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ACRP CCRA > CRA > Flashcards

CRA Flashcards

1
Q

NEI

A

National Eye Institute

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2
Q

NHLBI

A

National Heart, Lung, and Blood Institute

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3
Q

NHGRI

A

National Human Genome Research Institute

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4
Q

NIA

A

National Institute on Aging

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5
Q

NIAAA

A

National Institute on Alcohol Abuse and Alcoholism

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6
Q

NIAID

A

National Institute of Allergy and Infectious Diseases

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7
Q

NIAMS

A

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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8
Q

NIBIB

A

National Institute of Biomedical Imagine and Bioengineering

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9
Q

NICHD

A

National Institute of Child Health and Human Development

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10
Q

NIDCD

A

National Institute on Deafness and Other Communication Disorders

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11
Q

NIDCR

A

National Institute of Dental and Craniofacial Research

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12
Q

NIDDK

A

National Institute of Diabetes and Digestive and Kidney Diseases

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13
Q

NIDA

A

National Institute on Drug Abuse

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14
Q

NIEHS

A

National Institute of Environmental Health Sciences

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15
Q

NIGMS

A

National Institute of General Medical Sciences

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16
Q

NIMH

A

National Institute of Mental Health

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17
Q

NIMHD

A

National Institute on Minority Health and Health Disparities

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18
Q

NINDS

A

National Institute of Neurological Disorders and Stroke

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19
Q

NINR

A

National Institute of Nursing Research

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20
Q

NLM

A

National Library of Medicine

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21
Q

CIT

A

Center for Information Technology

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22
Q

CSR

A

Center for Scientific Review

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23
Q

FIC

A

John E. Fogarty International Center for Advanced Study in the Health Sciences

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24
Q

NCCAM

A

National Center for Complementary and Alternative Medicine

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25
Q

NCATS

A

National Center for Advancing Translational Sciences

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26
Q

CC

A

NIH Clinical Center

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27
Q

FAR

A

Federal Acquisition Regulations: System of uniformed policies and procedures governing acquisition or contracting actions of all executive agencies

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28
Q

Official FAR at 48 CFR Part 1-51

A

Part 1-51: guidelines for use of clauses

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29
Q

Official FAR at 48 CFR Part 52

A

Part 52: solicitation provision and contracts

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30
Q

Official FAR at 48 CFR Part 53

A

Part 53: Forms

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31
Q

Official FAR at 48 CFR Part 200+

A

Part 200 and up: agency-specific supplements

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32
Q

45 CFR 74

A

45 CFR 74: Principles for determining costs applicable to research and development under grants and contracts with hospitals

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33
Q

45 CFR 75:26

A

45 CFR 75:26 Audit requirements for for-profit organizations

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34
Q

48 CFR 31.2

A

48 CFR 31.2: Federal acquisition regulation contracts with commercial organizations

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35
Q

AAALACI

A

Association for the Assessment and Accreditation of Laboratory Animal Care International

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36
Q

AALAS

A

American Association for Laboratory Animal Science

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37
Q

Every institution that uses animals for federally funded laboratory research must have an _________.

A

IACUC: institutional Animal Care and Use Committee

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38
Q

Animal Welfare Act 1966

A

AWA and associated regulations are federal law overseen by the US Dept of Agriculture’s Animal and Plant Health Inspection Service. Excludes birds, rats and mice bred for research.

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39
Q

Public Health Service Policy on Humane Care and Use of Animals (PHS Policy)

A

Applies to those receiving PHS funds and covers all live vertebrates; Overseen by the Office of Laboratory Animal Welfare (OLAW)

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40
Q

A-102

A

A-102: Administrative Requirements to state/local government

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41
Q

A-110

A

A-110: Uniform administrative requirements to grants and agreements with institutions of higher education, hospitals and other non-profit organizations

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42
Q

A-21

A

A-21: Cost principles for educational institutions (universities, colleges..etc). This circular covers effort reporting requirement

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43
Q

A-87

A

A-87: Cost principles for state/local/tribal governments

44
Q

A-122

A

A-122: Cost principles for non-profit organizations

45
Q

A-133

A

A-133: Audit requirement of state/local governments and non-profit organizations

46
Q

A-134

A

A-134: Financial accounting principles and standards

47
Q

A-136

A

A-136: Financial reporting requirements

48
Q

PL106-107

A

PL106-107: Federal financial assistance management improvement Act (1999). It requires all federal agencies to use a single electronic system to post funding opportunities and accept electronic applications for federal grant opportunities. It encompasses all 26 Federal agencies. OMB chose Grants.gov to implement this agenda, and DHHS to serve as the managing partner for Grants.gov.

