This policy outlines faculty members' rights and responsibilities in the conduct of research at Stanford.

To carry out Stanford's research mission effectively, scholars are guaranteed certain freedoms.  Faculty have the right to academic freedom in the pursuit and support of research as defined in the statement of Principles Concerning Research, found in the Research Policy Handbook. Faculty have the right to disseminate the results and findings of his or her research without suppression or modification from external sponsors beyond those provisions explicitly stated in the policy on Openness in Research.  Members of the Academic Council have the right to engage in external consulting activities, subject to the University's, and in some cases their School's, limitations. It's important that faculty adhere to both the spirit and the letter of the policy.

Along with these freedoms come corresponding responsibilities:

Faculty members must be aware of their obligations to staff and students working as part of the research team. It is particularly important that at least annually, each faculty member should review intellectual and tangible property rights and responsibilities (for management of data in all media, for proper authorship attribution, etc.), with all members of the group under his or her direction, including staff, students, postdocs, and visiting scholars. Each member has the right to know who is sponsoring the research and supporting his or her salary or stipend.

On an individual level, the best interests of each staff member and student should be of particular concern. The University is committed to demonstrate support and appreciation for its staff. To that end, faculty members are encouraged to provide staff development opportunities and, if possible, a mentor relationship for those in their group.

Health and Safety

Each faculty member is responsible for training members of his or her team in appropriate health and safety procedures for that particular research area, and for management of those procedures in his or her laboratory or other workplace. PIs are also responsible to assure the periodic inspection of lab facilities, and to cooperate in any inspections by Stanford personnel or by external agencies.

Consulting by Academic Staff - Research

On an exception basis, members of the Academic Staff-Research occasionally may be permitted to engage in outside consulting activities under conditions outlined in the RPH, Conflict of Commitment and Interest for Academic Staff and Other Teaching Staff.

Fiscal Obligations

Although the legal agreement funding a sponsored project is between the sponsor and the Stanford University Board of Trustees, the overall responsibility for management of a sponsored project within funding limitations rests with the PI. Funds must be expended within the restrictions of the contract or grant, and if any overdraft should occur, it is the responsibility of the PI to clear the overdraft by transferring charges to an appropriate account.

Equipment Control

The control of both Stanford and Government-owned equipment is mandatory under Stanford's externally sponsored contracts and grants as well as under University policy. PIs are responsible for securing necessary approvals for the purchase of the equipment, proper tagging, inventory, utilization of equipment and disposal once equipment becomes excess.  For specific guidance, please refer to the Property Administration Manual.

Proposal Preparation

The cost of proposal preparation activities in support of new directions in research may not be charged to sponsored projects. Department Chairs and School Deans must ensure that non-sponsored project funds are available to offset the portion of the investigator's and his or her staff's salaries from sponsored projects for effort spent preparing proposals to support new directions in research. The cost of proposal preparation efforts for continuing research is appropriately charged to current projects. Also, should there be questions on which direct costs are subject to indirect costs as proposal budgets are prepared, please refer to the appropriate documents in the Research Policy Handbook.

Certification of Salaries and Expenses to Sponsored Projects

Sponsored project and cost sharing accounts must be reviewed and certified by the PI quarterly. It is the responsibility of each department chair and school dean to see that a system is in place to ensure that the PIs in their areas fulfill the requirement for review and certification of salaries and other expenditures, and to assure that salaries charged to sponsored projects correspond to effort expended on those projects, within the appropriate limitation for their school.

Technical and Invention Reports

Principal Investigators are responsible for submitting sponsor-required reports through the Office of Sponsored Research or the Research Management Group (OSR or RMG) on a timely basis.  The reports must be sent directly to your project monitor, with a copy to OSR or RMG at the same time so that contract and grant files are complete.

Patents and Copyrights

All participating researchers, including postdocs, students, and visiting scholars, must sign Stanford's Patent and Copyright Agreement (SU-18) before the commencement of any research activities.

That the principle of openness in research - the principle of freedom of access by all interested persons to the underlying data, to the processes, and to the final results of research - is one of overriding importance. Accordingly, it is the decision of the Senate that that principle be implemented to the fullest extent practicable, and that no program of research that requires secrecy (as hereafter defined) be conducted at Stanford University, subject to the exceptions set forth in Paragraph 4 of this Resolution.

That a research program shall be regarded as requiring secrecy:

• If any part of the sponsoring or granting documents that establish the project is not freely publishable

• If there is a reasonable basis for expectation that any documents to be generated in the course of the research project will be subjected by an outside sponsor to restrictions on publication for a period in excess of that reasonably required (i.e., more than 90 days) for the sponsor to ascertain whether information he or she is entitled to have treated as confidential would be disclosed by publication

• If access will be required in the course of the project to confidential data so centrally related to the research that a member of the research group who was not privy to the confidential data would be unable to participate fully in all of the intellectually significant portions of the project

The rules adopted by the Academic Council on September 29, 1967, are hereby amended and, as amended, are reaffirmed:

1. No research on a thesis or dissertation should be undertaken if, at the time the topic is set, there is any substantial possibility that it will lead to a secret thesis or dissertation.

2. No secret thesis or dissertation should be accepted as the basis for a degree unless, in the judgment of the Committee on Graduate Studies, the imposition of secrecy could not reasonably have been foreseen until the work was so far advanced that modification of the thesis topic would have resulted in substantial inequity to the student.

3. Scholarly activities not accessible for scrutiny by the entire Advisory Board should not be considered in connection with appointments, reappointments or promotions.

4. The University should enter no contract and accept no grant to carry out research if the grant or contract restrains the freedom of the University to disclose the:

• Existence of the contract or grant or,

• General nature of the inquiry to be conducted or,

• Identity of the outside contracting or granting entity or,

• The research results;

provided that this clause shall not apply either (a) to anonymous gifts or grants that do not call for the performance of specified lines of inquiry, or (b) to research grants or contracts from individuals or non-governmental entities who request anonymity out of a justifiable motivation to protect individual privacy.

A program of research, appropriate to the University on other grounds, shall not be regarded as unacceptable by reason of secrecy merely because one or more of the following circumstances exists:

This policy shall be reviewed at least annually by the Committee on Research in one of its meetings. This meeting and others primarily devoted to considering a revision of research policy shall be announced publicly through the website of the Committee on Research and/or other suitable means.

Multi-investigator research teams differ significantly from the individual faculty/graduate student research teams, which are the norm at Stanford. In particular, the former often consist of colleagues from different disciplines who perform different, specialized functions. It is possible for participants to have little knowledge or understanding of parts of the work performed by their colleagues. Sometimes, there is no single person who understands all the research.

With this in mind, the Committee on Research has drawn up the following guidelines for scholarly manuscripts emanating from multi-investigator research. We have endeavored to keep these simple and fundamental. As a consequence, the guidelines appear applicable to all scholarly collaborations in which multiple authorship is anticipated.

1. Principal investigators and senior faculty have special responsibilities to assure the overall cohesiveness and validity of the publications on which they appear as coauthors.
2. All authors in a group effort have a shared responsibility for the published result and should have the opportunity to review all sample preparation procedures and data, as well as all data acquisition and analysis procedures.
3. Each author in a group effort should have access to the manuscript prior to its being submitted for publication, and should agree to his or her inclusion as a coauthor. All the participants in the program should know that the paper is being prepared for publication.
4. Early in the project, each research group should define appropriate practices for the maintenance of data.

Stanford University does not discriminate on the basis of race, religious creed, color, national origin, ancestry, physical, or mental disability, medical condition, marital status, sex, age, sexual orientation, gender identity, veteran status, or any other characteristic protected by law, in connection with any aspect of employment at Stanford, or in its research agreements. Stanford also prohibits discrimination for any of these reasons in the admission of students, and in the administration of its educational policies and programs.

