Research Management Group– (RMG)


Policies, Compliance and other Resources

Questions regarding these policies and compliance?  Please contact your department's Research Process Manager (RPM) >>
For other questions, please contact Jeanne Heschele who maintains the RMG website.


Index of topics




Administrative expenses



RPH 15.4 Charging for Administrative and Technical Expenses
DoResearch webpage >>





uniform guidance (replaces A-21, A-110, and a-133



The Office of Management and Budget (OMB) issued the Uniform Guidance to supersede OMB Circulars A-21, A-110, and A-133 for federally sponsored agreements and new funding increments incorporating the Uniform Guidance awarded on or after December 26, 2014. See the DoResearch webpage >>

OMB Circulars A-21 and A-110 are still effective for federally sponsored agreements awarded before December 26, 2014.




Animal, human subject, and environmental safety compliance


Cancer Institute: Scientific Review Committee (SRC)
The SRC is charged with providing peer review of local, national, and international research studies involving cancer patients treated at Lucile Packard Children's Hospital and Stanford Hospital and Clinics; and study participants involved in cancer-related research at Stanford University. more >>

Environmental Health and Safety homepage more >>

Research Compliance
The Research Compliance Office (RCO) is responsible for oversight and management of Stanford’s Administrative (Compliance) Panels and ensures compliance with applicable policies, accreditation standards and external regulations.

IRB Registrations and Assurances-Research Compliance webpage >>

Environmental Health and Safety is responsible for the Biosafety and Radiological Safety Panels.
The Administrative panels report to the President through the Office of the Vice Provost and Dean of Research. 
more >>

Medical Human and Non-Medical Human Subject Research:
Human Subjects and IRB website >>
Human Rights Protection Program (HRPP) and Guidances including Human Subject Research Determination more >>
Contact information more >>
Required Tutorial on Human Subject Research Protection (CITI) more >>
Human subjects Federal-Wide Assurance Number FWA #00000935  RPH 5.2 >>
NIH Policy on IRB Review NIH Notice 05/01/2000 more >>
NIH Notice 08/25/2000: Required Education in the Protection of Human Subjects Participants more >>
Training in the Protection of Human Subjects in Research (RPH 5.7 >>)
Human Research Protection Program (RPH 5.2 >>)
IRB Review Fee  May 2006 memo

Animal Subjects
Administrative Panel on Laboratory Animal Care (APLAC) more >>
Animal Welfare Assurance Number: D16-00134 (A3213-01), 05/01/2017 - 05/31/2021 RPH 6.1 >>
AAALAC Accredited Unit Number 000679. Accreditation through 2018
USDA License Number: 93-R-004
VA Animal Welfare Assurance Number: A3088-01 Animal Setup and Boarding Rates for VA, Stanford, or PARE Admin Projects of VA Investigators 
NIH Proposal-Resources "animal" section
(Download document   containing the necessary resources animal section text for your NIH proposal)
Animal Subject protocol transactions should be submitted at the Animal Subjects eProtocol website [SUNET ID required]

Biosafety (Biohazardous Agents and Recombinant DNA)
Environmental Health and Safety Biosafety webpage more >>

Radiological Hazards
Radiological Hazards RPH 7.6 >>
Laser Safety RPH 7.7 >>
Radiological Safety-Environmental Health and Safety website more >>
* Nuclear Regulatory Commission (NRC) Number: 0676-43
* VA NRC Number: 04-23242-01For general information and assistance related to
Radiological Hazards, contact the Stanford Radiation
Safety Officer, Lance Phillips (650-725-1412)

 

 



Budget information templates

 

 

 

 




CArdinal curriculum

 

Link to the Office of Research Administration (ORA) online
Cardinal Curriculum Training for Research Administrators



conflict of interest

 

Index of topics: Overview, Policies, COI Disclosure and Review Procedures,
COI School Contacts, and COI Training and Other Information DoResearch COI webpage* >>

*New* Stanford University Outside Professional Activities Certification System (OPACS)
PHS Conflict of Interest Training

Who should take this training?
If you receive PHS funding, you must complete this training before a PHS award can be accepted on your behalf. Your certification is valid for four years. You must retake this training when your certification expires.
In addition to those faculty support with PHS funding, Stanford requires all newly-hired faculty to complete this training. It is available to all members of the Stanford community with SUNet IDs through this SeRA webpage >>.


