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2. Subcommittee on Research Business Models Appropriate Costs of the Research Enterprise Denise McCartney Associate Vice Chancellor for Research Administration Washington University November 17, 2003

3. The Scientific Partnership The Scientific Partnership is Beneficial but Complex University-Government relationships Relationships with Industry Collaboration with Community Agencies Hospital – Academic Medical Schools

4. The Scientific Partnership University –Government Partnership has a clear impact on: Research programs and direction Measures of academic quality Faculty leadership and participation Costs to support research Policies, procedures, technology Compliance Programs

5. Changes to the Partnership Affect Business Models Rapid pace of scientific change Unique models of collaborative research Potential impact on funding mechanisms Changing requirements for facilities Role of technology in research ‘Omics’ requires data mining and correlation to clinical systems Robotics Support for networks and relational databases

6. Changes to the Partnership Affect Business Models Rapid pace of scientific change Role of Clinical Researcher Clinical Practice vs. Research Mission Need to train and retrain them Multiple compliance responsibilities Competitive Compensation

7. Changes to the Partnership Affect Business Models Increased Compliance Requirements New or revised regulations, requirements or guidelines Responses of University, departments, agencies or inspectors general Variability of research programs may not allow for uniform implementation

8. Changes to the Partnership Affect Business Models Rapid Pace of Administrative Change Need to support new scientific initiatives and collaborations Development of new organizational models Research Program Compliance Offices

9. Changes to the Partnership Affect Business Models Rapid Pace of Administrative Change Impact of Technology E-grants University Administrative systems Increased Accountability More oversight, monitoring Implied compliance expectations Implementation of Different Agency Practices

10. Results of These Changes Unrecovered University Costs Unfunded Mandates Cost Sharing Capital Costs funded through depreciation Increased Administrative Complexity Adds Costs More sophisticated skill sets needed

11. What are Potential Solutions Recover True Costs of Research COGR Cost of Doing Business Report Under recovery of F&A expenses due to administrative cap Variable agency polices limiting reimbursement for expenses Costs associated with regulated and unfunded compliance requirements

12. What are Potential Solutions Reduce the Complexity of Business Processes Assess the value of new compliance initiatives Do these initiatives enhance the stewardship of funds, protection of subjects and the ethical conduct of research?

13. What are Potential Solutions Reduce the Complexity of Business Processes Assess the value of new compliance initiatives Does the new initiative fairly balance accountability and responsibility How to assess the impacts of the new initiatives? How to measure the outcomes?

14. What are Potential Solutions Reduce the Complexity of Business Processes Assess the costs of -7new compliance initiatives Explore options to offset the costs of significant new compliance requirements? Are the costs worth the outcomes? Do the agencies have the resources to implement?

15. What are Potential Solutions Reduce the Complexity of Business Processes Establish a single electronic platform that : Eliminates the need for Universities to develop technology and procedures for multiple agency systems Contains costs Reduces complexity Maintains the quality of scientific proposals, images and data

16. What are Potential Solutions Reduce the Complexity of Business Processes Reduce variable agency practices around common functions Scientific Integrity Policies COI reporting CV Formats

17. What are Potential Solutions Recognize Existing Accountability Models Many mechanisms already exist for monitoring accountability Peer Review Publication reviews, progress reports Effective compliance committees that modify behavior Audits and other monitoring mechanisms Accreditation programs Is there potential here?

18. What are Potential Solutions Recognize Existing Accountability Models Science is inherently self-correcting Publications Process of scientific validation Allow for the spontaneity of Science Unexpected results Negative results

19. Risks of the Potential Solutions New Models for Collaborative Research may require new administrative models Space allocation and reporting Faculty appointment, promotions and tenure Without additional appropriations, increased F&A costs may impact: Direct Costs Available for Research Investigator Competitiveness Investigator Satisfaction

20. Risks of the Potential Solutions Reduced Business Complexity Reduces Diversity Institutional Culture Reduced Flexibility Impact on smaller institutions Accreditation may result in too much standardization Proliferation of accreditation programs Technological Solutions to adopt single electronic platform may not be available