Policies Under Review:   CAP-140   Use Of University Property And Time, Place And Manner (comments due by 02/15/2018)

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CHAPTER 200 Academic Affairs



260 Research and Economic Development

The Office of Research and Economic Development provides leadership and support to Cal Poly faculty and students in their pursuit of excellence in their research and creative efforts. Research and Economic Development proactively strives to foster an environment in which the research and creative accomplishments of faculty and students are encouraged and rewarded.

The Office identifies and creates opportunities for financial support of these activities; advocates for Cal Poly's research activities, both on campus and at the local, state and national levels; and promotes the reputation of Cal Poly's research and scholarship locally, nationally and internationally. To achieve these ends the Office of Research and Economic Development, and its constituent Grants Development Office, collaborate with students, faculty, staff and administrators in programs, departments, colleges and administrative units of the University, with the Cal Poly Corporation, and with various private and governmental organizations.

261 Research

The research activities of the University are encouraged and guided by the University administration, in general, and in particular, by the academic deans and the vice president for Research and Economic Development. “Research” encompasses a variety of scholarly and creative activities, including basic and applied research, community outreach and demonstration projects, student research projects, and projects in the humanities and creative arts. While the teaching mission of the University is primary, research and professional development are recognized as essential functions of the faculty and key to maintaining the excellence of the teaching programs. In turn, the University is committed to providing the necessary environment to foster research and other professional development activities.

261.1 Compliance

Research activities at the University must comply with a variety of federal, state, CSU and University regulations. Several different policies, described in this section, address research compliance matters.

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261.1.1 Policy for Use of Human Subjects in Research

Introduction

California Polytechnic State University, San Luis Obispo, (hereafter, Cal Poly) is committed to the protection of human subjects in research and, as such, is guided by the principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects in Research (The Belmont Report), and is obligated by the policies of the Department of Health and Human Services (DHHS) and the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46), also known as the “Common Rule.” The actions of Cal Poly also will conform to all other applicable federal, state, and local laws and regulations regarding the conduct of research with human subjects.

To assist with this goal, the University has designated a committee, or Institutional Review Board (IRB), to review proposals for research involving human subjects and to evaluate both risk and protection against risk for those subjects, the researchers, and Cal Poly. It is the function of the IRB to:

  • evaluate research in terms of its compliance with ethical standards and the regulations set forth in the Federal Regulations regarding the health, welfare, safety, rights, and privileges of subjects; and
  • assist the investigator(s) in complying with federal, state, and local regulations, including Cal Poly policies governing research.

While individual researchers are ultimately responsible for their practices, the IRB's review is designed to provide objective input as an additional protection for the subjects. In addition, the independent review by the IRB is of benefit to those who could be held accountable for the research practices — the researchers and the University — and will seek to evaluate and minimize the potential risks for all.

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261.1.1.1 Applicability of this Policy

All institutions at which research involving human subjects is carried out are required by law to have an IRB to oversee those projects when the research is supported by a federal agency. Even if the research is not federally funded, however, it is Cal Poly's policy that a review of compliance with ethical guidelines be completed on all research involving human subjects conducted at Cal Poly, including, but not limited to, research:

  • conducted by or under the direction of any employee or agent of Cal Poly (including students) in connection with his/her institutional responsibilities;
  • conducted by or under the direction of any employee or agent of Cal Poly using any property or facility of Cal Poly; or
  • involving the use of Cal Poly’s non-public information to identify or contact human subjects.

These categories encompass reviews of all off-campus research on human subjects carried out by Cal Poly faculty, staff, and students when they are conducting the research as an aspect of their roles as faculty, staff, or students of the University; and also research conducted by external investigators at Cal Poly using faculty, staff, or students as subjects. Approval from another IRB (e.g., external research partner) does not serve in lieu of review by the Cal Poly IRB under the requirements of this policy. The IRB is not responsible for reviewing research on human subjects that is conducted by a University employee or student as a function of their independent consulting work or their personal work with another institution.

