web.mit.edu

Pre-Award Fundamentals of

Research Administration

NCURA Region I Annual Spring Meeting

May 7th, 2006

Portland, Maine

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FACULTY• Sara Clabby

Contract Administrator, Office of Sponsored Programs, Brown University

• Bethanne GiehlAssistant Director, Research Funding

Services

University of Massachusetts Medical School

• Celia GravelyProject Manager

Huron Consulting Services

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Frequently Asked Questions that will NOT be Answered…

• Why do faculty always wait until the last minute?

• Why does the government only add regulations, but never takes any away?

• Is it too late to find another line of work?

• Is there a profession with more acronyms than Research Administration?

• Why is this meeting room so hot?

• And…..

• Why is this room so cold?

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PreAward Fundamentals

• Rules & Requirements

Federal Guidelines

Sponsor Guidelines

Institution Policies• Sponsored Projects Administration

What we do

Who we are

Central and De-central• Why?

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Lifecycle of a Proposal/Award

Pre-Award Post-AwardDevelopment

Agency

Review

(6-9 mos)

Project Period

1stBudgetPeriod

2ndBudgetPeriod

3rdBudgetPeriod

NoCost

Extension

Revised Budget

Submit Renewal /

Competing-Contin

uation

Closeout

Final Reports

Submit Proposal

Pre-Award CostsAward

Award

Apply

Find/ExploreAdminister/Monitor(Post-Award Office)

Perform(Principal Investigator)

Technical Close(Principal Investigator)

Financial Close(Post-Award Office)

6“Research and development! My goodness!”

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The Rules and Who Makes ThemA Structure Based on:• Overarching Federal Regulations• Parties to the relationship

– Sponsors and Performers– Sponsors announce opportunities

• The formal Agreement between the parties– Grant; Contract; Cooperative

Agreement• Agreements contain a set of rules,

terms, and conditions– Statutes; regulations; standard

terms; specific conditions

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Who are our Sponsors?

• Federal Government

– Departments

• Agencies

– Independent Agencies

• State Government

• Foundations and Non-Profit Organizations

• Industry

– Large Entities (over 500 Employees)

– Small Entities (under 500 Employees)

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Examples of our SponsorsAgencies or Sponsors

DHHS Department of Health and Human ServicesPHS Public Health ServiceNIH National Institutes of Health

NSF National Science Foundation

DOD Department of DefenseAFOSR Air Force Office of Scientific

ResearchARPA Advanced Research Projects

OfficeARO Army Research OfficeONR Office of Naval Research

DOC Department of CommerceNIST Nat. Inst. of Standards and

Technology AHAAHA American Heart AssociationJDRFJDRF Juvenile Diabetes Research FoundationWhitakerWhitaker Whitaker FoundationMonsanto Monsanto IndustriesHP Hewlett-PackardMASS-Ed Massachusetts Department of EducationFL-F&W Florida Department of Fish and Wildlife

Federal

Non-Non-ProfitProfit

Industry

State

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How Sponsors Announce Opportunities

PA Program Announcement (sponsor publication, Federal

Register, FedBizzOpps) (grants, cooperative agreements)

RFA Request for Applications (grants, cooperative agreements)

RFP Request for Proposals (contracts)

RFQ Request for Quotation (contracts)

RFB Request for Bid (contracts)

BAA Broad Agency Announcement (grant, cooperative agreement, contract)

Response to Announcement in Form of Proposal

Also called application; quotation; bid

Lays out general plan of work, personnel, budget to meet stated objectives

un

solic

ited

solic

ited

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Types of Agreements:

• Most Common Types of Formal Agreements With the Federal Government

• Types of Award Actions

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Formal Agreements

• Most Common Types Of Formal Agreements

– Grant

– Cooperative Agreement

– Contract

Assistance Mechanisms

Procurement

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Formal Agreements: Assistance Mechanisms

• Grant– Purpose is to transfer money, property, services,

or anything of value to recipient in order to accomplish a public purpose

– Idea originates with “performer”– No substantial involvement is anticipated between

sponsor and recipient during performance of activity

• Cooperative Agreement– Principal purpose is to transfer funds to recipient

to accomplish a public purpose– Idea may originate with “performer”– Substantial involvement is anticipated between

sponsor and recipient during performance of activity

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Formal Agreements: Procurement Mechanisms

• Contract– Often called a “procurement

mechanism”– Sponsor determines that

procurement contract is appropriate

– Principal purpose is to acquire property or services for direct benefit or use of the sponsor

– Idea originates with “sponsor”

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Contract Types

• Fixed Price Contract

• Cost-reimbursement Contract

• Time-and-Materials Contract

• Labor-hour Contract

• Plus variations and combinations of each of the above

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Fixed Price Contracts

• Procurement of supplies or services on the basis of reasonably definite functional or detailed specifications.

• When costs can be estimated reasonably accurately.

• Imposes on contractor maximum incentive to control costs, but with minimum administrative burden.

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Cost-Reimbursement Contracts

• Procurement of non-commercial items which cannot be based on reasonably definite functional or detailed specifications (i.e., R&D).

• There is no incentive for contractor to control costs, thus government imposes tighter controls.

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CR/FP - How Do I Tell?

• Cost-Reimbursement– “Total estimated

cost” or “not to exceed amount”

– Invoicing based on expenditures

– Listed FAR clauses.

• Fixed Price– “Total Price”

– Invoicing based on milestones

– Generally, POs are fixed-price

– Listed FAR clauses

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Time-and-Materials and Labor Hour Contracts

• Reimbursement of hours worked, not costs incurred.• Fixed hourly rate that incorporates salary, fringe

benefits, F&A, and fee.• Rates invoiced must match proposed rates, regardless

of actual cost incurred.• Audit?• What to do about them…

– Don’t accept unless your financial system can support it.

