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 Statement As 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 Responsibilities The 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

Related Issue - Individual Investigator Agreements  The OHRP model IIA lists over a dozen obligations, most of which fall on the investigator. However, the concern is that under the current model the institution is still responsible, not the investigator.  How will the ANPRM impact these agreements?