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Compliance

Compliance

Mount St. Mary’s University has instituted various policies and procedures to ensure compliance with policies of the federal and non-federal organizations from which the university receives grant funding.

Guidelines and oversight

Many private foundations and federal agencies have strict guidelines on how their grants may be used, as well as reporting requirements, to ensure that the “grantee” (the Mount) is managing and using the funds for the correct and agreed upon purposes.The grants manager’s office is principally involved in the pre-award grant process, including the application process and submission of the grant proposal, while the grants financial administrator in the Office of Accounting and Finance helps to oversee the post-award financial process, including the establishment of accounts and disbursement of funds. Policies governing the roles of each side of the grants process (pre-award, award phase and post-award) are combined here for ease of use.

University policy in applying for and accepting public and private sponsored support

The university policy in applying for and accepting public and private sponsored support is as follows:

  1. To safeguard the best interests of the university, its faculty, administrators, staff and students.
  2. To ensure that all applications and potential awards are consistent with the mission and core values of the university.
  3. To ensure that the university is in compliance with any applicable federal, state, local or sponsor policies and regulations concerning the grant and that the university is able to provide for the effective conduct of the project and subsequent reporting to the sponsor.
  4. To ensure adequate review and approval of all applications in a timely manner prior to the submission and the commitment of university personnel, space and other financial resources that may be required in the conduct of the project. No application may be submitted and approved without a complete request for grant application/approval form (further referred to as an internal routing form) that has received the necessary review and approval.
  5. To ensure that all awards are reviewed and accepted by the department chair/academic dean and the grants administrator (GA) (and applicable vice presidents for advancement, business and finance, the provost, and/or the chief of staff), no award may be accepted or financial account set up without the completion, with applicable signatures, of the grant accounting control form.

Animal care and use

To ensure compliance with the highest humane, ethical, scientific and legal standards, all MSMU faculty members or students undertaking research on any vertebrate animal must follow the policies outlined by the IRB.

Bayh-Dole Act

For any federally sponsored research, MSMU is obligated by federal regulations to promptly report (within two months) to the appropriate federal agency any inventions conceived or reduced to practice during the course of a government-sponsored research program. The Bayh-Dole Act permits a university, small business, or nonprofit institution to elect to pursue ownership of an invention in preference to the government.

Buy American Act

This federal regulation, passed in the 1930s to protect American workers and reinforced by the Federal Acquisition Regulations, applies to certain federal contracts and grants above the micro-purchase threshold of $3,000 and includes flow down to sub-recipients. Awardees must certify that all articles, materials and supplies funded by these awards are American-made. Exceptions can be made in the case of:

  • unreasonable cost
  • unacceptable quantity or quality
  • use outside the U.S. only
  • conflict with the public interest
  • certain trade agreements
  • commercial items of information technology
  • domestic manufactured products (e.g., engines), if at least 50% of components are U.S.-made

Exceptions to the act must be identified in the project specifications and justified in the documents retained with procurement records relating to small purchases. False certification may be considered fraud and can result in debarment. The government also publicizes information about noncompliant awardees, who may not participate in federally funded projects for three years from the date that they are found noncompliant. This act is not the same thing as the Buy America Act of 1983, which applies only to procurement for mass-transit projects.

Conflict of interest

Though it is unlikely that MSMU faculty or staff have any financial conflict of interest, the federal government requires the Mount to annually document this information. Please see our conflict of interest policy and fill-out the conflict of interest disclosure form. Debarment and suspension certification is designed to prevent fraudulent or improper use of government funds, applies to all grants and cooperative agreements and to most contracts. Applicants must certify that they, their principals and their researchers:

  • aren’t debarred, suspended, ineligible for, or excluded from funding by any federal entity
  • haven’t been convicted of fraud or a criminal offense in connection with federal agreements within the past three years
  • haven’t been convicted of violating federal statutes within the past three years
  • haven’t been convicted of committing any form of theft or fraud within the past three years
  • haven’t been charged with any of these crimes by any government entity
  • haven’t had any government agreements terminated for cause or default within the past three years

False certification could result in termination of the grant and debarment, suspension or both.

Cost principles

Cost must meet the following general criteria in order to be allowable under federal awards:

  • Be necessary and reasonable for the performance of the federal award.
  • Conform to any limitations or exclusions set forth herein or by the federal awarding agency.
  • Be consistent with policies and procedures that apply uniformly to both federally-financed and other activities of the institution.
  • Not be included as a cost or used to meet cost sharing or matching requirements of any other federally- financed program in either the current or a prior period.

