The move follows a damning report on the US Food and Drug Administration's oversight of clinical trials, published in September 2007 by Daniel Levinson, the inspector general of the Department of Health and Human Services (DHHS).

Among the deficiencies noted in the report were that the FDA did not have any clear picture of the number of trials being conducted in human subjects and low rates of clinical trial site auditing (less than 1 per cent). Of the estimated 350,000 trial sites the FDA was believed to have inspected 2,855.

Moreover, when inspections did take place, they generally targeted completed trials and often focussed on verifying the quality of the data rather than human subject protection, according to the report.

In the latest move the US Offices for Human Research Protections and Public Health and Science are looking at a number of possible measures, including the need to provide guidance on setting up training and educational programmes to make sure individuals involved in the conduct, review and oversight of human clinical research are aware of their regulatory responsibilities.

The OHRP is also asking for feedback on whether the DHHS should develop a regulation requiring the implementation of such training and education programmes. Interested parties are invited to respond by September 2009.

This in turn follows recommendations from the Secretary's Advisory Committee on Human Research Protections (SACHRP) which recently said that the OHRP should require that initial and continuing training is provided for IRB members and staff, investigators, and certain institutional officials.

"The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions ... understand and meet their regulatory responsibilities for protecting human subjects," said the OHRP in a statement.

Aside from the issue of training, FDA News reports that the OHRP is also working with the FDA on expanding IRB registration to create a joint database to help identify IRBs and their activities.

One benefit of the proposed database is that it would encourage federally funded research institutions that do not use external IRBs to do so, according to the report.

The 2007 DHHS report also took issue with the fact that FDA did not maintain a clinical trial registry, so was unable to identify all ongoing trials and trial sites, as well as the lack of an IRB registry.