Category

Regulatory Compliance

A wide range of regulations and tools regarding intellectual property, cost sharing, responsible and ethical conduct of research, export controls, protocols, award acceptance and more.

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2025 Federal Administration Transition Information & Resources - This will be updated as new information is available.

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29 Topics

  • Export Controlled or Sanctioned Countries, Entities and Persons

    Alert: The US Department of the Treasury now requires export licenses for the export or import of ALL goods, services, or technology to or from the so-called Donetsk People's Republic or the Luhansk People's Republic of Ukraine, with the exception of certain agricultural commodities, medicine, and medical supplies. When considering whether or not a shipment, transfer, transmission, or disclosure

    July 8, 2024

  • Sponsored Receivables Management

    Sponsored Receivables Management (SRM) provides support for cash and receivables management for sponsored projects with the focus of maintaining a steady cash flow for the University. SRM processes interim invoices, draws against letters-of credit, applies payments and receipts and pursues collections for sponsored project awards, clinical trials, Academic Service Centers and Program Income. SRM

    May 8, 2025

  • Proposing and Charging Administrative Expenses

    Federal regulations (Uniform Guidance) and Stanford Policy state that clerical and administrative salaries should normally be treated as indirect costs unless costs meet four criteria. Non federal sponsors do not typically follow this rule. Four Criteria for federally sponsored projects For Federally sponsored projects, clerical and administrative salaries should normally be treated as indirect

    November 7, 2024

  • Export Controls: H1-B Deemed Export Certification

    Introduction Requirements and workflow related to H1-B Export Certification. Employer Requirements The Department of Homeland Security's US Citizenship and Immigration Services (USCIS) now requires all employers to assess whether an export license must be obtained prior to hiring any H1-B employee, and to certify to those findings. This certification requirement implements laws presently set forth

    November 28, 2023

  • Export Controls: Confidentiality Agreements

    This is a guide to understanding Stanford policies, procedures, and resources for non-disclosure and confidentiality agreements. In the course of their work, Principal Investigators and other researchers may be asked to accept confidential or restricted information, materials, software code, or technology from a sponsor or third party. The sponsor or third party will require that the researcher sign a Non-Disclosure Agreement (NDA).

    March 26, 2025

  • Export Controls: Overview

    During the course of open research, Stanford faculty, staff and students will likely, at one time or another, intersect with federal regulations that impose access, dissemination, or participation restrictions on the transfer of items and information regulated for reasons of national security, trade sanctions policy, anti-terrorism, or non-proliferation. Stanford is fully committed to complying with all laws and regulations that pertain to the conduct and dissemination of our research, including U.S. export control regulations which are discussed in this overview.

    March 26, 2025

  • COVID-19 Research Continuity Resources

    COVID-19 Research Continuity Resources Summary As soon as COVID-19 began spreading, Stanford researchers pivoted their focus to this crisis. Researchers quickly developed novel ways of testing for COVID-19, began testing drugs that might treat the disease and modeled the effects of social distancing. Other research efforts just getting underway will be generating insights for years to come. The

    March 28, 2025

  • Export Controls: Research and Encryption

    Introduction As a general rule, code developed here at Stanford is the product of non-proprietary, fundamental research. To reinforce this, and to avoid difficulties with federal export control regulations, researchers should upload Stanford-generated encryption code onto a publicly available website as soon as possible. Access to the code must not include login requirements or other password or

    August 11, 2023

  • Export Controls: Temporary Exports

    TMP Overview Unlike the export of information resulting from fundamental research, tangible exports of equipment, materials, and laptops plus intangible exports of commercial software, encryption code, and disclosure-restricted technical information are subject to export control regulations. The dual use Export Administration Regulations, however, make an exception to export license requirements

    August 9, 2023

  • eCertification System: Review and Certification of Expenditures

    The eCertification system supports a single consolidated review and certification process for managing sponsored project expenditures and cost sharing commitments. PIs can review and certify, as required, all sponsored project expenditures of any type online in one system Administrators with Task Manager authority can review all sponsored project expenditures of any type online in one system Drill

