frameworks for conducting international research · 2015-04-20 · faculty consulting group faculty...
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Frameworks for Conducting International ResearchInstitute for Translational Health SciencesMay 5, 2010
An Overview
• Opportunities
• UW Global Support Project
• Regulatory Compliance
• Special Interest
• Global Practices
Where do I find the money?
• U.S. Federal Government
• Domestic and Internationally-focused Foundations
• Internationally-based Industries
• International Organizations
• Foreign Governments
EU 7th Framework Programme• The Seventh Framework Programme (FP7) is
the EU’s main RTD funding programme for the period 2007-2013
• Total budget greater than €50 billion• Marine science and technology identified as a
priority cross-cutting theme• FP7 is made up of four specific programmes:
– Cooperation (€32.4bn) – Capacities (€4.1bn) – People (€4.75bn) – Ideas (€7.5bn)
Department of Homeland Security• International Research Grants offered by the Department
of Homeland Security (DHS)
• Annual solicitation for international research proposals, aligned with their science & technology mission(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– 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.
US AID
Results-Oriented Assistance: A USAID Sourcebook
Sourcebook Objectives: To create a "user friendly" 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
What Do I Do When I Get Funded?
UW Around the World
UWorld Subsidiaries• Botswana Ethiopia• Guyana Namibia• Mozambique Tanzania• China Research and Development Enterprise:
Beijing• South Africa (under SA law)• Spain and Kenya: In process• Haiti: Proposed• Peru: Early Stage
Core Steering TeamAssistant Vice President and Controller
-Senior staff from key admin support depts.-Senior school & college administrators
-Provost’s Office
Cash AdvancesProcess
Improvements
Project SponsorsVice Provost for Global Affairs
Vice Provost for Research
Global Support ProjectPhase I ─ Research & Sponsored Projects
Project Oversight Structure
Project AdvisorsAttorney General’s Office
Environmental Health & SafetyInternal Audit
Risk Management
Executive SponsorsUW Provost/EVP
Sr. Vice President, Finance and Facilities
Faculty Consulting GroupFaculty active in global research
& education
Non-resident Alien Tax
Process Improvements
International HR
Process Improvements
Are researchers complying with U.S. 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
Questions?
Which IRB has final authority? No regulation but “follow the money” is standard
Do all IRB regs apply int’l? FDA studies-yes
UW generally applied the Common Rule.
Does HIPAA apply? No
Is your research operation requiredto 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
Risks
• Delays in program activity
• Personal safety • Loss of assets• Regulatory
action
How do you make cash availablein 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”
Challenges:
“In absence of registration or legal status, take on as little administration as possible”
Bill Nicholson
Washington Ass’t A G
Methods for working in country (monetary )
• Registration or legal status
• Subcontract
• “find someone you trust”
• Carry cash
Examples
Foreign Exchange Regulation Act (India)
Must have permision
Must be Indian controlled
Must be Indian Citizen
Criminal Penalties
How should a research program hire staff to work in-country?
Considerations• Hire as university employee
vs. purchase services from an individual
• If a university employee, are pay & benefit package applicable, relevant and competitive locally?
• If a contract, does it have to meet in-country personnel laws and US/state agency employment laws?
Risks
• Won’t be competitive in tight job market in-country
• Create frustration for employees & program staff
• Salaries too high could negatively impact local employment norms
Challenges:
• Personal visa and tax issues: (may be cumulative)
• Generally need to be registered or have legal status
• Listed with in-country dept of labor– Withholding income
– Wage reports etc.
Building the FrameworkCommunication & Outreach
Single points of contact incentral offices Global Support Manager meets with
global programs to ID issues Website/portal http://www.washington.edu/admin/finmgmt/globalsupport/
Briefings with Deans Faculty Consulting Team
Human Resources Guidance for global hiring Internal job codes & benefit rates Expanded relocation compensation
Information Technology Country-specific connectivity information
Financial New guide for foreign tax issues Cash advance improvements
Legal •UW non-profit established in-country registration•Identified legal counsel in countries
Risk and Safety Guidance on insurance coverage while abroad
Checklist 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
Checklist Establishing Operations Abroad
• Create delegated authorities–Executing contracts–Hiring personnel–Financial management–Use of University trademarks/logos, etc.–Solicitation and/or gift acceptance–Relationships with local officials
• Develop array of administrative processing options to address unique needs
Checklist Establishing Operations Abroad
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
Checklist Closing Operations Abroad
• 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
International
partners may
have a
different set of
infrastructure
issues to
deal with!
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
Intellectual Property
• Intellectual Property laws and regulations– First to file (foreign)
– First to Invent (U.S.)
– Natural Products
• Humanitarian Purposes– Negotiate either in agreement or license
Export Control 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?
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. They may and will have a different set of policies and practices.
Singapore Statement on Research Integrity (July 2010)
“The World Conferences on Research Integrity represent effort to provide guidance for
promoting integrity in research throughout the world.”