– Argue on the basis of cost accounting standards; or– Negotiate a range to the allowable invoicing rates

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Grant vs. Contract

Grant• project conceived by investigator• agency supports or

assists• performer defines

details and retains scientific

freedom• agency maintains

cognizance• unilateral

Contract• project conceived by

agency• agency procures

service• agency exercises

direction or control• agency closely

monitors• bilateral

Comparing the Basic Types Of Agreements

COOPERATIVEGRANT AGREEMENT CONTRACT

BASIC PURPOSE Provide assistance Provide assistance with substantial Procure tangible with few restrictions involvement between parties goods and services

SOLICITATION METHOD Application kit or Request for Application Request for Proposal or guidelines Quote

AWARD INSTRUMENT Short, may refer to Describes involvement, party Long, detailed specs, general conditions relationships clauses, regulations,

andexpected result

INVOLVEMENT Generally none Substantial involvement May be extensiveBY SPONSOR

REBUDGETING Flexible Usually flexible More restrictive

EQUIPMENT TITLE Grantee Varies Varies

PERFORMANCE PERIOD Specified in Grant Specified in Coop. Agreement Specified in Contract

PATENT RIGHTS Usually favor recipient May be involved Provision in contract

PUBLICATIONS May ask to be informed May ask to be informed May be prior review/approval

TECHNICAL Annual summary report No more than quarterly Detailed, maybe monthly

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Hierarchy of Federal Regulations

Sources:• Statutory requirements

(i.e., an Act of Congress, becoming Public Law)

• Presidential Executive Order

• Federal regulations

• Sponsor’s terms/conditions

NIH Salary cap appears as statutory language in the HHS

appropriations act

Affirmative Action

NSF regulations on Uniform Administrative Requirements

appear in 45 CFR 602

NSF grant terms and conditions appear in the NSF Grant Policy Manual & NSF

Grant General Conditions (CG-1)

Examples:Examples:

How Do Federal Regulations Happen?

ORIGIN PUBLIC LAW PRESIDENTIAL FEDERAL AGENCY(statutory requirement) EXECUTIVE ORDER REGULATIONUNITED STATES CODE (USC)

Grants ContractsEXECUTIVE OMB-CIRCULARS FAR Councils OMB CLEARANCE

Transmittal Memos - civilianCOMMON RULE - defense

AGENCY CODE OF FEDERAL REGS (CFR) FEDERAL REGISTER(Dept/agency Specific) (rulemaking; comment period)

IMPLEMENTATION AGENCY REGS FEDERAL REGISTER FEDERAL REGISTERFEDERAL ACQUISITION REGS AGENCY GRANT REGS AGENCY REGS(contracts only) (FAR) FAR & SUPPLEMENTS FAR & SUPPLEMENTSAGENCY FAR SUPPLEMENTS (contracts)

EXAMPLES CIVIL RIGHTS (USC) DEBARMENT & SUSPENSION RECOMBINANT DNA (NIH)FOIA (USC & CFR) (Common rule-CFR) MISCONDUCT (NSF)HUMAN SUBJECTS (Common Rule-FR) COORDINATED REVIEW CONFLICT OF INTEREST (NSF, NIH)DRUG-FREE WORKPLACE (USC) VIETNAM ERA VETERANS DRUG-FREE WORKFORCE (DOD)LOBBYING (USC & FR)MISCONDUCT (NIH)

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Types of Award Actions

• New Award/Competing Award• Continuation Award/Non-competing

Award • Supplemental Award• Modification (e.g., budgetary revision,

change of key personnel, administrative change, termination notice)

• No-Cost Extension• Amendments (usually associated with

contracts)• Subaward

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Typical Elements of an Award Notice

• Awarding entity and authority• Award number• Recipient (institution)• Name of PI or project director• Reference to proposal or project title• Funding (total, incremental?)• Cost basis (reimbursement, fixed?)• Dates (start, end)• Reports, deliverables• Terms and conditions

– Stated in text, attached, or incorporated by reference

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Excerpt from Award Letter Federal

The National Science Foundation hereby awards a grant of $70,411 to NAME OF UNIVERSITY for support of the project described in the proposal referenced above as modified by revised budget dated June 2, 2005. This project, entitled "Cyclic Processes Within Surface-exposed Fractures Affecting Evaporation and Salinization Mechanisms," is under the direction of PI “Smith”. This award is effective August 1 , 2005 and expires July 31, 2006. This is a continuing grant which has been approved on scientific / technical merit for approximately 4 years. Contingent on the availability of funds and the scientific progress of the project, NSF expects to continue support at approximately the following level: FY 2006 $123,118 FY 2007 $121,019 FY 2008 $35,192.

This grant is awarded pursuant to the authority of the National Science Foundation Act of 1950, as amended (42 U.S.C. 1861-75) and is subject to NSF Grant General Conditions (GC-1), dated 6/15/05 available at http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gc1605.

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Office of Management and Budget Circulars

OMB Circulars for Cost Principles Applicable To All Awards

A-21 Cost Principles for Educational Institutions A-87 Cost Principles for State, Local and Indian Tribal Governments

A-122 Cost Principles for Non-Profit Organizations

Uniform Administrative Requirements

A-110 Grants and other Agreements with Institutions of Higher

Education, Hospitals, and other Non-Profit Organizations:

Uniform Administrative Requirements

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Office of Management and Budget Circulars

OMB Circulars for Uniform Administrative Requirements (contd.)

A-102 Uniform Administrative Requirements for Grants and Cooperative Agreements With State and Local

Governments

Regulations Applicable to Audits

A-133 Audits of States, Local Governments and Non-Profit Organizations

Regulations Applicable To Procurement Actions

FAR Federal Acquisition Regulations (first published, Federal Register, 9/19/83; on-going revisions)

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“Contemplating any business act, an employee should ask himself whether he would be willing to see it immediately described by an informed and critical reporter on the front page of his local paper, there to be read by his spouse, children, and friends.”

--- Warren E.Buffet

The Front Page of the Newspaper Test

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Responsible Conduct of ResearchCompliance Topics

•Responsible Conduct of Research•Research Misconduct•Financial Conflict of Interest•Human Subjects•Animal Care•Recombinant DNA•Hazardous Materials•Data Rights, Access, & Protection

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Responsible Conduct of Research

PHS requirement for trainees on K-30, T-32 and T-34 awards to complete instruction in the following: 1. Data acquisition, management, sharing, and ownership

2. Mentor/trainee responsibilities

3. Publication practices and responsible authorship

4. Peer review

5. Collaborative science

6. Human subjects

7. Research involving animals

8. Research misconduct

9. Conflict of interest and commitment

Institution determines content, length, format, and

who covered

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“About these experiments you’ve conducted for 12 years — no one remembers hiring you.”

