Ethics, Compliance, and Environmental Health and Safety
What this domain tests
Ethics, Compliance, and Environmental Health and Safety tests the non-technical controls that make bioindustry accountable: research ethics, animal welfare, dual-use oversight, compliance, occupational safety, and environmental protection.
Core rules
- Human research requires informed consent, ethics committee review, privacy protection, and honest reporting. Consent is ongoing, not a single signature.
- Animal welfare applies the 3Rs: replacement, reduction, refinement. Ethics review and humane endpoints are required.
- Dual-use research of concern (DURC) includes work that could generate knowledge, methods, or materials with high potential for misuse. Review, risk mitigation, and responsible communication are expected before publication.
- Compliance includes conflicts of interest, anti-bribery, whistleblowing channels, data integrity, and Nagoya Protocol benefit-sharing.
- EHS: chemical safety uses SDS and GHS labels; biological waste must be inactivated and segregated; sharps require rigid containers; spills need spill kits and reporting; radiation, fire, and ergonomic risks need controls.
- Environmental management follows the waste hierarchy, permits for wastewater and emissions, and ISO 14001; occupational health and safety follows ISO 45001.
Worked example
A researcher plans to publish the sequence of a toxin gene along with methods that increase its transmissibility. The institution’s DURC review should occur before submission. The committee may recommend redacting specific methods, delaying publication, or adding biosecurity justification. The reasoning is that publication is a risk decision, not only an academic one.
Traps that cost marks
- Starting research before ethics approval.
- Treating consent as a one-time event.
- Reducing the 3Rs to replacement only.
- Ignoring near-miss incidents.
- Releasing biological waste without validated inactivation.