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RACC CRA Exam - Fall 2020 > Certified Research Administrator > Flashcards

Certified Research Administrator Flashcards

1
Q

What are the 6 types of Proposals?

A 
Solicited
Unsolicited
New
Continuations
Supplemental
Contract
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2
Q

What does eRA stand for?

A

Electronic Research Administration

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3
Q

What is the NSF FastLane?

A

National Science Foundation site for submitting and reviewing proposals

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4
Q

What is Research.gov?

A

National Science Foundation site for Project Reporting

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5
Q

What is Grants.gov?

A

Unified site for interactions between grant applicants and Federal agencies

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6
Q

What is eRA Commons?

A

National Institutes of Health (NIH) Electronic Research Administration Portal

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7
Q

What is NIH RePORTer?

A

Research Portfolio Online Report Tools

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8
Q

What is iEdison?

A

Interagency Edison for reporting government funded inventions

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9
Q

What is PAMS?

A

Portfolio Analysis and Management System. Used by DOE.

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10
Q

What is FedConnect.net?

A

Gateway to Government Opportunities, Acquisition and Grants Portal

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11
Q

What is SAM.gov?

A

System for Award Management

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12
Q

What is USAspending.gov?

A

Searchable database for Federal awards

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13
Q

What is E-Verify.gov?

A

Site for instant verification of US work authorization

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14
Q

What is NSPIRES?

A

Web interface for submission to NASA

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15
Q

What is proposalCENTRAL?

A

E-granting website shared by many government, non-profit, and private grant-making organizations

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16
Q

What is Grant Solutions?

A

Department of Interior award Management system

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17
Q

Budgets should be _____?

A

Complete, accurate and adequate
Costs should be allowable, allocable, and reasonable
Conform to sponsor and Institution guidelines
Clearly justified

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18
Q

What is a NIH Modular Budget?

A

Used for NIH research grant mechanisms including R01, R03, R15, and R21
Not as detailed
$250,000 or less annually
Direct costs in increments of $25,000

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19
Q

What is the Federal Demonstration Partnership (FDP)?

A

Cooperative initiative among 10 federal agencies and 154 institutional recipients of federal funds.

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20
Q

What is SBIR?

A

Small Business Innovation Research

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21
Q

What are the three phases of SBIR?

A

Phase 1 (concept development)
awards generally up to $250,000
approx. 6 months in length
Small Business must perform at least 2/3 of the R&D work
Phase II (prototype development)
awards generally up to $750,000
up to 2 years in length
Small Business must perfom at least 1/2 of the R&D work
Phase III (marketplace or commercialization)
objective is for the small business to pursue the commercialization of the results

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22
Q

What is STTR?

A

Small Business Technology Transfer

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23
Q

What are the three phases of STTR?

A

Phase 1 (concept development)
awards generally up to $250,000
approx. 1 year in length
Small Business must perform at least 40% of the R&D work and research institution to perform at least 30%
Phase II (prototype development)
awards generally up to $750,000
up to 2 years in length
Small Business must perform at least 40% of the R&D work and research institution to perform at least 30%
Phase III (marketplace or commercialization)
Small business pursues this using funding other than STTR

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24
Q

What constitutes a Small Business in relation to federal funds?

A

at least 51% US owned
for profit
no more than 500 employees

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25
Q

What are the sections of Uniform Guidance?

A

Subpart A – Acronyms and Definitions, sections 1-99
Subpart B – General Provisions, sections 100-199
Subpart C – Pre-Award Requirements and Contents of Federal Awards, sections 200-299
Subpart D – Post Federal Award Requirements, sections 300-399
Subpart E – The Cost Principles, sections 400-499
Subpart F – Audit Requirements, sections 500-599
Appendices – I Funding Opportunities; II Contract Provisions; III Indirect Costs

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26
Q

COSO

A

Committee of Sponsoring Organizations of the Treadway Commision

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27
Q

COFAR

A

Council on Financial Assistance Reform

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28
Q

EUI

A

Energy Usage Index

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29
Q

FAIN

A

Federal Award Identification Number

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30
Q

FAC

A

Federal Audit Clearinghouse

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31
Q

FAPIIS

A

Federal Awardee Performance & Integrity Information System

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32
Q

GOCO

A

Government Owned Contractor Operated

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33
Q

IBS

A

Institutional Base Salary

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34
Q

IHE

A

Institution of Higher Education

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35
Q

PII

A

Personally Identifiable Information

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36
Q

PRHP

A

Post Retirement Health Plans

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37
Q

PTE

A

Pass Through entity

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38
Q

REUI

A

Relative Energy Usage Index

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39
Q

SPOC

A

Single Point of Contact

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40
Q

TFM

A

Treasury Financial Manual

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41
Q

VAT

A

Value Added Tax

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42
Q

What are the five “components” of Procurement?

A 
Micro-Purchases
Small Purchases
Sealed Bids
Competitive Proposals
Sole Source
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43
Q

Subrecipient vs Contractor/Vendor

A

Sub - provides services essential to the objective of the award. IDC only allowed on first $25,000
Vendor - provides goods/services ancillary to the objective of the award and as part of their normal business. IDC on full amount.

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44
Q

Bayh-Dole Act

A

Inventions arising from federally funded research projects are required to be reported to the government agency that funded the project. The Act permits businesses 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.

