Certified Research Administrator Exam Review
120 days
Deadline for cash draw down from federal funding sources
New Proposal
Initial request for support of a project that has not yet been funded
Small Business Administration (SBA)
Maintains and strengthens the nation's economy by aiding, counseling, assisting, and protecting the interests of small businesses, and by helping families and businesses recover from national disasters.
Program Requirements
Regulations Guidelines Administrative Requirements
FedBizOpps
The single point of universal electronic public access on the Internet for government-wide Federal procurement opportunities (contracts) that exceed $25,000.
Intellectual Property
"Creations of the mind" reduced to a tangible form that can be protected by patents, trademarks, copyrights, and some trade secrets
Office of Science and Technology Policy (OSTP)
A White House office to advise the President on scientific, engineering, and technological topics.
Applied Research Ethics National Association (ARENA)
A body created within PRIM&R as a professional community for institutional review board (IRB) and institutional animal care and use committee (IACUC) members, administrators and others interested in and concerned with applied research ethics.
Grant
A commitment from a corporation, foundation, government, etc. to provide financial assistance for a specific activity with an agreed upon budget in a specified period of time; requires substantial financial and progress/performance reporting
US-flagged company
A company that is registered and pays taxes in the U.S. or its territories.
Federal Demonstration Partnership (FDP)
A cooperative initiative among 10 federal agencies and 154 institutional recipients of federal funds 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.
Gift
A donation of materials, services, facilities, property, cash to an institution or investigator from individuals, corporations, foundations; typically unrestricted with no reporting or performance obligation
Cooperative Agreement
A funding arrangement between an institution and a federal government entity in which the governmental entity will have substantial scientific and programmatic involvement in the activity
Human research subject
A living individual about whom an investigator (whether profession or student) conducting research obtains: Data through intervention or interaction with the individual, or identifiable private information.
National Association of College Business Officers (NACUBO)
A membership organization for chief business and financial officers to advance the economic viability, business practices and support for higher education institutions in fulfillment of their missions
National Organization of Research Development Professionals
A national peer network of research development professionals that enhances competitive multi-, inter- and transdisciplinary research.
Grant Professionals Association (GPA)
A nonprofit association that builds and supports an international community of grant professionals committed to serving the greater public good.
Association of University Technology Managers ( AUTM)
A nonprofit organization to support and advance academic technology transfer globally.
Debarment
A prohibition from conducting business with federal government
National Endowment for the Arts (NEA)
A public agency dedicated to supporting excellence in the arts, bringing the arts to all Americans, and providing leadership in arts education. The Endowment is the largest national source of funds for the arts.
Supplement
A request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol.
Competing Continuation
A request for funding to renew, by one or more additional budget periods, a project period that would otherwise expire.
Sub-award/Sub-contract
A second tier contract or grant that states the primary funding has been provided by another, often government, sponsor; terms and conditions of the primary award are flowed down to the subawardee
Conflict of Interest
A situation in which a financial or other personal consideration could, or could have the appearance to, directly and significantly affect professional judgment in the design, conduct or reporting of research results
U.S. Department of the Treasury (TREAS)
A steward of United States economic and financial systems, promotes conditions for prosperity and stability in the U.S., and encourages prosperity and stability in the rest of the world.
Suspension
A tempory restriction on conducting business with the federal government
Modular Budget
A type of grant application in which support is requested in specified increments without the need for detailed supporting information related to separate budget categories
NIH Electronic Research Administration (eRA) Commons
A virtual meeting place where NIH and the grantee community can receive and transmit information for the purposes of extramural research administration.
NIH ASSIST (Application Submission System & Interface for Submission Tracking)
A web-based system used to prepare applications and to submit electronically through Grants.gov to NIH (and other participating agencies).
Assurance
A written guarantee or pledge that one will operate in a certain way or comply with certain terms and conditions of an award.
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Administered by the HHS Office for Civil Rights to regulate the protected health information (PHI) that is held or transmitted in any form to protect the privacy of the patient. Also allows for patients to have access to their health records.
United States Department of Agriculture (USDA)
Administers the Animal Welfare Act (AWA) through the Animal and Plant Health Inspection Service (APHIS).
