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CRA - Cert 2021 > RACC CRA 2021 > Flashcards

RACC CRA 2021 Flashcards

1
Q

Name at least 4 Research Administration Portals?

A
  1. NSF Fastlane and Research.gov
  2. Grants.gov
  3. eRA Commons/NIH ASSIST
  4. FedConnect.net and fbo.gov (beta.sams.gov)
  5. G-5 (DoEd)
  6. ProposalCENTRAL
  7. Grants.gov
  8. NIH RePORTER
  9. iEdison
  10. NSPIRES (NASA)
  11. USAspending.gov
  12. E-verify.gov
  13. Grant Solutions
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2
Q

CFDA

A

Catalog of Federal Domestic Assistance

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3
Q

What does beta.sam.gov (formerly FedBizOpps (FBO)) do?

A

It is the single government point-of-entry (GPE) for Federal government procurement opportunities over $25,000. Government buyers are able to publicize their business opportunities by posting information directly to FedBizOpps via the Internet. As of 11/2021 it is now called Contract Opportunities.

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4
Q

Name at least 4 types of Sponsors.

A
  1. Federal
  2. State/Local
  3. Private Foundations
  4. Professional Associations
  5. Commercial
  6. International
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5
Q

DHUD

A

Department of Housing and Urban Development

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6
Q

DOT

A

Department of Transportation

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7
Q

Name at least 3 Primary Independent Agencies

A 
NSF (National Science Foundation),
NASA (National Aeronautics and Space Administration),
US Agency for International Development,
National Endowment for the Humanities,
National Endowment for the Arts
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8
Q

What is SBIR and what does it do?

A

Small Business Innovation Research - It enables small businesses to explore their technological potential and provide incentive to profit from commercialization.

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9
Q

What is STTR and what does it do?

A

Small Business Technology Transfer - It is intended to bridge the gap between performance of basic science and commercialization. They MUST partner with a nonprofit research institution. An IP (intellectual property) agreement between small business and nonprofit research institution is REQUIRED.

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10
Q

Office of Laboratory Animal Welfare (OLAW) applies to _____________?

A

All live vertebrate animals.

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11
Q

Clinical faculty, Dr. Drugs, is conducting a drug clinical tests for a company. He also has direct shares in the company. Is this a financial conflict of interest (FCOI)?

A

YES

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12
Q

True or False: The Uniform Biological Material Transfer Agreement (UBMTA) is primarily for transfers between academic institutions and non-profit organizations.

A

TRUE

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13
Q

Which of the following provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects?
A. Federal Register
B. Code of Federal Regulations
C. FedBiz Opps
D. Catalog of Federal Domestic Assistance

A

B. Code of Federal Regulations (37 CFR 401)

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14
Q

At minimum, how frequently must the IACUC review a facility’s programs for humane care and use of animals, and inspect the animal facilities?

A

Annually

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15
Q

How long is an IACUC protocol approved for?

A

Three years.

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16
Q 
In which of the follow areas of IP (intellectual property) is the concept of work-for-hire germane?
A. Patents
B. Trademarks
C. Copyrights
D. Trade secrets
A

C. Copyrights - According to copyright law in the United States and certain other copyright jurisdictions, if a work is “made for hire”, the employer— not the employee— is considered the legal author.

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17
Q

What are the criteria for IRB approval according to CFR 46.111?

A
  1. Risks to subjects are minimized
  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
  3. Selection of subjects is equitable.
  4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative (45 CFR 46.116)
  5. Informed consent is documented or waived in accordance to 45 CFR 46.117
  6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
  7. Adequate provisions to protect the privacy of the subject and maintain confidentiality of the subject including
  8. Broad consent is obtained, documented, and protected1
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18
Q

What does Expanded Authority encompass?

A

Allows grantees to:

1) Approve 12 month NCX
2) Adjust budgets as project needs change (without change in scope)

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19
Q

Which groups are protected by the special guidelines as human research subjects per 45 CFR 46?

A
  1. Children
  2. Prisoners
  3. Pregnant women, fetuses, neonates [Subpart D]
  4. Individuals with impaired decision-making capacity
  5. Economically or educationally disadvantaged persons
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20
Q

IRB Committee consist of?

A

Must have at least 5 members. Must include at least one of these member:
Scientist, Non-scientist, and Non-affiliated with institution. One member can satisfy two categories.

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21
Q

What are Code of Federal Regulations (CFR)?

A

Regulations issued by executive branch agencies that affect the management of grants.

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22
Q

What does iEdison do?

A

On-line system that provides the interface for reporting intellectual property.

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23
Q

UNIFORM ADMINISTRATIVE REQUIREMENTS, COST PRINCIPLES, AND AUDIT REQUIREMENTS FOR FEDERAL AWARDS

A

2 CFR 200 also know as Uniform Guidance

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24
Q

2 CFR 200 Subpart E

A

Cost principles for regulating federal awards

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25
Q

What are the 3 types of Cost Sharing?

A

Mandatory, Voluntary - Committed, and Voluntary - Uncommitted

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26
Q

What does MTDC exclude?

A

Equipment, tuition remission, scholarships, capital expenses, rental, patient care, participant costs, subawards over $25K

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27
Q

If an awardee does not have a negotiated IDC rate, what is the de Minimis Rate?

A

10%

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28
Q

Cost Accounting Standards (CAS) for Institutions of Higher Education (IHE)

A

CAS 501: Consistency in estimating, accumulating and reporting costs,
CAS 502: Consistency in allocating costs incurred for the same purpose,
CAS 505: Accounting for Unallowable Costs, and
CAS 506: Cost accounting period (ie Fiscal Year)

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29
Q

What is CAS (2 CFR 200.419)?

A
  • Subpart E: Amendments to Disclosure Statements - 200.419(b)(2) for IHE
  • Applies to federal sponsored grants and contracts
  • Disclosure Statement for IHE entities receiving > $50M in federal sponsored agreements annually
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30
Q

UBIT

A

Unrelated Business Income Tax - IRS defines UBIT as the income from a trade or business regularly conducted by an exempt organization and not substantially related to the performance by the organization of its exempt purpose or function.
All fundamental research and applied research from specific organizations is exempt from UBIT.
Exempt organizations who fail to make research results available to the public in a timely manner may lose their exempt status and be subject to UBIT.

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31
Q

Fixed Amount Awards

A
  • Payments are based on meeting specific requirements of the Federal Award
  • Accountability is based on performance and results
  • Award amount is negotiated using cost principles as a guide
  • No governmental review of the actual costs incurred
  • Significant changes ie.PI, subaward, or scope) must receive sponsor written approval
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32
Q

Payments

A

Non-Federal entities other than states must use payment methods that minimize the time elapsing between the transfer of funds from the United States Treasury or the pass-through entity (PTE) and the disbursement by the non-Federal entity.

