Other Compliance Issues
1. Cost Sharing Policy and Procedures
2. Program Income Policy
3. Effort Reporting
4. Export Controls/ITAR
5. Intellectual Property
6. Research Integrity/Regulatory Compliance
1. Cost Sharing Policy and Procedures
Purpose: The purpose of these guidelines is to provide direction in accumulating and reporting cost sharing on all grants and contracts.
If cost sharing is offered in a proposal, either voluntarily or to comply with mandatory requirements and an award is received, the PI is responsible for working with the SR administrator to ensure all cost sharing commitments are met and adequately documented.
The complete policy and procedures for cost sharing may be reached through the following link: Cost Sharing Policy and Procedures.
Definition: When federal statute or agency regulations require that the university share in the cost of sponsored research projects, the university contribution is referred to as "cost sharing." In general, cost sharing and matching represents that portion of project or program costs not borne by the sponsor (generally the federal government). Cost sharing can be voluntary or mandatory (that is, required by means of a statute or law), and can take the form of either cash contributions or in-kind contributions.
Cash contributions: Cash contributions represent the recipient's (that is, SDSU or SDSU Research Foundation) cash outlay, including the money contributed to the recipient by non-Federal third parties.
In-kind contributions: In-kind contributions represent the value of all non cash contributions, including services and property, provided by the recipient and/or non-Federal third parties.
Policy: It is the policy of the Foundation and the University to only offer cost sharing in a proposal when it is a requirement of the request for proposal or the program announcement. There are several reasons for this. First, if University resources are committed to a project unnecessarily, then they are not available for instances when cost sharing is required. Second, cost sharing can have the effect of eroding an institution's Facilities and Administrative cost rate. Third, all cost sharing, even voluntary, must be tracked and accounted for in the Foundation's accounting records and leaves the Foundation and University open for audit concerns if not addressed properly. Fourth, it is time consuming and expensive to document cost sharing. Finally, certain faculty members who have many awards could become over committed, resulting in an inability to substantiate the promised levels of effort.
The sponsoring agency's program guidelines typically indicate whether or not cost sharing is mandatory for a specific proposal submission. The Foundation's Sponsored Research Development Office insures that the proposal budget reflects the proper level of cost sharing required. Since documenting cost sharing is a time consuming process, efforts are made not to offer either voluntary cost sharing, or mandatory cost sharing which is difficult or impossible to document. Whether it is mandated or voluntary, budgeted cost sharing must be documented in the post award phase of a project by the Principal Investigator. The Sponsored Research Administrator works with the PI to ensure all cost sharing is adequately documented and source documents are provided. The Sponsored Research Administrator summarizes the actual cost sharing received on an Excel worksheet, and maintains the worksheet and the source documentation in the award file.
Acceptable Cost sharing Items: Cost sharing or matching may consist of the following cost elements used to further project objectives:
- Salaries of SDSU faculty or staff who are paid by the University, and who devote a percentage of their compensated time to a sponsored project, without receiving reimbursement from the sponsor.
- Fringe benefit costs associated with contributed effort as described in item a.
- Indirect/Facilities and Administrative (F&Amp;A) costs foregone, where the Foundation requests less than the federally approved negotiated rate, and where the sponsor does not prohibit the use of indirect/F&Amp;A foregone as cost sharing.
- Rent foregone by the Foundation when a sponsor project occupies Foundation owned or rented space, and when there is less than full recovery of indirect/F&A costs.
- Other direct costs, such as supplies, equipment, or travel that are paid for from non-federal funding sources.
- Project costs financed by cash contributions by the recipient, or by cash donated to the recipient by third parties.
- Project costs represented by services and property donated by third parties (non-Federal public agencies and institutions, private organizations, and individuals).
Requirements: All matching contributions, both cash and in-kind, must adhere to the following criteria as required by 2CFR Part 215:
- Are verifiable from the recipient's records.
- Are not included as contributions for any other federally assisted project or programs.
