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Division of Pulmonary, Allergy & Critical Care Medicine |
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CONTENTS |
GRANTS AND CONTRACTS 101: A
Reference Guide for Pulmonary Division Researchers Last
updated on November 28, 2006 Dear Pulmonary Division Researchers: This Grants
and Contracts 101 page has been created to supplement and summarize
existing Columbia University research resources and information
in effort to clarify the grant application and submission process, assist in
budget preparation, provide information on funding opportunities, and post
announcements and policy changes. Please contact your grants manager for further assistance with
any and all matters related to grants, consortiums, contract negotiations,
agreements (i.e. MTA’s) as well as information regarding |
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■ Announcements-
“NIH Electronic submissions”
and “NIH revised forms” |
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■ Useful CU Contacts (Administrative Officials and
Signatories) |
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■ Budget Preparation and
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Useful Links:
§
CU Research
Administration – MEDICAL CENTER §
CUMC Institutional
Review Board §
CUMC
Office of Clinical Trials §
USING
eSNAP at CU, a tutorial §
****CU-
Institutional Information for Applications §
CU-
Application Preparation Forms and Tools §
Research Administration
Glossary §
CU Training
(i.e. NIH paylines and NIH scoring system explained) §
CUBHIS (Columbia
University Biomedical and Health Information Services) §
CU SOFTWARE AVAILABLE
(some software available for free download, i.e. ENDNOTE) §
CU
Statistical Consulting Services Available §
Administrative
Policy Library
§ NIH.gov - Office of Extramural Affairs § NIH Types of
Grant Programs (Mechanisms) § NIH Request
for Applications (RFA’s) § NIH Grant Review Process Video § NIH’s Scoring
System explained § NIH Regional Seminars on
Program Funding and Grants Administration § National
Heart, Lung, and Blood Institute - Model K08 Application § National Heart, Lung, and Blood Institute
- K23 Model Applications § NIH-Grant Writing Tips
Sheets § NIH Issued Notice of
Grant Awards (NGA’s) IPF#1833205 §
NIH Extramural
Awards By State and Foreign Site
§ NIH PROGRESS REPORT Listed by due date IPF#1833205 Other Links: §
InfoEd– Scheduled
to go live Oct 1st,2006 § “The
elements of Style” by William Strunk, Jr. §
Institutional
Tobacco Disclosure Statement Appendix (i.e., for FAMRI) CU
Face page w/ institutional signature required (use this when none are provided
by the agency) Many more...Forms |
ANNOUNCEMENTS: This just in.... via the AAMC: "The Washington Post
reported on Wednesday that Northrup Grumman has lost the contract to develop
and manage grants.gov, the government-wide grant application IT platform. The
contract has been awarded to General Dynamic Information Technology, which
"will create a new system by March 31..." The contract changes hands on November
1. The Post article notes that the
change puts into question the ability of the system to correct a major
impediment - its inability to seamlessly manage Mac-generated
applications. The change is also
calling into question NIH's February 1, 2007 deadline for the electronic
submission of all R01 applications.
The article reports the NIH is considering whether to push back the
deadline."
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Types of Sponsored Projects:
I.
GRANTS a.
Research b.
Training 1.
Individual Fellowships, 2.
Training Grants, 3.
Career Development Awards c.
Service d.
Other II.
CONTRACTS AND AGREEMENTS (i.e. MTA’s) III.
RESEARCH SUBCONTRACTS/ CONSORTIUM AGREEMENTS Terms between PI and 2nd cooperating
institution. IV.
SERVICE CONTRACTS V. COOPERATIVE AGREEMENTS (i.e. Multi-center, Clinical Trials funded by
Federal Government only.) To determine if a sponsored project is a
clinical trial, refer to the definition of
a clinical trial. |
I.
NEW APPLICATIONS PA’s compete with general pool of applicants
w/special consideration. a. Grant
or Cooperative Agreement b. Response
to Special Announcement: RFA-grants
(Request for Application) or PA
(ongoing Program Announcement) c. Unsolicited
Contract d. Response
to Special Announcement: RFP-contracts
(Request for Proposal) II.
