There have been significant discussions around implementation of the new regulations, following passage of the final rule in August last year. Institutions have been evaluating their disclosure and review processes, identifying where changes need to be made in order to remain compliant as requirements take effect.
There are additional considerations that should be part of the conversation as well.
- Many public institutions are required to disclose and manage external interests under state regulations, the scope of which may partially overlap the PHS requirements. For those institutions, however, the disclosure requirements may effect a broader population, include elements not required for PHS compliance, and may have different commitments regarding public access to the information.
- A report was issued by the Presidential Commission for the Study of Bioethical Issues in December last year. Although funding for research related to human subjects comes predominantly from PHS sources, significant funding is also provided by federal agencies not subject the Common Rule. Among the recommendations of the commission was to harmonize the Common Rule and existing regulations of the FDA – and then require that all federal agencies adopt consistent regulations for research impacting human subjects.
This raises the question of how institutions should structure their disclosure and review processes.
Some institutions have responded by revising their disclosure process to be comprehensive, collecting information on all external interests, regardless of PHS funding. They then use rules configured in the routing system to triage which employees have no financial interests, from those that have financial interests but do not require review, from those that have significant financial interest or financial conflict of interest that does require review for compliance with PHS guidelines. The triage process triggers subsequent review action as needed, without having to review every submission. All data elements required for state reporting, federal reporting, or public access requirements are meanwhile available and extracted as needed. This may, however, result in requesting additional information that is not necessarily needed for either federal or state compliance.
Other institutions have responded by creating different disclosure and review processes, depending on whether the investigator has research funding that is subject to PHS requirements, or the researcher is required to disclose under state requirements. This is achieved by including more complex logic in the design of the disclosure, as well as the routing system. This reduces the amount of information collected, and enables the institution to frame disclosure obligations in the context of specific federal and state requirements. This may, however, create an additional administrative burden of supporting and maintaining different processes.
The burden or benefit of either process is heavily dependent on the culture of the institution, which in many cases may also be reflective of the type of research performed at the institution.
A philosophical question goes to the nature of external interest disclosure and management in general. If the purpose is to mitigate the potential or appearance of bias, whether or not actual bias occurs, is the public interest better served by:
- All efforts that receive public funding, to promote confidence in how public resources are used?
- All research, regardless of source, to promote public confidence in research results in general?
- Focusing in greater detail on specific efforts that have the most direct impact on public welfare?
That question cannot be answered without also asking what level of confidence is appropriate, and what resources are available to ensure that confidence is maintained.
The same is currently true for institutions as they balance current requirements beyond the PHS regulations.
