The importance of a proportionate, risk-based approach to ethics approval: the HRA view

Last updated on 28 Jan 2019

The Health Research Authority exists to protect and promote the interests of patients and the public in health and social care research.

In a paper published last week in the journal BMC Medical Ethics, researchers at the University of Cambridge expressed their concerns that the ethics review and study set up of a project first submitted in 2013 took more than two years to be approved and involved a high number of individuals. 

We acknowledge and recognise the frustrations experienced by the researchers in the paper, which may be familiar to anyone who submitted a study before HRA Approval was implemented in 2016, but would like to ensure that readers consider this in the context of systems that were in place in 2013 and those that are in place now, more than five years later.

The HRA is committed to working with partners and the research community to ensure that our remit, to protect and promote the interests of patients and the public, is consistent with our strategic objective, to make it easier to conduct high-quality, responsible research in the UK.

Since 2016 there have been a significant number of improvements made to address most of the issues that the researchers describe in their publication, and further improvements are still underway following recent investment.  We cannot claim to have eradicated or tackled all of these problems which extend beyond the HRA Approval process, but we do believe that we have made significant improvements.

One of the important issues raised in this publication is the need for a proportionate, risk-based approach and we are committed to this way of working. Not only do we adopt a proportionate approach to our own reviews and assessments, but for relevant types of research that have limited impact on the NHS we can now provide proportionate and simplified mechanisms for site set-up.

We have recently received investment towards replacing the Integrated Research Application System (IRAS) to address many of the issues identified in the paper. In due course, this will provide a modern, simpler system, and provide additional functionality to support interaction between the various parties involved in study and site set-up as suggested by the authors.

There is a wealth of guidance available in IRAS, supported by broader information on our website, to help researchers design, develop and deliver their research efficiently and effectively. We have a new Learning Management System that makes it easier to find and access relevant learning resources for those unfamiliar with aspects of the research system.

We are always open to feedback from research applicants on new ideas to make things easier for researchers, and welcome researcher involvement in piloting new initiatives to ensure that they see the benefits intended.

When health research is safe, legal and ethical, evidence can be generated to create better care for patients. This can only be achieved when individuals and organisations at all stages of the research journey work together. This ensures that good quality applications become good quality studies, which generate good quality results that are accessible to all.

Teresa Allen, Chief Executive

Dr Janet Messer, Director of Approvals Service

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