Responsible Conduct of International Research


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The basics for submission, awarding, compliance and close out of international research and training programs.

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Responsible Conduct of International Research

  1. 1. Responsible Conduct of International Research: The Basics for Submission, Awarding, Compliance and Close Out of International Research and Training Programs
  2. 2. An Overview of Administrative and Compliance Issues <ul><li>_________________________________ </li></ul><ul><li>Preparation and Submission of Proposals </li></ul><ul><li>Setting up the Awards/Programs </li></ul><ul><li>Compliance and Assurances </li></ul><ul><li>Close-Out and Exit Strategies </li></ul>
  3. 3. 1. Where do I find the money? <ul><li>U. S. Federal Government </li></ul><ul><li>International Organizations </li></ul><ul><li>U.S. and Internationally Focused Foundations </li></ul><ul><li>Internationally-based Industries </li></ul><ul><li>International Governmental Organizations </li></ul><ul><li>Foreign Government Organizations </li></ul>
  4. 4. EU 7 th Framework Programme <ul><li>______________________________________________  </li></ul><ul><li>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. </li></ul><ul><li>FP7 is made up of four Secefic Programmes: </li></ul><ul><li>Cooperation (€32.4bn) </li></ul><ul><li>Capacities (€4.1bn) </li></ul><ul><li>People (€4.75bn) </li></ul><ul><li>Ideas (€7.5bn) </li></ul>
  5. 5. 7 th Framework Programme European Research Council (ERC) Starting Independent Research Grants - Information and Proposal Writing Events The UK Research Office – in its capacity as UK National Contact Point (NCP) for the European Research Council (ERC) – and in partnership with institutions from across the UK, will hold a series of information events for researchers (based in the UK or moving to the UK) interested in applying for the ERC Starting Grants. 
  6. 6. HRSA <ul><li>_____________________________________________ </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>
  7. 7. Fogarty International Center <ul><li>How to Apply for or Manage a Grant </li></ul><ul><li>Fogarty International Center (FIC) does NOT: </li></ul><ul><li>Accept unsolicited grant applications </li></ul><ul><li>Provide grants specifically for foreign travel to meetings or conferences </li></ul><ul><li>Provide training grants directly to students; we do provide training grants to institutions who select trainees. </li></ul><ul><li>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. </li></ul><ul><li>General NIH Grants Information </li></ul>
  8. 8. Department of Homeland Security <ul><li>___________ </li></ul><ul><li>International Research Grants offered by the Department of Homeland Security </li></ul><ul><li>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): </li></ul><ul><li>  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. </li></ul><ul><li>To learn more and to apply, visit and look under funding opportunity DHS-08-ST-108-002. </li></ul>
  9. 9. Bill and Melinda Gates Foundation <ul><li>_______________________________________________ </li></ul><ul><li>Now Accepting Proposals for Grand Challenges Explorations Round 2      </li></ul><ul><li>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 /explorations through November 2, 2008. </li></ul>
  10. 10. US AID ____________________________________ Results-Oriented Assistance: A USAID Sourcebook Sourcebook Objectives: To create a &quot;user friendly&quot; resource for USAID staff and Development Partners (e.g., private voluntary organizations (PVOs), non-governmental organizations (NGOs), cooperative development organizations, educational institutions, and private firms) on USAID's programming policies and procedures
  11. 11. 2. How Do I Submit a Proposal? <ul><li>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). </li></ul><ul><li>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. </li></ul>
  12. 12. 3. What Do I Do When I Get Funded? <ul><li>“ We’re not in Kansas any more…” </li></ul>
  13. 13. What do I do? <ul><li>First, celebrate! </li></ul><ul><li>Second, be sure to let OSP and your department administrator know. OSP will request that Grants and Contracts Accounting (GCA) set up an award. </li></ul>
  14. 14. Ethical/Business Frameworks for International Research