U.S. Department of Energy (DOE)
Advances national, economic, and energy security in the U.S.; to promote scientific and technological innovation in support of that goal; and to ensure environmental cleanup of the national nuclear weapons complex
Social Security Administration (SSA)
Advances the economic security of the nation's people through compassionate and vigilant leadership in shaping and managing America's Social Security programs.
National Council of University Research Administrators (NCURA)
Advances the profession of research administration through education and professional development programs, the sharing of knowledge and experiences, and the fostering of a diverse, collegial, and respected global community.
Expanded Authorities
Affords the university certain privileges to not seek prior approval, such as establishment of preaward spending 90 days prior to award and automatic approval of the initial no-cost extension up to 12 months
NIH Responsible Conduct of Research Policy
All trainees, fellows, participants, and scholars receiving support through any training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research, and the content must encompass 9 key areas of interest.
Cost Principles
Allowable Reasonable Allocable Consistent Treatment
IRB Exempt Review
Allowable for studies that involve human subjects but do not expose subjects to physical, social or psychological risks and falls into 1 of 6 categories.
Solomon Amendment
Allows for exemptions to the Family Educational Rights and Privacy Act to ensure military recruiters have access to directory information of students 17 years and older for purposes of military recruiting.
$25,000
Amount of a single module in a modular budget
Representation
An account or statement of fact concerning an offeror and its capabilities and abilities to perform that is viewed legally as an inducement to parties to enter into a contract.
Grants Management Officer
An agency official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions.
Collaboration Research Agreement
An agreement between two or more parties to work together on a particular research projects. Both parties perform research on the project and share results. Generally no funds are involved.
Confidential Disclosure Agreement (CDA)
An agreement for two or more parties to accept but not to disclose certain information from the disclosing party
Sponsored Research Agreement (SRA)
An agreement in which the a party funds the research activities of another in exchange for use of results of the research
Material Transfer Agreement (MTA)
An agreement to transfer materials between two or more parties
Program Announcement (PA)
An announcement by an agency requesting applications in the stated scientific areas, typically focused on a specific and narrow area of research (limited application deadlines)
Broad Agency Announcement (BAA)
An announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made.
Association of Independent Research Institutes (AIRI)
An association of independent, not-for-profit biomedical and behavioral research institutes whose mission is to enhance the ability of its members to improve human health and advance knowledge.
Council on Governmental Relations (COGR)
An association of leading research universities, affiliated medical centers and independent research institutes associated with managing federal research grants and contracts within research institutions.
proposalCENTRAL
An e-grantmaking website shared by many government, non-profit, and private grant-making organizations.
Fair Use
An exception to copyright laws that allows for copies to be made for the purposes of criticism, comment, news reporting, teaching, scholarship and research
National Science Foundation (NSF)
An independent federal agency created to promote the progress of science, to advance the national health, prosperity, and welfare, and to secure the national defense. The NSF annually funds approximately 20 percent of basic, federally-supported college and university research.
U.S. Agency for International Development (USAID)
An independent federal government agency that provides economic and humanitarian assistance in more than 100 countries to ensure a better future for us all. (https://www.usaid.gov)
National Endowment for the Humanities (NEH)
An independent grant-making agency of the United States government dedicated to supporting research, education, preservation, and public programs in the humanities.
Drug-Free Schools and Community Act Amendments of 1989
An institution must adopt and implement a drug prevention program to prevent the unlawfulpossession, use or distribution of illicit drugs and alcohol by all students and employees, and perform a biennial review of the program.
Drug-Free Workplace Act of 1988
An institution must establish a drug-free awareness program and certify that it will provide a drug-free workplace by notifying employees about prohibitions against unlawful manufacture, distribution, dispensation, possession or use of acontrolled substance in the workplace.
National Environmental Policy Act of 1969
An institution that receives an award for a project that may have implications for adverseenvironmental impact must comply with the Act, including submission of environmental impactstatement.
Federal Wide Assurance
An institution's formal agreement to comply with human subject protection regulations
NSF Fastlane
An interactive real-time system for working with the National Science Foundation
The Guide for Care and Use of Laboratory Animals, 8th edition (The Guide)
An internationally accepted reference on animal care and use in research that establishes responsibilities and standards for institutions, investigators and veterinarians, and requires institutions to establish policies related to the protection of animals used in research.
