Research Forum November 15, 2011 4 P.M. Room K2006, K-Wing Bldg.

1. Research Forum November 15, 2011 4 P.M. Room K2006, K-Wing Bldg.

2. 2012 NIH Budget • NIH Request in the President’s Budget = $32B • Senate Appropriation = $30.5B • Down by $200M from FY2011 • Areas of emphasis: • Technologies to accelerate discovery • Enhancing the evidence for health care decisions • New Innovator Award and Early Independence Award to support independence for younger researchers.

3. How NIH is managing with less • More money being directed to FOAs • Less availability for Investigator Initiated grants • R21 mechanisms being limited by certain ICs • Limited Submissions--Review policy • Lower Salary Caps • New Investigator awards are still a priority

4. NCATS • National Center for Advancing Translational Research (NCATS) • $20,000,000 for the Cures Acceleration Network • Rest of the funding coming from the dissolution of NCRR

5. Closing out the Era of ARRA • Guidance will be coming out soon that restricts or eliminates second no-cost extensions of ARRA funds • Any funds not drawn down by 9/30/2013 will be returned to the Treasury. • Projects need to end no later than 6/30/2013 in order to allow 90 days for the financial closeout.

6. Changes to the ERA Commons • Changes to how users log in to eRA Commons Federated authentication • Change of Grantee or Training Institution (Type 7 applications) and Administrative Supplements (Type 3 applications) working to transition to electronic applications • Transition to Research Performance Progress Report • Changes to Financial Conflict of Interest module to meet compliance needs • Future changes to improve security • Changes in system for Delegations

7. Research Performance Progress Report • RPPR Refining agency specific reporting and implementation requirements With goal to minimize impact on grantees • http://www.nsf.gov/bfa/dias/policy/rppr/index.jsp • NIH Implementation plan posted January 21, 2011 • Will implement in an electronic environment • Expect to pilot in January 2012 • Participating in Federal-wide data dictionary workgroup

8. 1st no cost extension • Effective October 1, 2011, NIH is requiring grantees to use the No-Cost Extension feature in the eRA Commons to notify NIH when they exercise their one-time authority to extend, without additional funds, the final budget period of a grant. • Once the eRA Commons link is closed, such an action becomes a prior approval request and must be submitted for consideration to the Grants Management office of the NIH awarding component. • see: NOT-OD-11-098

9. New forms • New forms (ADOBE-FORMS-B2) issued this summer, required after January 8th • currently used for most new FOA postings • Includes: fix for modular budget issue, updated construction budget form and support for up to 30 subaward budgets • Fellowship, Training and a few other programs will continue to use ADOBE-FORMS-B1 These programs don’t use the forms fixed in B2

10. Resubmission for New InvestigatorsOne time exception to standard dates

11. Changes to the Appeal Process • Tightens the window for filing • appeals accepted only after the summary statement has been distributed and no later than 30 days following Council meeting. • Can only appeal decisions, based on demonstrated flaws in the review process • Differences in scientific opinion will not be considered a basis for appeal

12. Grants Inventory and Summary

13. Types of Grants for Faculty • National grants • NIH Investigator Initiated Grants: R01, R21, R03 • Department of Defense • American Heart, American Cancer, Susan G. Komen • State: Ky Lung Cancer, KSCHIRT • University/School: • COBRE (NCRR): trans-Institute specific for universities in lower half of NIH-funded universities • School of Medicine Office of Research Grants • EVPRi Small Grants Program • Departmental or Center funds

14. Definition of Success Rates • http://report.nih.gov/award/success/Success_ByIC.cfm • If you know a program officer at an Agency, communicate with them so they can advise you how to position yourself to get grants

15. Grant Related Accounting Issues • Cost Share requirements • Monthly account reconciliation requirements • Effort Reporting • Research Compliance for Research • Institutional Biohazard Protocols: Environmental Health & Safety • Animal Care & Use Protocols: IACUC • Human Subjects Protection: IRB

16. Cost Share • Required Cost Share: Necessitated due to funding source rules (matching) – supported by Institution • Voluntary Cost Share: Want project to look more attractive to reviewer – supported by PI or department (NSF prohibits this) • Remember that funds come to PI and department as Research Incentive funds and salary release can be used as Cost Share if needed • Requires establishing Cost Share Account to come from departmental or institutional funds for audit trail

17. Account Reconciliation • Research Handbook defines University expectation of monthly account reconciliation • P.I. required review of accounts information on a monthly basis • UBM reporting of monthly reconciliation of accounts to School Research Office

18. Effort Reporting • Effort Reporting required by Research Handbook • UBM and PI must work together to have all grants with effort reflected on effort reports • Semi-annual review (updating) • When emails come to you asking for effort certification, look at the link provided or check with your UBM that all research effort is added • Does it match your Work Assignment?