School of Medicine Questions?
Questions about the requirements of these updated policies may be directed to Barbara Flynn, Director, School of Medicine Conflict of Interest Review Program. barbara.flynn@stanford.edu

Article: NIH Revised Conflict of Interest Rules
Q&A on the NIH's revised conflict of interest rules with Dr. Harry Greenberg, Senior Associate Dean for Research more >>

Stanford Industry Interactions Policy
Policy and Guidelines for Interactions between the Stanford University School of Medicine, the Stanford Hospital and Clinics, and Lucile Packard Children's Hospital with the Pharmaceutical, Biotech, Medical Device, and Hospital and Research Equipment and Supplies Industries ("Industry")
Stanford Industry Interactions Policy webpage >>

Memo to School of Medicine Faculty from Dr. Harry Greeenberg, Senior Associate Dean for Research
Download COI Policy Change Memo pdf  (April 20, 2012)
Required for individuals who receive PHS funding and for all newly-hired faculty: COI Training Module for faculty: Avoiding Financial Conflict of Interest Learning Module see above section >>




Contracts

 

The Research Management Group (RMG) Clinical Trial Contract Officers handle the following:
See the RMG CT Contract Officer department assignments >>

All clinical contracts (including clinical trials and clinical research)
"Clinical" means studies involving humans, human tissue or blood, or data from patients (besides clinical trials, examples are studies that involve a chart review to do a comparison of two study drugs, or studies that use a Stanford based patient dataset on the web-like the recent Stanford Heart Network agreement, or studies (sometimes called assay agreements) that support clinical trials, such as the CV med core lab).

The Office of Sponsored Research Contract Officers
The OSR Contract Officers handle:
-All contracts that have a government (federal, state or local) sponsor or prime
-All other contracts and subcontracts (foundations, other non-industry) that do not fit in the OTL definition above
OSR Contract Officer assignments >>

The Office of Technology and Licensing
The Industrial Contract Office handles:
-Non-clinical industry research agreements
-Vitro or animal studies for industry sponsors (only)
-All Material Transfer Agreements
-Contracting process and negotiaton

 

 

 
cost sharing




RPH 16.1 Cost Sharing Policy DoResearch webpage * >>
*this link goes to the new DoR webpage for renumbered RPH 15.3 policy (formerly RPH 3.5)
Cost sharing represents that portion of the total project costs of a sponsored agreement borne by the University, rather than by the sponsor. Cost sharing of direct expenditures represents a redirection of departmental or school resources from teaching or other departmental and school activities to support sponsored agreements.

 

 

 

 European Union General Data Protection Regulation (GDPR)

 

 

Effective May 25, 2018, Stanford University is required to comply with the European Union General Data Protection Regulation (GDPR) which regulates the collection, processing, storage, transfer, and protection of personal information, including data collected for research. The GDPR is a comprehensive privacy law that governs any entity that collects or processes the personal data of any citizen of the member states of the European Economic Area:
https://www.tripsavvy.com/countries-that-are-eeacountries-1626682


Proposal Intake Form:
As a result, Stanford has begun to collect information on sponsored projects to determine whether GDPR will affect the research data that will be collected. Beginning June 7, you will be prompted to answer the following questions on the PDRF or the Proposal Intake Form for all proposal submissions:

Human subjects: For research that includes human subjects, language for the consent will be provided to you during IRB review. The language will inform participants about their study data regulated under the GDPR.

Questions? If you have specific questions about GDPR, please contact the Privacy Office at privacy@stanford.edu or 650-725-1828. You can also find additional information on GDPR at https://privacy.stanford.edu/gdpr/training

 

 

 





export controls



RPH 8.1 Applicability and Policy Background, and Regulatory Authority DoResearch webpage**
This document codifies Stanford commitment to comply with all applicable laws and regulations concerning export controls.The policy describes those requirements, including requirements for record-keeping, and includes links to several resources for faculty and staff. As a reminder, export controls apply to any shipments of materials outside the borders of the United States, as well as to the disclosure of controlled data or material to foreign nationals to on our soil (a "deemed export").

RMG SoW's: The rule of thumb is that Steve Eisner in Export Control will review RMG SoW's if the sponsor or Prime Sponsor is DoD, NASA or another national security-related organization as follows:
(See also DoResearch Export Control webpage >>)
- Advanced Research & Development Activity
- Aerospace Corporation
- Air Force Office of Scientific Research
- Air Force Office of Scientific Research (AFOSR)
- Ames Laboratory
- ARMS CONTROL, DISARM
- Asian and Pacific Security Affairs
- Asian Office of Aerospace Research and Development (AOARD)
- ATOMIC ENERGY COMM
- Ben Gurion University of the Negev
- Free University of Iran
- King Abdulaziz City for Science and Technology, KACST
- King Abdullah University of Science and Technology
- Microelectronics Advanced Research Corp (MARCO)
- NASA Ames Research Center
- National Imagery & Mapping Agency
- National Reconnaissance Office
- Nonproliferation and National Security Institute (NNSI)
- Nuclear Regulatory Commission
- Office of Aviation Research, Federal Aviation Administration
- Office of the Director of National Intelligence
- U.S. Agency for International Development (USAID)
- University Corporation of Atmospheric Research
- US Agency for International Development





faculty salary and effort

 

Effort for Faculty and Staff DoResearch webpage* >>
Salaries constitute the largest component of the expenses charged to sponsored projects. It is essential that Stanford managers, including Principal Investigators (PIs), understand the basic principles underlying the allocation of effort, and the corresponding charging of salaries, to those projects.

Fiscal Responsibility of Principal Investigators RPH 3.0 >>
At Stanford, the Principal Investigator (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.