In addition, and in accordance with its policy on Openness in Research, Stanford does not limit participation in research activities on the basis of citizenship. This commitment to an open research environment supports the principle of freedom of access by all interested persons to the underlying data, to the processes, and to the final results of research, and preserves the ability of Stanford faculty to select the best qualified individuals to participate in research, including student participants.

Therefore, as a general proposition, Stanford does not enter into research agreements which permit discrimination on the basis of citizenship against individuals engaged in research activities proposed or conducted under its auspices.

In the following circumstances, where and to the extent permitted by applicable law and consistent with the principle stated above of freedom of access and participation, an exception to this policy may be considered in regard to citizenship restrictions.

The Committee on Research shall review the implementation of the above policy, and report its findings to the Senate of the Academic Council within three years of the 2009 revision.

The PI has overall responsibility for the technical and fiscal management of a sponsored project. This includes the management of the project within funding limitations, adherence to reporting requirements and assurance that the sponsor will be notified when significant conditions related to project status change. This document addresses specific responsibilities concerned with the financial management of sponsored projects. While responsibility for the day-to-day management of project finances may be delegated to administrative or other staff, accountability for compliance with Stanford policy and sponsor requirements ultimately rests with the PI.

Stanford University requires all PIs to review their obligations for stewardship of sponsor funds and compliance with applicable regulations. For that purpose, specialized briefings are conducted. Individuals may also certify their review of this material by taking the course entitled "Stewardship and Compliance for Principal Investigators".

To authorize the expenditure of funds to be charged directly to sponsored projects, the PI and originating department must assure that the:

• estimated charge is reasonable and necessary
• expenditure is allowable by the funding source and, if charged to a federally funded project, by OMB Circulars A-21 and A-110 or the Uniform Guidance
• expenditure is allocable to the project, i.e., provides benefit to the project
• funds are available within the authorized award amount and funding limitations
• justification for the expenditure is documented
• method of allocation of costs is appropriate and documented
• charge is coded with the correct Expenditure Type and charged to the correct account [Project Task Award (PTA)]
• charge has been processed through the appropriate University system
• salaries and wages charged are reasonable in relation to the work performed and to the individual’s total payroll distribution
• payroll charge to each sponsored project account does not exceed the effort devoted to that project 

Stanford Base Salary (SBS) is the annual compensation paid by Stanford to individuals whose time is spent on research, teaching and/or other activities.

Stanford Base Salary:

1. Includes regular and supplemental salary
2. Excludes bonus payments and extra compensation such as faculty housing allowance, tuition reimbursement, etc.
3. Excludes any income that an individual is permitted to earn outside of the Stanford responsibilities (e.g., consulting payments)
4. May not be increased as a result of replacing Stanford’s salary funds with sponsored project funds

Expenditure Statements are the official record of project expenses and the basis for cost reimbursements to Stanford.

Expenditures for sponsored projects and cost sharing accounts must be reviewed by a knowledgeable individual, i.e., the PI or designee (typically the financial or research administrator) so that adjustments can be made in a timely manner, and that rates of expenditures can be monitored to assure availability of funds.  To be considered timely, monthly expenditures must be reviewed within two months of the end of the month being reviewed.  This review is documented by means of the reviewer's signature on the Quarterly Expenditure Statement (RM149).

Any questionable charges must be brought promptly to the PI's attention, and, if needed, corrected by an appropriate transfer. Transfers should be initiated as soon as possible after a need has been identified. Whenever expenses are moved to or between sponsored accounts, the PI must assure that the project that ultimately pays the expense is the project that benefited from that expense, and that there is adequate documentation to support the appropriateness of the transaction. Procedures governing transfers of expense are defined in RPH, Cost Transfer Policy for Sponsored Projects.

Sponsored project and cost sharing accounts must be reviewed and certified by the PI quarterly. The following certification statement appears on Expenditure Statements for every sponsored project and cost sharing account:

The principal investigator confirms: to the best of my knowledge, salary and wages charged to this project are appropriate in relation to work performed on this project. All other costs charged to this project are, to the best of my knowledge, appropriate. Where required, corrections have been or will be made through the accounting system.

Project expenditures must be reviewed and certified every academic quarter, recorded by signature on the Quarterly Expenditure Statement (RM149). This certification is the responsibility of the project PI (or Co-PI). A PI may delegate the monthly review of expenditures for accuracy, but may not delegate certification of the appropriateness of the charges except as follows.  The PI may only delegate review and certification to a participating Academic Council member or PI eligible individual who is responsible for a portion of the statement of work and is identified as the Task Owner in the accounting system.

The purpose of the review and certification is to confirm that all expenses charged to the account are allowable, allocable to the project, and reasonable. The certification of salary expenditures confirms that salaries charged to the account are supported by a corresponding expenditure of effort during the time period being certified. The certification also assures that other expenditures are for items or services purchased and used during the project period as specified by the award. It is the PI's responsibility to seek a no-cost extension of the award if that is necessary in order to complete the project.

To be considered timely, the expenditure statement must be reviewed and signed within two months of the end of the academic quarter being certified.  A quarterly calendar detailing timeliness for both review of monthly expenditures and quarterly certifications of expenditures is available in the Related Items section of this policy.  Issues regarding the timely certification of expenditures should be discussed with the appropriate Department Chair, School Dean, and/or the Associate Vice Provost for Research or the Research Financial Compliance Services Office. 

Adequate explanation and documentation for all project charges must be maintained for four years after the sponsor closes out the award. Where documentation cannot be provided as to the allowability, allocability and reasonableness of any project expense, including but not limited to expenses incurred late in the project period, the sponsor may deny them. In this case, the PI, department or school will be expected to cover the expense from unrestricted sources.

Each school and independent laboratory must retain reviewed and certified Quarterly Expenditure Statements.

Any departure from the policy or procedures regarding summarization of Quarterly PI Review and Certification must be approved in advance by the Office of Vice Provost and Dean of Research (DoR) and Research Financial Compliance and Services Office (RFCS).

Federal regulations require certification of payroll distribution (total salaries and wages) for each faculty, staff, academic staff researcher (ASR), student and postdoctoral scholar whose Stanford salary is charged in whole or in part to one or more of the following:

• federally sponsored projects
• subawards with a federal prime sponsor where Stanford is a recipient
• cost sharing accounts for federally sponsored projects
• non federally sponsored projects that incorporate Office of Management and Budget (OMB) federal requirements (A-21 or the Uniform Guidance)

Faculty, and in rare situations designated certifiers, will review and certify employees’ payroll distribution on an annual basis beginning with calendar year 2013 salaries and wages using the eCertification system.  Prior to certification, the financial or research administrator shall review the annual payroll distribution for reasonableness. 

Faculty Self Certification

• Faculty members and individuals with PI waivers who charge any portion of their salary to any funding sources listed above will review and certify their own payroll distribution.

PI Certification of Employees:

• PIs will review and certify payroll distribution for staff, ASRs, students and postdoctoral scholars who perform work on his/her sponsored projects.
  • A PI may delegate the review of payroll expenditures for accuracy, but may not delegate certification of the appropriateness of the charges except as follows. The PI may only delegate review and certification to a participating Academic Council member or PI eligible individual who is responsible for a portion of the statement of work and is identified as the Task Owner in the accounting system.
  • In limited situations, the supervisor or other person with first-hand knowledge and/or suitable means of verification that the work was performed (designated certifier) will review and certify the payroll distribution. The Associate Vice Provost for Research must approve such exceptions.

Categories of Payroll Charges

The following payroll charges (salaries and wages) are to be reviewed and certified with the concept of reasonableness in relation to the work performed and to the individual’s 100% payroll distribution.  The PI or other designated certifier must have firsthand knowledge and/or suitable means of verification of the work performed and will review and certify the payroll distribution within the four categories as follows:

• Sponsored Projects: Payroll charges for each employee will be reviewed and certified by account [(Project Task Award (PTA)].  The payroll charge to each sponsored project account may not exceed the effort devoted to that project.  However, the payroll charge can be less than the effort devoted to that project.