261.1.1.2 Definitions

In accordance with federal guidelines for the protection of human subjects, research involving human subjects is defined as any systematic investigation of living human subjects that is designed to develop or contribute to generalizable knowledge.

Human subject is defined as a living individual, human materials, or identifiable private information about whom an investigator obtains data through interaction or intervention.

Systematic investigation is defined as an attempt to answer research questions using a methodological approach, incorporating data collection (both quantitative and qualitative) and data analysis, and permitting conclusions to be drawn.

Contributing to generalizable knowledge is defined as the dissemination and application of research findings to populations outside of the specific study population.

Human subjects research that requires review by the IRB includes, but is not limited to, faculty research, master's theses, and senior projects as well as research involving human subjects that is conducted on campus by parties not directly affiliated with the University. While the ethical principles for research are often applicable to classroom activities, demonstrations, and assignments, the IRB does not review classroom activities unless data will be collected and used in a systematic investigation that contributes to generalizable knowledge.

261.1.1.3 Overview of the Ethical Principles

Cal Poly's ethical guidelines for the use of human subjects in research are based on the principles and procedures outlined in the Code of Federal Regulations for the Protection of Human Subjects and the Office for Human Research Protections (OHRP) Policy and Guidance. The OHRP Policy and Guidance provides interpretation and discussion of the Federal Regulations related to the protection of human subjects. The Federal Regulations provides a common rule to be implemented across a broad spectrum of federal agencies including the National Aeronautics and Space Administration, the Environmental Protection Agency, the Consumer Product Safety Commission, the National Science Foundation, and the Departments of Agriculture, Energy, Education, Justice, Defense, Housing and Urban Development, and Health and Human Services. Cal Poly's policy is similarly intended to apply to the range of disciplines represented on campus while at the same time acknowledging the value of the ethical guidelines of individual disciplines' professional associations (e.g., the American Medical Association, the American Psychological Association, the American College of Sports Medicine, the American Association on Mental Deficiencies). Should a specific circumstance not be fully addressed by the Cal Poly policy, the Federal Regulations and the OHRP Policy and Guidance will provide the guidelines for the IRB's decision-making. The Federal Regulations will be the primary reference for the review of federally funded research.

The Federal Regulations and Cal Poly's guidelines draw heavily on the three basic ethical principles laid out in the Belmont Report, a 1979 report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. These three basic principles are: respect for persons, beneficence, and justice. Respect for persons entails treating individuals as autonomous agents who enter into research voluntarily and with adequate information (i.e., informed consent). Those with diminished autonomy, such as human fetuses (pregnant women), neonates, children, prisoners, and individuals who are in some way incapacitated, have a right to be protected. The second basic principle, beneficence, refers to the obligation to secure the well-being of research subjects. Possible benefits should be maximized, while possible harms should be minimized. The final principle explicated in the Belmont Report is that of justice. Justice implies that both risks and benefits of research should be distributed equally across various groups. For example, the burden of serving in research should not largely fall on certain groups such as the poor or the imprisoned, while others primarily benefit from the knowledge gained from the research.

The specific ethical criteria used to evaluate research proposals are provided in the Cal Poly Procedures and Guidelines for Human Subjects Research.

261.1.1.4 Authority and Assurance of Compliance

At the delegation of the Provost and Executive Vice President for Academic Affairs, the Vice President for Research and Economic Development at Cal Poly has designated the Dean of Research as the responsible Institutional Official (IO) for oversight of the university’s human research protections program. Cal Poly holds a Federalwide Assurance (FWA), FWA00000342, which is granted to IRBs that register with the OHRP.

261.1.1.5 IRB Membership

The Cal Poly IRB, has been established in accordance with the requirements of the current Federal Regulations, under 45 CFR 46.107.

