(2004; 102 pages)
4.5 Guidelines on conflict of interest in research
The previous review described a number of studies that showed that published studies that are funded by manufacturers are likely to support the manufacturers’ drugs. Published work does not always disclose relationships between manufacturers and researchers. Two studies have looked at research institutions’ policies about conflict of interest.
Lo et al.222 looked at 10 medical schools that received the largest amounts of National Institutes of Health funding in the US. They found wide variation and significant limitations in policies about conflict of interest in clinical trials. Five universities required disclosure of all possibly conflicting financial interests, independent of value. Universities varied in whether their policies covered non-faculty research staff. The authors recommend that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research.
McCrary et al.223 surveyed medical schools and other research institutions that received over US$5 million annually from the National Institutes of Health or the National Science Foundation, 48 journals and 17 federal agencies. They found five medical schools and 10 other research institutions had no policy on conflicts of interest. There was marked variation amongst the rest. Less than half of the journals (43%) had policies requiring disclosure of conflict of interest. The management of conflicts and penalties for non-disclosure were almost always totally discretionary. Only three institutions required financial interests to be disclosed to research subjects.
Many authors have called for researchers to explain clearly sponsoring company involvement in clinical trials149. There have also been calls for a prospective register of all trials to be set up, before the results are known. This would reduce the problems of bias in published findings. Stern and Simes point out that this should not be difficult in countries where ethical approval is required for trials, because the register could be added on to this process158.
CONCLUSION: many organizations, including many medical schools, research institutions and medical journals lack adequate policies for dealing with conflicts of interest. There is a strong case for all trials to be listed on a public register at the time they are set up.