49
Q

Small Business Act PL85-536

A

Government should aid, counsel, assist and protect the interest of small business concerns in order to preserve free competitive enterprise

50
Q

Davis-Bacon Act (DBRA)

A

Davis-Bacon Act (DBRA): It requires all contractors and subcontractors performing work on federal or DC construction contracts or federally assisted contracts in excess of $2K to pay their laborers and mechanics no less than the prevailing wage rates and fringe benefit rates

51
Q

Walsh Healy Public Contracts Act

A

Walsh Healy Public Contracts Act: Federal minimum wages for all hours worked, and time and a half regular rate of pay for all hours worked over 40 hours a week.

52
Q

Bayh-Dole Act (1980)

A

Bayh-Dohl Act: permits recipients of federal funds to take title of IP developed under federal funds; recipient is usually the institution not the PI. Govn’t gets nonexclusive, nontransferable, irrevocable, paid-up license for global use.

53
Q

Copyright

A

Copyright: vests in authors original works and prevents others from copying or manipulating. Must be fixed, tangible form of expression.

54
Q

Trademark

A

Trademark: words, slogans, designs, and other symbols that identify different products & brands in the marketplace. Flexible definition - can include shapes, color or sounds.

55
Q

Patents

A

Patent: provides the legal right to exclude others from practicing/manufacturing/developing a good. Criteria: novel, utility/use, non-obvious.

56
Q

Safe Harbor

A

Removal of 18 HIPAA specified identifiers

57
Q

Common Rule

A

The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies.

58
Q

Grant

A

Grant: Principal purpose is to accomplish a public purpose

59
Q

Cooperative Agreement

A

Cooperative Agreement: Substantial involvement is expected between the executive agency and the recipient

60
Q

Contract

A

Contract: Principal purpose is acquisition of property or services for direct benefit of Federal Govn’t

61
Q

Resource Conservation and Recovery Act (RCRA)

A

RCRA: Preference given to the purchase of specific products containing recycled materials identified in EPA guidelines

62
Q

Reasons for revision of budget & program plans

A
  • Change in scope
  • Change in key personnel
  • Absence for >3 months or a 25% reduction in time devoted to project by PI
  • Transfer between direct and indirect costs, if approval is required
  • Subawrads, unless described in the application and funded in the approved award
63
Q

Expanded Authorities

A
  • Pre-award costs 90 days prior to award (or >90 days with prior approval of fed awarding agency
  • Initiate a one-time extension of expiration date up to 12 months
  • Carry forward unobligated balances to subsequent funding periods
  • *Must refer to award document**
64
Q

Rebudgeting

A

Federal awarding agencies my, as its option, restrict the transfer of funds among DC categories for awards in which the federal share of the proj exceeds $100k and cumulative amount of such transfers exceeds 10% of total budget

65
Q

Post Award: Equipment

A

physical inventory required at least once every two years

66
Q

Copeland “Anti-Kickback” Act

A

Supplement to Davis-Bacon Act; Prohibits federal building/construction contractor/subcontractor from inducing an employee into giving up any part of the compensation that s/he is entitled to under the terms of his or her employment contract

67
Q

Davis-Bacon Act

A

Applies to contractors / subcontractors performing on federally funded or assisted contracts (including District of Columbia contracts) in excess of $2,000 for the construction, alteration, or repair of public buildings or public works. Laborers / mechanics employed under such contracts are paid no less than the locally prevailing wages and fringe benefits for corresponding work on similar projects in the area. The Department of Labor determines locally prevailing wage rates.

68
Q

Contract Work Hours & Safety Standard Act

A

TBD

69
Q

Rights to Inventions Made Under a Contract or Agreement

A

TBD

70
Q

Clean Air Act

A

TBD

71
Q

Federal Water Pollution Control Act

A

TBD

72
Q

Byrd Anti-Lobbying Amendment

A

TBD

73
Q

Debarment & Suspension

A

TBD

74
Q

Recipients of federal grant funds must retain records for a MINIMUM of:

1) 180 days after closeout
2) 18 months after the grant end date
3) 2 years after each grant budget year
4) 3 years from the submission of final progress report expenditure

A

Recipients of federal grant funds must retain records for a MINIMUM of 3 years from the submission of final progress report expenditure

75
Q

Which of the following is a characteristic of a cooperative agreement?