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33
Q

Uniform Guidance 2 CFR 200.430

A

Compensation Reporting is required when an individual is compensated by or agrees to contribute time to a federally sponsored project. Verified payroll distribution and cost/shared/contributed effort. Non-compliance results in disallowances.

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34
Q

What are the values and benefits of Service & Recharge Centers?

A
  • Enhance funding opportunities
  • Exceed individual investigator’s funds and capability
  • Serves as incubator-like function
  • Serves cross-department units
  • Has dedicated staff
  • Has an established fee structure (funds recovered cannot be for profit)
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35
Q

Components of an Institution’s Internal Controls

A
  • Controlled environment and activities
  • Risk Assessment
  • Information and communication
  • Monitoring
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36
Q

Objectives of an Institution’s Internal Controls

A
  • Transactions executed in compliance with regulations
  • Funds safeguarded against loss from unauthorized use
  • Processes and procedures promote efficiency
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37
Q

Cost Transfer

A

Is a process for moving an expenditure between projects/funds or expenditure types/account codes. It requires detailed justification, documentation, and authorization. It cannot be made to “spend out” a fund.

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38
Q

Uniform Guidance 2 CFR 200, Appendix III

A

Indirect (F&A) Costs Identification and Assignment, and Rate Determination for Institutions of Higher Education (IHEs)

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39
Q

Space Survey

A

Surveys space in an IHE to equitably distribute indirect costs by function based on depreciation on buildings, equipment and capital improvement, interest on debt associated with certain buildings, equipment and capital improvements, and operations and maintenance expenses.

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40
Q

Which Cognizant Agencies are responsible for negotiating and approving F&A rate?

A

Health and Human Services (HHS) and Office of Naval Research (ONR)

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41
Q

Performance Management

A

Agencies must require recipients to use OMB-approved standard government-wide information collections to provide financial and performance information. Agencies are expected to measure performance in a way that will help to improve program outcomes, share lessons learned, and spread the adoption of promising practices.

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42
Q

What is SF-425?

A

Federal Financial Report

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43
Q

When is SF-425 due?

A

Final Financial Report is due 90 days after project end date.
Non-Final Financial Report is due at end of calendar quarter (e.g. 3/31, 6/30, 9/30, 12/31)

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44
Q

What are the areas of concern on sponsor award financial reporting?

A
  • Misuse of funds
  • Unallowable costs
  • Allocation of costs
  • Accelerated spending
  • Unobligated balances
  • Reporting
  • Payment
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45
Q

Uniform Guidance 2 CFR 200, Subpart F

A

Federal audit of an organization’s systems (State, Local Government, and Non-profit Institutions) and internal controls with expenditures of $750,000 annually in federal awards (including both prime and subawards).

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46
Q

What is the administrative cap on federal negotiated F&A rates for universities?

A

26%

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47
Q

Federal law (FARs and UG) generally requires grant financial records to be kept a MINIMUM of how many years?

A

3 Years

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48
Q

What is Program Income?

A

Income earned from an award activity

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49
Q

What is the effect of cost share on the F&A rate?

A

It decreases it because Organized Research base is increased.

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50
Q

What is considered Program Income?

A

Program income includes, but is not limited to, income from fees for services performed; charges for the use or rental of real property, equipment or supplies acquired under the grant; the sale of commodities or items fabricated under an award; charges for research resources; registration fees for grant-supported conferences, and license fees and royalties on patents and copyrights.

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51
Q

Subrecipient Monitoring

A
  • Risk assessment
  • OMB compliance requirements
  • Technical monitoring
  • Review of subrecipient’s Single Audit Report
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52
Q

Simplified Acquisition Threshold

A

The dollar amount below which a non-Federal entity may purchase property or services using small purchase methods. Non-Federal entities adopt small purchase procedures in order to expedite the purchase of items costing less than the simplified acquisition threshold (e.g. Fixed Amount Subawards). (For 2021, it is $250,000)

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53
Q

e-Verify.gov

A

Site for instant verification of US work authorization for eligibility of working on federal contracts

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54
Q

Consultant vs. Employee

A

Is institution providing a workstation, materials, tools and supplies?
Is institution paying a set salary rather than for piece work?
Is institution in a continued relationship?
Is institution controlling method or result of work?

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55
Q

Federal fiscal year ends on what date?

A

September 30

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56
Q

What does the Bayh-Dole Act of 1980 address?

A

Ownership of intellectual property

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57
Q

37 CFR 401.14

A

Bayh-Dole Act of 1980 or Patent and Trademark Law Amendments Act permits businesses (large and small) and nonprofits (including universities) to retain ownership of the inventions made under federally funded research and contract programs, while also giving the government the license to practice the subject invention. In turn, the organizations are expected to file for patent protection and to ensure commercialization upon licensing for the benefit of public health within a year.

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58
Q

The Freedom of Information Act

A

The right of the General Public to access records in the possession of a federal agency

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59
Q

International Traffic in Arms Regulations (ITAR)

A

ITAR (22 CFR 120-130) is a United States regulatory regime (US State Department, Directorate of Defense Trade Controls (DDTC) to restrict and control the export of defense and military related technologies (including items listed on USML) to safeguard U.S. national security and further U.S. foreign policy objectives. Limited to US persons.

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60
Q

USML

A

United States Munition List

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61
Q

How often is each volume of the CFR is updated?

A

Once each calendar year and is issued on a quarterly basis.

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62
Q

Clinical Trial Agreement

A

A document signed between sponsor and institution for testing the efficacy and safety of a new drug, device, treatments or vaccine in human subjects.

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63
Q

What is effort reporting?

A

The percentage of total employment devoted to a particular project or activity on 12 months.

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64
Q

Which federal agency administers International Traffic in Arms (ITAR) regulations?

