Responsible Conduct of International Research: The Basics

for Submission, Awarding, Compliance and Close Out of International

Research and Training Programs

An Overview of Administrative and Compliance Issues

_________________________________

• Preparation and Submission of Proposals

• Setting up the Awards/Programs

• Compliance and Assurances

• Close-Out and Exit Strategies

1. Where do I find the money?

• U. S. Federal Government

• International Organizations

• U.S. and Internationally Focused Foundations

• Internationally-based Industries

• International Governmental Organizations

• Foreign Government Organizations

EU 7th Framework Programme

______________________________________________ • 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.

• FP7 is made up of four Secefic Programmes:• Cooperation (€32.4bn) • Capacities (€4.1bn) • People (€4.75bn) • Ideas (€7.5bn)

7th Framework ProgrammeEuropean 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. 

HRSA

_____________________________________________• 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.

• 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.

Fogarty International Center

• How to Apply for or Manage a Grant• Fogarty International Center (FIC) does NOT: • Accept unsolicited grant applications • Provide grants specifically for foreign travel to meetings or

conferences • Provide training grants directly to students; we do provide

training grants to institutions who select trainees. • 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.

• General NIH Grants Information

Department of Homeland Security

___________• International Research Grants offered by the Department of

Homeland Security• 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):

•  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.

• To learn more and to apply, visit www.grants.gov and look under funding opportunity DHS-08-ST-108-002.

Bill and Melinda Gates Foundation

_______________________________________________• Now Accepting Proposals for Grand Challenges

Explorations Round 2     

• 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 www.gcgh.org/explorations through November 2, 2008.

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

2. How Do I Submit a Proposal?

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).

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.

3. What Do I Do When I Get Funded?

“We’re not in Kansas any more…”

What do I do?

First, celebrate!

Second, be sure to let OSP and your department administrator know. OSP will request that Grants and Contracts Accounting (GCA) set up an award.

Ethical/Business Frameworks for International Research

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

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

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

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

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”

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

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

International

Partners may

Have a different

Set of Infra-

structure

Issues to

Deal with!

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

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

Special Considerations

1) Funding: What currency will be used?

2) Is it a grant or a contract?

3) Dispute Resolution: What laws/arbitration is agreed upon?

4) Export control and ITAR (International Trade in Arms Regulations)

5) Travel Carriers

6) In-country taxes and add-ons

Export Controls 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?

4. How do I handle Compliance Issues?

• IRB/IACUC (humans and animals)

• Conflict of Interest

• Scientific Integrity

• Antiquities Laws

• Intellectual Property laws and regulations– First to file (Int’l)– First to Invent (US)– Natural Products

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.

N.B. the Fogarty International Bioethics Education program.

5. What Happens When I Finish the Program or Project?

• 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

Lynne ChronisterAssistant Vice Provost for Research,

Executive Director of Sponsored Programs

207-543-4043lchronis@u.washington.edu