    May 8, 2025

  • Cost Sharing

    Introduction Cost sharing represents the portion of allowable, allocable, and reasonable [direct and indirect] costs of a sponsored project not paid for by the sponsor and are instead borne by the institution or third party. This topic guides you through proposing, accounting for, monitoring, and closing a cost sharing commitment. The definition, details, and procedures are outlined in RPH 15.3

    May 9, 2025

  • Intellectual Property

    Introduction Research at Stanford often results in intellectual property that may be protectable under patent, copyright or trademark laws. Stanford faculty, staff and students have certain responsibilities to the University regarding intellectual property and the University provides resources to help transfer Stanford technology for the public benefit. The Office of Technology Licensing (OTL) is

    May 12, 2025

  • Ethics and Compliance

    Introduction Ethics and compliance concepts are critical to research activities at Stanford University. These regulations serve to maintain the public trust; that is, trust in research results and outcomes; trust that patients and human subjects are given the best care and treatment; trust that public funds are spent for the benefit of all, and trust that scientific investigation is done

    July 3, 2024

  • Protocols

    Introduction Approval of research protocols by the appropriate Administrative Panel is required before beginning research that involves: human subjects; recombinant DNA molecules; human stem cells; human embryos or their derivatives; laboratory animals; infectious or biohazardous agents; radioactive isotopes; or ionizing, ultraviolet laser, and/or microwave radiation. Protocol Submission, Review

    May 9, 2025

  • Monthly Review and Quarterly Certification of Expenditures

    Introduction The purpose of PI quarterly 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

    May 8, 2025

  • Safety For Researchers

    Introduction Stanford's commitment to providing a safe environment for everyone creates particular requirements for PIs in research laboratories. Labs at Stanford house chemicals, equipment, and other materials that can pose hazards to health. The proper management of these hazards is not only good lab management, it is also a regulatory requirement. Emergency Contacts Emergency Fire, Police

    May 9, 2025

  • International Activity

    Introduction Stanford's commitment to providing a safe environment for everyone creates particular requirements for PIs in research laboratories. Labs at Stanford house chemicals, equipment, and other materials that can pose hazards to health. The proper management of these hazards is not only good lab management, it is also a regulatory requirement. Compliance and Operational Support Register

    July 8, 2024

  • Manage Research Data

    Introduction FAIRport Guiding Principles drive the University’s scientific data management. Make sure you understand the type of data you want to share or exchange. Your proposal may require a data management plan and your award may need a data use agreement. Sharing data Stanford provides guidance and resources for research data acquisition, sharing and management. Some data is subject to

    May 8, 2025

  • Record Retention

    Introduction While we live in the Information Age, not all information created or received by an organization rises to the level of being an official business record – this important subset requires deliberate management because these records provide evidence of business transactions, decisions and satisfaction of legal obligations. Record Retention Reference Guide Business Transaction Records Not

    May 8, 2025

  • COI: Disclosure and Review Procedures

    New NIH requirement for providing copies of agreement(s) related to employment or certain appointments with non-US entities Introduction Stanford University provides two different web-based applications to facilitate the disclosure and management of potential conflicts of commitment and interest. Annually, all faculty at Stanford are required to certify their understanding of and compliance with

    September 11, 2024

  • Capital Equipment

    Introduction Stanford defines an asset as capital equipment if it meets all the following three criteria unless otherwise specified by the sponsor terms and conditions. 1. Cost is $5,000 or greater 2. Useful life of more than one year, and 3. Individual, stand-alone, moveable, tangible item Responsibilities of Key Participants Key participants in the management of equipment are the PI, the

    May 13, 2025

  • COI: Conflicts of Interest Overview

    Faculty may complete their disclosure of outside professional activities and consulting at opacs.stanford.edu. This overview contains a brief review of the policies and procedures associated with the disclosure and management of conflicts of commitment and interest at Stanford University. This page also includes information to help identify and mitigate potential conflicts.