A

Department of State

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65
Q

Name 4 Executive Branch Agencies

A

HHS, DoD, DoE, DoEd, DoA, DoT, DHUD

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66
Q

MRI

A

Major Research Instrumentation Program (NSF Award)

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67
Q

REU

A

Research Experiences for Undergraduates (NSF Award)

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68
Q

CAREER

A

Faculty Early Career Development Program (CAREER)

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69
Q

GRFP

A

Graduate Research Fellowship Program (NSF Award)

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70
Q

Cooperative Agreements

A

Provide assistance to advance a public purpose with substantial sponsor involvement

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71
Q

Uniform Guidance At a Glance

A 
2 CFR Part 200
A Definition                 0-99
B General Provisions 100-199
C Pre-Award               200-299
D Post-Award             300-399
E Cost Principles        400-499
F Audit                        500-599
X Appendix                 I-IX
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72
Q

Uniform Guidance 2 CFR Part 200 Appendices Applicable to IHEs

A

Appendix I: Full Text of the Funding Opportunity Notice; Appendix II: Contract Provisions for Non-federal Entities; Appendix III: F&A Identification and Assignment for Higher Ed

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73
Q

Types of Proposal

A

New (solicited/unsolicided), Continuation, Renewal or competing continuation, Supplemental, Equipment

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74
Q

Info contained in a Federal Award (2 CFR 200.211)

A

16 data elements:

  1. Recipient name
  2. Recipient’s unique entity identifier
  3. FAIN
  4. Federal Award Date
  5. Period of Performance
  6. Budget Period
  7. Amount of Federal Funds Obligated by this action
  8. Total amount of Federal Award
  9. Total approved Cost Sharing or Matching
  10. Total amount of Federal Award including approved Cost Sharing or Matching
  11. Budget approved by the Agency
  12. Federal award description e.g. Award T&C, statutory requirements
  13. Name of Agency and Contact Official of the Agency
  14. Assistance Listings (formerly CFDA)
  15. Identification of whether the award is R&D
  16. Indirect Cost Rate
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75
Q

Uncommon Direct Costs

A 
Page Charges,
Protocol and Data-Related Costs,
Dependent Care Costs,
Short-Term Travel Visas (as opposed to longer term, immigration visas),
Participant Support Costs
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76
Q

FFATA

A

The Federal Funding Accountability and Transparency Act (FFATA), signed into law in 2006, required information about Federal awards to be posted on a single, searchable website that is open for public access which is www.USAspending.gov.

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77
Q

Federal Demonstration Partnership (FDP)

A

The Federal Demonstration Partnership is a cooperative initiative among 10 federal agencies and 217 institutional recipients of federal funds for Phase VII.
The FDP is a program convened by the Government-University-Industry Research Roundtable of the National Academies. Its purpose is to reduce the administrative burdens associated with research grants and contracts.

Developed Expanded Authorities
• Allowed at option of the agency
• Allow for 90 day pre-award costs
• One-time NCX up to 12 months
• Carry forward of unobligated balances to subsequent funding periods
• Waiver of some cost-related prior awards

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78
Q

FAPIIS

A

The Federal Awardee Performance and Integrity Information System (FAPIIS) is a database that contains information to support award decisions as required by the Federal Acquisition Regulation (FAR)

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79
Q

Post Award Requirements

A

Final Financial Report,
Final Progress Report,
Inventions,
Equipment and Property

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80
Q

Patents

A

Excludes others from making, using, and selling for 20 years from date on which application was filed in the US. It must be: Useful, Novel, & Non-obvious.

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81
Q

What types of patents are there?

A
  1. Design Patent - new and original design for an article of manufacture
  2. Plant Patent - invention, discovery or asexual reproduction of any distinct and new variety of plant
  3. Utility Patent - new machines and processes
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82
Q

Copyrights in Grants & Contracts

A
  1. Grantee has free to arrange Copyright unless prohibited by terms/conditions
    A. Provides a royalty-free license to the federal government.
    B. Grantees should adopt policy that will:
    a.Encourage the creative energies
    b.Permit portion of royalties to the institution
    c.Serve the public interest
  2. Employers generally own the Copyright for all work for hire, unless agreed otherwise in a signed written agreement.
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83
Q

Trademark

A

Titles, names, short phrases, and slogans, familiar symbols or designs

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84
Q

Material Transfer Agreement (MTA)

A

Agreement that covers transfer of incoming and outgoing research materials
with industry or academic colleagues outside home institution

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85
Q

Shelby Amendment

A

The Shelby Amendment is a law that Congress passed in 1998. It requires the Office of Management and Budget (OMB) to amend the OMB Circular A-110, thereby allowing members of the public to gain access to specific research data that has resulted from federally sponsored research projects through the Freedom of Information Act (FOIA).

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86
Q

FOIA

A

Freedom of Information Act

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87
Q

UEI

A

Unique Entity Identifier

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88
Q

Presidential Executive Order: E.O. 12372

A

“Intergovernmental Review of Federal Programs,” was issued with the desire to foster the intergovernmental partnership and strengthen federalism by relying on State and local processes for the coordination and review of proposed Federal financial assistance and direct Federal development.

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89
Q

What are Code of Federal Regulations (CFR)

A
  • Executive agencies implement laws and rules using CFR
  • Codification of general and permanent rules published in Federal Register
  • Divided into 50 titles representing broad areas subject to Federal regulation
  • Legally binding as statuatory law-
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90
Q

HHS Appropriations Act

A

Established NIH salary cap as law

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91
Q

NSF regulations on Uniform Administrative Requirements appear in 45 CFR 602

A

Is an example of federal regulations

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92
Q

NSF grant terms and conditions appears in NSF proposal and award policies and procedures guide

A

Is an example of program guidelines

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93
Q

NSF grant terms and conditions appears in NSF proposal and award policies and procedures guide

A

Is an example of program guidelines

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94
Q

Uniform Guidance

A

Effective 12/26/2014, it eliminated/supersedes OMB circulars A-21, A-50, A-102, A-87, A-110, A-122, A-133. It’s purpose is to streamline administrative burdens and strengthen oversight of federal grants. Terms are broad to employees to encompass all requirements (administrative, cost principles, audit) and all types of entities receiving Federal awards.

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95
Q

45 CFR 74

A

Governs the cost principles of Hospitals (HHS Regulations)

96
Q

Continuing Resolution

A

A type of appropriations legislation. An appropriations bill is a bill that appropriates money to specific federal government departments, agencies, and programs. The money provides funding for operations, personnel, equipment, and activities. A continuing resolution is a temporary funding measure that Congress can use to fund the federal government for a limited amount of time

97
Q

Impoundment Control Act of 1974

A

A United States federal law that governs the role of the Congress in the United States budget process. It established procedures to prevent the President and other government officials from unilaterally substituting their own funding decisions for those of the Congress. The Act also created the House and Senate Budget Committees and the Congressional Budget Office.

98
Q

Supplemental Appropriation

A

is an appropriation enacted subsequent to a regular annual appropriations act, when the need for funds is too urgent to be postponed until the next regular annual appropriations act.