Contract
An legally binding procurement relationship between a sponsor and an institution that will furnish a product or service as described by the sponsor; requires extensive financial reporting, progress updates and final results
Governmental Accounting Standards Board (GASB)
An organization of national associations of state and local governments officials established in 1994 that establishes financial reporting requirements for the government.
Resubmission
An unfunded application that has been modified following initial review and resubmitted for new consideration.
NSF Responsible Conduct of Research Policy
Any institution supported must have a plan to train and oversee students, graduate students and post-doctoral students in the responsible conduct of research, and the content of the plan is at the discretion of the university.
NIH Initial Peer Review Appeal
Applicants may submit appeals letter regarding the procedural aspects related to the completed initial peer review. The reason for appeal must be based on evidence of bias by one or more reviewer, conflict of interest by one or more reviewer, lack of appropriate expertise within the SRG, or factual errors made by one or more reviewer that could have substantially altered the outcome of the review.
Plant Patent
Applies to asexually reproduced whole plants
Design Patent
Applies to decorative or ornamental designs that are not useful
Food and Drug Administration (FDA)
Approves all clinical trials testing new drugs or devices, and its regulations apply regardless of funding source.
Composition of the IRB
At least 5 diverse members of varying backgrounds with professional competency to review scientific activities. Must include a non-scientific, non-affiliated member of the community.
Ship American Act
At least 50% of equipment, materials and commodities are to be shipped using U.S. flagcommercial vessels to the extent they are available and reasonable.
Clean Air Act of 1970
At the time of proposal submission, the institution must certify whether any facilities to be usedare listed as violating facilities by the EPA, and the institution must agree to comply with inspection, monitoring, entry and reporting requirements.
Clean Water Act (1977)
At the time of proposal submission, the institution must certify whether any facilities to be usedare listed as violating facilities by the EPA, and the institution must agree to comply with inspection, monitoring, entry and reporting requirements.
Statutory Requirements (Laws)
Authorizing Appropriation Public Policy
Intramural funding
Awards generated by endowments or other funds at an institution; typically awarded through an internal scientific review process with varying award/reporting terms
Increasing Seat Belt Use in the U.S. (1997)
By Executive Order, institutions are encouraged to adopt and enforce on-the-job seat belt usepolicies and programs.
USC (US Code)
Central collection and codification of public laws
FAR (Federal Acquisition Regulation)
Codified policies for acquisition of supplies and services by executive agencies. Applies only to federal contracts and flow-through awards
Well-designed budget
Complete, adequate and accurate within the sponsor norms and guidelines consistent with the narrative, justified clearly, and properly inflated for future years
The National Academies
Comprises the National Academy of Science, National Academy of Engineering and National Academy of Medicine. These private, nonprofit institutions that work together to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions.
Animal and Plant Health Inspection Service (APHIS)
Conducts site visits/review of records, as well as establishing the standards for handling, housing, transporting and feeding animals used in research.
Research Misconduct
Contrary to the interests of science, and to the health and safety of the public.
Facilities & Administrative Costs (F&A/Indirect Costs)
Costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program. These costs are also known as "indirect costs."
Direct Costs
Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy.
Elements of a Proposal
Cover letter (optional) Title Abstract Table of Contents Project Description/Scope of Work Biosketch/CV Budget and budget justification Appendices
National Research Act of 1974
Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Commission that published the Belmont Report in 1979. Also provides regulations for the protection of human subjects, including informed consent and review by IRBs.
Nine required topics in NIH Responsible Conduct of Research Policy
Data (acquisition, management and sharing of) Mentor/trainee responsibilities Publication practices Peer review Collaborative science Protection of human and animal subjects Research misconduct Conflicts of interest or commitment
DOD
Deadline for technical and financial reports is 90 days.
NIH
Deadlines for technical and financial reports is 120 days.
NSF
Deadlines for technical reports is 90 days and financial reports is 120 days.