- Are necessary and reasonable for proper and efficient completion of the project or program objectives.
- Are allowable under the applicable cost Principals (OMB Circular A-21, or other sponsor regulations if the sponsor is non federal).
- Are not paid by the Federal Government under another award, except where authorized by federal statute to be used for cost sharing or matching.
- Are provided for in the approved budget when required by the sponsoring agency.
- Conform to other provisions of 2CFR Part 215-23.
2. Program Income Policy
Program Income is defined as gross income earned by a grantee or its subcontractors that is directly generated by a grant-supported activity or earned as a result of the grant. Program income includes, but is not limited to, income from fees for services performed, the use or rental of real or personal property acquired under the grant, the sale of commodities or items fabricated under the grant, license fees for and royalties on and copyrights, and interest on loans made with grant funds. Program income does not include interest earned on advances of Federal funds or the receipt of principal on loans, rebates, credits, discounts, etc., or interest earned on any of them.
SDSU Research Foundation must comply with the federal reporting requirement to account for all program income related to projects financed with Federal funds. This requirement is set forth in 2CFR Part 215-24 and is summarized as follows:
All program income earned during the project period* shall be retained by the grantee and, in accordance with Federal awarding agency regulations or the terms and conditions of the award, shall be used in one or more of the ways listed in the following:
- Additional Funds: Added to funds committed to the project by the Federal awarding agency and grantee and used to further appropriate project or program objectives.
- Cost Sharing or Matching: Used to finance the non-Federal share of the project or program. (Income is added to the amount allowable for project costs.)
- Deduction of Funds: Deducted from the total project or program allowable cost in determining the net allowable costs on which the Federal share of costs is based. (Income is deducted from the amount reimbursed to the grantee from the sponsor.)
* The grantee is excluded from reporting program income earned from license fees and royalties for copyrighted material, patents, patent applications, trademarks, and inventions produced under an award unless the Federal awarding agency regulations or the terms and conditions of the award specify otherwise. (Patent and Trademark Amendments (35 U.S.C. 18) apply to inventions made under an experimental, developmental, or research award.)
If a federal agency authorizes the disposition of program income as Additional Funds or as Cost Sharing/Matching, any amount of program income in excess of the limits set by the agency shall be deducted from the total amount reimbursed to the grantee from the sponsor.
If the Federal awarding agency does not specify how program income is to be used in its regulations or on the notice of grant award, the grantee shall apply the Deduction of funds method to all projects or programs except research. For awards that support research, program income shall be used as Additional funds unless the awarding agency specifies otherwise or the grantee is subject to special award conditions.
Unless Federal awarding agency regulations or the terms and conditions of the award provide otherwise, the grantee is not obligated to report program income earned after the end of the project period to the Federal government.
If authorized by Federal awarding agency regulations or the terms and conditions of the award, any costs incidental to the generation of program income may be deducted from the gross income to determine the amount of program income, provided these costs have not been charged to the award.
Income from the sale of property shall be handled in accordance with the requirements of the Property Standards in 2CFR Part 215.30 through 215.37.
PROGRAM INCOME PROCEDURE:
Project Directors must identify all program income, regardless of sponsor (federal or non-federal) to SR Administration to enable the funds to be set up in the Foundation's accounting system and used appropriately to further the project goals and objectives.
- Upon being notified of program income associated with a Foundation project, the SR Administrator reviews the definition of program income and determines if the Foundation is obligated to report the type of income identified. (Unless listed as a requirement on the notice of grant award, we are not obligated to report program income earned from license fees and royalties for copyrighted material, patents, patent applications, trademarks, and inventions produced under an award.) Non-reportable program income is still deposited into a separate account and used to offset the project's expenses.
- The SR Administrator reviews the notice of grant award and/or the sponsor regulations to determine the sponsor requirements for using program income. (See Policy items Additional Funds, Cost Sharing or Matching, and Deduction).
