Funding Opportunities and Grant Basics for Postdoctoral Fellows. Presented by Michael Lemoine Office of Sponsored Programs

Transcription

1 Funding Opportunities and Grant Basics for Postdoctoral Fellows Presented by Michael Lemoine Office of Sponsored Programs

2 Objectives What types of funding are postdoctoral fellows eligible to apply for at MD Anderson Which sponsors will provide funding to postdoctoral fellows Discuss the timeline in which to apply for Opportunities How the internal MD Anderson policies and processes affect your submission 2

3 Plan Ahead Eligibility for awards depends upon Years of postdoctoral experience 6 mo ~ 1 yr into post doc F years into post doc K99/ R00 or K22 Citizenship Leaving the nest Appointment renewed Annually 5 years maximum for Postdoctoral position at MD Anderson after which Appointed to Faculty Take a Classified (non faculty position) Leave institution 3

4 Postdocs at MD Anderson Eligible for funding from Federal and non federal sponsors Training awards (T32) Fellowships (F31, F32, DoD Breast Cancer Postdoctoral Fellowship Award) Career Development Awards (K Awards) Travel Awards Postdocs cannot apply for Research Grants (R01, R21, DoD Breast Cancer Idea Award) Do you have your own lab? Do you supervise others? Compliance? 4

5 Grant versus Fellowship Grant - Financial assistance mechanism providing funding to an eligible grantee organization to carry out an approved research project. Supports independent research. PI- A faculty member of the Grantee Organization with the facilities, expertise and resources to carry out the project Grantee Organization the institution with which the PI is affiliated. Fellowship A training program where the sponsor specifies the individual receiving the award. Funds for study or training on a special project. Stipend miscellaneous expenses The purpose of a training award is to provide applicant protected time to become independent 5

6 Major Sources of Funding Federal NIH NSF DOD Non Federal Professional Societies Foundations Industry 6

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9 Considerations when Seeking Funding Opportunities Federal vs. non-federal sponsors Eligibility requirements Guidelines Career Stage Early Mid Late Type of Research Basic Science Cancer Research Other fields 9

10 OSP Website Inside MD Anderson Departments Sponsored Programs Funding Opportunities Fellowships? Community of Science (COS)

11 Community of Science Funding Opportunities Information Database Alerts Expertise News Key Word Searches Scholar Universe Workbench 11

12 Searching Community of Science 12

13 Federal Funding All funding opportunities for federal funding can be found on Search by key words Search by agency 13

14 Principal Investigator The individual judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. Early Stage Investigator (ESI) A Program Director/Principal Investigator New Investigator Within 10 years of completing his/her terminal research degree Within 10 years of completing medical residency (or the equivalent). 14

15 New Investigator A PI is considered a New Investigator if he/she has been the PI on of any of the following classes of awards: All Fellowships (F awards) All individual and institutional career awards (K awards) Loan repayment contracts (L30, L32, L40, L50, L60) All training grants (T32, T34, T35, T90, D43) Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting Awards G07, G08, G11, G13, G20 R13 S10, S15, S21, S22 A PI is identified as a New Investigator if he/she has not previously competed successfully for an NIH-supported research project other than the following (abbreviated list) Pathway to Independence Award-Research Phase (R00) Small Grant (R03) Academic Research Enhancement Award (R15) Exploratory/Developmental Grant (R21) Research Education Grants (R25, R90, RL9, RL5) Dissertation Award (R36) Shannon Award (R55) NIH High Priority, Short-Term Project Award (R56) Resource Access Award (X01) 15

16 Federal Funding Fellowships and Career Development Awards 16

17 Ruth L. Kirschstein National Research Service Award (NRSA) F Kiosk- Individual Fellowships F31 Individual pre-doctoral fellowships F32 Individual postdoctoral fellowships K Kiosk - Career Development Awards K01 Mentored Research Scientist CDA K22 Career Transition Award K99 Pathway to Independence Purpose to insure diverse pools of highly trained scientists will be available in adequate numbers and appropriate research areas to address the Nation s research needs 17

18 F Series Applications Candidate Qualifications Undergraduate institution Citizenship Eligibility Training Plan Must include NEW research experience Mentor Formal training plan Mentor Statement Mentor Successful record Mentee must walk on water 18

19 F Series Individual fellowships A NRSA fellowship cannot be held concurrently with another federally sponsored fellowship that provides a stipend or duplicates award Service Payback: Service obligation of 1 month for each month of support during the first 12 months Acceptable Payback positions Subsequent months under NRSA are acceptable as Payback Non NRSA positions acceptable (academic, government, commercial Teaching Research Training Health-related research Unacceptable positions Clinical practice Administrative responsibilities not related to research Government entitled to recover total amount of NRSA funds 19

20 NIH Career Development Awards: K Series K Awards Between F & R Series Purpose: Provide applicant with 3-5 years additional supervised research Training must be in area new to applicant Focus of K Awards progression to independence Candidate to provide plan to achieve independence 75% effort required Covers Salary, benefits and up to $30K for research resources 20

