All stages of biomedical research are influenced by their sources of funding. An extensive literature addresses the ways in which the design, conduct, outcomes and publication of research may be affected by industry support and, importantly, by researchers’ relations with industry, especially the pharmaceutical industry. This might take the form of researchers receiving financial or in-kind support to conduct a study or recruit participants, or being employed directly by a company.
Matters are complicated further by the increasing involvement of individual researchers in the commercialisation of their own work, and increasing acceptance that they may retain intellectual property, hold patents and maintain shareholdings in pharmaceutical or biotechnology companies related to their research. These circumstances raise particular questions about the independence of research and the reliability of data that are made available to the public.
Non-pecuniary interests also have the potential to impact negatively upon the independence and reliability of research and its dissemination. Researchers may, for example, be tempted to distort the design, conduct or publication of research because they are intellectually committed to a particular hypothesis, wish to protect their academic or clinical reputations, or need more publications for academic advancement. In many cases, these may be more significant than financial considerations.
While competing interests may not themselves result in harm to others involved in research, they may raise concern because of their potential to do so. In addition, they may complicate the process of interpreting the presentation of research results and impair public confidence in medical research.
These issues apply both to clinical and basic research. The vast majority of clinical trials are funded by the pharmaceutical industry. Clinical researchers may benefit directly from their research financially through payment for work performed in enrolling and managing patients in industry-sponsored studies or indirectly through investment in, or ownership of, companies sponsoring clinical trials, as a result of which they may have beneficial interests in the outcomes of these trials. They may also benefit from their research through non-financial means.
Opportunities to profit from clinical research financially or academically may affect or appear to affect researchers’ commitments to their primary obligations to pursue new knowledge or understanding through research, and to protect patients’ and research participants’ interests. Competing or conflicting interests may influence study design (including selection of study drug doses and comparison with placebo or active comparator), patient selection, data collection and analysis, adverse event reporting, or the presentation and publication of research findings. Financial conflicts may also arise when an investigator becomes involved in a commercial venture that may impinge on other aspects of his or her research.
The arguments about whether investigators with direct financial interests in the outcomes of research should be permitted to participate in such research are complex, as indeed are the organisation and structure of individual research projects. It is important that this complexity is appreciated and that a flexible approach is maintained. In individual instances, it is often possible to identify specific moments in the research process at which dualities may become conflicts and to devise specific
strategies to protect the integrity of the research process.
These Guidelines do not purport to provide a comprehensive guide for the conduct of research or of the business of Human Research Ethics Committees, for this, refer to the relevant extant publications. However, it is recognised that in such publications, the relationships between individual researchers and other practitioners involved in the conduct of research and industry are often either not well covered or do not contain sufficient detail to provide guidance to researchers working in particular settings. Accordingly, the following notes and recommendations are intended to enhance existing practices and provide a practical guide to practitioners.