Sponsored Projects and Regulatory Compliance Services (SPARCS)

1. Sponsored Projects and Regulatory Compliance Services (SPARCS) Matt Ronning Associate Vice Chancellor

2. Objectives • The Proposal and Award Process at NC State • Who to contact with Questions and to Get Started • PINS – Internal Approvals before you submit a proposal • You MUST work early • How to succeed in compliance matters • Export Controls – Keep it publishable! • Conflicts of Interest and Commitment • Scientific Integrity • Animals, Humans and substances.

3. Proposal and Award Processing

4. Get to Know your CROfficers • College Research Officers • Associate Dean for Research • Directors of Research Administration • Proposal and Award Processors and Associates • Budget Reviews • RFP Assistance • Awards Management Assistance • Etc. • Central Officers

5. SPARCS/Research Website http://www.ncsu.edu/sparcs/ http://www.ncsu.edu/sparcs/

6. Fundamental Issues • Why do we review proposals? • Why do we negotiate agreements? • Why does it take so long to set up an account • What are some opportunities to mitigate these delays? • Who do I talk to and get information from?

8. PINS – Project Information and Navigation System • http://www.ncsu.edu/sparcs/pins/ • What is it? • It is NC State University’s system to secure institutional approvals before proposals are submitted(required by sponsors). • It is entirely paperless – entirely! • How do I get help? 515-4267 or http://www.ncsu.edu/sparcs/help.html/

9. E-Portal to Research Admin Tools http://www.ncsu.edu/sparcs/era/

10. Compliance Continuum Behavioral/Integrity Subjects Export Controls Conflicts of Interest External Consulting Research Integrity Animal Use and Care Human Subjects Use Human Embryonic Stem Cells Radiological Safety Chemical and Biological Safety Hazardous Waste Management Substances

11. Export Controls • Definition of Fundamental Research • Access to relevant information: • http://www.ncsu.edu/research/guide/exports.html • Classified Research, not at NC State. You can have a clearance through a third party however for research or other purposes. Top Secret

12. Disclosure of Conflicts of Interest and Commitment

13. Why disclose? • Mitigate risk to the disclosing party and to the institution. • Maintain confidence in the self-regulation of the inherent and natural conflictsof interest • Ensure objectivity in science • The criminal statue of NC, NIH and NSF guidelines and UNC System Policy.

14. Interests & Commitments • Conflicts of Interests deal with your objectivity in executing your functional responsibilities as a member of the academy – that is, influences, real or apparent, that could compromise your ability to objectively propose, conduct or report research, development or other scholarly activity. If so, disclose them and work with the institution (department head and dean) to insert a means to ensure objectivity. • Conflicts of Commitment deal with your privilege to perform limited external professional activities for pay (consulting). Do you have time and is the activity consistent with your compact with the institution?

15. Who discloses • Every EPA employee, period. • Faculty • Professionals • Post docs • And all others • All others working on sponsored projects • SPA • Graduate Students

16. What is disclosed? • Significant financial interests • $10K or more than 5% • Textbooks, other classroom materials • IP owned by disclosing party and licensed TO THE UNIVERSITY • By employee or family member living in same household.

17. When to disclose? • Renew comprehensive disclosure annually – late summer • Update disclosure perpetually throughout the disclosure year • As circumstances change COI’s happen naturally throughout the year, they don’t happen magically on July 1. So, you have to update your disclosure as soon as your circumstances change.

18. How/Where? • Entirely web-based utility • Routes to Department Head, Center Director, Dean, Vice Chancellor as needed. • Consulting also requires approval through the Notice of Intent for External Professional Activities for Pay System • Conflicts of Commitment • Differ from Conflicts of Interest, how? – Financial interest versus time. • http://www.ncsu.edu/sparcs/coi/

19. Management Plans • When a real or perceived conflict exists • Establish parameters of operating with the conflict • Eliminate conflicts if management is impossible • Evaluate the speculative environment of the scientific community and the general public • Management plans should naturally fall out of the disclosure itself: • Disclosure Questions prompt for management plan components

20. External Consulting • Consulting is encouraged to the extent it develops your effectiveness as a member of the institution’s faculty. • Must file request 10 days prior to engagement • Exceptional circumstances arise – disclose anyway • Discuss with your dept head her/his expectation on commitment to institutional obligations

21. Signatures • Disclosing party: Certification of completeness, accuracy and where relevant commitment to the management plan • Department Head: Receipt and review of the disclosure for completeness and commitment to the management plan • On proposals and Consultations: submission is either free of COI or consistent with a management plan • See also, all of the other certs and reps you commit to in signing a proposal at http://www.ncsu.edu/sparcs/pins/certification_help.html

22. Misconduct in Scholarship Some basic management skills

23. What is it? • Falsification • Fabrication • Plagiarism • NSF, NIH, NC, NC State and UNC all have rules, policies, regulations and consequences • Web resources for scholarly integrity • http://www.ncsu.edu/sparcs/compliance/integrity/

24. Quick Reads • Honor in Science, Sigma Xi • The Responsible Researcher, Sigma Xi • On Being a Scientist, National Academies • Making the Right Moves, HHMI/GSK • ORI- Management of Biomedical Labs • Look at your professional societies, etc…

25. Only Principle for Today • Notebooks!

26. Digital Age of Documentation

27. Animals and Humans

28. Subjects - Compliance • Human Subjects in Research • http://www.ncsu.edu/irb • Animal Subjects • http://www.ncsu.edu/iacuc • All compliance • http://www.ncsu.edu/compliance/