    April 2, 2025

  • Cost Principles

    Introduction According to Stanford policy and federal regulations, an expense qualifies as a direct cost for a sponsored project when it meets all four cost principles. These principles govern costs that may be charged to federally sponsored projects either directly or indirectly. Stanford generally applies these cost principles to the expenditure of non federal funds as well, however, in some

    May 12, 2025

  • Export Controls: Penalties

    Introduction This topic presents an overview of legal authorities and penalties for export control violations. The Export Administration Regulations The Export Administration Regulations (EAR) provides the following sanctions: Criminal Sanctions Willful Violations University A fine of up to the greater of $1,000,000 or five times the value of the exports for each violation. Individual A fine of up

    March 29, 2021

  • Academic Integrity and Undue Foreign Interference

    The Global Engagement Review Program( GERP) is a voluntary advisory process created to evaluate potential undue foreign influence risks in the context of maintaining Stanford research’s open and welcoming community. The program coordinates input from multiple offices that advise on various aspects of foreign engagements to assess risks related to undue foreign influence, research security and integrity.

    May 9, 2025

  • Rates

    All federal and many non-federal sponsors recognize the need to reimburse the direct costs of research as well as the indirect costs. Known as Facilities and Administrative (F & A) costs, indirect costs are expressed in terms of a rate. The F & A rate is applied to eligible direct costs. Learn more on the application of F & A rates.

    May 9, 2025

  • COI: Training and Other Information

    COI Training COI Training Slide Deck Changes to Annual Disclosures of Outside Professional Activities Starting January 2025, Stanford will transition its annual disclosure process for outside professional activities from an annual static cycle (in spring) to a rolling 12-month cycle. This change is designed to enable more timely certifications while reducing and streamlining the peak workload

    April 9, 2025

  • Responsible and Ethical Conduct of Research

    Introduction Responsible and Ethical Conduct of Research applies to all researchers and research staff engaged in scholarly research. While written with all researchers in mind, special consideration has been given to the needs of students and postdoctoral scholars. The education of students at all levels includes appropriate training and oversight in the responsible and ethical conduct of

    July 27, 2023

  • Monitoring Project Expenses

    According to Stanford policy, PIs are responsible for the ongoing fiscal management of awarded projects, which includes regular monitoring against project period budgets. The Research Administrator supports the PI in fiscal management. Monthly Review by the Research Administrator in the eCertification System Sponsored project and cost sharing accounts must be reviewed by the Research Administrator

    May 9, 2025

22 How Tos

  • How To

    Certify on My Professional Outside Activities

    OPACS certifies compliance with the Faculty Policy on Conflict of Commitment and Interest. The system has been redesigned so information reported during previous years will not need to be re-entered. Upon certification of the annual disclosure, the data will remain in OPACS for future annual and transactional disclosures. To help with this process, a PDF of past annual disclosures can be

    March 25, 2025

  • How To

    Reconcile Expenditures

    Reconciliation is the process of comparing the entries in the eCertification System to supporting documentation and resolving any discrepancies. Most supporting documentation can be found by drilling down on specific expenditure in the system. Reconciling accounts on a regular basis, after month-end close, will help you to manage your sponsored funds to ensure that expenditures and revenues are

    November 7, 2024

  • How To

    Address a Concern About Non-compliance

    As members of the Stanford University community, faculty, staff, students, members of the Board of Trustees, University Officers and affiliates are responsible for sustaining the highest ethical standards of this institution, and of the broader community in which we function. The University values integrity, honesty and fairness and strives to integrate these values into its teaching, research and

    May 13, 2025

  • How To

    Get IRB/APLAC/Biosafety Protocols Approved

    Protocols are submitted and reviewed online using eProtocol. Remember that your protocol should be clearly written and easily understandable. Panel members represent a variety of disciplines, which means that some reviewers will not be as familiar with your field as you are.