Council on Financial Assistance Reform (COFAR)
Dedicated to coordinating financial assistance to effectively deliver, oversee, and report on grants and cooperative agreements, as well as sharing with executive departments and agencies best practices and innovative ideas for transforming the delivery of grant assistance.
Animal Welfare Act
Defines animals as "any live or dead dog, cat, monkey (non-human primate mammal), guinea pig, hamster, rabbit or other warm-blooded animal used for research, testing, experimentation or exhibition purposes or as a pet...", and ensures that animals intended for use in research, exhibition or as pets are provided humane care and treatment.
Fed Connect.net
Department of Energy online submission system
Non-indigenous Aquatic Nuisance Prevention and Control Act of 1990
Designed to prevent the introduction or dispersal of non-indigenous aquatic species into the watersof the U.S., and requires the principal investigator's protocol include an evaluation of the risk that the species, if itescapes or is released, will be a nuisance and a determination of necessary preventative measures.
Financial Reports
Detailed financial accounting of the award required based on the terms of the award.
Health and Human Services Office of Human Research Protection (OHRP)
Develops, monitors and provides oversight for federally funded research involving human subjects, and coordinates the issuance of Federal Wide Assurances.
Grants.gov
Electronic Research Administration system used by 26 federal agencies including DHHS, DOD and NASA as the source to find and apply for federal government grants, and to post competitive grant opportunities or Funding Opportunity Announcement (FOAs).
National Archives and Records Administration (NARA)
Enables people to inspect the record of what the federal government has done, enables officials and agencies to review their actions, and helps citizens hold them accountable.
Metric Conversion Act (1975)
Encourages research proposals and awards to utilize metric system.
U.S. Department of Justice (DOJ)
Enforces the law and defends the interest of the United States, ensuring public safety against threats foreign and domestic; providing federal leadership in preventing and controlling crime; seeking just punishment for those guilty of unlawful pursuits; and ensuring fair and impartial administration of justice for all Americans.
U.S. Department of Education (ED)
Ensures equal access to education and promotes educational excellence through coordination, management, and accountability in federal education programs. The Department works to supplement and complement educational efforts on all levels, encouraging increased involvement by the public, parents and students
U.S. Department of Transportation (DOT)
Ensures fast, safe, efficient, accessible, and convenient transportation that meets vital national interests and enhances the quality of life of the American people, today and into the future.
Health Research Extension Act of 1985
Established guidelines for the care and use of animals in PHS-funded research, and defined the establishment of Institutional Animal Care and Use Committees (IACUCs).
National Historic Preservation Act of 1966
Established review of federal projects on historic properties, and provides for additional protections.
Americans with Disabilities Act of 1990
Extends protection to individuals with disabilities, including that an organization cannot deny employment to disabled individuals unless the handicap puts the employee or co-workers at risk.
Research Misconduct
Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results.
Hotel and Motel Fire Safety Act of 1990
Federal Funds may not be used to sponsor a conference, meeting or training seminar held in ahotel or motel that does not meet the law's fire protection and control guidelines.
Bayh-Dole Act of 1980
Federal law passed to facilitate the transition of federally funded discoveries into the private sector
Institutional Review Board (IRB)
Federally mandated body responsible for reviewing all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency.
Amendments to the Food, Drug and Cosmetic Act
First time an American law included language requiring informed consent of people receiving experimental drugs, and that people receiving such drugs be notified of the risks and dangers associated with it.
Institutional Biosafety Committee
Formulates, recommends and monitors policies and programs for the control and safe use of hazardous biological agents, including non-exempt recombinant DNA, oncogenic viruses and infectious agents.
U.S. Department of Commerce (DOC)
Fosters and promotes the nation's economic development and technological advancement through vigilance in international trade policy, domestic business policy and growth, and promoting economic progress at all levels.
U.S. Department of Labor (DOL)
Fosters and promotes the welfare of job seekers, wage earners and retirees by improving their working conditions, advancing their opportunities, protecting their retirement and health benefits, and generally protecting worker rights and monitoring national economic measures.
