CRA Exam 323 Questions with Verified Answers,100% CORRECT

CRA Exam 323 Questions with Verified Answers Renewal application NIH - CORRECT ANSWER (aka Competing Continuation) Request for an additional period of support based on a previously funded project; compete with other c ...

CRA Exam 323 Questions with Verified Answers Renewal application NIH - CORRECT ANSWER (aka Competing Continuation) Request for an additional period of support based on a previously funded project; compete with other competing continuation, competing supplemental, and new applications for funds; If not funded, must use the "new" application to reapply and continuity with previous award will not be retained. Resubmission NIH - CORRECT ANSWER An unfunded application that has been modified following initial review and resubmitted for new consideration. FCOI - CORRECT ANSWER Financial Conflict of Interest Competing Revision Application NIH - CORRECT ANSWER Initial request for (or the award of) additional funds during a current project period to support new or additional activities; reflects an expansion of the scope of the grant-approved activities. Competitive revisions require peer review Extension Application NIH - CORRECT ANSWER Request for additional years of support beyond the years previously awarded Change of Organization Status Application NIH - CORRECT ANSWER rights to and obligations under an NIH grant(s) are acquired incidental to the transfer of all of the assets of the grantee or the transfer of that part of the assets involved in the performance of the grant(s). May result from legislative or other legal action, such as a merger or other corporate change. Change of Institute or Center Application NIH - CORRECT ANSWER Change of awarding NIH institute or center for the noncompeting continuation Change of Grantee or Training Institution Application NIH - CORRECT ANSWER Transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the completion date of the approved project period (competitive segment). Noncompeting Continuation Application NIH - CORRECT ANSWER Request or award for a subsequent budget period within a previously approved project for which a recipient does not have to compete with other applications. STTR - CORRECT ANSWER Small Business Technology Transfer R&D contracts - CORRECT ANSWER to obtain research services and other resources needed by the Federal Government; legally binding documents and used when the principal purpose of the transaction is to acquire a specific service or end product. cooperative agreement - CORRECT ANSWER is a support mechanism where the IC and extramural scientists work together during performance of the research. Under this mechanism, the IC and the extramural community are both responsible for ensuring clinical research is conducted. Used when: 1. Substantial programmatic involvement is anticipated between IC and the recipient during the performance of the research activities 2. The applicant responds to a specific announcement for cooperative agreements and must tailor the application to the announcement requirements CAS - CORRECT ANSWER Cost Accounting Standards IC - CORRECT ANSWER NIH Institutes and Centers FACILITIES AND ADMINISTRATIVE (F&A) COSTS - CORRECT ANSWER Allowable F&A costs may include: • Depreciation use allowance • Facilities operations and maintenance • General administration and general expense • Departmental administration • Sponsored project administration • Libraries The grantee institution assigns the costs to an F&A cost pool from which they are appropriately distributed to all organizational activities on the basis of a rate. The rate is a ratio of the F&A costs to a direct cost base. The amount awarded for F&A costs is determined by multiplying the rate by the allowable costs in the direct cost base for the project. Has exceptions (e.g., training, fellowships, career programs, cancer education, grants, and foreign grants) DIRECT COSTS - CORRECT ANSWER incurred in the conduct of the research project; may include: • Salaries and fringe benefits of the Principal Investigator, other key personnel, and supporting staff • Expenditures for project-related equipment and supplies • Fees and supporting costs for consultant services • Expenses for travel beneficial to the research • Research patient care costs • Alterations and renovations • Publications and other miscellaneous expenses • Contract services • Costs for consortium participants You must seek approval from the Program Director at least six weeks prior to submission if you anticipate submitting an application exceeding $500,000 in direct costs in any year of the project. If the requested amount is significantly greater than $500,000, you should receive approval even further in advance. grant - CORRECT ANSWER federal financial assistance, including money, property, or both, to an eligible entity to perform approved scientific activities with little or no government involvement. Grants are used when no substantial programmatic involvement is