SDSURF Project Administration Guide - Other Compliance Issues

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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.

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 principles (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

Introduction
Educational institutions conducting research, instruction, and/or other sponsored work under grants, contracts, and other agreements with the Federal government are required to comply with the costing principles described in OMB Circular 2 CFR PART 220. Section J.10 of Circular 2 CFR PART 220 describes the principles, criteria, and examples of how employee compensation for personal services rendered under sponsored agreements should be charged and subsequently documented.

The salary and wage costs of employees with a University (SDSU) appointment are compensated to the employee by SDSU, SDSU Research Foundation (SDSURF or the Foundation), or a combination of both. The Effort Reporting system described herein was established to meet the requirements of Section J.10 referenced above. This system was reviewed and approved by the Department of Health & Human Services in September, 1981.

The Effort Report contains comprehensive time and effort information including, percent of SDSU assignment, Reimbursed Time, Direct Pay (Reimbursed time), and Cost Sharing for faculty and staff who work on Federally sponsored programs as well as Non-Federally sponsored programs. To maintain consistency, Effort Reports are prepared, distributed, and certified for all employees with a SDSU appointment who work on sponsored agreements. The Foundation attempts to complete this process within 90 days of the end date of the Effort Reporting period. Effort reports are typically created 60 days after the end date of the term period. The reports are distributed to the employee for review and signature and the Foundation requests that the signed report be returned within approximately two weeks. Follow-up letters are sent and if necessary, phone calls and office visits are made to ensure the effort reports are completed and returned in a timely manner.

The Sponsored Research Administration department (SRA) is responsible for the preparation, dissemination, and collection of all Effort Reports. The SR assistant administrator gathers information during the academic year on all SDSU faculty and instructional staff. The information is gathered from workload forms, downloads from the Foundation's financial system, and cost sharing information provided by SRA administrators.

The recipient of an Effort Report is required to certify that the distribution of effort indicated is a reasonable estimate of all work performed during the period covered by the report.
Sections of the Effort Report
The sections of the Effort report are based on who compensated the employee, SDSU or SDSURF.

SDSU Compensated Effort: Within this section are the employee's net university appointment, reimbursed-time activity, and release-time activity. Release-time activity is identified as cost-sharing on the Effort Report.

Foundation Compensated Effort: This section includes any Foundation compensated effort. Contained within this section is compensation earned by the employee as "additional employment".
Effort Reporting Database
Effort Reporting documents are generated from a Microsoft Access database developed specifically for the purpose of tracking University and Foundation employees working on sponsored and non-sponsored agreements. The Access database downloads information electronically from the Foundation Banner Finance system, the SDSU payroll system and other database programs. Automated downloads include: University payroll information, direct pay payments, reimbursed time charges, and FTE calculations.
Preprocessing Inputs
At the beginning of each academic year the SR assistant administrator obtains the academic calendar and the SDSU fringe benefit rate from University Academic Affairs and inputs the data into the Effort Reporting database. The academic calendar shows the actual workdays and non-workdays for an academic year and twelve month appointments. This information allows the system to calculate percentage of FTE, salary, fringe amounts, and number of days worked for employees entered into the database.

The SDSU personnel appointment database is also downloaded into the Effort Reporting database at the start of each academic term. This information is used to verify all employee data inputs.

Banner fund codes are downloaded monthly to capture newly established funds. Downloading this data allows for the Banner Fund, Org, Account, and Program (FOAP) to automatically feed as employee data is input. It also provides a mechanism to determine if funds are valid or have not been set up in Banner.

Data Collection & Input
Reimbursed Time
Definition: Reimbursed Time is the mechanism whereby the SDSURF reimburses SDSU for a portion of an employee's regular position up to full time, for work that is outside the employee's regular work assignment and compensated from a different source of funds. The grant/contract fund purchases a percent of a faculty's time to work on a project. Their SDSU appointment is reduced accordingly.

Data Source: The employee data for "Reimbursed Time" on the Effort Report is manually input into the Effort Reporting database from the "Faculty Grant/Contract/GRIF Workload Form."

After an award is made, the college dean's office initiates a Faculty Grant/Contract/GRIF Workload form. This form is sent to the faculty member's SDSURF SR administrator. The SR administrator reviews the approved budget and balance available on the project fund, verifies the faculty member's current SDSU salary base, and prepares an Excel spreadsheet to calculate the total cost of the reimbursed salary and fringe benefits. If the proposed reimbursed time position is budgeted, the time period is in line with the funding period, and sufficient funds are available, the SR administrator approves and returns the original to the dean's office and forwards a copy of the form and Excel spreadsheet to the SR assistant administrator. The SR assistant sdministrator inputs the Reimbursed Time information into the Effort Reporting database. The dean's office forwards the original form to Academic Affairs, where it receives final approval and copies of the original are distributed to each participating office. (The SR assistant administrator receives the green copy of the original form.) If applicable, the SR assistant administrator establishes a general encumbrance for reimbursed time.

As the data is input into the system throughout the semester, the SR assistant administrator processes payment against the grant/contract funds via a journal voucher upload. The funds are transferred into a holding fund until the SDSURF receives an invoice from SDSU. Final payment to SDSU is not made unless the SR assistant administrator has the green copy of the Faculty Grant/Contract/GRIF Workload form that is signed by Academic Affairs (See Billing and Payment Process.)

Direct Pay/Reimbursed time
Definition: Additional employment is defined over the equivalent of a full time assignment within the California State University system and its auxiliaries. Such payments may be a one time, retroactive (Special Pays), or regular payment to individuals. These payments are routed through SR Administration, to Human Resources and Payroll departments for payment.