Nuremberg Code of 1947
Gave us the principles that: Informed consent of volunteers must be obtained voluntarily and without coercion. Human experiments should be based upon prior animal experimentation Anticipated scientific results should justify the experiment. Only qualified scientists should conduct medical research. Physical and mental suffering and injury should be avoided. There should be no expectation of death or disabling injury from the experiment
Catalog of Federal Domestic Assistance (CFDA)
Government-wide compendium of all federal programs, projects, services, and activities that provide assistance or benefits. It contains financial and nonfinancial assistance programs administered by federal departments and establishments. A unique five digit number, XX.XXX is assigned to each program, where the first two digits represent the funding agency and the second three represent the program.
Institution Signing Official
Has institutional authority to legally bind the institution in grants administration matters. All grants must flow through this person for submission.
Federal government
Has royalty-free license to use any copyrighted material resulting from federally funded work.
IRB Expedited Review
IRB review by a single reviewer allowed for studies that are no more than minimal risk and meet 1 of 9 criteria.
Financial Accounting Standards Board (FASB)
Independent, private-sector nonprofit that establishes Securities and Exchange Commission accounting standards for private and public companies (profit and nonprofit organizations).
Anti-Kickback Act of 1986
Individuals are prohibited from soliciting, accepting or attempting to accept any kickback for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract or a subcontract related to a prime contract.
Truth in Negotiations Act
Institution must disclose and certify all cost and pricing data for to sole source contracts exceeding $500,000.
Buy American Act
Institutions must certify in federal contracts that the products utilized were manufactured orproduced in the U.S.
Debt Delinquency
Institutions must certify in the proposal application that it is not delinquent on loans or other accounts to the federal government, and individuals receiving awards (e.g., NRSA fellowships) must certify he/she is not delinquent on any federal debt.
The Belmont Report
Issued in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research and defines the three basic principles for conduction research with human subjects: Respect for Persons, Beneficence and Justice.
Utility Patent
Items that are useful
Elements of an animal subject protocol
Justification for actual research, number and types of animals to be used Description of the procedures and any alternatives Degree of discomfort/distress that will be experienced with a justification Any/all required permits and/or licenses Euthanasia and disposal procedures
Salary Cap
Legislatively mandated provision limiting the direct salary (excluding fringe benefits and F&A) for individuals working on grants, cooperative agreements, and extramural research and development contracts.
70 years past copyright owner's death
Length of time a copyright is valid
20 years
Length of time a patent is valid
3 years
Length of time an IACUC approval is valid
1 year
Length of time an IRB approval is valid
Fabrication
Making up data or results and recording or reporting them.
Institutional Animal Care And Use Committee (IACUC)
Mandated by the Animal Welfare Act for research facilities that use animals and responsible for inspecting animal facilities, reviewing research protocols involving animals to ensure humane treatment and adherence to international standards, ensuring research methods minimize or eliminate use of animals in research, or minimize the pain and distress experienced by the animals.
Falsification
Manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.
Person Months
Metric for expressing the effort (amount of time) personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; eg, calendar year, academic year, and/or summer term; and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment.
Invention Reports
Must be completed annually to declare any inventions resulting from the award.
Progress Report
Must be submitted at least annually to update the sponsor on accomplishments toward the project goal, plans for the upcoming budget period, publications, and any significant changes or delays in the project and plans to resolve them.
PHS requirements for IACUC membership
Must include at least: 1 doctor of veterinary medicine trained in laboratory medicine 1 practicing scientist experienced in research involving animals 1 person not affiliated wtih the institution to represent the interests of the community 1 person whose primary concerns are in a nonscientific area
USDA requirements for IACUC membership
Must include at least: A chairman 1 doctor of veterinary medicine trained in laboratory medicine 1 person not affiliated wtih the institution to represent the interests of the community
Parent Announcement
NIH broad FOA allowing applicants to submit an investigator-initiated application for a specific activity code
Patent criteria
Novel Non-obvious Useful Supported by enabling disclosure
3 years
Number of years grant records must be maintained, unless otherwise noted in the Notice of Award.
Office of Laboratory Animal Welfare (OLAW)
Office that governs PHS-funded research using live, vertebrate animals. Mandates the use of The Guide for Care and Use of Laboratory Animals, and relies on a written certification/assuance by the institution that it will follow policy.
