research administration for scientists comp 918: research administration for scientists tim quigg,...

Research Administration for Scientists

COMP 918: Research Administration for Scientists

Tim Quigg, Associate Chair and LecturerComputer Science Department, UNC-Chapel Hill

International Research Projects: Administrative,

Budgetary, Legal and Practical Issues

© Copyright 2012 Timothy L. Quigg All Rights Reserved


Issues to Consider with Funded International

Research Projects Funding agency (U.S. or Foreign)? Single

source or multiple? What funding source rules apply? Are

there separate rules for each party? Limitations on applicants?

If the project will be funded by multiple sources (from different countries) are there any conflicting laws/rules?

What issues can get the PI or the institution in trouble?



Research Projects Who will be the prime – sub? Or does each

party have separate funding? Are all parties prepared to meet their

legal obligations? Have I ever worked with this foreign

collaborator before? This institution? If it’s a joint project but each party has its

own funding, are there conflicting issues, e.g., exclusive IP rights expected for both funders?



Research Projects Where is the project work to be performed?

Are there local governing laws to be considered?

Language, currency, import-export, visas?

Local logistics? What extra costs might be involved?



Research Projects What materials will need to be transferred

between locations? MTA’s? Export/import laws? Implications for intellectual property

ownership and/or bars to future research? Special needs for storing materials?

Costs?



Research Projects Are animal or human subjects involved?

Laws/rules in multiple countries? From multiple funding agencies?

Consider confidentiality and privacy laws as well as formal human subject laws.

Conflicting cultural norms in various countries? Among different groups in the same country?

We’ll begin with Projects Funded by U.S. Federal

AgenciesAny time a foreign or international

institution applies to a U.S. government agency for funding either directly or

indirectly (as a sub to a U.S. institution) they are subject to various U.S. “rules”

and policies!

Be certain the foreign institution has both the

willingness and the ability to comply before proceeding!

Foreign Institution Needs a DUNS

Data Universal Numbering System Number

In order to conduct business with the U.S. Federal Government, most organizations are required to obtain a DUNS number - a unique nine-character identification number provided by the commercial

company Dun & Bradstreet (D&B). You may call D&B at 1-866-705-5711 to register to obtain a DUNS

number.

The process of requesting a DUNS number takes about 10 minutes and

is free of charge.

Much of this presentation is based upon the National Institute of Health (NIH) approach to foreign grants. It generally applies to all U.S. federal agencies, but there may be some

exceptions, so be certain to check the agency-specific rules before

proceeding!Remember, private foundations or other non-governmental funding agencies are not bound by these

rules!

NIH Definitions Foreign Grant - A grant or cooperative agreement supporting research awarded to a foreign institution or international organization.

Grant – a legal instrument for transferring money, property, or services to the recipient in order to accomplish a public purpose of support or stimulation where there will be no substantial involvement between the federal agency and the recipient during performance.


Cooperative Agreement – a legal instrument for transferring money, property, or services to the recipient in order to accomplish a public purpose of support or stimulation where substantial involvement is expected between the government agency and the recipient.


Foreign Institution - An organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the

citizenship of the proposed PD/PI.

NIH DefinitionsForeign Grant - A grant or

cooperative agreement supporting research awarded to a foreign institution or international organization. International Organization - An

organization that identifies itself as international or intergovernmental and has

membership from, and represents the interests of, more than one country, without regard to whether the headquarters of the organization and location of the activity are

inside or outside of the US.

Who Is Eligible to Apply for Funding from U.S. Agencies?

In general foreign and international organizations are eligible to apply for many grants from U.S. government agencies, but usually they may not apply for contracts

Contract – an agreement, enforceable by law, between two or more competent parties, to do or not do something not

prohibited by law, for a legal consideration.


Who Is Eligible to Apply?

Simply check FOA (funding opportunity announcement) or BAA

(broad agency announcement) to determine eligibility

There are several “Foreign Specific Programs” available!


NIH DefinitionsForeign Component of a Domestic Project - The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to1) the involvement of human subjects or animals


NIH DefinitionsForeign Component of a Domestic Project - The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to(2) extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities


NIH DefinitionsForeign Component of a Domestic Project - The performance of any significant scientific element or segment of a project outside of the United States, either by the grantee or by a researcher employed by a foreign organization, whether or not grant funds are expended. Activities that would meet this definition include, but are not limited to(3) any activity of the grantee that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country


Foreign Components of a Domestic Project

often result in subcontracts or

consortium agreements!