21 Pathway to Independence K99/ R00 Provides postdocs with independent funding No Citizenship Requirements Allows up to 5 years support (two phases) Phase 1: 1-2 years mentored support for postdocs Phase 2: Up to 3 years independent support Must receive independent research position 21

22 K22 Career Transition Award Support to individual Postdoctoral fellows (F32/T32) in transition to faculty status Check institutes for eligibility K22 being eliminated by some Institutes (Replaced by K99) Check with Program Officer before applying html 22

23 Special instructions for K- Awards Letters of Reference At least three, less than five Address competence & potential for independence Do NOT send w/ application separate process List or Referees included in Other Attachments Type of Application K- awards not usually supplemented or renewed Start and End dates PI Contact information Reflect where applicant can be reached 23

24 Special instructions for K- Awards The Candidate = PI Register in era Commons Assigned PI role For K awards Multi PI not applicable Biosketch Mentor, Co-mentor Assigned role of Other Professional Enter Mentor or Co-mentor Provide Current and Pending support Exclude Overlap information and level of effort 24

25 K Awards Budget Refer to application instructions for allowable costs Minimum effort usually ~75% or 9 person months Indirect cost type Modified total direct cost Indirect cost rate = 8% Cognizant federal agency = Not applicable Reimbursed at 8% rather than the negotiated rate DHHS, Wallace Chan,

26 Budget Basics Salary Cap- Current NIH Cap $199,700 Effective January 1, 2010 Fringe Benefit Rate: 28% Cost of Living Increase: 3% Direct Costs- Costs specifically identified with a particular project or activity. Salaries Travel Research Costs Indirect costs (F&A) (IDC) - Costs incurred by a grantee that cannot be identified specifically with a particular project or program. Total costs All allowable costs (both direct costs and F&A costs. 26

27 K- Awards Cover letter required Required Include list of references For internal use not shared with reviewers Career Development Award attachments Items 2-5 (Candidate Information) Item 11 (Research Strategy) Provide Mentoring Plan only if required by FOA Follow page limitations of FOA Environment and Institutional Commitment Not to exceed 12 pages Institutional Commitment signed by Department Chair NOT OSP. 27

28 Biographical Sketch Personal Statement added: Briefly describe why your experience and qualifications make you particularly well-suited for your role in the project Publications revised: Limit the list of publications or manuscripts to no more than 15 Applicant is encouraged to make selections based on recency, importance to the field, and/or relevance to the application 28

29 Mentors Crucial Role in Grant writing Brainstorming Critiques proposal Name recognition Street cred Qualities Knowledgeable in your research area Relevant Publication record Current/ recent peer-reviewed funding 29

30 Which K is Right for You? Career Award Wizard READ Program Announcement READ Guidelines (different from announcement) Talk to Program Officer 30

31 SF 424 Guidelines Electronic Submission Activity Types K Awards Training Grants Fellowships Adobe Forms Elements of PHS 398 Special section on K & T Awards 31

32 Example: Program Announcement 32

33 Success Rates Career Development Awards (2009) K % K22 26 % K99 29 % Fellowships (2007) F % F % Training Grants (2007) T %

34 Non Federal Funding The Development Office Raise money for a list of broad Priority Programs established by the President in collaboration with the Provost and Executive Vice President, the Management Committee and the Research Council. Quarterly Guide to Private Funding Research Grants Fellowships Contact Carl Borne (713) Applications, Guidelines Specific questions about funding sources before proceeding with a proposal to a private funding source. 34

35 Fellowships from Quarterly funding guide 35

36 Development Office Procedures for Applying Contact the Development Office for guidelines and application forms. DO NOT CONTACT the foundation as an individual. Prepare application per sponsor guidelines Application reviewed by the Office of Sponsored Programs and the Development Office. Fellowships also reviewed by the vice president for educational programs. "blue checklist" signed by the department chairman, division head and the vice president for research. Proposals will not be accepted without them. Submit proposals at least seven working days before the deadline. If at first you don't succeed, try again 36

37 Program Announcements NON federal Grants 37

38 Requirements Doctoral degree (Ph.D., M.D., D.Phil. or equivalent) Within 2 years of obtaining degree Appointment at MD Anderson Host laboratory and advisor different from candidates pre-doctoral training 38

39 Odyssey fellows: 3 Years support Progress Reports required minimum of NRSA level plus fringe Up to $5,000 for lab supplies or research funds Application Deadline in March Award Start Date September 1 39

40 Don t Run Out of Time Critical component for a successful submission Allow your Administrator ample time to assist you in the process ample time to guide your grant application through the complex institutional and regulatory review Due to nature of grants.gov reviews, OSP needs to receive the final file 1.5 days in advance of the stated deadline. 40

41 Electronic Submission Process Find Opportunity and Download Application Package Complete FReD Checklist & FReD Addendum Prepare Application Submit Application to OSP for Review OSP submits Check Application Status Submission Complete Source

42 PI 10 days before due date Department The timeline helps everyone accomplish crucial tasks prior to the deadline 5 days before due date OSP 42

