# Presentation: 294954

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

- AAHRPP
- As A Self-Assessment Tool
- May, 2008

## Accreditation Process 

- Self Assessment - AAHRPP Evaluation Instrument

- Revise Program to AAHRPP Standards

- Submit Preliminary Application

- AAHRPP Response

- Revise Program and Submit Final Application

- AAHRPP Site Visit

- Site Visit Report

- Submit Response to Site Visit Report

- To Council on Accreditation

- 60 Days

- 30 Days

- 30 Days

## AAHRPP ApproachFive Domains 

- _ _
- Organization
- Research Review Unit
- Investigators
- Sponsored Research
- Participant (Community) Outreach

## 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

## Outcome

- What outcome is expected?
- Are written policies and procedures sufficient to achieve the outcome?

## 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?

## 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 P&Ps - corporate ethics., etc.

## 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

## Tips

- Cite regulations verbatim
- Don’t 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

## 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

## 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_

## 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

## 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

## 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)