• Cost Sharing: Payroll charges for each employee charged to a cost sharing account will be reviewed and certified by account.

• Over the Salary Cap: Payroll charges in this category will be reviewed and certified in aggregate.

• Non Sponsored Charges: Payroll charges in this category will be reviewed in aggregate based on an assessment of reasonableness in relation to the individual’s 100% payroll distribution.  The “Non-sponsored Charges” category may include the following:
  1. Faculty, Division, Departmental and School accounts that serve as a funding mechanism to supplement externally sponsored funding.  Payroll charges to these accounts represent additional effort/time expended that was not proposed or charged to sponsored accounts and will be considered in aggregate.
  2. Teaching responsibilities
  3. Preparation and submission of new and competitive sponsored proposals
  4. Non-sponsored research (funded by faculty, department, school or university funds)
  5. Clinical responsibilities
  6. Administrative responsibilities
  7. Other university responsibilities or activities

Review and Certification

The Federal Office of Management and Budget recognizes that in an academic setting, teaching, research, service, and administration are often inextricably intermingled. A precise assessment of factors that contribute to costs is not always feasible, nor is it expected. Reliance, therefore, is placed on estimates in which a degree of tolerance is appropriate.  Stanford's acceptable degree of tolerance is +/-5%.

1. An individual’s total payroll distribution/effort is equal to the total time spent on his/her university responsibilities.  Total payroll distribution/effort is not limited to 40 or any other specific number of hours. 
2. Outside consulting is not part of an individual’s university responsibilities.
3. Individuals are not required to maintain detailed time records of their actual work.

Certification Statement

After reviewing payroll charges information, PIs and other designated certifiers will certify:

To the best of my knowledge, the salary charges to individual sponsored projects and cost sharing accounts as well as the over the salary cap category and the non sponsored category are reasonable in relation to work performed under my direction.

If the payroll distribution for an individual is not reasonable or appropriate, the PI or designated certifier should not certify and should notify his or her research administration staff contact to make necessary changes. Review and certification must be completed by June 5, 2015.  Issues related to the timely certification of payroll distribution should be discussed with the Vice Provost and Dean of Research or the Research Financial Compliance Services Office. 

Recertification

If a payroll adjustment is made to a previously certified employee's payroll distribution, the certifier may need to recertify that employee's payroll distribution per the instructions below.  

Sponsored Projects or Cost Sharing:

Payroll adjustments more than +/-5% for an individual sponsored project or an individual cost sharing account must be recertified unless the adjustment is within the same SPO number.

Over The Salary Cap Category or Non Sponsored Category

Payroll adjustments that impact the category total more than +/-5% must be recertified.  Changes within these categories need not be recertified if they do not impact the Sponsored Projects or Cost Sharing categories.

Recertification must be completed within one month of notification by Research Financial Compliance and Services. There may be additional circumstances where the Dean of Research Office or RFCS requires recertification. For more information see the Payroll Distribution Recertification Matrix in Related Items below.

Staff at Stanford University, including Academic Staff-Research (non-faculty), accrue vacation as specified by University policy see below in Related Items Administrative Guide memo 22.5: Vacations. Stanford and the Office of Naval Research have established Vacation Accrual/Disability Sick Leave rates for exempt and nonexempt/bargaining unit staff. These accrual rates, reviewed and negotiated annually, enable Stanford to charge the appropriate funding source for vacation earned by benefits-eligible staff as they are working.

Proposal preparation costs are the costs of preparing proposals on potential Federal and non-Federal projects, including the development of data necessary to support Stanford's proposals.  These costs typically include salary for the PI and/or others. 

The cost of proposal preparation activities in support of new and competing sponsored proposals cannot be charged to sponsored projects except when explicitly allowed or required by the sponsor (e.g. NIH Mentored Career Development Awards).

The cost of proposal preparation efforts for a non-competing extension or continuing research may be charged to current related projects.

Work performed by faculty, academic staff researchers, instructors and regular staff that is related to current projects may also be related to new projects in development. Only the incremental effort associated with proposal preparation that does not benefit the existing project(s) needs to be identified and charged to an appropriate non-sponsored account.

PIs are responsible for the ongoing fiscal management of awarded projects, including regular monitoring against project period budgets. Federal grants policy (OMB Circular A-110) establishes the approved project budget as the financial expression of the project, and sponsors may evaluate the project against the budget at any time. Although sponsors allow certain flexibilities with respect to rebudgeting, unobligated balances, and preaward costs, Stanford University and sponsors expect expenditures to be reasonably consistent with the approved project and budget. Sponsors may question or restrict expenditures that appear inconsistent with the project plan and budget. PIs are obligated to request prior approval when budget and program plan revisions indicate a significant change in scope. Indicators of a change in scope can include, for example, significant expenditures beyond the amount authorized on the award, or requests for additional funding.

It is Stanford's expectation that projects will be managed within their established budgets. If, as a result of unusual circumstances or unanticipated project expenses, an account is in overdraft upon expiration of the term of the sponsored project, and if additional funds have not been received from the sponsor, the PI must identify an appropriate source of funds (e.g., gift, endowment, or operating budget) to cover the expense. The overdraft must be transferred to a cost sharing award in sufficient time to permit Stanford to comply with the financial reporting requirements of the original award (See Project Closeout, below).

The department must identify the source of funds to the Office of Sponsored Research or designated School office, which will create a cost sharing account. The department will then initiate the necessary expense transfer, including documentation of the nature of the expenses, noting they were legitimate project expenses but the funding was inadequate, and other reasons for the transfer. Such transfers must occur in sufficient time to permit Stanford to comply with the financial reporting requirements of Closeout, and the RPH: Cost Transfer Policy for Sponsored Projects.

The PI, department or school is responsible for the timely clearance of any unfunded expenditures from within its resources.

If additional time is needed to complete a project and there is an unexpended balance in the award, PIs may request that the period of performance of an award be extended. In some cases, Stanford officials are authorized to approve no cost time extensions; in other cases, agency prior approval is required. Requests for extensions should be initiated by a PI and processed in accordance with the terms of the sponsored award; in most cases, the countersignature of an authorized institutional office is required. To ensure compliance with the reporting requirements of awards, PIs are urged to submit no-cost time extension requests as soon as the need becomes apparent. Requests for a no cost extension should be submitted no later than the end date of the award (unless an earlier date is required by the agency.) Award closeouts cannot be delayed to accommodate pending requests submitted after the award end date.

If final technical reports are to be completed after the project end date, and funds from the project are available to pay these expenses, a no cost extension should be obtained from the sponsor to cover the expense of producing and distributing those reports. If funds are not available from the project, then the PI, department or school must identify unrestricted funds to pay final report costs.

PIs are responsible for overseeing the proper closeout of sponsored projects, including the timely submission of all required reports (including final technical reports). While central offices prepare and submit final administrative reports, including financial and property reports, they do so on the basis of documentation created in the department. PIs must assure that such documentation is adequate and readily available. In addition, PIs are responsible for ensuring that any necessary final financial adjustments and documentation (e.g., final invoices from vendors or subrecipients) are received promptly after the end of the award.

If an approval to close an award has not already been provided by the PI, the Office of Sponsored Research will prepare and submit financial reports based on the information reflected in the financial system. In addition, some financial reports may require the PI's signature.

Stanford's Faculty Policy on Conflict of Commitment and Interest establishes requirements for faculty disclosures (on both an annual and an ad hoc basic) of financial interests and professional relationships related to research projects, and for annual certifications of policy compliance. In addition, Stanford's policy requires that faculty members seeking funding from an external sponsor comply with the disclosure requirements of that sponsor.