anticipated between NIH IC and the recipient & There is no expectation on the part of IC of a specified service or end product other than generating knowledge NSF - CORRECT ANSWER National Science Foundation NIH - CORRECT ANSWER National Institute of Health (under DHHS) NASA - CORRECT ANSWER National Aeronautics and Space Administration USAID - CORRECT ANSWER US Agency for International Development NEH - CORRECT ANSWER National Endowment for Humanities NEA - CORRECT ANSWER National Endowment for the Arts SBIR - CORRECT ANSWER Small Business Innovation Research DVA - CORRECT ANSWER Department of Veteran Affairs DOT - CORRECT ANSWER Department of Transportation DOA or USDA - CORRECT ANSWER Department of Agriculture DOE (?) - CORRECT ANSWER Department of Education DOE - CORRECT ANSWER Department of Energy IES - CORRECT ANSWER Institute of Educational Sciences (under Dept of Ed) DOD - CORRECT ANSWER Department of Defense ONR - CORRECT ANSWER Office of Naval Research AFOSR - CORRECT ANSWER Air Force Office of Scientific Research ARO - CORRECT ANSWER Army Research Office DARPA - CORRECT ANSWER Defense Advanced Research Projects Agency DHHS - CORRECT ANSWER Department of Health and Human Services CDC - CORRECT ANSWER Center for Disease Control FDA - CORRECT ANSWER Food and Drug Administration (under DHHS) OMB - CORRECT ANSWER Office of Management and Budget NAICS - CORRECT ANSWER North American Industrial Classification System SOW - CORRECT ANSWER Scope of Work FAR - CORRECT ANSWER Federal Aquisition Regulations CFDA - CORRECT ANSWER Catalog of Federal Domestic Assistance Mandated by OMB Circular A-89 GSA - CORRECT ANSWER General Service Administration RPPR - CORRECT ANSWER Research Performance Progress Report OCRBP - CORRECT ANSWER Office of Clinical Research and Bioethics Policy (NIH) OBA - CORRECT ANSWER Office of Biotechnology Activities (NIH) F&A - CORRECT ANSWER Facilities and Administration (costs) IHE - CORRECT ANSWER Institution of Higher Education POP - CORRECT ANSWER Period of Performance FDP - CORRECT ANSWER Federal Demonstration Partnership FFATA - CORRECT ANSWER Federal Funding Accountability and Transparency Act MTDC - CORRECT ANSWER Modified Total Direct Costs RFP - CORRECT ANSWER Request For Proposal NoA - CORRECT ANSWER Notice of Award DS-2 - CORRECT ANSWER Disclosure Statement CASB - CORRECT ANSWER Cost Accounting Standard Board IACUC - CORRECT ANSWER Institutional Animal Care and Use Committee IRB - CORRECT ANSWER Institutional Review Board IP - CORRECT ANSWER Intellectual Property FOIA - CORRECT ANSWER Freedom of Information Act NERF - CORRECT ANSWER Non-Exclusive Royalty Free OLAW - CORRECT ANSWER Office of Laboratory Animal Welfare WMA - CORRECT ANSWER World Medical Association CFR - CORRECT ANSWER Code of Federal Regulations PHS - CORRECT ANSWER Public Health Services T&C - CORRECT ANSWER Terms and Conditions IBC - CORRECT ANSWER Institutional BioSafety Committee OSHA - CORRECT ANSWER Occupational Safety and Health Act FLSA - CORRECT ANSWER Fair Labor Standards Act ITAR - CORRECT ANSWER International Trafficking in Arms Regulations EAR - CORRECT ANSWER Export Administration Regulations OFAC - CORRECT ANSWER Office of Foreign Asset Control UBMTA - CORRECT ANSWER Uniform Biological Material Transfer Agreement OFPP - CORRECT ANSWER Office of Federal Procurement Policy OHRP - CORRECT ANSWER Office of Human Research Protection EPA - CORRECT ANSWER Environmental Protection Agency IDC - CORRECT ANSWER Indirect Cost; excludes: -equipment >$5K -capital expenditures -patient care -rent -tuition/scholarships/fellowships -participant support -Subaward over $25K DOC - CORRECT ANSWER Department of Commerce SBA - CORRECT ANSWER Small Business Administration DOI - CORRECT ANSWER Department of the Interior HIPAA - CORRECT ANSWER Health Insurance Portability and Accountibility Act COGR - CORRECT ANSWER Council on Governmental Regulations SAM - CORRECT ANSWER System for Award Management USPTO - CORRECT ANSWER US Patent and Trademark Office D&F - CORRECT ANSWER Determination and Finding (FAR 1.701) SAT - CORRECT ANSWER Simplified Acquisition Threshold ($150K in 2016) NIOSH - CORRECT ANSWER National Institute for Occupational Safety and Health FSRS - CORRECT ANSWER FFATA Subaward Reporting System TSDF - CORRECT ANSWER Treatment, Storage and Disposal Facility CO - CORRECT ANSWER Contract Officer COTR - CORRECT ANSWER Contracting Officer's Technical Representative NRC - CORRECT ANSWER Nuclear Regulatory Commission CHP - CORRECT ANSWER Chemical Hygiene Plan GHS - CORRECT ANSWER Globally Harmonized System IDP - CORRECT ANSWER Individual Development Plan EDP - CORRECT ANSWER Executive Development Plan RCR - CORRECT ANSWER Responsible Conduct of Research DOL - CORRECT ANSWER Department of Labor ADEA - CORRECT ANSWER Age Discrimination in Employment Act ADA - CORRECT ANSWER Americans with Disabilities Act RCRA - CORRECT ANSWER Resource Conservation and Recovery Act NARA - CORRECT ANSWER National Archives and Records Administration DUNS - CORRECT ANSWER