FR (Federal Register)
Official daily publication of rules, proposed rules and notices by federal agencies, as well as executive orders and presidential documents
Executive Orders
Official documents by which the President manages government operations
NIH RePORTER (Formerly CRISP)
Official query search tool for research awards and results funded by NIH.
U.S. Department of Homeland Security (DHS)
Operates under its three primary missions: Prevent terrorist attacks within the United States, reduce America's vulnerability to terrorism and minimize the damage from potential attacks and natural disasters.
Expense monitoring
Practice that ensures there are no posting areas, that all charges are compliant with acceptable charging practices, there are sufficiant justifications for expenses and purchase timing is appropriate.
Public Responsibility in Medicine and Research (PRIM&R)
Professional organization with two core goals: creating a strong and vibrant community of ethics-minded research administration and oversight personnel, and providing educational and professional development opportunities that give that community the ongoing knowledge, support, and interaction it needs to raise the bar of research administration and oversight above regulatory compliance.
Society of Research Administrators International (SRA)
Professional society that provides education, professional development and the latest comprehensive information about research management
Age Discrimination Act of 1975
Prohibits an institution from unreasonable discrimination on the basis of age in any activityreceiving federal assistance.
Title IX of the Education Amendments of 1972
Prohibits recipients of federal awards from excluding an individual from any activity receivingfederal support or assistance on the basis of sex.
Civil Rights Act of 1964
Prohibits recipients of federal awards from excluding persons from participation in receivingbenefits or subjecting them to discrimination because of race, sex, color or national origin.
U.S. Department of the Interior (DOI)
Protects and provides access to the nation's natural and cultural heritage, including responsibilities to Indian tribes and island communities. Departmental goals include resource protection and usage, overseeing recreational opportunities, serving communities, and excellence in management.
Environmental Protection Agency (EPA)
Protects human health and the environment. Since 1970, the EPA has been working for a cleaner, healthier environment for the American people.
Family Educational Rights and Privacy Act (Buckley Amendment)
Protects personally identifiable information maintained in student educational records.
Privacy Act of 1974
Protects private information against misuse by federal agencies and applies to personal information of US citizens and lawful aliens maintained in systems of records of agencies in the executive branch.
Copyrights
Protects published and unpublished literary, scientific and artistic works against unauthorized reproduction and distribution regardless of the form of expression, but must be in a tangible or material form.
2 CFR Part 200, Subpart F: Audit Requirements
Provides audit instructions, report requirements, and responsibilities.
2 CFR Part 200, Subpart A: Acronyms & Definitions
Provides definitions for 99 terms found in the Uniform Guidance that provide additional details to make the document easier to understand.
2 CFR Part 200, Subpart E: Cost Principles
Provides guidance on direct vs. indirect costs, F&A rates and effort reporting.
Departmental Appeals Board (DAB)
Provides impartial, independent review of disputed decisions under more than 60 statutory provisions, and hears appeals from HHS program decisions.
2 CFR Part 200, Subpart B: General Provisions
Provides information on effective date and implementation and Conflict of Interest Requirements.
2 CFR Part 200, Subpart D: Post-Federal Award
Provides regulations for procurement, performance/financial reporting, record retention, subaward vs subcontract, subrecipient monitoring, cost sharing, program income and close out.
2 CFR Part 200, Subpart C: Pre-Federal Award
Provides requirements for funding announcement, terms and conditions of awards, pre-award costs and public access to award information.
Informed Consent
Provides that participants fully understand and accept: They are participating in experimental research Their participation is completely voluntary and hey have a right to refuse to participate, or leave the experiment at any time The risks and benefits associated with participation in the study They fully understand the nature of the study and what is to be done
U.S. Department of Defense (DOD)
Provides the military forces needed to deter war and protect the security of the United States through five major areas: peacekeeping and war-fighting efforts, Homeland Security, evacuation and humanitarian causes.
The Common Rule
Published in 1991, it is the federal policy for the protection of human subjects. Its main elements are requirements for assuring compliance, for obtaining and documenting informed consent, and for the Institutional Review Board's membership, function, operations, review of research and record keeping.
Micropurchase
Purchase under $15,000 that does not require 3 recent quotes.