In addition to requirements for an institutional policy on conflict of interest, several federal agencies have their own requirements for disclosures related to their sponsored research projects; these include the Public Health Service (PHS) and related components such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), as well as the National Science Foundation (NSF). This policy provides specific guidance related to the requirements of those agencies.

PHS requires that, for each proposal submitted to that agency, the Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (Investigators) certify that he or she has appropriately disclosed any Significant Financial Interests (SFI) related to his or her institutional responsibilities to Stanford. These SFI disclosures must be updated at least annually and within thirty days of entering into a new relationship with a company/organization or discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI. Before an award can be accepted, Stanford must determine:

1. If the SFI is related to the Investigator's research responsibilities and to the specific research award in question
2. If the SFI creates an FCOI
3. If an FCOI is determined to exist, then a Management Plan detailing how the conflict will be managed, reduced, or eliminated must be developed and implemented.

At Stanford, each School will handle this responsibility for its own Investigators, relying on the annual (OPACS) and transactional/ad hoc disclosures submitted by faculty as required by Stanford's Faculty Policy on Conflict of Commitment and Interest in RPH.

PHS components including the NIH require that Investigators disclose to a designated representative of the institution all SFIs that would reasonably appear to be related to the Investigator's institutional responsibilities which include: research and other scholarly activities; clinical care activities; teaching or educational activities; and administrative activities.

SFI means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse/domestic partner or dependent children) that reasonably appear to be related to the Investigator's institutional responsibilities:

• With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000
• With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests that is not paid through Stanford

An FCOI means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

[1] The requirements regarding Investigator financial conflicts of interest in research funded under PHS grants or cooperative agreements can be found at http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf, pp 53283-53288.

NSF requires Stanford to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced or eliminated prior to the expenditure of the award funds. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.

As provided by Stanford’s Faculty Policy on Conflict of Commitment and Interest in RPH, NSF requires that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF or in entities whose financial interests would reasonably appear to be affected by such activities.

The term “investigator” means the principal investigator, co-principal investigators/co-project directors, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.

As specified by NSF, the term “significant financial interest” (SFI) means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

The term does not include:

• salary, royalties, or other remuneration from the applicant institution
• income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities
• income from service on advisory committees or review panels for public or nonprofit entities
• an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity
• salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $5,000 during the twelve month period

NOTE: Although current NSF regulations specify a higher threshold for SFI than PHS (NIH), Stanford policy identifies $5,000 as the monetary threshold. Similarly, in non-publicly traded companies, PHS and Stanford policy identify any equity amount as the threshold.

NSF requires Stanford to ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. Stanford must also ensure that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.

Stanford designates individuals to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to:

• public disclosure of significant financial interests
• monitoring of research by independent reviewers
• modification of the research plan
• disqualification from participation in the portion of the NSF-funded research that would be affected by significant financial interests
• divestiture of significant financial interests
• severance of relationships that create conflicts

Stanford must have adequate enforcement mechanisms, provide for sanctions where appropriate and must keep NSF’s Office of the General Counsel appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest. Grantee notifications of conflict of interest that cannot be managed, reduced, or eliminated must be submitted electronically via the NSF FastLane system by the Dean of Research Office.

Stanford must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.

[2] The conflict of interest policies of the NSF can be found at: http://www.nsf.gov/pubs/policydocs/pappguide/nsf08_1/aag_4.jsp

Date: August 22, 2012

Principal Investigators must complete a Proposal Development & Routing Form (PDRF) in order to document that all requirements related to the submission of a funded research proposal have been met. If the PI indicates the existence of a related financial interest, the PDRF links to questions about those financial interests that may reasonably appear to be related to the research project, including:

1.     Name of company/organization (foundation, society, other)  

2.     What is the nature of your activity/financial interest with the company/organization? (check all that apply)

__ Board of Directors membership 
__ Advisory Board membership
__ Consultant (other than Advisory Board or Board of Directors membership)
__ Licensing of your Stanford or non-Stanford intellectual property
__ Ownership of stock or stock options or other ownership interests
    (excluding investments for which you do not directly control investment
      decisions, such as mutual funds) 
__ Payment for royalties for inventions (not paid through Stanford)
__ Payment for lectures
__ Payment for preparation of papers or reports    
__ Payment for product evaluation 
__ Legal consultant or expert witness
__ Executive or other employee position with company/organization
__ This is a financial interest/activity of my spouse/domestic partner or dependent child   

3.     What is the total amount of your financial interest (or that of your spouse/domestic partner or dependent children) in this company/organization?

__ $1 - 4,999

__ $5K - $9,999K

__ $10K - 19,999K

__ $25 - 49,999K

__ $50K - 99,999K

__ $100 - 199,999K

__ greater then $200,000

4.     If this entity is a company, is it

__ Publicly traded or 
__ Privately held or Start Up

The general concepts of conflict of commitment and interest, as set forth in the Faculty Policy on Conflict of Commitment and Interest in RPH, and PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications in RPH. are applicable with certain modifications to the Academic Staff and Other Teaching Staff. Academic Staff and Other Teaching Staff members are referred to the full text of the Faculty Policy on Conflict of Commitment and Interest in RPH for further discussion of the points presented here.

Academic Staff and Other Teaching Staff, employed on a full-time basis at Stanford, owe their primary professional allegiance to the University, and their primary commitment of time and intellectual energies should be to the programs on which they are working. Whenever an individual's outside activities interfere with professional obligations to Stanford, a conflict of commitment exists. In the case of Academic Staff and Other Teaching Staff working at Stanford on a part-time basis, this general principle applies to the extent of the Stanford appointment. Individuals on less than full-time appointments may engage in consulting relationships and other employment, to the degree that those activities do not interfere with their obligations to Stanford.

The following points of policy relate to conflicts of commitment:

1. Outside consulting privileges are not normally available to full time Academic Staff and Other Teaching Staff. They may consult only with permission, as noted below. Under no circumstances may any Academic Staff or Other Teaching Staff member's outside consulting work exceed the limits imposed by the faculty consulting policy, i.e., 13 days per calendar quarter (that is, one day in seven) on a full-time equivalent basis. (See further discussion in Section IV, below.) Academic Staff and Other Teaching Staff may not use University resources or personnel, including facilities, staff, students or other trainees, equipment, or confidential information, except in a purely incidental way, as part of any outside consulting or business activities or for any other purposes that are unrelated to the education, research, scholarship or public service missions of the University. 


NOTE: Permission for full-time members of the Academic Staff or Other Teaching Staff to consult, including the reasons for such permission, must be in writing, normally on a prospective basis, by the department/program chairman (for members of the Academic Staff-Teaching or Other Teaching Staff), or by the principal investigator (for members of the Academic Staff-Research), or by the director of the appropriate library (for members of the Academic Staff-Libraries). If such permission is granted, the department/program chair or PI or library director is responsible for assuring that the consulting activities of the Academic Staff member individual do not adversely impact the achievement of program or project goals or subject the University to financial or reputation risk. He or she may require periodic written or oral reports from the Academic Staff or Other Teaching Staff member in order to discharge this responsibility. The content of these reports, and the basis for the permission itself, are subject to review by the department chair, relevant dean, or Vice Provost and Dean of Research. See further discussion below. 


2. Academic Staff and Other Teaching Staff must maintain a significant presence on campus (main or overseas) throughout each quarter in which they are employed by Stanford, consistent with the scope of their appointment.
3. Academic Staff and Other Teaching Staff must not allow other professional activities to detract from their primary allegiance to Stanford. For example, individuals employed on a full-time basis must not have outside managerial responsibilities nor act as a principal investigator on sponsored projects that could be conducted at Stanford University but instead are submitted and managed through another institution.

