Consensus Conference on Misconduct in Biomedical Research 28th and 29th October 1999

Consensus Statement

Patients benefit not only from good quality care but also from good scientific research. We all expect high standards of scientific and medical research practice. The integrity, probity, skill and trustworthiness of scientific and medical researchers are essential if public confidence is to be assured. In the design and execution of biomedical and healthcare research, public participation is essential. The Joint Consensus Conference on Misconduct in Biomedical Research was convened in order to debate, address and offer guidance on key questions because "every single case [of fraud and misconduct] reduces public confidence, abuses the use of public and charitable funds, and causes insult and frustration to the vast majority of careful, honest workers"¹.

The definition of research misconduct

"Behaviour by a researcher, intentional or not,
that falls short of good ethical and scientific standards."

No definition can or should attempt to be exhaustive. It should allow for change. The definition should not be read as being restricted to fabrication, falsification of data and plagiarism. It is intended to cover the whole range of research misconduct.

How do we promote good research?

• By affirming a culture through example in which honesty and integrity are expected of every individual and misconduct is not tolerated.

• Through education, training and vigilance from the outset, starting with undergraduate entry and continuing through lifelong learning.

• By ensuring formal training of all supervisors of research.

• By establishing effective and efficient mechanisms for monitoring, auditing and ethics review, appropriate to the design of the study.

• By provision of expert advice, guidance and training for ethics committees.

• By respecting consent and confidentiality.

• By having a framework for and promulgating written guidance on good research practice including publication policy and dissemination of results.

• By designing procedures to ensure that funds are only allocated within a framework for good research practice and when local systems for managing allegations of research misconduct are shown to be established and effective.

• By investigating all allegations of research misconduct firmly, fairly and expeditiously.

• By developing effective and impartial local systems for employers (the universities, NHS, industry and research institutes) to manage allegations of research misconduct, including reference to disciplinary procedures or referral for criminal investigation.

• By providing access to appropriate support for whistleblowers and researchers.

What should happen next?

• A national panel should be established - with public representation - to provide advice and assistance on request. The panel might:

  • Develop and promote models of good practice for local implementation

  • Provide assistance with the investigation of alleged research misconduct.

  • Collect, collate and publish information on incidents of research misconduct

• We expect that this paper will be given the fullest possible dissemination by the sponsoring bodies and that the three Royal Colleges of Physicians and the Faculty of Pharmaceutical Medicine will convene at the earliest opportunity a meeting with the General Medical Council and appropriate partners to establish and consider the remit of the national panel.

BACKGROUND PAPERS

These will be published in Proceedings of Royal College of Physicians of Edinburgh, Volume 30, January 2000 as a supplement.

Copies available from the Publications Department at a cost of £5.00 each.

1. Chantler and Chantler, BMJ 1998; 316:1726.