Certified Research Administrator Flashcards
1
Q
What are the 6 types of Proposals?
A
Solicited Unsolicited New Continuations Supplemental Contract
2
Q
What does eRA stand for?
A
Electronic Research Administration
3
Q
What is the NSF FastLane?
A
National Science Foundation site for submitting and reviewing proposals
4
Q
What is Research.gov?
A
National Science Foundation site for Project Reporting
5
Q
What is Grants.gov?
A
Unified site for interactions between grant applicants and Federal agencies
6
Q
What is eRA Commons?
A
National Institutes of Health (NIH) Electronic Research Administration Portal
7
Q
What is NIH RePORTer?
A
Research Portfolio Online Report Tools
8
Q
What is iEdison?
A
Interagency Edison for reporting government funded inventions
9
Q
What is PAMS?
A
Portfolio Analysis and Management System. Used by DOE.
10
Q
What is FedConnect.net?
A
Gateway to Government Opportunities, Acquisition and Grants Portal
11
Q
What is SAM.gov?
A
System for Award Management
12
Q
What is USAspending.gov?
A
Searchable database for Federal awards
13
Q
What is E-Verify.gov?
A
Site for instant verification of US work authorization
14
Q
What is NSPIRES?
A
Web interface for submission to NASA
15
Q
What is proposalCENTRAL?
A
E-granting website shared by many government, non-profit, and private grant-making organizations
16
Q
What is Grant Solutions?
A
Department of Interior award Management system
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
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
19
Q
What is the Federal Demonstration Partnership (FDP)?
A
Cooperative initiative among 10 federal agencies and 154 institutional recipients of federal funds.
20
Q
What is SBIR?
A
Small Business Innovation Research
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
22
Q
What is STTR?
A
Small Business Technology Transfer
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
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
25
What are the sections of Uniform Guidance?
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
26
COSO
Committee of Sponsoring Organizations of the Treadway Commision
27
COFAR
Council on Financial Assistance Reform
28
EUI
Energy Usage Index
29
FAIN
Federal Award Identification Number
30
FAC
Federal Audit Clearinghouse
31
FAPIIS
Federal Awardee Performance & Integrity Information System
32
GOCO
Government Owned Contractor Operated
33
IBS
Institutional Base Salary
34
IHE
Institution of Higher Education
35
PII
Personally Identifiable Information
36
PRHP
Post Retirement Health Plans
37
PTE
Pass Through entity
38
REUI
Relative Energy Usage Index
39
SPOC
Single Point of Contact
40
TFM
Treasury Financial Manual
41
VAT
Value Added Tax
42
What are the five "components" of Procurement?
```
Micro-Purchases
Small Purchases
Sealed Bids
Competitive Proposals
Sole Source
```
43
Subrecipient vs Contractor/Vendor
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.
44
Bayh-Dole Act
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.
45
What is excluded from MTDC?
```
Equipment
Capital Expenditures (including software)
Patient Care
Tuition
Rental Costs
Scholarships/Fellowhships
Participant support
Subcontracts in excess of $25,000
```
46
What are the 5 components of FAIN?
```
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
```
47
What types of awards does the National Science Foundation encourage?
Proposals that contribute to the advancement of societally relevant outcomes.
48
What Merit Criteria does the National Science Foundation use to review proposals?
Intellectual Merit and Broader Impacts
| Goal is research that is Transformative
49
What is the "de minimus" IDC/F&A rate?
10%
50
For what changes does an NSF award require prior approval?
Change in:
Scope
PI or Co-PI
Subcontractor
51
What Public Health Service agencies are within DHHS (Department of Health and Human Services)?
NIH
FDA
CDC
NIOSH
52
What are the types of NIH funding?
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)
53
R01
Research Project Grant Program
NIH's most commonly used grant program
generally awarded for 3-5 years
54
R03
Small Grant Program
Limited to two years of funding
Direct costs up to $50,000
not renewable
55
R13 and U13
Support for Conference and Scientific Meetings
| award amounts vary, up to 5 years
56
R15
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
57
R21, R33
Exploratory/Developmental Research Grant Award
up to two years
limited to $275,000 for full project
58
R34
Clinical Trial Planning Grant
usually 1 year, cannot exceed 3
limited to $100,00 per year
59
R41/R42
Small Business Technology Transfer (STTR)
60
R43/R44
Small Business Innovative Research (SBIR)
61
R56
High Priority, Short-Term Project Award
| Investigators may not apply
62
R24
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
63
R25
Education Projects
to promote appreciation for and interest in biomedical research, provide training, and/or develop ways to disseminate scientific discover into public health
64
X01
Resource Access Program
| Includes programs where access to a specific NIH research resource is needed to conduct certain research
65
K01
Mentored Research Scientist Career Development Award
| most common early career award
66
K99/R00
Pathway to Independence
67
What actions require NIH preapproval under expanded authorities
```
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
```
68
Intellectual Property timelines for
Patent
Trademark
Copyright
Patent - 20 year from date filed
Trademark - 10 years
Copyright - 70 years after death
69
Laboratory Animal Welfare Act
1966 - passed by Congress
Covered dogs, cats, rabbits, hamsters, guinea pigs and primates
Amended in 1790 to become Animal Welfare Act (AWA)
70
The Improved Standards for Laboratory Animals Act
1985 passed by Congress
established standards for exercise and psychological well-being
minimize pain and distress
use of anesthetics
71
Health Research Extension Act
1985 passed by Congress
| directed NIH to establish guidelines for the proper care of animals to be used in biomedical & behavioral research
72
OLAW
Office of Laboratory Animal Welfare
73
AAALAC
Association for Assessment and Accreditation of Laboratory Animal Care International
74
How long is IACUC protocol approved for?
