CRA Flashcards
NEI
National Eye Institute
NHLBI
National Heart, Lung, and Blood Institute
NHGRI
National Human Genome Research Institute
NIA
National Institute on Aging
NIAAA
National Institute on Alcohol Abuse and Alcoholism
NIAID
National Institute of Allergy and Infectious Diseases
NIAMS
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIBIB
National Institute of Biomedical Imagine and Bioengineering
NICHD
National Institute of Child Health and Human Development
NIDCD
National Institute on Deafness and Other Communication Disorders
NIDCR
National Institute of Dental and Craniofacial Research
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases
NIDA
National Institute on Drug Abuse
NIEHS
National Institute of Environmental Health Sciences
NIGMS
National Institute of General Medical Sciences
NIMH
National Institute of Mental Health
NIMHD
National Institute on Minority Health and Health Disparities
NINDS
National Institute of Neurological Disorders and Stroke
NINR
National Institute of Nursing Research
NLM
National Library of Medicine
CIT
Center for Information Technology
CSR
Center for Scientific Review
FIC
John E. Fogarty International Center for Advanced Study in the Health Sciences
NCCAM
National Center for Complementary and Alternative Medicine
NCATS
National Center for Advancing Translational Sciences
CC
NIH Clinical Center
FAR
Federal Acquisition Regulations: System of uniformed policies and procedures governing acquisition or contracting actions of all executive agencies
Official FAR at 48 CFR Part 1-51
Part 1-51: guidelines for use of clauses
Official FAR at 48 CFR Part 52
Part 52: solicitation provision and contracts
Official FAR at 48 CFR Part 53
Part 53: Forms
Official FAR at 48 CFR Part 200+
Part 200 and up: agency-specific supplements
45 CFR 74
45 CFR 74: Principles for determining costs applicable to research and development under grants and contracts with hospitals
45 CFR 75:26
45 CFR 75:26 Audit requirements for for-profit organizations
48 CFR 31.2
48 CFR 31.2: Federal acquisition regulation contracts with commercial organizations
AAALACI
Association for the Assessment and Accreditation of Laboratory Animal Care International
AALAS
American Association for Laboratory Animal Science
Every institution that uses animals for federally funded laboratory research must have an _________.
IACUC: institutional Animal Care and Use Committee
Animal Welfare Act 1966
AWA and associated regulations are federal law overseen by the US Dept of Agriculture’s Animal and Plant Health Inspection Service. Excludes birds, rats and mice bred for research.
Public Health Service Policy on Humane Care and Use of Animals (PHS Policy)
Applies to those receiving PHS funds and covers all live vertebrates; Overseen by the Office of Laboratory Animal Welfare (OLAW)
A-102
A-102: Administrative Requirements to state/local government
A-110
A-110: Uniform administrative requirements to grants and agreements with institutions of higher education, hospitals and other non-profit organizations
A-21
A-21: Cost principles for educational institutions (universities, colleges..etc). This circular covers effort reporting requirement
A-87
A-87: Cost principles for state/local/tribal governments
A-122
A-122: Cost principles for non-profit organizations
A-133
A-133: Audit requirement of state/local governments and non-profit organizations
A-134
A-134: Financial accounting principles and standards
A-136
A-136: Financial reporting requirements
PL106-107
PL106-107: Federal financial assistance management improvement Act (1999). It requires all federal agencies to use a single electronic system to post funding opportunities and accept electronic applications for federal grant opportunities. It encompasses all 26 Federal agencies. OMB chose Grants.gov to implement this agenda, and DHHS to serve as the managing partner for Grants.gov.
Small Business Act PL85-536
Government should aid, counsel, assist and protect the interest of small business concerns in order to preserve free competitive enterprise
Davis-Bacon Act (DBRA)
Davis-Bacon Act (DBRA): It requires all contractors and subcontractors performing work on federal or DC construction contracts or federally assisted contracts in excess of $2K to pay their laborers and mechanics no less than the prevailing wage rates and fringe benefit rates
Walsh Healy Public Contracts Act
Walsh Healy Public Contracts Act: Federal minimum wages for all hours worked, and time and a half regular rate of pay for all hours worked over 40 hours a week.
Bayh-Dole Act (1980)
Bayh-Dohl Act: permits recipients of federal funds to take title of IP developed under federal funds; recipient is usually the institution not the PI. Govn’t gets nonexclusive, nontransferable, irrevocable, paid-up license for global use.
Copyright
Copyright: vests in authors original works and prevents others from copying or manipulating. Must be fixed, tangible form of expression.
Trademark
Trademark: words, slogans, designs, and other symbols that identify different products & brands in the marketplace. Flexible definition - can include shapes, color or sounds.
Patents
Patent: provides the legal right to exclude others from practicing/manufacturing/developing a good. Criteria: novel, utility/use, non-obvious.
Safe Harbor
Removal of 18 HIPAA specified identifiers
Common Rule
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies.
