Ethical Frameworks for  International Research
Presenters <ul><li>Richard  Deckelbaum, MD,CM, FRCP(C) </li></ul><ul><li>Columbia University </li></ul><ul><li>Christina B...
Who is Responsible? <ul><li>Individual Investigators and Research teams: </li></ul><ul><ul><li>Human and animal protection...
CASE STUDY University of Washington Global Support Project Credit to: Ann Anderson   Associate Vice President and Controll...
“ We’re not in Kansas any more…”
<ul><li>Core Steering Team </li></ul><ul><li>Assistant Vice President and Controller </li></ul><ul><li>Senior staff from k...
Are researchers complying with US human subject standards in their international research? <ul><li>Considerations </li></u...
Is your research operation required to establish legal status in-country? <ul><li>Considerations </li></ul><ul><li>Legal s...
How do you make cash available in countries that don’t have well-established banking systems? <ul><li>Considerations </li>...
How should a research program hire staff to work in-country? <ul><li>Considerations </li></ul><ul><li>Hire as university e...
Building the Framework <ul><li>Communication & Outreach </li></ul><ul><ul><li>Single points of contact in </li></ul></ul><...
Checklist for  establishing  operations abroad <ul><li>Determine whether nature of operations requires legal registration ...
Checklist for  establishing  operations abroad (con’t) <ul><li>Consider the following: </li></ul><ul><ul><li>Strategic sig...
Checklist for  closing  operations abroad <ul><li>Establish closing decision-making criteria </li></ul><ul><li>Identify tr...
Lessons learned <ul><li>There is no one best way…many options must be available </li></ul><ul><li>Creative and compliant s...
<ul><li>International </li></ul><ul><li>Partners may </li></ul><ul><li>Have a different </li></ul><ul><li>Set of Infra- </...
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Ethical Frameworks for International Research

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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.

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Ethical Frameworks for International Research

  1. 1. Ethical Frameworks for International Research
  2. 2. Presenters <ul><li>Richard Deckelbaum, MD,CM, FRCP(C) </li></ul><ul><li>Columbia University </li></ul><ul><li>Christina Boesz, Inspector General </li></ul><ul><li>National Science Foundation </li></ul><ul><li>Lynne Chronister, Office of Research </li></ul><ul><li>University of Washington </li></ul>
  3. 3. 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>
  4. 4. CASE STUDY University of Washington Global Support Project Credit to: Ann Anderson Associate Vice President and Controller, Financial Management 206-543-4993; [email_address] Kate Riley, Ph.D Project Manager, Global Support Project www.washington.edu/admin/finmgmt/globalsupport/ Lawrie, Robertson, Director of Finance and Administration School of Public Health and Community Medicine [email_address]
  5. 5. “ We’re not in Kansas any more…”
  6. 6. <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
  7. 7. 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>
  8. 8. 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>
  9. 9. 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>
  10. 10. 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>
  11. 11. 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>http://www.washington.edu/admin/finmgmt/globalsupport/ </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>
  12. 12. 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>
  13. 13. 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>
  14. 14. Checklist for closing operations abroad <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>
  15. 15. Lessons learned <ul><li>There is no one best way…many options must be available </li></ul><ul><li>Creative and compliant solutions can be established—but risk can’t be totally eliminated </li></ul><ul><li>Challenges are not unique among institutions but answers are unique by country </li></ul><ul><li>Situations “on the ground” can change very rapidly; we need to be able to respond quickly </li></ul>
  16. 16. <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>

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