99
Q

Anti-Deficiency Act

A

is legislation enacted by the United States Congress to prevent the incurring of obligations or the making of expenditures in excess of amounts available in appropriations or funds. The law was initially enacted in 1884, with major amendments occurring in 1950 and 1982. It prohibits federal employees from making or authorizing an expenditure from, or creating or authorizing an obligation under, any appropriation or fund in excess of the amount available in the appropriation or fund unless authorized by law.

100
Q

OFAC

A

Office of Foreign Assents Controls under Department of Treasury administers and enforces economic sanctions programs including prohibiting trade or financial transactions.

101
Q

True or False: FAR governs contracts and Uniform Guidance governs grants (or financial assistance)

A

True

102
Q

False Claims Act 31 USC 3729

A

A person who receives a benefit, by reason of fraud; makes a fraudulent statement; or knowingly conceals a material fact is liable to the state for a civil penalty equal to the full amount received plus triple damages.

103
Q

Program Fraud Civil Remedies Act 3 USC 3801-3812

A

To establish an administrative remedy against any person who makes, or causes to be made, a false claim or written statement to any of certain Federal agencies. There is civil penalties.

104
Q

Administrative Procedures Act

A

Governs the process by which federal agencies develop and issue regulations. It includes requirements for publishing notices of proposed and final rulemaking in the Federal Register, and provides opportunities for the public to comment on notices of proposed rulemaking

105
Q

What are Export Controls?

A

Restriction on technology transfer, critical items, and services to foreign person/countries for reasons of foreign policy and national security.

106
Q

What are Sanctions?

A

Sanctions programs are administered and enforced by Office of Foreign Assets Control (OFAC) and utilize the blocking of assets and trade restrictions to accomplish foreign policy and national security goals. Sanctioned transactions for goods or services to specific countries and individuals or organizations on US Government Restrict Party Lists. Sanctions for one party may not be the same for another party.

107
Q

What are the current sanctioned countries listed at the Office of Foreign Assets Control (OFAC)? (11/9/21)

A

Cuba, Iran, North Korea, Crimea, Sudan, Syria

108
Q

Regulatory Exclusions and Fundamental Research in IHEs

A

Exchange of public domain information, educational information, and fundamental basic/applied research

109
Q

Examples of Export Controlled Research Indicators

A

Agreements containing publication or nationality restrictions, Information with proprietary restrictions/non-disclosure terms/limited distribution information (e.g. classified data)

110
Q

What are the two types of Exports?

A
  1. Physical export (outside of US borders)

2. Deemed Exports (inside the US) - ex. transferring export to a non-US person inside the US

111
Q

US Person

A

US Citizens, Lawful Permanent Residents (Green Card Holders), Protected political stature (refugee, asylee, amnesty), US Companies (incorporated to do business in US)

112
Q

EAR

A

Export Administration Regulations (15 CFR 300-799) - US Commerce Department, Bureau of Industry and Security (BIS), Commodities, software and technology on Commerce Control List (CCL), Predominantly commercial/civilian application items and technologies, Exports may occur after a licensing evaluation (ie Cellphone, low level)

113
Q

NRC

A

Nuclear Regulatory Commission (10 CFR 110)

114
Q

DOE

A

Department of Energy (10 CFR 810) - Along with NRC, regulate export of nuclear reactors, fuel, sensitive nuclear technologies)

115
Q

FACR

A

Foreign Asset Control Regulations (31 CFR 500-599) by US Department of Treasury, Office of Foreign Asset Controls (OFAC).

116
Q

Small Business Act

A

In the Small Business Act of July 30, 1953, Congress created the U.S. Small Business Administration, whose function was to “aid, counsel, assist and protect, insofar as is possible, the interests of small business concerns.”

117
Q

Davis-Bacon Act

A

The Davis Bacon Act of 1931 is a federal law that requires all on-site employees be paid fair wages, benefits, and overtime (also known as the “prevailing wage”) weekly while working on government-funded construction, alteration, or repair projects at a minimum threshold of $2,000.

118
Q

Contract Work Hours and Safety Standards Act

A

The Contract Work Hours and Safety Standards Act (CWHSSA) is a United States federal law that covers hours and safety standards in construction contracts.

The Act applies to federal service contracts and federal and federally assisted construction contracts worth over $100,000, and requires contractors and subcontractors on covered contracts to pay laborers and mechanics employed in the performance of the contracts one and one-half times their basic rate of pay for all hours worked over 40 in a workweek. This Act also prohibits unsanitary, hazardous, or dangerous working conditions on federal and federally financed and assisted construction projects.

119
Q

Walsh Healy Public Contracts Act of 1936

A

The Walsh-Healey Public Contracts Act (PCA), as amended, establishes minimum wage, maximum hours, and safety and health standards for work on contracts in excess of $15,000 for the manufacturing or furnishing of materials, supplies, articles, or equipment to the U.S. government or the District of Columbia. Walsh-Healey establishes overtime pay for hours worked by contractor employees in excess of 40 hours per week, and sets the minimum wage equal to the prevailing wage as determined by the Secretary of Labor. The law prohibits the employment of youths less than 16 years of age and convicts (only those currently in prison), except under certain conditions.[1] The Act sets standards for the use of convict labor, and job health and safety standards. The Walsh-Healey Act does not apply to commercial items.

120
Q

Copeland Anti-Kickback Act of 1934

A

Supplements the Davis-Bacon Act. It prohibits a federal building contractor or subcontractor from inducing an employee into giving up any part of the compensation that he or she is entitled to under the terms of his or her employment contract.

121
Q

FAR

A

Federal Acquisition Regulations -
Defines content of procurement agreements
Defines process by which government purchases goods and services
Codified at 48 CFR 1

122
Q

What is the purpose of a grant?

A

Provide assistance with little involvement by the sponsor.

123
Q

What is a contract?

A

Procure tangible good and services through an acquisition with extensive sponsor involvement with detailed specifications, clauses, regulations and expected results and deliverables. Subject to FAR flow down (FAR 2.101). Not an assistance award.

124
Q

Debarment and Suspension

A

The FAR allows for contractors to be suspended or debarred due to fraud, false claims, forgery, bribery, tax delinquency/evasion, receiving stolen property, and defaulting on a federal loan, and violation of drug free workplace act.

125
Q

Subcontract

A

Subcontract means any contract, as defined in FAR subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contract or a subcontract. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

126
Q

FAR Flow Down Requirements

A

FAR clauses included in Government contracts that prime contractors are required to flow down to their subcontractors in their subcontracts. Includes debarment and suspension, standards for financial systems, cost principles, and administrative requirements.