Categories of direct costs

The federal government generally supplies the recipient of a federal grant or contract with the funds necessary to cover the expenditures directly associated with a project; these categories of costs are described as allowable costs. There are other expenditures, however, that the federal government deems inappropriate and will not reimburse; these categories of costs are described as unallowable costs (example: alcoholic beverages). Furthermore, there are certain categories of costs that are allowable only when pre-approved by the federal awarding agency.

Drug-Free Schools and Communities Act/Drug-free workplace

In compliance with the federal Drug-Free Schools and Communities Act, MSMU is committed to providing an environment that is free from the use, sale, possession or distribution of illegal drugs or the improper or abusive use of legal drugs or alcohol on MSMU premises.

Equal employment opportunity

It is the policy of MSMU not to discriminate improperly against any matriculated student, employee or prospective employee on account of race, color, religion, ethnic or national origin, age, gender, sexual orientation, veteran status, disability or any other protected classification. Such policy is in compliance with the requirements of Title VII of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, the Rehabilitation Act of 1973, and all other applicable federal, state and local statutes, ordinances and regulations.

Export controls

Export controls are the United States laws and regulations that regulate and restrict the release of critical technologies, technical data, software code, equipment, chemical and biological materials and other materials, and information and services to foreign nationals and foreign countries for reasons of foreign policy and national security. Export control regulations, as well as boycott programs, have the potential to impact many aspects of the freedoms typically associated with research in a university setting, including publication rights, international collaboration, sending or bringing equipment to foreign countries (including laptops and cell phones), and the sharing of research technology (verbally, in writing or visually) with persons who are not U.S. citizens or permanent residents. Most of MSMU’s activities and travel to foreign countries are either not affected by export control laws, or they are subject to an exemption. Fundamental research—basic and applied research in science and engineering, the results of which are published and shared broadly within the scientific community—generally is not subject to export controls and trade sanctions. Proprietary research and industrial development are more likely to be. Projects that involve engagement with sanctioned countries or entities also may be subject to restrictions. If you have questions or think that your research may apply, please contact the Office of Grants Management.

Fly America Act

Generally, if a traveler is traveling on funds provided by the federal government, he/she must use a U.S. flag carrier (an airline owned by an American company), regardless of cost or convenience. If you are scheduling international travel that is federally funded, you must ensure that all flights, where possible, are scheduled on U.S. flag carriers or on foreign air carriers that code share with a U.S. flag carrier. Code sharing occurs when two or more airlines “code” the same flight as if it was their own. In other words, a U.S. airline may sell a seat on the plane of a foreign air carrier; this seat is considered the same as one on a plane operated by a U.S. flag carrier. Compliance with the Fly America Act is satisfied when the U.S. flag air carrier's designator code is present in the area next to the flight numbers on the airline ticket, boarding pass, or on the documentation for an electronic ticket (passenger receipt). For example, Delta has a codeshare agreement with Air France to Paris, France. If the boarding pass (flight coupon) or e-ticket identifies a flight as DL, the requirements of the Federal Travel Regulations would be met, even if the flight was on an Air France airplane. If however, the boarding pass (flight coupon) or e-ticket identifies the flight as an AF, then the requirements of the Federal Travel Regulations would not be met.

Exceptions to the Fly America Act

The biggest exception to the Fly America Act is the Open Skies Agreement. The United States government has entered into several air transport agreements that allow federally funded transportation services for travel and cargo movements to use foreign air carriers under certain circumstances. See the current Open Skies Agreements.

What do these Open Skies Agreements mean to you?

  • European Union: When traveling to a destination serviced by a European Union airline, MSMU travelers flying on a federal grant can fly on either a U.S. carrier or an EU (European Union) carrier as long as they touch down in an EU country.
  • Australia: MSMU travelers using federal dollars can use an Australian airline only if a point of origin/destination is either the U.S. or Australia and there is no city-pair contract flight between the two points (origin and destination).
  • Switzerland: MSMU travelers using federal dollars can use a Swiss airline only if a point of origin/destination is either the U.S. or Switzerland and there is no city-pair contract flight between the two points (origin and destination).
  • Japan: MSMU travelers using federal dollars can use a Japanese airline only if a point of origin/destination is either the U.S. or Japan and there is no city-pair contract flight between the two points (origin and destination).

