The US drug regulator made the comments in new draft guidance issued earlier this week, explaining that it wants to remind institutional review boards (IRBs) they play a critical role in the clinical research process.
It said that while some of the recommendations – such as the types of documentation that should be reviewed during inspections - have already been communicated to IRBs that have approached the agency, the new document is the first time that all of its guidelines have been collated.
Investigators
With regards to clinical investigators the Food and Drug Administration (FDA) said that although current regulations make trial sponsors responsible for reviewing training and expertise IRBs also have a role, pointing to regulations 21 CFR 56.107(a) and 21 CFR 56.111.
“In order to fulfill these responsibilities, the IRB needs information about the qualifications of the investigator(s) to conduct and supervise the proposed research” it said, adding that even with prior knowledge of an investigator an IRB should still be able to obtain proof the institution involved.
IRBs working with investigators for the first time will need to dig a little deeper according to the FDA, which recommends reviewing the individual’s curriculum vitae and verifying membership of professional organisations.
The agency also advises that IRBs check lists posted on its website to determine if an investigator has been the subject of any warning letters or disqualification proceedings.
Site reviews
The FDA also sets out it recommendations regarding trial site reviews, again underlining the role IRBs have to play in such activity.
“In the great majority of instances, an IRB will likely be familiar with the research site or institution at which the clinical investigator has proposed to conduct the research; in such cases, additional assessment of a site's adequacy will probably not be necessary.
“In other cases, the IRB may need additional information in order to assess the site where the proposed research will take place to ensure it can adequately execute the protocol requirements.”
Similarly, for sites new to the IRB more detailed checks on the “adequacy of the facility’s staff and equipment, including the availability of emergency or specialized care if the need should arise” should be conducted.
IND
The final area the FDA touches on is the role IRBs play in determining whether an IND, or IDE in the case of medical device trials, is required.
It says that “the IRB should ask the investigator whether he/she considered the need to obtain an IND or IDE and the basis for any determination as to whether an IND/IDE is or is not needed.”