COMPETING CONTINUATION (RENEWAL) Application to obtain funds to continue a
project beyond the currently funded project period. Competes with general
pool of applicants. III.
RESUBMISSION/AMMENDED APPLICATIONS Modified resubmissions for previously denied
Grants or Renewals. For Renewal resubmissions, a request can be made for
no-cost extensions or funded extensions to allow PI time to resubmit Renewal. IV.
NON-COMPETING CONTINUATION Funding agency is committed or “obligated” to
support the project for several years but awarded its funds on a yearly basis
through a non-competing continuation application or renewal. V. SUPPLEMENTAL APPLICATIONS Request for an increase in support for the
expansion of a project or meet unforeseen costs. VI.
EXTENSION/NO FUND EXTENSIONS Request to fund the research for an additional
period. Under the Federal Demonstration Project, a one-time no-fund extension
up to 12 months can be approved by the Office of Grants and Contracts without
approval of the funding agency—only for Federal Grants. VII.
TRANSFER of Sponsored Project to the
HEALTH SCIENCES Allows a new PI to bring their on-going
sponsored projects to the institution. Requires relinquishment form or letter
from the original awarded institution and acceptance of the grant from --Excerpts from CU Grants
and Contracts Manual of Policy and Procedures, 1998 |
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1.
General Research Grants (non-clinical trials) Signing Official Cheryl
Mapou, Senior Project Officer Office of
Research Administration 2. General Research MTA’s, Contracts/Agreements Reviewer Victoria
Malia, J.D., Assoc Director Office of Science and Technology Ventures
(STV) Signing Official Ofra
Weinberger, Director Office of Science and Technology Ventures
(STV) 3. Clinical Trials Government Grants Reviewers Sharon
Levine, Project Officer Signing Official Daniel
Calto, Director of Research Administration Office of
Research Administration 4. Clinical Trial Contracts/Agreements Reviewer/Negotiations Darnell
Benjamin, J.D., Mgr Fin-Clin Trials Signing Official Daniel
Calto, Director of Research Administration Office of
Research Administration 5. Service Agreements (ie. outsourcing of laboratory
testing) Contact
the Purchasing Department 6. For Strategy and General Council, especially for large
scale grants, please consult with: Jamie
Rubin, Ph.D. Director
of Research Development, Department
of Medicine Assistant
Professor of Clinical Medicine, Radiation Oncology |
Grant Preparation and Submission Process: The 10 Step Process
1.
PI’s must forward any links, RFA’s or grant
details. If not, simply describe the
type, amount and length of award for which you wish to apply and identify the
sponsoring agency and deadline. 2.
PI’s must forward a list of all individuals to
be named on the grant, including % effort (multiply by 12 to get the # of
calendar months for the new NIH forms), roles, and their department/division
if non-pulmonary. If any individuals outside of CU are to be included, a
consortium subcontract proposal may be required. A CU
subcontract Proposal Face Sheet will be required by CU for each
subcontract in addition to the agency requested forms. Your grants manager will need contact information of
participants outside of CU. Getting materials from other institutions can be
a lengthy process and should be addressed early on. All CU personnel named on a grant must have
a current Conflict
of Interest (COI) statement. All personnel working with human
subjects or patient medical information must complete a one time Health Insurance Portability and
Accountability Act (HIPAA) Certification.
All Key Personnel involved in human subjects research must
additionally have Good
Clinical Practice (GCP) certification. All three certifications are completed
in RASCAL. The GCP
course is also available online. 3.
If animals or human subjects are involved, IACUC and/or IRB approval must be obtained by
the PI. Even if pending, please
provide IRB or IACUC numbers. Please
check directly with the Institutional
Animal Care and Use Committee (IACUC) and the CUMC Institutional
Review Board (IRB) for procedures to obtain approval and an estimated
time for approval. 4.
