OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Dr. Michael Donnenberg is the Senior Associate Dean for Research and Research Training and Professor of Internal Medicine and of Microbiology and Immunology in the VCU School of Medicine. In this article, he shares his thoughts on the topic of ethics and integrity, with an emphasis on the importance of the independent operation of the IRB.

What are your thoughts on the importance of an independent IRB?

Medical advances cannot occur without human subjects research. However, history shows that, whatever their good intentions, clinical researchers need independent review of their human subjects research plans for two main reasons: (1) human nature doesn’t allow us to objectively analyze the risks and benefits of our own work, and (2) the pubic needs to have confidence that human subjects research will not be conducted if the risks outweigh the benefits.

What role does an independent IRB play in the integrity of research?

The IRB must operate independently to insure the best interests of the research subjects are at the forefront. This imperative is incompatible with outside influence of any kind.

How could undue influence or coercion of an IRB or IRB member impact a research study and/or research outcomes?

Undue influence, let alone coercion, could sway an IRB to overlook risks to human subjects, which could jeopardize their wellbeing and the entire study. When adverse events occur, it is the duty of the researcher to report them, which can result in an investigation. If the investigation calls into question the IRB decision, the entire study might be closed.

What impact could undue influence or coercion of the IRB have on a school or institution’s research portfolio?

The above scenario can quickly snowball, calling into question other studies. The reputation of the institution can suffer, the public perception of research can degrade, and the study subjects who gave their consent to be part of clinical research will have done so in vain. These are not theoretical outcomes. These have occurred. An independent IRB is critical to insure that they don’t happen again.

Categories IRB Education and Training
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