Purpose: “… to establish a much-needed agreement on the basic principles that should inform all research”
Wellcome Trust
“…all research in developing countries should:
– (ensure)…the prospective treatment will or might foreseeably become available to local patients on a sustainable basis.
– (ensure).. prospective treatment will or might foreseeably become affordable locally.
– (ensure)…prospective treatments could be delivered within existing structures.”
NIH Support
• International Research Ethics Education And Curriculum Development Award (R25)
The Fogarty International Center (FIC) invites applications for International Research Ethics Education and Curriculum Development awards to develop graduate level curricula and provide opportunities for developing country academics, researchers and health professionals in international research ethics related to performing research involving human subjects.
University of Ibadan: Mission
• “To expand the frontiers of knowledge through provision of excellent conditions for learning and research.
• To produce graduates who are worthy in character and sound judgment.
• To contribute to the transformation of society through creativity and innovation.
• To serve as a dynamic custodian of society's salutary values and thus sustain its integrity”
University of Ibadan website
How do I handle Compliance Issues with International Partners?
P.I. Responsibilities (primary)– IRB/IACUC (humans and animals)– Conflict of Interest– Scientific Integrity– Antiquities Laws
Institutional Responsibilities (primary)– Almost 80 Assurances– e.g. Drug Free workplace and workforce
Geoff Grant, May, 2005
Ensuring Ensuring Research Research
Protection:Protection:PrinciplesPrinciples & &
ResponsibilitiesResponsibilities
•SEVIS/Visas (new)•Export controls (new)•Title IX •Lobbying •Debarment•Drug Use
•Reasonable Allocation of Costs•Salary Charges/Effort Reporting•Indirect Costs•Cost Sharing
Conduct of Research Protections/Safeguards
Cost Policy/Financial Management
Public Policy Requirements
Ensure validity of results/maximize return on public investment
Provide safety/welfare of subjects & environment
Ensure fair & reasonable costs to government
Meet national social, economic, security interests
IRB Regulation Spaghetti!
“The U.S. regulations are “exported” to other countries and interpreted by researchers…
NBAC has noted that even for domestic researchers, the U.S. regulations are at times difficult t interpret and require clarification…understanding and interpreting …in other settings could prse even more profound difficulties.”
National Bioethics Advisory Commission, Chapter 1, April, 2001
Other issues: Ethical Concerns
When and how should placebo-controlled trials be used?
Example: NIH/ACTG 076 study regarding maternal to child transmission of HIV. Standard of care in U.S.; not so in developing nations.
Resources for Human Subjects Protection
OHRP website
International Compilation of Human Research Protections, 2010 Edition
Compiled By: Office for Human Research Protections, DHHS
http://www.hhs.gov/ohrp/international
Conflict of Interest
• Federal and UW Policy
• You may have a Conflict of Interest (COI) if you have a Significant Financial Interest in the sponsor of your research.
• UW must manage, reduce or eliminate any COI on a sponsored project
• Determined by review in Office of Research
UW Policy on SFI
• Financial Interest means any interest of economic or monetary value of an investigator/inventor and/or a member of that person's immediate family (spouse, parent, child, grandparent, grandchild, or sibling) that could reasonably appear to affect or to be affected by the particular research or technology transfer transaction …
Conflict of Interest
SFI Disclosure Form Statement
The PI affirms that all investigators on the project have read the UW Investigator Significant Financial Interest Disclosure Policy for Sponsored Projects and that the proposed project does or does not require investigators to complete the UW Significant Financial Interest Disclosure Form. (Attach the completed form if applicable).
International Example
Some of the Chinese universities accept and seek funds from commercial entities and endorse their products e.g. toothpaste.
This would be unacceptable in the U.S.
Scientific Misconduct: U.S.
• Fabrication, falsification or plagiarism in proposing, performing or reviewing research or in reporting results
• It does not include honest error or differences in interpretations or judgments or differences of opinion
• Sequestration of data, materials and files
Responsibilities of Researchers
• To avoid misconduct
• To assure integrity in conducting of research, including proper assignment of credit in publication
• To report instances of misconduct
• To report instances of retaliation against those who bring good faith charges of misconduct
Finland
Misconduct in research is “gross negligence and irresponsibility” e.g. understatement of another’s contributions, negligence in referring to earlier findings, publication of same results several times.
Fraud in Science is falsification, fabrication, plagiarism and misappropriation.
Conducting Investigations
• Even within the EU (7th framework) there is no consistency.
• Who takes the lead on investigations? • Does the institution lead the investigator or is it
done by the government?
Global Science Forum, Organization for Economic and Cooperation and Development, Tokyo, Japan, 2007
The quick harvest of applied science is the usable process, the
medicine, the machine.
Lincoln Barnett (1950)
Thank you!
Lynne Chronister
Assistant Vice Provost for Research
Director of Sponsored Programs
206-543-4043