School of Medicine Policy on Sponsored Program Faculty Salary Support
The new RPH 3.1 policy eliminates the wording that requires a minimum of 1%. However, in the School of Medicine we have our own policy that requires ALL faculty participating on a sponsored project to devote effort and budget for that effort. Therefore, in the SoM there is not much of a change. RMG webpage >>

 




fellowships vs. grants

 

Definition of Sponsored Projects and Distinctions from Other Forms of Funding RPH 13.1 >>
RPH 13.1(4) includes a definition of fellowships/scholarships and student aid, as distinguished from sponsored projects.
Postdoctoral Fellowships are not normally defined as sponsored projects. However, because they typically provide support for the recipient’s research activities, applications are processed through the research administration offices of the University. This helps to assure appropriate internal controls as regards to research policy, as well as the inclusion of the funds in the appropriate base for the calculations of Stanford’s indirect cost rates and the appropriate classification of the research space.

Attachment A, Checklist for Determining Whether Funding is a Postdoctoral Fellowship or a Sponsored Project. Download checklist >> PDF file
The above form is also available on the new DoResearch webpage for RPH 13.1: Scroll to the bottom of the new DoResearch webpage RPH 13.1 to the Related Items section, click on the "Documents" tab, and select Attachment A.

RPH 13.2  Categories of Sponsored Projects RPH 13.2 >>

 

 

Financial aspects of sponsored projects

 

A new Research Policy Handbook policy (RPH) on Program Income has been created in RPH, Chapter 15 Financial Aspects of Sponsored Projects. Find out what program income is and how to account for it in the DoResearch website, RPH 15.9 Program Income.

1. Definition
Stanford defines program income as gross income earned by Stanford that is directly generated by a supported activity of a federal award or earned as a result of the federal award during the award’s period of performance.

2. What Is Included in Program Income
Program income includes but is not limited to income from:

3. What Is Not Included in Program Income
Program income does not include:

 

 

 

 

 

Financial Officer

 

 

Financial Officer

Tim Reuter, Director
Office of Sponsored Research Post Award
Stanford University
3160 Porter Drive
Palo Alto, CA 94304
Ph: 650-721-1758
Email: treuter@stanford.edu

 

The Financial Officer oversees the OSR Post-Award organization.
The OSR Post-Award organization provides financial post-award services for sponsored awards. The following activities are supported:
· Set up accounts in the Oracle Financials system
· Review cost transfers for compliance with University and sponsor policies
· Set up and fund cost-sharing PTAs
· Close out awards
· Prepare quarterly, annual, and final financial reporting
· Monitor sponsored project activities during the life of the award
· Coordinate billing and line of credit draws with Receivables/Cash Management (RCM)
· Coordinate with Administrative Services
· Coordinate audits with Research Financial Compliance Services
· Serve as a liaison with sponsors, central University offices, and school and department groups

 


gifts vs. sponsored projects


 Forms
FINGATE webpage: Quick Steps: Process Donor Gift Checks>>

Go to the above webpage for:
Gift Transmittal Forms < $1,000
Gift Transmittal Forms > $1,000
Additional form for Gifts > $20,000: Gift or Sponsored Project Determination Process and Checklist form

Cardinal Curriculum Course: Gift Administration at Stanford webpage >>
Individuals who are involved in the processing of gifts, including those who complete and sign gift transmittal forms, are required to be adequately trained.  

Gift vs. Sponsored Projects and Distinctions from Other Forms of Funding   RPH 13.1 >>
Defines sponsored projects, as distinguished from gifts and other supported activities, and illustrates the major categories of sponsored projects, i.e., organized research (including both sponsored research and University research), sponsored instruction, and other sponsored activities. Updated on April 8, 2016: "The period of performance and return of unspent funds are no longer by themselves an indication that funding must be accepted as a sponsored project." and "Attachment A. to RPH 13.1, Determining Whether Funding is a Gift or Sponsored Project has been updated to reflect the new Gift or Sponsored Project Screening Questions in the Gift Transmittal System:

Checklist for Determining Whether Funding is a Gift or Support for a Sponsored Project
Download checklist >> PDF file
The above form is also available on the new DoResearch webpage for RPH 13.1 Definitions of Categories of Sponsored Projects (formerly RPH 3.2) : Scroll to the bottom of the new DoResearch webpage RPH 13.1 to the Related Items section, click on the "Documents" tab, and select "Checklist for Determining Whether Funding is a Gift or Support for a Sponsored Project".

 

Graduate students on research grants

 

RPH 15.6 Tuition Allowance for Research Assistants 
DoResearch webpage >>

Memos for the charging of Graduate Student Research Assistant salary and tuition
2015-2016 MIninimum RA/TA Salaries
Vice Provost of Graduate Education (VPGE) webpage >>

Please note: the School of Medicine and other schools pay higher rates than those which appear in the Research Policy Handbook RA/TA Salary memo. For specific details, please contact your department's Research Process Manager (RPM) >>.

