You are here

DRAFT
ORC Accomplishments February, 2013 - February, 2016

 

Biosafety Program (BSP)

Memberships

  • Continuing Corporate Member of the American Biological Safety Association (ABSA), which Certifies UH Biosafety Personnel and Keeps them Informed of Current Biosafety Issues, Professional Standards, Regulatory Initiatives, Instructional Resources, and Research Findings through Publications and Conferences

Registered Biologics Program (RBP)

  • Fulfilled Requirements for CDC/USDA-APHIS Certificate of Registration
  • Responded Successfully to On-Site Observations Made by Regulatory Agencies
  • Established Federally Required Occupational Health Program
  • Established Federally Required Initial and On-Going Suitability Assessment Program, which was Approved by the Relevant Collective Bargaining Units
  • Established Federally Required Respiratory Health Program
  • Established Federally Required Immune System Health Program (Vaccinations and Minimizing Exposure [e.g., use of appropriate PPE, Minimizing Duration of Exposure to Hazards and of Stressors to Immune System, including prolonged use of respirator])
  • Established Federally Required Health and Safety Risk Assessment Program
  • Substantively Revised Federally Required Biosecurity Plan
  • Substantively Revised Federally Required Biosafety Plan
  • Substantively Revised Federally Required Incident Response Plan
  • Wrote or Significantly Revised Many Standard Operating Procedures
  • Developed RBP Courses
  • Developed RBP Knowledge and Performance Tests
  • Developed and Implemented RBP Drills and Assessment Instruments for Drills
  • Developed Criteria for Inspections of RBP Facilities and Operations
  • Responded to Press Inquiries
  • Responded to Request by White House Committee on Science and Technology
  • Joined CDC Program to Reduce Inventory of Biomaterials Inappropriately Stored or Used or No longer of Value to the University
  • Participated in Monthly JBF Informational/Managerial meetings

Institutional Biosafety Committee (IBC) Administration

  • Administered Monthly and Special Meetings of IBC
  • Researched and Selected IBC Management Software
  • Conducted Inspections

Inspections

  • Inspected more than 400 Laboratories Annually for Compliance with Federal/State Regulations and University Policy

Dual Use Research of Concern (DURC)

  • Led Nation in Writing and Obtaining System Approval of UH DURC Policies & Procedures
  • Convened Inaugural Meeting of DURC Review Committee

Transporting Microorganisms and HDOA Permits

  • Worked with HDOA to Explore Streamlining Process for Obtaining Permits to Import Microorganisms
  • Modified BSBP Form
  • Collected Data for Annual Inventory of Microorganisms and Toxins

Waste Disposal

  • Established System for Proper Disposal for Sharps
  • Established System for Securing Autoclave Waste before Collected by Waste Management

Decontamination

  • Devised Innovative Method to Decontaminate Laboratory Computers Efficiently
  • Decontaminated Areas of Malfeasant Dumping of Potentially Unsafe Biological Wastes
  • Devised System to Prevent Theft of Potentially Hazardous Autoclave Wastes

Animal Resource Center (ARC)

AAALAC Accreditation

  • Contracted with Consultants to Assess Readiness of UHM to become AAALAC Accredited
  • Applied for AAALAC Accreditation

ARC Operations

  • Reduced Operational Costs of ARC Substantially

Animal Welfare Program (AWP)

Memberships

  • Continuing Member of the National Association For Biomedical Research (NABR), which Acts as a Liaison between UH and Federal Agencies Regulating the Care and Use of Laboratory Animals; Offers UH Analyses of Issues, Sample Responses, and Suggests Strategies; Serves as a Resource for the Media, Offering Factual Information about the Role of Animals in Biomedical Research; and Advises UH on Dealing with Concerned Citizens

Authorizations

  • Fulfilled Requirements for USDA Certificate of Registration
  • Fulfilled Requirements for OLAW Assurance
  • Increased Revenue by Acquiring Private Clients

IACUC Administration

  • Administered Monthly and Special Meetings of IACUC
  • In Cooperation with UVS and ARC, Planned and Presented Two Courses (IACUC 101/301), Attracting Renown Speakers and an International Audience of More than 100 Attendees
  • Upgraded IACUC Management Software

Post Approval Monitoring

  • Enhanced PAM of Facilities and Operations where Approved Vertebrate Animal Protocols are Performed

Fish Advisory Committee (FAC)