A “Contracts & Grants” RASCAL IS CREATED: This is an institutional cover sheet designed,
in part, as a checklist of vital information for an upcoming grant
submission. It also serves as a kind of internal alert to CU officials that a
proposal is on it’s way. I will notify you when it’s time to FINALIZE the
RASCAL. Once RASCAL is finalized, no
changes can be made to the RASCAL. The RASCAL should be finalized and
approver’s must approve before the grant can be signed by the institutional
official. (Soon this will be replaced
by the Info Ed grants administration system). 5.
A BUDGET IS PREPARED: While a
section to assist you with budget preparation can be found below, you need
only meet with your grants manager to help you with this process and apply
all the rules as necessary. An excel template has also been provided for you
convenience using the latest NIH forms. 6.
ADDITIONAL INFORMATION IS GATHERED BY YOUR
GRANTS ADMINSTRATOR: Bio’s for all key
personnel are requested and collected as well as the names of all Department Administrators
of those PI’s not in this department. In some cases, letters of support and
“other support” form pages are also requested. 7.
ADDITIONAL MATERIALS TO BE PROVIDED BY THE PI: Title, Abstract/Summary, Bio, Resource page,
Science Section (even in draft form), and other materials as requested. For
NIH grants, the new NIH forms
(rev. 04/06) are mandatory, as of June 1, 2006. For non NIH grants, use forms
provided by sponsoring agency. If no forms are provided, you may use NIH
PHS398 forms as templates. 8.
REVIEW: Basic
grant: A draft will be reviewed by
Cheryl Mapou, Grants and Contracts, for institutional signature. The draft for signature must include: final
budget and budget Justification; abstract, key personnel list and face page;
draft science and bio’s; and a printed copy of the grant guidelines if an RFA
(Request for Applications). You may
consult with Cheryl as you gather your materials. Clinical
Trial: Reviewed/Approved by Sharon
Levine, Project Officer, Clinical Trails Office, and final draft submitted to
Daniel Calto, Office of Research Administration, for institutional signature.
9.
SIGN: Approvals
and institutional signatures are obtained (see below for details). The PI must sign before submitting for
institutional signature. Blue ink is advised
so as not to misplace original signatures. The signed face page and the final application is collated,
copied and Fed Ex’d. PI’s are welcome
to participate in this process and celebrate the completion of a job well
done! 10.
SEND:
PI’s will be notified when the application has been sent. Electronic versions
of application materials, hard copy of the completed application, and Fed Ex
Tracking Numbers are provided to PI’s upon request. Any Notices of Grant Awards (NGA’s) will go
to the Office of Research Administration who will notify us of the grant
award and create an SPBA (Sponsored Project Budget Authorization-
Account). Recent NIH awards are
posted on eRA; to search for Columbia University Health Sciences, type in our
IPF#: 1833205. REQUIRED APPROVALS I. PH Hospital Units- All involved
administrative unit/department heads must sign internal cover sheets (Rascal
grants module). Involved resources include: space, labs, pharmacies, equipment,
and/or personnel. II. a) Office of Research
Administration, Cheryl Mapou, Project Officer must approve all non-clinical trial proposals and
contracts. May submit a signed letter as to pending signatures to OGC; they
accept e-mail or fax approvals, letter or sign-off on Internal cover sheet;
may send duplicate covers for simultaneous signatures: —OR— b) OTHER APPROVALS AS NEEDED III. Consortium
Agreements with non-affiliated institutions require documents necessary
to develop a consortium arrangement. An authorized representative is required
to submit a letter stating willingness to participate in project and enter
into a consortium agreement. Should include approved budget and proposed role
unless included in proposal. IV. Establishment of New Institutes, Centers or Programs—Must
be approved by the Dean/Vice President and Provost and may require University
Senate and authorization of Trustees. Contact the Office of the VP for Health
Sciences. V. Additional Facilities, Renovations, and Space—require
sign-off on Internal Cover Sheet by Dean/Chairman/Director or administrator
indicating approval of facilities statement. a.