Byrd Amendment of 1990
Recipients of federal awards are prohibited from using appropriated federal funds to pay anyperson for influencing or attempting to influence any officer or employee of an agency, a memberof Congress, an officer or employee of Congress, or an employee of a member of Congress withrespect to the award, its continuation, renewal, amendment or modification.
The Three Rs of animal research
Refine procedures to minimize discomfort Reduce number of animals used Replace animals with simulations or other options
EDGAR (Education Department General Administrative Regulations)
Regulations for administering discretionary and formula grants awarded by the Department of Education.
Request for Proposal (RFP)
Request for Proposals announce that agencies would like to award a contract to meet a specific need outlined by the sponsor, and requires a business and technical proposal (single application deadline)
Noncompeting Continuation
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
BAFO (Best and Final Offer)
Requests during the negotiation period when applicant is asked to reply with best and final offer in response to a procurement opportunity
Military Recruiting (1995, 2004)
Require that no federal funds from applicable agencies be available to an institution that has been determined by the Secretary of Defense to have a policy or practice of prohibiting access to its students for the purpose of military recruiting.
Salary certification
Required demonstrated correlation between work performed and compensation paid.
Prior Approval
Required for any change in scope, significant budgeting changes, changes in principal investigaor or recipient organization, or transfer of significant program work to a subawardee or consortium not previously identified in application.
IRB Full Board Review
Required for protocols with more than minimal risk involving human subjects, and must be conducted in a convened meeting with a majority/quorum of members present.
USA Patriot Act
Requires both individuals and institutions to not produce, acquire, retain (stockpile), or possess types and quantities of any biological materials and/or delivery systems that are not "reasonably justified" for peaceful and prophylactic purposes, including for bona fide research.
Davis -Bacon Act
Requires contractors and subcontractors working on federal government construction projects to pay no less than minimum wage, and to pay wages at least weekly.
Rehabilitation Act of 1973
Requires employers to take affirmative action to employ qualified handicapped individualswithout discrimination based on physical or mental handicaps.
Freedom of Information Act (FOIA)
Requires federal agencies to disclose any information requested unless it falls under one of 9 exemptions that protect interests such as personal privacy, national security, and law enforcement.
Constitution Day (2004) Public Law 108-477
Requires the head of each federal agency and all federally-funded schools offer employee and students training on the U.S. Constitution; to be given on Constitution Day, to coincide with the signing of the Constitution on September 17, 1787.
Food and Drug Administration (FDA)
Responsible for ensuring: Food is safe, wholesome and sanitary Human and veterinary drugs, biologics and devices are safe and effective Cosmetics are safe Electronic devices emitting radiation are safe Regulated products and devices are accurately represented to the public
Responsibilities of the IRB
Review and approve/disapprove all non-exempt human subject research protocols, ensure the informed consent process is adequate and in accordance with federal regulations, and notify investigators in writing of decisions.
CFR (Code of Federal Regulations)
Rules made by federal agencies and executive departments, and divdied into 50 titles that represent broad subject areas.
U.S. Department of Agriculture (USDA)
Serves all Americans through anti-hunger efforts, through stewardship of nearly 200 million acres of national forest and rangelands, and through product safety and conservation efforts.
National Aeronautics and Space Administration (NASA)
Serves as the nation's forefront of such exploration and continues to pioneer in aeronautics, exploration systems, science, and space operations.
Smoke-Free Workplace (1994)
Services to children funded by federal funds must be provided in smoke-free facilities.
Grants.gov
Source to find and apply for federal government
Mandatory spending
Spending (budget authority and outlays) controlled by laws other than annual appropriations acts. (ex. Pell Grants, student loans, Medicare, Medicaid)
Discretionary Spending
Spending (budget authority and outlays)controlled in annual appropriations acts, announced as an RFA and results in a grant or cooperative agreement
90 days
Standard deadline for financial and technical reports unless otherwise noted in the Notice of Award.
U.S. Department of Veterans Affairs (VA)
Strives for excellence in patient care and veteran's benefits for its constituents through high-quality, prompt, and seamless service to United States veterans.
