(Dealing With Research Misconduct in the United Kingdom)
(An American perspective on research integrity)
In order to create a regulatory body to oversee clinical research, you need to bring together representatives of scientific and medical societies with people from research institutions, commercial laboratories, pharmaceutical companies, lawyers and politicians. Only then will this group be able to agree a definition of good research conduct and set down procedures for ensuring that it is adhered to, writes Drummond Rennie, Deputy Editor of the Journal of the American Medical Association (JAMA) in this week's BMJ.
Rennie offers advice for the UK on setting up an appropriate regulatory body such as the American Office of Research Integrity. In the US well publicised episodes of research misconduct forced the scientific establishment to address the issue of misconduct a decade ago and this experience has important messages for the UK, says the author.
He says that the medical community in the UK should stop being shocked at the fact that research fraud goes on - "the bestowal of a scientific or medical degree is not accompanied by a guarantee of honesty." Scientists, says Rennie, should be taught about good and bad research practices and about research ethics, in order that they know what constitutes acceptable and unacceptable practices.
An essential step in rebuilding trust in the wake of a breach of research ethics, is to show that justice has been done. Rennie believes that this should be administered by a central body (not by each individual research institution) which has universally applicable rules, developed by prestigious scientific and medical bodies. The authors strongly advocates a case for including the legal profession within the process as they have "a great deal of practice with sorting our guilt from innocence".
Contact:
Drummond Rennie, Deputy Editor (West), JAMA, Institute for Health Policy Studies, San Francisco, USA rennie@itsa.ucsf.edu
(Conduct unbecoming - the MRC's approach)
Imogen Evans details the approach for handling allegations of research fraud that has been adopted by the Medical Research Council (MRC). She defines scientific misconduct as "fabrication, falsification, plagiarism or deception in proposing, carrying out, or reporting results of research and deliberate, dangerous or negligent deviations from accepted practice in carrying out research". The author also details the procedure for investigating an allegation. She concludes that "notwithstanding its seriousness, scientific misconduct is an extreme and unusual occurrence. Of greater day to day importance to the MRC is the need to ensure that standards of good practice are maintained in our establishments". To this end the MRC is currently preparing a guide to good research practice to be published later this year.
Contact:
Imogen Evans, Research Strategy Manager, Medical Research Council, London imogen.evans@headoffice.mrc.ac.uk
(An editor's response to fraudsters)
Editors are faced with a dilemma when there is clear evidence that the piece of research submitted for their editorial consideration has been conducted fraudulently - what is the editor's duty? Professor Michael Farthing, Editor of Gut and chairman of the Committee on Publication Ethics, discusses the difficulties and responsibilities faced by editors of medical publications. Farthing argues that the "preservation of research integrity is just another aspect of public health". With a drinking water inspectorate to protect domestic water supplies and a food standards agency to ensure that the food we buy and eat is safe, the author suggests that there is an urgent public need for an independent agency to formalise the maintenance of research and the detection and prosecution of fraudsters. He concludes that the next step should be for the Government to commission a report along the lines of the James report on food standards and then use similar mechanisms to establish an independent Research Standards Agency.
Contact:
Professor Michael Farthing, Digestive Diseases Research Centre, St Bartholomew's and the Royal London School of Medicine and Dentistry, London
(Deception: difficulties and initiatives)
"Every single case (of research fraud) reduces public confidence, abuses the use of public and charitable funds and causes insult and frustration to the vast majority of careful, honest workers", notes Sir Cyril Chantler, principal of the United Medical and Dental School of Guy's and St Thomas's Hospital and Shireen Chantler, of the Foundation for the Study of Infant Deaths. They call for the development of systems that inspire public confidence, protect the integrity of medical research and of individual researchers, but are not overly bureaucratic and intrusive.
The authors recognise that much medical research is carried out by people who are not members of the medical profession and therefore not accountable to a regulatory body. They argue that clear guidelines on good practice should be available to all who undertake it. All should receive formal education on ethics and good practice in research and the fact that they have done it should be recorded and audited.
Chantler and Chantler raise concerns about the concept of an investigating body as they fear it could become a large bureaucracy of uncertain efficacy and that instead employers should be responsible for dealing with complaints. Each employer, whether pharmaceutical company, university or hospital should be required to set up a scientific misconduct committee, say the authors. These committees could then in turn be audited by a small national body.
Contact:
Sir Cyril Chantler, Principal, United Medical and Dental Schools of Guy's and St Thomas's Hospitals, Guy's Hospital, London C.Chantler@kcl.ac.uk
(Honest advice from Denmark)
Scientific misconduct most often takes place in the grey zone between legislation and unwritten guidelines for good scientific standards, says Povl Riis of the Ministry of Science in Denmark. He advises that the UK should create an independent national system covering all health sciences - medicine, dentistry, pharmacy - and the drug industry and agencies. The committee should have a judicial chairman, for instance a High Court Judge, he says and the prestige associated with having a judge as chairman reduces the likelihood of subsequent court trials. The rules and guidelines of the system must be able to secure fairness for whistleblowers and accused scientists alike.
Riis suggests that the national committee should divide its procedural operations into two phases - the inquiry and the investigation. Punishment is best left to the institutions employing those found guilty of misconduct, but they should also be obliged to report back to the national committee. The budget for such a committee could be covered by a joint funding by interested parties, for a pilot period of three years, concludes Riis.
Contact:
Professor Povl Riis, Ministry of Science, 7 Nerievej, DK-2900 Hellerup, Denmark