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45
Q

What is excluded from MTDC?

A 
Equipment
Capital Expenditures (including software)
Patient Care
Tuition
Rental Costs
Scholarships/Fellowhships
Participant support
Subcontracts in excess of $25,000
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46
Q

What are the 5 components of FAIN?

A 
First two digits - Agency Identifier
Next two digits - Fiscal Year
Next eight digits - Program Code
Next one digit - Instrument Type
Last three digits - Sequential Number
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47
Q

What types of awards does the National Science Foundation encourage?

A

Proposals that contribute to the advancement of societally relevant outcomes.

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48
Q

What Merit Criteria does the National Science Foundation use to review proposals?

A

Intellectual Merit and Broader Impacts

Goal is research that is Transformative

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49
Q

What is the “de minimus” IDC/F&A rate?

A

10%

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50
Q

For what changes does an NSF award require prior approval?

A

Change in:
Scope
PI or Co-PI
Subcontractor

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51
Q

What Public Health Service agencies are within DHHS (Department of Health and Human Services)?

A

NIH
FDA
CDC
NIOSH

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52
Q

What are the types of NIH funding?

A

Research Award Programs (R series)
Career and Development Awards (K series)
Research Training and Fellowships (T and F)
Cooperative Agreements (U series)
Program Project / Center Grants (P series)

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53
Q

R01

A

Research Project Grant Program
NIH’s most commonly used grant program
generally awarded for 3-5 years

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54
Q

R03

A

Small Grant Program
Limited to two years of funding
Direct costs up to $50,000
not renewable

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55
Q

R13 and U13

A

Support for Conference and Scientific Meetings

award amounts vary, up to 5 years

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56
Q

R15

A

Academic Research Enhancement Award (AREA)
small project in biomedical and behavioral sciences
Direct cost limited to $300,00 for full project
limited to 3 years

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57
Q

R21, R33

A

Exploratory/Developmental Research Grant Award
up to two years
limited to $275,000 for full project

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58
Q

R34

A

Clinical Trial Planning Grant
usually 1 year, cannot exceed 3
limited to $100,00 per year

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59
Q

R41/R42

A

Small Business Technology Transfer (STTR)

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60
Q

R43/R44

A

Small Business Innovative Research (SBIR)

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61
Q

R56

A

High Priority, Short-Term Project Award

Investigators may not apply

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62
Q

R24

A

Resource-Related Research Projects
Used in a wide variety of ways to provide resources for problems where multiple expertise is needed to focus on a single complex problem in biomedical research or to enhance research infrastructure

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63
Q

R25

A

Education Projects
to promote appreciation for and interest in biomedical research, provide training, and/or develop ways to disseminate scientific discover into public health

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64
Q

X01

A

Resource Access Program

Includes programs where access to a specific NIH research resource is needed to conduct certain research

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65
Q

K01

A

Mentored Research Scientist Career Development Award

most common early career award

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66
Q

K99/R00

A

Pathway to Independence

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67
Q

What actions require NIH preapproval under expanded authorities

A 
Changes to scope
Change in status of Key Peronnel
Issuance of Subaward/Consortium not included in proposal (after awarded)
Carryover in excess of 25%
Equipment in excess of $25k
Second NCE
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68
Q

Intellectual Property timelines for
Patent
Trademark
Copyright

A

Patent - 20 year from date filed
Trademark - 10 years
Copyright - 70 years after death

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69
Q

Laboratory Animal Welfare Act

A

1966 - passed by Congress
Covered dogs, cats, rabbits, hamsters, guinea pigs and primates
Amended in 1790 to become Animal Welfare Act (AWA)

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70
Q

The Improved Standards for Laboratory Animals Act

A

1985 passed by Congress
established standards for exercise and psychological well-being
minimize pain and distress
use of anesthetics

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71
Q

Health Research Extension Act

A

1985 passed by Congress

directed NIH to establish guidelines for the proper care of animals to be used in biomedical & behavioral research

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72
Q

OLAW

A

Office of Laboratory Animal Welfare

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73
Q

AAALAC

A

Association for Assessment and Accreditation of Laboratory Animal Care International

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74
Q

How long is IACUC protocol approved for?

A

three years

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75
Q

When is an IACUC protocol required?

A

When a live vertebrate animal is used in teaching, breeding or research

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76
Q

What Federal Regulations govern IACUC?

A

USDA (AWA 9 CFR)
PHS (Policy on Humane care & Use of Laboratory Animals & the “Guide”, and the Health Research Extension Act of 1985)

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77
Q

How often are IACUC inspections?

A

semi-annual

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78
Q

Nuremberg Code

A

1947
Required informed consent of subjects
Required qualified researchers with ethical responsibility
Research must be necessary, avoid unnecessary suffering/injury, have managed risks

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79
Q

Declaration of Helsinki

A

1964
Interest of science and society should NEVER take precedence over considerations related to the wellbeing of the subject.
Covers biomedical research, medical research, clinical research (treatment)

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80
Q

US Surgeon General’s Requirement

A

1966

Research institutions establish local policies for human subject protection

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81
Q

National Research Act

A

July 12, 1974
Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Commission was charged with the following task: –identify the basic ethical principles

  • develop guidelines to be followed
  • specifically consider the following areas:
  • the boundaries between research and medicine (the conflict)
  • criteria for what is considered appropriate of risk vs. benefit (the debate)
  • define what is informed consent in various research

2) Requires each entity to established a board (to be known as an ‘Institutional Review Board’) to review biomedical and behavioral research involving human subjects conducted at or sponsored by such entity in order to protect the rights of the human subjects of such research.