127
Q

Human Subjects Research (45 CFR 46.102(f))

A

A human subject is “a living individual about whom an investigator (whether professional or student) conducting research:

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

128
Q

sIRB

A

Single IRB policy (45 CFR 46.114) for NIH-sponsored multi-site studies, where the same protocol is used at multiple US sites involving non-exempt human subjects research

129
Q

Examples of sIRB exceptions

A
  1. International site(s)
  2. Individual IRB review is required by tribal law
  3. A federal agency determines and documents that the sIRB model is not appropriate.
130
Q

OHRP

A

Office for Human Research Protections operates under HHS umbrella. They establish and register IRBs and issues Federal Wide Assurance (FWA).

131
Q

NIH Clinical Trial

A

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes

132
Q

US Surgeon General’s Requirement (1966)

A

Research Institutions establish local policies for human subject protection through prior review. Sparked origin of IRB.

133
Q

FDA

A

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Oversees adherence to GCPs (Good Clinical Practices).

134
Q

Human Subjects Research History

A

Nuremberg Code of 1946 -> International code of ethics due to WWII
Declaration of Helsinki of 1964 ->
National Research Act of 1974 ->
- established requirement for IRB
- Belmont Report in 1979
- The Common Rule (June 1991, 45 CFR 46 Subpart A)

135
Q

Nuremberg Code of 1946

A
  • Informed consent required for experiments.
  • Experiments must be scientifically necessary and conducted by qualified personnel.
  • Human trials should be preceded by animal studies and surveys of a disease’s natural history.
  • Benefit to science must be weighed against risks and suffering of experimental subjects.
136
Q

Helsinki Declaration 1964

A

Clinical research should be based on animal and laboratory experiments.
Clinical research should be conducted and supervised only by qualified medical workers.
Clinical research should be preceded by a careful assessment of risks and benefits to the patient.
Human beings should be fully informed and must freely consent to the research.
Responsibility for the human subject must always rest with a medically qualified person, and never with the subject.
Results of experiments that do not comply with ethical guidelines should not be accepted for publication.
Special care must be taken with informed consent of minors.
Also mentions consideration of the welfare of animal subjects and the environment.

137
Q

National Research Act 1974

A

Required regulations to be codified and all PHS funded research to be reviewed by IRB.
Milestone:
Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research [45 CFR 46]
Established IRB procedures.
Special protections for pregnant women and fetuses [45 CRF 46 Subpart B]

138
Q

45 CFR 46 Subpart C

A

Special protections for prisoners.

139
Q

Belmont Report of 1979

A
  • Respect: recognizes the autonomy of humans and requires clear informed consent and respect for privacy and confidentiality
  • Beneficence: Research must be shown to be beneficial and reflect the Hippocratic idea of do no harm.
  • Justice: The benefits to some must be balanced against the risks to subjects. Equitable selection of subjects.
140
Q

45 CFR 46 Subpart D

A

Special protections for children

141
Q

“Common Rule”

A

Common Federal Policy for the Protection of Human Subjects (Standardized)
16 federal agencies adopt the regulations of 45 CFR 46 subpart A.
Subparts B, C, D adopted by many agencies totaling to 20 federal entities.
Basically, it polices special protections for vulnerable populations.

142
Q

21 CFR 50 and 56

A

Human subjects research regulated by the FDA

143
Q

Registrations and Assurances for Human Subjects Research

A
  • IRB must register with Office of Human Research Protections (OHRP-HHS) when involved in federal research
  • IRB must register with FDA before reviewing clinical investigators for FDA regulated products
  • Federal-wide Assurance (FWA)
144
Q

FWA

A

Federal Wide Assurance is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research. Also, an institution must have an FWA in order to receive Department of Health & Human Services (DHHS) support for research involving human subjects. This is the principal mechanism for compliance oversight by the Office for Human Research Protections.

145
Q

IRB Reviews & Approvals

A
  1. Initial Review
    1a. Full Board - review/approval by a convened meeting of the board
    1b. Expedited - review/approval using an expedited process
    1c. Exempt - review/approval of low risk research
  2. Continuation/Renewal
  3. Amendment/Modification
146
Q

IRB Reporting

A
  • Unanticipated problems involving risk
  • Adverse reactions/events
  • Non-compliance
147
Q

OHRP

A

Office for Human Research Protections

  • Under HHS Umbrella
  • Establishes and registers IRBs
  • Issues FWA (Federal Wide Assurance)
148
Q

IND

A

The United States Food and Drug Administration’s Investigational New Drug program is the means by which a pharmaceutical company submits application to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved.

149
Q

What are the 3 types of Investigational New Drug (IND)?

A
  1. Investigator IND: submitted by physician who initiates & conducts the study
  2. Emergency IND: allows the FDA to authorize use of experimental drug in emergency situation
  3. Treatment IND: submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions
150
Q

IDE

A

Investigational Device Exemption is a process for “sponsor” to obtain FDA approval to use an investigational new device.

151
Q

AE/SAE

A
  1. Adverse Event (Any type of health issue that occur in a clinical trial participant; May or may not be related to the intervention)
  2. SAE: Serious Adverse Event
152
Q

What are the phases of a clinical trial?

A

Pre-clinical + 4 Phases:

  • Laboratory studies
  • Phase I: tests the safety on a small group of healthy subects
  • Phase II: tests safety on afflicted subjects and control subjects for efficacy
  • Phase III: study expanded to larger group at multiple sites, double blinded, FDA approval
  • Phase IV: intervention approved, post-marketing,refine dosage and side effects, additional monitoring after FDA approval
153
Q

What is a Protocol?

A

It is the recipe, the statement of work, the step by step in a research or trial.

  • establishes outcome
  • animal/patient exclusion/inclusion criteria
  • determines the budget
  • establish how data is collected/manage
154
Q

ICH GCP

A

International Conference on Harmonization - Good Clinical Practice. Endorsed by the FDS.
3 main goals: To protect the right, safety and welfare of humans participating in research, to assure quality, reliability and integrity of data collected, and to provide standards and guidelines for the conduct of clinical research.

155
Q

ICF

A

A. Informed Consent Form (process)

  1. Research description
  2. Risks
  3. Benefits
  4. Alternatives
  5. Confidentiality
  6. Compensation
  7. Contacts
  8. Voluntary participation and withdrawal
156
Q

CRF

A

Case Report Form - Patient data collected and submitted to sponsor

157
Q

What are the 3 main types of Clinical Research?