Graduate Student Assistantships
Administrative Guide Memo 10.2.1:
Graduate Student Assistantships more >>

Graduate Student Assistantship Salary and Tuition Allowance Tables
Links to Graduate Financial Support-GFS webpages:
Academic Year 2018-2019 more >>
Academic Year 2016-2017 more >>
Academic Year 2015-2016 more >>

NIH NRSA Requirements (Graduate Student Compensation)
Stanford clarification: The Graduate Student Compensation Limit for Fiscal Year 2016 NRSA awards research grants is tied to the "0" level of experience stipend level for postdocs.  Therefore, the limit is $43,692 (salary plus benefits and tuition) when budgeting graduate students on research grants.

NIH Notices-stipend level changes:
NIH Stipend Levels for FY2016
NIH Stipend Levels for FY2015
NIH Stipend Levels for FY2014
NIH Stipend Levels for FY2012
NIH Stipend Levels for FY2011
NIH Stipend Levels for FY2010
NIH Stipend Levels for FY2009  
NIH Stipend Levels for FY 2008

(Reference: Office of Postdoctoral Affairs Salary Guidelines webpage >>.)






indirect cost waiver

 

IDC Waiver requests- School of Medicine
Please contact your department's Research Process Manager (RPM) >> for assistance.

IDC Waiver Requests-Outside the School of Medicine
RPH 15.2 Facilities and Administrative (Indirect Cost) Waivers RPH 15.2 >>

Looking for the F&A Waiver Request Form:
Go to the RPH 15.2 webpage* >> , scroll down to "Related Items" and click on the Documents tab.   For case-by-case waiver requests, per see RPH 15.2(5), outside of the School of Medicine only, individuals must submit a F&A Waiver Request Form. This form is available for downloading by going to the "Related Items" section of the RPH 15.2 webpage >> then clickin on the "Documents" tab. The policy revision (Sept. 2008) distinguishes between pre-approved and case-by-case waivers, and clarifies the criteria required for each. It also explains those circumstances in which indirect cost waivers will not be approved

Looking for the Pre-Approved IDC Waiver List?
Go to the RPH 15.2 webpage* >> , scroll down to "Related Items" and click on the "Documents" tab.

Verification of nonprofit  "GuideStar"-national database of nonprofit organizations
Provides Tax ID# and financial information for indirect cost waivers
http://www.guidestar.org  (This is a free service which requires registration to access.)

 

 



indirect cost crossover between departments

 

School of Medicine Policy on Indirect Cost Crossovers Between Departments RMG webpage >>
The development of the Operating Budget each year includes a determination of the amount of indirect costs to be allocated to each department. One of the factors that impact this allocation is the amount of indirect costs generated by each department, which in the past has been adjusted by crossovers between departments.

An indirect cost crossover policy is necessary in order to establish uniform procedures in accounting for crossovers and to encourage understanding and cooperation among principal investigators and department administrators that will enhance research efforts in the school.




infrastructure charge policy

 

University Policy on Infrastructure Charge DoResearch Infrastructure webpage >>

School of Medicine Policy for Infrastructure Charge
School of Medicine Infrastructure Charge Exemption Request Form(to download RMG Forms webpage >>)

On September 1, 2005, the University implemented a revised infrastructure charge policy that increased the infrastructure charge to 8%.
T he infrastructure charge applies to:
(1) non-sponsored revenue sources, and
(2) non-federally funded sponsored awards that carry an indirect cost rate of 0%.

At the time of implementation, the Dean decided to help mitigate the impact on trainees and junior faculty by covering this cost on behalf of Departments. In the January 9, 2006 Dean’s Newsletter, the Dean wrote about this infrastructure charge and the effort to provide some mitigation and further stated that the decision would be re-evaluated in three years. Due to fiscal challenges, we have had to re-evaluate many policies, and we have now determined that this infrastructure cost most appropriately resides at the Department, and not at the Dean’s level. This is consistent with the other Schools in the University. It also brings the SoM approach for gift and sponsored funding activities as it relates to infrastructure charges into alignment. It has been the policy for many years that when a donor refuses to allow infrastructure charges against their gift, the Department must provide an alternate unrestricted PTA to which the infrastructure cost can be charged. Effective in FY 2012, this became the practice for all new and renewal awards non-federal sponsors. Effective July 1, 2015, departments are responsible for all ISC for new and future expense on existing awards.

The Research Management Group (RMG) works with faculty who are submitting grant proposals to ascertain if the sponsor will pay indirect costs. When it is determined that a non-federal sponsor does not allow indirect costs, the department will be required to provide an alternate PTA for the infrastructure cost. In accepting these fellowships and grants we are incurring real costs – and it is often worth doing so in order to support trainees and junior faculty. The department will be responsible for the applicable infrastructure expenses. The Dean will continue to pay the Stanford University tax on these revenue sources at a rate of 6.89% on all sponsored funding, and at a rate of 9.16% on all gifts.

