IRBs Need Clear Guidance on Restricting Trials’ Use of Data, SACHRP Says
Regulators should issue guidance clarifying that IRBs have the power to restrict trials’ and investigators’ use of certain data and set criteria for such data restrictions, says the Secretary’s Advisory Committee on Human Research Protections (SACHRP).
In a unanimous vote at its triannual meeting last week, SACHRP approved four recommendations, starting with a call for the FDA and HHS’s Office for Human Research Protections (OHRP) to issue guidance explaining that the authority IRBs have to suspend or terminate a study extends to the use of data collected in violation of the Common Rule and equivalent FDA regulations.
The committee’s second recommendation focused on developing clear criteria for judging violations. Some examples of violations include data collected without proper consent, using or publishing data that would likely cause direct harm to trial participants, or when the integrity of data has been compromised by researchers failing to adhere to regulatory and ethical standards.
IRBs want to know where their authority applies and how far they can go with enforcement.
“The purpose [of the recommendation] is to send a message to investigators and other researchers going forward that if they don’t follow the requirements for ethics review, for protocols and with all the regulations, that there are consequences,” said David Forster, WCG chief compliance officer and co-chair of SACHRP’s subcommittee on harmonization.
In its third recommendation, SACHRP said institutions and IRBs should consider, in advance, whether they plan to wield authority to restrict the use of data. If they do, their policies should be written and made publicly available. The fourth recommendation calls for a system of weighing the nature and magnitude of violations to determine how severe enforcement actions should be.