  15. 15. Who is Responsible? <ul><li>Individual Investigators and Research teams: </li></ul><ul><ul><li>Human and animal protections, integrity in the conduct of research </li></ul></ul><ul><li>Government: </li></ul><ul><ul><li>Setting standards and providing guidance and resources </li></ul></ul><ul><li>Institutions: </li></ul><ul><ul><li>Policy, infrastructure and facilitation </li></ul></ul>
  16. 16. <ul><li>Core Steering Team </li></ul><ul><li>Assistant Vice President and Controller </li></ul><ul><li>Senior staff from key admin support depts. </li></ul><ul><li>Senior school & college administrators </li></ul><ul><li>Provost’s Office </li></ul>Cash Advances Process Improvements Project Sponsors Vice Provost for Global Affairs Vice Provost for Research Global Support Project Phase I ─ Research & Sponsored Projects Project Oversight Structure Project Advisors Attorney General’s Office Environmental Health & Safety Internal Audit Risk Management Executive Sponsors UW Provost/EVP Sr. Vice President, Finance and Facilities Faculty Consulting Group Faculty active in global research & education Non-resident Alien Tax Process Improvements Sub-contracting Process Improvements International HR Process Improvements
  17. 17. Are researchers complying with US human subject standards in their international research? <ul><li>Considerations </li></ul><ul><li>Does the host country require its own IRB? </li></ul><ul><li>Are there aspects of local context that must considered? </li></ul><ul><li>Is it truly “informed consent”? </li></ul><ul><li>Is the value to the country clear if human specimens are taken? </li></ul><ul><li>Risks </li></ul><ul><li>Subjects may be negatively impacted due to participation </li></ul><ul><li>Future research in-country may be prohibited </li></ul><ul><li>Researcher can’t publish without IRB approval </li></ul>
  18. 18. Is your research operation required to establish legal status in-country? <ul><li>Considerations </li></ul><ul><li>Legal status may be required to open a bank account, lease space and pay local salaries </li></ul><ul><li>Involve your legal counsel </li></ul><ul><li>Engage in-country legal counsel </li></ul><ul><li>Thoroughly understand risks & benefits of registration options </li></ul><ul><li>Risks </li></ul><ul><li>Delays in program activity </li></ul><ul><li>Personal safety </li></ul><ul><li>Loss of assets </li></ul><ul><li>Regulatory action </li></ul>
  19. 19. How do you make cash available in countries that don’t have well-established banking systems? <ul><li>Considerations </li></ul><ul><li>Checks issued from US </li></ul><ul><li>Electronic wires to foreign bank account </li></ul><ul><li>Work with local “logistics” firm </li></ul><ul><li>Pay vendors directly from US institution via PO </li></ul><ul><li>Subcontract with foreign institution or non-profit </li></ul><ul><li>Risks </li></ul><ul><li>Program activity may be disrupted </li></ul><ul><li>Inefficient operations using wires </li></ul><ul><li>Excessive foreign banking “fees” </li></ul>
  20. 20. How should a research program hire staff to work in-country? <ul><li>Considerations </li></ul><ul><li>Hire as university employee vs. purchase services from an individual </li></ul><ul><li>If a university employee, are pay & benefit package applicable, relevant and competitive locally ? </li></ul><ul><li>If a contract, does it have to meet in-country personnel laws and US/state agency employment laws? </li></ul>Risks <ul><li>Won’t be competitive in tight job market in-country </li></ul><ul><li>Create frustration for employees & program staff </li></ul><ul><li>Salaries too high could negatively impact local employment norms </li></ul>
  21. 21. Building the Framework <ul><li>Communication & Outreach </li></ul><ul><ul><li>Single points of contact in </li></ul></ul><ul><ul><li>central offices </li></ul></ul><ul><ul><li>Global Support Manager meets with </li></ul></ul><ul><ul><li>global programs to ID issues </li></ul></ul><ul><ul><li>Website/portal </li></ul></ul><ul><ul><li> </li></ul></ul><ul><ul><li>Briefings with Deans </li></ul></ul><ul><ul><li>Faculty Consulting Team </li></ul></ul><ul><li>Human Resources </li></ul><ul><ul><li>Guidance for global hiring </li></ul></ul><ul><ul><li>Internal job codes & benefit rates </li></ul></ul><ul><ul><li>Expanded relocation compensation </li></ul></ul><ul><li>Information Technology </li></ul><ul><ul><li>Country-specific connectivity information </li></ul></ul><ul><ul><li>Financial </li></ul></ul><ul><ul><ul><li>New guide for foreign tax issues </li></ul></ul></ul><ul><ul><ul><li>Cash advance improvements </li></ul></ul></ul><ul><ul><li>Legal </li></ul></ul><ul><ul><ul><li>UW non-profit established-in-country registration </li></ul></ul></ul><ul><ul><ul><li>Identified legal counsel in countries </li></ul></ul></ul><ul><ul><li>Risk and Safety </li></ul></ul><ul><ul><ul><li>Guidance on insurance </li></ul></ul></ul><ul><ul><ul><li>coverage while abroad </li></ul></ul></ul>