1) Involves 2 or more institutions
2) Is more restrictive than a contract
3) Is used when federal involvement is required

A

A cooperative agreement Is used when federal involvement is required.

76
Q

Expanded authorities delegate which of the following?

1) Change of Institution
2) Modification of budget
3) Renovation of laboratory space
4) Change of PI

A

Expanded authorities delegate modification of budget.

77
Q

Despite expanded authorities, prior approval from a granting agency is required for which of the following?

1) A one-year no-cost extension
2) Change of personnel paid from the grant
3) Change of principal investigator or project scope
4) Transfer of funds from one budget category to another

A

Despite expanded authorities, prior approval from a granting agency is required for change of principal investigator or project scope.

78
Q

An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of:

1) $10,000
2) $25,000
3) $50,000
4) $100,000

A

An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of $100,000.

79
Q

The Bayh-Dole Act addresses

1) Publication rights to all intellectual property
2) Fixed price contracts for federally sponsored research
3) Extension of collaborative business opportunities
4) Ownership of intellectual property resulting from federal sponsored research

A

The Bayh-Dole Act addresses ownership of intellectual property resulting from federal sponsored research.

80
Q

State and local governments are subject to which of the following OMB Circulars?

1) 2 CFR 220 (A-21)
2) A-102
3) 2 CFR 230 (A-122)
4) A-133

A

A-102

81
Q

For copyrighted works which result from federally sponsored activities, the federal government usually requires

1) Disclosure of the copyright only
2) One copy for the official archives
3) A royalty-bearing, exclusive, and irrevocable license
4) A royalty-free, nonexclusive, and irrevocable license

A

For copyrighted works which result from federally sponsored activities, the federal government usually requires a royalty-free, nonexclusive, and irrevocable license.

82
Q

Effort Reporting

A

A-21: Annual, CM/% overall activity, suitable means of verification
A-122: Monthly*, % or hourly reporting, first-hand knowledge

83
Q

Allowable under A-21:

  • Commencement & Convocation Costs?
  • Deans of Faculty and Graduate Schools?
  • Scholarships and student aid costs?
  • Student activity costs (e.g. intramurals ,clubs, etc)?
A
  • Commencement & Convocation Costs? NO (w exceptions)
  • Deans of Faculty and Graduate Schools? YES
  • Scholarships and student aid costs? YES (w restrictions)
  • Student activity costs (e.g. intramurals ,clubs, etc)? NO (unless specifically provided for in the sponsor agreement)
84
Q

Exports

A

Any oral, written, electronic or visual disclosure, shipment, transfer or transmission of commodities, tech info, tech data, assistance or software codes

  • Anyone outside the US
  • A non-US individual
  • A foreign embassy or affiliate
85
Q

Deemed Export

A

An export of technology or source code (except encryption source code) is “deemed” to take place when it is released to a foreign national within the United States.

86
Q

Drug Free Workplace Act (1988)

A

Recipients of federal grant funds must provide written notification to all employees working on federally-funded grants/contracts that they must abide by inst drug-free workplace policies & must notify employer of convictions

87
Q

Drug-Free Schools & Communities Act (1989)

A

Recipients of federal grants must dev and implement programs to prevent the unlawful possession, use, or distribution of illicit drugs and alcohol. Regulators conduct biennial review of the programs effectiveness and consistency of enforcement.

88
Q 
Stark Law
 Part 1 (1992)
 Part 2 (1993)
 Part 3 (2007)
A

Prohibits physician referrals of medicare and medicaid patients if the physician (or an immediate family member) has a financial relationship with that entity

89
Q

Fundamental Research

A

Fundamental Research means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community

90
Q

False Claims Act (FCA)

A

The FCA does not require proof of a specific intent to defraud the U.S. government. Healthcare providers can be prosecuted for conduct that leads to the submission of fraudulent claims to the government.