 





institutional rates

 

Policy:
Facilities and Administrative (Indirect Cost) and Fringe Benefit Rates RPH 15.1 >>

Rates
DoResearch webpage* >>
*This "Rates" webpage includes: Chart for F&A Cost Rates, Fringe Benefit Rates, Vacation Accrual/Disability Sick Leave Rates, Other Rates, and Non-sponsored receivable rates.
Fringe Benefit Rates Chart (includes new final FY16 rates) more >>

Stanford and the Office of Naval Research (ONR) have agreed on predetermined Facilities and Administrative (F&A, or Indirect Cost) rates for University fiscal years 2017 and 2018. more >>

New & Competing Proposals
Effective August 2, 2016 all new proposals and competitive segments for awards with performance start dates after August 31, 2016 shall use the predetermined FY2017 and FY2018 F&A  rates.

Awards with Performance Start Dates on or after August 2, 2016 through August 31, 2016:
These awards are subject to the final FY2016 rates for the remainder of FY2016 and to the predetermined FY2017 and FY2018 rates beginning September 1, 2016. The FY2018 rates will remain in effect (“fixed”) for the life of the award or until the next competitive submission.

Indirect Cost (IDC) Exception List
List of U.S. based non-profit sponsors on the pre-approved IDC exception list. SeRA webpage >>



The "Cost of Conducting" Research

For more information, see the DoResearch Costs of Conducting Research webpage >>

The following Cost of Federally Sponsored Research Infographic was created by the Council on Government Relations, Association of American Universities, and the Association of Public and Land-Grant Universities.
Per the diagram: " The total cost of federally sponsored research includes a combination of both direct and facilities and administrative (F&A) costs. Both types of expenditures are key [to] an institution's ability to conduct cutting-edge research. F&A consists of construction and maintenance costs of laboratories and high-tech facilities; energy and utility expenses, and safety, security, and other government-mandated expenses. These costs are real and research cannot be conducted without them."
Download a PDF fille of the infographic >>

 

 

 





intellectual property

 

RPH 9 Intellectual Property RPH 9 >>
RPH 9.1 Inventions, Patents and Licensing (Formerly RPH 5.1)
RPH 9.2 Copyright Policy . (Formerly RPH 5.2)
RPH 9.3 Administration of Copyright Policy
RPH 9.4 Tangible Research Property (Formerly RPH 5.3)
RPH 9.5 Other intellectual property: Trademarks, Patents, and Proprietary Information

Patent and Copyright Agreement for Personnel at Standord Form (SU-18)
To download the instructions for completing the online SU-18 form via AXESS, you need to go to the new DoResearch RPH 9.1 Inventions, Patents, and Licensing webpage >> (formerly RPH 5.1), scroll down to the bottom of the webpage to the "Related Items" section and then click on the "Document Tab".





internal proposal deadline policy

 

School of Medicine Internal Proposal Deadlines
A new School of Medicine RPM/RMG internal proposal deadline policy for grants, contracts, subcontracts, and fellowships.  For more information, please see this webpage >>

For PIs in other Schools: Office of Sponsored Research (OSR) internal proposal deadline policy
DoResearch webpage >>





material transfer agreements (mta)

    

Material Transfer Agreements (MTAs) are short contracts governing the transfer of tangible research property (often biological materials) for in vitro research use. For more information:

Industrial Contract Office (ICO) webpage >> with links to sections devoted to Researchers, Administrators, and Industry

 

 


nih Policy Highlights


 

 

nih data use certification (DUC)

 

The NIH has certain datasets that they will send Stanford researchers only after we sign a “Data Use Certification.” When completing the NIH DUC application, faculty should select their respective OSR Grant and Contract Officer as the signing official.  OSR will review the DUC and submit it electronically.  OSR will also route a PDRF to the PI for approval.  The DUC will receive a SPO# and will be tracked in SeRA.
A list of previously approved NIH data use certifications can be found at http://www.stanford.edu/group/ICO/researcher/reResources.html.

If you have questions, you may contact your OSR Grant and Contract Officer (CGO). The OSR CGO assignment list is located in DoResearch Pre-Award Operations.  Click on “Pre-Award Contract and Grant Officer Assignments” located near the bottom of the page.  A PDF version of the assignment list will display.  Scroll to the section listing the School of Medicine.  Find your department, then find the assigned OSR CGO.

 

 

nih policy on good clinical practice training for nih awardees involved in nih-funded clinical trials
and stanford citi training



STANFORD TRAINING:
Collaborative IRB Training Initiative (CITI)
The CITI trainings offered through the Research Compliance Office include modules in good clinical practice. These modules offer a general overview and are free of charge. See the Spectrum Training webpage >>
For more information about CITI training, see the Research Compliance Office website:
http://humansubjects.stanford.edu/new/resources/training/citi.html

 

NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
Notice NOT-OD-16-148
This policy is effective January 1, 2017

This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). (per this webpage >>) The principles of GCP help assure the safety, integrity, and quality of clinical trials. GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.

This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. (see the NIH definition of clinical trials NOT-OD-15-015 >>)

Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Clinical trial staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.


 

 


nih policy regarding dissemination of nih-funded clinical trial information

 

Per NIH Notice NOT-OD-16-149: The National Institutes of Health (NIH) is issuing this policy to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. The policy establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov.

