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CERTIFIED RESEARCH ADMINISTRATOR EXAM
STUDY GUIDE|2025-2026|100%
VERIFIED|A+GRADE
What did the Federal Health Research Extension Act (1985) result in? ANS:->>
- Resulted in the PHS policy on Human Care and Use of Laboratory Animals establishing the Animal Welfare Assurance Intergovernmental Personnel Act (IPA) Agreement – ANS:->> - allows university faculty to temporarily be assigned to a federal agency while maintaining their university status (usually less than 3 years) Modular budget (NIH) ANS:->> - budget with direct costs requested in $25, modules, up to $250,000 per year. Typical modular budgets request the same number of modules per year. Used for R01, R03, R15, R25 funding mechanisms. Modular budget justification(s) - ANS:->> 1. Personnel justification (name, role, # of person months)
- Consortium justification - ANS:->> include total costs (direct+indirect) rounded to nearest $1k for each subaward - including personnel roles and months; and if foreign or domestic
- Additional justification - ANS:->> used to describe any variation in module requests between years; and any work conducted off-site FedConnect.net - ANS:->> Gateway to Government Opportunities, Acquisition and Grants Portal sam.gov - ANS:->> System for Award Management: register to do business with the US government obtain a Unique Entity Identifier (UEI) from sam.gov
UEI - ANS:->> united entity identifier 12 digit alphanumeric ID assigned by sam.gov final implementation on April 4, 2022 NSF:PAPPG, NIH:? - ANS:->> Grants Policy Statement (NIH-GPS) the NIH is part of what department? - ANS:->> US Department of Health and Human Services (DHHS) NIH is one of 8 what? - ANS:->> Public Health Service Bonus: along with ACF, AHRQ, CDC, CMS, FDA, HRSA, and SAMHSA How many NIH institutes and centers (ICs) are there? How many have funding authority? ANS:->> - 27 24 with funding authority Bonus: 3 without are NIH Clinical Center, Center for Info Technology, and Center for Scientific Review 3 common funding instruments - ANS:->> 1. Grants
- Contracts
- Cooperative Agreements
proposalCENTRAL - ANS:->> E-granting website shared by many government, non-profit, and private grant- making organizations Grant Solutions (eRA) - ANS:->> Department of the Interior award management system FDP - ANS:->> Federal Demonstration Partnership: initiative to reduce administrative burden associated with research grants and contracts FDP is a cooperative initiative among federal agencies and institutional recipients of federal funds - ANS:->> 10 federal agencies, 217 institutional recipients FDP primary benefit - ANS:->> simplified and streamlined terms and conditions across FDP member federal agencies What clearinghouse does the FDP maintain? ANS:->> - FCOI Institutional Clearinghouse Institutes can certify their institutional compliance with PHS FCOI requirements Scientific Review Officer (NIH) - responsible for scientific and technical review; managing the peer review process point of contact for applicants during review process Program Official (NIH) - responsible for the programmatic, scientific, or technical aspects of a grant; provides scientific guidance to PIs; reviews progress reports Grant Management Officer (NIH) - responsible for administrative management of grants Research Project Grants series (NIH) - Primarily R and U awards
But not all RPGs are Rs; not all Rs are RPGs). Includes R01, R15, R21, DP1, P Small Business Grants series (NIH) - SBIR & STTR - R41, R42, R43, R Center Grants series (NIH) - Most P awards Other Research Grants (NIH) - conference grants - R13 Resource grants - R24, R others? Research Career Development Awards series (NIH) - K awards Research Training and Fellowships series (NIH) - T series and F series Cooperative agreements series (NIH) - U series NIH's most common grant - R01 discrete, specific research project no funding limit unless specified in FOA; must obtain prior approval for over $500k in any one year generally 3 - 5 years A modular budget must be used when... - An application will meet all of these requirements:
- is for an R01, R03, R15, R21, and R34 (or cooperative agreement equivalent)
- requests no more than $250k in direct costs (excluding consortium F&A) in any budget period
How long is the standard NSF proposal review process? - six months Review process: reviewers selected, peer review, program officer recommendation, division director review How many institutes does the NIH have? Centers? - 21 institutes 6 centers what is the primary purpose of a procurement contract? - delivery of goods and services for the benefit of the government what funds a federal procurement contract? - federally appropriated funds which means modifications on an annual basis (required congressional approval); future funding is not promised, only anticipated what oversight are contracts subject to? - Federal Acquisition Regulations (FAR)