19. NIH Training Grants • Ruth L. Kirschstein National Research Service Awards (NRSA) Training Grants and Fellowships • NRSA individual F30 (pre-MD/PhD), F31 (predoc), F32 (postdoc); F33 (senior fellows) • T-Series Training Grants • T32: Pre-/Postdoctoral Fellows (2 years, pre- and postdoc) • T35: Short-term Training Grant (1-3 months, summer med students) • K-series • K01, K03, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99 • http://grants.nih.gov/training/careerdevelopmentawards.htm

20. Research Integrity Training • All F, K, & T training grants have requirements for RI training • NIH is looking for at least 8 contact hours (face to face) at each career stage. • Undergraduate • Post Bacc • Graduate • Post Doc • Faculty

21. Research Integrity Training • Areas of training • conflict of interest - personal, professional, and financial • policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices • mentor/mentee responsibilities and relationships • collaborative research including collaborations with industry • peer review • data acquisition and laboratory tools; management, sharing and ownership • research misconduct and policies for handling misconduct • responsible authorship and publication • the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

22. Research Integrity Training • Summer medical students: T35 and SRSP • For Pre- and Post-doctoral Fellows on F/K/T32 fellowships on the HSC, there is a 1 credit course BIOC630: Responsible Conduct of Research: Survival Skills & Research Ethics • Postdoctoral Fellows will complete online training and engage in 4 contact hours per year of Research Integrity Training • Faculty: Being planned by Allison Ratterman and HSCRO Grant faculty are highly encouraged to participate in facilitating the training as a means to fulfilling this requirement.

23. Conflict of Interest • Revised regulations finalized August 25, 2011 • Must be implemented by August 24, 2012

24. Key Changes to the Regulation • Thresholds decreased from $10,000 to $5,000 • Non-public threshold remains at ‘any’ • Thresholds now aggregated across categories • Value of entire relationship

25. Key Changes to the Regulation • Disclosures requirements • Across entire institutional role • Academic, Business, Clinical, Research, Institutional • Institution will make determination based upon disclosed information

26. Key Changes to the Regulation • Disclosures requirements • Income from seminars, lectures, teaching or service on advisory committees or review panels must be disclosed if not received from: • Government agency • Institution of higher education • Research institute affiliated with institution of higher education • Academic teaching hospital • Medical center

27. Key Changes to the Regulation • Disclosures requirements • Reimbursed or sponsored travel related to institutional responsibilities, if not received from: • Government agency • Institution of higher education • Research institute affiliated with institution of higher education • Academic teaching hospital • Medical center

28. Key Changes to the Regulation • Training on Conflict of Interest Policy • Before engaging in funded work and every four years thereafter • Immediately upon designated circumstances • New to institution • Changes in institutional policy • Findings of non-compliance

29. Key Changes to the Regulation • Public disclosure of identified conflicts of interest • Institution must make policy available to public • Institution will determine and make information available to public • Regular updates required

30. Key Changes to the Regulation • Increased reporting requirements to funding agencies • Timing • Frequency • Depth of information provided • Specifics on identified COI – includes entity, value of interest, nature of relationship, description of how interest impacts research, key elements of management plan • Subcontracts • Non-compliance • Mitigation plans

31. Contact Information • Sponsored Programs Development: Kimberly Lalley, Director kalall01@louisville.edu • Research Integrity Program: Dr. Allison Ratterman, Director akgrif01@louisville.edu • Human Studies Protection Program Office: Becky Higgins, Interim Director rhhigg01@louisville.edu • IACUC Office: Angela Bryant, angela.bryant@louisville.edu • Biosafety Office: Carol Whetstone, ctwhet01@louisville.edu • SOM Research Office: Russ Prough Vice Dean for Research raprou01@louisville.edu

32. Questions?