1. Working with Foreign Collaborators: A Program Perspective Cynthia Grossman, PhD Program Officer, Division of AIDS Research National Institute of Mental Health 2010 NIH Regional Seminar-Philadelphia

2. International Collaboration Slide courtesy of Stephano Bertuzzi

3. Dr. Francis Collins

4. Outline Overarching considerations in working with foreign institutions and investigators US-based investigators collaborating with foreign investigators Foreign investigators as primary grantees Conclusion and key ingredients for success

5. Overarching Considerations Foreign Institutions function differently Communication: Language, Time Zones, Internet Access Resources: Journal article access, sponsored programs staff Regulations: Different funding streams (Government, Foundation) Plan for delays, differences and dialogue

6. Overarching Considerations Start Early Foreign Institution Registration: Grants.gov Can complete prior to grant submission NIH Funding for Foreign Institutions Check FOA and talk with IC program staff Collaboration is critical No parachute research Collaboration required in announcements and considered by review committees

7. Funding Collaborations Grants are given to Institutions NOT Individuals Traditional Subcontract/Consortium U.S. Institution responsible Requires a formalized agreement Substantial involvement Independent contractor Specific scope of work (time and price)

8. Outline Overarching considerations in working with foreign institutions and investigators US-based investigators collaborating with foreign investigators Foreign investigators as primary grantees Conclusions and key ingredients for success

9. Tips for U.S. Investigators U.S. Institutional Support Connect with centers or institutes in global health Identification of Key Personnel Local hierarchy in foreign organization Key personnel change = program approval Understand local reimbursement systems Salary support for local investigators Project delays = no salary for support staff

10. Tips for U.S. Investigators On-going Project Monitoring Progress Reports Updating Program Officers Monitoring Budget Human Subjects Protections Staff Management The US-based PI remains responsible!

12. Outline Overarching considerations in working with foreign institutions and investigators US-based investigators collaborating with foreign investigators Foreign investigators as primary grantees Conclusions and key ingredients for success

15. Tips for Foreign Investigators Eligible does not equal competitive Publication record Previous funding: best if from NIH Justification of foreign site

16. Tips for Foreign Investigators Application Review Criteria for Grant Applications for Foreign Institutions and International Organizations 1) whether the project presents special opportunities for furthering research programs through the use of unusual talents, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources; and, 2) whether the proposed project has specific relevance to the mission and objectives of the NIH Institute/Center (IC) and has the potential for significantly advancing the health sciences in the United States and the health of the people of the United States. Note these additional criteria are not applied to applications from domestic institutions with foreign components.

17. Tips for Foreign Investigators F & A – “NIH provides limited F&A costs (8 percent of total direct costs less equipment) to foreign institutions and international organizations to support the costs of compliance with NIH requirements including, but not limited to, protection of human subjects, animal welfare, and research misconduct. NIH will not support the acquisition of, or provide for depreciation on, any capital expenditures, or support the normal, general operations of foreign and international organizations” What if the foreign site takes a percentage off the “top”? What if they wish to pay as a direct cost a compliance expense – IRB, audit… ?

18. Tips for Foreign Investigators Unallowable Costs Major alterations and renovations. Costs for major A&R (>$500,000). Customs and import duties. Consular fees, customs surtax, value-added taxes (VAT) and other related charges. Supplements due to currency fluctuation. Once an award is made, the NIH will not routinely make adjustments for currency exchange fluctuations through the issuance of supplemental awards. NIH recognizes that some foreign countries have significantly high inflation rates. Grantees are reminded that they may not invest grant funds to defray the cost of inflation.

19. Zimbabwe: Inflation Dips to 6,500 Percent Financial GazetteFinancial Gazette (Harare) 19 September 2007

20. Tips for Foreign Investigators Payment Generally, NIH pays foreign institutions and international organizations by U.S. Treasury check issued by the NIH Office of Financial Management (OFM) on a predetermined quarterly advance basis, usually in four equal installments. Foreign grantees are strongly encouraged to use U.S. banks to ensure that payments arrive on time. Grantees are required to maintain grant funds in an interest bearing account; however, interest earned in excess of $250 per year in the aggregate on advances of Federal funds must be returned in U.S. dollars by reimbursement check to the NIH Office of Financial Management at the address below, or reflected on the annual Financial Status Report.

22. Select Agent Requirements Awardees who conduct research involving select agents must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all select agent work sponsored by NIH funds before using these funds for any work directly involving select agents.

23. Select Agent Requirements Must address to NIH satisfaction key elements prior to use of funds. The key elements: Safety Security, Training, Procedures for ensuring only approved/appropriate individuals have access to the select agent Any applicable local laws equivalent to 42 CFR 73

24. Outline Overarching considerations in working with foreign institutions and investigators US-based investigators collaborating with foreign investigators Foreign investigators as primary grantees Conclusions and key ingredients for success

25. Keys to Success Communication Collaborators and staff Collaborators and NIH Understand unique policies, regulations and practices Foreign site differences Be in it for the long haul In reality and grant description Be patient

26. THANK YOU! Cynthia Grossman grossmanc@mail.nih.gov