Prior to developing the proposal, all parties should sign a

Collaboration Agreement that contains:CDA (confidential disclosure agreement) – the

parties may need to share confidential information in the process of preparing the proposal.

Detailed responsibilities of each party, time schedules and other pertinent information associated with preparing the proposal.

Prior agreement concerning any legal or other important issues, e.g., method and

frequency of payment!


Prior to developing the proposal, all parties should sign a

Collaboration Agreement that contains:A plan to address how progress reports,

financial status reports, and other required activities will be completed in a timely manner.

Agreement on methods for formal communications, language (English or multiple), currency for budgets and payments, and other potential problem areas.

Acknowledgement of and willingness to comply with any and all governing laws!

If there is a problem, identify and resolve it before wasting time developing the proposal!


NIH Requirements for Administering Sub-awards, Subcontracts and Consortium Agreements with Foreign Institutions

Policy requirements “flow down”. A domestic institution administering a subcontract to a foreign institution must assure the U.S. funding agency that it is holding its collaborator to the policies required for foreign institutions. Likewise, if the foreign grantee is the primary grantee, it must assure the U.S. funding agency that its American collaborator is following all the policies required for U.S. institutions.


Potentially Troublesome Issues: Budgets All budgets must be stated in U.S.

dollars There are a few costs that are generally

unallowable on budgets from foreign or international institutions

Costs Generally Unallowable Under Grants to Foreign

Institutions Major Alterations & Renovations costing over $500,000

Customs and Import Duties including consular fees, customs surtax,

value- added taxes and other related charges

Patient Care Costs – except in extraordinary circumstances as

approved in proposal!


Potentially Troublesome Issues: Budgets All budgets must be stated in U.S.

dollars There are a few costs that are generally

unallowable on budgets from foreign or international institutions

All budgets are subject to the applicable cost principles by type of applicant organization

Yes, that means foreign universities are subject to A-21!


Potentially Troublesome Issues: Payment Always in U.S. dollars via wire transfer

Encouraged (required) to use either U.S. bank or a bank with U.S. Branch

Must maintain grant funds in separate interest bearing bank account

Interest earned in excess of $250 on advances must be returned to

the funding agency or reflected on Financial Status Report (FSR)


Potentially Troublesome Issues:

Financial Reporting Always in U.S. dollars using applicable currency rate at time of FSR

FSR’s submitted annually within 90 days of end of budget period

Funds not spent at end of project must be returned to funding agency


Potentially Troublesome Issues: Audits Audit required if foreign institution

has spent > $500,000 on one or more awards from a U.S. agency in a year:

• financial-related audit of awards in accordance with Government Accounting Standards (GAS) - also known as Yellow Book or• an audit that meets OMB

Circular A-133 standards



Intellectual Property Must comply with the Bayh-Dole Act invention reporting requirements:• Allows recipients of U.S. federal funds

to retain ownership of patents• U.S. government retains non-exclusive

license to practice the invention – “government-use license” • In exchange, recipients must ensure

commercial use of patents through licensing or new company creation



Animal Welfare Must provide and have approved by the U.S. funding agency an Animal Welfare Assurance for foreign institutions

This constitutes institutional assurance and certification of compliance with

the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and a commitment to follow the International Guiding Principles for Biomedical Research Involving Animals.



Use of Select Agents Grantees who conduct research involving Select Agents must complete registration with the U.S. Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) or the U.S. Department of Agriculture (USDA), depending on the agent. No U.S. agency funds can be used if the final registration certificate is denied.


Human Subjects ProtectionAll proposed NIH-funded human subjects research, domestic or foreign, must include an Institutional Federal-wide Assurance (FWA) approved by the HHS Office for Human Research Protections (OHRP) http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html

FWA is a document designating the Institutional Review Board (IRB) that will review and oversee the research, specify the ethical principles under

which the research will be conducted, and names the individuals who will be responsible for the proper conduct of

research!

http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html



Human Subjects ProtectionAll proposed NIH-funded human subjects research, domestic or foreign, must include also:

Annual review and approval of proposed research by an Institutional Review Board (IRB) or

Institutional Ethics Committee (IEC) registered under the FWA

Human subjects education for all personnel involved with the design or conduct of human subjects research

All of the Same Issues Must be Considered with Projects

Funded by Non-U.S. AgenciesThe World Bank

Other International AgenciesCountry-specific Grants

EU Grants

Be certain your institution has both the willingness and the

ability to comply before proceeding!

research administration for scientists comp 918: research administration for scientists tim quigg,...

Documents

future research

international institution

duns number

scientistsforeign institution

multiple countries

separate funding

multiple funding agencies

funding source rules