A

To study an investigational product’s effects on health and illness:

  1. Patient-oriented research
  2. Epidemiological and behavioral studies
  3. Outcomes and health services research
158
Q

IBC

A

Institutional Biosafety Committee:
• Provides oversight for safe handling an containments of infectious microorganisms and hazard biological materials
• 5 person committee
• Nature of the research defines the level of review and containment required
• Non-exempt research requires registration
• Includes the CDC list of Select Agents

159
Q

Health Research Extension Act of 1985

A

Directed NIH to establish guidelines for the proper care of animals to be used in biomedical & behavioral research (basically this law follows the money) funded by PHS. Established OLAW (Office of Laboratory Animal Welfare) and that each research facility establish an Institutional Animal Care and Use Committee (IACUC)

160
Q

Animal Research

A

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

161
Q

AWA

A

Animal Welfare Act (9 CFR Subchapter A) of 1966 is stewarded by USDA and established minimum standards for handling, housing, transporting and feeding of animals. Animal and Plant Health Inspection Service conducts site visits/review of records annually.

162
Q

Animal Welfare Assurance

A

Animal Welfare Assurance (separate from AWA of 1966) - No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with the Policy

163
Q

AWA

A

Animal Welfare Act of 1966
Minimum standards for handling, housing, transporting, and feeding
Animal and Plant Health Inspection Service conducts site visits/review of records annually.
USDA is steward of Animal Welfare Act

164
Q

OLAW

A

Office of Laboratory Animal Welfare - In charge of insuring PHS policy is followed when PHS funds are used for animal research. Applies to all live, vertebrate animals. Relies on certification by institution(s).

165
Q

Which animals does Animal Welfare Act not cover?

A

Birds, rats and mice. (They are covered under OLAW (PHS policies))

166
Q

The IACUC consist of?

A

They meet at least once every six months and consist of at least three members.
USDA - 3 (must have a chair person)
PHS/VA - 5 (does not need a chair person)
One member must be DVM, and one non-affiliated member of the animal facility, one member must be a practicing scientist (USDA optional), and one nonscientist (USDA optional)

167
Q

What are the functions of a IACUC?

A
  1. Protocol Review: review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals
  2. Submit annual report
168
Q

What are the major responsibilities of IACUC?

A
  • semi-annual review of programs
  • semi-annual inspection of facilities
  • review of each protocol for approval
  • suspend animal use activities if there is a violation of policies
169
Q

When are reviews of animal protocols conducted by IACUC?

A

Annual review of protocol report and full review of protocols every 3 years.

170
Q

What is the role of IBC when research involves select agents on the CDC list?

A

When research involves select agents, entities must do the following:
- Designate a Responsible Official (RO)
- Develop the following:
□ A safety plan and laboratory compliance program
□ An emergency response plan
□ A security risk assessment
□ A record management system
□ A theft, loss, or release notification procedure
- Applies to all use of identified agents/toxins and is applicable both to individuals and entities

171
Q

Safety and Health Requirements for Potential Exposure of CDC list of Select Agents?

A
  1. Community Notification
  2. Containment
  3. Emergency Preparedness
  4. Security
172
Q

Radiation Safety

A
  • Licensed use of radiation sources, radioisotopes, radio labeled compounds
  • Regulated by the Nuclear Regulatory Commission (NRC) and States
  • Radiation Safety Committee (RSC) reviews and approves use and Protocols
  • Training required
173
Q

OSHA

A

Occupational Safety and Health Administration standards:
• Affects all facilities using hazardous chemicals (even if using small quantitites)
○ Includes blood bourne pathogens
• Institutional Chemical Hygiene Plan must minimize employee exposure
• Information and training
• Medical exam for persons showing symptoms of chemical exposure

174
Q

Conflict of Interest (COI)

A

○ Individual’s professional judgement at risk of being biased by secondary interest - threatens bias (actual vs potential - meaningless)
§ Threshold (minimum amount)
□ SBIR/STTR - SFI Thresholds the same
® Exemption Phase I might not be subject to the requirement depending on RFP/PA
§ Management Plan
○ Institution’s Policy ensures against making biased research decisions because of financial holdings

175
Q

ICOI

A

Institutional conflicts of interest -
An institution or one of its senior officials has a financial interest that poses a risk of bias decision making resulting in possible harm to research subjects or other employees

176
Q

OCI

A 
Organizational Conflict of Interest
- Typically exist in the context of federally funded contracts.  An OCI can arise in several scenarios including:
		○ Biased ground rules
		○ Unequal access to information
- Impaired Objectivity
177
Q

How do COI impact research objectivity?

A

• “Scales” are tipped towards the secondary interest so that there could be a negative outcome.
• Two primary ethical considerations
○ Diminished research objectivity
○ Harm to research subjects due to distorted judgement
• Influencing study design to favor certain outcomes
• Restricting publications
• Avoiding adverse events reporting
• Distorting interpretations of data

178
Q

What are the three safeguards against conflict of interest?

A

• Create transparency
○ Disclosure to study team, publications, human subjects
• Reduce the COI
○ Modify research plan, have someone else consent patients or serve as PI
○ Reduce or limit financial interest (prohibit consulting income after $50K received)
• Eliminate the COI
○ Conflicted individual cannot be involved in the research
○ Conflicted individual’s institution will be a research site
• Sell equity interest

179
Q

Name two possibilities for SFI (Significant Financial Interest)?

A

□ For a single publicly traded entity, payments and equity+ value (determined through public prices) > $5,000 in total
□ For a single non-publicly traded entity, payments* > $5,000 or any equity interest
*payments = salary, consulting fees, honoraria, IP payments, travel reimbursements, income from investment vehicles (payments are additive from same entitity)
+equity interest: stock, stock options, other ownership interest

180
Q

Name two examples that allow investigators to be exempt from financial disclosure?

A
  1. Payments or equity unrelated to investigator’s institutional responsibilities
  2. If investigator receive ≤$5,000 in payments from a single entity
  3. Income or payments from institution, which includes travel paid with institutional funds, including sponsored projects
  4. Income from a U.S. federal, state, or local government agency; a U.S. institution of higher education or research institute affiliated with a U.S. institution of higher education; or a U.S. academic teaching hospital, medical center
  5. Income from investment vehicles, such as mutual funds and retirement accounts, if investigator do not directly control the investment decisions made in these vehicles.
181
Q

How often do Investigators needs to be trained on COI?

A

Every 4 years

182
Q

The FCOI regulatory framework requires Investigators to…

A

disclose their significant financial interests (SFI) that reasonably appear related to their institutional responsibilities annually and within 30 days of acquiring a new significant financial interest (SFI) and must disclose in context of himself/herself, spouse, and dependent children living in his/her household

183
Q

Federal regulations of FCOI is administered by?

