For studies jointly sponsored with CUH or CPFT please contact the relevant R&D office. In addition, please contact the Clinical School Research Governance Officer.
For CTIMPS please see CCTU guidance
Guidance on incident reporting for non-CTIMPS solely sponsored by the University
This guidance covers
- Harm to Participants
- Protocol breaches
- Protocol violations
Harm to participants
As soon as a researcher is aware of any of the above occurring in a research study which has resulted or may result in harm to participants, it should be reported to the following people
- Research Governance Office: firstname.lastname@example.org and email@example.com
- The Insurance office: firstname.lastname@example.org and email@example.com
- The Research office: firstname.lastname@example.org
The Research Governance Officer will in turn inform the Legal Services Office, the Head of the Research Office and the Registrary, as the University’s Senior Compliance Officer.
The researcher should provide as much information as is available at this stage. DO NOT WAIT until an investigation has been carried out to report the incident.
While it is important to monitor the participant’s condition and show proper concern for a participant who has suffered harm, this should be done in consultation with the insurance office.
IN ADDITION the relevant ethics committee should be informed .
Study received NRES ethics approval
If the study was approved by an NRES ethics committee then see guidance at http://www.hra.nhs.uk/research-community/during-your-research-project/safety-reporting and if an incident relating to safety has taken place please follow the guidance on the following website:
The Safety Reporting form can be found here
Study received University Ethics Committee approval
If the study was approved by an internal University Research Ethics Committee please contact the Secretary to the Committee and they will advise you what documentation they expect to see copies of all paperwork submitted to the Ethics Committee in relation to the incident should be copied to the Research Governance Officer, the Insurance Office and the Research Office as set out above.
The Clinical School/University would expect an investigation to be carried out by the Head of the relevant department and a report submitted to the Insurance Office and Research Governance Officer within 15 days at the very latest. This should set out what has occurred and if necessary what steps are being taken to ensure that there is no recurrence of the incident. A further investigation may also be advisable involving someone independent of the original study.
The Insurance Office and the Research Governance Officer will liaise with the insurers and Legal Services who, in turn, will provide advice about any required press releases, letters to injured parties and how the matter should be taken forward.
If there has been harm to participants, the study should be HALTED until:-
- the Insurance Office AND
- the Research Governance Officer, following guidance from the Senior Compliance Officer and Legal Services have approved the resumption of the study.
Protocol Violations and Breaches
NRES approved studies
A protocol violation is a change to the protocol, made without permission as a result of error or fraud/misconduct. If this happens you should inform the research governance officer as soon as possible.
NRES does not have to be notified of minor protocol violations unless they constitute a “serious breach”.
A “serious breach” is defined as a breach of protocol of the conditions or principles of Good Clinical Practice (or equivalent standards for conduct of non-CTIMPS) which is likely to affect to a significant degree the safety or physical or mental integrity of the trial subjects, or the scientific value of the research.
The following people should be informed immediately:
- Research Governance Officer: email@example.com
- The Insurance office: firstname.lastname@example.org and email@example.com
- The Research office: firstname.lastname@example.org
“Serious” breaches need to be notified by the Sponsor (Research Governance Officer on behalf of the University) to NRES within 7 days of the matter coming to their attention
The Chief Investigator for the study should therefore supply the Governance Officer with details, as soon as possible, of
- When the breach occurred,
- The location
- Who was involved
- The outcome and any information given to participants
- What action will be taken to ensure that this does not happen again
Internal University Ethics Committee approved studies
When a serious protocol breach occurs on a study reviewed by an internal ethics committee the following people should be informed immediately
- Secretary to the relevant ethics committee email@example.com for CPREC and HBREC
- Research Governance Officer firstname.lastname@example.org
- The Insurance office email@example.com and firstname.lastname@example.org
- The Research office email@example.com
The same information as required by NRES should be provided to all parties