IRB Review Fee Memo (Dec. 2006)
This memo contains information on current IRB Review fees charged for the review of new industry-sponsored clinical trials, i.e., all studies which test an investigational drug or device on human subjects and are sponsored by private, for-profit entities.
NHLBI Clinical Research Guide
Preparing, submitting and managing a clinical research award can be challenging. This site is designed to guide potential investigators in organizing a clinical research application and to provide information on conducting a study and maintaining an award.
Human Research Protection Program (RPH 7.0)
This policy summarizes in one document comprehensive information about the organization, scope, authority and responsibilities associated with Stanford University's program for the protection of human research subjects.
Guidance on Human Subject Determination Download file containing definitions of Human Subject Research. Under the organization's policies and proceudres an activity is human research if it is described in any one of the following:
(1) FDA regulations
(2) DHHS regulations or other Common Rule Regulations
(3) VA Regulations or
(4) Any other applicable state or local regulations, e.g. California State regulations
Human Subject Determination Form - Download form
(Send form via email to Celia Molvin at celia.molvin@stanford.edu)
School of Medicine and University policy and procedures
Conflict of Interest Annual Disclosure and Ad Hoc Disclosure
procedures
Tips for faculty for managing their outside relationships in order to avoid conflict of commitment and interest
Conflict of interest Supplmental form:
"Disclosure of Financial Interests Related to Research Activity" must be completed by the PI and attached to the SU-42 for each proposal. See Forms webpage.
Non-clinical industry research agreements
Vitro or animal studies for industry sponsors (only)
Handles all Material Transfer Agreements
Contracting process and negotiation
Office
of Sponsored Research/School of Medicine Team
(Click on "Office Group" and select "Medicine")
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).
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
Research Policy Handbook: Export Controls (RPH 10.2)
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.
Stanford webpage on Export Controls includes: templates that can be downloaded and used to document appropriate exemptions and exceptions to licensing requirements, as well as a "decision tree" to help in determining when such documentation is needed.
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").
Clarification of OMB A-21 Treatment of Voluntary Uncommitted
Cost
Sharing and Tuition Remission Costs, OMB Memo M-0106, January5,
2001 [ PDF file ]
NIH
Requirements (NIH website) (Graduate Student Compensation)
Revised
Jan. 2006
The Graduate Student Compensation Limit for Fiscal Year 2006
NRSA awards research grants is tied to the "0" level of experience stipend level for postdocs . Therefore,
the new limit is $36,996 (salary plus benefits and tuition) when budgeting graduate students
on research grants.
Stanford procedures for
Grants.gov at Stanford webpage
The Grants.gov at Stanford site was created to facilitate the transition to electronic grant application submission via Grants.gov.
• Use this website for guidance on submitting through Grants.gov.
• Find tips to help you a void pitfalls and benefit from lessons learned by faculty, administrators, Institutional Representatives, and central offices who have already submitted grant application packages through Grants.gov.
• Find information about new business practices, and additions to Stanford policy resulting from the new electronic submission process.
IDC Waiver Request--please contact your RPM for assistance.
Policy RPH 3.10, Indirect Cost Waivers
Updated to incorporate recent changes in the university Infrastructure Charge rate and process.
Verification of nonprofit
organizations tax exempt status
"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.)
Effective June 1, 2006, a copy of the complete and final sponsor application along with a signed/completed SU-42 must be submitted to your institutional representative at least 5 full working days in advance of the sponsor's due date.
This requirement applies both to proposals that will be submitted electronically as well as those being submitted on paper. The five day lead time does not include the time required by your local unit/department/school for their review
New ORA website. (Mac users-please use Safari or Firefox internet browsers to access this website.)
Office of Sponsored Research--School of Medicine Team
The Contract Officers for the School of Medicine are now located
at 651 Serra Street, Room 220. Contact list
Payment
Addresses/Wire Transfer Information
Stanford's Federal Tax ID No.: 941156365.
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:
By First Class Mail:
Stanford University
P.O. 44253
San Francisco, CA 94144-4253
By Federal Express:
Stanford University Lockbox 44253
C/O Regulus
42840 Christy Street, Suite 100
Fremont, CA 94538
Tel: 510-492-6759
If a Wire Transfer is involved, please send it to: Wells Fargo Bank
420 Montgomery Street
San Francisco, CA 94163
As of June 1, 2000, PI Training will be required before an award
can be accepted.
Online PI training (The navigation
button, "NEXT". at the bottom of the webpage below will advance you
through the materials. You will need your SUNET ID and password to
proceed.)
OSR webpage which provides various tools to assist the departments in establishing subawards under sponsored agreements.
RPH 3.7, Subawards
Revised to reflect custodial transfer of subaward issuance and oversight from Procurement and Internal Audit to OSR. Also includes new forms and processing requirements.
Vacation Charges
Managing salary charges to pay for earned and accumulated vacation. Dean of Research vacation resource webpage.