Data Universal Numbering System; for NIH unique nine-digit identification number for each physical location of organization SFI - CORRECT ANSWER Significant Financial Interests COI - CORRECT ANSWER Conflict of Interest NCPHSBBR - CORRECT ANSWER National Commission for the Protection of Human Subjects of BioMedical and Behavioral Research FWA - CORRECT ANSWER Federalwide Assurance (Human Research) HRSA - CORRECT ANSWER Health Resources and Services Administration ORI - CORRECT ANSWER Office of Research Integrity AAHRPP - CORRECT ANSWER Association for the Accreditation of Human Research Protection Programs IND - CORRECT ANSWER Investigational New Drug CDM - CORRECT ANSWER Clinical Data Management APHIS - CORRECT ANSWER Animal and Plant Health Inspection Service AAALAC - CORRECT ANSWER Association for Assessment and Accreditation of Laboratory Animal Care IHS - CORRECT ANSWER Indian Health Service SAMHSA - CORRECT ANSWER Substance Abuse and Mental Health Services Administration VAS - CORRECT ANSWER Vertebrate Animals Section (of NIH proposal) AAU - CORRECT ANSWER Association of American Universities UTSA - CORRECT ANSWER Uniform Trade Secrets Act ULC - CORRECT ANSWER Uniform Law Commission NDA - CORRECT ANSWER Non-Disclosure Agreement GPEA - CORRECT ANSWER Government Paperwork Elimination Act ERA - CORRECT ANSWER Electronic Research Administration NSPIRES - CORRECT ANSWER NASA Solicitation and Proposal Integrated Review and Evaluation System PAMS - CORRECT ANSWER Portfolio Analysis and Management System (DOEnergy) NLM - CORRECT ANSWER National Library of Medicine EIR - CORRECT ANSWER Extramural Invention Report PVP - CORRECT ANSWER Plant Variety Protection RAC - CORRECT ANSWER Recombinant DNA Advisory Committee USML - CORRECT ANSWER United States Munition List CCL - CORRECT ANSWER Commerce Control List FCPA - CORRECT ANSWER Foreign Corrupt Practices Act USC - CORRECT ANSWER U.S. Code ACM$ - CORRECT ANSWER Award Cash Management $ervice CMIA - CORRECT ANSWER Cash Management Improvement Act EDGAR - CORRECT ANSWER Education Department General Administrative Regulations GAAP - CORRECT ANSWER Generally Accepted Accounting Principles GASB - CORRECT ANSWER Governmental Accounting Standards Board FASB - CORRECT ANSWER Financial Accounting Standards Board IBS - CORRECT ANSWER Institutional Base Salary VUCS - CORRECT ANSWER Voluntary Uncommitted Cost Share CDA - CORRECT ANSWER Career Development Award (NIH) GAAS - CORRECT ANSWER Generally Accepted Auditing Standards GAGAS - CORRECT ANSWER Generally Accepted Government Auditing Standards (Yellow Book) GAO - CORRECT ANSWER Government Accountability Office OIG - CORRECT ANSWER Office of the Inspector General SEFA - CORRECT ANSWER Schedule of Expenditures of Federal Awards COSO - CORRECT ANSWER Committee of Sponsoring Organizations of the Treadway Commission COMPETES - CORRECT ANSWER Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science (Act) CRADA - CORRECT ANSWER Cooperative Research And Development Agreement OSTI - CORRECT ANSWER Office of Science and Technology Information GFP - CORRECT ANSWER Government Furnished Property GFM - CORRECT ANSWER Government Furnished Material Davis-Bacon Act - CORRECT ANSWER The Davis-Bacon act of 1931 is a United States federal law that establishes the requirement for paying the local prevailing wages and fringe benefits on public works projects for laborers and mechanics. It applies to "contractors and subcontractors performing on federally funded or assisted contracts in excess of $2,000 for the construction, alteration, or repair (including painting and decorating) of public buildings or public works". Biohazard Level 1 - CORRECT ANSWER Work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and present minimal potential hazard to laboratory personnel and the environment. Work is typically conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment. Example: Chicken Pox Biohazard Level 2 - CORRECT ANSWER Work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that: 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in BSCs or other physical containment equipment. Example: HIV Biohazard Level 3 - CORRECT ANSWER Work with indigenous or exotic agents that may cause serious or lethal disease via aerosol transmission (inhalation). Strictly controlled and must be registered with government agencies Ventilation must provide ducted, directional airflow with no re-circulation; must have all BL-2 protestions plus more protective primary barriers as necessary (scrub suits, respirators, etc). Examples: West Nile, Yellow Fever Biohazard Level 4 - CORRECT ANSWER Work with agents that are extremely dangerous and pose a high risk of life-threatening disease. Maximum protection and containment. Complete clothing change/shower/decontamination of all meterials before leaving the facility. Class III Biosafety cabinet. Usually work is done in separate, isolated buildings with dedicated supply/exhaust ventilation through HEPA filters. Examples: Ebola, Lassa Virus, or any agent