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

lchronis@uw.edu