The UK’s Health Research Authority (HRA) has made some strong proposals to encourage researchers to register clinical trials and report research results. We should all support these proposals before the end of the consultation period on 28th July 2014.
The HRA has already made registration of clinical trials a condition of ethical approval to run a trial in the UK which was a great initiative and we hope it will be taken up by bodies globally. All of your responses to their consultation last year were central to them adopting this good proposal. Now they are consulting on proposals to extend this condition and on how they should monitor compliance with it.
The HRA proposes that their declaration, which all researchers have to sign when they apply for ethical approval to do a trial, should include a check on whether the researchers have complied with transparency and reporting standards in past trials. We think it is a very good idea to use the research declaration to do this. The declaration already asks researchers to commit to good research conduct which should be interpreted as a commitment to registration and reporting research. The World Medical Association first said so in 1964!
The HRA also proposes extending the registration requirement to trials that don’t come under the HRA’s existing conditions (this generally means clinical trials that started before September 2013). We support this. Registration of all trials is the minimum of AllTrials is calling for and really is what all the people who volunteer for clinical trials expect to happen.
We have told the HRA that we fully support their very strong and reasonable proposals which will make a difference to the amount of clinical research findings available. Please do write, however shortly, with your support too. HRA’s proposals are set out below. The full consultation paper is here and you can send your response to the HRA by emailing firstname.lastname@example.org by 28 July 2014.
Proposal 1 – update of 30 September 2014 Sponsor Declaration
The HRA proposes that the 30 September 2014 Sponsor Declaration be updated to require declaration that all the sponsor’s trials approved since 30 September 2013 have been registered. Where this condition has not been met, the REC will require it to be fulfilled as a condition for approving proposed new studies submitted by that Sponsor. This provides the REC with a checkpoint to review records of the Sponsor’s previous studies, and to ensure either that registration details are complete, or that registration deferral periods agreed with the HRA still apply.
We strongly support this proposal. It asks for no more than compliance with the HRA’s existing conditions.
Proposal 2 – further update of Sponsor Declaration from 01 April 2015
The HRA proposes that, from 1 April 2015, the Sponsor Declaration for a new trial be updated to require confirmation that all the Sponsor’s actively recruiting trials have been registered, including those approved before this became a condition of a favourable REC opinion (30 September 2013). The REC will require this as a condition of favourable opinions for new applications made by the Sponsor. This provides the REC with a checkpoint to review records of the Sponsor’s previous studies, and to ensure either that registration details of all those trials currently recruiting are complete, or that registration deferral periods agreed with the HRA still apply.
This is an additional requirement to that introduced on 30 September 2013, so the lead time will enable Sponsors to take any steps needed to register studies that are still recruiting. At the time the requirement comes into force, Sponsors will have had time to take steps to meet the requirement, so no further action would be required at the point new applications are submitted.
The HRA plans to implement this requirement from 01 April 2015.
We fully support this proposal to extend the HRA’s existing condition to other trials currently being run by the researcher. Researchers are already ethically obliged to have done this. Delaying the implementation of this policy until April 2015 to allow researchers to take the necessary steps is reasonable.
Proposal 3 – using IRAS to notify forthcoming requirements
The HRA proposes to update the Sponsor and Chief Investigator Declaration on the IRAS form (or other suitable place) to highlight what may become future expectations. This will enable Sponsors and Investigators to plan to meet future requirements, and to be aware of and contribute to the development of these.
Initially, this would mean using IRAS to announce the implementation of Proposals 1 and 2 (as finally agreed after consultation). It would also indicate to Sponsors and Chief Investigators that:
– the HRA is likely to extend the requirements for retrospective registration to clinical trials that have stopped active recruitment. Sponsors are advised to plan now to register older studies, or to be able to explain if this is impossible
– the HRA wishes to set standards for reporting research findings. In due course the Declaration by the Sponsor and/or Chief Investigator is likely to be used to monitor rates of reporting of research findings.
– in due course, the HRA is planning to extend requirements for study registration to study types beyond clinical trials. Where appropriate public registers exist, such studies should be registered, and registration notified to the REC. If no registration possibilities exist, such studies should be notified to RECs so that the HRA can start to gather evidence beyond clinical trials.
Use of the IRAS form will ensure that those who may need to meet new requirements for ethics approval will have been given appropriate advance notice. Use of IRAS will complement other HRA communication channels, including its website and ‘HRA latest’.
We fully support this proposal. We strongly support the suggestion to extend requirement for trials to be registered to old trials. We strongly support the suggestion to set standards for reporting clinical research results.
We commend the HRA for taking on international lead on clinical trial registration and reporting. Their work is extremely valuable and useful to the UK and internationally. Please write to the HRA this week and tell them you think so too if you agree.