Earlier this year the US Government Accountability Office (GAO) gave details of a sting operation into institutional review boards (IRB) that led to Coast IRB going out of business. The GAO said the IRB system is “vulnerable to unethical manipulation” and there were calls for reform.
Speaking to Outsourcing-Pharma James Saunders, vice president (VP) of New England IRB (NEIRB), explained that this focus on the alleged flaws in IRB oversight has made pharma and contract research organisations more wary when selecting an IRB.
Saunders added that increased focus on IRB standards meant NEIRB was keen to communicate news of the successful audit by the US Food and Drug Administration (FDA) and demonstrate its “good standing” with the agency.
NEIRB was audited in November 2008, prior to news of the sting operation, and Saunders is unsure how the process will change now that the GAO has alleged there are weaknesses in the system.
In July the FDA begin to require IRBs to register, giving the organisations until mid-September to sign up. Although this occurred after the GAO sting Saunders said that the change was “in the works anyway”.
The Office for Human Research Protections (OHRP), which also deals with IRBs, has always required organisations to register. NEIRB is now registered with both the FDA and OHRP.
NEIRB was confident it would pass the FDA audit because it has over six years’ accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This is a voluntary accreditation that “few independent IRBs have”, according to Saunders.
The IRB maintains its standards by working to standard operating procedures (SOP). Saunders explained that because FDA regulations allow scope for interpretation IRBs implement SOPs.
These represent an IRB’s interpretation of FDA guidelines and are used by the agency to check that a board is in compliance with its internal standards.