Ethics & Human Research
Institutional Review Board Obligations Regarding Study Funding Sufficiency
ABSTRACT Given their obligations to ensure ethical research, we argue that institutional review boards (IRBs) bear a responsibility to minimize the possibility that proposed clinical studies will terminate early for insufficient funding. Underfunded studies raise several ethical concerns, including potentially failing to satisfy the social value requirement for research, the possibility of leaving study participants worse off, and exposing participants to the “completion misconception,” thereby impairing adequate informed consent. Although the practice is not currently typical, IRBs should confirm funding sufficiency before approving a study, ideally working with institutional offices or other experts skilled in budget review. In most cases, IRBs should withhold approval from studies lacking full funding at the point of review. In exceptional cases, however, an IRB may approve an important but underfunded study if the researcher discloses funding insufficiency and termination risk to prospective participants, does not leave participants worse off, has a clear funding plan, and follows checkpoints for securing funding within a reasonable timeframe. Even with IRB attention to study budgets at the point of approval, subsequent events outside an IRB’s control may cause a study to lose its originally promised funding. To minimize these cases and their impact, IRBs can encourage institutions to buttress their funding agreements, seek sponsor certifications, require notification of material funding changes, and support investigators through contingency planning and communication with participants.
