NIH Training Grants: A Walking Tour Map

Presenters Panelists: Dr. Paula Flicker, Program Director, Biophysics Branch, NIGMS, National Institutes of Health Lisa Moeller, Team Leader, NIGMS, National Institutes of Health Chad Henry, Director, Research Administration, George Warren Brown School of Social Work, Washington University in St. Louis Mary Palmer, Trainer/Research Process Manager, Research Management Group, Stanford University Moderator: Samantha Westcott, Grant Manager, Division of Biology, California Institute of Technology

Lisa Moeller National Institutes of Health

Overview of the NIH ► Comprised of 27 Institutes and Centers ► All of them have some things in common ► Each of them is unique in some ways ► Extramural Research support teams:  Review  Grants Management  Program

NIH Institutes & Centers

The NIH Extramural Team Review Program Grants Management

Grants Management Officer Monitors administrative and fiscal aspects of the grant ► Assures compliance with Federal laws and NIH administrative policies and procedures ► Responsible for maintaining the official grant files for grant awards ► Is the only NIH official authorized to obligate the NIH to funds or other terms and conditions of award

Grants Management Specialist Acts as an agent of the GMO ► Assures compliance with Federal laws and NIH policies and procedures ► Analyzes grant applications prior to award ► Prepares award for GMO release ► Reviews and responds to grantee prior approval requests ► Assures documentation of official grant files

Overview ► Purpose of Kirschstein-NRSA: To help ensure that a diverse pool of highly trained scientists are available in adequate numbers in the appropriate research areas to assume leadership roles related to the Nation’s biomedical, behavioral and clinical research agenda.

FY 2007 President’s Budget Request Total NIH Budget Authority $28.6 Billion Research Project Grants 52% $15,166 Billion Research Project Grants 52% $15,166 Billion $764M Training $683M Ks $1,447 Billion $764M Training $683M Ks $1,447 Billion Training 3% $764 Million Training 3% $764 Million

Two Support Mechanisms ► Individual Fellowships (Fs): Award to support a specific individual (F30, F31, F32, F33) ► Institutional Training Grants (Ts): Award to an institution to support a training program (T32, T34, T35)

Total Number of Pre-Doctoral and Post-Doctoral Positions on NIH Training Grants and Fellowships*

FY2007 Estimates Individual Fellowships (Fs)  2007 (est) $126,000,000 3,030 FTTPs Institutional Training Grants (Ts)  2007 (est) $638,000,000 14,546 FTTPs

NIH Research Training Budgets NIH Research Training Budgets

Total Number of NIH Pre- and Post-Doctoral Training Positions on T’s and F’s Supported by Institute or Center, FY 2005 (NRSA)

Mary Palmer Stanford University

NIH Funding Mechanisms ► Grant  Financial Assistance to perform approved activities: ► Research ► Training ► Contract  Acquisition of Goods or Services ► Cooperative Agreement  Grant support with substantial federal involvement

Institutional Kirschstein-NRSAs (a.k.a.) Training Grants Purpose To develop or enhance research training opportunities for individuals, selected by the institution who are training for careers in specified areas

Purpose of Training Trainees must have opportunity to carry out supervised biomedical or behavioral research with the goal of developing or extending their research skills and knowledge Trainees must have opportunity to carry out supervised biomedical or behavioral research with the goal of developing or extending their research skills and knowledge

Receipt Dates ► January 25, May 25, Sept. 25 ► Varies among ICs: Many use only 1 or 2 dates ► Progress Report Receipt Dates Vary

Application Requirements ► Application submitted by Institution (not individual). ► Domestic, non-profit public or private institutions ► Research training must fall within the mission of the NIH awarding components

► Programs can consist of Predoc, Postdoc, or combination ► Short-term Appts.: solely (T35) or in combination with pre & post T32 ► Prebaccalaureate (T34)  MARC USTAR—NIGMS  COR--NIMH Application Requirements

Trainee Citizenship Requirements ► Must be Citizen, non-citizen national, or lawfully admitted for permanent residence. ► Permanent residency ► Fellowships: Must have been admitted for permanent residency at the time of award ► Training Grants: Must have been admitted for permanent residency at time of appointment

Degree Requirements Degree Requirements ► Predoc : Baccalaureate degree & be enrolled in doctoral program leading to Ph.D., comparable research doctoral degree or dual research/clinical doctorate like the MD/Ph.D. ► Postdoc: Ph.D. or M.D. or comparable doctoral degree from an accredited domestic or foreign institution

Definition of postdoctoral scholar ► An individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his/her chosen career path.