In keeping with the Federal Regulations, the Cal Poly IRB must:

  • have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted under the authority of the Cal Poly IRB. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. Since the IRB may review research that involves vulnerable categories of subjects (such as children, prisoners, pregnant women, or physically or mentally disabled persons) consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
  • employ nondiscriminatory selection in compliance with CSU Executive Order 1097, and all other applicable laws of non-discrimination.
  • include at least one member who is qualified as a scientist and one member who is qualified as a non-scientist. Both a scientist and a non-scientist member are required for quorum at all meetings convened with the full IRB.
  • include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
  • ensure that no members will participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

The IRB may at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available in the IRB membership. These individuals may not vote with the IRB.

Other considerations: The IRB can have as many members as necessary for it to perform its duties effectively. The appointing authority should ensure that it does not become so large that its management becomes cumbersome.

The non-affiliated member(s) of the IRB shall be from the local community-at-large. The person(s) selected should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to the type of community from which the institution will draw its research subjects. The nonaffiliated member(s) should not be vulnerable to intimidation by the professionals on the IRB, and their services should be fully utilized by the IRB.

The chair of the IRB should be a highly respected individual from within the institution, fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the institutional community falls primarily on the shoulders of this individual. The IRB must be and must be perceived to be fair and impartial, immune from pressure either by the institution's administration, the investigators whose protocols are brought before it, or other professional and nonprofessional sources. The Chair may designate other IRB members to perform duties, as appropriate, such as reviews, signature authority, or other IRB functions.

The IRB members and the chair are appointed by the Dean of Research. IRB members who are faculty should be tenured, so as to avoid pressure or influence from more senior faculty or administrators. Due to the level of experience and relevant expertise needed to perform IRB duties, there are no term limits for IRB members, and they will continue to serve as long as they demonstrate knowledge of regulations, an understanding of the application of the ethical principles, and have time available to devote to the associated responsibilities. The Dean of Research will conduct annual reviews of the chair, IRB members, and IRB composition for compliance with Federal Regulations and Cal Poly policy and procedures, and will determine and seek action if a conclusion is made that a member’s participation should be discontinued. If it is necessary to add new or replace exiting members, several methods are used to identify candidates: the existing members may be asked to provide recommendations; faculty with expertise in areas specific to the types of projects reviewed may be contacted directly; open calls will be announced via campus websites and distributed emails; interested persons may contact the Dean of Research to express interest; or the Dean of Research may identify and recruit potential members.

The IRB should meet at least once per quarter during the academic year. A list of current IRB members is available from the Office of Research and Economic Development, Bldg. 38, Rm. 154; (805) 756-1508.

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261.1.2 Regulations, Policies and Standards for the Care and Use of Animal Subjects in Teaching and Research

The humane care, use, and treatment of vertebrate animals used for instruction, research, or related purposes is a campus responsibility. It is the policy of California Polytechnic State University to comply with federal, state, University, and other regulatory requirements as they relate to the acquisition, care, use and treatment of animals in the performance of authorized instruction and research. The Institutional Animal Care and Use Committee must provide assurance to a number of agencies that animals in all projects and activities are humanely cared for, used and treated in accordance with professionally acceptable standards. Accordingly, the committee has been charged with oversight and review of all qualifying campus animal care and use facilities and procedures.

In order to provide for the adequate discharge of this responsibility, all ongoing or proposed projects or activities in which vertebrate animals are used in teaching and/or research must be reviewed by the committee. This policy is applicable regardless of whether extramural funds or intramural funds are used, and includes those cases where no reimbursement for such study is involved.

Full policy text can be found at http://research.calpoly.edu/policyanimaluse.

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Reference:

