Dividing central and local IRB responsibilities
Researchers offer suggestions
When research institutions and their IRBs work with centralized IRBs, questions arise about which board handles which responsibilities.
Researchers with the Clinical Trials Transformation Initiative (CTTI) took a close look at this, coming up with a study that suggests these common roles for central IRBs:
- research education and training of IRB personnel;
- register with FDA and OHRP;
- notify sites of accreditation changes;
- ensure ethical standards and regulations;
- collate site-specific information;
- approve informed consent forms;
- provide copies of IRB decisions, rosters and minutes; and
- notify sites of non-compliance concerns.1
Suggested responsibilities for local IRBs include the following:
- education and training of investigators and study coordinators;
- credentialing of staff;
- maintaining Federalwide Assurance (FWA);
- conducting security and privacy reviews; and
- ensuring investigator compliance and conflict of interest.1
Either IRB could evaluate local context or provide waiver of authorization under HIPAA, and both IRBs could execute IRB authorization and assess investigator qualifications.1
- Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013:Jan. 30, 2013. n