Grant
Grant: Principal purpose is to accomplish a public purpose
Cooperative Agreement
Cooperative Agreement: Substantial involvement is expected between the executive agency and the recipient
Contract
Contract: Principal purpose is acquisition of property or services for direct benefit of Federal Govn’t
Resource Conservation and Recovery Act (RCRA)
RCRA: Preference given to the purchase of specific products containing recycled materials identified in EPA guidelines
Reasons for revision of budget & program plans
- Change in scope
- Change in key personnel
- Absence for >3 months or a 25% reduction in time devoted to project by PI
- Transfer between direct and indirect costs, if approval is required
- Subawrads, unless described in the application and funded in the approved award
Expanded Authorities
- Pre-award costs 90 days prior to award (or >90 days with prior approval of fed awarding agency
- Initiate a one-time extension of expiration date up to 12 months
- Carry forward unobligated balances to subsequent funding periods
- *Must refer to award document**
Rebudgeting
Federal awarding agencies my, as its option, restrict the transfer of funds among DC categories for awards in which the federal share of the proj exceeds $100k and cumulative amount of such transfers exceeds 10% of total budget
Post Award: Equipment
physical inventory required at least once every two years
Copeland “Anti-Kickback” Act
Supplement to Davis-Bacon Act; Prohibits federal building/construction contractor/subcontractor from inducing an employee into giving up any part of the compensation that s/he is entitled to under the terms of his or her employment contract
Davis-Bacon Act
Applies to contractors / subcontractors performing on federally funded or assisted contracts (including District of Columbia contracts) in excess of $2,000 for the construction, alteration, or repair of public buildings or public works. Laborers / mechanics employed under such contracts are paid no less than the locally prevailing wages and fringe benefits for corresponding work on similar projects in the area. The Department of Labor determines locally prevailing wage rates.
Contract Work Hours & Safety Standard Act
TBD
Rights to Inventions Made Under a Contract or Agreement
TBD
Clean Air Act
TBD
Federal Water Pollution Control Act
TBD
Byrd Anti-Lobbying Amendment
TBD
Debarment & Suspension
TBD
Recipients of federal grant funds must retain records for a MINIMUM of:
1) 180 days after closeout
2) 18 months after the grant end date
3) 2 years after each grant budget year
4) 3 years from the submission of final progress report expenditure
Recipients of federal grant funds must retain records for a MINIMUM of 3 years from the submission of final progress report expenditure
Which of the following is a characteristic of a cooperative agreement?
1) Involves 2 or more institutions
2) Is more restrictive than a contract
3) Is used when federal involvement is required
A cooperative agreement Is used when federal involvement is required.
Expanded authorities delegate which of the following?
1) Change of Institution
2) Modification of budget
3) Renovation of laboratory space
4) Change of PI
Expanded authorities delegate modification of budget.
Despite expanded authorities, prior approval from a granting agency is required for which of the following?
1) A one-year no-cost extension
2) Change of personnel paid from the grant
3) Change of principal investigator or project scope
4) Transfer of funds from one budget category to another
Despite expanded authorities, prior approval from a granting agency is required for change of principal investigator or project scope.
An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of:
1) $10,000
2) $25,000
3) $50,000
4) $100,000
An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of $100,000.
The Bayh-Dole Act addresses
1) Publication rights to all intellectual property
2) Fixed price contracts for federally sponsored research
3) Extension of collaborative business opportunities
4) Ownership of intellectual property resulting from federal sponsored research
The Bayh-Dole Act addresses ownership of intellectual property resulting from federal sponsored research.
State and local governments are subject to which of the following OMB Circulars?
1) 2 CFR 220 (A-21)
2) A-102
3) 2 CFR 230 (A-122)
4) A-133
A-102
For copyrighted works which result from federally sponsored activities, the federal government usually requires
1) Disclosure of the copyright only
2) One copy for the official archives
3) A royalty-bearing, exclusive, and irrevocable license
4) A royalty-free, nonexclusive, and irrevocable license
For copyrighted works which result from federally sponsored activities, the federal government usually requires a royalty-free, nonexclusive, and irrevocable license.
Effort Reporting
A-21: Annual, CM/% overall activity, suitable means of verification
A-122: Monthly*, % or hourly reporting, first-hand knowledge
Allowable under A-21:
- Commencement & Convocation Costs?
- Deans of Faculty and Graduate Schools?
- Scholarships and student aid costs?
- Student activity costs (e.g. intramurals ,clubs, etc)?
- Commencement & Convocation Costs? NO (w exceptions)
- Deans of Faculty and Graduate Schools? YES
- Scholarships and student aid costs? YES (w restrictions)
- Student activity costs (e.g. intramurals ,clubs, etc)? NO (unless specifically provided for in the sponsor agreement)
Exports
Any oral, written, electronic or visual disclosure, shipment, transfer or transmission of commodities, tech info, tech data, assistance or software codes
- Anyone outside the US
- A non-US individual
- A foreign embassy or affiliate
Deemed Export
An export of technology or source code (except encryption source code) is “deemed” to take place when it is released to a foreign national within the United States.
