Flying Blind: How Thorough are IRBs when Assessing Scientific Value?

Background: Institutional Review Boards (IRBs) in the United States play a crucial role in ensuring the ethical conduct of clinical trials, including assessing the scientific merit of studies to justify the risks to participants. However, prior research suggests that many IRBs do not systematically evaluate scientific merit, raising concerns about the approval of low-quality trials.

Objective: To investigate whether IRBs provide adequate guidance on assessing scientific merit in their Standard Operating Procedures (SOPs) and other relevant materials.

Using the concept of "deserved trust" to strengthen the value and integrity of biomedical research.

It is commonplace for science leaders and others to claim that the future of biomedical research rests in large part upon the public's trust. If true, it behooves the biomedical research community to understand how it avoids taking chances with that trust. This commentary, which builds upon comments of noted trust scholar Russell Hardin about how best to enjoy trust, assumes that the key to being trusted is deserving to be trusted.

Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them.

Research Ethics Committees (RECs) play a critical gatekeeping role in clinical trials. This role is meant to ensure that only those trials that meet certain ethical thresholds proceed through their gate. Two of these thresholds are that the potential benefits of trials are reasonable in relation to risks and that trials are capable of producing a requisite amount of social value.