Stanford University School of Medicine Policy on Clinical Trials Disclosure (Oct. 7, 2016) (Clinicaltrials.gov)
Link to document (updated 11/16/2016): more >>

 

 





NIH public access-nih video training tools on you tube

 

NIH has published the following training videos to You Tube to address training needs of faculty and administrative staff with respect to the Public Access Policy.   A tabel of contents with links to the following seven videos can be found on this YouTube webpage >>

 

 



nih quick links


 

 



nih research performance progress report (rppr)

 


On 3/9/2012 NIH announced its intention to implement the Research Performance Progress Report (RPPR) through a new eRA Commons Module in the fall of 2012.  See NIH notice NOT-OD-12-083 >>.

The RPPR replaced the:
- PHS Non-competing Continuation Progress Report (PHS 2590 >>)
- eSNAP module in the eRA Commons
- NIH and AHRQ Ruth L. Kirschstein National Research Service Award Individual Fellowship Progress Report for Continuation Support (PHS 416-9 >>).

What this means for Principal Investigators with NIH awards:
Principal Investigators who utilize the NIH Commons to prepare and submit their progress reports will have the RPPR link available to them in the Commons.   Upon selecting this link, the PI will have the option of launching a progress report via eSNAP or via RPPR.  Come 2013, the eSNAP module will be eliminated and the RPPR module will remain.  We encourage all Principal Investigators to begin utilizing the RPPR module to prepare their progress reports so that when it is fully implemented in 2013, it is not new to you.

Full implementation for fellowships and all awards issued under the Streamlined Non-competing Award Process (SNAP) is scheduled for awards made in Calendar Year 2013.  Implementation for complex mechanisms and non-SNAP awards has not been determined and further guidance will be provided at a later date.

Implementation also includes the following agencies:
Food and Drug Administration (FDA); Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC)

Additional Information:
Information and training materials is available on the NIH RPPR website >> and on the RPPR: Pilot and FDP Early Access>> website
A video with more information is available at:  http://nrc59.nas.edu/RPPR_Pilot_%20Training.wmv.

 

 



Nih salary cap


Policy: RPH 15.5 Salary Cap Administration RPH 15.5 >>
Presents procedures for implementation of agency regulations that set a maximum salary level for project participants (salary cap). Currently, the only agencies that establish salary caps are the Department of Health and Human Services (DHHS), which includes the National Institutes of Health (NIH), and the Department of Defense (DoD). The NIH salary cap is indexed to a specified Executive Pay Level and changes periodically.

DoResearch Salary Cap resource webpage >>

Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2018
Notice Number: NOT-OD-18-137
Release Date: March 7, 2018
At this time, NIH has not received a FY 2018 appropriation, and is operating under a Continuing Resolution, the "Continuing Appropriations Act, 2018" (Public Law No: 115-56), that applies the terms and conditions of the Consolidated Appropriations Act, 2017.

The Consolidated Appropriations Act, 2017, restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management has recently released new salary levels for the Executive Pay Scale. Effective January 7, 2018, the salary limitation for Executive Level II is $189,600.

For awards issued in those years that were restricted to Executive Level II (see Salary Cap Summary, FY 1990 – FY 2017 , including competing awards already issued in FY2018, if adequate funds are available in active awards, and if the salary cap increase is consistent with the institutional base salary, grantees may rebudget to accommodate the current Executive Level II salary level. However, no additional funds will be provided to these grant awards.



Note:  the School of Medicine encourages the Department to charge the salary over the cap to the operating budget in event there is not an appropriate donor restricted fund.


Links to NIH webpages:
NIH Salary Cap Summary webpage >>

Links to NIH webpages for previous years:
NIH Salary Cap Notice 2017
NIH Salary Cap Notice 2016
NIH Salary Cap Notice 2015
NIH Salary Cap Notice 2014
NIH Salary Cap Notice 2012
NIH Salary Cap Notice 2011
NIH Salary Cap Notice 2010   
NIH Salary Cap Notice 2009 
NIH Salary Cap Notice 2008
NIH Salary Cap Summary 1990-2008*

Please note:  the School of Medicine allows salary over the cap to be charged to Department operating budgets.



nih training grants

 

Graduate Student Tuition Rates
2015-2016:  webpage >>
2014-2015:  webpage >>

Health Insurance Rates:
Health Insurance Rates (Postdoctoral Fellows) webpage >>
Health Insurance Rates (Graduate Students)- Vaden Health Center Stanford webpage >>

NIH Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels
NIH Stipend Levels fo FY2017*
*Effective with all Kirschstein-NRSA awards made on or after October 1, 2016, the annual stipend levels in the above notice apply to all individuals receiving support through institutional research training grants or individual fellowships, including the Maximizing Access to Research Career (MARC) and Building Infrastructure Leading to Diversity (BUILD) programs.
NIH Stipend Levels for FY2016
NIH Stipend Levels for FY2015
NIH Stipend Levels for FY2014
NIH Stipend Levels for FY2012

NIH NRSA Taining Grants & Fellowships
Comprehensive NIH NSRA webpage.

