RACC CRA 2021 Flashcards

Question

What are the 3 types of Cost Sharing?

Answer 1

Mandatory, Voluntary - Committed, and Voluntary - Uncommitted

Answer 2

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

Answer 3

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

Answer 4

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

Answer 5

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

Answer 6

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

Answer 7

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

Answer 8

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

Answer 9

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

Answer 10

- Controlled environment and activities - Risk Assessment - Information and communication - Monitoring

Answer 11

- Transactions executed in compliance with regulations - Funds safeguarded against loss from unauthorized use - Processes and procedures promote efficiency

Answer 12

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

Answer 13

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

Answer 14

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

Answer 15

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

Answer 16

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

Answer 17

Federal Financial Report

Answer 18

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

Answer 19

- Misuse of funds - Unallowable costs - Allocation of costs - Accelerated spending - Unobligated balances - Reporting - Payment

Answer 20

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

Answer 21

Income earned from an award activity

Answer 22

It decreases it because Organized Research base is increased.

Answer 23

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

Answer 24

- Risk assessment - OMB compliance requirements - Technical monitoring - Review of subrecipient's Single Audit Report

Answer 25

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

Answer 26

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

Answer 27

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

Answer 28

September 30

Answer 29

Ownership of intellectual property

Answer 30

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

Answer 31

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

Answer 32

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

Answer 33

United States Munition List

Answer 34

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

Answer 35

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

Answer 36

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

Answer 37

Department of State

Answer 38

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

Answer 39

Major Research Instrumentation Program (NSF Award)

Answer 40

Research Experiences for Undergraduates (NSF Award)

Answer 41

Faculty Early Career Development Program (CAREER)

Answer 42

Graduate Research Fellowship Program (NSF Award)

Answer 43

Provide assistance to advance a public purpose with substantial sponsor involvement

Answer 44

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

Answer 45

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

Answer 46

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

Answer 47

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

Answer 48

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

Answer 49

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

Answer 50

The Federal Demonstration Partnership is a cooperative initiative among 10 federal agencies and 217 institutional recipients of federal funds for Phase VII. The FDP is a program convened by the Government-University-Industry Research Roundtable of the National Academies. Its purpose is to reduce the administrative burdens associated with research grants and contracts. Developed Expanded Authorities • Allowed at option of the agency • Allow for 90 day pre-award costs • One-time NCX up to 12 months • Carry forward of unobligated balances to subsequent funding periods • Waiver of some cost-related prior awards

Answer 51

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

Answer 52

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

Answer 53

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

Answer 54

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

Answer 55

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

Answer 56

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

Answer 57

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

Answer 58

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

Answer 59

Freedom of Information Act

Answer 60

Unique Entity Identifier

Answer 61

"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.

Answer 62

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

Answer 63

Established NIH salary cap as law

Answer 64

Is an example of federal regulations

Answer 65

Is an example of program guidelines

Answer 66

Is an example of program guidelines

Answer 67

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

Answer 68

Governs the cost principles of Hospitals (HHS Regulations)

Answer 69

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

Answer 70

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

Answer 71

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

Answer 72

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

Answer 73

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

Answer 74

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

Answer 75

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

Answer 76

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

Answer 77

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

Answer 78

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

Answer 79

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

Answer 80

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

Answer 81

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

Answer 82

1. Physical export (outside of US borders) | 2. Deemed Exports (inside the US) - ex. transferring export to a non-US person inside the US

Answer 83

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

Answer 84

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

Answer 85

Nuclear Regulatory Commission (10 CFR 110)

Answer 86

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

Answer 87

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

Answer 88

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

Answer 89

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

Answer 90

The Contract Work Hours and Safety Standards Act (CWHSSA) is a United States federal law that covers hours and safety standards in construction contracts. The Act applies to federal service contracts and federal and federally assisted construction contracts worth over $100,000, and requires contractors and subcontractors on covered contracts to pay laborers and mechanics employed in the performance of the contracts one and one-half times their basic rate of pay for all hours worked over 40 in a workweek. This Act also prohibits unsanitary, hazardous, or dangerous working conditions on federal and federally financed and assisted construction projects.

Answer 91

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

Answer 92

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

Answer 93

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

Answer 94

Provide assistance with little involvement by the sponsor.

Answer 95

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

Answer 96

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

Answer 97

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

Answer 98

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

Answer 99

A human subject is "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Answer 100

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

Answer 101

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

Answer 102

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

Answer 103

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

Answer 104

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

Answer 105

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

Answer 106

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

Answer 107

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

Answer 108

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

Answer 109

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

Answer 110

Special protections for prisoners.