    May 9, 2025

  • How To

    Request an Indirect (F&A) Cost Waiver on a Proposal

    The Dean of Research will consider requests for F&A cost waivers in very limited circumstances. The PI’s Research Administrator and the PI should initiate the request, and it must be approved by the PI and the PI’s school dean's office before being sent for approval to the Dean of Research. The request can be submitted from the SeRA Proposal Development Routing Form (PDRF) Budget Questions page

    September 11, 2023

  • How To

    Access and Complete PI Training

    Stanford requires each of its PIs including those with University Research to complete a brief review of topics regarding the PIs responsibility for protecting individuals and the University, and for compliance with laws and regulations that touch on all aspects of the research enterprise. The University will not release project funding for a PI who has NOT satisfied this requirement. Go to PI

    May 7, 2024

  • How To

    Get a PI Waiver

    Eligibility to act as a principal investigator (PI) or co-principal investigator (Co-PI) on externally funded projects is a privilege limited to members of the Academic Council and to the University Medical Line (UML) faculty. This policy limitation is in place because PIs are responsible for determining the intellectual direction of the research and scholarship, and for the training of graduate

    July 6, 2023

  • How To

    Provide Funds to an International Visiting Scholar at the Beginning of Their Trip to Stanford

    To pay your visiting scholar an honorarium and/or subsistence funds on arrival or near the beginning of their stay on campus, they need to be added to the Oracle system in advance of their arrival on campus. The departmental administrator can initiate this process in Oracle Financials to get the visiting scholar into the system to verify their identity. The departmental administrator can request a

    October 15, 2024

  • How To

    Find My Patents, My Royalty Information, or the Status of My MTAs

    The Office of Technology Licensing Researcher Portal serves as a gateway to: detailed patent, marketing and financial information on your active inventions information on your industrial sponsored research, collaborations and MTAs the online disclosure form for submitting new inventions the MTA Routing (eMTA) form for submitting new material transfer agreements

    May 12, 2025

  • How To

    Disclose an Invention

    Stanford faculty, staff and students can submit an Invention and Technology Disclosure through the Researcher Portal on the Office of Technology Licensing (OTL) website. The disclosure should fully describe the new aspects of the invention, including the critical solution it provides and its advantages and benefits over current technologies. To preserve patent rights, inventors should disclose

    May 12, 2025

  • How To

    Find Information About Industry Affiliates Programs

    Industrial affiliate programs are designed to facilitate the transfer of knowledge to society and the dialog between academia and industry. Supported by corporate membership fees, these programs provide an avenue for industry to contribute to and sustain research and teaching in Stanford departments and programs of interest. Companies receive facilitated access to research programs and to

    April 7, 2021

  • How To

    Handle a Non-disclosure Agreement

    A company may ask you to sign a non-disclosure agreement (NDA) to discuss a possible research project at Stanford. If you understand the NDA terms and are comfortable complying with them, you may sign on your own behalf. Individual researchers do not have the authority to sign on behalf of the University or their departments. Stanford generally does not sign NDAs (also called CDAs), as the

    May 13, 2025

  • How To

    Ship Dangerous or Hazardous Goods Outside the U.S.

    You may be in violation of Federal Law and create a public safety hazard if you ship biological materials, dry ice, lithium batteries, hazardous materials, or any other “Dangerous Goods” unless you have received specific training and the material is properly packaged and labeled. Complete training for shipping chemical or biological materials, or arrange for a certified hazardous materials shipper

    May 9, 2025

  • How To

    Manage My Research Team

    There are many ways to go about building a research team—some more effective than others. If you are charged with or are interested in building a research team, there are several considerations to keep in mind: Bring together members with diverse backgrounds and experiences to promote mutual learning. Make sure each person understands his or her roles, responsibilities, and contributions to the

    April 12, 2021

  • How To

    Ship or Hand-carry Stanford Owned or Controlled Equipment, Supplies, Software, Biological Material or Other Goods to Countries Outside of the U.S.