Human subjects

MSMU faculty and students strive to advance knowledge within their respective academic disciplines. In order to accomplish this goal most effectively, the Mount community believes that adherence to strict ethical norms is essential. Values such as honesty, respect for the rights and dignity of human beings, and the humane treatment of animals are not only important for living an ethical life but are among the values that underlie excellent research. However, ethical decisions may often be complex when weighing the common good with the integrity of the study and so MSMU has established the Institutional Review Board (IRB) to ensure that Mount faculty and students have considered all relevant ethical issues when designing and conducting their research.

Institutional Review Board

Purpose

The Institutional Review Board (IRB) has the responsibility of reviewing all academic and administrative research that collects data that record the biological, psychological or personal aspects of individuals under the auspices of Mount St. Mary’s University. The primary duty of the IRB is the protection of subjects from potential physical or psychological harm as outlined by the U.S. Department of Health and Human Services (HHS), and the ethical codes of appropriate organizations, and to insure that the research obeys all appropriate federal and state laws.

Membership

The IRB consists of five members, appointed by the Vice President for Academic Affairs, to serve three years. A member can be reappointed. One is appointed from the Department of Psychology; one from the other academic areas of business, social or natural science; one with ethical expertise from a department outside the business and science departments, typically from philosophy or theology; one from an administrative office; one from outside the campus, with no formal ties to Mount St. Mary’s University. Among the five members will be a person who has expertise with research with legally defined minors. A chair will be elected by the members.

Responsibilities

  1. The IRB formally meets at least once a year for the purpose of learning, reviewing and updating the ethical and legal aspects of research that is likely to occur at the University. The IRB assumes that the administrators, faculty and students are familiar with the ethical guidelines of their respective research fields. However, the IRB can be solicited for guidelines in such matters, as necessary. The IRB will inform the community regarding the specific procedures for the ethical review. The IRB regularly reports its minutes to the faculty.
  2. The IRB uses the HHS guidelines of three categories of subject participation research: at risk, at minimal risk, and at no risk. The IRB provides the community with the defining criteria for the three categories. “At risk” projects receive a full review in a committee meeting. Projects “at minimal risk” are given an “expedited review” by circulating a submitted standard ethics review form through campus e-mail. Any members of the IRB can request the Chair to call a meeting for full review of a project if there is “at risk” concern. “At no risk” research does not have to be reviewed. “At risk” or “at minimal risk” research data collection may not proceed until written approval is received by the researcher. When approval is denied, recommendations for re-submission may be made.
  3. Research involving vertebrate animals is subject to ethical review according to standards set by appropriate organizations. The amount and nature of current animal research at Mount St. Mary's University does not justify a separate University Animal Care and Use Committee (UACUC). Therefore, the review of such work will be done by the IRB. If the IRB needs the services of an outside expert to evaluate a specific project, the University will provide for the services of a laboratory-animal veterinarian to review the proposal. The amount and nature of animal research will be monitored to justify the future implementation of an UACUC, if needed.
  4. Records of all ethical proposals, approvals and disapprovals, are maintained by the IRB. An annual report is made to the faculty and Vice President for Academic Affairs. Researchers are required to keep the completed informed consent forms of subjects of approved research on file for a period of three years. In the case of student research, the faculty mentors keep the informed consents on file. Replications of research projects and follow-up research projects must submit new ethics review proposals.
  5. Official HHS guidelines can be found in the Code of Federal Regulations, Title 45, Part 46 (Protection of Human Subjects).

Laboratory safety

It is MSMU policy to provide a safe and healthful environment, free from recognized hazards that may cause serious injury to students, employees and visitors. This is accomplished by maintaining a comprehensive safety, health, and environmental program that involves all employees. MSMU will conduct all of its activities in compliance with applicable standards, codes, regulations and laws. Every person at the institution understands that safety and health are not additional job responsibilities, but are an integral part of every task.

Misconduct in science

All faculty members in science areas funded by the National Institutes of Health (NIH) and the National Science Foundation (NSF) should be familiar with “Procedures for Dealing with and Reporting Possible Misconduct in Science.” These procedures cover cases of fabrication, falsification, plagiarism, and other serious deviation from accepted practices of proposing, carrying out, or reporting results for research. They also cover material failure to comply with federal requirements for protection of research, human subjects, or the public; for ensuring the welfare of laboratory animals; or failure to meet other material legal requirements governing research.

Period of performance

MSMU may only charge to the federal award allowable costs incurred during the period of performance.