with unknown risks of transmission. Biohazard Symbol - CORRECT ANSWER Created by Dow Chemical Company in 1966 "Wanted something memorable but meaningless so they could educate people on what it means" Biohazardous Waste - CORRECT ANSWER Any waste containing infectious materials or potentially infectious substances (blood, sharps, or other wastes that could cause injury during handling). AKA: Infectious Waste or Biomed Waste Biological Hazards - CORRECT ANSWER Biological substances that pose a threat to the health of living organisms, primarily that of humans. Disposal of Biological Hazards - CORRECT ANSWER Red sharps containers and other contaminated biohazard waste must be collected by a licenced biohazard waste hauler. Non-contaminated waste can be disposed of as medical waste. Hazardous Materials - CORRECT ANSWER Any items or agent which has the potential to cause harm to humans, animals, or the environment, either by itself or through interaction with other factors. Can be Biological, Chemical, Radiological, and/or Physical Nuremberg Trials - CORRECT ANSWER 1945-1946 Nazis performing medical experiments without subject's consent. Led to the creation of the Nuremberg Code Example: studying the effects of a human only drinking salt water for 3-4 months Nuremberg Code (4 points) - CORRECT ANSWER Outlines and defines the ethical conduct of medical experiments. 1) All research must have requirements for informed consent (must be voluntary) 2) Research must have benefits to society 3) Research must avoid any unnecessary risk 4) Must be run by scientifically qualified investigators Thalidomide - CORRECT ANSWER 1962 Seen as a "cure all" (especially for morning sickness) and was sold to the public without a study into potential side effects Caused severe birth defects The Declaration of Helsinki was created as a direct result Declaration of Helsinki - CORRECT ANSWER 1964 Build on the Nuremberg Code Recommendations: 1) Research with humans should be based on lab and animal experimentation 2) Research should be conducted by a medically/scientifically qualified individual 3) Risks should not exceed benefits Declaration of Helsinki 1975 review - CORRECT ANSWER 1) There must be an independent review of research protocols 2) Provided requirements for informed consent Syphilis Study at Tuskegee - CORRECT ANSWER 1932-1972 Targeted African Americans Subjects were told they would receive free medical care for Syphilis but received nothing Researchers deliberately withheld Penicillin from subjects, despite it being the known cure for Syphilis National Research Act - CORRECT ANSWER 1974 Established the existence of Institutional Review Boards to review biomedical and behavioral research involving human subjects Commission for the Protection of Human Subjects in biomedical/behavioral research Identified basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects Belmont Report - CORRECT ANSWER 1979 A report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Prompted in part by the Tuskegee Syphilis Study The three fundamental ethical principles for using any human subjects for research are: 1) Respect for Persons 2)Beneficence 3) Justice Respect for Persons - CORRECT ANSWER One of the three fundamental ethical principles for using any human subjects in research outlined by the Belmont Report. Researchers must be truthful and conduct no deception -Collect informed consent. Must include Information, Comprehension, and Voluntariness. Must protect the privacy of the subject. -Subjects with diminished autonomy (Vulnerable Populations) are entitled to protection including: children, prisoners, pregnant women, fetuses Beneficence - CORRECT ANSWER One of the three fundamental ethical principles for using any human subjects in research outlined by the Belmont Report. -Subject should not be harmed -Research should maximize possible benefits and minimize possible harm -Assessment of risks and benefits. Justice - CORRECT ANSWER One of the three fundamental ethical principles for using any human subjects in research outlined by the Belmont Report. -Benefits and Risks of the study must be distributed fairly -Fair procedures for subject selection The Common Rule - CORRECT ANSWER 1991 45CFR Part 46 A rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. The basic DHHS policy for the protection of human subjects. -Requirement for assuring compliance by research institution -Requirements for obtaining and documenting informed consent -Requirements for IRB membership, function, operations, review of research, and record keeping Adopted by 15 federal departments and agencies 45CFR Part 46 - CORRECT ANSWER The Common Rule Office of Human Research Protection - CORRECT ANSWER (OHRP) Office within DHHS in charge of implementing regulations relating to the protection of human subjects in research. OHRP - CORRECT ANSWER Office of Human Research Protection (DHHS) Federal Wide Assurance - CORRECT ANSWER (FWA) A FWA is an agreement between a research institution and DHHS to comply