Skip to main content
NCBI home page
The BMJ logoLink to The BMJ
. 2002 Nov 16;325(7373):1174.

Undisclosed payments in research

Patients have the right to know motivations of researchers

Jacqueline M Atkinson 1
PMCID: PMC1124645  PMID: 12433773

Editor—Rao and Sant Cassia discussed the ethics of undisclosed payments to doctors recruiting patients in clinical trials.1 For many years now the greater Glasgow community and primary care local research ethics committee has insisted that reference to doctors' payment is included in the patient information sheet that goes to all potential participants. I object to the payment being hidden behind such phrases as “your doctor's research fund will be paid,” which a number of medical research ethics committees allow, and I note that the phrase “for the additional work involved” often appears.

Although the NHS and NHS Scotland are the remit of two different parliaments, cross border acceptance of approval by medical research ethics committees exists. Patients are also likely to see the NHS as a whole and the ethical principles of doctors and other healthcare professionals as not having regional variations. In the interests of equality (as well as informed consent) British guidelines need to be developed on this and other minimum requirements of information to be given to patients. This could include the amount of payment. My quick, non-random survey of my non-medical family and friends shows that the size of the payment and the potential overall income are underestimated.

Other types of personal gain exist for researchers that I also believe potential participants should know about—when the work forms part of the requirements for a degree. Some people who already have a professional qualification and who are using “their” patients in research do not always believe that it is necessary to inform patients that they are registered for a degree for which this research is necessary. Such research may not always reach publication and may be designed as a learning experience rather than a complete piece of research. If patients are to be expected to take part in research for altruistic reasons they have a right to know what reasons motivate the people carrying out the research.

References

  • 1.Rao JN, Sant Cassia LJ. Ethics of undisclosed payments to doctors recruiting patients in clinical trials. BMJ. 2002;325:36–37. doi: 10.1136/bmj.325.7354.36. . (6 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ. 2002 Nov 16;325(7373):1174.

Guidelines already exist

Frank O Wells 1

Editor—I write as a member and former chairman of the ethical issues committee of the Faculty of Pharmaceutical Medicine, a former medical director of the Association of the British Pharmaceutical Industry, and a member of two research ethics committees. Rao and Sant Cassia make several points that disregard the truth about phase IV clinical trials and do not differentiate between phase IV clinical trials and the safety assessment of marketed medicines, both of which are subject to strict guidelines.1-1 These should be familiar to members of research ethics committees but are clearly unfamiliar to the authors of this paper.

Phase IV clinical trials, soon to be covered by the national legislation that follows the adoption of the European directive on clinical trials, are scientific projects already subject to ethical review. They are conducted in accordance with protocols submitted to medical and local research ethics committees as appropriate, and payments to be made are clearly included in the application for ethical review. Neither they nor safety assessment studies are designed solely to familiarise doctors with new and recently licensed medicines. They may well be required by the licensing authority to be conducted to establish a more robust safety database for a new medicine.

Rao and Sant Cassia seem to be ignorant of what they can already do about the concerns they express. This year's BMA annual meeting endorsed the need for the suggested fee for clinical research to be widely published so that research ethics committees, among others, can have up to date independent advice on an agreed benchmark for payment to doctors taking part. Every phase IV study sponsored by a pharmaceutical company must be submitted to the appropriate research ethics committee(s), which can turn down an application if the payment is thought to be coercive. Studies into the safety assessment of marketed medicines do not need review by research ethics committees, but a BMA suggested payment exists for these, too. If a third party believes that a study is a marketing exercise masquerading as a research project or a safety assessment study, a complaint can be referred to the Prescription Medicine Code of Practice Authority and the company sanctioned if the complaint is upheld.

I agree that undisclosed payments to doctors recruiting patients in clinical trials would be unethical. However, payments must be disclosed to research ethics committees, which must therefore ensure that disclosure is complete and what is disclosed is acceptable.

References

  • 1-1.Rao JN, Sant Cassia LJ. Ethics of undisclosed payments to doctors recruiting patients in clinical trials. BMJ. 2002;325:36–37. doi: 10.1136/bmj.325.7354.36. . (6 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Publishing Group

RESOURCES