Human Subjects
A specially 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
What is an Institutional Review Board or IRB?
CAS
What is Cost Accounting Standards?
Monitor subrecipients to ensure that Federal awards are used for authorized purposes in compliance with laws, regulations, and the provisions of contracts or grant agreements and that performance goals are achieved.
What is subrecipient monitoring?
Allows the secretary of defense to deny federal grants to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus
What is the Solomon Amendment?
Defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results
What is research misconduct?
A 1981 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. Assuring compliance by research institutions Provides for informed consent, IRBs, and protections for vulnerable subjects.
What is the Common Rule?
FOIA
What is the Freedom of Information Act?
When the Contractor is reimbursed for allowable costs incurred during contract performance. A total cost estimate is prepared and the award contains a ceiling that may not be exceeded without Sponsor approval
What is a cost reimbursement contract?
Travelers using federal funding must use US flag airlines for all air travel and cargo transportation. Exceptions are open skies agreements (w/ EU members including Iceland & Norway; Australia; Switzerland; and Japan) DOD funded projects are not allowed to use Open Skies agreements
What is the Fly America Act?
The recipient's designated official(s) reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
What is a financial conflict of interest?
Report influenced by Nuremberg Code and declaration of Helsinki
Based on 3 ethical principles:
1. Respect
2. Beneficence
3. Justice
What is the Belmont Report, 1979?
SBIR
What is the Small Business Innovation Research (SBIR) program?
Indvidual authorized by a government warrant to issue awards and modifications. May legally bind the government
Who is a Contracting Officer?
Executive Order that all federal contractors over $150k must use E-verify system to validate all new hires are eligible for employment in the US.
What is the Employment Eligibility Verification?
Making up data or results and recording or reporting them.
What is fabrication?
The group in an experiment or study that does not receive treatment by the researchers and is then used as a benchmark to measure how the other tested subjects do.
What is the control group?
IHE
Institution of Higher Education
Regulation which requires some federal contractors to have a written drug-use policy and follow certain requirements to certify that they maintain a drug-free workplace
What is the Drug-Free Workplace Act, 1988?
National uniform standards for health information and patient information is used only for authorized purposes and patient privacy is protected
What is the Health Insurance Portability and Accountability Act (HIPPA)?
Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
What is falsification?
A process by which an experimental study drug or treatment is given to large groups of people (1000-3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely
What is a Phase III Clinical Trial?
GOCO
What is Government Owned, Contractor Operated?
Doctrine that states that standard clauses established by federal regulations may be considered as being in every Federal contract, even if intentionally omitted. Enforced on the premise that government contractors are presumed to be familiar with the FAR.
What is the Christian Doctrine?
Act that prohibits federal contractors from receiving kickbacks from employees or subcontractors for wages earned on federal projects. Must provide weekly statement of compliance
What is the Copeland Act?
The appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
What is plagarism?