NIH Website:  FAQ's re: NRSA Training Grants

Stanford Biosciences NIH Training Grant Resource webpage (SUNET ID required for access.)





non-Disclosure Agreements (NDAs) and Confidentiality Disclosure Agreements (CDAs) or Confidentiality Agreements



Confidentiality Agreements webpage* >>
*this link takes you to the new DoResearch webpage formerly entitled, "Handling Non-Disclosure or Confidentiality Agreements"

In the course of their Stanford work, Principal Investigators and other researchers may be asked to accept confidential, proprietary or restricted information, materials, software code or technology from a third party. The third party - a company or a government agency, for example - will require that the researcher sign a Non-Disclosure Agreement (NDA), sometimes also called a Confidential Disclosure Agreement (CDA) or Confidentiality Agreement.

These can come up in the context of several kinds of institutional arrangements, including equipment or software loans, technology licensing, data sharing agreements, or material transfer agreements. In these kinds of university agreements, a Stanford office, usually the Office of Sponsored Research or the Industrial Contracts Office, will be involved and can negotiate appropriate terms on behalf of the University.

In other cases, a third party may ask an individual at Stanford to sign such an agreement as part of an ongoing or proposed activity in which there is mutual interest, such as a clinical trial or potential collaborative research project. In these cases, the NDA is between the third party and the individual. The researcher cannot sign on behalf of Stanford University.

 

 



payment addresses / wire transfer information


What should I do with checks received in my department?
Checks received in the department for payment on sponsored projects must be forwarded to the OSR Lockbox for deposit. Please do not mail them to the OSR office. Payments are to be made payable to Stanford University. Each check payment or wire transfer must reference the research project title, agreement number, invoice or voucher number, and the name of the Principal Investigator for identification. Any documentation or notes indicating the fund to which the money should be applied must be forwarded with a photocopy of the check to the appropriate OSR representative for retention in the file.  This includes a copy of any check remittance/advice or an attached memo or letter.  Preferred documentation includes  a sponsored projects (SPO)  number and/or award numbers. In general, the sponsor should not send checks directly to the department. The sponsor  should  be instructed to send checks  directly to OSR's  lockbox at the following address:

 

Stanford's Tax ID Number: 941156365

First Class Mail
(U.S. and Foreign):

Stanford University Lockbox
P.O. 44253
San Francisco, CA 94144-4253


Wire or ACH Payments
Domestic and Foreign

Name of Bank:            Wells Fargo Bank
Address:                      420 Montgomery St.
                                    San Francisco, CA 94163
Swift Code:                 WFBIUS6S (Foreign)
Sort/Routing/ABA:    121000248 (Domestic)
Bank Account number:
School of Medicine staff and faculty: to obtain this account number, please contact your department's Research Process Manager (RPM) in the Research Management Group.
Note: Please ask remitters to include information which describes who the funds are from and what they are for in the message line.

Detailed questions about the payments should be directed to
ORA Accounts Receivable

FedEx Certified/Overnight Mail

Wells Fargo Bank-Lockbox Services
Attn: Stanford University, Dept. #44253
3440 Walnut Ave, Bldg A, Window H
Fremont , CA 94538-2210

Verification of Package Receipt:
(510) 745-5200

Stanford Payment Contact

Miguel de los Santos, Accounting Manager
Sponsored Receivables Management
Stanford University
482 Galvez Modulars
Palo Alto, CA 94305
Ph: 650-725-1780
Email: migueld@stanford.edu

 




pi certification and quarterly

 

School of Medicine
RMG webpage: Quaterly Post Award Reporting Policy and Procedure

University Monthly Review and Quarterly PI Review and Certification
DoResearch webpage >>

 

 

piF- Proposal intake form- required

 

 

 





pi training, stewardship and compliance

 

Online training: Principal Investigator Responsibilities at Stanford University
PIs are responsible for the intellectual direction of research and scholarship and for educating and training students. In carrying out these critical tasks, PIs are also responsible for compliance with laws and regulations that touch on all aspects of the research enterprise. Regardless of their field of research and scholarship, all PIs should understand the requirements that flow from law and agency regulations pertaining to environmental health and safety, expenditures of project funds, financial disclosures and conflicts of interest, invention disclosures, and reporting of scientific misconduct. Depending on the type of research being done, there are also important requirements related to research methods, e.g., use of chemicals and other hazardous materials, human subjects, lab animals, radiological hazards, and biosafety.

To protect the individual as well as the university, Stanford requires each of its PIs to complete a brief review of these topics. PIs can do this by reviewing the material on the DoResearch website. Stanford University will not release project funding for a PI who has NOT satisfied this requirement.

