1. Research Administration for Scientists COMP 918: Research Administration for Scientists Tim Quigg, Associate Chair and Lecturer Computer Science Department, UNC-Chapel Hill International Research Projects: Administrative, Budgetary, Legal and Practical Issues © Copyright 2012 Timothy L. Quigg All Rights Reserved

2. Research Administration for Scientists Issues to Consider with Funded International Research Projects  Funding agency (U.S. or Foreign)? Single source or multiple?  What funding source rules apply? Are there separate rules for each party? Limitations on applicants?  If the project will be funded by multiple sources (from different countries) are there any conflicting laws/rules?  What issues can get the PI or the institution in trouble?

3. Research Administration for Scientists Issues to Consider with Funded International Research Projects  Who will be the prime – sub? Or does each party have separate funding?  Are all parties prepared to meet their legal obligations?  Have I ever worked with this foreign collaborator before? This institution?  If it’s a joint project but each party has its own funding, are there conflicting issues, e.g., exclusive IP rights expected for both funders?

4. Research Administration for Scientists Issues to Consider with Funded International Research Projects  Where is the project work to be performed?  Are there local governing laws to be considered?  Language, currency, import-export, visas?  Local logistics? What extra costs might be involved?

5. Research Administration for Scientists Issues to Consider with Funded International Research Projects  What materials will need to be transferred between locations?  MTA’s? Export/import laws?  Implications for intellectual property ownership and/or bars to future research?  Special needs for storing materials? Costs?

6. Research Administration for Scientists Issues to Consider with Funded International Research Projects  Are animal or human subjects involved?  Laws/rules in multiple countries? From multiple funding agencies?  Consider confidentiality and privacy laws as well as formal human subject laws.  Conflicting cultural norms in various countries? Among different groups in the same country?

7. We’ll begin with Projects Funded by U.S. Federal Agencies Any time a foreign or international institution applies to a U.S. government agency for funding either directly or indirectly (as a sub to a U.S. institution) they are subject to various U.S. “rules” and policies! Be certain the foreign institution has both the willingness and the ability to comply before proceeding!

8. Foreign Institution Needs a DUNS Data Universal Numbering System Number In order to conduct business with the U.S. Federal Government, most organizations are required to obtain a DUNS number - a unique nine-character identification number provided by the commercial company Dun & Bradstreet (D&B). You may call D&B at 1-866-705-5711 to register to obtain a DUNS number. The process of requesting a DUNS number takes about 10 minutes and is free of charge.

9. Much of this presentation is based upon the National Institute of Health (NIH) approach to foreign grants. It generally applies to all U.S. federal agencies, but there may be some exceptions, so be certain to check the agency-specific rules before proceeding! Remember, private foundations or other non-governmental funding agencies are not bound by these rules!

10. NIH Definitions Foreign Grant - A grant or cooperative agreement supporting research awarded to a foreign institution or international organization. Grant – a legal instrument for transferring money, property, or services to the recipient in order to accomplish a public purpose of support or stimulation where there will be no substantial involvement between the federal agency and the recipient during performance.

11. NIH Definitions Foreign Grant - A grant or cooperative agreement supporting research awarded to a foreign institution or international organization. Cooperative Agreement – a legal instrument for transferring money, property, or services to the recipient in order to accomplish a public purpose of support or stimulation where substantial involvement is expected between the government agency and the recipient.

12. NIH Definitions Foreign Grant - A grant or cooperative agreement supporting research awarded to a foreign institution or international organization. Foreign Institution - An organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed PD/PI.

13. NIH Definitions Foreign Grant - A grant or cooperative agreement supporting research awarded to a foreign institution or international organization. International Organization - An organization that identifies itself as international or intergovernmental and has membership from, and represents the interests of, more than one country, without regard to whether the headquarters of the organization and location of the activity are inside or outside of the US.

14. Who Is Eligible to Apply for Funding from U.S. Agencies? In general foreign and international organizations are eligible to apply for many grants from U.S. government agencies, but usually they may not apply for contracts Contract – an agreement, enforceable by law, between two or more competent parties, to do or not do something not prohibited by law, for a legal consideration.

15. Research Administration for Scientists Who Is Eligible to Apply?  Simply check FOA (funding opportunity announcement) or BAA (broad agency announcement) to determine eligibility  There are several “Foreign Specific Programs” available!

16. Research Administration for Scientists NIH Definitions Foreign Component of a Domestic Project - The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to 1) the involvement of human subjects or animals

17. Research Administration for Scientists NIH Definitions Foreign Component of a Domestic Project - The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to (2) extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities

18. Research Administration for Scientists NIH Definitions Foreign Component of a Domestic Project - The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to (3) any activity of the grantee that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country

19. Research Administration for Scientists

20. Prior to developing the proposal, all parties should sign a Collaboration Agreement that contains:  CDA (confidential disclosure agreement) – the parties may need to share confidential information in the process of preparing the proposal.  Detailed responsibilities of each party, time schedules and other pertinent information associated with preparing the proposal.  Prior agreement concerning any legal or other important issues, e.g., method and frequency of payment!

