Re: Clinical trial data for all drugs in current use
Dear Dr Godlee
I read your editorial with great interest.
The Health Research Authority is a Special Health Authority established on 1 December 2011. We promote and protect the interests of patients and the public in order to support both their confidence and participation in health research, and improvements in the nation’s health. We do this by ensuring that research involving members of the public is ethically reviewed and approved, that they are provided with the information they need to help them decide whether they wish to take part, and that their opportunity to do so is maximised by simplifying the processes by which high quality research is assessed.
We recognise that failure to publish the results of research not only presents a significant risk to patient safety, but also constitutes research misconduct.
The National Research Ethics Service is part of the HRA, and research ethics committee review already includes consideration of applicants’ plans to register their research (on clinicaltrials.gov for example) and publish research. The Integrated Research Application System (IRAS) – the single online system for applying for permissions and approvals for health research, including clinical trials – asks whether the research will be registered on a public database, and how researchers intend to report and disseminate the results.
The final report on the research should be submitted to the main REC within one year of its conclusion. This applies to all research, including Clinical Trials of Investigational Medicinal Products.
NRES conducted work in 2008 showing that many studies submitted to RECs were not, at the time, registered. It took the initiative to publish summaries of ethically approved studies submitted by researchers online. We recognise that the quality of these summaries is currently variable, but believe that NRES-approved research must be published online to promote transparency, encourage registration and support its publication. We believe that publication will also have the beneficial effect of encouraging participation in health research.
The decision by an ethics committee to give a favourable opinion will include consideration of plans for registration, publication and further use of data and tissue. Historically NRES has not been able to follow up on these intentions. The HRA now intends to monitor compliance, and identify researchers, funders and institutions who are not registering or publishing ethically approved research.
We will do this by routinely reviewing the final report to identify any failure to comply with researchers' declared intentions to publish, register or make study information or tissue available one year after the final report. We are currently exploring how best to implement these improvements and safeguards, and expect to establish a new system early in 2013.
Whilst publication can be assessed administratively, any consideration of failure to publish will need review by officers of ethics committees, who will determine whether the reasons not to publish are acceptable, or if not, whether the issue needs referring to the HRA Board, potentially with advice from the HRA National Research Ethics Advisors’ Panel. The HRA does not have powers to investigate research misconduct but it can request that the Sponsors of research investigate concerns identified by HRA or brought to its attention. We will at the very least make ethics committees aware when an applicant has not fulfilled the promise on previous applications, and it will be for the ethics committees to consider how this may influence their opinion when considering new applications from the same sponsor.
The HRA is committed to making it easier to do good quality ethical research in the UK, and sees great potential in gathering evidence of good conduct – including publication – that would enable a lighter touch when considering the suitability of researchers and sponsors who can show they have fully delivered on previously declared intentions.
Rapid Response:
Re: Clinical trial data for all drugs in current use
Dear Dr Godlee
I read your editorial with great interest.
The Health Research Authority is a Special Health Authority established on 1 December 2011. We promote and protect the interests of patients and the public in order to support both their confidence and participation in health research, and improvements in the nation’s health. We do this by ensuring that research involving members of the public is ethically reviewed and approved, that they are provided with the information they need to help them decide whether they wish to take part, and that their opportunity to do so is maximised by simplifying the processes by which high quality research is assessed.
We recognise that failure to publish the results of research not only presents a significant risk to patient safety, but also constitutes research misconduct.
The National Research Ethics Service is part of the HRA, and research ethics committee review already includes consideration of applicants’ plans to register their research (on clinicaltrials.gov for example) and publish research. The Integrated Research Application System (IRAS) – the single online system for applying for permissions and approvals for health research, including clinical trials – asks whether the research will be registered on a public database, and how researchers intend to report and disseminate the results.
The final report on the research should be submitted to the main REC within one year of its conclusion. This applies to all research, including Clinical Trials of Investigational Medicinal Products.
NRES conducted work in 2008 showing that many studies submitted to RECs were not, at the time, registered. It took the initiative to publish summaries of ethically approved studies submitted by researchers online. We recognise that the quality of these summaries is currently variable, but believe that NRES-approved research must be published online to promote transparency, encourage registration and support its publication. We believe that publication will also have the beneficial effect of encouraging participation in health research.
The decision by an ethics committee to give a favourable opinion will include consideration of plans for registration, publication and further use of data and tissue. Historically NRES has not been able to follow up on these intentions. The HRA now intends to monitor compliance, and identify researchers, funders and institutions who are not registering or publishing ethically approved research.
We will do this by routinely reviewing the final report to identify any failure to comply with researchers' declared intentions to publish, register or make study information or tissue available one year after the final report. We are currently exploring how best to implement these improvements and safeguards, and expect to establish a new system early in 2013.
Whilst publication can be assessed administratively, any consideration of failure to publish will need review by officers of ethics committees, who will determine whether the reasons not to publish are acceptable, or if not, whether the issue needs referring to the HRA Board, potentially with advice from the HRA National Research Ethics Advisors’ Panel. The HRA does not have powers to investigate research misconduct but it can request that the Sponsors of research investigate concerns identified by HRA or brought to its attention. We will at the very least make ethics committees aware when an applicant has not fulfilled the promise on previous applications, and it will be for the ethics committees to consider how this may influence their opinion when considering new applications from the same sponsor.
The HRA is committed to making it easier to do good quality ethical research in the UK, and sees great potential in gathering evidence of good conduct – including publication – that would enable a lighter touch when considering the suitability of researchers and sponsors who can show they have fully delivered on previously declared intentions.
Competing interests: No competing interests