Statement on ethical review for multi-centre trials
The Radiation Health Committee notes that there have been some issues in consistently applying the requirements of the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (RPS 8). The Committee is considering revising the Code but, in the interim, has issued this statement in relation to multi-centre trials.
The key issue is how the code should apply under the National Mutual Acceptance (NMA) arrangements for multi-centre trials where review is undertaken by a single central Human Research Ethics Committee (HREC). In these situations, there may be:
- differing assessments by the participating centres as to the level of radiation exposure involved
- differing assessments of which exposures constitute “standard care” and which are additional exposures.
Both factors contribute to the level of risk for the trial participants that must be assessed against the expected benefits of the research.
The Committee’s view is that the Coordinating Principal Investigator (CPI) should submit one radiation safety risk assessment for lead HREC consideration in reviewing the balance of risk and benefit. Ideally, this assessment will include the highest assessed dose available at the time. The assessment must include a justification for these exposures that will be additional to normal clinical management for the trial participants.
The Ethics Approval Certificate should list the radiation risk category (in accordance with the Code) considered by the lead HREC in giving its approval.
Each participating site’s Governance Officer should then review their local site’s radiation safety risk assessment and the approval certificate. If the radiation risk category assessed by the site is the same as or lower than the risk category listed on the approval certificate, the project can be accepted (i.e. Governance Authorised) without the need for further HREC review. In cases where the radiation risk category assessed by the site is deemed higher than that specified on the approval certificate, then the site’s Principal Investigator should seek additional approval (or amendment of the approval) via the CPI from the lead HREC.