21. Research Administration for Scientists Prior to developing the proposal, all parties should sign a Collaboration Agreement that contains:  A plan to address how progress reports, financial status reports, and other required activities will be completed in a timely manner.  Agreement on methods for formal communications, language (English or multiple), currency for budgets and payments, and other potential problem areas.  Acknowledgement of and willingness to comply with any and all governing laws!  If there is a problem, identify and resolve it before wasting time developing the proposal!

22. Research Administration for Scientists NIH Requirements for Administering Sub- awards, Subcontracts and Consortium Agreements with Foreign Institutions Policy requirements “flow down”. A domestic institution administering a subcontract to a foreign institution must assure the U.S. funding agency that it is holding its collaborator to the policies required for foreign institutions. Likewise, if the foreign grantee is the primary grantee, it must assure the U.S. funding agency that its American collaborator is following all the policies required for U.S. institutions.

23. Research Administration for Scientists Potentially Troublesome Issues: Budgets  All budgets must be stated in U.S. dollars  There are a few costs that are generally unallowable on budgets from foreign or international institutions

24. Costs Generally Unallowable Under Grants to Foreign Institutions  Major Alterations & Renovations costing over $500,000  Customs and Import Duties including consular fees, customs surtax, value- added taxes and other related charges  Patient Care Costs – except in extraordinary circumstances as approved in proposal!

25. Research Administration for Scientists Potentially Troublesome Issues: Budgets  All budgets must be stated in U.S. dollars  There are a few costs that are generally unallowable on budgets from foreign or international institutions  All budgets are subject to the applicable cost principles by type of applicant organization  Yes, that means foreign universities are subject to A-21!

26. Research Administration for Scientists Potentially Troublesome Issues: Payment  Always in U.S. dollars via wire transfer  Encouraged (required) to use either U.S. bank or a bank with U.S. Branch  Must maintain grant funds in separate interest bearing bank account  Interest earned in excess of $250 on advances must be returned to the funding agency or reflected on Financial Status Report (FSR)

27. Research Administration for Scientists Potentially Troublesome Issues: Financial Reporting  Always in U.S. dollars using applicable currency rate at time of FSR  FSR’s submitted annually within 90 days of end of budget period  Funds not spent at end of project must be returned to funding agency

28. Research Administration for Scientists Potentially Troublesome Issues: Audits Audit required if foreign institution has spent > $500,000 on one or more awards from a U.S. agency in a year: financial-related audit of awards in accordance with Government Accounting Standards (GAS) - also known as Yellow Book or an audit that meets OMB Circular A-133 standards

29. Research Administration for Scientists Potentially Troublesome Issues: Intellectual Property Must comply with the Bayh-Dole Act invention reporting requirements: Allows recipients of U.S. federal funds to retain ownership of patents U.S. government retains non-exclusive license to practice the invention – “government-use license” In exchange, recipients must ensure commercial use of patents through licensing or new company creation

30. Research Administration for Scientists Potentially Troublesome Issues: Animal Welfare  Must provide and have approved by the U.S. funding agency an Animal Welfare Assurance for foreign institutions  This constitutes institutional assurance and certification of compliance with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and a commitment to follow the International Guiding Principles for Biomedical Research Involving Animals.

31. Research Administration for Scientists Potentially Troublesome Issues: Use of Select Agen ts Grantees who conduct research involving Select Agents must complete registration with the U.S. Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) or the U.S. Department of Agriculture (USDA), depending on the agent. No U.S. agency funds can be used if the final registration certificate is denied.

32. Potentially Troublesome Issues: Human Subjects Protection All proposed NIH-funded human subjects research, domestic or foreign, must include an Institutional Federal-wide Assurance (FWA) approved by the HHS Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html FWA is a document designating the Institutional Review Board (IRB) that will review and oversee the research, specify the ethical principles under which the research will be conducted, and names the individuals who will be responsible for the proper conduct of research!

33. Research Administration for Scientists Potentially Troublesome Issues: Human Subjects Protection All proposed NIH-funded human subjects research, domestic or foreign, must include also:  Annual review and approval of proposed research by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) registered under the FWA  Human subjects education for all personnel involved with the design or conduct of human subjects research

34. All of the Same Issues Must be Considered with Projects Funded by Non-U.S. Agencies The World Bank Other International Agencies Country-specific Grants EU Grants Be certain your institution has both the willingness and the ability to comply before proceeding!