sachrp panel: holding external irbs accountable
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SACHRP Panel: Holding External IRBs Accountable. David L. Wynes, Ph.D. Vice President for Research Administration Emory University July 21, 2009. Perspective. I am the Institutional Official for Emory’s FWA - PowerPoint PPT PresentationTRANSCRIPT
SACHRP PANEL: HOLDING EXTERNAL IRBS ACCOUNTABLE
David L. Wynes, Ph.D.Vice President for Research Administration
Emory University
July 21, 2009
Perspective
I am the Institutional Official for Emory’s FWA
I am the current Co-Chair (& former Chair) of the Council on Accreditation for the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
IO Signature/Assurance Responsibilities
Federal Wide Assurance
Individual Investigator Agreement
IRB Authorization Agreement
Misc. Institutional Agreements
FWA Obligations the IO is assuring: The Institution must ensure that ALL IRB(s) designated under the
FWA have written procedures meeting IRB obligations under 45 CFR 46; meeting space and sufficient staff to support the IRB’s review and
recordkeeping duties; and appropriate knowledge of the local research context for all
research to which the FWA applies.
Upon request, the Institution must provide a copy of the written procedures to OHRP and any department or agency conducting or supporting research covered by the FWA.
The Institution is responsible for ensuring that the IRB(s) designated under the FWA agree to comply with the FWA terms.
Types of Human Subject Research Studies
I believe that there are two distinct categories of studies potentially impacted by this ANPRM.
Multi-Center Clinical Trials Collaborative project in which more
than one site is “engaged” in human subject research
Institutional Official Decision Process
Nature of the research Role of investigators at each institution Nature of relationship
On-going, multiple studies Single study
Entity conducting IRB review Comfort with competence
Accredited? Ability to monitor activities as appropriate Research covered by FWA?
Position StatementAs an Institutional Official at a large research university, I strongly endorse the principles described in the DHHS March 5, 2009, Advanced Notice of Proposed Rule Making. While there are multiple factors that impact an IO’s decision to rely on an external IRB or IORG, this ANPRM addresses a key factor in those decisions.
Division of ResponsibilitiesThe division of responsibilities
proposed in the ANPRM between the Institution and the IRB/IORG are appropriate in that they reflect responsibilities that should fall within the purview of each entity.
I believe that the majority of responsibilities identified in the ANPRM as potentially falling on either party can be assigned.
Responsibilities which should rest with the IRB: Written procedures for
Initial and continuing review Review more often than annually or
independent verification required Prompt reporting to the IRB of changes
Reporting to the Investigator suspension or termination by the IRB
Fulfilling IRB recordkeeping requirements
Responsibilities that should be determined case-by-case
Reporting IRB determinations of Unanticipated problems involving risks to subjects or others
Serious or continuing non-compliance
Suspension or Termination of IRB approval