Drug Free Workplace Act (1988)
Recipients of federal grant funds must provide written notification to all employees working on federally-funded grants/contracts that they must abide by inst drug-free workplace policies & must notify employer of convictions
Drug-Free Schools & Communities Act (1989)
Recipients of federal grants must dev and implement programs to prevent the unlawful possession, use, or distribution of illicit drugs and alcohol. Regulators conduct biennial review of the programs effectiveness and consistency of enforcement.
Stark Law Part 1 (1992) Part 2 (1993) Part 3 (2007)
Prohibits physician referrals of medicare and medicaid patients if the physician (or an immediate family member) has a financial relationship with that entity
Fundamental Research
Fundamental Research means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community
False Claims Act (FCA)
The FCA does not require proof of a specific intent to defraud the U.S. government. Healthcare providers can be prosecuted for conduct that leads to the submission of fraudulent claims to the government.
Phases of clinical trials
Phase I trials: Initial testing of experimental drug/treatment in 20–80 people to evaluate safety and side effects.
Phase II trials: Experimental drug/treatment is administered to 100–300 people for effectiveness and further safety evaluation
Phase III trials: Experimental drug/treatment is administered to 1,000–3,000 to confirm effectiveness, safety, monitor side effects, compare to standard treatments.
Phase IV trials: Post FDA approval and available to the public. Safety tracking for risks, benefits, and best use.
NUREMBERG CODE – POST WWII 1947
Resulted from the violence committed by Nazi physicians.
- Pre-clinical animal studies must precede human research
- Investigator must be knowledgeable in condition
- Societal benefit
- Voluntary consent is essential
- Risks minimized relative to benefits
- Subjects have the right to end research participation
THE DECLARATION OF HELSINKI - 1964
International living document.
- Subjects’ well-being precedes the interests of science and society.
- Some populations are vulnerable and require special protections.
- Experimental procedures must be detailed in a protocol, which is submitted to an IRB.
- Assessment of risks and benefits to subjects is required prior to research.
- Subjects must be informed volunteers. If they cannot consent for themselves, legally authorized representatives must consent on their behalf.
- Informed consent must be documented
TUSKEGEE SYPHILIS STUDY (1932-1972)
U.S. Public Health Service study on syphilis in 600 poor African-American men in rural Tuskegee, Alabama.
In the 1947, when penicillin became the drug of choice, researchers withheld treatment.
THE BELMONT REPORT-1979
Three core ethical principles:
- Respect for persons: ability of a person to direct his/her own actions. Getting informed consent a requirement and an individual must be capable of freely authorizing his/her participation
- Beneficence: Harms must minimizing and benefits must be maximizing for study participants
- Justice: Even distribution of benefits and burdens; impartial subject selection
45 CFR Part 46
Federal regulation encompassing human research, protections for vulnerable populations and IRBs
IRB Requirements
- 5 members of varying backgrounds including 1 community member
- Must meet at least annually
- Must have a quorum present
- Decisions must be in writing
Federal Funding Accountability and Transparency Act (FFATA)
he intent is to empower every American with the ability to hold the government accountable for each spending decision. The end result is to reduce wasteful spending in the government.
EDGAR
Electronic Data Gathering, Analysis, and Retrieval system, performs automated collection, validation, indexing, acceptance, and forwarding of submissions by companies and others who are required by law to file forms with the U.S. Securities and Exchange Commission (SEC).
provisional rate
A maximum provisional rate is a temporary rate established to permit funding and reimbursement of indirect costs pending establishment of a final rate (that rate determined at the end of an accounting period using “actual” direct and indirect cost data.)
CHALLENGE GRANT
A grant that provides monies in response to monies from other sources, usually according to a formula. A challenge grant may, for example, offer two dollars for every one that is obtained from a fund drive. The grant usually has a fixed upper limit, and may have a challenge minimum below which no grant will be made. This form of grant is fairly common in the arts, humanities, and some other fields, but is less common in the sciences. A challenge grant differs from a matching grant in at least one important respect: The amount of money that the recipient organization realizes from a challenge grant may vary widely, depending upon how successful that organization is in meeting the challenge. Matching grants usually award a clearly defined amount and require that a specified sum be obtained before any award is made.
Council on Governmental Relations (COGR)
COGR’s primary function is to provide advice and information to its membership and to make certain that federal agencies understand academic operations and the impact of proposed regulations on colleges and universities. COGR helps to develop policies and practices that fairly reflect the mutual interests and separate obligations of federal agencies and universities in research and graduate education.
Federal Demonstration Partnership
purpose is to reduce the administrative burdens associated with research grants and contracts.
Broad Agency Announcement (BAA)
The Broad Agency Announcement is a technique for United States government agencies to contract for basic and applied research and certain development. 48 CFR 35.016
Recharge Center
Recharge centers are entities within the university that provide fee-based services to the university research community. Most commonly, these are laboratory-based core facilities, but a variety of non-laboratory centers also exist. Although recharge centers typically offer services to non-university customers, the majority of their users are university affiliates.
NCI
National Cancer Institute
