ethical frameworks for international research
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Post on 25-May-2015
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Introduce the who is responsible and how to build to framework, introduce the case study of the Global Support Project at University of Washington.TRANSCRIPT
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Ethical Frameworks for International Research
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Presenters
Richard Deckelbaum, MD,CM, FRCP(C)Columbia University
Christina Boesz, Inspector GeneralNational Science Foundation
Lynne Chronister, Office of ResearchUniversity of Washington
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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
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CASE STUDYUniversity of Washington
Global Support Project
Credit to:Ann Anderson
Associate Vice President and Controller, Financial Management206-543-4993; [email protected]
Kate Riley, Ph.DProject Manager, Global Support Project
www.washington.edu/admin/finmgmt/globalsupport/
Lawrie, Robertson, Director of Finance and AdministrationSchool of Public Health and Community Medicine
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“We’re not in Kansas any more…”
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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
Sub-contracting
Process Improvements
International HR
Process Improvements
Non-resident Alien Tax
Process Improvements
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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
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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
Risks
• Delays in program activity
• Personal safety
• Loss of assets• Regulatory
action
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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”
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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
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Building the Framework
• Communication & Outreach Single points of contact in central 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
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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
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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
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Checklist for 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
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Lessons learned
• There is no one best way…many options must be
available
• Creative and compliant solutions can be established
—but risk can’t be totally eliminated
• Challenges are not unique among institutions but
answers are unique by country
• Situations “on the ground” can change very rapidly;
we need to be able to respond quickly
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International
Partners may
Have a different
Set of Infra-
structure
Issues to
Deal with!