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Research Misconduct

• Research misconduct defined

does not include honest error

or honest differences in interpretations or judgments of data.

• Government-wide policy issued by OSTP, December 2000• Designed to replace existing PHS and NSF rules and to be

adopted by all federal funding agencies • Changes adopted by NASA, NSF, VA, USDA, DOE, EPA,

DHHS and DOL

“fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”

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Research Misconduct

• Institutions must develop policies and procedures to deal with allegations of misconduct to include:

– Definitions

– Written policy

– Description of inquiry and investigational phases

– Process for protection of whistleblowers

– Reporting to agency (process, timing)

– Retention of records

– Certification requirements

• DHHS requires Assurance Annual Report on Possible Misconduct

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Financial Conflict of Interest

• PHS Regulation and final NSF policy effective on October 1, 1995

• Regulation / policy similar in content• Major components of the regulations:

– Contractors / grantees must have adequate policies

– Disclosures of financial interests of faculty and family must be made by PIs and others having decision- making authority over conduct of work

– Financial interest defined as $10,000 annual income or 5% equity whichever is less

– Contractors/grantees have discretion over who reviews disclosures

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Financial Conflict of Interest• Specific criteria for review will be at

institution’s discretion

• Management of conflicting financial interests must be undertaken

• Applications must contain certifications

• Institutional records are subject to federal review

Bottom lineBottom line is that at a minimum, institutions must have written policies in compliance with federal

regulation/policy.

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Financial Conflict of Interest

• Investigator Conflict of Interest versus Institutional Conflict of Interest

• Institutional Conflict of Interest– Equity Interest in Company– Licensing Interest– Interest Held by Institutional Officers

• Human Subject Consideration– Informed Consent– May 2004 DHHS Guidance

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Confidentiality of Patient Records(meant to protect patients seeking drug and alcohol treatment)

Applicability:• All programs funded in whole or

in part by federal funds• Flow-down requirement to

subrecipients• Records cannot be used to

initiate or substantiate criminal charges

• Records can only be released with consent of patient except:– when identity withheld– when authorized by court

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Confidentiality of Patient Records: HIPAA

• Health Insurance Portability and Accountability Act of 1996 (HIPAA)– Congress failed to

pass legislation before 8/21/99, which resulted in authorization of DHHS to issue regulation

– Final Rule issued on August 14, 2002; Implementation by April 14, 2003

• http://aspe.hhs.gov/admnsimp/pvcfact1.htm

• 45 CFR Part 160

• Provisions:– Patient Education on

Privacy – Patient Guaranteed

Access to Medical Records– Patient Must Give Prior

Approval Before Release of Records

– Release of Minimum Necessary for Health Care Purposes Only

– Provide Recourse if Violated – Civil and Criminal Penalties Through the DHHS Office for Civil Rights

– Records for Research Purposes; Oversight by IRB or Privacy Board

http://aspe.hhs.gov/admnsimp/pvcfact1.htm

http://aspe.hhs.gov/admnsimp/pvcfact1.htm

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Functions and Organization of Sponsored Projects Administration

• Functions

• Organizational Participants

• Organizational Models

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May be handled by

different offices

Functions of Research Administration: Examples

• Policy and procedure development, implementation

• Funding opportunity development, promotion, advancement

• Interpretation of guidelines, preparation and review of proposals

• Stewardship and accountability• Financial and programmatic

oversight• Project performance and delivery• Subcontracts, purchase of goods

and services

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More Examples

• Training• Negotiation, dispute resolution• Reports

– Progress– Fiscal– Final

• Certification, compliance• Risk management• Transfer to public benefit,

economic development, communication of outcomes

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Organizational Participants

• Executive Administration

• Academic and Research Divisions

• Business Divisions

• Legal Office

• Other

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“Friend of the administration or

friend of research?”

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Organizational Models

• Unified

– Under one division at the institution

– May have other offices distributed (e.g., compliance)

• Separate

– Parallel

– Under academic and business divisions

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Organizational Models

• Organizational Models Depend on:– Tradition– Philosophy– Size and mission of

institution– Experience

• Key to success with any model:

COMMUNICATION

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Why Sponsored Projects?(The Institution’s Perspective)

• Increase Status/Prestige

• Attract New Faculty and Students

• Train Future Scientists/Teachers

• Upgrade Programs and Build Infrastructure

• Enhance Connections With Other Segments of Society

• Service to State/County

Often centered around institution’s standing and missionOften centered around institution’s standing and mission

Sponsored Projects

Sponsored Projects

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Expectations Made of Our Faculty

• Take a few minutes and consider the range of expectations and demands placed on our faculty.

What expectations can you identify?

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How DO Faculty Learn to Write

Proposals?

How DO Faculty Learn to Write

Proposals?

Quality of Quality of IdeaIdea

Match to SponsorMatch to Sponsor

Infrastructure Infrastructure SupportSupport

FacultyFacultyFacultyFacultyConducting Research

and Scholarship

Conducting Research

and Scholarship

Department/college

committee service

Department/college

committee service

Uni

vers

ity c

omm

ittee

serv

ice

Uni

vers

ity c

omm

ittee

serv

ice

Tea

chin

g/pr

epar

ing

lect

ure

s/gr

adin

g

Tea

chin

g/pr

epar

ing

lect

ure

s/gr

adin

g

Maintain currency withliterature

Maintain currency withliterature

Perso

nal/f

amily

life

Perso

nal/f

amily

life

Write proposals

Write proposals

Prepare/presen

t

professional papers

Prepare/presen

t

professional papers

Promotion and tenure

Promotion and tenure

Student advisingStudent advising

Professional service

Professional service

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Common Goals: Research Administrator and Investigator

• Increase Sponsored Program Activity and Publication of Results to Advance Knowledge

• Enhance Educational Opportunities for Students

• Expand Research and Public Service Activities

• Streamline and Improve the Research Environment

• Protect and Minimize Risk to Individuals and Institution

Sponsored Projects

Sponsored Projects

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The Research Administration Balancing Act

• Research administrators seek a balance of interests that respects the shared responsibilities throughout the institution.