Rental of non-university space
approved by Deputy VP for Finance and Budget. b. New
Construction require approval, feasibility study and price quotation from
Health Sciences Facilities Management office and may require additional
approvals from the Space Policy Committee, the University Budget Committee
and the Trustees. VI. Special Liabilities or Insurance—Must
be approved by the Director of Risk Management. Potential liability risk to PH may require
approval of the PH President. VII. New Use of Health Sciences Central Computers—Administrator
or Director of appropriate computer center and any involved Administrator
or Director. VIII. Major Library Acquisitions—Approvals required
from the Assistant VP and Associate Dean for Scholarly Resources. IX. Human Subjects—Approval required from the Institutional
Review Board (IRB), x5-5883, in compliance with Federal Regulations
(45CFR46). Protocols require departmental and institutional approvals for a
period of one year. PI’s must pass the
“Human Subjects in Research” certification exam. Original
GCP Certofocation Memo. X. Vertebrate Animals—Approval required from the Institutional
Animal Care and Use Committee (IACUC), 5-2404, in compliance with Health
Sciences and Public Health Service (PHS) Policy. All personnel listed on the
protocol must complete certification on humane care and use of laboratory
animals. All animals are ordered from
the XI. Recombinant DNA or RNA— Approval required from the
Institutional Recombinant DNA Biosafety Committee (IBC), 212-795-3067. Five year approval
registration document “Memorandum of Understanding” to be sent to OGC. XII. Radioactive Material— Approval required from the
Joint Radiation Safety Committee of Columbia-Presbyterian Medical Center
(JRSC), 212-305-5660. All radioactive material must be ordered
through Radiation Safety, 212-305-0304. XIII. Hazardous Materials—The Environmental Health
and Safety Office (EHS) provides info. and assistance, 212-795-3067. XIV. Service to the Community—Projects which provide
health or medical services to the public or CU community requires approval
from the Office of the Deputy Vice President for External Relations
and may require approval of the President of Presbyterian Hospital. XV. Irving Center for Clinical Research—use
of the center requires sign-off of the Director on Internal Cover
Sheet. XVI. Cancer Related—use of --Excerpts
from CU
Grants and Contracts Manual of Policy and Procedures, 1998 |
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Your grants manager will work
closely with you to complete a budget. Simply contact them 3 weeks before the
deadline to begin a draft. To draft
your own budget, please reference the following information. Download the Applications
will request direct costs in $25,000 modules, upto a total direct costs request of $250,000 per year for all
unsolicited new, revised, and competing continuation grants and competing
supplements, as well as applications responding to RFAs for these mechanisms: R01—Competing individual research
project grants R03—small grants R15—Academic Research
Enhancement Awards R21—exploratory/developmental grants R41—Small Business Technology Transfer
grants, Phase I R43—Small Business Innovation Research
grants, Phase I Detailed
categorical budget info will not be submitted with the application; budget
form pages of the application kits will not be used. Additional narrative budget justification
will be required only if there is a variation in the number of modules requested
from a previous year. Applicants should consider the direct cost of the
entire project period in determining the total for each budget year. Salaries (Base + A1) To
be confirmed by the appropriate Divisional/Departmental Administrator of each
individual outside of the Pulmonary Division. Salaries used in year one
should reflect the salary effective on the project start date whenever
possible. Inflation rate should be calculated at 3% for each consecutive year
(except on the salary cap). All CU
personnel receiving salary must be included in the detailed budget page and
justification. For the most up to date information on CU rates,
please consult the CU- Institutional
Information for Applications Page. Current
CU fringe benefit rates (26.8% Gov, 31% Private) Key
personnel must have a measurable % effort with or without salary. As needed, non-salaried persons may be
considered “Other significant contributors”. Technicians, GRA’s etc. are
usually not considered key personnel. Indicate
positions to be filled as “to be named”. Please note that departments within
the University may require salaries to correspond with the % effort. Consultants Generally,
a consultant is someone outside of Equipment & Supplies Those items
costing more than $2,500 are defined as "equipment". Those items
costing less than $2,500 should be put in the "supplies" category. Patient Care Costs Specialized tests not done
in a hospital laboratory or a licensed, commercial testing laboratory are not
considered patient care costs and must be included under "Other Direct
