Risk in research: serious breach notifications and safety reporting

As part of the work to underpin the development of a replacement for the Research Governance Framework when the HRA became a Non Departmental Public Body, a report was produced which considered a review of adverse events in research, evidenced from breach notifications.

Research Ethics Committees (RECs) are notified when any breach of the study protocol or the principles of Good Clinical Practice (GCP) in research has been identified. The HRA retains the information pertaining to breaches for the purpose of monitoring individual breaches.

This project focused on actual evidence of non-compliance to the principles of GCP and the study protocol, as reported through the standard breach reporting processes, and the adverse effects which such breaches have had. The purpose of undertaking this project and producing this report is to highlight the types of issues which do occur, look at the common themes and trends which have been identified and to share learning more widely.

The report was issued for comment from 26 May 2014 until 4 July 2014. A summary of the recommendations from the report are detailed below.

Next steps

The HRA has reviewed the comments received with a summary available here. The HRA is considering the findings from this exercise in its drafting of a replacement to the RGF. The new UK Policy Framework for Health and Social Care Research will be reviewed at the HRA Board meeting on 21 January 2015 with a comment period to follow.

Recommendations

• The importance of well planned and written protocols and internal processes.

Protocols and internal procedures should be clear, comprehensive and easily accessible by the relevant people.

• The importance of protocols and internal processes being followed.

Well planned and written protocols and procedures are only effective if they are followed. Not adhering to the protocol has the potential for adverse impact in a number of ways and to all parties involved. For study participants, this compromises any informed consent given, for the researcher there is a potential for the credibility of study data to be compromised as well as a reputational risk and for sponsors there is often a financial and resource implication, particularly where a suspension to recruitment or extensive investigation or monitoring is required.

• The importance of good communication processes and lines of responsibility.

There should be clear designation of responsibility and accountability with clear lines of communication between all those involved in research. Communication pathways should be clear in terms of what, how, who, when and why with documented roles and responsibilities.

• The importance of document management systems or good version control

There is often a requirement for documents to be revised and updated during the lifespan of studies and these requirements are often initiated by varying organisations. It is therefore important to ensure that the competent authority and ethics committee have reviewed and approved the most current version and that all those involved in undertaking research procedures are aware of the most current and approved version. Good document control for all is essential and needs improvement.

• The need to ensure learning rather than just delivering training

It is important to ensure that members of the research team are aware of the correct procedure but also that they fully understand what this requires and the importance of following it and that understanding and compliance is confirmed. It is also important to understand the wider context of error. If an individual makes an error due to insufficient time to complete a number of tasks, providing training will not in itself solve the problem or reduce the risk of the error being repeated.

• The importance of encouraging open and honest reporting

It is widely recognised in healthcare that a culture of openness and honesty promotes safety. In clinical practice, incident reporting is strongly encouraged so that lessons can be learnt and improvements made. This principle is equally as valid in research both clinical and non-clinical. Errors can only be rectified and improvements made to reduce adverse impacts and increase the quality of research outcomes if they are reported in a timely way. For this to be truly effective, a culture of openness and honesty is essential with a focus on improvement rather than consequence.