The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) have today jointly published guidance on insurance and compensation for Phase I clinical trials.
The guidance is published on the BIA website
and is also available here
The guidance, which has been developed in consultation with NRES and the Department of Health, is for trials including first-in-man studies involving healthy volunteers. The guidance also applies to studies conducted in patient volunteers without the target disease to provide additional pharmacokinetic data about the medicine under research.
The guidance is intended for use by Phase I clinical trial sponsors, clinical research organisations and Research Ethics Committees (RECs). It has been developed to provide authoritative recommendations on the level of insurance and other aspects of insurance cover. The guidance is based on industry best practice and complements wider industry guidance on conducting Phase I clinical studies.
Statement of insurance cover – guidance for REC applicants
Published alongside the industry guidance is a template Statement of Insurance Cover, developed by NRES to give Phase 1 trial sponsors a consistent document to provide to the REC with applications for ethical review. A version of the statement for use by applicants available here
The statement will provide the REC with clear assurances that adequate cover will be in place for the trial and will enable the sponsor to compensate a volunteer in the event of injury resulting from participation in the trial, irrespective of the volunteer’s ability to prove fault on the part of the sponsor or anyone else connected with the study.
As well as assuring trial volunteers and RECs of the protections in place, these assurances will accelerate the REC review process, enabling clinical trials to start more quickly, and thereby enhancing the clinical development environment in the UK.
The statement will in due course be incorporated into the standard application for Phase I clinical trials within the Integrated Research Application System (IRAS)
for health and social care research in the UK.
In the interim, until IRAS is updated, Phase 1 trial applicants are required to include the statement as a supporting document. This applies to all new applications submitted from 1 August 2012. Question A76 of the current application form in IRAS may be left blank.
Where an application names more than one sponsor, each co-sponsor is expected to make equivalent arrangements and should provide a separate version of the statement.
Guidance for RECs
NRES has issued supporting guidance for REC offices and members on procedures for checking that the insurance cover in Phase 1 trials complies with the industry guidance. The guidance is available here
Health Research Authority
National Research Ethics Service 27 June 2012