three years
75
When is an IACUC protocol required?
When a live vertebrate animal is used in teaching, breeding or research
76
What Federal Regulations govern IACUC?
USDA (AWA 9 CFR)
PHS (Policy on Humane care & Use of Laboratory Animals & the "Guide", and the Health Research Extension Act of 1985)
77
How often are IACUC inspections?
semi-annual
78
Nuremberg Code
1947
Required informed consent of subjects
Required qualified researchers with ethical responsibility
Research must be necessary, avoid unnecessary suffering/injury, have managed risks
79
Declaration of Helsinki
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)
80
US Surgeon General's Requirement
1966
| Research institutions establish local policies for human subject protection
81
National Research Act
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.
82
The Belmont Report
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.
83
International Ethical Guidelines for Biomedical Research
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
84
The Common Rule
June 18, 1991
standardized procedures across the different federal agencies
requires IRB
infractions have serious consequences
85
Revised Common Rule
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
86
OHRP
Office for Human Research Protections
87
OASH
Office of the Assistant Secretary for Health
88
OS
Office of the Secretary
89
IRB Board Membership diversity requirements
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
90
When is IRB Approval Required?
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
91
What is the definition of Human Subjects Research?
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.
92
What are the criteria for an Exempt IRB Review?
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
93
What are the criteria for an Expedited IRB Review?
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.
94
What criteria requires a Full Board IRB Review?
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.
95
What are the 8 criteria for IRB Approval?
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.
96
IACUC
Institutional Animal Care and Use Committee
97
CRO
Clinical Research Organization
98
CFR
Code of Federal Regulations
99
CRF
Case Report Form
100
DSMB
Data and Safety Monitoring Board
101
FWA
Federal-wide assurance
102
GCP
Good Clinical Practices
103
ICF
Informed Consent Form
104
IDE
Investigational Device Exemption
105
IND
Investigational New Drug
106
IRB
Institutional Review Board
107
RCT
Randomized Controlled Trial
108
RFA
Request for Applications
109
SAE
Serious Adverse Event
110
UAP
Unanticipated Problem
111
ITAR
International Traffic in Arms Regulations
112
EAR
Export Administration Regulations
113
OFAC
Office of Foreign Assets Control
114
What are the Regulatory Exclusions from Export Controls and Sanctions?
Public Domain Information
Educational Information
Fundamental Research (basic/applied research with no access and dissemination controls)
115
What are the indicators of Export Controlled Research?
Agreements containing publication or nationality restrictions ("access and dissemination controls")
Information with proprietary restrictions/non-disclosure terms/limited distribution information
116
Define Exports
```
Physical Exports (outside of US borders)
Deemed Exports (inside the US)
```
117
Define US Person
US Citizens
Lawful Permanent Residents (Green Card Holders)
Protected Political status (asylee, refugee, amnesty)
US Companies (incorporated to do business in US)
118
DDTC
US State Department, Directorate of Defense Trade Controls
119
USML
US Munitions List
120
BIS
US Commerce Department, Bureau of Industry and Security
121
CCL
Commerce Control List
| Commodities, software and technology
122
NRC
Nuclear Regulatory Commission
123
DOE
US Department of Energy
124
FACR
Foreign Asset Control Regulations
125
Which countries are comprehensively sanctioned under FACR?
Cuba, Iran, Syria, North Korea
126
Define Fundamental Research
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
127
Define Clinical Research
Broad: The study of health & illness in people
Narrowed: Study of an investigational product
-Effects
-Absorption/distribution
128
What are the three main types of Clinical Research?
patient-oriented research
epidemiological and behavioral studies
outcomes and health services research
129
Define Clinical Trial
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
Define Protocol
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
What are the stages of Clinical Trials?
