NIH Proposed Use of a Central IRB
(C-IRB) for NIH-funded multi-site
studies
Committee on Clinical Research
January 26, 2015
1
Clinical Research Program submission of MGH
faculty comments on NIH’s draft policy requiring
• NIH-funded multi-site clinical studies carried out in
US mandated to use Central IRB (C-IRB)
• exceptions for site to use local IRB require
justification
MGH comments summarize the collective opinions of
MGH clinical investigators.
2
Define Responsibilities of C-IRB and the
Institution.
IRB primary role per federal regulations: Protecting human
subjects involved in research.
Additional responsibilities delegated to IRBs over years
– educate investigators about federal regulations (FDA, HIPAA, COI, etc.),
– document investigator’s chief approval to conduct a study,
– document approval by key ancillary department(s)
– investigate allegations of misconduct.
Suggested faculty recommendation to NIH
– Final Rule present models of allocation of responsibilities to the C-IRB
and those to be retained by the institution
– define the entities to be held accountable for IRB and investigator
infractions / misconduct
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The Central IRB Business Model:
Currently, IRB does not charge for initial or continuing review for
NIH-funded studies.
Final NIH rule should clearly state
– how the C-IRB will be paid for initial protocol review, continuing
review, amendment review, AE/SAE reports, etc.
– what, if any, administrative documentation the local IRB will be
required to maintain.
– the indirect costs included award are intended to cover IRB
administrative costs.
4
Information technology considerations:
Currently, there are no specific data security protections for IRBreviewed research.
– regulations require IRB’s to determine for each study “when
appropriate [that] there are adequate provisions to protect the
privacy and to maintain the confidentiality of data.”
Recommendation: NIH should
- address a minimum standard for data protection.
– offer a secure site located on an institution’s intranet where the
local IRB, site investigators, and CTSA, if applicable, can access
IRB-approved documents , correspondence, meeting minutes
5
Tracking and publishing metrics:
Currently, no metrics on time to IRB approval of a protocol from
submission time.
Recommendation: NIH should track and make publically
available on a published schedule metrics on all C-IRBs which
reports
– time to initial approval of the protocol and study documents by
the central IRB;
– time to approval for submission of protocol amendments and
other actions for which the central IRB will be responsible; and
– time to approval from the time local site PIs submit
information/documents required by the central IRB, and
– the methodology for data collection from C-IRBs
6
Opportunity to Acquire Important New
Data
Currently there is no information on AEs/SAEs reported
on studies approved by C-IRBs and Academic IRBs.
Final Rule provides an opportunity to assess differences
in risk assessment which may exist between C-IRBs
and Academic IRBs.
Recommendation:
- while maintaining anonymity, develop a case mix
adjusted methodology for tracking injury to subjects
- set standards for safety/injury reporting
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Harmonizing the rule across federal agencies:
Currently FDA regulations for device studies link the local IRB to
the parent institution.
Recommendation:
– FDA regulations should be revised prior to mandating the use of
a single IRB for multicenter studies. This would address
multicenter studies sponsored by other federal agencies (DOD,
AHRQ, etc.)
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