IN DEVELOPMENT

Project Development and Administration

**Approximately 30% of CRA exam is made up of this section**

Marketing – Internal and External

  • Identification of funding opportunities
  • Identification of internal capabilities

Resource Documents, Application Materials, and Information


Dissemination of Information/Publications


Liaison

  • Internal
  • Federal Agencies Directory

Funding Instruments

  • Grant or Cooperative Agreement?
  • Gift vs Grant
  • Grant Agreement
  • Contract
  • Grants
    • Initiation-Investigator
    • Purpose-Assistance For the public good (not to be restricted for commercial or internal use)
    • Solicitation Method Funding Opportunity Announcement (FOA), Request for Proposal or Request for Application (RFP, RFA)
    • Award Instrument-Scope may remain somewhat flexible, Terms and conditions may be included but are generally limited in nature and are not typically restrictive. For Federal Grants, terms incorporate the Uniform Guidance (formerly OMB Circulars A-21, A-110, and A-133) and are often supplemented with agency-specific grant guidelines. May include multiple budget periods
    • Involvement by Sponsor-Generally none
    • Re-budgeting-Normally flexible terms
    • Equipment Title-Grantee
    • Performance Period-Specified in Grant
    • Applicable Guidelines & Regulations-Uniform Guidance (formally A-21, A-110, A-133). May be supplemented with agency-specific guidelines

Public Relations


Agency Structure and Practice

  • Proposal Writing
  • Budget Preparation
  • Documentation to Meet Sponsor Requirements
  • Internal Proposal Processing
  • Negotiation Techniques
  • Contracting Basics

  • Monitoring Activity
  • Reports on Progress and Financial Status
  • Continuation Funding
  • Close Out
  • Changes in Project Status

Conflicts of Interest


Bioethics


Human Subjects

  • History
    • Nuremberg Trials (1945-1949) – Held to bring Nazi war criminals to justice for crimes against peace and crimes against humanity
    • Henry Beecher Article (1966): “Ethics and Clinical Research” – Article describing ethical misconduct and lack of informed consent in more than 50 research projects. It was later reduced to 25 projects for publication, as it was rejected as originally presented
    • The Belmont Report (1979) – Report to summarize the basic ethical principles and regulations to be followed during biomedical and behavioral research involving human subjects
      • Respect for Persons-Informed Consent and protection for those with the diminished capacity/autonomy
      • Beneficence -Maximum benefit and least harm. For the greater good, do no harm.
      • Justice-Must be equitable and you must justify the exclusion of populations.
  • The Common Rule
  • Definition of Human Research: Data collected on or of human subjects via interaction or intervention
  • IRB facilitates the ethical use of human subjects in research studies and compliance with federal requirements
  • Minimal Risks – Probability and magnitude of harm/discomfort during research that is not greater than that encountered in life
  • Informed Consent: “It is an obligation of the researcher to clearly communicate risks to participants using language that is easily understood by them and does not minimize or mask the risk associated with the research.”
  • Vulnerable Populations Criteria:

    • Physical -Human subjects that could be easily harmed physically (subjects with diminished capacity) i.e. children, people with disabilities, pregnant women.
    • Environmental – Human subjects prone to coercion or undue influence (subjects with diminished autonomy), i.e. prisoners, employees in workplace research, students, and children.
  • NCSU IRB Training
  • 45 CFR 46.111: CRITERIA FOR IRB APPROVAL OF RESEARCH
  • Structure of the IRB
    • Each IRB should have at least 5 voting members, at least 1 scientist, 1 non-scientist, 1 healthcare professional, 1 community member (has no employment or contractual obligation to the entity), and the chair. *If you are going to be regularly reviewing a vulnerable population IRB is required to have a representative from said population.
  • Three types of IRB reviews:
    • Exempt
    • Expedited
    • Full board review
  • Oversight of the IRB is conducted by the Office of Human Research Protections

Institutional Animal Care and Use Committee (IACUC)