Principal Investigator (PI) Training overview
05/13/2014: Per Patti McCabe in the Dean of Research Office, the former database containing individuals who have completed the PI training is no longer available. A replacement database will be available in the near future via this webpage:
http://doresearch.stanford.edu/training/piship

Stewardardship and Compliance for Principal Investigators-PI training:
http://doresearch.stanford.edu/training/piship/stewardship-and-compliance-principal-investigators

 




pi waivers

 

Prinicipal Investigator (PI) Eligibility and PI Waiver webpage* >>
*this webpage takes you to the School of Medicine RMG webpage containing information on Principal Investigator (PI) and the various types of PI waivers and procedures.








postdoctoral fellows on research grants

 

Fellowship office at the RMG (Procedures>>

Minimum Salary for Postdoctoral Fellows
The University Provost establishes minimum funding levels based on the years of cumulative research experience a Postdoctoral Scholar has when appointed. The minimum annual funding (salary and/or stipends) amounts are available on the following webpage:

Office of Postdoctoral Affairs-Funding Guidelines
The FY19 minimum postdoc funding levels are now available (effective 9/1/18):
https://postdocs.stanford.edu/funding-guidelines




subawards

 

Subawards DoResearch webpage* >>

RPH 16.1 Definitions and Classifications RPH 16.1  >>
This policy was revised to reflect custodial transfer of subaward issuance and oversight from Procurement and Internal Audit to OSR. Also includes new forms and processing requirements.


New OSR Form 45: Subawards Issued under Government Contracts
The new form can be found on DoResearch at https://doresearch.stanford.edu/research-administration/financial-concepts/subawards.
When subrecipients are included in Stanford projects funded by Federal and State Contracts, the government requires that Stanford perform a Fair & Reasonable Cost Analysis and provide a Sole Source Justification for each subrecipient. To facilitate securing the required components, the OSR Form 45 was created. Previously a multi-part form, the Form 45 is now integrated to include all components on a single form. The new integrated form will streamline the Form 45 process and ensure all required components are completed. When appropriate, department personnel can send out the form for the subrecipient to complete their portion (i.e. cost price analysis, attach supporting documentation, and electronically sign). Once the information is received from the subrecipient, your PI can then review the subrecipient’s responses, complete the sole source justification on the Form 45, and electronically sign the PDF.
For any questions or comments, contact Laura Register (laregist@stanford.edu).

New OSR Form 33: Subrecipient Statement of Collaborative Intent
The new OSR Form 33 has been reformatted and renamed to align with our participation in the Federal Demonstration Partnership Expanded Clearinghouse Pilot.

Effective August 17, 2016 the OSR Form 33 was renamed and revised from the Subrecipient Commitment Form to the Subrecipient Statement of Collaborative Intent. The FDP pilot will test the use of a national data repository which collects and provides the institutional profiles of FDP members instead of requesting such information on a transactional basis (i.e. with each proposal). While during the pilot (and maybe beyond) we will use of centralized institutional profiles of participating FDP members, the FDP recognizes that institutions will still need to collect project-level information and commitments as part of their proposal development process (i.e. Letter of Intent). Therefore, you will see the new form is broken down into two parts – FDP pilot members will only need to complete Part 1 Letter of Intent, and Part 2 will also need to be completed by everyone else.

Please download and use the revised form if you will be proposing with a subaward, or issuing a subaward to a collaborative institution.

If you receive pushback from any organization in completing the new Form 33 Statement of Collaborative Intent, please contact Mich Taniguchi Payne (michiko@stanford.edu) or Laura Register (laregist@stanford.edu) and they will be happy to speak to the subrecipient regarding the requirement.

 

 


 


telecommunications rate for the school of Medicine


On 9/1/2012, the School of Medicine implemented a telecommunications/converged communication rate for distributing the desktop phone service costs back to individual units/departments. This was in response to the University’s announcement that they would no longer bill desktop phone services directly to individual depts/units through monthly detailed statements. Instead, the desktop phone service is now charged in a single lump sum to a SoM Dean’s Office fund and the SoM distributes the desktop phone service costs back to individual units/departments through the charging of the telecommunication rate.

Original memo >> PDF   for more information

Background and FAQ >>  PDF   for more information

Converged Communications (ITCC) Application of Charges (Decision Tree) and Rates PDF


*Application to PTAs Administered through SoM
The telecommunication charge applies to sponsored project and non-sponsored project PTAs administered through the School of Medicine only.  It does not apply to the following Award types:

Excluded Award Types  PDF


*Application to Sponsored Project PTAs Administered through SoM
For non-government/non-federal sponsored projects, RMG will calculate the 3% rate on all salaries (i.e. faculty, staff, postdocs, and students, and TBN positions) listed on the proposal budget and then enter the amount as a line item in the Other Expenses category as a “Telecommunications Charge”.

NOTE- direct charging of Stanford ITS provided desk-top telephone services will no longer be allowable in the School of Medicine.


 


veterinary service center (vsc) charges

 

Department of Comparative Medicine animal care rates >> (SUNET ID required for access)
The Veterinary Service Center (VSC) is a component of the department of Comparative Medicine that oversees all laboratory animal care and use at Stanford University. The VSC is responsible for assuring that all use of animals is humane and complies with all relevant policies and legal requirements.


Download the VSC Animal Services Budget Worksheet  (11/15/2017)  

 

 

 


Other administrative offices

 

 

 

Other miscellaneous links:



 

 

 

 

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