• Research administrators balance facilitating the research, teaching, and public service activities of faculty, students and other investigators while accommodating the priorities and stewardship expectations of the institution, governmental entities, sponsors and the public.

Internal Stakeholders

Internal Stakeholders

External Stakeholders

External Stakeholders

Proposal Development

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Proposal Development• Gather Funding Information• Disseminate Funding Information• Help Develop Sponsor Contacts• Provide Proposal Assistance• Produce Workshops and Manuals

Proposal Preparation for Faculty

Departmental Administrators

Specific Sponsors

Electronic Proposal Submission

Budgets

• Administer In-House Grants Programs

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Types of Proposals

• Letter of Inquiry

• Letters of Intent

• Preliminary Proposals

• Concept Papers

• White Papers

• Formal Proposals

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Letter of Inquiry or Preliminary Proposal

• Letter ProposalUsed by private foundations for screening

to second stage

• Preliminary ProposalUsed by both federal and non-federal

sponsors

• Length:3 – 5 pages

• Formatcover letter and 3 – 4 page proposal, or All information in 3 – 5 page letter

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Letter of Inquiry orPreliminary Proposal

• Elements to be covered:

Areas of research/content of project (be rather specific)

Needs and purpose statement

Unique qualifications, abilities, and facilities

Benefits/anticipated results of the project

Estimate of cost (no detailed budget)

Offer to meet

Request for response

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Concept Paper/White Paper

• Concept Paper:Generally internal working document

or used for informal feedback

• White Paper:Concept paper sent unsolicited to a

sponsor

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Formal Proposal

• Put together according to guidelines established by sponsor

• Always use forms and format required by sponsor

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Formal Proposal (continued)

• The Usual Sections:

Title/Cover Page with appropriate signatures

Abstract (less than one page)

Statement of Work

Key Personnel CVs/Bio Sketch

Detailed budget with Justification

Facilities/Resources Statement

Appendices (as needed and

allowable by sponsor)

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Formal Proposals (continued)

• Parts:

• Scientific/Program Description

• Representations and Certifications

• Budget

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Formal Proposals (continued)

• The Science

A concise explanation of the project

the whatwhyhow

Usually must conform to a specified structure and page limitations

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Formal Proposal (continued)• Administrative Sections –

The Reps. & Certs.

Certifications may be incorporated into the proposal, i.e., the Checklist Page for NIH, the Cover Page for NSF

Or the certifications can be separate, i.e., “Certifications and Assurances for Assistance Agreements” for the Defense Agencies and Standard Form 424B for DED, EPA, etc.

May also need “Certification Regarding Lobbying” and “Disclosure of Lobbying Activities”

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• OMB Circular A-110

Uniform Administrative Requirementsfor Grants and Agreements withInstitutions of Higher Education andOther Non-profit Organizations

Subpart A – GeneralSubpart B – Pre-Award RequirementsSubpart C – Post-Award RequirementsSubpart D – After the Award RequirementsAppendix A – Contract Provisions

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• A-110 Subpart A – GeneralEffect of A-110 on Other Issuances

Awards subject to A-110, all other administrative requirements codified in program regulations, manuals, handbooks inconsistent with this circular are superseded, unless required by statute or authorized by the deviations provisions of this circular

DeviationsExceptions to A-110 are permitted in unusual circumstances by OMB

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• A-110 Subpart A (cont.)Subawards

A-110 should be flowed down to sub-recipients which fall under this circular

• A-110 Subpart B – Pre-AwardAgency Decides on Appropriate Award InstrumentGrant: Principal Purpose is to Provide Support to Accomplish a Public PurposeCooperative Agreement: Same as a Grant, Except Substantial Involvement is Expected by the Awarding Agency

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• A-110 Subpart B (cont.)Contract: Principal Purpose is Acquisition of Property or Services for Direct Benefit of GovernmentForms Used When Applying for Assistance:

Agencies must comply with 5CFR part 1320 – “Controlling Paperwork Burdens on the Public”Applicants shall use SF-424 series, or forms and instructions prescribed

by agency

Programs covered by E.O. 12372 “Intergovernmental Review of Federal Programs” – applicants must complete

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• A-110 Subpart B (cont.) appropriate sections of SF 424 and send a copy of proposal to the state coordinating office.Debarment and Suspension

Agencies and recipients must comply with the non-procurement common rule

Special Award ConditionsAdditional requirements may be imposed

by agencies if:

Recipient has history of poor performance

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• A-110 Subpart B (cont.)Recipient is not financially stable

Recipient has management system

that does not meet standards

Recipient has not conformed with

terms and conditions of previous

award

Recipient is not responsible

Recipient must be notified in writing

Special conditions removed once

corrections are made

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• Basically, the Agency is looking for us to certify compliance with all of their statutory requirements

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Budget Development

• Include both direct and F&A costs

• Should be detailed• Include only allowable costs• If required, include matching

or cost-sharing (if cost-sharing is proposed it should be proportional between direct and F&A)

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Budget Development (cont.)

• Direct Costs:Costs that can be identified specifically

with a particular sponsored project,

an instructional activity, or any other

institutional activity; or that can be

directly assigned to such activities

relatively easily with a high degree of

accuracy

Examples of Direct Costs:

Salary of Researcher (including FB)

Laboratory Supplies

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• Facilities and Administrative(F&A) CostsCosts that are incurred for common or joint objectives, and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity

Examples of F&A Costs:Salary of Department AdministratorBuilding utility and maintenance

costsPurchasing, Controllers’ offices

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• Composition of Total CostsA-21, section C.1.

The cost of a sponsored agreement is

comprised of the allocable direct

costs incident to its performance, plus

the allocable portion of the allowable

F&A costs of the institution…

Therefore, Federal sponsors reimburse

the institution for the allowable costs

of a project, including direct costs and

F&A costs….

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• Elements of Direct CostsSalaries and Wages

Fringe Benefits (FB)

Equipment

Expendable Supplies and Materials

Travel

Subcontracts

Consultants

External

Interdepartmental

Other

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• Salaries and WagesInstitutional Policy on Academic Year

Salary RecoverySummer SalaryPostdoctoral Research AssociatesUndergraduate & Graduate Students (salaries or stipends?)Technical and Clerical Support*

Use Percent of Effort, Not Hourly Wage

Include Increases for COLA and Merit- based AdjustmentsFollow institutional policies on FB

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• EquipmentNote the differences between the sponsor’s equipment definitions/ thresholds and your institution’s

General purpose equipment is not allowable as a direct cost unless programmatically necessary and used exclusively/primarily for research

• Expendable Materials/SuppliesMust be programmatically necessary; general office supplies should be treated as an F&A cost – unless a major program.

