AMS SAPPHIRE, LLC
 
Materials engineer  and chemists  examine scanning electron micrographs

 

 


Research Compliance Consulting Services
 
 

The mission of Research Compliance Consulting is to provide project assistance to college and university research administration, particularly in areas related to federal and state research regulations

Click here for a print version of Research Compliance Consulting's services.

Our approach:

  • Responsive to your specific requests and concerns
  • In consultation and collaboration with you
  • Tailored to your specific institutional context – your research portfolio and your institution’s administrative culture, and crafted in your institutional format and voice
  • Embracing the concept that a compliance program is a supportive partner working to enhance a vital facet of quality within research enterprise operations.  In this approach audit is an important tool but not a compliance program, and monitoring programs emphasize helping research teams do it right.

Subject expertise:

  • Research compliance program design and operation
  • Research policy and administration including stem cell research, tissue and data banking, data ownership and management, etc.
  • Human subjects protection programs
  • Humane animal care and use programs
  • Individual conflict of interest
  • Institutional conflict of interest
  • Export controls
  • Scientific integrity
  • Sponsored research topics including effort reporting
  • Clinical research topics including contracting, budgeting and billing
  • HIPAA and research interfaces
  • Institutional response to proposed new federal or state research regulations

A sampling of our services:

  • Assistance in designing and establishing an institutional compliance program incorporating the classic elements outlined in federal guidance
  • Analysis of specific regulatory or ethical topics and their operational implications
  • Background on peer institution approaches to research issues
  • Presentations to senior administrators and boards, to faculty, to staff, to other stakeholders
  • Facilitation of research administrative task groups
  • Policy drafts
  • Procedure drafts
  • Institutional communication drafts
  • Training materials

 

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