IRB failings compromise trial safety and validity; OHRP

The findings were published by the Office for Human Research Protections (OHRP) in a review of institutional review board (IRB) activities.

In the review, which is based on compliance oversight determination letters from the past few years, the OHRP details numerous IRB failings that could have an impact on the safety and validity of clinical trials.

One of the significant findings is that IRB members voted on protocols on which they were also investigators, which contravenes US Department of Health and Human Services (HHS) regulations.

In addition to these conflicts of interest the composition of some IRBs is flawed, with the members collectively lacking the background and experience required by the HHS.

Race, gender, cultural backgrounds and sensitivity to issues such as community attitudes, in relation to the locality of the research, must all be considered when forming an IRB.

As well as failing to comply with this some IRBs have lacked a member who is not associated with the institution the board is reviewing.

Further composition errors were made by not including a non-scientist in expedited review procedures and failing to have a prisoner or suitable representative present when reviewing trials on inmates.

These oversights may be attributed to the IRB chairperson and members lack of understanding of the HHS regulations. Deviation from these regulations is raised in the review, with particular reference to not comprehending the regulations that are in place to safeguard the rights and welfare of human subjects.

However, the OHRP also puts the difficulties facing IRBs in context, saying that the boards are under resourced. In particular they lack sufficient meeting space and staff to perform their review and recordkeeping duties.

The complete OHRP review can be found here​.