81


• TravelAdhere to Institutional Policy and Agency GuidelinesDistinguish between Domestic and Foreign TravelForeign Travel may require prior approval from sponsor prior to trip (even if in original budget/proposal

• SubcontractsProposed costs should be Reasonable and Allowable (however, keep in the mind the sub-contractor may be under different cost principals)

82


• ConsultantsExternal: required expertise needed for the project which cannot be provided by faculty or staff at the institution; rate must be reasonable; in most instances, consultants’ level of effort and participation should not rise to the level of “key personnel” – that would imply substantive programmatic work

Interdepartmental: in some instances, a faculty or staff member may serve on a project as a consultant, but only if the expertise required is not part of this person appointment or job function

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• Other Direct CostsCommunicationsPublicationsAnimal Care CostsHuman Subject CostsShop ChargesMaintenance/Service ContractsComputer CostsGraphic Arts/Photographic ServicesRental/Lease of FacilitiesConstruction/Renovation/Remodeling Costs

All of the above must be programmatically necessary!

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• What Does “Allowable” Mean?An allowable cost must be:

REASONABLE: A prudent business

person would have purchased this item

and paid this price.

ALLOCABLE: It can be assigned to the

activity on some reasonable basis.

CONSISTENTLY TREATED: Like costs must

be treated the same in like circumstances,

as either direct or F&A costs.

If a cost cannot meet the above criteria, it is

unallowable, no matter what it is for.

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• What Does “Allowable” Mean? (cont.)

An “allowable” cost is one that is eligible for

reimbursement by the federal government.

Contrast with:

PERMISSIBLE BY INSTITUTION: A cost is

permitted by institution, as outlined in its

various administrative policies or procedures.

ALLOWABLE BY AGENCY: A cost is permitted

by the policies of the sponsoring agency or

the terms of an award.

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• Assessing Whether a Cost Is

Allowable or UnallowableA cost may be “expressly” unallowable,

i.e., it is always unallowable as either

a direct or indirect.

Unallowable activities: fund raising,

alumni relations, lobbying, etc.

Unallowable transactions: alcohol,

entertainment, fines, etc.

A cost may be allowable but only as an

indirect/F&A cost, not a direct charge,

e.g., proposal preparation

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• Assessing Whether a Cost Is

Allowable or Unallowable (cont.)

Generally, it is not the type of cost that

determines allowability, it is the purpose

and circumstance of the expenditure. Many

categories of costs are allowable as a

direct or indirect, e.g. salaries, travel,

materials, etc.

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• Third Party Agreements

Types of third party agreements:

Purchase Order

Subcontract/Subgrant/Subagreement

Consulting Agreement

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• Purchase Order

A particular kind of agreement issued to enter into a legally-binding commitment with an outside vendor for the acquisition of goods and services. Normally the purchasing department is responsible for purchase orders, and for their negotiation or revision where necessary.

Vendor Subcontracts: used for the procurement of goods or services from

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• Purchase Order (cont.) an organization which provides the

goods or services to many different

purchasers as part of its normal

business operations within a competitive

environment. These subcontracts (or

purchase orders) are not subject to

compliance requirements of the Federal

award (per A-133).

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• Subawards/Subcontracts/Subgrants/SubagreementsWhatever you call them…

A written agreement with a third party for the acquisition of services or goods or for the conduct of prescribed activities or functions under an award.

Subrecipient Subawards: used to procure substantive programmatic work under a grant or contract. The sub-recipient has responsibility for programmatic

92


• Subawards (cont.) decision making and measurable

performance requirements related

directly to the award. Sub-recipients

must adhere to federal compliance

requirements.

• Subaward Process RequirementsLetter of Intent

Statement of Work

Period of Performance

Budget

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• Process Requirements (cont.)Other Documentation

F&A Cost Agreement

Cost Justification

Statement of Work Approval

Certifications/Assurances (these

are usually part of the subaward

agreement)

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• Consulting AgreementA form of subcontractAn agreement issued for services too urgent, temporary, specialized, or highly technical to be provided by existing university personnel. Consulting agreements are not issued to procure “substantive programmatic work.”Consultants operate as independent contractors without detailed supervision, like subcontractors. Unlike subcontractors, they most often participate on a “work-for- hire” basis.

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• Consulting Agreements (cont.)Remember – a “consultant” is not an

“employee.”

If am employee is misclassified as an

“consultant,” the institution is subject to

fines and penalties.

Employer/employee relationships imply:

More discretion to direct or control the

contents of work and results to be

accomplished and means by which

accomplished

Continuing relationship whether full-

96


• Consulting Agreements (cont.) time, part-time, seasonal, or short duration.Set HoursGuaranteed minimum pay and pay intervalsMutual right to terminate without liabilityFurnishing of facilities, supplies, and equipment needed to accomplish workTraining supplied

Some Possible Considerations For Consulting Agreements:

Prior Approval to Publish, Etc.Work-For-Hire

97


• Consulting Agreements (cont.)Conflict of Interest

Indemnification

Flow-through Provisions from Prime

Rate Limitation

Sponsors May Set Allowable Rates

Consultants

Travel Is In Addition to Daily Rate

98


• Cost-Sharing/Matching Costs

is the portion of the cost of a project not borne by the sponsoring agency

Types of cost sharing:

Mandatory

Voluntary

Voluntary Uncommitted

99


• What Can be Used to MeetCost Sharing?