43 Select Opportunity READ Instructions READ Instructions Read NIH Guidelines Fill out Grant Forms Collect Biosketches and LOS Complete FReD & FReD Addendum Applications due in OSP for review OSP submits to Sponsor Start Budget Work on Research Plan Sponsor Deadline Suggested Prep time Required by OSP Business days until GRANT deadline 43

44 Deadlines for Grants Standard NIH DOD Varies with Program and Mechanism Komen Internal M.D. Anderson Funding Sources Deadlines Odyssey Program ROUTING & APPROVAL THE BUDGET AND THE PROPOSAL DETAILS NEED TO BE COMPLETELY FINISHED AND SUBMITTED FOR APPROVAL AT LEAST 5 BUSINESS DAYS PRIOR TO THE SUBMISSION DEADLINE. THIS IS TO ALLOW ENOUGH TIME TO SUCCESSFULLY COMPLETE THE ELECTRONIC ROUTING PROCESS AND ACCOMMODATE ANY REVISIONS THAT MAY BE NECESSARY. 44

45 Some NIH Standard Due Dates Mechanism Description Form Cycle I Cycle II Cycle III T Series Institutional NRSA & Training Grants SF 424 January 25 May 25 September 25 K- Series- New Research Career Development K Series renewal, resubmission, revision F Series Fellowships New, renewal, resubmission Research Career Development SF 424 SF 424 February 12 March 12 Individual NRSA SF 424 April 8 June 12 July 12 August 8 October 12 November 12 December 8 NOTE: Grant Deadline is 5 PM local time on the grant due date 45

46 Review & Award Cycles Stage Cycle I Cycle II Cycle III Scientific merit Review June-July October November February - March Advisory Council Review Earliest Project Start Date September- October January February December April July May June 46

47 What to Submit to OSP Submit FReD Checklist Completed and Signed FReD Addendum Full Copy of Grant Application Original face page if original signature required by sponsor Grant application instructions (RFA, PA, etc.) Detailed budget even if application does not require one If your department has been deployed to use Coeus (new preaward system) vs FReD, then please discuss with your dept s grant staff 47

48 <KO ee uss> or <Koy-os> Electronic Research Administration software system Standardize and increase the efficiency of grant submissions Prepare proposals, route them to obtain internal approvals, and submit them to sponsors electronically. Coming soon to your department 48

49 OSP Process Overview 1. Application received, file created and assigned to GA 2. If clinical procedures are included -route to CRF for Cost analysis 3. GA Preliminary review 4. Provide comments to Department 5. GA secondary review 6. Senior GA review 7. OSP approval, submission and signature 49

50 Grant Submission OSP review completed and changes made All Mandatory documents completed Budget Finalized All attachments uploaded Press Check Package for Errors final grant application (adobe file) to by 12 PM the day before the due date 50

51 With Special Thanks Postdoctoral Students Association Christine Lesch, Ph.D. Sofie Claerhout, Ph.D. Office of Sponsored Programs (OSP) Melinda Cotten Juan Alejandro Jennifer Nixon 51

52 GRANT APPLICATION CHECKLIST 1. General Proposal information a. Application Type (Select one): Continuation New Renewal Resubmission Revision b. Activity Type (Select one): Organized Research Construction Clinical Trial Training Public Service c. Start Date: End Date: Format (Choose one): Electronic Paper d. Award Number (resubmission/ renewal only): e. Sponsor: f. Letter of intent required: Yes NO g. Sponsor Deadline: h. Funding Opportunity #: i. Sponsor Proposal # (if resubmission or renewal): j. Award Type(Select one): Grant NIH Training Grant Contract Cooperative Agreement k. Title of Project: l. Sponsored Activity Title(title of FOA): m. Responding to(type of Sponsor)(Select one): Federal Non Federal Internal Unsolicited SBIR STTR n. CFDA # (federal sponsors only): o. Budget Type: Modular Detailed p. Cover letter: Optional Mandatory 2. Internal Documents for review Hint: (use section 5: Special Review [next page] to help you ) a. Created and submitted FReD Checklist for proposal b. Download and complete Clean FReD Addendum (Don t forget to include FReD Checklist # on FReD Addendum) c. Internal detailed budget for Modular budget 3. Lead Organization: (Select either a or b ) a. MDACC Lead Dept. (Dept. receiving funds): b. Other c. Performance Site 1 (if necessary) d. Performance Site 2 (if necessary) 4. Senior/ Key Persons (KP) Multi PD/PI project Yes No PD/PI era Commons Login % effort KP 1 Role era Commons Login % effort KP 2 Role era Commons Login % effort KP 3 Role era Commons Login % effort KP 4 Role era Commons Login % effort KP 5 Role era Commons Login % effort KP 6 Role era Commons Login % effort Page 1