with federal regulations concerning research involving human subjects, including the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46. Only type of assurance currently accepted and approvedby OHRP Every research institution must have one FWA - CORRECT ANSWER Federal Wide Assurance Institutional Review Board - CORRECT ANSWER (IRB) A specifically constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in funded biomedical or behavioral research OHRP must approve of each review board formed and it's members. IRB - CORRECT ANSWER Institutional Review Board IRB Members - CORRECT ANSWER At least 5 members. Federal regulations require that membership of the IRB include at a minimum, one member whose primary concerns are in scientific areas, one member whose primary concerns are in nonscientific areas, numerous members representing more than a single profession, and at least one individual not affiliated with the institution. IRB review - CORRECT ANSWER Full Review Expedited Review Exempt (not reviewed) IRB Review Full - CORRECT ANSWER -The study has a greater than minimal risk -Clinical Trials, vulnerable populations -Does not meet the requirements for exempt or expedited -Reviewed during monthly IRB meetings IRB Review Expedited - CORRECT ANSWER -Presents no more than a "minimal risk" for human subjects -Sureys, focus groups -Study does not qualify for an exemption but there are no additional risks -7 categories for initial review IRB Review Exempt - CORRECT ANSWER -Not reviewed by the IRB -Poses no more than minimal risk -Non invasive, educational, document review IRB wants to know about every study - CORRECT ANSWER -Purpose of Research -Study Details -Funding Source -Benefits/Risks -Precautions IRB's Role - CORRECT ANSWER 1) Review risk assessment 2) Review privacy and confidentially 3) Confirm 0 ethical concerns 4) Review the consent process/document IRB can terminate a previously approved study if - CORRECT ANSWER 1) They discover unanticipated harm OR 2) The study is not following IRB regulatins Vulnerable Population - CORRECT ANSWER Certain human subjects are categorized as vulnerable populations and require special treatment with respect to safeguards of their well-being. Examples include pregnant women, human fetuses and neonates, children, cognitively impaired persons, prisoners, students and employees, and educationally disadvantaged individuals. IRB possible decisions - CORRECT ANSWER Approve Conditionally Approve Table Reject IRB Documentation Requirement - CORRECT ANSWER IRB documentation must be kept for a minimum of 3 years Research - CORRECT ANSWER A systematic investigation designed to develop or contribute to generalizable knowledge Human Subjects - CORRECT ANSWER A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information Protocol - CORRECT ANSWER A formal description and design for a specific research project involving human subjects, vertebrate animals, or biohazards Informed Consent Required Elements - CORRECT ANSWER 1) Study description 2) Reasonably foreseeable risks and discomforts 3) Reasonably foreseeable benefits 4) Disclosure of alternative procedures/treatments 5) Confidentially of records 6) Compensation and Treatment for Injury 7) Contact Information 8) Voluntary participation "As Necessary" Elements of Informed Consent - CORRECT ANSWER 1) Risks are currently unforeseeable 2) investigators ma terminate participation 3) Additional Costs 4) Consequences for subject withdrawal 5) Significant new findings 6) # of subjects participating Continuing Review - CORRECT ANSWER Continuing review, sometimes referred to as "IRB renewal," of human subjects research projects is required at least annually even if no changes have occurred to the recruitment materials, research procedures, or subject population during the IRB approval period. 2 CFR 200.430 - CORRECT ANSWER Effort Reporting Requirements (UG) Expanded Authorities - CORRECT ANSWER "Expanded authorities" refer to a limited number of actions that normally require awarding agency prior approval but for which HHS has waived its authority and given this authority to the grantee -Carryover of unobligated balances from one budget period to the next successive budget period -Cost-related prior approvals for direct cost items, including research patient care costs and equipment -Extension of final budget period of a project period without additional funds -Pre-award costs up to (and including) 90 days before the beginning date of the initial budget period of a new or competing continuation award -Transfer of performance of substantive programmatic work to a third party (by subaward or a contract under the grant) Office of Research Integrity - CORRECT ANSWER (ORI) The Office of Research Integrity Oversees and directs Public Health Service (PHS) research integrity activities Within DHHS ORI - CORRECT ANSWER Office of Research Integrity Patent - CORRECT ANSWER Granting of a property right to the inventor. "The right to exclude others from making, using, offering for