CashThird Party Contributions (however, federal funds cannot be used as cost sharing on federal funds)Unrecovered F&A costs (can be used if agency has approved)Establishing values for contributions of services and property (in accordance with applicable cost principles)Volunteer Services: if necessary and integral part of project

100


• Cost Sharing (continue)Other employee services (valued at

regular rate of pay + fringe benefits)

Donated supplies (must be reasonable

and at fair market value)

• Cost Sharing ConsiderationsCash and third party in-kind

contributions must meet all of the

following criteria:

Are verifiable from the recipient’s records

101


• Cost Sharing Considerations (continued)Cannot be used as cost sharing on other federal projectsAre necessary and reasonable for accomplishment of project objectivesAre allowable under the cost principlesAre not paid by the Federal government under another awardAre provided for in the approved budget when required by Federal agencyConform to other provisions of A-110, as applicable

102


• Potential Problems Associated with Cost Sharing

Can we demonstrate to the funding

agency that the cost sharing

commitment has been fulfilled? Do

track cost sharing on a project-by-

project basis?

Are we treating cost sharing consistently

with other project costs, i.e., classify

it as organized research?

103


• Potential Problems (cont.)Are we overstating our F&A rate by not capturing cost sharing?

Do effort reports capture cost shared effort (both mandatory and voluntarily committed)?

Are the same cost sharing funds used to meet the matching requirements on more than one project?

Do we recover cost sharing expenditures through our F&A rate?

104


• Facilities and Administrative CostsPoints to Consider:F&A cost recovery is the reimbursement for actual costs incurred by the institution in support of sponsored projectsF&A costs are incurred on all institutional activities, not just sponsored researchF&A costs are REAL COSTS!A significant portion of F&A cost not recoveredWhen an external sponsor pays less than the full F&A rate, the unrecovered F&A costs must be absorbed by the institution (it’s an institutional decision)

105


• Types of F&A Rate BasesTotal Direct Costs (TDC)

All direct costs of researchModified Total Direct Costs (MTDC)

All direct cost of research less:EquipmentSubcontracts in excess of $25,000Tuition RemissionPatient CareCapital ExpendituresRental CostsScholarships & Fellowships

Other items may be excluded where necessary to avoid a serious inequity in the distribution of F&A

106


• F&A Rate Bases (cont.)Salaries and Wages (S&W)

Can only be used with the Simplified

Method

• Types of F&A Cost RatesProvisional – Estimated rate used when

parties cannot agree on an equitable

rate. May be replaced by fixed or

predetermined rate before the end of

the fiscal year.

Predetermined – Rate established for

107


• F&A Cost Rates (cont.) for period, normally 2 to 4 years. No carry forward provision.

Fixed with Carryforward – Rate established for period. Over/under recovery is determined and an adjustment is applied to a subsequent rate negotiation.

• F&A Rate Versus F&A RecoveryF&A is often waived or reduced for cost sharingF&A rate calculation based on recoverable

108


• Rate Versus Recovery (cont.) costs, i.e., all awards receive a full

allocation of F&A, not recovery

In reality, institutions subsidize a

significant portion of F&A costs

• On-Campus Research RateApplied to on-campus organized

research activities

Most frequently used rate; may be the

only rate negotiated

109


• Off-Campus Research RateApplied to sponsored agreements at off-

campus facilities

Off-Campus is usually not a university-

owned facility

Recovers administrative costs associated

with sponsored agreements

Typically is the “A” portion of the On-

Campus Research Rate; “F” costs are

direct charged

The “A” portion is generally 26% because of federal cap

110


• Other Sponsored ProgramsInstitutions with large amount of non- research sponsored projects may negotiate a separate rate for these projects

• Rates for Specific FacilitiesThe costs of certain programs/facilities may be unique enough to warrant a separate F&A rateExamples: Agricultural Experiment Station; Federally Funded Research and Development Center (FFRDC); University Medical Center

111

Proposal Review

• Typical Institutional Checklistfor Proposal ReviewCorrect FormsInternal Review Checklist/Approval FormCompatibility with Internal Review Checklist

Intellectual PropertySpace NeedsRenovation RequirementsCost Sharing/MatchingHuman Subject Use

review and approvalAnimal Use

review and approval

112

Proposal Review (cont.)

• Checklist for Proposal Review (cont.)

Recombinant DNA

review and approval

Conflict of Interest Policy

Publications/Proprietary Information

Restrictions

Hazardous Materials

Undergraduate & Graduate Students

Page Limitations

Type Size Limitations

All Elements of Proposal Included

113


• Checklist (cont.)Correct Rates Used

Budget Correct

Signatures

Subcontractor Commitment Letter

All Certifications Included

If RFP, is Exception Letter Needed

If Foundation/Corporation, on

“restricted” list

Requirement for State Review Ascertained

Correct Number of Copies, Deadline Date

Mailing/Delivery Address

114


• Checklist (cont.)Method of Transmittal, Packaging

Instructions

Limitation on Number of Proposals

from Institution

And You’re Done!!!

115

Pre-Award: Part IIProposal Submission & Review

• Certifications & Representations

• Routing & Internal Approval Signatures

• Special Consideration

• Peer Review, Site Visits,

• Pre-Award & Audits

116

Representations and Certifications for Proposals

• Civil rights, Non-discrimination• Delinquent Federal Debt• Drug-free Workplace• Drug-free Workforce• Debarment and Suspension• Drug- and Alcohol-free Schools• Procurement Integrity• Small Business Utilization &

Subcontracting• Lobbying

117

Debarment and Suspension (Final Rule May 1989)

• Regulations implemented by common rule (Grants)• Federal Acquisition Regulations (Contracts)

– BACKGROUND: Development of a government-wide system for transactions with federal agencies to detect fraudulent or improper use of government funds

– APPLICABILITY: Agreements in excess of $25,000. Flow down required

– CERTIFICATION: Applicants, their principals and researchers are not:1. Presently debarred or suspended2. Have not been convicted or had civil judgment for fraud rendered within a three

year period3. Are not presently charged by a Government entity4. Have not had a public transaction terminated for cause or default within a three

year period

Sanctions: Termination, debarment or suspension of awardee.Sanctions: Termination, debarment or suspension of awardee.