  22. 22. <ul><li>International </li></ul><ul><li>Partners may </li></ul><ul><li>Have a different </li></ul><ul><li>Set of Infra- </li></ul><ul><li>structure </li></ul><ul><li>Issues to </li></ul><ul><li>Deal with! </li></ul>
  23. 23. Checklist for establishing operations abroad <ul><li>Determine whether nature of operations requires legal registration within the host country </li></ul><ul><ul><li>Will vary by country </li></ul></ul><ul><ul><li>May require outside legal counsel </li></ul></ul><ul><ul><li>Options may be impacted by University’s legal definition </li></ul></ul><ul><ul><li>Registration may have unintended impacts (e.g., perception by local population) </li></ul></ul><ul><li>Establish internal review/approval process, including explicit definition of roles </li></ul><ul><li>Create delegated authorities </li></ul><ul><ul><li>Executing contracts </li></ul></ul><ul><ul><li>Hiring personnel </li></ul></ul><ul><ul><li>Financial management </li></ul></ul><ul><ul><li>Use of University trademarks/logos, etc. </li></ul></ul><ul><ul><li>Solicitation and/or gift acceptance </li></ul></ul><ul><ul><li>Relationships with local officials </li></ul></ul>
  24. 24. Checklist for establishing operations abroad (con’t) <ul><li>Consider the following: </li></ul><ul><ul><li>Strategic significance </li></ul></ul><ul><ul><li>Political stability </li></ul></ul><ul><ul><li>Financial stability </li></ul></ul><ul><ul><ul><li>Banking </li></ul></ul></ul><ul><ul><ul><li>Ability of local partners to provide working capital </li></ul></ul></ul><ul><ul><li>Financial sustainability </li></ul></ul><ul><ul><ul><li>Consistent funding source (e.g., grants and contracts, tuition, fees) </li></ul></ul></ul><ul><ul><ul><li>Availability of funds subsidize </li></ul></ul></ul><ul><ul><ul><li>Unexpected costs </li></ul></ul></ul><ul><ul><ul><ul><li>Logistics </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Legal </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Unrecovered indirects </li></ul></ul></ul></ul><ul><ul><li>Safety and security </li></ul></ul><ul><li>Develop array of administrative processing options to address unique needs </li></ul>
  25. 25. Special Considerations <ul><li>Funding: What currency will be used? </li></ul><ul><li>Is it a grant or a contract? </li></ul><ul><li>Dispute Resolution: What laws/arbitration is agreed upon? </li></ul><ul><li>Export control and ITAR (International Trade in Arms Regulations) </li></ul><ul><li>Travel Carriers </li></ul><ul><li>In-country taxes and add-ons </li></ul>
  26. 26. Export Controls Red Flags <ul><li>Shipping equipment to a foreign country? </li></ul><ul><li>Collaborating with foreign colleagues in foreign countries? </li></ul><ul><li>Working with a company subject to a US boycott? </li></ul><ul><li>Training foreign nationals in using equipment? </li></ul><ul><li>Using another parties’ proprietary information? </li></ul><ul><li>Sponsor approval rights over publications or foreign national participation? </li></ul>
  27. 27. 4. How do I handle Compliance Issues? <ul><li>IRB/IACUC (humans and animals) </li></ul><ul><li>Conflict of Interest </li></ul><ul><li>Scientific Integrity </li></ul><ul><li>Antiquities Laws </li></ul><ul><li>Intellectual Property laws and regulations </li></ul><ul><ul><li>First to file (Int’l) </li></ul></ul><ul><ul><li>First to Invent (US) </li></ul></ul><ul><ul><li>Natural Products </li></ul></ul>
  28. 28. MYTH ! <ul><li>Other parts of the world have a different set of values when it comes to the integrity of research and what constitutes research misconduct. </li></ul><ul><li>N.B. the Fogarty International Bioethics Education program. </li></ul>
  29. 29. 5. What Happens When I Finish the Program or Project? <ul><li>Establish closing decision-making criteria </li></ul><ul><li>Identify transition issues </li></ul><ul><ul><li>Contractual </li></ul></ul><ul><ul><li>Financial </li></ul></ul><ul><ul><li>Human Resources </li></ul></ul><ul><ul><li>Infrastructure </li></ul></ul><ul><ul><li>Legal structure </li></ul></ul><ul><ul><li>Partnerships </li></ul></ul><ul><li>Create handover to “surviving” entity, if applicable </li></ul><ul><li>Complete “Close-Out” Requirements for Sponsors </li></ul>
  30. 30. Lynne Chronister Assistant Vice Provost for Research, Executive Director of Sponsored Programs 207-543-4043 [email_address]