    Review the Stanford Export Controls Decision Tree to determine if your item is on an export control list. Contact Stanford’s Export Control Office if your item is on a list or if you need assistance. Next, screen your recipient and your recipient’s organization against US export control Restricted Party Lists. Finally, document your export by filing the appropriate export control form.

    August 9, 2023

  • How To

    Sign a Non-disclosure or Confidentiality Agreement That Is Export Control Compliant

    In some cases, non-disclosure requests are embedded in the content of several kinds of institutional agreements between the University and the sponsor or third-party. Examples of such institutional agreements include equipment or software purchases or loans, technology licensing, data sharing agreements, and material transfer agreements. In these kinds of institutional agreements, a Stanford

    May 19, 2021

  • How To

    Travel to Cuba, Iran, Syria, North Korea, or Sudan on Stanford University Business

    Immediately contact Stanford’s Export Control Office so it can be determined if you can travel to these countries without an export license. Cuba, Iran, Syria, North Korea and Sudan are subject to US financial and trade sanctions. Travel to and transactions with these countries are regulated. Read Memo from Ann Arvin, Vice Provost and Dean of Research

    August 9, 2023

  • How To

    Travel Outside the U.S. With a Stanford-owned Laptop, Cell Phone, PDA or Flash Drive

    Determine whether your travel will allow you to meet the terms and conditions set forth on the Annual TMP Certification for items 1 through 5 by completing the Temporary Export Property Checklist, since by signing the form you are becoming personally accountable for complying with those terms and conditions. If your travel will not allow you to meet the Annual TMP Certification's terms and

    August 9, 2023

  • How To

    Protect Your Computing Devices When Traveling Internationally

    When you travel internationally, the safeguards provided by the Stanford University computing environment are not available. Important data on devices such as laptops, notebooks, iPads, smart phones, MP3 players, thumb drives, SD cards, SIM cards, cameras must be properly protected. Furthermore, if you travel to countries that are known for computer and network-based espionage (e.g., network

    May 13, 2025

  • How To

    Put in Place a Data Use Agreement

    A data use agreement (DUA) is an agreement that is required under the Privacy Rule and must be entered into before there is any use or disclosure of a limited data set (defined below) to an outside institution or party. A limited data set is still protected health information (PHI), and for that reason, covered entities like Stanford must enter into a data use agreement with any recipient of a

    April 3, 2021

  • How To

    Access CITI RECR Training

    STEPS Go to the CITI website. You are in the page titled " Login through my Institution". Select Stanford University from the list. You will be prompted to go through the Stanford web auth page. Select View Courses next to Stanford University CITI provides two different types of required training for Stanford personnel: training in the protection of human subjects in research, and training in the

    May 25, 2023

  • How To

    Properly Review the F&A Rate on Monthly Expenditure Report

    Compare the F&A rate on your monthly expenditure report to the awarded rate. The awarded rate is either the negotiated rate found on the Facilities & Administrative (F&A) Cost Rates Table or a reduced rate. If you are working with a negotiated rate, make sure the rate is correct for the project's activity (research, instruction, or other) and that the proper location is used (on campus, off campus

    July 8, 2024

1 Glossary Terms

  • Animal Subject

    An animal subject is a live, vertebrate animal used as an integral part of a test, experiment, or other evaluation procedure including health research or clinical trials

    May 9, 2025

13 Forms & Tools

  • FAQ

    Cost Sharing FAQs

    Cost Sharing Frequently Asked Questions 1. If an individual commits 50% FTE to a project, what is that 50% of? What does the concept of 100% FTE mean? For a full-time employee, 100% Full-Time Equivalent (FTE) encompasses all of the time that an individual spends doing the work for which he or she is being paid. For exempt staff, including faculty and Academic Staff, compensation is not based on

    May 9, 2025

  • Template

    Conditions of Gift Letter Templates

    Research Support Attachment 1, the Conditions of Gift Letter Template for Research Support, is recommended for documenting simple, one-time expendable gifts from companies, professional foundations, and associations supporting faculty research. This template may be used for gifts of any amount, but is not to be used for endowment gifts, pledges (multi-year commitments), or building projects

    May 9, 2025

  • FAQ

    COVID Resources

    Please visit this link for the latest COVID-19 information for Faculty, Researchers and Research Administrators.