53 5. Compliance/ Special Review Does the proposal involve the following? a. Vertebrate Animals Yes No Pending IACUC Protocol #(s) b. Biohazard Materials Yes No Pending IBC Protocol #(s) c. Recombinant DNA Yes No Pending IBC Protocol #(s) d. Human Subjects Yes No Pending IRB Protocol #(s) e. Radioactive Isotopes Yes No Pending RSC Protocol #(s) f. Conflict of Interest Yes No g. Cost Sharing Mandatory Salary Cap Voluntary If mandatory, provide FOA#: 6. Forms and attachments a. Key Personnel attachments 1. Principal Investigator Biosketch Letter of Support 2. Key Person 1 Biosketch Letter of Support 3. Key Person 2 Biosketch Letter of Support 4. Key Person 3 Biosketch Letter of Support 5. Key Person 4 Biosketch Letter of Support 6. Key Person 5 Biosketch Letter of Support 7. Key Person 6 Biosketch Letter of Support 8. Key Person 7 Biosketch Letter of Support b. Other Project Information Page attachments (Required*) 1. Project Summary/ Abstract* 2. Project Narrative* 3. Bibliography and reference cited 4. Facilities and Resources 5. Equipment 6. Other attachments (only if applicable) c. Budget attachments 1. Select appropriate budget type (circle one only) Modular Detailed 2. For Modular Budget a. Personnel Justification b. Additional Narrative Justification (only if Modules are different from year to year) c. Consortium Justification (if subcontracts) Page 2

54 3. Detailed Budget a. Budget Justification i. Senior/ Key Persons 1. Includes OSCs and consultants ii. Other Personnel iii. Equipment over $5,000 iv. Travel 1. Domestic 2. Foreign v. Trainee Costs (primarily reserved for training grants) vi. Other Direct Costs 1. Materials and Supplies 2. Publication Costs 3. Consultant Services 4. ADP/ Computer Services 5. Subawards/ Consortium Contractual Cost 6. Equipment/ Utility User Fees 7. Alterations and Renovation 8. Other 4. For Consortium a. A separate budget justification is needed for each Consortium to be included like a detailed budget justification d. Research Plan Attachments 1. Introduction to application (for Resubmissions only) 2. Specific Aims 3. Research Strategy 4. Inclusion enrollment report 5. Progress Report publication list (not applicable to NIH grants) 6. Protection of human subjects 7. Inclusion of Women and Minorities 8. Targeted/ Planned Enrollment 9. Inclusion of Children 10. Vertebrate Animals 11. Select Agent Research 12. Multiple PI Leadership Plan (if yes to Multi PD/PI project in section 4 senior Key persons, attach Multiple PI Plan here) 13. Consortium/ Contractual Arrangements 14. Letters of Support See Key person attachments 15. Resource Sharing Plan 16. Appendix 7. Notes Page 3

55 Updated 2/8/2010 Grant Terms Desk Reference 1 Active Support A section of the Other Support document that lists all sponsored projects (federal and non-federal grants, clinical trials and private industry projects) a senior/ key person devotes specific measurable effort on a project whether or not salary support is requested. Award- Funds obligated by a sponsor for a particular project. Biographical Sketch A document required for senior/ key persons in the submission of a grant to a sponsor. Page limits vary based on application guidelines. The current* format requires the length to be no more than 4 pages in length and contain four sections Personal Statement, Positions and Honors, Selected Peer reviewed publications and Research Support. Bridge Funding- Institutional/ NIH provide funds available to use for support of research needs other than faculty salary when extramural funding has been temporarily interrupted. Calendar months (CM) - Is the metric for expressing the effort (amount of time) personnel devote to a specific project that converts the percent effort to person months for a 12 calendar month (CM) appointment. To calculate calendar months, multiply the percentage of your effort associated with the project times 12 (months) Ex. 5% effort = 0.6 CM (0.05 * 12.0) or (0.12 * 5.0) =0.6 calendar months (CM) Cancer Prevention and Research Institute of Texas (CPRIT) - CPRIT is a funding agency created in Texas to fund cancer research in the state. It was established to create and expedite innovation in the area of cancer research and breakthrough in the prevention of cancer and cures for cancer. CPRIT application are processed by the Office of Research Administration (ORA). Clinical Research Finance (CRF) - Internal MD Anderson department that covers all functions related to funding of research clinical trials. Guided by federal and state regulations, CRF ensures adequate funding for clinical trials and to ensure compliance with federal billing regulations. CRF provides coverage analysis development, contract budget review, monitoring of research charge capture and audits clinical trial activity. Congressionally Directed Medical Research Programs (CDMRP) An electronic system used for Department of Defense (DOD) grants; where PI submits Pre-Applications and can track the status of their submission. These monies result from congressional appropriation on the behalf of consumer advocates to provide money for research into specific medical indications. Conflict of Interest (COI) A situation in which financial or other personal considerations may affect, or have the appearance of affecting an individual s professional judgment in exercising any M. D. Anderson duty or responsibility or in the conducting or reporting of any type of research. Excluded are interests held in blind trusts or mutual funds. Conflict of Interest Committee (COIC) A Committee at MD Anderson charged with the responsibility of assessing compliance with the Conflict of Interest policy and reviewing plans for managing conflicts of interest. The COIC is coordinated by the Office of Research Administration. COIC Database- a database maintained by ORA where disclosures of potential conflicts of interest are submitted. COI disclosures are placed into 3 categories based on level of concern. All disclosures are prereviewed by the ORA for completeness and for regulatory compliance. Inasmuch as possible, disclosures with a compensation amount and/or value less than $10,000 are reviewed administratively on a weekly basis by the COIC chair. Consortium Agreement - A formal agreement where a research project is carried out by the grantee and one or more other organizations that are separate legal entities. Under the agreement, the grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties (See Subaward).