sale, or selling" the invention in the US or importing the invention to the US Term is usually 20 years Issued by the US Patent and Trademark Office Patents - CORRECT ANSWER 1) Utility 2) Design 3) Plant Utility Patent - CORRECT ANSWER Granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, composition of matter, or any new/useful improvement thereof Design Patent - CORRECT ANSWER Granted to anyone who invents a new, original, and ornamental design for an article of manufacture Plant Patent - CORRECT ANSWER Granted to anyone who invents or discovers and asexually reproduces and distinct/new variety of plant 37 CFR Part 401 - CORRECT ANSWER Bayh-Dole Act Bayh-Dole Act - CORRECT ANSWER 1980 Permits businesses and non-profits to retain ownership of the inventions made under federally funded research and contract programs, while also giving the government license to practice the subject of invention Organizations are expected to file for patent protection and commercialize for the benefit of public health Encourages universities to participate in tech transfer Catalog of Federal Domestic Assistance - CORRECT ANSWER Compendium of federal programs, projects, services, and activities that provide assistance or benefits to the American public Description of every federal assistance program in the country (grants) CFDA - CORRECT ANSWER Catalog of Federal Domestic Assistance Federal Register - CORRECT ANSWER Daily journal of the US Government where rules are introduced daily Code of Federal Regulations - CORRECT ANSWER Codification of the general and permanent rules published in the Federal Register where new rules are finalized CF - CORRECT ANSWER Code A-21 - CORRECT ANSWER Cost Principles for Education Institutions A-89 - CORRECT ANSWER Catalog of Federal Domestic Assistance A-110 - CORRECT ANSWER Uniform Administrative Requirements for Grants and other agreements with institutes of higher education, hospitals, and other non-profit A-122 - CORRECT ANSWER Cost Principles for non-profit organizations A-133 - CORRECT ANSWER Audit of states, local governments, and non-profit institutions Uniform Guidance Subpart A - CORRECT ANSWER Acronyms and Definitions Uniform Guidance Subpart B - CORRECT ANSWER General Provisions Uniform Guidance Subpart C - CORRECT ANSWER Pre-Award Requirements Uniform Guidance Subpart D - CORRECT ANSWER Post Award Requirements Uniform Guidance Subpart E - CORRECT ANSWER Cost Principles Uniform Guidance Subpart F - CORRECT ANSWER Audit Requiremenets Uniform Guidance Appendices - CORRECT ANSWER Funding Opportunities, F&A information Uniform Guidance effective date - CORRECT ANSWER 12/26/2014 Funding Mechanisms - CORRECT ANSWER Assistance Procurement Assistance Funding Mechanisms - CORRECT ANSWER Grant Cooperative Agreement Procurement Funding Mechanisms - CORRECT ANSWER Contract Uniform Guidance Subpart E Replaces - CORRECT ANSWER A-21 Uniform Guidance Subpart C and D Replaces - CORRECT ANSWER A-110 Uniform Guidance Subpart F Replaces - CORRECT ANSWER A-133 Uniform Guidance - COI - CORRECT ANSWER Requires agencies to establish conflict of interest policies for federal awards Uniform Guidance - Funding Notices - CORRECT ANSWER Agencies are required to give 30 days, preferably 60, days notice prior to the deadline 200.112 - CORRECT ANSWER UG Conflict of Interest Policy 200.203 - CORRECT ANSWER Notices of Funding Opportunities 200.204 - CORRECT ANSWER Agency Review of Merit Proposals Uniform Guidance - Agency Review of Merit Proposals - CORRECT ANSWER Requires agencies to design and execute a merit review process for applications 200.206 - CORRECT ANSWER Standard Application Requirements Uniform Guidance - Standard Application Requirements - CORRECT ANSWER Agency forms must comply with the Paperwork Reduction Act of 1995. Continues push towards standard pre and post award forms 200.303 - CORRECT ANSWER Internal Controls Uniform Guidance - Internal Controls - CORRECT ANSWER Establish and maintain effective internal controls 200.306 - CORRECT ANSWER Cost Sharing or Matching Uniform Guidance - Cost Sharing/Matching - CORRECT ANSWER Voluntary committed cost sharing is not expected in proposals and is not used as a factor during the merit review. Subrecipient - CORRECT ANSWER A subaward is for the purpose of carrying out a portion of a Federal Award and creates a Federal Assistance relationship with the subrecipient. -Intellectual Activity Contractor - CORRECT ANSWER A contract is for the purpose of obtaining goods and services for the non-federal entity's own use and creates a procurement relationship with the contractor -Providing a service 200.331 - CORRECT ANSWER Requirements for Pass-Thru entities Requirements for Pass-Thru entities 200.331 - CORRECT ANSWER Established a 10% de minimus rate Established prescriptive monitoring requirements Fixed Amount Subawards - CORRECT ANSWER Up to $150,000 200.413 - CORRECT ANSWER Direct Costs 200.430 - CORRECT ANSWER Time and Effort Certification 200.453 Materials and Supplies - CORRECT ANSWER Allows