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Sherry Davis, Manager Pacific Northwest National Laboratory Human Research Protection Program

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Sherry Davis, Manager. Pacific Northwest National Laboratory. Human Research ... Cite regulations verbatim. Don't create unnecessary policies and procedures ... – PowerPoint PPT presentation

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Title: Sherry Davis, Manager Pacific Northwest National Laboratory Human Research Protection Program


1
Sherry Davis, ManagerPacific Northwest National
Laboratory Human Research Protection Program
  • AAHRPP
  • As A Self-Assessment Tool
  • May, 2008

2
Accreditation Process
Self Assessment - AAHRPP Evaluation Instrument
Revise Program to AAHRPP Standards
Submit Preliminary Application
60 Days
AAHRPP Response
Revise Program and Submit Final Application
AAHRPP Site Visit
30 Days
Site Visit Report
30 Days
Submit Response to Site Visit Report
To Council on Accreditation
3
AAHRPP ApproachFive Domains
  • Organization
  • Research Review Unit
  • Investigators
  • Sponsored Research
  • Participant (Community) Outreach

4
First Step - Perform Gap Analysis
  • 77 Elements
  • Assess Policies and Procedures Using
  • Modified AAHRPP Self-Assessment Tool
  • Applicable Regulations
  • OHRP Guidance
  • AAHRPP Tip Sheets
  • Other HRPP Examples
  • Focus on Outcome

5
Outcome
  • What outcome is expected?
  • Are written policies and procedures sufficient to
    achieve the outcome?

6
Example The Institutional Official
  • Who is your Institutional Official?
  • What are the IOs duties?
  • When is s/he required to perform those duties?
  • Where is s/he located in the organization?
  • Why have an Institutional Official?
  • How is s/he appointed, educated, kept informed?

7
Policies and Procedures
  • Should describe operational steps required to
    meet regulatory and guidance requirements
  • Must be written
  • May be other written guidance - SOPs, policy
    statements, checklists, guidelines, etc.
  • Can include other referenced PPs - corporate
    ethics., etc.

8
Policies and Procedures (cont)
  • Should
  • Reflect actual practice
  • Provide enough detail to be understandable
  • Incorporate or reference the regulations
  • Provide interpretations for key regulatory terms
  • Non-compliance
  • Describe the actions that are taken
  • Describe the person who performs the actions
  • Describe the timing of the actions

9
Tips
  • Cite regulations verbatim
  • Dont create unnecessary policies and procedures
  • Use simple, consistent formats
  • Make sure directions and forms are consistent
  • Write once, refer many (WORM)
  • Reporting
  • Use same procedures - Expedited Review
  • Initial Review
  • Modifications/Changes
  • Continuing Review
  • Use OHRP Charts/Guidance
  • Use AAHRPP Tip Sheets

10
Problem Areas
  • Conflict of Interest
  • Institutional
  • IRB Members/Consultants
  • Researchers/Immediate family members
  • FDA
  • Reporting Adverse Events and Unanticipated
    Problems
  • Reporting Noncompliance and Allegations of
    Noncompliance
  • Expedited Review

11
AAHRPP Site Visit - Expectations
  • Visible organizational awareness and support
  • Clear lines of communication, authority and
    responsibility
  • Policies and procedures
  • Meet regulatory requirements
  • Appropriate for program needs
  • Clearly documented, communicated, implemented and
    enforced
  • Adhered to in actual practice

12
Challenges
  • Painfully long and frustrating process
  • Demand on staff time and resources
  • Difficult to maintain routine work duties
  • DOE mind-set difficult for outsiders
  • Not as flexible as purported to be
  • Confusing written communications
  • Mixed messages
  • Unreasonable/crushing response times

13
Challenges (cont.)
  • Typically 2-3 years to complete
  • Initial state of program
  • Number of staff assigned
  • Other responsibilities/demands
  • Perpetual Maintenance
  • AAHRPP annual and other reporting requirements
  • Full application for re-accreditation every 3
    years
  • Expensive

14
On the Positive Side
  • Excellent Way to Improve Program
  • In-depth program assessment
  • Improved and developed new
  • policies and procedures
  • documentation
  • Standardization and consistency
  • Better understanding and implementation of the
    regulations
  • Encourages continual improvement
  • Enhanced communication and awareness of the HRPP
  • Client and Peer (OHRP) recognition
  • Marketing Tool (Proposals)
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