CRA Exam LATEST EDITION 2024/25 GUARANTEED GRADE A+

Renewal application NIH (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 An unfunded application that has been modified following initial review and resubmitted for new consideration. FCOI Financial Conflict of Interest Competing Revision Application NIH 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 Request for additional years of support beyond the years previously awarded Change of Organization Status Application NIH 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 Change of awarding NIH institute or center for the noncompeting continuation Change of Grantee or Training Institution Application NIH 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 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 Small Business Technology Transfer R&D contracts 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 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 Cost Accounting Standards IC NIH Institutes and Centers FACILITIES AND ADMINISTRATIVE (F&A) COSTS 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 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 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 National Science Foundation NIH National Institute of Health (under DHHS) NASA National Aeronautics and Space Administration USAID US Agency for International Development NEH National Endowment for Humanities NEA National Endowment for the Arts SBIR Small Business Innovation Research DVA Department of Veteran Affairs DOT Department of Transportation DOA or USDA Department of Agriculture DOE (?) Department of Education DOE Department of Energy IES Institute of Educational Sciences (under Dept of Ed) DOD Department of Defense ONR Office of Naval Research AFOSR Air Force Office of Scientific Research ARO Army Research Office DARPA Defense Advanced Research Projects Agency DHHS Department of Health and Human Services CDC Center for Disease Control FDA Food and Drug Administration (under DHHS) OMB Office of Management and Budget NAICS North American Industrial Classification System SOW Scope of Work FAR Federal Aquisition Regulations CFDA Catalog of Federal Domestic Assistance Mandated by OMB Circular A-89 GSA General Service Administration RPPR Research Performance Progress Report OCRBP Office of Clinical Research and Bioethics Policy (NIH) OBA Office of Biotechnology Activities (NIH) F&A Facilities and Administration (costs) IHE Institution of Higher Education POP Period of Performance FDP Federal Demonstration Partnership FFATA Federal Funding Accountability and Transparency Act MTDC Modified Total Direct Costs RFP Request For Proposal NoA Notice of Award DS-2 Disclosure Statement CASB Cost Accounting Standard Board IACUC Institutional Animal Care and Use Committee IRB Institutional Review Board IP Intellectual Property FOIA Freedom of Information Act NERF Non-Exclusive Royalty Free OLAW Office of Laboratory Animal Welfare WMA World Medical Association CFR Code of Federal Regulations PHS Public Health Services T&C Terms and Conditions IBC Institutional BioSafety Committee OSHA Occupational Safety and Health Act FLSA Fair Labor Standards Act ITAR International Trafficking in Arms Regulations EAR Export Administration Regulations OFAC Office of Foreign Asset Control UBMTA Uniform Biological Material Transfer Agreement OFPP Office of Federal Procurement Policy OHRP Office of Human Research Protection EPA Environmental Protection Agency IDC Indirect Cost; excludes: -equipment $5K -capital expenditures -patient care -rent -tuition/scholarships/fellowships -participant support -Subaward over $25K DOC Department of Commerce SBA Small Business Administration DOI Department of the Interior HIPAA Health Insurance Portability and Accountibility Act COGR Council on Governmental Regulations SAM System for Award Management USPTO US Patent and Trademark Office D&F Determination and Finding (FAR 1.701) SAT Simplified Acquisition Threshold ($150K in 2016) NIOSH National Institute for Occupational Safety and Health FSRS FFATA Subaward Reporting System TSDF Treatment, Storage and Disposal Facility CO Contract Officer COTR Contracting Officer's Technical Representative NRC Nuclear Regulatory Commission CHP Chemical Hygiene Plan GHS Globally Harmonized System IDP Individual Development Plan EDP Executive Development Plan RCR Responsible Conduct of Research DOL Department of Labor ADEA Age Discrimination in Employment Act ADA Americans with Disabilities Act RCRA Resource Conservation and Recovery Act NARA National Archives and Records Administration DUNS Data Universal Numbering System; for NIH unique nine-digit identification number for each physical location of organization SFI Significant Financial Interests COI Conflict of Interest NCPHSBBR National Commission for the Protection of Human Subjects of BioMedical and Behavioral Research FWA Federalwide Assurance (Human Research) HRSA Health Resources and Services Administration ORI Office of Research Integrity AAHRPP Association for the Accreditation of Human Research Protection Programs IND Investigational New Drug CDM Clinical Data Management APHIS Animal and Plant Health Inspection Service AAALAC Association for Assessment and Accreditation of Laboratory Animal Care IHS Indian Health Service SAMHSA Substance Abuse and Mental Health Services Administration VAS Vertebrate Animals Section (of NIH proposal) AAU Association of American Universities UTSA Uniform Trade Secrets Act ULC Uniform Law Commission NDA Non-Disclosure Agreement GPEA Government Paperwork Elimination Act ERA Electronic Research Administration NSPIRES NASA Solicitation and Proposal Integrated Review and Evaluation System PAMS Portfolio Analysis and Management System (DOEnergy) NLM National Library of Medicine EIR Extramural Invention Report PVP Plant Variety Protection RAC Recombinant DNA Advisory Committee USML United States Munition List CCL Commerce Control List FCPA Foreign Corrupt Practices Act USC U.S. Code ACM$ Award Cash Management $ervice CMIA Cash Management Improvement Act EDGAR Education Department General Administrative Regulations GAAP Generally Accepted Accounting Principles GASB Governmental Accounting Standards Board FASB Financial Accounting Standards Board IBS Institutional Base Salary VUCS Voluntary Uncommitted Cost Share CDA Career Development Award (NIH) GAAS Generally Accepted Auditing Standards GAGAS Generally Accepted Government Auditing Standards (Yellow Book) GAO Government Accountability Office OIG Office of the Inspector General SEFA Schedule of Expenditures of Federal Awards COSO Committee of Sponsoring Organizations of the Treadway Commission COMPETES Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science (Act) CRADA Cooperative Research And Development Agreement OSTI Office of Science and Technology Information GFP Government Furnished Property GFM Government Furnished Material Davis-Bacon Act 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 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 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 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 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 Created by Dow Chemical Company in 1966 "Wanted something memorable but meaningless so they could educate people on what it means" Biohazardous Waste 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 Biological substances that pose a threat to the health of living organisms, primarily that of humans. Disposal of Biological Hazards 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 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 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) 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 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 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 1) There must be an independent review of research protocols 2) Provided requirements for informed consent Syphilis Study at Tuskegee 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