Statement
• Decisions and conditions documented

• HREC not properly constituted
• Reviews not documented
• Review not against the National Statement

Researchers conduct research ethically, comply with approvals and conditions, and report as required.

• Researcher compliance with approval conditions
• Required reporting (adverse events, amendments)
• Researcher competence and declarations

• Conditions not complied with
• Required reports not made
• Researcher conduct unmonitored

Research is monitored proportionate to risk, including adverse event and safety reporting, amendments and progress reporting.

• Monitoring plan proportionate to risk
• Adverse event / safety reports
• Amendment and progress/final reports

• No monitoring of approved research
• Adverse events not reported
• Amendments not reviewed

Use single/streamlined ethical review to minimise duplication for multi-site research.

• Single/streamlined review arrangements
• Mutual acceptance of review
• Records of accepted reviews

• Duplicate reviews for multi-site research
• No streamlined review process

Disclose and manage conflicts of interest of researchers, institutions and review bodies.

• Conflict-of-interest declarations
• Management/mitigation of conflicts
• COI register

• Conflicts not declared
• Conflicts unmanaged

Establish processes to receive and handle complaints about the conduct of research.

• Complaints handling process
• Records of complaints and outcomes
• Information to participants on how to complain

• No complaints process
• Complaints not recorded or actioned

Institutions and researchers are accountable for the ethical conduct of research and for managing research misconduct.

• Accountability arrangements
• Research misconduct management process
• Reporting to relevant authorities

• No accountability arrangements
• Misconduct not managed
• No reporting of breaches

Identify, assess and manage the types and levels of risk (harm, discomfort, burden, inconvenience) and weigh them against potential benefit throughout the research.

• Documented risk identification and assessment
• Risk management / mitigation plan
• Risk-benefit weighing in the protocol

• Risks not assessed by type/level
• No mitigation plan
• Risk-benefit balance not documented

Obtain consent that is voluntary and based on sufficient information and adequate understanding of the research and its implications.

• Participant information and consent materials
• Evidence of voluntary, informed consent
• Process for ongoing consent

• Consent not voluntary or informed
• Inadequate participant information
• No record of consent

Where consent is qualified or waived, this is justified and approved by a review body in accordance with the prescribed conditions.

• Justification for qualified/waived consent
• Review body approval of waiver
• Conditions for waiver satisfied

• Consent waived without justification
• No review-body approval of waiver
• Waiver conditions not met

Research has merit and is conducted with integrity: justifiable by potential benefit, based on current literature and sound design, conducted by suitably qualified people with appropriate facilities, and reported honestly.

• Justification of research merit
• Evidence of sound design and researcher competence
• Honest reporting / data integrity

• Research lacking merit or sound design
• Researchers not suitably qualified
• Selective or dishonest reporting

There is fairness in recruitment, in the burdens and benefits of research, and in access to its benefits; no unfair burden on particular groups.

• Fair participant selection criteria
• Equitable distribution of burdens and benefits
• Fair access to outcomes

• Exploitative recruitment
• Unfair burden on vulnerable groups
• Inequitable access to benefits

The likely benefit of the research justifies any risks of harm or discomfort to participants; researchers minimise risks and maximise benefits.

• Risk-benefit justification
• Measures to minimise harm
• Welfare monitoring of participants

• Risks not justified by benefit
• No harm-minimisation measures
• Participant welfare not monitored

Respect for human beings recognises their intrinsic value, autonomy, privacy and welfare, including the protection of those with diminished autonomy.

• Respect for autonomy and consent
• Privacy protections
• Protection of those with reduced capacity

• Autonomy not respected
• Privacy not protected
• No safeguards for reduced-capacity participants