A
  • NIH/PHS funds - Promoting Objectivity in Research (42 CFR 50, Subpart F)
  • NSF funds - Conflict of Interest Policies
184
Q

Who determines financial conflict of interest (FCOI)?

A

Institution’s Policy oversight by a designated official ensures against making biased research decisions because of financial holdings on NSF and PHS funds.

185
Q

AAALAC

A

Association for Accreditation of Laboratory Animal Care International:

  • Nonprofit private organization
  • Accrediting body is Voluntary
  • Gold Standard, ergo more NIH funding?
  • Re-inspected every three years
  • Best Practices with emphasis on Occupational Health
186
Q

OSI

A

Office of Scientific Integrity established by FDA 42 CFR Part 50, Subpart A

187
Q

OIG

A

Office of Inspector General (NSF)

188
Q

ORI

A

Office of Research Integrity (HHS)

189
Q

Define Research Misconduct

A

Research Misconduct (42 CFR Part 93) defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results

190
Q

Institutional Policy Requirement for Research Misconduct

A
  1. Investigate allegations
  2. Notify sponsor
  3. Protect whistleblowers
  4. Restore reputation
  5. Informing scientific & administrative staff
191
Q

How does ORI oversee research misconduct?

A

Promoting research integrity is a responsibility shared between an institution that receives U.S. Public Health Service funding and ORI. In many situations, allegations are first brought to the attention of the research integrity officer (RIO) at the institution where the alleged misconduct occurred. The institution must notify ORI if it determines that an investigation is warranted. Allegations of research misconduct also may come directly to ORI. In this scenario, ORI will assess the allegation to determine whether it falls within its jurisdiction. If it does, ORI then forwards the case to the institution where the alleged research misconduct took place for its subsequent inquiry and investigation (as warranted). ORI always is available to assist the institution with its inquiry and investigation to ensure that it follows the regulatory requirements. ORI has no direct involvement in the decision-making by an institution. When an institution completes its investigation, ORI reviews the institution’s findings and process and then make its own independent findings. If ORI determines that misconduct has occurred, HHS imposes administrative actions (see #8) that protect the public against any further misuse of public funds by the researcher. If ORI does not issue findings against a respondent, this does not negate the institution’s findings. ORI’s findings are independent of the institution’s findings.

192
Q

Responsible Conduct of Research (RCR) Training

A

NIH - All NIH staff who have direct involvement in proposing, performing, reviewing or reporting research, or who receive research training; Substantial face-to-face interaction with didactic and small group discussions

NSF - Undergraduates, graduate students and postdocs who receive NSF funding must receiving RCR training. Allows all training to be completed online (e.g. CITI)

193
Q

HIPAA

A

The Health Insurance Portability and Accountability Act of 1996 is a United States federal statute enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1996. Stiff Penalties for non-compliance by institution.

194
Q

What are the three basic rules of HIPAA?

A
  1. Privacy
  2. Security
  3. Breach Notification
195
Q

PHI

A

Protected Health Information and is any information in a medical record that can be used to identify an individual, and that was created, used, or disclosed in the course of providing a health care service, such as a diagnosis or treatment.

196
Q

What is the Privacy Rule in PHI?

A

It establishes conditions for use and disclosure of individually identifiable health information by covered entities for research purposes. De-identified health information may be used or disclosed for research purposes. Defines how individuals will be informed of uses and disclosures of their medical information used for research

197
Q

Can PHI be disclosed?

A

Covered entities may use and disclose PHI for research with individual authorization, or without individual authorization under the following limited circumstances
• Documented IRB or Privacy Board approval
• Preparatory to research
• Research on PHI of decedents
• Limited Data Sets with a Data Use Agreement (DUA)

198
Q

Stevens Amendment

A

Requires acknowledgement of federal sponsorship in publications (ie statements, press releases, bid solicitations, etc)

Acknowledgement should include:
The percentage of the total cost of the program or project which is financed with federal money
The dollar amount of federal funds for the project or program
Include a disclaimer that contents are the responsibility of the author(s), not the sponsor

199
Q

What information is NOT released under FOIA?

A
  • Pending or disapproved applications
  • Financial information of an individual such as salaries
  • Information subject to the Privacy Act of 1974
  • Confidential personal or medical information
  • Summaries of discussion of application by advisory bodies
  • Proprietary information
200
Q

Anti-Lobbying

A
  • Use of appropriated funds to pay a person to influence or attempt to influence a federal official or employee
  • Prohibits recipients of federal funds from using those funds to obtain, modify or extend a federal award
  • Applies to grants, contracts and cooperative agreements, Penalties apply
201
Q

Solomon Amendment (Military Recruiting on Campus)

A

The 1996 Solomon Amendment is the popular name of 10 U.S.C. § 983, a United States federal law that allows the Secretary of Defense to deny federal grants (including research grants) to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus.

202
Q

National Historic Preservation Act

A

The National Historic Preservation Act of 1966 was passed primarily to acknowledge the importance of protecting our nation’s heritage from rampant federal development. It was the triumph of more than a century of struggle by a grassroots movement of committed preservationists.

203
Q

Metric usage in Federal government programs

A

§ 518.15 Metric system of measurement.
The Metric Conversion Act, as amended by the Omnibus Trade and Competitiveness Act (15 U.S.C. 205), declares that the metric system is the preferred measurement system for U.S. trade and commerce. The Act requires each Federal agency to establish a date or dates in consultation with the Secretary of Commerce, when the metric system of measurement will be used in the agency’s procurements, grants, and other business-related activities.

204
Q

How many months does NSF restrict PI salaries?

A

2 months.

205
Q

PAPPG

A

Proposal & Award Policies & Procedures Guide: Chapter II of the NSF Proposal Preparation and Submission Guidelines

206
Q

Can a Non-US citizen apply for a NIH K award?

A

Yes

207
Q

What is the role of a Scientific Review Officer?

A
  • Ensures fair and unbiased evaluation of scientific and technical merit
  • Provides a summary of the evaluation
  • Reviews applications for completeness and conformance with application requirements
  • Point of contact for applicants during the review process
208
Q

What is Transformative Research?

A

Transformative research involves ideas, discoveries, or tools that radically change our understanding of an important existing scientific or engineering concept or educational practice or leads to the creation of a new paradigm or field of science, engineering, or education. Such research challenges current understanding or provides pathways to new frontiers.