  1. Date approved by the President: May 24, 2006
  2. Office responsible for implementation: Research and Economic Development
  3. Date when the policy is to be reviewed and by whom (where stipulated): Editorial changes made May 20, 2015 by ACS per ORED.
  4. Related University Policies/Documents/Manuals/Handbooks:
    1. Policy on the Administration of Sponsored Programs at California Polytechnic State University (Cal Poly)
    2. CSU-EO890
  5. Any laws, regulations or codes of practice which should be referred to in conjunction with the policy:
    1. Animal Welfare Act, Public Law 89-544, 1966, and succeeding amendments.
    2. 1996 Guide to the Care and Use of Laboratory Animals, National Academy of Sciences
    3. Public Health Service Policy on Humane Care and Use of Laboratory Animals, as amended in August 2002, and any subsequent revisions
    4. Applicable provisions and regulations of Title 9, California Administrative Code, CALOSHA; Applicable provisions and regulations of the California Department of Public Health; Applicable provisions and regulations of the California Department of Fish and Game
    5. Applicable provisions and regulations of the Endangered Species Act of 1973, P.L. 93-205, and succeeding amendments;
    6. Applicable provisions and regulations of the Marine Mammal Protection Act of 1972, P.L. 92-522, and succeeding amendments.

261.1.3 Policy on Conflict of Interest in Externally Funded Research

Investigators will disclose to the responsible representative of the institution all significant financial interests of the Investigator (including those of the Investigator’s spouse and dependent children) (i) that would reasonably appear to be affected by the activities funded or proposed for funding, or (ii) in entities whose financial interests would reasonably appear to be affected by such activities.

The term “Investigator” means the Principal Investigator, Co-Investigators, and any other person at the institution who is responsible for the design, conduct, or reporting of activities funded or proposed for funding.

Investigators must provide all required financial disclosures at the time a proposal is submitted to any potential funding agency. Investigators must update those financial disclosures during the term of the award, either on an annual basis, or as new reportable significant financial interests are obtained (including during the course of the project if award is made). The Investigator must complete the “Investigator’s Statement of Economic Interest” and other disclosure statements (1) whenever he/she makes application for a new or renewal contract or grant, of (2) whenever a gift is specified by a donor for a specific Investigator or for a specific project for which the Investigator is responsible. The disclosure must be made before the proposed gift is accepted or application for funding is made for a new or renewed project or grant. The activity may not proceed without completion of the financial disclosure statement. An “Investigator’s Statement of Economic Interests” form must be filed within 90 days after the gift funds are exhausted, or the project is completed.

Full policy text can be found at http://research.calpoly.edu/policyCOI.

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Reference:

  1. Date approved by the President: May 24, 2006
  2. Office responsible for implementation: Provost and Vice President for Academic Affairs
  3. Date when the policy is to be reviewed and by whom (where stipulated): Periodically by Conflict of Interest in Research Committee, Editorial changes made May 20, 2015 by ACS per ORED.
  4. Related University Policies/Documents/Manuals/Handbooks:
    1. Policy on the Administration of Sponsored Programs at California Polytechnic State University (Cal Poly)
    2. CSU-EO890
  5. Any laws, regulations or codes of practice which should be referred to in conjunction with the policy:
    1. California Government Code 87300
    2. CSU Conflict of Interest Code

261.1.4 Policies and Procedures for the Handling of Allegations of Scientific Fraud and Serious Misconduct

Fraud in the conduct of research undermines the scientific enterprise and erodes the public trust in the University community to conduct research and communicate results using the highest standards and ethical practices. All members of the academic community - students, staff, faculty, and administrators - share the responsibility to maintain practices and standards that will ensure the ethical conduct of research, and procedures for the detection and appropriate handling of violations of these practices and standards.

The policies and procedures herein apply to faculty, staff, and students. They are not intended to address all academic issues of an ethical nature. For example, the conduct of students in examinations, discrimination and affirmative action issues, and other areas are covered by other institutional policies. Disciplinary actions, if any, also may involve other existing policies and procedures. For example, faculty and staff are covered by individual collective bargaining agreements and state law, and students are subject to the Campus Student Disciplinary Process.

Cal Poly will pursue every complaint about conduct that raises legitimate suspicion of scientific fraud or serious misconduct. All allegations should be reported to the Dean for Research. If he/she has a conflict of interest, the allegation should then be referred to the Provost and Vice President for Academic Affairs. Accusations against students will also be reported to the Vice President for Student Affairs.

Full policy text can be found at http://research.calpoly.edu/policyfraud.

