Ïã¸ÛÁùºÏ²Ê

Dr Wakefield was struck off the medical register by the GMC in 2010 following an investigation into allegations of serious professional misconduct relating to his research into a possible link between autism and MMR. The research, published in The Lancet in 1998, was conducted when Dr Wakefield worked at the Royal Free Medical School, which merged with Ïã¸ÛÁùºÏ²Ê later that year.

Today's paper sets out the subsequent development of Ïã¸ÛÁùºÏ²Ê's research governance framework and identifies lessons from the whole episode that may be of value to the wider HE sector.

Ïã¸ÛÁùºÏ²Ê's research governance framework has undergone significant revision and is now overseen by the Ïã¸ÛÁùºÏ²Ê Research Governance Committee (RGC), which did not exist at the time of the Wakefield incident. The Ïã¸ÛÁùºÏ²Ê RGC is chaired by Ïã¸ÛÁùºÏ²Ê's Vice-Provost (Research) and has a broad membership including the Vice-Provosts Health and Enterprise, the senior officers responsible for Registry and Academic Services, HR, and Research Strategy and Governance, a lay member of Ïã¸ÛÁùºÏ²Ê Council and six academic representatives.Ìý Its terms of reference include the co-ordination of the operation of research governance processes and oversight of the operation of Ïã¸ÛÁùºÏ²Ê's procedure for investigating and resolving allegations of misconduct in academic research.Ìý

Ïã¸ÛÁùºÏ²Ê is confident that the failings the case exposed in Ïã¸ÛÁùºÏ²Ê's governance structure have been fully addressed, and that the rigorous procedure now in place to address alleged research misconduct would be more effective in investigating any similar allegations that might arise in future.

There is broad recognition of the need to raise the profile of research governance issues across the sector.Ìý In January 2012, the BMJ and the Committee on Publication Ethics (COPE) jointly held a meeting on research misconduct in the UK which attracted national leaders across the health and university sectors.Ìý The meeting reflected that the impact of individual cases of misconduct can range far beyond any individual institution.Ìý It also agreed that that the UK's mechanisms for ensuring good research conduct and investigating research misconduct need to be strengthened.

Ïã¸ÛÁùºÏ²Ê has also sought detailed advice from the UK Research Integrity Office with regards to the scope, remit and processes for a potential further investigation specifically into the Dr Wakefield incident. However, given the passage of time, the fact that the majority of the main figures involved no longer work for Ïã¸ÛÁùºÏ²Ê, and the fact that Ïã¸ÛÁùºÏ²Ê lacks any legal powers of compulsion, Ïã¸ÛÁùºÏ²Ê has decided it will not now be carrying out an investigation into this specific case.

Professor Sir John Tooke, Ïã¸ÛÁùºÏ²Ê Vice Provost (Health) says: "Ïã¸ÛÁùºÏ²Ê has learned a great deal from its involvement in the MMR affair and has introduced a research governance framework that is robust and fit for purpose.

"The test now for Ïã¸ÛÁùºÏ²Ê - and for the sector more widely - is twofold.Ìý First, to ensure that research governance processes and procedures are properly embedded into the management infrastructure of the organisation. Secondly, to test and re-test those procedures to ensure that they are robust and workable and reflect best practice from other organisations.

"To that end, institutions should be encouraged to think self-critically about their own framework, to review processes and procedures annually, and to share anonymised cases with other related organisations. Only by consciously and actively raising the profile of research governance issues across - as well as within - institutions, will the UK biomedical sector develop a framework that is truly fit for purpose."

Links:

MMR and the development of a research governance framework in Ïã¸ÛÁùºÏ²Ê