118

Procurement Integrity

• Applicability:– All federal contracts– Certification required when contract exceeds

$100,000/year– No flow-down requirement

• Requirements:– No competing contractor or any officer, employee or

consultant of such contractor shall:• make any offer or promise of future employment• offer any money, gratuity, or other thing of value to any procurement

officer of such agency• solicit any proprietary data or source selection information concerning

such procurement

– Key to Compliance: inform PI, and others, of requirements

119

Utilization of Small and Small Disadvantaged Business Concerns

• Applicability:– Most contracts in excess of $100,000– Flow-down to subcontractors

• Special requirements:– When contract is in excess of

$500,000, subcontracting plan required and special reporting requirements apply

– Subcontracting” means procurement of goods and services

• Subcontracting plan compliance and reporting can be handled by either purchasing office, research administration, or by project administrator

120

Lobbying Terms Defined• Lobbying activities include:

– Lobbying contacts– Preparation and planning for lobbying– Collaboration with others, such as

associations– Most public activities exempted

• Lobbying contact means:– Any oral, written or electronic

communication– Certain contact with executive officials– Certain contacts with legislative officials– With regard to

• Legislation• Federal rule, regulation, policy• Federal program (contracts, grants, loans, etc.)

Use of appropriated funds to pay a person

to influence or attempt to influence a federal official or employee in

connection with a specific award is

prohibited by law; disclosure required if

use of non-appropriated funds to

pay for lobbying activities

121

Lobbying

• Applicability:– All federal agreements – Flow-down to subcontractors is required

• Aspects Of Compliance:– Lobbying costs may not be paid from federal funds– “Federal funds” interpreted to mean direct costs only– Certification required for awards over $100,000– Disclosure of lobbying expenses required in certain

instances

122

Certification Signatures

• Authorizing Official– Chief Executive or those delegated authority

• Supported by internal approvals and signatures– PI, department, dean, business officers

• Signature is indication of assurances, representations and certifications

• See agency program guides and forms for summary of assurances that are made by signature of authorizing official and principal investigators

123

Typical Institutional Checklist for Proposal Review

• Compliance with Sponsor Requirement

• Compliance with Institutional Policies

• Compliance with Statutory Requirements

• Application Completeness• Appropriateness of Budget• If applicable, review Guidelines

of Solicitation

124

Solicitations – Special Considerationat Time of Institutional Review

contractscontracts

grants and cooperative agreements

grants and cooperative agreements

– RFP Request for Proposals– RFQ Request for Quotation– RFB Request for Bid

– RFA Request for Applications

• Proposers must register objections to proposed terms and conditions, scope of work, etc., at the time of response. It may be the only opportunity to take exception.

• For example:– resist using hours for faculty and professional staff

125

Peer Review• Primary basis for most

funding decisions• Variations: some contract

procurements may be based on a combination of qualifications and proposed cost (administrative and scientific review)

• Role of program official is a variable

• Evaluations are anonymous, and given in summary form to applicant on request

• Reviews usually assign scores, rankings, or categories

• Funding decisions are based on available funds

• Amount of award may be unilateral, or may be negotiated

See program guides or solicitation for details about review criteria

If the proposal is rejected by the sponsor, the PI should obtain the reviews from the sponsor, address the issues, and resubmit the proposal

127

Negotiation of Awards, Dispute Resolution

Negotiation Framework:• Clear channels of communication; documentation• Know institutional policies; be familiar with scope of work and your

history with the sponsor, project, PI, …• Terms and Conditions: programmatic and business

Negotiations with federal sponsors often include:• Budget level; Project Goals; Business Standards

Negotiations with non-federal sponsors often include:• Academic principles (freedom, publications, ownership of data and

reports)• Intellectual property• Business standards (salary basis, academic calendar)• Financial reporting (level of detail)

128

Intellectual Property Bayh-Dole Act - 37 CFR Part 401

• Allows retention of entire right, title, and interest throughout the world to each invention made with federal funding

• Government Retains nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention for or on behalf of the government

• Requirements:– Disclosure within two months after inventor discloses to

institution– Election of title within two years of disclosure to agency– Filing of initial patent application within one year of electing

title

129

Material Transfer Agreement Considerations

See Uniform Biological Material Transfer Agreement for standard model (http://www.autm.net/ubmta/UBMTAWord.doc)

Ensure it is an institutional rather than a personal agreementClearly and specifically define material involvedDefine use to which material is (and is not) to be put, and how to

return or dispose of unused quantities.Define limitations on use and what is to be considered confidentialMay address use of names of organizations involvedOwnership of derivativesCommercial/Non-commercial usePublications (usually requires acknowledgement, perhaps co-

authorship)Indemnification

http://www.autm.net/ubmta/UBMTAWord.doc

http://www.autm.net/ubmta/UBMTAWord.doc

130

Clinical Trials

The institution is usually reimbursed on a per patient basis often with a fixed F & A rate of 20 - 30% TDC

• Negotiation concerns:– Ownership of Data– Ownership and Confidentiality of

Patient Records– Publication of Results– Patent Rights– Indemnification – Billing of Third-party Carriers for

Costs– Liability for Subject Injury– Informed Consent Requirements– F&A Costs

131

Electronic Research Administration

• A Definition of ERA

• What It Means for Sponsored Projects Offices

• The Future of ERA

132

NIH Mail Room at Proposal Deadline

Each day NSF receives a stack of proposals the equivalent of 2-3 stories high

133

ERA: A Definition

• Electronic Research Administration simply means using electronic tools to perform the activities related to research administration. Keeping step with technology and the business world.

• Goal to work more efficiently – time is money

134

ERA: What It Means for Sponsored Projects

• Less Paper

• Training in multiple sponsor systems

• ERA Initiatives from Sponsors

NEED FOR LOTS & LOTS OF PATIENCE!!!

135

ERA: Federal Transactions

• NSF FastLane– Proposal Review– Proposal Preparation & Submission– Checking Proposal Status– Project Report Submission –

Progress and Fiscal

• NIH Commons– Edison Invention Reporting – now

interagency– CRISP – searchable database of

federally funded biomedical research – Electronic Streamlined Noncompeting

Award Process (e-SNAP)

136

ERA Today• Improvements in Technology • More Customized Programs• Not Yet a Paperless Environment• Expanded Federal Participation –

Grants.Gov– http://www.grants.gov

• “a common face of the government, offering all grantees (state and local governments, universities, small businesses, etc.) full service grants processing across all functions in the grant life cycle.”