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
What are the elements of Informed Consent?
```
Research Description
Risks
Benefits
Alternatives
Confidentiality
Compensation
Contacts
Voluntary participation and withdrawal
```
133
What is an Adverse Event?
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
What makes an Adverse Event "serious"?
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
ICH-GCP
International Conference on Harmonization-Good Clinical Practice
136
What are the three main goals of ICH-GCP?
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
OHRP
Office for Human Research Protections
138
What are the three parts of The Belmont Report?
Respect for Persons
Beneficence
Justice
139
SDN List
Specially Designated Nationals & Blocked Persons
140
Byrd Amendment
(official title: "Limitations on Use of Appropriated Funds to Influence Certain Federal Contracting and Financial Transactions")
1989. 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
Buy America Act
1939. 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
Civil Rights Act
1964. 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
Confidentiality of Patient Records (PL92-255)
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
Clean Air Act
1970. 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
Clean Water Act
1977. Provided a basic structure for regulating the discharge of pollutants into US waters; requirements apply to all agreements in excess of $100K.
146
Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act
1970. 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
Contract Work Hours & Safety Standards Act
1962. (A-110/SF424) All contracts over $100K; 1) 40hr work week + overtime (1.5x). 2) no unsanitary, hazardous or dangerous conditions.
148
Copeland (Anti-Kickback) Act (PL 107-217)
1934. (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
CREATE (Cooperative Research and Technology Enhancement) Act
2004. 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
Davis-Bacon Act
1931. 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
Debarment and Suspension
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
Drug Abuse Office and Treatment Act
1972. 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
Drug Free Workplace Act
1988. 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
Drug Free Schools & Communities Act
1989. 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
Employment of the Handicapped - Rehabilitation Act
1973. 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
Employee Polygraph Protection Act
1988. 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
Endangered Species Act
1973. 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
Equal Employment Opportunity
1965. 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
Equal Pay Act (amended Fair Labor Standards Act)
1963. 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
Executive Order 12372 (The Coordinated Review Process)
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
Fair Labor Standards Act
1938. 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
False Claims Act (aka "Lincoln Law", "Informer Act", "Qui Tam statute")
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
Family and Medical Leave Act
1993. 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
Food and Drug Administration Amendments Act (FDAAA)
2007. 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
Define Grant
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
Define Cooperative Agreement
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
Define Contract
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
Define Indefinite Delivery Indefinite Quantity
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
Define Time and Materials
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
FAR
The Federal Acquisition Regulation
| Title 48 of the Code of Federal Regulations
171
What is the Organization of the FAR?
```
Chapter 1: The Basic FAR
Chapter 2+: Specific Agency Supplements
Parts 1-51: Prescriptions
Part 52: The Clauses
Part 53: Sample Government Forms
```
172
DFARS
Department of Defense Federal Agency Regulation Supplement
173
NFS
NASA FAR Supplement
174
EDAR
Department of Education Acquisition Regulation
175
What is the purpose of the FAR?
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
When do you need to consult the FAR?
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
Contracting Officer (CO)
Authorized by a government warrant to issue awards and modifications
May legally bind the government
178
Contracting Officer's Technical Representative (COTR)
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
FAR 52.227-17 Special Works
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
FAR 52.227-14 Rights in Data
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
FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (June 2016)
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
DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting (Dec. 2015).
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
FAR 52.227-1 Authorization & Consent
Allows a Contractor to use any invention covered by a U.S. patent to accomplish the research covered under the contract
184
FAR 52.227-3 Patent Indemnity
Allows the government to be indemnified for a patent infringement if the contractor is delivering services in the open market
185
FAR 52.227-11 Patent Rights-Retention by the Contractor
Allows the Institution the right to elect ownership of patents it develops under the contract
Implements the Bayh-Dole Act
186
FAR 52.215-2: Audit & Records-Negotiation
Establishes the Government’s rights to access and audit a Contractor’s records
187
FAR 52.216-7: Allowable Cost & Payment
Establishes which cost principles apply to the Contractor
| Default clause applies commercial cost principles of FAR Part 31.2 to the contract
188
FAR 52.230-5, Cost Accounting Standards—Educational Institutions
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
FAR 52.232-22: Limitation of Funds
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
FAR 52.245-1: Government Property
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
Fly America Act (FAR Section 47)
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
Shelby Amendment
| or Data Access Act,
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
COI
Conflict of Interest
194
Define Conflict of Interest
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
How do conflicts of interest impact research objectivity?
“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
What are the COI federal regulations?
- Public Public Health Service (PHS) “Promoting Objectivity in Health Service” regulations
- National Science Foundation (NSF) “Conflict of Interest Policies”
197
Define Cost Sharing
Cost sharing or matching means the portion of project costs not paid by the awarding agency or sponsor
198
What are the types of Cost Sharing?