91
Q

Phases of clinical trials

A

Phase I trials: Initial testing of experimental drug/treatment in 20–80 people to evaluate safety and side effects.
Phase II trials: Experimental drug/treatment is administered to 100–300 people for effectiveness and further safety evaluation
Phase III trials: Experimental drug/treatment is administered to 1,000–3,000 to confirm effectiveness, safety, monitor side effects, compare to standard treatments.
Phase IV trials: Post FDA approval and available to the public. Safety tracking for risks, benefits, and best use.

92
Q

NUREMBERG CODE – POST WWII 1947

A

Resulted from the violence committed by Nazi physicians.

  • Pre-clinical animal studies must precede human research
  • Investigator must be knowledgeable in condition
  • Societal benefit
  • Voluntary consent is essential
  • Risks minimized relative to benefits
  • Subjects have the right to end research participation
93
Q

THE DECLARATION OF HELSINKI - 1964

A

International living document.

  • Subjects’ well-being precedes the interests of science and society.
  • Some populations are vulnerable and require special protections.
  • Experimental procedures must be detailed in a protocol, which is submitted to an IRB.
  • Assessment of risks and benefits to subjects is required prior to research.
  • Subjects must be informed volunteers. If they cannot consent for themselves, legally authorized representatives must consent on their behalf.
  • Informed consent must be documented
94
Q

TUSKEGEE SYPHILIS STUDY (1932-1972)

A

U.S. Public Health Service study on syphilis in 600 poor African-American men in rural Tuskegee, Alabama.
In the 1947, when penicillin became the drug of choice, researchers withheld treatment.

95
Q

THE BELMONT REPORT-1979

A

Three core ethical principles:

  • Respect for persons: ability of a person to direct his/her own actions. Getting informed consent a requirement and an individual must be capable of freely authorizing his/her participation
  • Beneficence: Harms must minimizing and benefits must be maximizing for study participants
  • Justice: Even distribution of benefits and burdens; impartial subject selection
96
Q

45 CFR Part 46

A

Federal regulation encompassing human research, protections for vulnerable populations and IRBs

97
Q

IRB Requirements

A
  • 5 members of varying backgrounds including 1 community member
  • Must meet at least annually
  • Must have a quorum present
  • Decisions must be in writing
98
Q

Federal Funding Accountability and Transparency Act (FFATA)

A

he intent is to empower every American with the ability to hold the government accountable for each spending decision. The end result is to reduce wasteful spending in the government.

99
Q

EDGAR

A

Electronic Data Gathering, Analysis, and Retrieval system, performs automated collection, validation, indexing, acceptance, and forwarding of submissions by companies and others who are required by law to file forms with the U.S. Securities and Exchange Commission (SEC).

100
Q

provisional rate

A

A maximum provisional rate is a temporary rate established to permit funding and reimbursement of indirect costs pending establishment of a final rate (that rate determined at the end of an accounting period using “actual” direct and indirect cost data.)

101
Q

CHALLENGE GRANT

A

A grant that provides monies in response to monies from other sources, usually according to a formula. A challenge grant may, for example, offer two dollars for every one that is obtained from a fund drive. The grant usually has a fixed upper limit, and may have a challenge minimum below which no grant will be made. This form of grant is fairly common in the arts, humanities, and some other fields, but is less common in the sciences. A challenge grant differs from a matching grant in at least one important respect: The amount of money that the recipient organization realizes from a challenge grant may vary widely, depending upon how successful that organization is in meeting the challenge. Matching grants usually award a clearly defined amount and require that a specified sum be obtained before any award is made.

102
Q

Council on Governmental Relations (COGR)

A

COGR’s primary function is to provide advice and information to its membership and to make certain that federal agencies understand academic operations and the impact of proposed regulations on colleges and universities. COGR helps to develop policies and practices that fairly reflect the mutual interests and separate obligations of federal agencies and universities in research and graduate education.

103
Q

Federal Demonstration Partnership

A

purpose is to reduce the administrative burdens associated with research grants and contracts.

104
Q

Broad Agency Announcement (BAA)

A

The Broad Agency Announcement is a technique for United States government agencies to contract for basic and applied research and certain development. 48 CFR 35.016

105
Q

Recharge Center

A

Recharge centers are entities within the university that provide fee-based services to the university research community. Most commonly, these are laboratory-based core facilities, but a variety of non-laboratory centers also exist. Although recharge centers typically offer services to non-university customers, the majority of their users are university affiliates.

106
Q

NCI

A

National Cancer Institute

ACRP CCRA (13 decks)

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