Working with Foreign Collaborators: A Program Perspective

Christopher Gordon, PhDBranch ChiefDivision of AIDS ResearchNational Institute of Mental Health

2010 NIH Regional Seminar-Portland, Oregon

International Collaboration

Slide courtesy of Stephano Bertuzzi

Dr. Francis Collins

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

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

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

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)

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

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

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!

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

Tips for Foreign Investigators

Eligible does not equal competitive

• Publication record• Previous funding: best if from NIH• Justification of foreign site

Tips for Foreign InvestigatorsApplication Review Criteria for Grant Applications for Foreign Institutions and International Organizations1) 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.

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… ?

Tips for Foreign InvestigatorsUnallowable 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.

Zimbabwe: Inflation Dips to 6,500 PercentFinancial Gazette (Harare)19 September 2007

Tips for Foreign InvestigatorsPaymentGenerally, 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.

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.

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

Other Considerations

• Travel – Fly America Act Applies• Review NoA to determine SNAP vs. non-

SNAP • SNAP follow normal requirements EXCEPT

annual FSR must be submitted• Non-SNAP for normal requirements

• FSRs – required annually for all awards• Audit Requirements – required if

expended $500,000 or more from DHHS awards

Prior Approval

• Change of PD/PI – required• Change of grantee organization –

required• Addition of foreign consortium -

required

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

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

THANK YOU!

Christopher Gordoncgordon1@mail.nih.gov