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82
Q

The Belmont Report

A

April 18, 1979
Generated the following definitions:
Research- to contribute to generalize knowledge
Practice – interventions, with the reasonable expectation of success, to enhance well-being of the patient. The purpose is provide diagnosis, preventative or reactive care.
“Experimental”- Something that is untested. This does not mean something is automatically research. It is the responsibility of the medical committees to insist radical new procedures to be tested by formal research first.

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83
Q

International Ethical Guidelines for Biomedical Research

A

1982
Ethical justification and scientific validity of research
Ethical review
Informed consent
Vulnerability of individuals, groups, communities, and populations
Equity regarding burdens and benefits
Compensation for injury
Strengthening of national or local capacity for ethical review
Obligations of sponsors to provide health care services

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84
Q

The Common Rule

A

June 18, 1991
standardized procedures across the different federal agencies
requires IRB
infractions have serious consequences

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85
Q

Revised Common Rule

A

2018
Revised regulations take into account advancements in science & technology, as well as a rapidly changing research landscape
Changes to:
-definition of human subject to include both identifiable data and identifiable bio specimens
-exempt criteria
-opportunity to opt-in or opt-out of having data or specimens used for future research

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86
Q

OHRP

A

Office for Human Research Protections

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87
Q

OASH

A

Office of the Assistant Secretary for Health

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88
Q

OS

A

Office of the Secretary

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89
Q

IRB Board Membership diversity requirements

A

At least one scientist
At least one non-scientist
At least one health care professional
At least one community member who (or his/her immediate family) has no employment or contractual relationships with the entity

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90
Q

When is IRB Approval Required?

A

At the bare minimum, IRB approval is required from an entity when seeking funds or contracts from an agency that has accepted the common rule. However, the entity’s federal wide assurance can cause an entity to agree to apply the requirements to all human research regardless of the funding source

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91
Q

What is the definition of Human Subjects Research?

A

A systematic investigation designed to develop or contribute to generalizable knowledge through studying “human subjects”. A Human subject is defined as:
A living individual about whom an investigator either: Obtains information or data through intervention or interaction with the individual
or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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92
Q

What are the criteria for an Exempt IRB Review?

A

not involve pregnant women,
not involve prisoners
not involve mentally impaired persons
not involve minors in survey research unless it is a standard education test

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93
Q

What are the criteria for an Expedited IRB Review?

A

Be of minimal risk to the subjects
Must not involve pregnant women, prisoners or mentally impaired persons
Fit into at least one specific, clearly define category.

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94
Q

What criteria requires a Full Board IRB Review?

A

Research that involves greater than minimal risk
Involves vulnerable populations
Must be reviewed by a quorum and the vote needs a majority
The IRB has the ability to approve, contingently approved with modifications, table, table and require modifications and disapprove.

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95
Q

What are the 8 criteria for IRB Approval?

A

1 Risks to subjects are minimized
2 Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonable be expected to result
3 Selection of subjects is equitable
4 Informed consent will be sought from each prospective subject
5 Informed consent will be appropriately documented
6 When appropriate, there are adequate steps for monitoring the collected data for the safety of subjects
7 When appropriate, the are adequate provisions to protect the privacy of subjects and maintain confidentiality of data
8 When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

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96
Q

IACUC

A

Institutional Animal Care and Use Committee

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97
Q

CRO

A

Clinical Research Organization

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98
Q

CFR

A

Code of Federal Regulations

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99
Q

CRF

A

Case Report Form

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100
Q

DSMB

A

Data and Safety Monitoring Board

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101
Q

FWA

A

Federal-wide assurance

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102
Q

GCP

A

Good Clinical Practices

103
Q

ICF

A

Informed Consent Form

104
Q

IDE

A

Investigational Device Exemption

105
Q

IND

A

Investigational New Drug

106
Q

IRB

A

Institutional Review Board

107
Q

RCT

A

Randomized Controlled Trial

108
Q

RFA

A

Request for Applications

109
Q

SAE

A

Serious Adverse Event

110
Q

UAP

A

Unanticipated Problem

111
Q

ITAR

A

International Traffic in Arms Regulations

112
Q

EAR

A

Export Administration Regulations

113
Q

OFAC

A

Office of Foreign Assets Control

114
Q

What are the Regulatory Exclusions from Export Controls and Sanctions?

A

Public Domain Information
Educational Information
Fundamental Research (basic/applied research with no access and dissemination controls)

115
Q

What are the indicators of Export Controlled Research?

A

Agreements containing publication or nationality restrictions (“access and dissemination controls”)
Information with proprietary restrictions/non-disclosure terms/limited distribution information

116
Q

Define Exports

A 
Physical Exports (outside of US borders)
Deemed Exports (inside the US)
117
Q

Define US Person

A

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

118
Q

DDTC

A

US State Department, Directorate of Defense Trade Controls

119
Q

USML

A

US Munitions List

120
Q

BIS

A

US Commerce Department, Bureau of Industry and Security

121
Q

CCL

A

Commerce Control List

Commodities, software and technology

122
Q

NRC

A

Nuclear Regulatory Commission

123
Q

DOE

A

US Department of Energy

124
Q

FACR

A

Foreign Asset Control Regulations

125
Q

Which countries are comprehensively sanctioned under FACR?

