IRB - Human Subjects
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The following standard assurances are most commonly required by all federal agencies. Assurance forms are generally included in the funding agency's application materials. A standard form can be provided by the Office of Sponsored Programs if your funding application does not include these.
Drug Free Workplace
All grants or contracts made by a federal agency after March 18, 1989 require that applicant organizations assure the federal government that all work on these projects will occur in a drug-free workplace. As part of the certification process, Western Kentucky University is required by law to develop a drug-free workplace policy which applies to all personnel engaged in the performance of a grant or contract funded with money from a federal source. This policy also applies to undergraduate students and graduate students paid from funds acquired directly from a federal agency.
The policy states in part 1) that the unlawful manufacture, distribution, dispensation, possession, or use of a controlled substance is prohibited in the workplace; 2) that as a condition of employment employees must abide by the terms of the statement; and 3) that any employee convicted of a drug violation occurring in the workplace is required to notify his/her immediate supervisor no later than 5 days after the conviction. The policy outlines the sanctions which may be taken if an employee violates the policy. Such sanctions may include termination of employment, satisfactory completion of a rehabilitation program, or suspension. Employees paid from funds granted from the U.S. Department of Defense are subject to requirements of a more comprehensive policy. The Department of Human Resources retains copies of the policy and informs all new employees of this policy. All project directors and principal investigators should obtain a copy of the policy and inform their employees of its contents.
Public Law 101-121 states that applicants for federal funding must provide the following information on any grant, contract or cooperative agreement exceeding $100,000: 1) certification that no federally appropriated funds have been paid or will be paid to any person influencing or attempting to influence a federal employee in connection with the appropriation of federal funds; 2) submission of standard form LLL ("Disclosure Form to Report Lobbying") if non-federal funds are used to pay any person for influencing or attempting to influence a federal employee in connection with the appropriation of federal funds.
Debarment, Suspention, and Other Responsibility Matters
Applicants for federal funding are required to certify that they and their principals, including consultants and subcontractors, are not presently debarred, suspended, or declared ineligible from covered transactions by any Federal agency; are not nor have within a three-year period been convicted or had a civil judgment rendered against them for commission of fraud or a criminal offense in connection with a (Federal, State or local) transaction or violation of Federal or State antitrust statutes; and have not within a three-year period had one or more public transactions terminated for cause or default.
Federalwide Assurances (FWAs)
The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP. Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46.
Federal Policy for the Protection of Human Subjects ('Common Rule')
The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.
Belmont Report (Belmont Report)
All Principal Investigators and Co-Investigators using human subjects as research participants are required to read and adhere to the principles contained in the Belmont Report, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research."
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