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Reference:

  1. Date approved by the President: May 24, 2006
  2. Office responsible for implementation: Research and Economic Development
  3. Date when the policy is to be reviewed and by whom (where stipulated): Editorial changes made May 20, 2015 by ACS per ORED
  4. Sunset clause (where stipulated):
  5. Related University Policies/Documents/Manuals/Handbooks:
    1. Policy on Conflict of Interest in Externally Funded Research;
    2. Policy for the Use of Human Subjects in Research; Regulations, policies and standards for the care and use of animal subjects in teaching and research; Policy on the Administration of Sponsored Programs at California Polytechnic State University (Cal Poly)
    3. CSU-EO890
  6. Any laws, regulations or codes of practice which should be referred to in conjunction with the policy:
    1. Federal policies and regulations on responsible conduct of research, including scientific fraud and misconduct
    2. Guidelines of the Office of Research Integrity

261.1.5 Policy on the Administration of Sponsored Programs at Cal Poly

Sponsored programs provides significant benefits to the University and furthers its educational mission by facilitating research, workshops, conferences, and other projects that enrich the scholarly endeavors of faculty and students and enhance the services provided by the University to California communities and the nation. This document delineates or refers to policies, procedures and organizational structures for the administration of grants and contracts denoted as sponsored programs/projects. All procedures and actions are designed to conform to federal and state laws and regulations, CSU, University and Foundation policies. In the event that a given contract or grant contains terms and conditions that are not in conflict with, but are more restrictive than, those provided in the campus policy, the more restrictive terms and conditions of the grant or contract shall prevail. The intent of this policy is to ensure that the administration of sponsored programs maximizes the benefits of these programs; effectively supports faculty, students, and administrators in securing funding for and carrying out sponsored activities; and is in compliance with CSU policy including Executive Order 890 or its successor. (See http://www.calstate.edu/EO/EO-890.pdf).

Full policy text can be found at http://research.calpoly.edu/policysponsprog.

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Reference:

  1. Date approved by the President: May 24, 2006
  2. Office responsible for implementation: Various administrative offices
  3. Date when the policy is to be reviewed and by whom (where stipulated): Editorial changes made May 20, 2015 by ACS per ORED.
  4. Sunset clause (where stipulated):
  5. Related University Policies/Documents/Manuals/Handbooks: Various policies and guidelines referenced in the full policy
  6. Any laws, regulations or codes of practice which should be referred to in conjunction with the policy: Various, referenced in the full policy and related policies
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Reference:

  1. Date approved by the President: May 24, 2006
  2. Office responsible for implementation: Research and Economic Development
  3. Date when the policy is to be reviewed and by who (where stipulated): Editorial changes made May 20, 2015 by Administrative Compliance Services (ACS) per Office of Research and Economic Development (ORED)
  4. Related University Policies/Documents/Manuals/Handbooks:
    1. Policy on the Administration of Sponsored Programs at California Polytechnic State University (Cal Poly)
    2. CSU-EO890
  5. Any laws, regulations or codes of practice which should be referred to in conjunction with the policy:
    1. Federal Policy for the Protection of Human Subjects
    2. Office of Human Research Protections (OHRP) Institutional Review Board (IRB) Guidebook
    3. The Belmont Report, 1979

262 Policy for the Establishment, Evaluation and Discontinuation of University Centers and Institutes

A center or institute may be formed as an organizational entity within the University if the teaching, research, or public service activities of the faculty members who participate will be improved or if the activities cannot be supported by a single department. A center or an institute can enhance professional development opportunities for faculty, build links with industry and the community, provide identifiable campus entities for practitioners, foster interdisciplinary work, aid in obtaining external support, and complement the instructional program. An institute is a unit that has more than one interest and/or function. A center is a unit with one interest and/or function. An institute may encompass a number of units or centers.

A proposed center or institute must receive conceptual approval from the Academic Deans’ Council and Provost and Vice President for Academic Affairs before a formal proposal can be submitted. Full approval requires Academic Senate review, ad hoc administrative review, Deans Council recommendation, recommendation by the Provost and Vice President for Academic Affairs to the President, and Presidential approval. Centers and institutes undergo regular evaluation through the University's Academic Program Review Process. They may be discontinued as a result of this process, or at any time according to the bylaws of the unit.