A

Cuba, Iran, Syria, North Korea

126
Q

Define Fundamental Research

A

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

127
Q

Define Clinical Research

A

Broad: The study of health & illness in people
Narrowed: Study of an investigational product
-Effects
-Absorption/distribution

128
Q

What are the three main types of Clinical Research?

A

patient-oriented research
epidemiological and behavioral studies
outcomes and health services research

129
Q

Define Clinical Trial

A

A research project to test the safety or efficacy of a drug, device or other treatment; must develop or contribute to generalizable knowledge

Key: Administering the intervention

130
Q

Define Protocol

A

the “recipe” for the study; tells step-by-step how to conduct the study

  • establishes primary outcome
  • establishes inclusion/exclusion criteria
  • determines feasibility and budget
  • verifies how data will be collected and managed
131
Q

What are the stages of Clinical Trials?

A

Laboratory/Preclinical: new treatment is tested in animal or cell studies to determine if it would be safe and effective for people; IRB approval
Phase I: tests the safety of medication/treatment on a small group (~20-80) of healthy people; one site
Phase II: continues safety and effectiveness testing with a slightly larger(~100-300) group of patients with disease/condition; randomized; adds blinded control group; go/no-go
Phase III: studies safety, effectiveness and dosing of treatment on hundreds to thousands of people, usually at multiple sites; usually double blind
Phase IV: studies long-term effectiveness, comparing new treatment to standard treatment; refine dosage and side effects

132
Q

What are the elements of Informed Consent?

A 
Research Description
Risks
Benefits
Alternatives
Confidentiality
Compensation
Contacts
Voluntary participation and withdrawal
133
Q

What is an Adverse Event?

A

ANY type of health issue that occurs in a clinical trial participant

  • very common
  • may or may not be related to the trial/intervention
134
Q

What makes an Adverse Event “serious”?

A

an adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following:
Death
Life-threatening
Inpatient hospitalization, or prolongation of existing hospitalization
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Congenital anomaly/birth defect

135
Q

ICH-GCP

A

International Conference on Harmonization-Good Clinical Practice

136
Q

What are the three main goals of ICH-GCP?

A

To protect the right, safety and welfare of humans participating in research
To assure quality, reliability and integrity of data collected
To provide standards and guidelines for the conduct of clinical research

137
Q

OHRP

A

Office for Human Research Protections

138
Q

What are the three parts of The Belmont Report?

A

Respect for Persons
Beneficence
Justice

139
Q

SDN List

A

Specially Designated Nationals & Blocked Persons

140
Q

Byrd Amendment
(official title: “Limitations on Use of Appropriated Funds to Influence Certain Federal Contracting and Financial Transactions”)

A
  1. Institutions must certify that no appropriated funds were or will be expended to pay any person for influencing or attempting to influence an officer or an employee of any agency, a member of Congress, an officer or employee of Congress in connection with a specific award. A college/university must disclose if they have made or agree to make any payment with nonfederal funds for the purpose of influencing a specific award over $100,000.
141
Q

Buy America Act

A
  1. Establishes a general preference for domestic articles, materials and supplies to protect the American worker by saving and creating jobs; applicable to all awards.
142
Q

Civil Rights Act

A
  1. Title VI: 1st of many statutes enacted to protect individual civil rights - bars recipients of federal funds from excluding persons because of race, sex, color or national origin from participation in receiving benefits or otherwise subjecting them to discrimination under federally supported programs or activities. Law also interpreted to cover discrimination against those persons with limited English proficiency (LEP). Sex includes pregnancy, childbirth or related medical conditions. Title VII adds the prohibition of discrimination based on religion.
143
Q

Confidentiality of Patient Records (PL92-255)

A

Enacted to protect persons with substance abuse problems who seek treatment. Law is referenced in the SF424 and are applicable to any activity that is funded in whole or part by a Federal agency.

144
Q

Clean Air Act

A
  1. Required EPA to establish national standards for air quality; requires certification of best efforts to comply with the standards at the facility where the work is to be performed.
145
Q

Clean Water Act

A
  1. Provided a basic structure for regulating the discharge of pollutants into US waters; requirements apply to all agreements in excess of $100K.
146
Q

Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act

A
  1. Prohibits hospitals with Fed funds from discriminating against alcohol abusers/ alcoholics suffering from medical conditions in admission or treatment solely because of their alcohol abuse. Sanctions: Violation may result in payment withholding, termination or suspension of all awards, or debarment and suspension of awardee.
147
Q

Contract Work Hours & Safety Standards Act

A
  1. (A-110/SF424) All contracts over $100K; 1) 40hr work week + overtime (1.5x). 2) no unsanitary, hazardous or dangerous conditions.
148
Q

Copeland (Anti-Kickback) Act (PL 107-217)

A
  1. (A-110 & SF424) Unlawful to force, intimidate, threaten to fire, or otherwise induce any person to give up compensation paid under a contract for construction or repair of public buildings/works financed in whole or part by the US; applies to all contracts over $2K that include construction or repair.
149
Q