56 Updated 2/8/ CORE (Clinical Oncology Research System) The Clinical Oncology Research system is a clinical research information management system. It is an integrated database and web application that functions with the Protocol Data Management System (PDMS). These systems are used by the clinical trials programs to facilitate administration and regulatory compliance of human subject research. Cost Sharing - The portion of a sponsored project s total costs that are paid by M. D. Anderson, rather than by the sponsor. Cost sharing results in the redirection of departmental or institutional resources to support sponsored research activities. Cost Sharing Types Mandatory: Required by the sponsor as a condition of obtaining an award. Must be included in the contract or grant proposal to receive consideration from the sponsor. Salary-cap: Results when an individual s Institutional Base Salary exceeds a sponsor s salary limitation or salary cap. The prorated excess is a form of mandatory cost sharing that must be funded by an appropriate and allowable non-sponsored source. NOTE: the salary cap does not apply to DOD applications. Voluntary Committed: Represents effort proposed that was not required by the sponsor and that is in excess of effort paid by the sponsor and or mandatory cost sharing, becomes an obligation once the proposal is awarded. Close Out- The act of completing all internal procedures and sponsor requirements to terminate or complete a research project. Department of Defense (DOD) the federal department responsible for safeguarding national security of the United States. There is a research component of the DOD known as CDMRP that funds medical research through grants and contracts with grantee organizations. NOTE: The DOD does not use a salary cap. Direct Costs - Clearly identifiable costs related to a specific project. General categories of direct costs include, but are not limited to, salaries and wages, fringe benefits, supplies, contractual services, travel and communication, equipment and computer use. era (electronic Research Administration)- Conducting research administration by utilizing electronic resources such as the Internet, the World Wide Web, form templates, databases and other electronic tools. esnap (electronic Streamlined Noncompeting Award Process) - Allows an institution to review grant data and submit a progress report online (access via era Commons); PI must use program if the grant is identified as eligible. era Commons - A secure meeting place on the Web where research organizations and grantees electronically receive and transmit information about the administration of biomedical and behavioral research grants. To register in era Commons, contact your GA. Executive Order "Intergovernmental Review of Federal Programs," structures the Federal government's system of consultation with State and local governments on its decisions involving grants, other forms of financial assistance, and direct development. The Standard Form 424 cover sheet for grant applications asks whether the application "is subject to review by state executive order process"; UTMDA is not subject to review on all applications. Export Control Laws restricting certain types of information, technologies, and commodities that can be transmitted overseas to individuals, including U.S. citizens, or made available to foreign nationals on U.S. soil. Export control regulations include those implemented by the Department of State through its International Traffic in Arms Regulations (ITAR), the Department of Commerce through its Export Administration Regulations (EAR) and the Treasury Department through its Office of Foreign Assets Control (OFAC). ORA provides support and guidance for any issues related to export controls.

57 Updated 2/8/ FReD (Funded Research Database) A database created at MD Anderson Cancer Center. It is an on-line tracking system for grants, sponsored agreements and material transfer agreements. FReD functions to track workflow and status of a sponsored project. It provides basic record keeping function for research compliance (human subjects, vertebrate animals and biosafety). Each sponsored project receives a checklist number upon submission to of FReD into the system. FReD Addendum- Created on September 1, The FReD Addendum fills gaps in the essential regulatory compliance information required for Sponsored Project to be funded by external sponsors at MD Anderson. FReD checklist An entry into the FReD system when external funds are requested to conduct research at MD Anderson. Each time a checklist is created, it generates a new checklist number. A FReD Checklist is created for all research related projects and when new or additional money comes in for the grant. This includes non-competing continuation (progress reports) or a revised contract with additional funding. Fringe Benefits- Employee benefits paid by the employer. (e.g., FICA, Worker's Compensation, Withholding Tax, Insurance, etc.) For federal proposals, the fringe benefit rate should be budgeted at 28%. Funding Opportunity Announcement (FOA) - Statement of competition for the availability funds for grants and/or cooperative agreements. An FOA can be a Program Announcement (PA), a Parent Announcement or a request for applications (RFA). Funding Types (federal): Old NIH Term New Grants.gov Term Notes New New An application submitted for funding for the first time. Includes multiple submission attempts in the same round. (Type 1) Competing Continuation Renewal Previous year of funding for the project have elapsed. Competing for additional years of funding to continue original project. (Type 2) Competing Supplement Revision Request for additional funds for a current award to expand the scope of work. Contact the awarding agency for advice on submitting any revision/ supplement application. (Type 3) Revision or Amended Application Resubmission Application previously reviewed. A revised or amended application addresses reviewer feedback. (A1/A2) Progress Report Continuation NIH does not use the SF424 (R&R) for Continuation applications. Type 5; Progress Reports (SNAP) are submitted directly to era Commons for others paper is still submitted) Grant Administrator (GA) The person in the Office of Sponsored Programs which is responsible for the accurate review and submission of grants from MD Anderson to the external federal and non-federal sponsors. Grants and Contracts (GC) The department at M.D. Anderson that handles post-award accounting and financial issues for sponsored projects once funding arrives at the institution. Human Subjects Research- Federal regulations define research as "A systematic investigation designed to develop or contribute to general knowledge." A Human Subject is defined as "A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." IACUC (Institutional Animal Care and Use Committee) The IACUC is coordinated through the office of