Full policy text can be found at http://research.calpoly.edu/content/centers-institutes-and-specialized-laboratoriesfacilities.

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Reference:

  1. Date approved by the President: May 24, 2006
  2. Office responsible for implementation: Research and Economic Development
  3. Date when the policy is to be reviewed and by whom (where stipulated): Editorial changes made May 20, 2015 by ACS per ORED.
  4. Related University Policies/Documents/Manuals/Handbooks:
    1. Policy on the Administration of Sponsored Programs at California Polytechnic State University (Cal Poly)
    2. CSU EO-890
    3. CSU EO- 751
    4. Guide to the administration of gifts, sponsored support and other resources acquired through external relationships

263 Intellectual Property Policy

Purpose. The University is committed to providing an intellectual environment in which all members of the academic community – whether they are faculty engaged in life-long professional development, students pursuing educational objectives, or staff dedicated to their own career goals – learn to the fullest extent possible. The University also recognizes and values creativity and innovation as part of this learning process. Similarly, the University recognizes the importance of, and wishes to encourage, the transfer of new knowledge, generated in the University, to the private sector for the public good. At the same time, as a publicly funded institution, the University must be a good steward of the public resources provided to it, and must safeguard against the use of public funds for private gain. Scope. This policy addresses the rights to, interest in, and protection and transfer of intellectual property created by University faculty, staff and students. Issues not directly considered in this policy, including disagreements concerning its application or interpretation, will be addressed and resolved consistent with applicable law and collective bargaining agreements. In the event of a conflict between this policy and the collective bargaining agreements, the bargaining agreements shall prevail. Policies affecting the use of the University's names or symbols are covered elsewhere.

The full text of the University’s policy and procedures on Intellectual Property may be viewed online at: http://research.calpoly.edu/policyIP or https://digitalcommons.calpoly.edu/cgi/viewcontent.cgi?article=1637&context=senateresolutions .

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Reference:

  1. Date approved by the President: August 17, 2006
  2. Office responsible for implementation: Research and Economic Development
  3. Date to be reviewed and by whom: Editorial changes made May 20, 2015 by ACS per ORED.
  4. Sunset clause (where stipulated):
  5. Related University policies/documents/manuals/handbooks:
  6. Laws, regulations or codes of practice that should be referred to in conjunction with the policy: none cited

264 Indirect Cost Recovery and Uses

264.1 Definition of Indirect Costs

Indirect costs, also called F & A (facilities and administrative) costs, are defined by the federal government as those costs incurred in the development, administration and conduct of sponsored projects that go above and beyond the direct costs of a specific project. Such indirect costs include expenses for space and facilities (excluding renovations and new construction), office and laboratory equipment, maintenance, utilities, library use, basic telephone and computer support, accounting functions, and department, college and University administrative costs incurred in the conduct of government- and privately sponsored research, development, instructional, training, service, consulting, and demonstration projects.

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264.2 Recovery of Indirect Costs

It is the policy of the CSU and the University to seek full indirect cost reimbursement for each sponsored project, whether administered by the University or the Corporation. The University and Corporation negotiate periodically with the federal government to establish an indirect cost rate (percentage), which, when applied to the direct costs of a sponsored project, results in full indirect cost recovery. It is the expectation of the federal government that this rate will be used for all sponsored projects carried out by the University.

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264.3 Use of Indirect Costs

Recovered indirect costs are used to support the administrative costs associated with sponsored projects, including the staffing and operations of Corporation Sponsored Programs and the University’s Grants Development Office. Recovered indirect costs that remain after meeting such expenses will be allocated to various uses in support of future sponsored projects and research and development activities. At the end of each fiscal year, the Dean of Research submits to the President a report on sponsored program activities during that year, including recovered indirect cost income, and makes recommendations for the allocation of any uncommitted indirect cost funds.

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