CREATE (Cooperative Research and Technology Enhancement) Act

A
  1. Enhances research among Universities, private and public sectors by treating joint inventions as if they had a single owner but only if the collaborators had signed an agreement prior to the invention being created.
150
Q

Davis-Bacon Act

A
  1. Requires contractors to pay laborers and mechanics at/above min wage specified in determination made by the Sec. of Labor.
    Requires contracts over $2K to pay wages not 1x/week (DoLabor).
151
Q

Debarment and Suspension

A

EO 1989. Developed gov-wide debarment and suspension system; applies to all Fed assistance awards and contracts over $100K;
applicants certify that neither they, their principals, nor their researchers are debarred, suspended, or proposed for such actions.

152
Q

Drug Abuse Office and Treatment Act

A
  1. Prohibits discrimination against drug abusers suffering from medical conditions because of their drug abuse or dependence by
    any private or public general hospital that receives any federal support.
153
Q

Drug Free Workplace Act

A
  1. Requires that no federal funding will be available for institutions or individuals that do not have a drug-free workplace policy; requires the institution to certify that it will publish a statement notifying employees of unlawful activities in the workplace - it will
    establish an awareness program for informing employees - assure that each employee engaged in a federal program be given a copy of
    the statement - notify the agency of any engaged employee convictions and impose sanctions or require participation in a drug abuse
    assistance program; applies to all federal contracts with individuals and all other contracts for $25K or more with some exceptions.
154
Q

Drug Free Schools & Communities Act

A
  1. 1) Requires schools, colleges and universities to implement and enforce strict drug prevention programs and policies as a condition to receive federal financial assistance; 2) covers the unlawful possession, use, or distribution of illicit drugs and alcohol by all students and employees on institutional premises or as part of any of its activities; 3) program should include at a minimum annual distribution in writing to each employee and student of standards of conduct, a description of legal sanctions/ health risks and any drug
    or alcohol counseling/treatment or rehabilitation programs that are available; there must be a biennial review of the program.
155
Q

Employment of the Handicapped - Rehabilitation Act

A
  1. Requires employers to take affirmative action to employ, and to advance in employment qualified handicapped individuals without discrimination based on physical/mental handicaps; an institution must execute with each award or have on file with the agency, an assurance that federally funded activities will be made available and accessible to handicapped persons.
156
Q

Employee Polygraph Protection Act

A
  1. Generally prevents employers from using lie detector tests, either for preemployment screening or during the course of employment, with certain exemptions. Employers generally may not require or request any employee or job applicant to take a lie detector test, or discharge, discipline, or discriminate against an employee or job applicant for refusing to take the test. Employers are required to display the EPPA poster in the workplace for their employees.
157
Q

Endangered Species Act

A
  1. Authorizes the determination and listing of species as endangered or threatened and prohibits the unauthorized taking, possession, sale and transport of those species; applies to any federal activity, including grants and contracts.
158
Q

Equal Employment Opportunity

A
  1. Requires awardees to take affirmative action to provide equal opportunity without regard to race, color, religion, sex, or nationality to persons employed or seeking employment. Applies to grants providing construction funds, all non construction contracts, all contractors/subcontractors with 50 or more employees and the contract is in excess of $50K, all construction contracts in excess of $10K. In A-110.
159
Q

Equal Pay Act (amended Fair Labor Standards Act)

A
  1. Prohibits employers/unions from paying different wages based on sex - if workers perform equal work in jobs requiring “equal skill, effort, and responsibility… performed under similar working conditions,” workers must receive equal pay. Doesn’t prohibit other discriminatory hiring practices.
160
Q

Executive Order 12372 (The Coordinated Review Process)

A

1982.
Executive Order 12372, “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.

161
Q

Fair Labor Standards Act

A
  1. Established a min hourly wage, min overtime pay, and limitations on child labor (in age and hours worked). Some exceptions are present for min wage payments to employers with <20 employees, students, apprentices and workers with disabilities.
162
Q

False Claims Act (aka “Lincoln Law”, “Informer Act”, “Qui Tam statute”)

A

More inclusive than the “Truth in Negotiations Act” by not only policing negotiations. Improper costing, product substitutions, failure to comply with contract specifications and filing of false claims with gov health care programs. All contracts - no threshold. 31 U.S.C. Sections 3729-33.

163
Q

Family and Medical Leave Act

A
  1. Provides an entitlement of up to 12 weeks of job-protected, unpaid leave during any 12-month period without employer interference or restraint for the following reasons: Birth and care of the employee’s child, or placement for adoption or foster care of a child with the employee; Care of an immediate family member (spouse, child, parent) who has a serious health condition; or Care of the employee’s own serious health condition. Also gives employees the right to file a complaint with the Wage and Hour Division of the Department of Labor’s Employment Standards Administration, file a private lawsuit under the Act (or cause a complaint or lawsuit to be filed), and testify or cooperate in other ways with an investigation or lawsuit without being fired or discriminated against in any other manner. Applicable to all public agencies (state & local governments) & local education agencies (public and private schools); and any private sector employer who has 50+ employees each working day during at least 20 calendar weeks in the current or preceding calendar year. Title II of FMLA covers most federal employees.
164
Q

Food and Drug Administration Amendments Act (FDAAA)

A
  1. Mandates that a “responsible party” (i.e., the sponsor or designated principal investigator) register and report results of certain “applicable clinical trials”, interventional studies of drugs, biologics, or devices that are subject to FDA regulation.
165
Q

Define Grant

A

Financial assistance mechanism providing money, property or both, to an eligible entity to carry out an approved project or activity.