58 Updated 2/8/ Research Administration (ORA). It is organized to satisfy the requirements of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The purpose of the IACUC is to ensure compliance with federal, state and institutional regulations regarding the care and use of animals for research. If animals will be involved, those sections of the application that involve the use of vertebrate animals must be reviewed and approved by the IACUC to confirm compliance of all experimental procedures and treatment with federal regulations. IACUC will provide either an ACUF an assurance # approval date or IACUC review date if they approve the grant proposal. PI must have AALAS online training and submit an eacuf (electronic animal care and use form) to be processed by the IACUC staff. IBC (Institutional Biosafety Committee) The IBC is coordinated through the Office of Research Administration (ORA). The purpose of the IBC is to insure the Institution s obligations and compliance with current governmental requirements, including those required by the National Institutes of Health (NIH) and the Center for Disease Control (CDC). The IBC reviews protocols involving hazardous biological agents, hazardous chemicals, recombinant DNA and transgenic organisms. IBC members must review proposed research only as it relates to issues that may affect the safety of personnel, the public, and the environment. OSP routes the grant to ORA for compliance approval. PI must have laboratory specific training and submit through the eibc to be screened by the IBC staff. (Indirect) Costs/ (F&A) Facilities and Administrative Costs - Costs related to expenses incurred in conducting or supporting research or other externally-funded activities but not directly attributable to a specific project. General categories of indirect costs include general administration (accounting, payroll, purchasing, etc.), sponsored project administration, plant operation and maintenance, library expenses, departmental administration expenses, depreciation or use allowance for buildings and equipment and student administration and services. Institutional Official An individual working in a research organization's business office who has signature or other authority. That person is the same as Grants.gov's Authorized Organizational Representative (AOR) and the Commons' Signing Official (SO). Melinda Cotton is that person MD Anderson. The IO term is also used for animal welfare and has direct reporting obligations to the Office of Laboratory Animal Welfare. Raymond DuBois is that person at MD Anderson. Institutional Review Board (IRB) The IRB is coordinated through the Office of Clinical Research. The IRB is an administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both federal regulations and institutional policy. All grants must go through IRB at M.D. Anderson that involve Human Subjects. Institutional Research Grant (IRG) Institutional Research Grants are internally funded individual awards of up to $50,000, and are distributed over a 1 or 2 year period. Funding is provided as "seed money" for the initiation of projects by promising junior investigators. Recipients of IRG individual awards must submit a progress report upon the completion of their research projects. The major purpose of the Program is to allow faculty, particularly more junior faculty, to obtain preliminary data to improve the competitiveness of their national grants. IRG s are supported through ORA. Internal Budget- A categorical breakdown of the direct costs associated with the proposed application. This document is used internally to verify that costs are appropriately captured for the project. Investigational New Drug (IND) - Status given by the FDA to a new drug or biological product to be used in a clinical investigation. Job Data Update Form (JDUF) A form used to initiate position and employee job related changes, such as changing the source of salary funds to and from grant accounts.