Which federal agency is the primary user of Other Transactional Authority Agreements (OTA)? - Department of Defense Where does the Other Transactional Authority Agreement (OTA) authorization comes from? - section 845 of the 1994 National Defense Authorization Act Indefinite Delivery Indefinite Quantity (IDIQ) - A contract that provides for an indefinite quantity of goods or services, with a stated lower and upper limit, within a fixed time period. Title 48 of the Code of Federal Regulations - Federal Acquisition Regulations (FAR) body of laws passed by congress codified in title 48 of CFR When to consult the FAR? - When:
- responding to an RFP
- receiving a federal contract as a prime
- receiving a federal contract as a sub
- issuing a subcontract under a federal contract What does Uniform Guidance Section 200.330 require? - subrecipient risk assessment What does 2 CFR Section 331 of the UG mandate? - subrecipient monitoring What act required entities establish an IRB? - National Research Act ( National Research Act of 1974 - Authorized the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with developing an ethical code and guidelines for researchers
- at least one non-scientist
- at least one health care professional
- at least one community member Cognizant Agency - The Federal agency which (on behalf of all Federal agencies) is responsible for: reviewing, negotiating, and approving cost allocation plans, indirect cost rate and similar rates; monitoring non-Federal audit reports; conducting Federal audits as necessary; and resolving cross-cutting audit findings. For universities, it is often DHHS or the DoD/ONR Predetermined Rate (indirect) - permanent rate for a specified period (2- 4 years) Fixed rate (indirects) - becomes the negotiated permanent rate for a specified period. Any over or under of actual costs are included as an adjustment during rate re-negotation Provisional rate - A temporary rate applicable to a specified period that is used for funding, interim reimbursement and reporting indirect costs on federal awards, pending the establishment of a "final" rate for that period. What rate is the administrative portion of F&A capped at? - 26% Uniform Guidance Section 200.306 - Cost-sharing requirements Uniform Guidance Subpart E - Cost Principles Equipment (2 CFR 200.1) - tangible personal property; useful lifespan > 1 year, per-unit acquisition cost
= $5,000 (or your org's capitalization level if less than $5k
Micro-Purchase Threshold - $10,000 (up from $3,500 as of 8/31/2020) expedited purchases; does not require competitive bidding Simplified Acquisition Threshold - $250,000 - Dollar amount below which a non-Federal entity may purchase property or services using small purchase methods. Title to Equipment on federally funded awards - for grants and coop agreements, title vests with the non-federal entity (i.e. SU) but it is conditional unless agency is specifically authorized to vest without further obligation What cost does the UG allow to be incurred after the period of performance end date and charged to a federally funded project, and under what circumstances is it allowed? - Publications It must be posted and included in the closeout, final billing, and final financial reporting; and as long as the sponsor as noted as a funder of the research in the publication. 5 required elements of the new NIH Data Management and Sharing Plan - 1. Data Type - types and amount of scientific data generated and/or used
- Related Tools, Software, and/or Code - tools needed in order to access or replicate data
- Standards -
- Data Preservation, Access, and Associated Timelines
- Access, Distribution, and Reuse Considerations Nuremberg Code - a set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War (1946) Required consent, comprehension of knowledge of what may occur, voluntary
What did the revised common rule (2018) expand the definition of human subjects to include? - identifiable data and identifiable biospecimens When are you required to report to the Office of Human Research Protection (OHRP)? - In a funded protocol, when the following occurs:
- unanticipated problem
- continuing noncompliance
- serious noncompliance
- suspended by the IRB
- terminated by the IRB UG Subpart A - Acronyms and Definitions UG Subpart B - General Provisions UG Subpart C - Pre-Award/ Contents of Awards UG Subpart D - Post-Award Requirements UG Subpart E - Cost Principles UG Subpart F - Audit Requirements How many appendices does the uniform guidance have? - 12 FAIN - Federal Award Identification Number COSO - Committee of Sponsoring Organizations of the Treadway Commission
What term has replaced the CFDA term? - Assistance Listing Number (ALN) Program income - gross income earned by a recipient from activities part or all of the cost of which is either borne as a direct cost by a grant or counted as a direct cost towards meeting a cost sharing or matching requirement of a grant. Where is Conflict of interest addressed in the UG? - Subpart B - General Provisions specifically, 200. 200.211 - Info Contained in a Federal Award - Provides standard 15 data elements to be included in all federal awards in full text or by reference:
