The IAC and Accreditation

1
The IAC and Accreditation

• CREC Summer School
• June 19, 2006

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IRB Advisory Committee or IAC

• Primary Responsibility
• Provide centralized oversight of the Case Human
  Research Protection Program (HRPP)
• Secondary Responsibility
• Share resources and best practices among member
  institutions and other institutions within our
  community to ensure the protection of
  participants in human research.

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Case HRPP

• Covers all human research conducted by any
  student, employee, or faculty member of Case, UHC
  and MHS as part of his or her job
  responsibilities with that organization, or any
  human research conducted by an independent
  contractor of these organizations as part of the
  organizations contract.
• For any human research in which Case acts as the
  grantee, employees of the Louis Stokes Cleveland
  Department of Veterans Affairs Medical Center
  (LSCDVAMC) and the Cleveland Clinic are also
  responsible for complying with the Case HRPP.

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IAC Structure

• The Case HRPP Institutional Official (Case
  Provost and Vice President) appoints an
  Organizational Official (Associate Vice President
  for Research or equivalent) to oversee the Case
  HRPP.
• The Organizational Official chairs the IAC and
  has been appointed by the appropriate member
  Institutional Officials within the Case HRPP to
  grant approval to additions or revisions to Case
  HRPP policies and procedures that have been
  reviewed and approved by a vote of the majority
  of IAC members so they may be implemented within
  the Case HRPP.
• Each member Institution has two votes. The IAC
  Chair may vote in the event of a tie.
• Concerns about the Case HRPP may be brought
  directly to the IAC or can be forwarded through
  the appropriate Institutional Official to the
  Office of the Provost.
• If the IAC Organizational Official changes then
  each member Institutional Official must concur
  regarding the appointment of a new Organizational
  Official.

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IAC Membership

• Each Institution shall be represented by the IRB
  Chairperson (or his/her appointed representative)
  and head of the respective IRB Administrative
  Office (IAO).
• The IAO Head is the person responsible for
  overseeing the administrative activities of the
  IRB and possesses an appropriate knowledge base.
• Each Member Institution shall formally appoint
  both representatives and notify the Case Research
  Compliance Officer (CO) of any changes of its
  representatives.
• Guests (investigators, administrators, students,
  etc) may attend a meeting of the IAC upon
  approval of the IAC Chair.

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IAC Member Responsibilities

• Attend scheduled meetings - generally monthly,
  but not less frequently than twice per annum.
• Develop and implement HRPP policies, procedures,
  shared resources.
• Submit Institutional Semi-Annual Compliance
  Reports.
• Cooperate with IAC efforts to address
  institutional non-compliance.
• Conduct Quality Improvement Reviews.
• Provide for external institutional IRB auditing
• Require appropriate personnel to participate in a
  continuing education program

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Ongoing IAC Initiatives

• AAHRPP accreditation
• Uniform or harmonized policies and procedures
• e.g., common definition of human subjects
  research, determining the IRB of record
• Sharing resources

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Human Subjects Research

• Is the proposed activity a systematic
  investigation?
• Will the proposed activity develop or contribute
  to generalizable knowledge?
• Will the proposed activity involve collecting
  data through an interaction or intervention with
  a living individual?
• 4. Will the proposed activity involve collecting
  private identifiable information about a living
  individual?

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Human Subjects Research

• 5. Will the proposed activity involve the use of
  a drug on one or more human participants, other
  than the use of a marketed drug in the course of
  medical practice?
• 6. Will the proposed activity involve the use of
  a medical device on one or more human
  participants, other than the use of a marketed
  medical device in the course of medical practice?
• Will the proposed activity involve the use of a
  medical device on human specimens, other than the
  use of a marketed medical device in the course of
  medical practice, where the activity is being
  done to determine the safety or effectiveness of
  the device and data from the activity will be
  submitted to, or held for inspection by the FDA?
• Will the proposed activity involve the use of one
  or more of the following FDA-regulated articles
  on one or more human participants and produce
  data that will be submitted to, or held for
  inspection by, the FDA?
• Food or dietary supplement that bears a nutrient
  content or health claim
• Food or color additive for human consumption
• Infant formula
• Biologic product for human use
• Electronic product for human use
• Other article subject to the Food, Drug and
  Cosmetic Act

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IRB of Record - Considerations

• Does the activity meet the definition of human
  subjects research?
• Is the human subject research conducted by an
  agent of the Case HRPP?

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IRB of Record - Considerations

• Where are the investigators based?
• What is the nature of the research (e.g.,
  cancer-related, non-medical)?
• Where will the research take place?
• Which institutions patients are being studied or
  facilities are being used?

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IRB of Record - Process

• Initial assessment by principal investigator (in
  consultation with IRB office or Office of
  Research Compliance)
• Evaluation by eligible IRB of record
• Evaluation by IRB office(s) of other
  institution(s) involved

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When more than one IRB is required

• Vulnerable populations
• Protocol poses a high compliance risk

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AAHRPP Accreditation

• AAHRPP is the Association for the Accreditation
  of Human Research Protection Programs.
• AAHRPP was founded in 2001 by seven national
  organizations with a strong interest in research.
  
• AAHRPP is governed by a Board of Directors and
  maintains a pool of site visitors, who are
  experts in various research fields and
  representatives from the public. A Council on
  Accreditation with public members makes final
  determinations about accreditation.
• AAHRPP's national office is located in downtown
  Washington, DC.

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Who?

• University Hospitals of Cleveland, The
  MetroHealth System and Case
• 2 UHC IRBs
• 1 MHS IRB
• Case Social/Behavioral IRB
• Case Cancer IRB

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Who?

• Five Domains
• Organization
• Research Review Unit
• Investigators
• Sponsored Research
• Participant Outreach

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When?

• Preliminary Assessment 2003
• Preliminary Application November 2004
• Final Application August 2005
• Site Visit January 2006
• Site Visit Response March 2006
• Council Review June 2006

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What?

• Raised Institutional Awareness
• Identified Compliance Problems
• Coordinated Policy Development

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Local Changes?

• Extensive policy and procedure changes for IRBs
  and other compliance areas
• Parental Permission
• Informed Consent Process
• Unanticipated Problems and Adverse Events
• Conflicts of Interest
• Privacy and Confidentiality
• Non-English Speaking Populations

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Future

• Evolution of current program through
  communication, education and on-site evaluation

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Contacts

• Eric Cottington, Ph.D
• AAHRPP Organizational Official
• 368-4515 or emc14_at_case.edu
• Christian LaMantia
• Case Research Compliance Officer
• 368-4513 or clt_at_case.edu