59 Updated 2/8/ Just-in-Time (JIT) - Refers to the application timeframe that requires applicants to send additional information to the NIH only if an award is likely. Key Person (Senior/ Key Person) - The PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Consultants also may be considered key personnel if they meet this definition. Zero percent effort or as needed is not an acceptable level of involvement for key personnel. MTA (Material Transfer Agreement) - A legal document defining the conditions under which research or other materials can be transferred and used among research laboratories. Legal Services initiates the MTA process and approves the agreement language. The ORA addresses MTA compliance and provides institutional signature at MD Anderson. PI must fill out a request via FReD (in the FReD MTA module) when a research project is interested in obtaining research materials from outside UTMDACC (i.e. an M.D. Anderson investigator has a research project that will use transgenic animals created by a collaborator at another institution. An MTA is to protect the intellectual property rights and publication rights of UTMDACC, as well as providing the appropriate disclaimers and indemnification necessary in order to protect the institution. MTA compliance review is required to ensure human subject projection, IACUC, IBC, and export control adherence requirements. Modified Total Direct Cost (MTDC) At M.D. Anderson, the basic indirect costs which are calculated on a subset of direct costs. MTDC = All direct costs (equipment > $ 5,000) (patient care costs) (tuition and fees) (space rental/ alterations and renovations) (the first $25,000 [total costs] of each subcontract) Multiple PD/PI Option on a Federal grant that allows applicants and their institution to identify more than one PI on a single grant application. The goal is to encourage collaboration among equals when that is the most appropriate way to address a scientific problem. It is expected to encourage interdisciplinary and other team approaches to biomedical research. All applications using the Multiple PD/PI model must attach a PI leadership plan with the application and a contact PI must be listed on the application. NCI (National Cancer Institute) A federal agency that is part of the National Institutes of Health and the U.S. Department of Health and Human Services. The NCI's main responsibilities include coordinating the National Cancer Program; conducting and supporting cancer-related research; training physicians and scientists; and disseminating state-of-the-art information about cancer detection, diagnosis, treatment, prevention, control, palliative care, and survivorship. NIH (National Institutes of Health) - A federal agency with a mission to improve the health of the people of the United States. NIH is a part of the Public Health Service which is part of the Department of Health and Human Services. NIH Salary cap ($199,700) a legislatively-mandated provision limiting the direct salary (also known as salary or institutional base salary, excluding fringe benefits and F&A costs) for individuals working on NIH grants, cooperative agreement awards, and extramural research and development contracts. When preparing budgets, allowances should be made for future increases in the salary cap, just as they do for future increases in pay raises for people not subject to the salary cap. Other Sponsors may indicate a different salary cap or none at all. Non-competing continuation- A year of continued support for a funded grant. Progress reports for continued support do not undergo peer review but are administratively reviewed by the Institute/Center and receive an award based on prior award commitments. No Cost Extension - An extension of the period of performance beyond the expiration date (usually one year) to allow the principal investigator to finish a project. No additional costs are provided. Notice of Grant Award (NoA /NGA/ NOGA) - The legally binding document that notifies the grantee and others that an award has been made, contains or references all terms and conditions of the award and

60 Updated 2/8/ documents the obligation of Federal funds to the grantee. The NoA may be in letter format and may be issued electronically. Previously known as Notice of Grant Award (NGA). Office of Research Administration (ORA) The department at MD Anderson is responsible for research administration under the Provost including monitoring research compliance related to research integrity, Conflict of Interest (COI), animal care and use (IACUC), Biosafety (IBC) and radiation safety (RSC) lab compliance in coordination with EH&S.. Additionally, they are responsible for research contracts (MTA and export controls) laboratory space reviews, departmental external reviews, and any special projects as requested by the Provost, CPRIT applications as well as Internal funding (IRG and internal bridge). Office of Sponsored Programs (OSP)- The department at MD Anderson that serves as the authorized institutional official pre-award activities/ processing for external sponsors and ensures the MD Anderson's due diligence for compliance and integrity in research administration for external sponsors. OSP performs accurate and timely application reviews for approval, award negotiation and compliance certifications of grants and contracts. Other Significant Contributors - Participants in a grant or application who contribute substantively to the project with an indefinite level of effort. Applications should include biosketches but not other support information. Also see key personnel. Other Support a document required for all applications that are selected to receive grant awarded and included detailed financial information. Other support is usually requested after peer review during JIT and for progress reports. Other support has three main sections, active support, pending support and overlap. Overlap A section of the other support document that describes and duplicating research or budgetary items already funded by an NIH grant. There are three types, Commitment a Senior/ Key person s time commitments exceeds institutional limits. Budgetary - duplicate budgetary items are requested in an application but already are provided by another source. Scientific same research is proposed in more than one application or is submitted to two or more funding sources. Pending support- A section of the other support document listing research proposals submitted to a sponsor but not yet awarded. Included on the other support document for a JIT request however the effort on pending projects is NOT counted as part of a senior/ key persons effort profile. NOTE 1: Not needed for Other Support document for a progress report. NOTE 2: Not used to calculate effort. Parent Announcements A type of Funding Opportunity Announcement (FOA) also known as investigatorinitiated or unsolicited applications for which the Principal Investigator may propose research that does not fit under a specific PA or RFA and enables NIH to receive the application from Grants.gov. Person months- See Calendar Months PDMS (Protocol Data Management System) - An internal MD Anderson clinical research information management system, used for clinical trials programs and facilitates the collection and analysis of patient research data. Office of Protocol Research defines new protocols to PDMS, enters the eligibility requirements and treatment plan, and enables PDMS to accept patient registrations when the protocol has met all approvals. PDOL (Protocol Document On-Line)- An internal MD Anderson database that supports and facilitates protocol documents through their complete life cycle, including the submission, review, and approval processes performed by the Clinical Research Committee (CRC) and IRB. It is a Lotus notes application that uses several Lotus Notes databases with a single interface to allow ease of navigation. PHS (Public Health Service) - Umbrella organization of the U.S. Government. The NIH is the largest Agency within the PHS.