for the purchase of computers on grants even if it is not solely dedicated to the award 200.461 - CORRECT ANSWER Publication and Printing Costs Uniform Guidance Single Audit Threshold - CORRECT ANSWER $750,000 200.474 - CORRECT ANSWER Dependent care costs Exports - CORRECT ANSWER Any oral, written, electronic, or visual disclosure, shipment, transfer, or transmission of comodities, technology, information, technical data, assistance or software codes to: -Anyone living outside the US (incl US citizen) -A non-US individual (wherever they are) -A foreign embassy or affiliate Export Governing Agencies - CORRECT ANSWER Department of Treasury Department of Commerce Department of State FACR - CORRECT ANSWER Foreign Assets Control Regulations Foreign Assets Control Regulations - CORRECT ANSWER Department of Treasury Control: travel abroad, transactions with foreign individuals or countries, export and import EAR - CORRECT ANSWER Export Administration Regulations Export Administration Regulations - CORRECT ANSWER Department of Commerce Control: dual-use goods/software/technology predominately civilian in nature but may include military applications. Also: Anti-boycott provisions ITAR - CORRECT ANSWER International Traffic in Arms Regulations International Traffic in Arms Regulations - CORRECT ANSWER Department of State Control: Goods/software/information specifically designed, developed, or modified for military or intelligence applications. Also: Defense services Fundamental Research - CORRECT ANSWER Basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community Fundamental Research Exclusion - CORRECT ANSWER Research results generated during the course of fundamental research are excluded from the requirements of export control laws and regulations. No license is needed to share these results, even if they relate to items or technology that is otherwise controlled. Deemed Export - CORRECT ANSWER Transfers of technology to a foreign national within the US OFAC - CORRECT ANSWER Office of Foreign Asset Control US dept of Treasury Examples of OFAC Country Sanctions - CORRECT ANSWER Cuba Democratic Republic of Congo Iran North Korea Sudan Syria *not a comprehensive list and is updated periodically FCA False Claims Act - CORRECT ANSWER American federal law that imposes liability on persons and companies (typically federal contractors) who defraud governmental programs. FCA does not require proof of specific intent to defraud the federal government Majority of cases are from whistleblowers FCA - CORRECT ANSWER False Claims Act Examples of FCA claims - CORRECT ANSWER -Falsifying records -Double-billing -Submitting bills for services never performed/items never purchased -"knowingly" making false statements Qui Tam Action - CORRECT ANSWER Whistleblower filing a lawsuit Anti-kickback Act of 1986 - CORRECT ANSWER Prohibits a personal from soliciting or accepting any kickback related to a federal subcontract Stark Law - CORRECT ANSWER Prevents physicians from referring Medicare patients for health services to an entity with which there is a financial relationship AND Entity cannot submit Medicare claims for services resulting from such a referral. Welsh-Healey Public Contacts Act - CORRECT ANSWER Requires contractors under contracts exceeding $10K to pay employees the federal minimum wage plus time and a half for any hours worked over 40 in a workweek Service Contracts Act - CORRECT ANSWER Requires contractors under contracts exceeding $2,500 to pay service employees to be paid no less than the prevailing wage/benefits in the locality Contracts Work Hours and Safety Standards Act - CORRECT ANSWER Requires contractors to pay laborers and mechanics at least time and a half for all hours worked over 40 in a workweek; and prohibits unsanitary, hazardous, or dangerous working conditions Copeland Anti-Kickback Act - CORRECT ANSWER Prohibits inducing an employee to give up and part of his/her compensation to which he/she is entitled to under a contract of employment Byrd Amendment - CORRECT ANSWER Prohibits the use of appropriated funds to pay for lobbiests Simpson Craig Amendment - CORRECT ANSWER Makes any organization that is tax-exempt ineligible for federal funds to engage in lobbying Simpson Craig Amendment AKA... - CORRECT ANSWER Lobbying Disclosure Act of 1995 Lobbying Disclosure Act of 1995 AKA... - CORRECT ANSWER Simpson Craig Amendment Title IX - CORRECT ANSWER 1975 Broadly prohibits discrimination on the basis of sex in any education program or activity receiving federal financial assistance Age Discrimination Act of 1975 - CORRECT ANSWER Prohibits discrimination on the basis of age in programs and activities receiving federal financial assistance ADA Americans with Disabilities Act - CORRECT ANSWER 1990 Wide ranging civil rights law that is intended to protect against discrimination based on disability ADA - CORRECT ANSWER American with Disabilities Act Utilization of Small Business and Small Disadvantaged Business Concerns - CORRECT ANSWER Created