Stanford University is an institution of public trust; Academic Staff as well as faculty must respect that status and conduct their affairs in ways that will not compromise the integrity of the University or that trust.

A conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal financial gain. A conflict of interest depends on the situation, and not on the character or actions of the individual.

Academic Staff and Other Teaching Staff should conduct their affairs so as to avoid or minimize conflicts of interest, and must respond appropriately when conflicts of interest arise. Conflicts of interest must be disclosed to Stanford when personal financial relationships or activities with outside entities occur that would reasonably appear to be related to an Academic Staff member's Stanford institutional responsibilities for research/scholarship or education/teaching.

The following points of policy relate to conflicts of interest:

1. Academic Staff and Other Teaching Staff must foster the open and timely exchange of results of scholarly activities, informing faculty, students and colleagues about outside obligations and activities that might influence the free exchange of scholarly information.
2. Academic Staff and Other Teaching Staff must disclose on a timely basis the creation or discovery of all potentially patentable inventions created or discovered in the course of their University activities or with more than incidental use of University resources. If intellectual property rights are to be claimed, ownership of such inventions must be assigned to the University regardless of source of funding. The inventor will share in royalties earned.
3. Academic Staff and Other Teaching Staff must disclose on an annual and transactional/ad hoc basis to their supervisor, or to the principal investigator on their research, when they (or their spouse/domestic partner or dependent children) have a financial interest (defined below) in, an outside entity that would reasonably appear to be related to their institutional responsibilities. Disclosures of such interests are also required when the individual  is engaged in a specific transaction, including:

• gifts
• sponsored projects
• technology licensing arrangements
• protocols that use human subjects, animals, or stem cells
• material transfer and collaboration agreements
• certain procurements (e.g., sole source or from a privately-held company)

In such cases, review and approval by the school dean, the cognizant dean for COI or the designated COI program administrator will be required prior to entering into the proposed arrangement.

4. Financial interests or other outside activities that are disclosed and deemed to be related to one or more of the Academic Staff or Other Teaching Staff member's institutional responsibilities will be further reviewed to determine if the financial interest or relationship could have a direct and significant effect on the performance of his or her responsibilities. If such a situation exists, the conflict will need to be eliminated or managed according to a plan provided to the individual by the cognizant dean for COI. Other administrative actions, such as disclosure in publications and public talks, may be required when the financial interest is not considered likely to directly and significantly affect performance of institutional responsibilities.
5. Academic Staff and Other Teaching Staff who are approved for Principal Investigator status are required to file appropriate transactional/ad hoc COI disclosures as required as well as an annual disclosure certifying compliance with the Faculty Conflict of Commitment and Interest Policy in RPH.

If a situation raising questions of conflict of commitment or interest arises, Academic Staff and Other Teaching Staff must discuss the situation with their supervisor, principal investigator, or with the department chair or school dean or the person designated to assess conflicts of commitment and interest in their school or independent laboratory.

The decision to permit consulting by an Academic Staff or Other Teaching Staff member will depend on the circumstances of each situation, including the needs of the program or project, the individual's role and the scope of his or her appointment. Such permission is subject to review as circumstances change. If permission is granted, time spent on consulting must be in addition to, rather than part of, the regular effort expected of the individual's University work.

It is the responsibility of each Academic Staff and Other Teaching Staff member who wishes to engage in outside consulting to be aware of the University's limits on such activities. A full-time Academic Staff member's consulting activities may never exceed 13 days per calendar quarter (that is, one day in seven). This maximum applies to all periods of University employment, including vacations, quarter breaks, or other paid time off from work. Department chairs or PIs may limit an Academic Staff member's outside consulting activities to fewer than 13 days per quarter as necessary to meet University programmatic needs or project goals.

This policy is a University-wide policy. In addition, there may be further restrictions placed on Academic Staff and Other Teaching Staff consulting activities within individual schools or independent laboratories, centers and institutes. Academic Staff should request information about further policy limits from the school dean's office or the Dean or Research.

When an Academic Staff or Other Teaching Staff member is involved in activities not directly associated with Stanford (e.g., independent consulting, other business activities, publications, etc.), use of Stanford's name and marks is limited to identification of the individual by his or her affiliation (e.g., Jane Smith, Senior Lecturer, Stanford University) and must be consistent with the guidance provided in Administrative Guide Memo 15.5. The title may only be used only during the term of the appointment at the University and must always be used in its entirety; it cannot be abbreviated or altered.

In the event of conflict between the provisions of any consulting agreement and the terms and conditions of employment of an Academic Staff or Other Teaching Staff member by Stanford, the latter shall prevail. The following sentence (or one similar) should be included in Academic Staff or Other Teaching Staff member's outside consulting agreements: “The terms and conditions of employment and appointment by Stanford University and the provisions of any agreement between Stanford and external sponsors of projects on which the consultant works as part of his/her University duties, shall prevail in the event of any conflict with the provisions of this Agreement."

In the course of technology licensing, and in developing, marketing, selling and licensing various types of distance learning, Stanford University sometimes has the opportunity to acquire equity. This policy enables Stanford University to receive a benefit from equity. While potential conflict of interest issues are addressed through the Faculty Policy on Conflicts of Commitment and Interest RPH, the policy on Conflict of Commitment and Interest for Academic Staff in RPH, the Staff Policy on Conflict of Commitment and Interest in the Administrative Guide Memo 15.4 and through management of the University's equity separate from the Office of Technology Licensing (OTL) or an affected school or department. Equity includes shares of stock, and also other forms of equity (such as warrants, options, interest in limited partnerships or limited liability companies) that lend themselves to distribution in the manner contemplated.

1. The University may accept equity as one form of compensation for license rights, subject to a conflict of interest review if appropriate.
2. Of the total amount of equity which is to be issued for a particular license, fifteen percent (15%) of such equity ("the Administrative Share") will be issued to the University for the benefit of the Office of Technology Licensing ("OTL") to cover its general administrative expenses.
3. The remaining equity to be issued for the license, after deducting the Administrative Share, will be considered as "Net Equity."
4. One third (1/3) of the Net Equity will be issued to the Inventor(s) as the Inventor(s)'s Shares. Following issuance of Net Equity, it shall be the sole responsibility of the Inventor(s) to manage the Inventor(s)'s Shares and to comply with any tax, legal or contractual obligations associated with the distribution, ownership, or disposition of the Inventor(s)'s Shares.
5. The remaining two thirds (2/3) of Net Equity will be issued to the University as the University Share. The OTL Research and Fellowship Fund, administered by the Vice Provost and Dean of Research, will receive the University Share, less any unreimbursed OTL direct expenses.
6. All equity received by the University will be managed by Stanford Management Company.

1. The University may accept equity as one form of compensation for distance learning, subject to a conflict of interest review.
2. The Provost, or his designees, will determine the allocations of equity under this policy. In making this determination, factors to take into account include: 1) any royalties or other compensation received from the affected parties; 2) any seed funds or other support given by the school or department to the long distance venture; 3) the value of the university's name to the venture; 4) the value to the distance learning venture that was added by each of the parties; and 5) such other factors as are deemed relevant.
3. Of the total amount of equity which is to be issued for a particular venture, fifteen percent (15%) of such equity ("the Administrative Share") will be issued to the University for the benefit of the Office of Technology Licensing (OTL). If Learning Technology and Extended Education (LTEE) or the Stanford Center for Professional Development (SCPD) has contributed significantly to the licensing of the work, the Dean of Research may allocate a portion of the 15% to LTEE or SCPD, as appropriate.
4. The remaining equity to be issued for the license, after deducting the Administrative Share, will be considered as "Net Equity."
5. Up to one third (1/3) of the Net Equity may be issued to the Creator(s) as the Creator(s)'s Shares. Following issuance of Net Equity, it shall be the sole responsibility of the Creator(s) to manage the Creator(s)'s Shares and to comply with any tax, legal, or contractual obligations associated with the distribution, ownership, or disposition of the Creator(s)' Shares.
6. The "Creator" or "Creators" are those individual(s) who created the intellectual content for the distance learning venture. If there is more than one Creator, they will generally share equally in the Creators' Share. If there are no readily identifiable Creators because the distance learning venture is a group project, was largely created by University or Departmental resources or for any other reason, then the Creators' Share will go to the University as set forth in paragraph 7. A committee appointed by the Provost [see 2 above] will make the determination of the apportionment of the "Creator" share.
7. The remaining Net Equity will be issued to the University as the University Share. The Office of the Provost will determine how such proceeds are to be distributed. A department or school may petition the Office of the Provost to receive a portion of the equity for its particular teaching and education purposes.
8. All equity received by the University will be managed by Stanford Management Company.
9. Any disputes about any issues covered by this policy shall be submitted to the Provost who will attempt to informally resolve the dispute and, failing that, appoint a Panel to decide each dispute. Any objections to the decision of the Panel must be made in writing within 30 days of the decision of the Panel to the President, and the President of his designee will make a final and binding determination of the dispute.

