To what extent do research ethical concerns fall under the purview of an IRB?
I was recently asked this question at a round-table. It is largely a broad question which requires a broad answer.
In many ways ethical concerns fall heavily under the purview of the IRB, and in some ways they do not. We have several “ethical principles” that are currently applied in our review processes (e.g., Nuremberg Code, Declaration of Helsinki, Belmont Report, 21st Century Cures Act, 2017 changes to the Common Rule, etc.).
These guidance and regulations governing research with human subjects have evolved in sophistication and complexity and will continue to evolve frequently, as we evolve technologically.
The core ethical values of the Nuremberg Code and the Belmont principles (respect for persons, beneficence, and justice) guide the design and review of ethical research.
“How” we apply these principles however, is primarily done on a study-by-study basis. Naturally, invasive procedures and drug studies are likely to have more scrutiny applied to them compared to a minimal risk study.
The combination of these principles with federal regulations (DHHS/OHRP/Common Rule and FDA, as well as other federal agency’s individual regulations) create a structure that accommodate our desire as a society to expand our scientific knowledge, while at the same time enabling us to, and ensuring that we protect and show compassion for the people who volunteer for our research studies.
It’s important to acknowledge that regulations on their own do not guarantee that a study will be ethical. However, these regulations do guide us (ethics committees, IRBs, as well as the investigators themselves) to rely on human judgment in the design of research, how IRBs/ECs make decisions, and how investigators interact with their human subjects. Together, we (PIs, IRBs, etc.) drive research forward.
The IRB member may be strongly opposed to the research on personal grounds, which may be valid and important for the Board to consider. It should not, however, come between the review and approval of the research. This is one reason why we have a diverse Board. If every single member on that board shared the same concern, then the issue is clearly one to be examined carefully and may result in delays in approval.
While it would be inappropriate to disapprove a study on the grounds of one person thinking it was unethical in some way, it is expected and appropriate for reviewers/board members to voice any ethical concerns they may have (or any concerns for that matter.)
To clarify the application of ethics in research review, IRB’s aren’t here to “pass judgment” but rather to apply the ethical principles and ensure the research falls under compliance with applicable laws and regulations while protecting the rights and welfare of human subjects.