A grant is used whenever a sponsor anticipates no substantial programmatic involvement with the recipient during the performance of the project - the recipient conducts the work independently and reports the results to the sponsor.

166
Q

Define Cooperative Agreement

A

A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement

Substantial involvement means that, after award, the sponsor’s scientific or program staff will guide, coordinate or participate in the project activities

167
Q

Define Contract

A

A mutually binding legal relationship obligating the seller to furnish the supplies or services and the buyer to pay for them. (FAR 2.101)
Primary purpose is the delivery of goods and services for the benefit of the Government.

168
Q

Define Indefinite Delivery Indefinite Quantity

A

Issued when a set quantity of goods or services are needed, but not known or specified (although there can be minimums and maximums.) The Sponsor issues Task Orders for the delivery of the goods or performance of the services during the life of the contract.

169
Q

Define Time and Materials

A

Allows a Sponsor to acquire supplies or services based upon specific labor hours and actual material costs. Because Universities do not track time using an hourly time-keeping system, it is impossible for us to report and certify hours on an invoice. A T&M agreement is not appropriate for a University.

170
Q

FAR

A

The Federal Acquisition Regulation

Title 48 of the Code of Federal Regulations

171
Q

What is the Organization of the FAR?

A 
Chapter 1: The Basic FAR
Chapter 2+: Specific Agency Supplements
Parts 1-51: Prescriptions
Part 52: The Clauses
Part 53: Sample Government Forms
172
Q

DFARS

A

Department of Defense Federal Agency Regulation Supplement

173
Q

NFS

A

NASA FAR Supplement

174
Q

EDAR

A

Department of Education Acquisition Regulation

175
Q

What is the purpose of the FAR?

A

To benefit the federal government in terms of:
-Cost (both administrative and price of services:
-Quality
-Efficiency
Establish uniform acquisition procedures for all federal agencies
Promote competition among government contractors
Minimize administrative operating costs
Obtain services at the best value to the government
Conduct government business with integrity, fairness and transparency

176
Q

When do you need to consult the FAR?

A

Responding to an RFP
Completing Reps & Certs
Receiving a federal prime contract
Incorporated in full text
Incorporated by reference
Receiving a subcontract under a federal prime
Issuing a subcontract under a federal prime

177
Q

Contracting Officer (CO)

A

Authorized by a government warrant to issue awards and modifications
May legally bind the government

178
Q

Contracting Officer’s Technical Representative (COTR)

A

Appointed by the CO to monitor technical performance and progress
reviews and approves deliverables
reviews and approves invoices
limited authority CANNOT legally bind the government

179
Q

FAR 52.227-17 Special Works

A

Prevents the release, distribution and publication of any data first produced in the performance of this award. All data and deliverables will belong to the Government.
Prescribing Clause at 27.409(e) sets forth the limited situations in which this clause is required. It should be removed unless it directly applies (i.e., when research is for internal government use).

180
Q

FAR 52.227-14 Rights in Data

A

Requires the prior written consent of the Government to establish a claim in copyrightable data first produced or delivered under the contract
Prescription at FAR 27.409(e) allows the use of Alt. IV:
A contractor may establish a claim to the copyrightable data first produced or delivered under the contract
Specifically for use in contracts to universities performing fundamental research

181
Q

FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (June 2016)

A

When government contract information is stored on a non-governmental system, that system must meet 15 specific requirements.
Applies to ALL federal agency contracts
These requirements are in addition to any specific agency requirements.

182
Q

DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting (Dec. 2015).

A

Required in all DoD contracts and subcontracts
Requires safeguarding all controlled government information (any technical information with a Distribution Statement B-F limitation, critical system operations security information, export controlled information, etc.)
Requires compliance with all National Institute of Standards and Technology (NIST) Special Publication 800-171.

183
Q

FAR 52.227-1 Authorization & Consent

A

Allows a Contractor to use any invention covered by a U.S. patent to accomplish the research covered under the contract

184
Q

FAR 52.227-3 Patent Indemnity

A

Allows the government to be indemnified for a patent infringement if the contractor is delivering services in the open market

185
Q

FAR 52.227-11 Patent Rights-Retention by the Contractor

A

Allows the Institution the right to elect ownership of patents it develops under the contract
Implements the Bayh-Dole Act

186
Q

FAR 52.215-2: Audit & Records-Negotiation

A

Establishes the Government’s rights to access and audit a Contractor’s records

187
Q

FAR 52.216-7: Allowable Cost & Payment

A

Establishes which cost principles apply to the Contractor

Default clause applies commercial cost principles of FAR Part 31.2 to the contract

188
Q

FAR 52.230-5, Cost Accounting Standards—Educational Institutions

A

Specifically tailored to universities
Incorporates OMB Uniform Guidance, (formerly A-21 Principles for Determining Costs Applicable to Grants, Contracts and Other Agreements with Educational Institutions)