It may be in the best interests of technology transfer and distance learning to include equity as partial consideration of a license agreement. Young, privately-held companies often do not have the requisite cash reserves to compete with an established company for rights to Stanford property. An offering of equity is a means of enabling small companies to license Stanford technology or otherwise participate with Stanford in distance learning ventures. However, the acceptance of equity presents two potential problems: risk and the generation of conflicts of interest.

Risk is an issue because, at the time equity is given, it generally has no value. Whether or not it will acquire value will depend on the overall success of the company, which is a function of many factors that may not relate to the technology being licensed or the educational content being distributed. Therefore, Stanford University will always require some cash as part of the upfront license agreement.

Equity has considerable potential for creating conflicts of interest for inventors, creators and the University because equity holders are part owners of the company. As owners, they stand to gain considerably if the company does well, and therefore there may be incentives to take actions and make decisions that favor the interests of the company over the academic missions of the University.

Stanford's Faculty Policy on Conflict of Commitment and Interest in RPH recognizes these potential conflicts and requires disclosure and intervention as necessary to manage them. However, since departments and schools are involved in key personnel and facilities decisions, conflict of interest can also be a concern at the organizational and institutional levels.

Stanford University's Federalwide Assurance for the protection of human subjects, along with the related assurances for Stanford Hospital and Clinics, Lucille Salter Packard Children's Hospital, the Palo Alto Veterans Institute for Research, and the Veteran's Administration Palo Alto Health Care System are all provided below in "Related Items" as PDF files.

Incorporated into Stanford's Federalwide Assurance are:  The Belmont Report and Code of Federal Regulations, 45 CFR 46, Protection of Human Subjects.

View the assurances by selecting Documents in the Related Items section below.

Some specific types of studies have triggered questions with respect to investigators' responsibilities and the need to obtain prospective review and approval of the IRB:

Stanford University supports a wide range of both undergraduate and graduate student research projects involving human subjects -- from course-related research exercises to Ph.D. dissertation studies.

A pilot study is a preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer subjects) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Such a pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review. Data collected from a pilot study cannot be used as research data.

An oral history study may not require IRB review because it is not generally thought to be a systematic investigation designed to contribute to generalizable knowledge beyond the individual being interviewed. However, when using oral history as a technique in human subject research it may require IRB review. Researchers proposing such work are strongly encouraged to contact the IRB to determine whether their project requires approval.

Research conducted in conjunction with program evaluations or quality assurance measures may or may not fall under the jurisdiction of the IRB. If such a project is conducted with the intent to develop or contribute to generalizable knowledge, it should be submitted for IRB review. For clarification, please contact the IRB to discuss the details of your project.

In developing and testing new drugs with therapeutic potential it is usually necessary to conduct studies on human volunteers. This remains true for drugs, including but not limited to opiate analgesics, which are known to have significant potential for addiction in some individuals. In order to serve the goal of minimizing potential risk to human subjects, these guidelines review special features of studies involving human volunteers receiving potentially addicting drugs.

Human volunteer subjects who may receive drugs with significant potential for addiction (examples include but are not limited to opiates, cocaine, alcohol) in a study must be informed that the drug(s) they may (or will) receive are known to have a significant potential for addiction in some individuals. If the magnitude of the risk of addiction in relevant populations is known it should be specified.

With some exceptions, potential volunteer subjects who have a known history of addiction should be excluded from studies of drugs with a significant potential for addiction. The informed consent should indicate that potential subjects should not participate in the study if they have any history of addiction to a drug or to alcohol. Subjects should be asked to check off a box on the consent form to indicate that they do not have such a history.


Furthermore, investigators may wish to incorporate a confidential pre-screening questionnaire about prior drug use history in such studies. Investigators may also choose to perform urine drug screening of subjects. If pre-screening questionnaires or urine testing is utilized, subjects should be informed as to how the confidentiality of these data will be maintained, and to whom they may be released.

The exceptions to this exclusion policy are those protocols which require the participation of addicted patient subjects to answer a scientific question (e.g., the effect of moderate doses of alcohol on a biologic variable which might predict subsequent relapse or give insight into the etiology of the disorder.) The justification for experimental ingestion or intoxication must be included in the application.

Potential volunteer subjects who have direct physical access to and routine handling of addicting drugs in the regular course of their work duties should be excluded from studies of drugs with a significant potential for addiction and to which the subject has access.


It is known clinically that addiction to certain types of medications is an occupational hazard of certain groups of health care workers. Although the prevalence within each group is not well-established, it is a well-described hazard for personnel who meet the following functional definition: personnel with direct physical access to and routine handling of addicting drugs in the regular course of their work duties. In particular, there is a risk for addiction to opiates, sedative-hypnotics, and cocaine. The health care workers in this group may vary depending on the drug involved and on the practice setting of the worker. However, typically the group with regular access includes: anesthesiologists; emergency room physicians; ward, operating room, post-anesthesia care unit, emergency room, and intensive care unit nurses; pharmacists. The exclusion stated above applies to those who meet the functional definition above, and not specifically to any general title or job description.


It is also known that health care workers who are addicted to medications can often effectively hide the signs and symptoms of their addiction. This exclusion guideline would therefore operate to prevent the harm that would result if an addicted subject was inadvertently included in a study of the drug to which the subject is addicted.

Health care workers who would be excluded under this Guideline make up a small component of the available volunteer pool for the testing of new therapeutic drugs. Thus, their participation is not required to ensure proper testing and validation of the safety of new or existing addicting drugs. Therefore, any risk of addiction in this group, no matter how small, cannot ordinarily be justified by the scientific benefit to be gained by their participation in studies of addicting drugs. It is generally expected that potential subjects who are health care workers who have direct physical access to and/or routine handling of addicting drugs in the regular course of their clinical duties will be excluded from studies in which an addicting drug to which they have access will be administered. If an investigator believes that inclusion of such personnel is necessary for the scientific goal of the study, a special application that justifies inclusion of these personnel must be made in the submission to the IRB.


The informed consent should indicate that potential subjects who meet the functional definition should not participate in the study, and subjects should be asked to check off a box indicating that they do not meet this functional definition.

It is the policy of Stanford University that the use of either live or deceased vertebrate animals for solely instructional purposes is permitted when:

1. The cognizant instructor(s) judges that the educational goals of the program or course will be best achieved by such usage
2. The Administrative Panel on Laboratory Animal Care determines that such usage is humane, proper, and appropriate, consistent with government principles and regulations for the utilization and care of vertebrate animals used in teaching and research. Only the minimum number of animals essential to instructional objectives should be used. Instructors should be encouraged to use alternatives to animals whenever possible

Academic departments and programs should alert prospective students if any courses which are required for a major or degree involve the use of animals. This requirement may be met by a statement to the effect that some required courses for certain degrees may involve use of animals tissue, and that interested students should seek further information about such requirements from the department. Normally this statement should appear in Courses and Degrees.