209
Q

Discretionary spending

A

Discretionary spending is what the President and Congress must decide to spend for the next fiscal year through annual appropriations bills. This category of spending includes most defense programs, as well as important non-defense investments such as support for elementary and secondary education, veterans’ health care, homeland security, workforce training, infrastructure, scientific research, public health, clean energy, advanced manufacturing, public safety, and other programs.

210
Q

Mandatory Spending

A

Mandatory Spending is for mandatory programs by establishing permanent laws. Rules include such things as who is eligible for benefits, how the benefits should be calculated, and when benefits should be paid. Two of the largest mandatory programs are Social Security and Medicare, which provide retirement security for millions of Americans. Other mandatory programs include Medicaid and the Children’s Health Insurance Program (CHIP), subsidies for health insurance purchased through the marketplaces, unemployment compensation, income and nutrition assistance for children and families facing poverty, civilian and military retirement, certain farm programs, and veterans’ pensions and education benefits.

211
Q

NEA

A

The National Endowment for the Arts is an independent agency of the United States federal government that offers support and funding for projects exhibiting artistic excellence. It was created by an act of the U.S. Congress in 1965 as an independent agency of the federal government.

212
Q

NEH

A

The National Endowment for the Humanities is an independent federal agency of the U.S. government, established by the National Foundation on the Arts and the Humanities Act of 1965, dedicated to supporting research, education, preservation, and public programs in the humanities.

213
Q

USAID

A

The United States Agency for International Development is an independent agency of the United States federal government that is primarily responsible for administering civilian foreign aid and development assistance.

214
Q 
At what procurement level must a cost-analysis be done?
A. Micro-purchase
B. Simplified Acquisition Threshold
C. Small purchase
D. Large Acquisition Threshold
A

B. Simplified Acquisition Threshold

215
Q

Fixed Rate Indirect Cost with carry-forward

A

means an indirect cost rate which has the same characteristics as a predetermined rate, except that the difference between the estimated costs and the actual, allowable costs of the period covered by the rate is carried forward as an adjustment to the rate computation of a subsequent period.

216
Q

Justification for IHEs to request Indirect Costs

A

It helps IHE recover administrative and shared costs.

217
Q

Pre-award Spending

A

Is allowed at the discretion of awardee with prior funding agency approval with the understanding that the awardee assumes the risk for all pre-award costs should the award not be made.

218
Q

How are indirect cost rates established?

A

It is based on prior actual costs.

219
Q

Third-Party Cost Sharing

A

Third party may contribute cost sharing to an award via donated cash, supplies, materials, and/or volunteer services to a project.

220
Q

True or False: If your invention that was created at a non-profit institution with federal funds has been disclosed in a publication over a year before you file a patent application, you will still be granted a patent.

A

False. You have file within a year.

221
Q

Indemnification Clause

A

Clauses in contracts that set out to protect one party from liability if a third-party or third entity is harmed in any way.

222
Q

Federal Financial Assistance Management Improvement Act of 1999

A

The Act requires each agency to develop and implement a plan that streamlines and simplifies the application, administrative, and reporting procedures for Federal financial assistance programs.

223
Q

Anti-Lobby Certification

A

HHS’ implementing regulation, 45 CFR Part 93, requires, upon submission that initiates agency consideration of such person, or receipt by such person, of a certification and disclosure form, if required, of a Federal contract, grant or cooperative agreement exceeding $100,000

224
Q

Interinstitutional Animal Welfare Assurance

A

Provide written assurance to OLAW that performance site has assurance, tie grantee to performance site IACUC

225
Q

Domestic Animal Welfare Assurance

A

Written assurance that US organization controls own facility and conduct research on site; animal program with IO, IACUC, veterinarian; and has PHS funding

226
Q

What is facility costs in indirect cost rates?

A

Facility costs are defined as depreciation on building, equipment and capital improvement, interest on debt associated with certain buildings, equipment and capital improvements, and operations and maintenance expenses. Space survery conducted to distribute the costs by function.

227
Q

Indirect Rate Calculation

A

Numerator Expenses (depreciation & interest, operations & maintenance, library, and administration) divided by Denominator Expenses (sponsored agreements; cost sharing/matching)

228
Q

FSRS

A

FFATA Subaward Reporting System

229
Q

ORCID

A

Open Researcher and Contributor Identifiers (ORCID iDs) - Unique, persistent digital identifiers that distinguish individual investigators and can be used to connect researchers with their contributions to science over time and across changes of name, location, and institutional affiliation. These free identifiers are assigned and maintained by the non-profit organization ORCID.

230
Q

Payback

A

Requirement that the recipient of a NRSA postdoctoral fellowship engage in qualified health-related research, health-related research training, or health-related teaching activities for a length of time equal to the period of NRSA support received. Only the first year of training incurs a payback obligation. In general, payback activity must involve at least 20 hours per week and be conducted over 12 consecutive months; special exceptions may be considered on a case-by-case basis. See Ruth L. Kirschstein National Research Service Awards-Payback for additional information.

231
Q

Responsible party

A

Responsible party is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to refer to the entity or individual who is responsible under FDAAA for registering a clinical trial and submitting clinical trial information to ClinicalTrials.gov.

232
Q

Revision application

A

As defined in the Federalwide SF424 (R&R): An application that proposes a change in 1) the Federal Government’s financial obligations or contingent liability from an existing obligation, or 2) any other change in the terms and conditions of the existing award. Note in general for NIH applicants, #2 would not require the submission of another application. NIH recipients use revision applications to request an increase in support in a current budget period for expansion of the project’s approved scope or research protocol. Applicants must apply and undergo peer review. The previous NIH term was “competing supplemental.” NOTE: The former NIH term “revision,” is now “resubmission”. A revision has a suffix in its application identification number; e.g., S1

233
Q

What is max federal employees that can serve on a Scientific a review Group?

A

No more than one-fourth of the members of any SRG may be Federal employees, as noted in 42 CFR 52(h)

234
Q

Non-Federal share

A

When cost sharing or matching is required as a condition of an award, the portion of allowable project/program costs not borne by the Federal government.

235
Q

Third-party in-kind contribution

A

The value of non-cash contributions (i.e., property or services) that: (1) Benefit a federally assisted project or program; and (2) Are contributed by non-Federal third parties, without charge, to a non- Federal entity under a Federal award.

236
Q

Unobligated Liquidation

A

For financial reports prepared on a cash basis, obligations incurred by the non-Federal entity that have not been paid (liquidated). For reports prepared on an accrual expenditure basis, these are obligations incurred by the non-Federal entity for which an expenditure has not been recorded.

CRA - Cert 2021 (1 decks)

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