SBIR/STTR grants Hatch Act - CORRECT ANSWER 1939 Attempted to limit the political activities of employees in federal, state, and local governments. The goal being to enforce political neutrality among civil service Prohibits federal employees from: - holding public office -Influencing elections -Participating/managing political campaigns -exerting undue influenceon government hiring Hatch Act Prohibits - CORRECT ANSWER Prohibits federal employees from: - holding public office -Influencing elections -Participating/managing political campaigns -exerting undue influenceon government hiring Remedies for Noncompliance (UG) - CORRECT ANSWER -Temporally withhold cash payment -Disallow all or part of the cost/activity -Wholly/partly suspend or terminate the award -Initiate suspension/debarment proceedings -Withhold further Federal awards -Other legally available actions IDC Exclusions (7) - CORRECT ANSWER -equipment >$5K -capital expenditures -patient care -rent -tuition/scholarships/fellowships -participant support -Subaward over $25K Single Audit Requirement - CORRECT ANSWER $750K or more in federal awards in the entity's FY Lapses in Internal Controls - CORRECT ANSWER Deficiency Material Weakness Significant Deficiency Clinical Trial - CORRECT ANSWER 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. First Agency to Conduct a Clinical Trial - CORRECT ANSWER Navy (citrus) Phase I Clinical Trial - CORRECT ANSWER Testing of drug on healthy volunteers for dose-ranging Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II Clinical Trial - CORRECT ANSWER Testing of drug on patients to assess efficacy and safety The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III Clinical Trial - CORRECT ANSWER Testing of drug on patients to assess efficacy, effectiveness and safety (usually multi-center trials on a much larger patient groups). The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV Clinical Trial - CORRECT ANSWER Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use GCP - CORRECT ANSWER Good Clinical Practices; regulations and guidelines which set minimum standards for clinical trials. They are designed to accomplish two primary purposes: -to ensure the quality and integrity of data obtained from clinical testing, and -to protect the rights and welfare of clinical subject Sponsored Project Proposal - CORRECT ANSWER A formal request for financial support from an extramural source Pre-Proposal - CORRECT ANSWER A short description of a project that does not involve a binding commitment of university resources. A Pre-Proposal is also known as... - CORRECT ANSWER Preliminary proposal, white paper, letter of intent, or concept paper Proposals - CORRECT ANSWER New Continuation Renewal of competing continuation Supplemental Contract Proposal Solicited Proposal - CORRECT ANSWER A proposal that is submitted in response to a specific work statement from the sponsor. A Request for Proposals (RFP) or Request for Applications (RFA) is sometimes used by sponsors to solicit proposals for specific research, development, or training projects or to provide specific services or goods. Unsolicited Proposal - CORRECT ANSWER A written proposal for a new or innovative idea that is submitted to an agency for the purpose of obtaining a contract with the government, and that is not in response to an RFP, broad agency announcement, or any other government-initiated solicitation or program. Program Announcements Funding Opportunity Announcement Request for Application (RFA) Unsolicited Proposals - CORRECT ANSWER Program Announcements Funding Opportunity Announcement Request for Application (RFA) Unsolicited Proposal Award Mechanism - CORRECT ANSWER Grant or Cooperative Agreement Solicited Proposals - CORRECT ANSWER Request for Proposal Request for Quotation Request for Bid Broad Agency Announcement Solicited Proposal Award Mechanism - CORRECT ANSWER Contract Grant/Cooperative Agreement General Proposal Elements (8) - CORRECT ANSWER Title Abstract Table of Contents Project Description/Scope of Work Vitae/Biosketch Budget and Justification Facilities/resources available Appendices NIH Proposal Review Criteria (5) - CORRECT ANSWER Significance Investigator Innovation Approach Environment NSF Proposal Review Criteria (2) - CORRECT ANSWER Intellectual Meritit Broader Impacts NSF Proposal Submission Website - CORRECT ANSWER Fastlane NIH Proposal Submission Website - CORRECT ANSWER Grants.gov NASA Proposal Submission Website - CORRECT ANSWER NSPIRES Invention Reporting Website - CORRECT ANSWER iEdison Occupational Safety and Health (OSH) Act - CORRECT ANSWER The law requires employers to provide their employees with working conditions that are free of known dangers. Occupational Safety and Health Administration (OSHA) - CORRECT ANSWER With the Occupational Safety and Health Act of 1970, Congress created the Occupational Safety and Health Administration (OSHA) to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. OSHA - CORRECT ANSWER Part of the Department of Labor