Answer 111

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

Answer 112

Special protections for children

Answer 113

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

Answer 114

Human subjects research regulated by the FDA

Answer 115

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

Answer 116

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

Answer 117

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

Answer 118

- Unanticipated problems involving risk - Adverse reactions/events - Non-compliance

Answer 119

Office for Human Research Protections - Under HHS Umbrella - Establishes and registers IRBs - Issues FWA (Federal Wide Assurance)

Answer 120

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

Answer 121

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

Answer 122

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

Answer 123

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

Answer 124

Pre-clinical + 4 Phases: - Laboratory studies - Phase I: tests the safety on a small group of healthy subects - Phase II: tests safety on afflicted subjects and control subjects for efficacy - Phase III: study expanded to larger group at multiple sites, double blinded, FDA approval - Phase IV: intervention approved, post-marketing,refine dosage and side effects, additional monitoring after FDA approval

Answer 125

It is the recipe, the statement of work, the step by step in a research or trial. - establishes outcome - animal/patient exclusion/inclusion criteria - determines the budget - establish how data is collected/manage

Answer 126

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

Answer 127

A. Informed Consent Form (process) 1. Research description 2. Risks 3. Benefits 4. Alternatives 5. Confidentiality 6. Compensation 7. Contacts 8. Voluntary participation and withdrawal

Answer 128

Case Report Form - Patient data collected and submitted to sponsor

Answer 129

To study an investigational product's effects on health and illness: 1. Patient-oriented research 2. Epidemiological and behavioral studies 3. Outcomes and health services research

Answer 130

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

Answer 131

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

Answer 132

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

Answer 133

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

Answer 134

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

Answer 135

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

Answer 136

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

Answer 137

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

Answer 138

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

Answer 139

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

Answer 140

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

Answer 141

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

Answer 142

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

Answer 143

1. Community Notification 2. Containment 3. Emergency Preparedness 4. Security

Answer 144

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

Answer 145

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

Answer 146

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

Answer 147

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

Answer 148

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

Answer 149

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

Answer 150

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

Answer 151

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

Answer 152

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

Answer 153

Every 4 years

Answer 154

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

Answer 155

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

Answer 156

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

Answer 157

Association for Accreditation of Laboratory Animal Care International: - Nonprofit private organization - Accrediting body is Voluntary - Gold Standard, ergo more NIH funding? - Re-inspected every three years - Best Practices with emphasis on Occupational Health

Answer 158

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

Answer 159

Office of Inspector General (NSF)

Answer 160

Office of Research Integrity (HHS)

Answer 161

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

Answer 162

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

Answer 163

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

Answer 164

NIH - All NIH staff who have direct involvement in proposing, performing, reviewing or reporting research, or who receive research training; Substantial face-to-face interaction with didactic and small group discussions NSF - Undergraduates, graduate students and postdocs who receive NSF funding must receiving RCR training. Allows all training to be completed online (e.g. CITI)

Answer 165

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

Answer 166

1. Privacy 2. Security 3. Breach Notification

Answer 167

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

Answer 168

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

Answer 169

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

Answer 170

Requires acknowledgement of federal sponsorship in publications (ie statements, press releases, bid solicitations, etc) Acknowledgement should include: The percentage of the total cost of the program or project which is financed with federal money The dollar amount of federal funds for the project or program Include a disclaimer that contents are the responsibility of the author(s), not the sponsor

Answer 171

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

Answer 172

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

Answer 173

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

Answer 174

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

Answer 175

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

Answer 176

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

Answer 177

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

Answer 178

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

Answer 179

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

Answer 180

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

Answer 181

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

Answer 182

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

Answer 183

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

Answer 184

B. Simplified Acquisition Threshold

Answer 185

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

Answer 186

It helps IHE recover administrative and shared costs.

Answer 187

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

Answer 188

It is based on prior actual costs.

Answer 189

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

Answer 190

False. You have file within a year.

Answer 191

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

Answer 192

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

Answer 193

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

Answer 194

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

Answer 195

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

Answer 196

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

Answer 197

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

Answer 198

FFATA Subaward Reporting System

Answer 199

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

Answer 200

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

Answer 201

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

Answer 202

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

Answer 203

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

Answer 204

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

Answer 205

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

Answer 206

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

RACC CRA 2021 Flashcards

(236 cards)