- The SR Administrator establishes a 9-ledger fund in Banner to deposit and monitor all program income received for the project.
- As funds are received, the SR Administrator will deposit the checks/cash into the 9-ledger fund established to receive the income.
- The SR Administrator will approve expenditures against the program income fund based on the criteria used to approve similar costs on Foundation accounts. (See Project Administration Guide, Section II. F. Expenditure Processing)
- Facilities and Administrative Costs (F&A) and Fringe Benefit rates will be applied to program income 9-ledger funds at the same rate as the sponsored project associated with the fund or at a minimum of 6%, whichever is greater.
- Project Directors should ensure all funds received for program income are forwarded to the appropriate SR Administrator for deposit into a program income fund. Project Directors should also monitor the monthly budget reports produced for program income funds in a manner consistent with that used to monitor his/her other project funds.
- SR Administrators will monitor and reconcile program income funds in a manner consistent with the method used to administer grant funds.
- SR Administrators in conjunction with Finance & Accounting will ensure that program income costs are included on sponsor required financial reports and are accurately reported to the Federal Government.
3. Effort Reporting
An effort report is an employee "certification report" that is required from all Universities that administer federally sponsored projects. The purpose of the effort report is to verify, via certification by the individual performing the work, that the effort distribution in the payroll system is a reasonable reflection of how the individual's effort was actually performed. Effort reports are prepared at the end of each academic period and after winter, spring and summer breaks for all employees identified as faculty and/or instructional staff who have worked on a sponsor agreement or have been compensated by a SDSU Research Foundation fund. Salaried and hourly employees certify their effort each pay period via timesheets prior to receiving payment for the work performed.
The effort report summarizes all payments to the individual for the specified time period including direct pay for additional employment, reimbursed time paid to the university for faculty effort released to perform grant work, cost-shared effort paid by the university and not charged to the program, and instructional effort. The Sponsored Research Administration department is responsible for the preparation, dissemination, and collection of all effort reports. The effort report is reviewed and certified by the individual performing the work, or in unusual circumstances, by the PI or other responsible individual with direct knowledge of the work being performed. If the effort worked deviated from the distribution of effort as reflected in the payroll system, the individual notes this on the effort report and certifies to the actual effort worked. The sponsored research administration office will reallocate the effort in the payroll system upon receipt of the modified effort report. Once effort is certified, it cannot typically be reallocated.
4. Export Controls/ITAR
Current export law controls both hardware and information concerning a wide range of designated "Defense Articles" in a way that may have a substantial impact on research at U.S. universities. As a general proposition, a "deemed export" (one requiring a license and imposing access restrictions) exists whenever a foreign national on U.S. soil may be exposed to or be able to access in any manner an export-controlled item or information.
From the current federal regulations may flow a cascade of effects adverse not only to research at SDSU Research Foundation, but to U.S. universities generally. Although there is a general exception for "fundamental research" under the export control regulations, certain universities have been informed either by manufacturers or by governmental agencies that scientific equipment provided to them or developed by them is subject to export controls.
Export control restrictions have been in place for many years. However, recent events have brought these issues to the forefront once again. Every award (grant, cooperative agreement, and contract) is subject to the export control regulations whether or not there is an explicit clause within the award document. Also, individuals carry responsibilities with regard to the export of certain materials on the critical technology list. Although most activities SDSURF is involved in meet the exclusion test as fundamental research, some do not (such as when the activity is, in export language, a "deemed export" such as a training activity). Questions regarding the applicability of export controls on a specific program should be directed to the director of sponsored research development at the proposal stage or to the sponsored research administrator on active awards.
5. Intellectual Property
The Technology Transfer Office (TTO) manages all aspects of an intellectual property (IP) with the goal of bringing qualifying properties to the open market. It helps to identify discoveries and creative works that need protection and have commercial potential. In addition, the TTO provides appropriate documents for the protection of IP, such as confidential disclosure documents. Managing the commercialization of these inventions, authored works, and other projects is also part of the TTO service. Other services include patent, copyright, and trademark filing, technology assessment, as well as marketing and marketing research. For additional information access: http://tto.sdsu.edu/.
