The HRA web pages also provide guidance on the communication of research outcomes to participants. INVOLVE, the national advisory group supporting public involvement in NHS, has produced Public Involvement in Research: Impact on Ethical Aspects of Research (PDF, 528 KB). Patient and public involvement may help to guide this process. It is important to establish whether a participant will want to be actively informed of trial results, or whether they would like the onus to be left with them to obtain the results. Informing participants of results acknowledges their contribution, shows respect and sees them not simply as a means to the researchers’ ends. The International Committee of Medical Journal Editors (ICMJE) members simultaneously published an editorial on Sharing Clinical Trials Data that outlines proposed new requirements for authors to comply with mandatory data-sharing practices. This guidance summarises the good clinical practice principles to follow when sharing individual participant data using a controlled access system. Guidance on the Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials, has been produced for publicly funded clinical trials. ![]() The sharing of the data produced in a clinical trial has the potential to provide benefits to patients and the scientific community. The NIHR Journals Library will help disseminate the findings of the research commissioned by these programmes and will provide an important permanent and comprehensive record of the work which has been funded. Authors will be required to report the nature of patient/public involvement in their study and to produce a clear ‘plain English’ summary within their report so that the findings are widely accessible. For non-commercial trials, it is strongly recommended that the CONSORT guidelines are followed when preparing final study reports.įinal reports of studies funded by a number of NIHR programmes will be published as part of the NIHR Journals Library and its guidance for authors must be followed. ![]()
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