Costs". “Real costs” must be used and billing quotes are required. NIH Grants Policy Statement is a valuable resource for searching policies and procedures on numerous topics for NIH grants: http://grants.nih.gov/grants/policy/nihgps_2003/
This link will take you to a section which includes a subsection titled “Research Patient Care Costs”: http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part13.htm
This information regarding allowable Research Patient Care Costs is adapted from the 45CFRPart74, Appendix E. It is towards the end of this linked section and there are specific allowable costs lists associated with the Patient Care Agreement: http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=45&PART=74&SECTION=91&YEAR=2001&TYPE=TEXT
Patient care. The cost of routine and ancillary or special services to research patients is an allowable direct cost of research agreements. a. Routine services shall include the costs of the regular room, dietary and nursing services, minor medical and surgical supplies and the use of equipment and facilities for which a separate charge is not customarily made. b. Ancillary or special services are the services for which charges are customarily made in addition to routine services, such as operating rooms, anesthesia, laboratory, BMR-EKG, etc. c. Patient care, whether expressed as a rate or an amount, shall be computed in a manner consistent with the procedures used to determine reimbursable costs under Pub. L. 89-97 (Medicare Program) as defined under the ``Principles Of Reimbursement For Provider Costs'' published by the Social Security Administration of the Department of Health and Human Services. The allowability of specific categories of cost shall be in accordance with those principles rather than the principles for research contained herein. In the absence of participation in the Medicare program by a hospital, all references to the Medicare program in these principles shall be construed as meaning the Medicaid program. Other Please include GRA tuition
and fees here for each GRA, for each year. Current GRA salaries,
tuition and fees. No fringe
for GRA’s should be added. Consortiums As of November 2004, the new
NIH policy states that consortium F&A costs will no longer come out of
the applicant’s Direct Cost limit. You may request such costs in addition to
the direct cost limit or modular amount. This change is meant to encourage
the use of consortiums. Consortium costs are not
calculated in CU’s F&A with the exception of upto $25,000 per consortium
for the entire project period (not per year as is commonly mistaken). Facilities and
Administration Costs, a.k.a. Indirect Costs or A-21 (currently
61% for gov. grants) Current
CU Indirect Cost Rate Agreement Indirect costs are the
additional expenses incurred by the university due to the sponsored research
activity of its faculty, for example, the utilities, waste disposal,
maintenance and depreciation costs of running a laboratory. In order to
measure these costs, colleges and universities follow a process established
under government rules (Circular A-21)
for recovery of these monies. There are many types of
costs associated with research that are not included in the A-21 calculation
for organized research. Exclusion of
such costs from the Direct Cost (DC) is what’s called the Modified Total
Direct Cost (MTDC), and used only to calculate F&A cost. MTDC x F&A rate= F&A DC + F&A = TDC (Total Direct Cost) Exclusions include a portion
of salaries of faculty engaged in departmental research (A-2), Graduate
Research Assistant (GRA) student tuition and fees, equipment (for items
$2,500 or greater), patient care costs, renovations/alterations and subcontracts
greater than $25,000. These costs are routinely borne by the University. The
above items contribute to what we call the "full" costs of
research.
The numerator consists of
three main cost components: Administrative (university-wide, school-based,
and department-based); Facilities (operation and maintenance of buildings and
depreciation); and library. Each of these
components contribute to the numerator, an amount based on the total actual cost that is assignable
to sponsored research. |
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Funding Opportunities and Resources:
http://www.cumc.columbia.edu/research/funding.htm While databases are very
useful, they require you visit and search regularly. A very good
supplement/alternative is the use of listserv and e-mail alerts, which are
linked to major “funding resource” databases. Sponsored Programs
Information Network (SPIN) Database, for example, uses SMARTS—an e-mail
alert system that matches your profile (from the “GENIUS” module) with
opportunities from SPIN. Several other such services are listed here. These
list serv’s are highly customizable, amendable and automatically send you
e-mail alerts as soon as a new funding opportunity is added that matches your
pre-set criteria. Also available for
general counsel and assistance is: Jamie Rubin, Ph.D. Director of Research Development, Department of Medicine Assistant Professor of Clinical Medicine,
Radiation Oncology |