189
Q

FAR 52.232-22: Limitation of Funds

A

Requires the Contractor to notify the Government:
-When expenditures reach a certain threshold (usually 75%)
-If expenditures are more or less than the obligated total
Also establishes that the Contractor has a 60 day period to request supplemental funding or a no cost extension

190
Q

FAR 52.245-1: Government Property

A

Gives the Contractor:

  • Title to property and tangible assets purchased with federal funds
  • When acquired property is less than $5,000
  • And Government Contracting Officer has approved the purchase
  • Requires property to be labeled, tracked and reported (DD 1662)
  • Reports must be submitted annually and are required for close-out
191
Q

Fly America Act (FAR Section 47)

A

Transportation on government contracts must occur on a U.S. flag air carrier
Exceptions can be made when:
-No US carrier flies the required route
-US carrier involuntarily re-routes traveler to a foreign carrier

192
Q

Shelby Amendment

or Data Access Act,

A

was attached to the Omnibus Appropriations Act for FY1999, P.L. 105- 277, mandated the Office of Management and Budget (OMB) to amend Circular A-110 to require federal agencies to ensure that “all data produced under a [federally funded] award will be made available to the public through the procedures established under the Freedom of Information Act [FOIA].”

193
Q

COI

A

Conflict of Interest

194
Q

Define Conflict of Interest

A

a situation in which an individual’s professional judgment is at risk of being biased by a secondary interest, resulting in possible harm. Can involve individuals or institutions.

195
Q

How do conflicts of interest impact research objectivity?

A

“Scales” are tipped towards the secondary interest are tipped towards the secondary interest are tipped towards the secondary interest are tipped towards the secondary interest so that there could be so that there could be a negative outcome.
Two primary ethical considerations: primary ethical considerations: primary ethical considerations: primary ethical considerations: primary ethical considerations:
1. Diminished research objectivity Diminished research objectivity Diminished research objectivity Diminished research objectivity Diminished research objectivity Diminished research objectivity
2. Harm Harm to research subjects research subjects research subjects research subjects due to distorted due to distorted due to distorted judgement

196
Q

What are the COI federal regulations?

A
  • Public Public Health Service (PHS) “Promoting Objectivity in Health Service” regulations
  • National Science Foundation (NSF) “Conflict of Interest Policies”
197
Q

Define Cost Sharing

A

Cost sharing or matching means the portion of project costs not paid by the awarding agency or sponsor

198
Q

What are the types of Cost Sharing?

A

Mandatory
Voluntary Committed
Voluntary Uncommitted

199
Q

Define Mandatory Cost Sharing

A

Required in funding opportunity announcement as a condition for application of the award;
accounted for in proposal as a percentage or stated amount;
tracked and reportable to the sponsor

200
Q

Define Voluntary Committed Cost Sharing

A

Neither expected by the sponsor nor it is considered during proposal merit reviews;
Once committed on a voluntary basis in the proposal, it becomes a binding requirement of Federal award; Cost sharing must be recorded, tracked against the project and reported.

201
Q

Define Voluntary Uncommitted Cost Sharing

A

May be provided after grant is awarded, not outlined in proposal;
No obligation or binding agreement with sponsor;
No reporting or commitment to be met.

202
Q

Define Indirect/Facilities and Administrative Costs

A

The costs incurred for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved.

203
Q

Define Cognizant Agency

A

the federal agency responsible for reviewing, negotiating and approving your indirect rate proposals

204
Q

Define Predetermined F&A Rate

A

a permanent rate established for a specified current or future period and is not subject to adjustment

205
Q

Define Fixed F&A Rate

A

becomes the negotiated rate for a specified period, usually based on the institution’s fiscal year.

206
Q

Define Provisional F&;A Rate

A

a temporary rate applicable to a specified period, used with the cognizant agency does not have sufficient data to justify a predetermined or fixed rate, or when the parties cannot agree on an equitable rate.

207
Q

Define Final F&A Rate

A

if the provisional rate is not replaced by a predetermined or fixed rate before the end of the institution’s fiscal year, then a final rate will be established by the cognizant agency, and upward or downward adjustments from the provisional rate will be made based on the actual allowable costs incurred.

208
Q

What is the Simplified Acquisition Threshold?

A

$250,000

209
Q

Define Selective Inattendance

A

a mindset where the researcher is predisposed to overlook important data or to misperceive critical observations that do not fit the hoped-for findings.

210
Q

Define Biohazard

A

an agent or material of biological origin that is potentially hazardous to humans, animals or plants

211
Q

Define Biosafety

A

addresses safe handling and containment of biohazards;

protects researchers, support staff, the environment and the public

212
Q

BSL

A

Biosafety Levels

213
Q

RG

A

Risk Group

214
Q

Risk Group 1

A

not associated with disease in healthy adult humans;

no or low individual and community risk

215
Q

Biosafety Level 1

A

Not known to cause disease in healthy adult humans. Work can be performed on an open bench.