137

Electronic Data RetentionConversion of Paper Records to Electronic Form• Department of Health and Human Services (HHS)• Office of Grants and Acquisition Management

(OGAM) Action Transmittal 99-1 (8/9/99) (http://www.hhs.gov/grantsnet/gps/ogamat.htm)

– Applicability: HHS Grantees receiving the majority of Federal funding from HHS awarding agencies

– Subject: Use of Electronically Imaged Record Storage

– Purpose: Permits the substitution of electronically imaged records for original records and encourages grants recipients to do so

– Action: Organizations that would like to implement the use of electronic records may do so provided the institution establishes the appropriate procedures and notifies DHHS in writing

138

Federal Demonstration Partnership

• Intent: To reduce administrative burdens in order to increase research productivity by standardizing and simplifying federal regulations.

• Background: Began as a two year pilot program with Florida universities and five federal agencies. Originally called the Florida demonstration project.

• Goal: To demonstrate that accountability may be maintained while simplifying research administration.

• The Federal Demonstration Partnership currently governs grant awards only; contracts and cooperative agreements are not included.

139

Monitoring Requirements

Recipients are responsible for:– Monitoring each project, program,

subaward, function or activity supported by award

– Ensuring subrecipients have met audit requirements

140

a living individual; investigator obtains (1) data through intervention or (2) identifiable private information

a systematic investigation designed to contribute to generalizable knowledge

Research Involving Humans

Research

Human Subjects

Research

Human Subjects

indirect activities (survey, observation)

direct activities or intervention (interview, blood draw)

ANDANDANDANDANDANDANDANDANDAND

141

Elements of Compliance with Human Subjects Regulations

• FWA• Approval from Institutional

Review Board (institutional or local)

• Compliance with requirements - – Institutional– OHRP– Sponsor

142

To provide for the humane care and use of live vertebrate animals in biomedical and behavioral research, teaching or testing.

Use of Animals in Research, Teaching, and Testing

Research

Teaching

Testing

Research

Teaching

Testing

ANDAND

ANDAND

143

Elements of Compliance withAnimal Care Regulations

• Assurance Number

• Approval from Institutional Animal Care & Use Committee

• Compliance with requirements - – Institutional– AAALAC, OLAW– Sponsor

145

Research Involving Recombinant DNA Molecules

Applicability Applies to research funded by public or private agencies external to the NIH if

the Institution receives NIH funds for related research. Recombinant DNA molecules are either: (i) molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (ii) molecules that result from the replication of those cells. Revised guidelines issued by the National Institutes of Health in October 2000 - http://www4.od.nih.gov/oba

Institutional Requirements1. Establish and implement policies that comply with NIH

guidelines2. Establish an Institutional Biosafety Committee (IBC) that

a) has at least 5 members selected because of their expertise - 2 unaffiliated, 1 plant expert, 1 animal containment expert, and a Biological

Safety Officer if BL 3 or BL 4 or large scale research is conductedb) reviews and approves all non-exempt rDNA research c) keeps minutes and makes them available to the public on request

146

Research Involving Recombinant DNA Molecules (continued)

Institutional Requirement (continued)

3. Report as required to NIH a) the source(s) of the DNA and nature of the inserted DNA sequence

b) the hosts and vectors to be used c) whether a deliberate attempt will be made to express a foreign

gene d) containment conditions specified in the Guidelines

Exempt categories1. Those that are not in organisms or viruses2. Those consisting entirely of DNA segments from a single

nonchromosomal or viral DNA source3. Those consisting entirely of DNA from a prokaryotic host including its

indigenous plasmids or viruses when propagated only in that host or when transferred to another host by established physiological means4. Certain recombinant DNA molecules consisting entirely of DNA segment

from different species that exchange DNA by known processes

147

Research Involving Human Gene Transfer

• Investigators must:– Obtain prior RAC review, IRB approval and all

applicable regulatory authorizations for experiments involving deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants.

– Obtain IND from the Food and Drug Administration if required.

– Submit to NIH, no later than 20 working days after enrollment, a copy of the approved informed consent document, the protocol approved by the IBC and the IRB, the IBC approval and the IRB approval, a brief written report on recommendations of the RAC and any modifications required by the FDA, any NIH grant number, the IND number and the date of initiation.

– Submit Annual Data Report Forms to NIH Office of Biotechnology Activities.

– Clinical trial sites added after RAC review, must submit materials to NIH/OBA prior to any enrollment.

– Submit Serious Adverse Events immediately to IRB, IBC, Office for Human Research Protections (if applicable) and NIH OBA, followed by full written report to each.

148

Hazardous Materials• Statutory Basis

– Sections 103 and 107 of the Contract Work Hours and Safety Standards Act (40 USC 327-330), supplemented by DOL regulations at 29 CFR, Part 5

– FAR, Subpart 23.3– OMB Circular A-110, Subpart D, Appendix

A• Applicability

– All awards over $2000 for construction– All awards over $2500 for other activities

• Requires– Notification to employees– Preparation and submission of a material

safety data sheet

149

USA PATRIOT Act• “Uniting and Strengthening

America Act by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001” was signed by President Bush on October 26, 2001.– Mission: To deter and punish

terrorist acts in the U.S. and around the world and to enhance law enforcement investigatory tools. Criminalized possession and use of a type or quantity of Select Agents not reasonably justified by bona fide research or other peaceful purpose. Criminalized possession, use, or transfer by a restricted person.

150

Data Access and RetentionBasis For Requirement:• ... "Financial records, supporting documents, statistical

records, and all other records pertinent to an award shall be retained for a period of three years from the date of the submission of the final expenditure report”…

• OMB APRIL 11, 1994 LETTER TO NSF GENERAL COUNSEL...."The term 'all other records pertinent to an award' was meant to encompass all records that were produced in connection with a grant. Therefore, laboratory records and primary data should be retained for three years and the recipient should provide access to the records.”

OMB CIRCULAR A-110 SECTION.53(b)

151

Project Close-outResponsibility:• Institution’s Sponsored Projects Office is usually

responsible for overseeing the close-out of awards.

Report Responsible Person/office• Technical Principal Investigator• Equipment Central Property Control Office• Patent/Invention Sponsored Project Office

Collaboration with PI and Technology Transfer Office

• Fiscal Accounting Office• Subrecipients Sponsored Projects Office with PI and

Accounting Office

Reports from Subrecipients Needed in Advance in

Order to Incorporate into Reports to Sponsor

152

“I already wrote the paper. That’s why it’s so hardto get the right data.”

153

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