6. Research Integrity/Regulatory Compliance
SDSU is committed to achieving the highest standards in its conduct of research. Through the University Research Council, standing committees implement federal, state and institutional policies associated with research compliance as well as research development and promotion. The Division of Research Administration has oversight of regulatory assurances between the federal government and the University. These assurances are agreements that detail the responsibilities of those involved in the conduct of research to ensure the research is carried out in a manner consistent with accepted standards of ethical research practices. Programs that support research integrity and compliance include:
Animal Subjects
SDSU is committed to ensuring the humane care and use of all animals associated with its research and teaching programs. Stringent federal laws and policies, such as the federal Animal Welfare Act, regulate the use of animals in research. The SDSU Animal Care and Use Program meets or exceeds all requirements through oversight by the Office of Laboratory Animal Care and the Institutional Animal Care and Use Committee. The Animal Care and Use Program is housed within Graduate & Research Affairs' Division. Program components include:
- Office of Laboratory Animal Care (OLAC)
The primary objective of the SDSU Office of Laboratory Animal Care (OLAC) is to ensure that each animal at the University receives the highest quality of care tailored to its individual needs. The OLAC includes on its staff a veterinarian board certified in Laboratory Animal Medicine, a Vivarium Manager, and laboratory animal technicians and caretakers.
The OLAC staff observes animals daily to ensure their health and welfare. The veterinarian serves as a member and consultant to the Institutional Animal Care and Use Committee on matters relating to animal health and veterinary care. The campus veterinarian participates in reviewing animal studies, performing facility inspections, and assisting in training faculty and students who will be working with animals.
Animal Care Technicians provide daily care for laboratory animals. The first qualification for obtaining a position in OLAC is having compassion for animals. Many of the technical staff are graduates of animal health technology programs of universities or technical schools. On-the-job training, informal lectures, and formal course work provide personnel with knowledge of the laws governing animal research and methods of proper care and handling of a wide variety of animal species. OLAC encourages employees to take certification examinations that are offered through the American Association for Laboratory Animal Science.
The Office of Laboratory Animal Care, in conjunction with the Institutional Animal Care and Use Committee, monitors and ensures compliance with federal and state laws, regulations, and guidelines governing the care, use, and housing of animal subjects used in research, testing, and teaching. OLAC provides services and resources needed by investigators to accomplish their animal research objectives and assists in providing training in laboratory animal care and use to technical personnel, students, and faculty. - Institutional Animal Care and Use Committee (IACUC)
The SDSU Institutional Animal Care and Use Committee (IACUC) is a committee of the University Research Council and is administered through Graduate and Research Affairs. The Vice President for Research is the "Institutional Official" responsible for research and teaching involving animal subjects.
Through the IACUC, which includes veterinarians, scientists, and private citizens as members, SDSU ensures that all research, testing or educational instruction involving animals is conducted in a humane manner using the fewest number of animals possible to obtain valid results. Charged with this responsibility, the IACUC:- Reviews all proposed uses of live vertebrate animals in research, teaching and testing, including regular reviews of all ongoing projects.
- Inspects all the animal facilities at least once every six months. Any deficiencies noted are classified as "significant" or "minor". The Institute of Laboratory Animal Resources (ILAR) Guide for the Care and Use of Laboratory Animals (the Guide) will be used as a basis for the evaluation. Expected completion dates for deficiencies to be corrected will be specified. If required, any corrections required by the USDA will be reported to the USDA.
- Reviews the animal care and use program at least once every six months.
- Submits semi-annual reports of facility inspections and program reviews to the Institutional Official (Vice President for Research).