  • Established FAC to Inspect all Fish Teaching and Research Facilities and Operations
  • FAC Inspected 17 Facilities

Veterinary Services Program  (VSP)

  • Created Questionnaire that is used by FAC during Inspections of Fish Teaching and Research Facilities

Aquatic Animal Diagnostic Laboratory (AADL)

  • Created AADL
  • Published Trifold Brochure about the AADL
  • Conducted Workshops for Aquatic Animal Producers
  • Made Presentations at Aquatic Animal Conferences
  • Wrote and Submitted CTSA Grant Proposal

Human Studies Program (HSP)

IRB Administration

  • Administered Monthly and Special Meetings of Three IRBs
  • Explored Possibility of Creating a Native Hawaiian IRB
  • Initiated a Post Approval Monitoring Program (PAM) to Confirm Protocol and Regulatory Compliance

IRB Protocol Management Software

  • Researched, Selected, and Implemented Commercial Software to Manage IRB Protocols

AAHRPP Accreditation

  • Attended AAHRPP Conference to Learn about Accreditation Standards and Network with Other Institutions Having or Seeking Accreditation
  • Contracted with Consultants to Assess Readiness of UHM to become Accredited
  • Applied for AAHRPP Accreditation

Research Integrity Program

  • Fulfilled Requirements for HHS/ORI Assurance
  • Revised UH Policy on Handling Allegations of Research Misconduct
  • Created UH Policy on Handling Allegations of Whistleblower Retaliation
  • Conducted Assessments and Inquiries into Allegations of Research Misconduct
  • Created Procedures for Handling Allegations that Involve Multiple Compliance Committees
  • Initiated Program to Foster and Measure an Environment of Research Integrity, which is a Requirement for Receiving HHS funding
  • Provided Alternative Dispute Resolution Services
  • Established and Implemented a Process for ORC to Assist Relevant Parties to Reach an Agreement on Management Plans for Faculty Members that Disclose Conflicts of Interest

Research Excellence Initiative (REI)

  • Wrote Monthly Newsletter to Stimulate Discussion on Candidate Best Practices for Leading and Managing Productive and Responsible Research Programs
  • Wrote UH Policies for Conducting Good Laboratory Practices (GLP) Act Studies
  • Wrote UH Standard Operating Procedures (SOPs) for Conducting GLP Studies

Administrative Services Program (ASP)

  • Consolidated All Program-Specific Financial Operations into One Program (ASP)
  • Increased Accounts Receivable for AVS by Collecting on Outstanding Invoices
  • Reduced Overhead of ORC by Reorganizing and Terminating Positions
  • Experimented with Having an ORC Satellite Location at JABSOM
  • Renewed ABSA Contract Annually
  • Renewed NABR Contract Annually
  • Conducted Day-Long Retreat for All ORC Staff Members to Foster esprit de corps and to Establish ORC Vision, Values, Mission, and Goals to Form the Foundation for Strategic Planning

Information Technology Program (ITP)

New ORC Website

  • Provided Interface to Allow Authorized Staff Members to Add or Otherwise Modify Content of ORC Website Easily
  • Provided Inline Commenting/Annotating
  • Provided Interface to Allow Authorized Staff Members to Add Quotations to ORC Website and Display each Sequentially
  • Provided Interface to Allow ORC Staff and Users to Post/Read Information on Social Media Sites
  • Developed Policies for Terms and Use of the Website
  • Conformed to 508 Requirements for Website Accessibility
  • Developed Website Privacy Policy
  • Established Website Philosophy and Design Specifications

IT Support

  • Acquired and Maintained IT Equipment and Software
  • Obtained IT Equipment to Facilitate Inquires and Investigations of Research Misconduct

Administration Software

  • Renewed Annually Oracle™ Enterprise Edition Software Maintenance Contract Required for TOPAZ™ IACUC/ARC Administration Software
  • Renewed Annually TOPAZ™/Granite™ Software for IACUC/ARC Administration Software
  • Renewed Annually Key™ Solutions eProtocol™ Software
  • Renewed Annually CITI™ On-LIne Compliance Education Subscription

Education and Communication Program (ECP)

  • Increased Number of Educational Presentations for Each ORC Program
  • Posted Relevant Messages on Social Media Outlets (e.g., Twitter™©Facebook™©)
  • Established Program for ORC Staff Members and Compliance Committee Members to Take Courses to Become Better Informed about their Compliance Responsibilities