Instructors must inform their students during the first week of class if animals or animal tissue will or may be used as part of that course. Students who have concerns about the use of animals may then choose whether or not to take the class. Students should feel free to discuss their concerns with the instructor, but should be aware that instructors and departments are not obligated to alter course requirements which are consistent with University policies.

Any faculty member who intends to use vertebrate animals for teaching purposes must submit an Animal Use Protocol signed by the department chairperson to the Administrative Panel on Laboratory Animal Care. Reuse of previously approved preserved material requires no approval. Courses taught each year with no significant changes in animal usage must submit a Renewal Animal Use Protocol each year.

The protocol must include information about the source from which animals are procured. In addition, the protocol must explain why animals are needed to achieve the goals of the course, and justify the species and the number of animals to be used. If the Administrative Panel on Laboratory Animal Care questions the species of animal chosen, the procurement process, the number of animals to be used or other related matters, such questions need to be resolved before the animals may be ordered.

Live vertebrate animals must be cared for according to the Department of Comparative Medicine policies and procedures governing the use of laboratory animals. Disposal of animal tissue must be in compliance with relevant health and safety regulations.

The care and use of laboratory animals procured by Stanford University for teaching, research, and related activities are governed by policies designed to keep the University in compliance with all relevant external regulations for the humane treatment of laboratory animals. Occasionally, Stanford investigators engage in collaborations with or provide services to outside institutions that require the transportation of non-Stanford owned laboratory animals onto the Stanford campus. This document sets forth procedures that must be followed in these situations so that the animals involved are treated humanely, there is appropriate risk management, and the University remains in compliance with relevant external regulations.

The owners of non-Stanford laboratory animals must assume responsibility for the animals' welfare while on the campus and act in a supervisory role in overseeing the animals' welfare. Stanford personnel may serve as assistants.

When non-Stanford owned laboratory animals are to be brought to Stanford as a result of a collaboration between Stanford investigators and an outside institution, the Administrative Panel on Laboratory Animal Care (A-PLAC) requires the following:

• an A-PLAC application form, for review and approval, covering the work to be done at Stanford
• an abstract of an approved protocol covering the portion of the collaborative effort to take place at the outside institution and the corollary IACUC approval document. (In special circumstances, the full protocol may be required.)
• the outside institution's Public Health Service (PHS) Assurance Number, US Department of Agriculture (USDA) Registration Number, or their certificate of registration from the State of California. (This will be required in most, if not all, cases.)

When non-Stanford owned laboratory animals are to be brought to campus as a result of Stanford providing services to an outside entity (e.g., use of special equipment), the A-PLAC requires the following before approval can be granted:

• Proof that a Research Participation Agreement or other contractual arrangement has been approved by the University
• A description of the procedures to be performed on the animals at Stanford including: transportation arrangements, anesthesia or other chemical or physical restraint methods, experimental manipulation, euthanasia, or anything else pertinent to the care and use of the laboratory animals while they are on the campus
• Documentation showing that all portions of the research activity occurring at the outside entity involving these animals have been approved by that entity's Institutional Animal Care and Use Committee. That document must further display either the outside institution's PHS Assurance Number, USDA Registration Number, or their certificate of registration from the State of California.

Animals may not be held on the Stanford campus overnight without a formal transfer of ownership to Stanford. The A-PLAC and the Attending Veterinarian must approve all such arrangements.

Non-Stanford owned laboratory animals may not be brought to or taken from the Stanford campus without the prior review and approval of the A-PLAC. The A-PLAC will review such requests in consultation with the Attending Veterinarian who must be notified in advance when approved transportation of laboratory animals will occur. The Attending Veterinarian can be reached at 723-3876.

In July 1991, a California law took effect mandating that Stanford, and all other California employers, develop, implement, and maintain a workplace Injury and Illness Prevention Program (IIPP). The IIPP sets forth specific requirements for training, reporting hazards and accidents, inspecting the workplace, correcting hazards, and keeping records. In the spring of 1991, health and safety policies were adopted at Stanford which reflected the requirements of the IIPP and responsible institutional conduct regarding environmental and health and safety hazards.

Stanford University makes all reasonable efforts to:

• Protect the health and safety of Stanford University faculty, staff and students
• Provide safe workplaces - academic, research, and administrative - for faculty, staff, and students
• Provide information to faculty, staff, and students about health and safety hazards
• Identify and correct health and safety hazards and encourage faculty, staff, and students to report hazards
• Provide information and safeguards for those on campus and in the surrounding community regarding environmental hazards arising from operations at Stanford University

Stanford University is committed to strong programs of accident and injury prevention and to complying with all environmental and health and safety laws and regulations. Good health and safety practices are a responsibility of each faculty member, staff member, and student.

Line responsibility for good health and safety practice begins with the supervisor in the workplace, laboratory or classroom and proceeds upward through the levels of management. In academic areas, supervisors include the lab directors, class instructors, PIs and faculty, or others having direct supervisory authority. Academic levels of management are the department chairperson or Independent Lab director, dean, the Dean of Research, and the Provost. Administrative levels of management include mid-management, directors, and vice presidents. Final responsibility for health and safety policy and programs rests with the President of the University.

The Director of Environmental Health and Safety (EH&S) is responsible for recommending University-wide health and safety policies; ensuring overall institutional compliance with policies, statutes, and regulations; monitoring the effectiveness of the safety programs; and providing central health and safety services to all areas of the University.

The Departments of Public Safety and EH&S shall provide guidelines for emergency response plans. Every building shall have individual emergency response plans. The plan shall include evacuation and assembly procedures, posted evacuation maps, reporting and communication practices, training, and drills. Exits shall remain free of obstructions and materials that could render the exit hazardous. In areas where hazardous materials are used, handled, or stored, the emergency response plan shall conform to the Emergency and Hazardous Material Release Response policy set forth in this chapter.

Required documentation and records shall be kept to demonstrate compliance with statutes, regulations and standards. Examples of records that need to be maintained include:

• Records of training which must include who was trained, who provided the training, what did the training cover, and what date did the training take place
• Records of workplace inspection and hazard correction which must include who conducted the inspection, the inspection date, any unsafe conditions or practices found, and the corrective measures taken
• Records of disciplinary action for failure to comply with health and safety policies and practices

Environmental Health and Safety has outlined its Injury and Illness Prevention Program based on a mnemonic, T R I C K, which should help supervisors implement their IIPP responsibilities:

• Train employees when first hired or when a new hazard is introduced
• Report accidents and hazardous conditions - instruct employees to do the same
• Inspect your workplace for hazards
• Correct hazards found in the workplace
• Keep records

This memorandum announces changes in the University's Laboratory Animal Occupational Health Program (LAOHP) applicable to all faculty, staff, students and visiting scholars who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas. This program is authorized by federal regulations and Stanford's external accrediting agency. The LAOHP has been designed to:

• Protect individuals from work-related risks associated with exposure to animals through a program of species-specific health information, education, and risk-based medical evaluation
• Protect the health of research animals from certain transmissible diseases
• Be pertinent to the species with which individuals are exposed and the work they perform
• Be minimally intrusive
• Be cost-effective

The LAOHP has been revised as follows. Stanford University has opened its own Occupational Health Center (SUOHC) for Stanford employees, which will provide occupational medicine services as well as guidance pertaining to LAOHP.

The requirements for participation in the LAOHP depend upon an individual's level of potential risk. There are two defined categories of risk within the LAOHP: Risk Category 1 (RC1) and Risk Category 2 (RC2). The Administrative Panel on Laboratory Animal Care (A-PLAC) will determine the risk category for research and teaching individuals during the protocol review process.