  • Keywords – Live Vertebrate Animals
    • Mission – To make sure animals are cared for properly and used humanely
      • Reviews approves or disapproves protocols for the use of animals for research and teaching
      • Inspect housing facilities and laboratories at least every 6 months
      • Required to review program for care and use of animals at least once every 6 months
      • Authorized to suspend animal care and use activity that fails to comply with regulations or protocols
    • USDA Animal Welfare Act (1966)
      • Set standards for humane treatment for certain animals that are exhibited to the public, bred for commercial sale, used in medical research, or transported commercially
      • NC State is a registered research facility under the Animal Welfare Act and has an approved Animal Welfare Assurance Statement with the Office of Laboratory Animal Welfare (OLAW), a part of NIH
      • When inspectors have any findings, they report to the USDA and requests a correction of items within a time frame. If not corrected within the time allotted or if it an immediate threat to animal welfare, the USDA has the option to pursue appropriate compliance and enforcement of actions, which may include fines or suspension of institution’s USDA registration
    • NIH – Policy on Humane Care and Use of Laboratory Animals (1985)
      • Provides backing for guidelines governing the use of animals by institutions funded by Public Health Service (PHS – NIH, FDA, etc)
      • Governs the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia agents, and appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals
    • Public Law 99-158: Animals in Research (Office of Laboratory Animal Welfare)
    • NCSU IACUC FAQs
    • SPARCS IACUC Website

Professional

  • Patents and Trademarks
  • Copyrights
  • Licensing
  • Commercialization
  • Data
  • Proprietary Information

Content to go here.


Legal Requirements and Sponsor Interface

**Approximately 30% of CRA exam is made up of this section**

  • Overview of Regulatory and Legislative Process
  • Governmental Relations
  • Mandated Requirements

  • Representations and Certifications
    • Federal Drug-Free Workplace and Drug-Free Schools
    • Federal Debt Delinquency
    • Federal Debarment/Suspension
    • Lobbying
    • Conflicts of Interest
    • Scientific Misconduct
    • Other
  • Federal Management Requirements
    • Federal Acquisition Regulations
    • Federal Assistance Administrative Regulations
    • 2 CFR (Uniform Guidance and OMB Circulars)
  • Institutional Committees
    • Institutional Review Board (IRB)
    • Institutional Animal Care and Use Committee (IACUC)
    • Other
  • Lobbying Disclosure Requirements / Family Education Rights and Privacy Act (FERPA)
  • Institutional and Sponsor Publication Requirements
  • HIPAA Health
  • International Traffic in Arms Regulation (ITAR) / Export Administration Regulations (EAR)

Text to go here.


Financial Management

**Approximately 25% of CRA exam is made up of this section**

  • Proposal Development
  • Accounting Management
    • Accounting Systems/Management Information Systems
      • Sponsor Documents
      • Internal Documents
    • Accounting Processes
      • Effort Reporting
      • Service Centers
      • Program Income
      • Internal Controls
  • Cost Transfers
  • Rebudgeting

  • Direct Costs
  • Indirect Costs
  • Indirect Cost Rates
    • Development
    • Negotiation
  • Cost Sharing

  • Types
  • Internal and External Requirements
  • Allowable Costs


General Management

**Approximately 15% of CRA exam is made up of this section**

  • Specialized Facilities
  • Property, Utility, and Equipment Management
    • Inventory Control
    • Sale/Disposal of Equipment and Property
    • Lease vs. Purchase
    • Capital Expenditures
    • Sharing/Pooling
  • Safety and Health Requirements and Procedures
  • Hazardous and Nonhazardous Materials
  • Security
  • Renovation and Construction – Differentiation and Impact Analysis
  • Biohazards
  • Other

  • Basic Legal Concepts
  • Management of Contracts and Purchasing
  • Termination and Appeals

Text goes here.

  • Employee/Labor Relations
  • Career Development/Training
  • Staffing Performance, Accountability, and Human Resources
  • Affirmative Action/Equal Employment Opportunity
  • Compensation