61 Updated 2/8/ PHS 398 Application Form (paper version) for a PHS Grant The PHS 398 instructions contain information for preparing grant applications to the National Institutes of Health (NIH) and other Public Health Service agencies for: Public Health Service (PHS) Research Grants Career Development Awards (K-awards) Institutional Research Training including Ruth L. Kirschstein National Research Service Awards (NRSA) (Training Grants) PHS 2590 An application for Continuation of a PHS Grant; Non-Competing Continuation Progress Report. The PHS 2590 forms are to be used when projects awarded by the NIH are excluded from esnap reporting procedures, typically for applications submitted using PHS 398 forms (paper applications). Principal Investigator (PI) The individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. At M.D. Anderson, this is typically a faculty level or higher position unless otherwise specified by the Funding Opportunity Announcement. Priority Score A numerical rating of an application reflecting the scientific merit of the proposed research relative to stated evaluation criteria. It is derived from the rating given a research proposal by each member on a review committee and is used to help determine which approved proposals will be granted awards, based on funds available. Proposal Central- an e-grantmaking website shared by many government, non-profit, and private grantmaking organizations. ProposalCENTRAL ( Program Announcement - An announcement by an NIH Institute or Center requesting applications in certain scientific areas. It describes existence of a research opportunity and may convey expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program. Program/Project Officer - A sponsor's designated individual officially responsible for the technical, scientific or programmatic aspects of a particular grant, cooperative agreement or contract. This individual serves as the counterpart to the principal investigator/project director of the grantee/contractor organization. The program/ project officer deals with the grantee/contractor organization staff to assure programmatic progress. Progress Reports Periodic, usually annual, report submitted by the grantee and used by sponsors to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report. Radiation Safety Committee (RSC) - The RSC is coordinated through the Office of Research Administration. The Radiation Safety Committee functions to provide compliance with State regulations, and address safety concerns for patients, staff, and visitors regarding the use of radioactive materials. The Radiation Safety Committee regulates the use of all radioactive material and ionizing radiation-producing equipment in all areas of the institution. The Radiation Safety Committee establishes policy relating to the acquisition, use, storage, and disposal of radioactive material. Request for Applications (RFA) - The official statement inviting grant or cooperative agreement applications to accomplish a specific program purpose. RFAs indicate the amount of funds set aside for the competition, have a specific study section for the RFA and generally identify a single application receipt date. Request for Proposals (RFP) - Announces that NIH would like to award a contract to meet a specific need, such as the development of an animal model. RFPs have a single application receipt date and are published in the NIH Guide for Grants and Contracts.

62 Updated 2/8/ SF424 Research & Related (R&R) The forms and guidelines used for electronic submission of grants that is gradually replacing the PHS 398 forms and guidelines. Only used for federal grants (NIH/DOD), via Grants.gov A complete application to NIH and other PHS agencies will include SF424 (R&R) components and PHS398 components. Specific Funding Opportunity Announcements (FOAs) will clearly indicate which forms and submission process an applicant should use. Signing Official (SO) - Charged with the institutional authority to legally bind the institution in grants administration matters. This term is used in conjunction with the NIH era Commons. The SO can register the institution, and create and modify the institutional profile and user accounts. The SO also can view all grants within the institution, including status and award information. For most institutions, the Signing Official (SO) is located in its Office of Sponsored Programs. See Institutional Official Specialized Programs of Research Excellence (SPOREs) This grant is funded through specialized center grants (P50s) that promote interdisciplinary research and move basic research findings from the laboratory to clinical settings, involving both cancer patients and populations at risk of cancer. MD Anderson has 11 SPORE grants (more than any other US medical institution) Sponsored Agreement/ Program A formal contract between M.D. Anderson and a sponsor (federal or nonfederal) for a specific research project to be conducted by the Principal Investigator (usually a faculty member) The PI and the private industry have discussed working together on a project and develop a joint agreement. The PI does not need to submit a pre-contract proposal through OSP b/c they have already identified what will be used to fund the project. With grants, the PI will usually respond to a Funding Opportunity Announcement (FOA) program announcement that has been posted and apply for the money. Grants come through OSP before funding. Subaward, Subcontract, Subgrant or Subagreement - A Collaborative arrangement in support of a research project in which part of an activity is carried out through a formal agreement between a grantee and one or more other organizations. See consortium agreement. Susan G. Komen for the Cure- A foundation that funds breast cancer research. Funding opportunities can be found at Applications are submitted via The salary cap for the Komen Foundation is different from the NIH cap ($186,600 for FY2009 and 2010) Task Order Agreement (TOA) -- A legally binding document authorizing work and appropriating funds as a supplement to a basic contract. Total Direct Costs (TDC) -- The total of all direct costs of a project (including all subcontract direct costs) Total Project Costs -- The total allowable direct and indirect costs incurred by the institution to carry out an approved project or activity (includes all subcontract costs). Workscope- (Scope of Work) - the proposed work that is to be completed by the awardee if the project is funded. It includes the methodology, approach, or other aspects of the project objectives as identified in the project at the time of award. Other glossary sources NIH Glossary ( ORA Research Administration Glossary (