Responsible Conduct of International Research: The Basics for ...

1. Responsible Conduct of International Research: The Basics for Submission, Awarding, Compliance and Close Out of International Research and Training Programs

3. 1. Where do I find the money? U. S. Federal Government International Organizations U.S. and Internationally Focused Foundations Internationally-based Industries International Governmental Organizations Foreign Government Organizations

4. EU 7th Framework Programme ______________________________________________� The Seventh Framework Programme�(FP7) is the EU�s main RTD funding programme for the period 2007-2013. With a total budget of more than �50 billion, and marine science and technology identified as a priority cross-cutting theme, FP7 offers major opportunities for Irish marine researchers. FP7 is made up of four Secefic Programmes: Cooperation (�32.4bn) Capacities (�4.1bn) People (�4.75bn) Ideas (�7.5bn)

6. HRSA _____________________________________________ The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, is the primary Federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable. Comprising six bureaus and 12 offices, HRSA provides leadership and financial support to health care providers in every state and U.S. territory. HRSA grantees provide health care to uninsured people, people living with HIV/AIDS, and pregnant women, mothers and children. They train health professionals and improve systems of care in rural communities.

7. Fogarty International Center How to Apply for or Manage a Grant Fogarty International Center (FIC) does NOT: Accept unsolicited grant applications Provide grants specifically for foreign travel to meetings or conferences Provide training grants directly to students; we do provide training grants to institutions who select trainees. If interested in these types of training grants, please see the Directory of Grants and Fellowships in the Global Health Sciences for information about other agencies and organizations that may meet your needs. General NIH Grants Information

8. Department of Homeland Security ___________ International Research Grants offered by the Department of Homeland Security The Department of Homeland Security (DHS) is making its yearly solicitation for international research proposals, aligned with S&T�s mission, issued (pending the availability of appropriated funds): �evaluation of novel tools or approaches to confronting homeland security challenges;  �Basic research to provide data, understandings, or models that support S&T efforts or policy decisions; and  �S&T and operations research evaluations to support revolutionary improvements in DHS�s mission and its component agencies� operations. To learn more and to apply, visit www.grants.gov and look under funding opportunity DHS-08-ST-108-002.

9. Bill and Melinda Gates Foundation _______________________________________________ Now Accepting Proposals for Grand Challenges Explorations Round 2 ���� SEATTLE�-- The Bill & Melinda Gates Foundation announced today that it is now accepting grant proposals for Round 2 of Grand Challenges Explorations, a five-year US$100 million initiative to encourage bold and unconventional research on new global health solutions.�Proposals for six topics will be accepted online at www.gcgh.org/explorations through November 2, 2008.

10. US AID

11. 2. How Do I Submit a Proposal? Universities approve and submit proposals for the PI�s. The authorizing signature will be someone designated by the university. At UW, Lynne Chronister is the authorizing signature (me). At UW we send proposals through an Electronic system called SAGE for routing through all of the approval channels. The form used is called and eGC1. Most sponsors accept proposals electronically and Sponsored Programs does the actual electronic submission.

12. 3. What Do I Do When I Get Funded? �We�re not in Kansas any more��

13. What do I do? First, celebrate! Second, be sure to let OSP and your department administrator know. OSP will request that Grants and Contracts Accounting (GCA) set up an award.

14.  Ethical/Business Frameworks for International Research

15. Who is Responsible? Individual Investigators and Research teams: Human and animal protections, integrity in the conduct of research Government: Setting standards and providing guidance and resources Institutions: Policy, infrastructure and facilitation

17. Are researchers complying with US human subject standards in their international research? Considerations Does the host country require its own IRB? Are there aspects of local context that must considered? Is it truly �informed consent�? Is the value to the country clear if human specimens are taken? Risks Subjects may be negatively impacted due to participation Future research in-country may be prohibited Researcher can�t publish without IRB approval

18. Is your research operation required to establish legal status in-country? Considerations Legal status may be required to open a bank account, lease space and pay local salaries Involve your legal counsel Engage in-country legal counsel Thoroughly understand risks & benefits of registration options

19. How do you make cash available in countries that don�t have well-established banking systems? Considerations Checks issued from US Electronic wires to foreign bank account Work with local �logistics� firm Pay vendors directly from US institution via PO Subcontract with foreign institution or non-profit Risks Program activity may be disrupted Inefficient operations using wires Excessive foreign banking �fees�

20. How should a research program hire staff to work in-country?

21. Building the Framework

22. International Partners may Have a different Set of Infra- structure Issues to Deal with!

23. Checklist for establishing operations abroad Determine whether nature of operations requires legal registration within the host country Will vary by country May require outside legal counsel Options may be impacted by University�s legal definition Registration may have unintended impacts (e.g., perception by local population) Establish internal review/approval process, including explicit definition of roles Create delegated authorities Executing contracts Hiring personnel Financial management Use of University trademarks/logos, etc. Solicitation and/or gift acceptance Relationships with local officials

24. Checklist for establishing operations abroad (con�t) Consider the following: Strategic significance Political stability Financial stability Banking Ability of local partners to provide working capital Financial sustainability Consistent funding source (e.g., grants and contracts, tuition, fees) Availability of funds subsidize Unexpected costs Logistics Legal Unrecovered indirects Safety and security Develop array of administrative processing options to address unique needs

25. Special Considerations Funding: What currency will be used? Is it a grant or a contract? Dispute Resolution: What laws/arbitration is agreed upon? Export control and ITAR (International Trade in Arms Regulations) Travel Carriers In-country taxes and add-ons

26. Export Controls Red Flags Shipping equipment to a foreign country? Collaborating with foreign colleagues in foreign countries? Working with a company subject to a US boycott? Training foreign nationals in using equipment? Using another parties� proprietary information? Sponsor approval rights over publications or foreign national participation?

27. 4. How do I handle Compliance Issues? IRB/IACUC (humans and animals) Conflict of Interest Scientific Integrity Antiquities Laws Intellectual Property laws and regulations First to file (Int�l) First to Invent (US) Natural Products

28. MYTH ! Other parts of the world have a different set of values when it comes to the integrity of research and what constitutes research misconduct. N.B. the Fogarty International Bioethics Education program.

29. 5. What Happens When I Finish the Program or Project? Establish closing decision-making criteria Identify transition issues Contractual Financial Human Resources Infrastructure Legal structure Partnerships Create handover to �surviving� entity, if applicable Complete �Close-Out� Requirements for Sponsors

30. Lynne ChronisterAssistant Vice Provost for Research,Executive Director of Sponsored Programs207-543-4043lchronis@u.washington.edu