- recipient name
- recipient UIE
- FAIN
- Federal Award Date
- Period of Performance start and edn date
- budget period start and end date
- Amount of federal funds obligated in this action
- Total amount of federal funds obligated
- Total approved cost share, if applicable
- Total amount of award plus cost share
- Budget approved by the federal award agency
- Federal award description
- Name of Federal awarding agency and contact info
- Assistance Listings Number and Title
- Identification of whether award is R&D
- Indirect cost rate for federal award FAPIIS - Federal Awardee Performance and Integrity Information System
Davis-Bacon Act - requires contractors and subcontractors working on federal government construction projects to pay "prevailing wages" to their employees FFATA - Federal Funding Accountability and Transparency Act; Prime awardees are required to report on SU awards greater than $30k Public can review use of federal funds at usaspending.gov DATA of 2014 - Digital accountability and transparency act Directed at federal agencies to create data reporting standards for the financial Info to be more consistent, reliable, searchable for the public FOIA - Freedom of Information Act, requires disclosure of all governmental information unless exempt under Act. Shelby Amendment 1999 Public Law 105- 277 - Ensures that all research data produced under an award and cited I support of a law will be made available to the public through the procedures established under the Freedom of Information Act. Open data policy - federal law makes all data collected by the government "open by default" except for personal information or data related to national security Contracts in excess of what amount must contain a provision that requires the non federal awardee to agree to comply with the Clean Air Act? - $150, Flows down to subcontractors or Subawards that meet that threshold In what year was the Laboratory Animal Welfare Act (AWA) CFR 9, subpart A
passed? - 1966 Dropped the word "Laboratory" in 1970 Which 6 species were covered under the first Lab AWA iteration? - dogs cats hamster s guinea pigs rabbits nonhuman primates What species did the 1970 amendment to the AWA add as covered under this act? - otehr wild mammalian species used in research but excluded mice, rats, birds, and agricultural animals animals now covered before, during, after research (full life) What requirements were added via the 1985 amendment to the AWA in The Improved Standards for Lab Animals Act (PL 99-198)? - - standards for exercise of dogs, psychological well-being of nonhuman primates
- standards to minimize pain and distress required proper use of anesthetics, analgesics, tranquilizers
- required researchers consider alternatives to painful procedures
- required an IACUC to approve and monitor all research conducted
- required that each facility provide training to all personnel involved in research Animal welfare act standards address what 8 animal care areas - - housing
- feeding
- facilities where animals are housed How often must the IACUC review and inspect the research facility's program and facility? - every 6 months IACUC Protocol Review potential outcomes- - Two Methods of Review:
- Full Committee Review (FCR)
- Designated Member Review (DMR): All members receive the protocol and determine if it needs full committee review. If not, chairman assigns one or more reviewer. Three Actions of Full Committee Review
- Approve
- Require modifications to secure approval
- Withhold approval What was changed in 2022 regarding ongoing IACUC protocol reviews? - It was an annual review process; now it is only required every 3 years by the AWA An IACUC protocol can only be suspended when (what conditions)? - at a convened meeting of the IACUC with a quorum present if violation is severe enough but meeting isn't possible yet, IACUC chair could ask the PI to voluntarily suspend work until meeting OR they will hold an emergency meeting IACUC responsibilities (6) - Review program for humane care/use of animals (at least every six months) Inspect animal facilities (at least every six months)
Prepare reports of semiannual program review/facility inspections Review concerns involving care/use of animals Review & approve, require modifications in, or withhold approval of protocols related to the care and use of animals Suspend activities involving animals (when necessary) OLAW (office of Lab animal welfare) is in charge of insuring PHS policy is followed when PHS funds are utilized for animal research applicability - all vertebrate species The Guide for the Care and Use of Laboratory Animals is the main guidance document for which orgs: -
- OLAW (PHS)
- AAALAC International (accreditation)