Mandatory
Voluntary Committed
Voluntary Uncommitted
199
Define Mandatory Cost Sharing
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
Define Voluntary Committed Cost Sharing
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
Define Voluntary Uncommitted Cost Sharing
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
Define Indirect/Facilities and Administrative Costs
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
Define Cognizant Agency
the federal agency responsible for reviewing, negotiating and approving your indirect rate proposals
204
Define Predetermined F&A Rate
a permanent rate established for a specified current or future period and is not subject to adjustment
205
Define Fixed F&A Rate
becomes the negotiated rate for a specified period, usually based on the institution's fiscal year.
206
Define Provisional F&;A Rate
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
Define Final F&A Rate
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
What is the Simplified Acquisition Threshold?
$250,000
209
Define Selective Inattendance
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
Define Biohazard
an agent or material of biological origin that is potentially hazardous to humans, animals or plants
211
Define Biosafety
addresses safe handling and containment of biohazards;
| protects researchers, support staff, the environment and the public
212
BSL
Biosafety Levels
213
RG
Risk Group
214
Risk Group 1
not associated with disease in healthy adult humans;
| no or low individual and community risk
215
Biosafety Level 1
Not known to cause disease in healthy adult humans. Work can be performed on an open bench.
216
Risk Group 2
```
Associated with disease;
rarely serious'
preventative measures or treatment often available;
moderate individual risk;
limited community risk;
most common for clinical research
```
217
Biosafety Level 2
Associated with disease;
routes of transmission include percutaneous injury, ingestion, mucous membrane exposure;
work in BSC
218
Risk Group 3
Associated with serious or lethal disease;
Preventative measures or treatment may be available;
high individual risk;
low community risk
219
Biosafety Level 3
Associated with serious disease with potentially lethal consequences;
potential for aerosol transmission;
high containment facility
220
Risk Group 4
Likely to cause serious or lethal disease;
preventative measures or treatment are not usually available;
high individual risk;
high community risk
221
Biosafety Level 4
Associated with life threatening diseases;
high risk of aerosol transmission;
specialized high containment facility
222
Department of Labor Biohazard Mandate
OSHA
29 CFR Part 1910.1030: Occupational Exposure
to Bloodborne Pathogens (Bloodborne
Pathogens Standard)
223
Department of Health and Human Services (DHHS) Biohazard Mandates
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
Department of Agriculture (USDA) Biohazard Mandate
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
Department of Transportation (DOT) Biohazard Mandate
49 CFR Parts 100‐185: Hazardous Materials Regulations
226
US Postal Service Biohazard Mandate
601:10 Mailability: Hazardous Materials
227
Environmental Protection Agency (EPA) Biohazard Mandate
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
America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act of 2007 or America COMPETES Act
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
The Public Health Service defines research misconduct as:
Plagiarism, Fabrication, and Falsification
230
FDP
Federal Demonstration Partnership
231
What is the purpose of the Federal Demonstration Partnership (FDP)?
to reduce the administrative burdens associated with federally sponsored research.
232
What is the office name for "Uniform Guidance"?
Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards
233
HRSA
Health Resources and Services Administration
234
How many NIH institutes and centers award extramural research funding?
24
235
What does the Federal Select Agents Program do?
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
What is Dual Use Research (DUR)?
Research conducted for legitimate purposes that generated knowledge, information, technologies, and/or products that can be utilized for both benevolent and harmful purposes
237
An allegation of research misconduct generally involves what phases?
Inquiry
Investigation
Adjudication
238
How often must an institution's Federal Wide Assurance (FWA) be renewed?
Every 5 years
239
From where does The Common Rule originate?
The Belmont Report
240
U24
Resource related Research Projects Cooperative Agreement
| Designed to support projects contributing to improvement of the capacity of resources to serve biomedical research
241
EDGAR
Education Department General Administrative Regulations
242
How often are laws codified in the Code of Federal Regulations (CFR)?
Every 6 months
243
When should clinical trials be registered in CT.gov?
Within 21 days of first enrollment
244
CRADA
Cooperative Research and Development Agreement
| Allows for technology to be transferred from the government to a non-government entity
245
When must a new invention be disclosed?
Within 2 months of discovery
246
COGR
Council on Government Research
247
CFDA
Catalog of Federal Domestic Assistance
248
APHIS
Animal and Plant Health Inspection Service
249
What is the threshold for a single audit?
$750,000 on federal awards
250
What is the IDC rate limit on NIH K awards?
8%
251
UMBTA
Uniform Biological Material Transfer Agreement
252
Is an IP agreement required for SBIR or STTR grant?
No
253
What can't be obtained under a Freedom of Information Act (FOIA) request?
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.