- Submits an annual report to the Public Health Service, National Institutes of Health (NIH), and Office of Laboratory Animal Welfare (OLAW) detailing changes in the animal care and use program, changes in IACUC membership, and the results of the semi-annual facility inspections and program reviews.
- Submits annual reports to the USDA.
- Investigates all concerns involving the care and use of animals at SDSU.
- Makes recommendations to the Institutional Official regarding the animal care and use program, animal facilities, and the care and use training programs available to personnel.
- May suspend a previously approved animal related activity if the committee determines that the activity is not being conducted in compliance with the Animal Welfare Act, PHS policy, or the Institutional IACUC policies.
- Ensures that investigators have appropriate training to use animals as they propose in their animal protocol forms (APFs).
- Cooperates with other administrative units at SDSU to ensure compliance with other University policies and other new regulations involving animals as the need arises. This includes Graduate and Research Affairs, (e.g., which oversees completion of Materials Transfer Agreements and student Thesis Committee Appointment Forms), the SDSU Research Foundation (e.g., contract and grant proposal routing forms), and Environmental Health & Safety (e.g., authorizations for use of radioactive materials and controlled substances). http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=20.
Biosafety
SDSU is responsible for ensuring that recombinant DNA research or experiments involving biological materials or potentially hazardous materials are conducted in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) and the CDC Biosafety in Microbiological and Biomedical Laboratories guidelines to promote safe and responsible practices. On behalf of SDSU, the Institutional Biosafety Committee (IBC) reviews research for this purpose. The IBC is a committee of the University Research Council appointed by the Vice President for Research.
Graduate and Research Affairs' provides administrative support to the IBC. The IBC membership is determined based on federal guidance and includes a biosafety officer, an animal expert, scientists, and private citizens.
Principal Investigators using biohazardous materials or conducting experiments involving recombinant DNA in their laboratories must obtain approval from the IBC. To initiate this process, the investigator must complete a Biological Use Authorization (BUA) Form. The BUA may be reviewed and approved by the Institutional Biosafety Officer (IBO) for BL-1 experiments. The IBO and the IBC will review research involving BL-2 or BL-3 experiments.
http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=22
Conflict of Interest
The Conflict of Interest Committee evaluates research when an investigator discloses a significant financial interest that may influence the conduct of the activity. The Committee determines what, if any, conditions or restrictions should be imposed on the investigator or research protocol in order to manage, reduce or eliminate such conflicts of interest.
The conflict of interest and commitment policies of the University serve as a guide to faculty and other employees with principal responsibility for research projects conducted at San Diego State University and establish procedures to be followed to comply with State and Federal requirements for review and oversight of research. http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=44
Human Research Protection Program
SDSU assumes responsibility for the protection of the rights and welfare of human subjects in accordance with federal regulations and SDSU's Federal Wide Assurance issued by the U.S. Department of Health and Human Services. The Institutional Review Board (IRB), a standing committee of the University Research Council, reviews research involving human subjects to ensure that all projects conform to the federal and institutional regulations and policies. This site is designed to provide access to information for the faculty, students, and employee's of SDSU who plan to conduct research that involves human subjects. http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=19
Responsible Conduct of Research
SDSU is committed to maintaining the highest standards in the conduct of research and scholarship. SDSU's policy on Integrity in Research and Scholarship is approved by the Academic Senate as well as the Department of Health and Human Services' Office of Research Integrity (ORI). Information and educational materials to facilitate the responsible conduct of research are available through the following web sites.
Research Integrity/Misconduct Policy
http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=23
Human Research Protection Program - Education and Training in Research Ethics
http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=19&PHPSESSID=887e4714ff46e090743043cb49dacfad
Project TRES
http://projecttres.org/
Education and Training in the Care and Use of Laboratory Animals
http://gra.sdsu.edu/research.php?areaid=2§ionid=10&subsectionid=41
Office of Research Integrity (ORI)
http://ori.hhs.gov/
Responsible Conduct of Research Education Consortium (RCREC)
http://rcrec.org/