Research Ethics & Reporting

A living person about whom, or from whom, a researcher obtains data, samples or identifiable information through intervention or interaction, including persons whose identifiable records or material are studied.

A duly constituted body competent under the applicable national or institutional framework to review and approve research involving humans, and to grant waivers within its authority.

Voluntary agreement to participate in research, given with adequate understanding of purpose, procedures, risks, benefits and data handling, by a person with capacity or an authorised representative, documented as required and freely revocable.

Explicit, specific and documented consent to the publication of identifiable information, images or case details, given with knowledge that publication will be public and permanent. Distinct from, and not implied by, consent to participate.

A participant whose capacity to consent freely or fully may be limited by age, capacity, dependency, confinement, displacement, acute distress or unequal power, requiring additional safeguards.

A documented decision by a competent ethics body dispensing with individual consent within a defined scope, on grounds permitted by the applicable framework.

A prospective study assigning human participants to interventions to evaluate health-related effects, as understood in recognised international definitions.

Entry of a trial in a recognised public registry before enrolment of the first participant. Registration after enrolment is late registration and is not equivalent.

A publicly accessible, free registry meeting recognised standards including a minimum dataset — a WHO ICTRP primary registry, ClinicalTrials.gov, or an equivalent. Proprietary or non-public records do not qualify.

The document specifying a study's objectives, design, participants, interventions, outcomes and analysis plan, with version and date, against which conduct and reporting are assessed.

A recognised, design-specific statement of the minimum information a research report should contain, catalogued by sources such as the EQUATOR Network, applied in its current version under D4.

Research reasonably anticipated to provide knowledge, products or technologies that could be directly misapplied to pose a significant threat to public health, safety, agriculture, the environment or security.

Containment principles, technologies and practices preventing unintentional exposure to, or release of, biological agents.

Measures preventing loss, theft, misuse, diversion or intentional release of biological agents, related materials or associated information.

An organised collection of human biological specimens and associated data maintained under documented consent, ethics and governance arrangements for current or future research.

Consent permitting a defined range of future research uses under stated governance conditions. It is not unrestricted consent and does not authorise uses outside the scope communicated to participants.

Data, specimens, knowledge or remains subject to legitimate collective, cultural, Indigenous or custodial governance in addition to any individual consent requirements.

Information about inherited or acquired genetic material that may identify individuals, relatives or populations and may therefore require heightened privacy, access and community safeguards.

The documented origin, collection context, ownership or custodianship, transfers and permitted use of biological material, data or culturally governed resources.