Risk Category 1 (RC1)

Risk Category 1 (RC1) is considered higher risk and encompasses Veterinary Service Center (VSC) personnel, other dedicated animal care staff, and individuals who work with non-human primates (including unfixed tissue and bodily fluids), hoofed mammals (e.g., swine, goats, sheep, cows), wild rodents, and certain field studies. The specific risk factors are variable and dependent upon specific uses and handling identified in the animal care and use protocol application.


RC1 Participation Requirements

All individuals in RC1 group must complete and submit the LAOHP Health Questionnaire prior to the A-PLAC approval of an individual to work on a related protocol or assignment. Each questionnaire will be evaluated by a Stanford University Occupational Health Center (SUOHC) Clinician to determine the level of potential exposure and whether further steps are necessary. Specific medical surveillance can also be requested by Environmental Health & Safety (EH&S) and/or the SUOHC for any individual, based upon identified risk factors.



Risk Category 2 (RC2) 

Risk Category 2 (RC2) is for all individuals involved in animal care and use protocols that do not fall within the RC1 participation group.


RC2 Participation Requirements

All individuals in RC2 group are provided with information, educational materials and periodic updates on potential health and safety issues associated with the particular animal species or research material with which they work. These individuals are strongly encouraged to complete and submit the LAOHP Health Questionnaire, but this questionnaire is optional for members of RC2 participation group.

Another major change in the LAOHP program, as of July 2007, has been the opening of an on-site Occupational Health Center for all Stanford University faculty, staff, students, and visiting scholars who work directly with vertebrate animals, unfixed animal tissues or body fluids, and those who work in animal housing areas.

The SUOHC is located in the 
Environmental Services Facility
480 Oak Rd. (M/C 8007)
phone: (650) 725-5308.



The SUOHC is staffed with occupational health clinicians with experience in providing health-care services to individuals involved with laboratory animals. Each Health Questionnaire submitted by individuals from RC1 (mandatory) and RC2 (optional) is evaluated by the SUOHC clinician for potential exposures, individual health risk factors, and a determination as to whether further intervention steps or follow-up interactions are necessary. The SUOHC also provides the health-care services for VSC and other Stanford University Occupational Health programs. Contents of the Health Questionnaire and clinically related communications between the medical provider and the individual become part of the individual's Occupational Medical Record; maintenance and confidentiality of the Medical Record is dictated by appropriate Federal and State Regulations.

The SUOHC staff and other specialized personnel also provide periodic in-service training, seminars and education programs. These programs emphasize the specific risks associated with different types of laboratory animals and provide guidance to research and support personnel on appropriate methods of exposure control and protection.

Stanford is concerned about the safety and welfare of its faculty, staff, and students. We are committed to alerting individuals to potential work-related health risks and counseling them on methods to avoid workplace hazards. We must also comply with outside regulations associated with the use and welfare of animal subjects. The LAOHP for individuals who work with vertebrate animals is an integral part of achieving these goals.

Your cooperation is essential to the success of this program. If you have any questions about the occupational health program or SUOHC, please contact EH&S (723-0448) or SUOHC (725-5308). Please contact the A-PLAC Office (723-4550) with questions about the animal research protocols and risk level assigned.

Possession and use of radioisotopes must be authorized under a broad scope radioactive materials license issued to Stanford University by the State of California or the US Nuclear Regulatory Commission. All machines which produce ionizing radiations for which State registration is required must be registered centrally in the name of the Board of Trustees. All projects must comply with pertinent regulations and relevant terms of licenses.

The authority to review and approve uses of radioactive materials and radiation-producing machines is delegated to the Administrative Panel on Radiological Safety (APRS), which also recommends radiation policies to the President through the Office of the Vice Provost and Dean of Research. The APRS monitors compliance with regulations, license conditions and policies utilizing the Health Physics staff of the Environmental Health and Safety Department. All regulated radiation activities are open to inspection by the Health Physics staff. Detailed policies and procedures governing the acquisition, use, and disposal of radiation sources are found in the Radiation Safety Manual, available from Health Physics. The Manager of Health Physics, i.e., the Radiation Safety Officer (RSO), is designated in all licenses. The RSO may deny or withdraw approval to use a radiation source where an imminent threat to health and safety, non-compliance, or unsafe practice is found, pending review by the APRS.

Some of the responsibilities of Health Physics are to:

• Serve as consultants to the faculty and staff in radiation safety matters
• Provide general surveillance of radiation and contamination levels
• Inspect projects to determine compliance with regulations and standards
• Distribute personnel dose measurement devices and maintain records of radiation exposures to users
• Maintain centralized accountability of machines and materials
• Provide for the inspection of new shipments of radiation sources and safe disposal of materials and devices
• Provide for the calibration of radiation measurement instruments used in the personnel protection program
• Provide radiation safety training to personnel

Health Physics also provides advice and safety support to faculty utilizing lasers, ultra-violet light, radiowave, EMF, MRI, and microwave sources to assist them in maintaining compliance with regulations and published standards.

It is Stanford University policy that all PI/Laboratory Directors must assume primary responsibility for the proper use, handling, and disposal of all biohazardous agents and recombinant DNA molecules associated with their research. Stanford PIs and research personnel must comply with applicable Federal, State and local regulatory standards, as well as any administrative requirements established by applicable institutional committees. Failure to comply with this policy may result in an administrative review and a possible suspension of approval by the Administrative Panel on Biosafety (APB) to work with biohazardous agents and/or non-exempt recombinant DNA molecules.

It is Stanford University policy that:

• All activities involving the use of Biosafety level (BSL) 2 or 3 agents must have prior approval by the Administrative Panel on Biosafety (APB), who will review the scope of work and assure that the work is being performed at the appropriate biosafety level as described in the CDC/NIH Guideline, Biosafety in Microbiological, and Biomedical Laboratories
• All research personnel using BSL 2 or 3 biohazardous agents must be appropriately trained and familiar with the safety procedures in handling these materials. The PI/Laboratory Director is responsible for training and ensuring that all biohazardous agents are used at the appropriate level of biological containment
• All APB approved applications involving the use of BSL 2 agents are valid for a maximum of three years  and must be reviewed for changes annually by the Biosafety Officer; duration of BSL 3 approvals are for one year
• APB approval is not required for experiments which involve the use of BSL 1 agents exclusively (without the use of recombinant DNA molecules). However, any investigator working with human blood, clinical specimens, human tissues/tissue culture, or other potentially infectious materials must still meet the compliance requirements of the OSHA Bloodborne Pathogen Standard. (See the Stanford Biosafety Manual, Chapter 6 available below in "Related Items")
• APB approval to work with biological agents does not constitute institutional approval to work with radioactive materials, research laboratory animals, or human subjects. The use of radioactive materials, research laboratory animals, or human subjects as an adjunct to biological research is discussed in Section IIIA of this policy
• Shipping of biological goods that are classified as hazardous by Federal agencies must be done according to all regulations. Shipping of hazardous or non-hazardous biological goods that entails the use of dry ice must still follow all regulatory restrictions as dry ice is considered a dangerous good for air shipment purposes. Additional information on shipping procedures and requirements can be found at the Biosafety website (Shipping) or in the Biosafety Manual, Chapter 9, available below in "Related Items".

All application forms submitted to the Biosafety Officer are reviewed by the APB at a convened meeting with a quorum. Upon approval, an application will be reviewed on an annual basis. Upon expiration of approval, the PI must submit a new application for review and approval by the APB.

The use of recombinant DNA (rDNA) is regulated by the National Institutes of Health (NIH); the guidelines can be found in the publication Guidelines for Research Involving Recombinant DNA Molecules; these guidelines are the official guide to all rDNA work done at Stanford. It is important to realize that following these guidelines is the responsibility of all investigators at Stanford University and not solely investigators that are funded by NIH.