216
Q

Risk Group 2

A 
Associated with disease;
rarely serious'
preventative measures or treatment often available;
moderate individual risk;
limited community risk;
most common for clinical research
217
Q

Biosafety Level 2

A

Associated with disease;
routes of transmission include percutaneous injury, ingestion, mucous membrane exposure;
work in BSC

218
Q

Risk Group 3

A

Associated with serious or lethal disease;
Preventative measures or treatment may be available;
high individual risk;
low community risk

219
Q

Biosafety Level 3

A

Associated with serious disease with potentially lethal consequences;
potential for aerosol transmission;
high containment facility

220
Q

Risk Group 4

A

Likely to cause serious or lethal disease;
preventative measures or treatment are not usually available;
high individual risk;
high community risk

221
Q

Biosafety Level 4

A

Associated with life threatening diseases;
high risk of aerosol transmission;
specialized high containment facility

222
Q

Department of Labor Biohazard Mandate

A

OSHA
29 CFR Part 1910.1030: Occupational Exposure
to Bloodborne Pathogens (Bloodborne
Pathogens Standard)

223
Q

Department of Health and Human Services (DHHS) Biohazard Mandates

A

Centers for Disease Control and Prevention (CDC)
-42 CFR Part 73: Possession, Use and Transfer of Select Agents and Toxins
Public Health Service (PHS)
-42 CFR Part 71: Foreign Quarantine
-42 CFR Part 72: Interstate Shipment of Etiologic Agents
National Institutes of Health (NIH)
-NIH Guidelines for Research Involving Recombinant
or Synthetic Nucleic Acids Molecules (NIH Guidelines)

224
Q

Department of Agriculture (USDA) Biohazard Mandate

A

Animal and Plant Health Inspection Service
-Possession, Use and Transfer of Select Agents and Toxins
• 7 CFR Part 331 (Plants)
• 9 CFR Part 121 (Animals)
• 7 CFR Part 351 (Plants): Importation of Plants or Plant Products by Mail
• 9 CFR Part 122 (Animals): Organisms and Vectors

225
Q

Department of Transportation (DOT) Biohazard Mandate

A

49 CFR Parts 100‐185: Hazardous Materials Regulations

226
Q

US Postal Service Biohazard Mandate

A

601:10 Mailability: Hazardous Materials

227
Q

Environmental Protection Agency (EPA) Biohazard Mandate

A

Medical Waste Tracking Act of 1988
– 40 CFR Parts 22 and 259: Standards for Tracking and Management of Medical Waste
– Virginia Department of Environmental Quality (DEQ)
• 9 VAC 20‐120: Regulated Medical Waste Regulations

228
Q

America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act of 2007 or America COMPETES Act

A

required that institutions have a plan in place to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by the National Science Foundation to conduct research

229
Q

The Public Health Service defines research misconduct as:

A

Plagiarism, Fabrication, and Falsification

230
Q

FDP

A

Federal Demonstration Partnership

231
Q

What is the purpose of the Federal Demonstration Partnership (FDP)?

A

to reduce the administrative burdens associated with federally sponsored research.

232
Q

What is the office name for “Uniform Guidance”?

A

Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards

233
Q

HRSA

A

Health Resources and Services Administration

234
Q

How many NIH institutes and centers award extramural research funding?

A

24

235
Q

What does the Federal Select Agents Program do?

A

oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products

236
Q

What is Dual Use Research (DUR)?

A

Research conducted for legitimate purposes that generated knowledge, information, technologies, and/or products that can be utilized for both benevolent and harmful purposes

237
Q

An allegation of research misconduct generally involves what phases?

A

Inquiry
Investigation
Adjudication

238
Q

How often must an institution’s Federal Wide Assurance (FWA) be renewed?

A

Every 5 years

239
Q

From where does The Common Rule originate?

A

The Belmont Report

240
Q

U24

A

Resource related Research Projects Cooperative Agreement

Designed to support projects contributing to improvement of the capacity of resources to serve biomedical research

241
Q

EDGAR

A

Education Department General Administrative Regulations

242
Q

How often are laws codified in the Code of Federal Regulations (CFR)?

A

Every 6 months

243
Q

When should clinical trials be registered in CT.gov?

A

Within 21 days of first enrollment

244
Q

CRADA

A

Cooperative Research and Development Agreement

Allows for technology to be transferred from the government to a non-government entity

245
Q

When must a new invention be disclosed?

A

Within 2 months of discovery

246
Q

COGR

A

Council on Government Research

247
Q

CFDA

A

Catalog of Federal Domestic Assistance

248
Q

APHIS

A

Animal and Plant Health Inspection Service

249
Q

What is the threshold for a single audit?

A

$750,000 on federal awards

250
Q

What is the IDC rate limit on NIH K awards?

A

8%

251
Q

UMBTA

A

Uniform Biological Material Transfer Agreement

252
Q

Is an IP agreement required for SBIR or STTR grant?

A

No

253
Q

What can’t be obtained under a Freedom of Information Act (FOIA) request?

A

Information/data that is NOT covered by the Freedom of Information Act (FOIA) includes:

Non-agency records and personal records.

Public requests for access to physical artifacts or scientific samples (e.g. core samples, sediment, rocks, fossils, specimen samples, blood samples). Access to some samples can be arranged through our laboratories.
Files that are protected from disclosure by any of nine exemptions and three exclusions (e.g. classified records, personal medical records, and trade secrets).
Records of your current employment with the USGS.
Records of your employment with the USGS after you have retired.

RACC CRA Exam - Fall 2020 (1 decks)

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