Data Source: The information in this section of the Effort Report comes from two sources: 1) retroactive Lump Sum (Special Pay) payments for total effort during a specified time period and 2) appointment set up via a Temporary Employee Appointment form and paid twice a month for effort worked during the preceding pay period.

The reimbursed time appointments and lump sum (special pay) information is downloaded from the Banner HR system by the SR assistant administrator into the effort reporting database on a monthly or as needed basis. The SR assistant administrator corrects any errors and then transfers the information to the effort reports. The effort reporting database calculates the percent of effort and allocates it by reporting period for each employee.
Cost Sharing
Definition: For purposes of this document, cost sharing is defined as the percentage of effort obligated as in-kind that the employee works on an active sponsored agreement, however SDSU is not reimbursed for associated salary and wage costs of the employee for that effort.

Data Source: When setting up a cost sharing file for a new award, the SR administrator forwards a Cost Sharing memo to the SR assistant administrator. If changes are made to the amount of effort cost shared on the individual whose effort is being documented, a revised memo is sent to the SR assistant administrator. The SR assistant administrator manually enters the cost sharing obligation indicated on the cost sharing memo into the appropriate reporting period in the effort reporting database.

Distribution and Return of Signed Effort Reports
The effort reports and cover letters are distributed to faculty via campus mail. Reports are requested to be reviewed, signed and returned within two weeks of receipt. As signed effort reports are returned to the SR assistant administrator, they are marked as "Signed and Received" in the effort reporting database. The original, signed reports are kept on file by academic term.

Effort certification reports are utilized as the primary means of reconciling effort paid to effort worked. Because additional time sheets are no longer required for faculty, all faculty must certify their effort by verifying and signing an effort report at the end of each academic term.

First Notice Effort Reports
Within approximately, within 60 days of the last day of an Effort Reporting period (fall and spring semesters, winter, summer and spring break), the SR assistant administrator verifies that all data needed to compile the effort reports for the specified reporting period has been input into the database. When all data has been input and transferred, the First Notice Effort Reports and cover letters are printed. The SR assistant administrator audits the reports for accuracy and any errors found are corrected and revised reports are printed. Once this review process is completed, Effort Reports are distributed via campus mail.

Second and Third Notice Effort Reports
Second Notice Effort Reports are distributed via campus mail to individuals who did not sign and return the First Notice Effort Report within two weeks of receipt. The SR assistant administrator prints the Second Notice Effort Reports and cover letters and distributes to the appropriate individuals with a request to review, sign and return the Effort Report within two weeks.

Third Notice Effort Reports

if the employee is not able to sign, a Department Dean or Chair who has direct knowledge of the individual's effort for the stated period, using suitable means of verification that the work was performed, can sign in place of the individual and must include an explanation as to why the employee is unable to sign. Additional follow-up and documentation may be requested for third-party certifications.

Billing and Payment Process (Reimbursed Time)
As reimbursed time is entered into the database from the Faculty Grant/Contract/GRIF Workload forms, it is batched and journal vouchers are uploaded into Banner to charge the grant/contract funds. The funds are held in a holding fund set up by Finance and Accounting for the fall and spring academic term. When SDSU bills the SDSURF, the SR assistant administrator prepares the invoice for payment from the holding fund.

The SDSURF receives two invoices for fall and two for spring. The first invoice is for 50% of the total due and the second invoice is for the remaining 50%. The first invoice for the fall academic term is normally received in November and the second invoice is received in January. The first invoice for the spring academic term normally is sent in April and the second invoice is received in July.

The first invoice for the spring academic term also includes additional billing for the fall academic term. Additional invoices are periodically received for outstanding costs due to reimbursed time submitted late, salary increases and other revisions. Any changes to reimbursed time must be recharged through the database to correct Effort Reports and correctly charge the SDSURF funds.

Specialized Reports
The Effort Reporting database produces the following reports for each of the reporting periods (fall and spring semesters, as well as winter, summer and spring breaks).

ER Summary Activity by College, by Employee
This report displays the total appointment, university appointment, reimbursed time, reimbursed time, direct pay, cost sharing for each employee. The report also indicates if an Effort Report has been printed and signed/returned.

RT Detailed Activity by Employee, by College
This report displays the SDSURF fund number and project title, the start and stop dates, the net FTE and salary amount for each employee.

RT Billing Summary by College
This report displays the billing summary by employee for each college and includes the SDSURF FOAP, percent FTE, reimbursed time, and retroactive adjustments paid. The report also calculates the amount of fringe benefits paid.

ER Detailed Activity by College
This report is sorted by department and displays the SDSURF fund number and project title, the unadjusted net FTE, reimbursed time, reimbursed time, and cost sharing for each employee within the department.

These reports are used to track and monitor compliance with the effort reporting policy. Instances where a faculty member has not returned the required effort certification after all follow up attempts has failed are forwarded to the managers and director of SR Administration for review and assistance. Follow up with faculty may include telephone calls, e-mails, or requests for the SR administrator to attempt to obtain the report in person. The department chair or college dean may be asked to verify the hours worked if attempts to obtain the individual faculty members certification are unsuccessful.

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&sectionid=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&sectionid=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&sectionid=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&sectionid=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&sectionid=10&subsectionid=23

Human Research Protection Program - Education and Training in Research Ethics
http://gra.sdsu.edu/research.php?areaid=2&sectionid=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&sectionid=10&subsectionid=41

Office of Research Integrity (ORI)
http://ori.hhs.gov/

Responsible Conduct of Research Education Consortium (RCREC)
http://rcrec.org/