U.S. Department of State (DOS)
Strives to create a more secure, democratic and prosperous world for the benefit of the American people and the international community.
iEDISON
System used for compliance with Bayh-Dole Act that requires government funded inventions be reported to the federal agency who made the award.
Program Officer
The agency official responsible for the programmatic, scientific, and/or technical aspects of a grant.
Institutional Base Salary
The annual compensation paid by an organization for an employee's appointment, whether that individual's time is spent on research, teaching, patient care, or other activities. Base salary excludes any income that an individual is permitted to earn outside of duties for the applicant/grantee organization. Base salary may not be increased as a result of replacing organizational salary funds with NIH grant funds.
Plagiarism
The appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
U.S. Department of Health and Human Services (HHS)
The federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.
Fly-America Act (Public Law 108-176)
The law enacted by Congress to protect American Air carriers competing in international markets by requiring that U.S. flag air carriers must be used for travel between the U.S. and a foreign country or between foreign countries that ischarged to a federal project.
Corporation for National and Community Service (CNCS)
The nation's largest grant-maker supporting service and volunteering. Through Senior Corps, AmeriCorps and the Learn and Serve America programs, the Corporation is a catalyst for change and offers every American a chance to contribute through service and volunteering. (https://www.nationalservice.gov)
Federal Register
The official daily publication for rules, proposed rules, and notices of federal agencies and organizations, as well as executive orders and other presidential documents, Published by the Office of the Federal Register, National Archives and Records Administration (NARA).
Request for Application (RFA)
The official statement that invites grant or cooperative agreement applications to accomplish a narrowly defined program purpose
Cost Sharing
The portion of the direct costs of a federally assisted project not borne by the federal government
Institute of Museum and Library Services (IMLS)
The primary source of federal support for the nation's 122,000 libraries and 17,500 museums. The Institute serves as a leader in providing services to enhance learning, sustain cultural heritage, and increase civic participation.
Patent
The primary type of intellectual property that can generate revenue for investigators and universities
Congruency
The process that verifies the federal grant and IACUC protocol match
PL (Public Law)
The publication of the full text of a law enacted by Congress and signed by the President
Research Data
The recorded factual material commonly accepted in the scientificcommunity as necessary to validate research findings.
Technology Transfer
The release of material developed, patented and owned by a research institution to the private sector for licensing and commercialization
Certification
The submission of documents that serve as guarantees that the award applicant meets certain standards or will comply with certain governmental acts.
Total Project Costs
The total allowable costs (both direct and indirect costs) incurred by the grantee to carry out a grant-supported project or activity. Total project costs include costs charged to the NIH grant and costs borne by the grantee to satisfy a matching or cost-sharing requirement.
Vulnerable Subjects (45 CFR 46, Subparts B-D)
Three specific classes of individuals provided extra protection under law for being used as research subjects: Pregnant women, fetuses and neonates Prisoners Children
$250,000
Total amount allowed to be requested per year through a modular budget
2 CFR Part 200
Uniform Administrative Requirements, Cost Principles, & Audit Requirements for Federal Awards
IDIQ (Indefinite Delivery/Indefinite Quantity)
Used when the length of and amount of services are not clearly identified and could be variable.
The Association and Accreditation of Laboratory Animal Care, (AAALAC) International
Volunteer accreditation agency for institutions with animal research programs.
NSPIRES (NASA Solicitation and Proposal Integrated Review and Evaluation)
Web-based system to support the entire lifecycle of NASA research solicitation and selection, from the release of solicitation announcements through NOI and proposal submission, the peer review and the decision process.
Stevens Amendment
When issuing statements, press releases and other documents describing projects funded in whole or in part with federal funds, all grantees must state the percentage of the total costs of the project financed with federal money; the dollar amount of federal funds for the project; and the percentage and dollar amount of the total costs of the project that are financed by nongovernmental sources.
U.S. Department of Housing and Urban Development (HUD)
Works to increase homeownership, support community development and increase access to affordable housing free from discrimination. HUD fulfills this mission through high ethical standards, management, and accountability, and by forming partnerships with community organizations.
Shelby Amendment
grantee institution must provide data that is consistent with the definition of research data andresponsive to a request made under the Freedom of Information Act.