    February 27, 2023

  • Checklist

    Openness in Research Checklist

    Stanford University Openness in Research CHECKLIST The principle of openness in research is one of overriding importance to this University. Accordingly, no program of research that requires secrecy may be conducted at Stanford, other than the exceptions specifically allowed in the University's Openness in Research policy (Research Policy Handbook 1.4). Use this checklist when reviewing: requests

    July 3, 2024

  • Reference List

    List of Unallowable Expenditure Types

    Certain expenses that are appropriate expenditures of University funds are ineligible for reimbursement by the federal government. When coding an expense for an activity that is allowable to be paid with University funds, but unallowable for indirect cost recovery you must identify that expense as unallowable for reimbursement. Use the List of Unallowable Expenditure Types below to find the

    May 9, 2025

  • Export Controls: Restricted Party Screening

    This tool evaluates the potential export/trade sanctions and foreign engagement compliance risks associated with persons and entities with whom we wish to partner.

    April 24, 2025

  • Guide

    Export Controls: Openness in Research Checklist

    Introduction Guidelines for ensuring that agreements comply with Stanford's Openness in Research policy. Applicability No program of research that requires secrecy may be conducted at Stanford, unless it meets one of the exceptions set out in the University's Openness in Research policy. Use this questionnaire when reviewing: requests for proposals or project solicitations program award notices

    August 9, 2023

  • Checklist

    Export Controls: Tools and Checklists

    General Tools and Checklists The following are important resources in the general area of export controls. They will help to introduce the topic, as well as provide the information needed in specific situations. Export License Certification Reference Guide A comprehensive summary of Stanford export control policies, position responsibilities, resources, best practices and documentation

    July 8, 2024

  • Export Controls: Sample Letters and Clauses for Faculty, Students, and Staff

    Downloadable letters and agreement language can be found below in Related Items section and can be used by faculty, students, and staff at Stanford in situations where correspondence is needed to document Stanford's exclusion from, or adherence to, US export control regulations. Fundamental Research Letter This letter will be of assistance for international travel by Stanford foreign national

    August 9, 2023

  • Reference List

    Export Controls: Chemicals, Chemical Agent Precursors, Propellants, Explosives, and Energetic Materials

    Chemicals, Chemical Agent Precursors, Propellants, Explosives, and Energetic Materials The ITAR controls certain military-related chemicals, chemical agent precursors, propellants, explosives and energetic materials at Category V and Category XIV of the US Munitions List (USML). Likewise, the EAR regulates exports of certain dual use propellants and chemicals at ECCNs 1C111 and 1C350, respectively

    August 9, 2023

  • Reference List

    Export Controls: Pathogens and Toxins

    Pathogens and Toxins Department of Commerce dual-use export control-listed pathogens and toxins are listed below. These pathogens and toxins are found on the Commerce Control List (CCL) in Category 1 at ECCNs 1C351 through 1C360. Please note that export controls also apply to genetic elements and genetically modified organisms that contain DNA associated with the pathogenicity of these biological

    August 11, 2023

  • Reference List

    Export Controls: Munitions and Dual-Use Items

    Munitions and dual-use Items items, information, and software subject to U.S. Export Control laws and used in a university environment are generally categorized on one of two lists: U.S. Munitions List (USML )published by the U.S. State Department in its International Traffic in Arms Regulations (ITAR), and the Commerce Control List published by the U.S. Commerce Department in its Export Administration Regulations (EAR). Learn more.

    March 26, 2025

30 Announcements