NRSA Limitations Duration of Support  Predoc: 5 years  Postdoc: 3 Years  Aggregate limits, including any combination from individual and/or institutional awards Exceptions/Waiver  Physicians/Clinicians  Interruptions (break in service)  Other  Waiver requests require IC prior approval.

T32 Training Grant ► The primary means of supporting graduate and postdoctoral research training to help ensure that a diverse and highly trained workforce is available to assume leadership roles related to the Nation’s biomedical, behavioral and clinical research agenda. ► The primary objective is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation.

T32 Training Grant ► Institutional Awards not individual fellowships ► Investigator-led and requires faculty trainers ► Supports pre-doctoral and post-doctoral trainees ► Training positions awarded at the institutional-level

T32: Application Preparation ► Read Program Announcement: PA ► Determine Faculty PI ► Contact the relevant NIH Center or Institute ► Confirm participating departments, programs, and faculty members ► Allow as much time as possible (months!)

URLs for T32 Preparation grants1.nih.gov/grants/guide/pa-files/PA html grants1.nih.gov/training/faq_training.htm grants.nih.gov/grants/guide/notice-files/NOT-OD html grants1.nih.gov/grants/guide/notice-files/NOT-OD htm htm

T32 Budget Development Components ► Stipends ► Tuition and Fees ► Trainee Travel ► Trainee Related Expenses (including Health Insurance) ► Facilities and Administrative Costs - 8% MDTC ► Prior approval for direct costs exceeding $500k/year

Stipends ► Subsistence Allowance to help defray living expenses ► Not a salary, not considered employees of either Government or Institution ► NIH publishes levels in NIH Guide when increases are approved ► Grantees may supplement

Stipends (cont.) ► Predoctoral: One level for all individuals, regardless of years of experience ► Postdoctoral: Stipend level determined by number of years of relevant postdoctoral experience at time of award. ► Subsequent year based on initial level + 1 year

Budgeting: Stipend Levels Career Level Stipend for FY 2007 Undergraduates in the MARC and COR Programs: Freshmen/Sophomores$7,812 Juniors/Seniors$10,956 Predoctoral $20,772 Postdoctoral Years of Experience: 0$36,996 1$38,976 2$41,796 3$43,428 4$45,048 5$46,992 6$48,852 7 or more$51,036

Budgeting: Tuition & Fees ► Postdocs: Tuition is limited for specific courses required by the training program. ► NIH will award an amount per postdoc equal to 60% of the level requested with a maximum award of $4,500 per year. ► If postdoc is in a formal degree granting program, then the amount awarded per trainee will be up to $16,000 per year.

Budgeting: Tuition & Fees (cont.) ► Predoc: Tuition is requested for the degree program the trainee is enrolled in. ► NIH will award an amount per trainee equal to 60% of the level requested, with a maximum of $16,000 per year. ► Be sure to request your full needs and NIH will apply the appropriate formula.

Budgeting: Travel ► Usually per/trainee formula bases, varies among institutes ► Scientific meetings are ok ► Training experience away from insitution OK but requires IC approval. ► Not travel from residence to institution

Budgeting: Training Related Expenses & Health Insurance ► Health Insurance is now included in the established amount for Training Related Expenses. This is a change from previous applications. Amounts are established by NIH. ► Predoctoral trainees: $4,200 ► Postdoctoral trainees: $7,850

T32 Budgeting: Entire Period & Budget Justification ► For each year you will have to show the amount you are requesting in each budget category. ► Budget Justification should include an explanation describing the basis for the budget categories requested. Include the aniticipated postdoctoral levels.

T32 Application ► Face Page ► Form Page 2:  Description/Abstract  Performance Site(s)  Key Personnel  Significant Contributors  Human Embryonic Stem Cell Disclosure ► Table of Contents

More on the T32 Application ► Detailed Budget ► Entire Budget ► Biosketches:  Program Director/Principal Investigator  Other Biosketches ► Resources ► Checklist

T32 Research Training Plan ► Background ► Program Plan  Administration  Faculty  Training  Program Evaluation  Trainee Candidates ► Minority Recruitment ► Responsible Conduct of Research Plan ► Human Subjects ► Animal Subjects ► Select Agents

T32 Mentorship Plan ► Craft a well-described mentorship plan:  Time commitments  Defined goals and needs  Expertise and expectations of mentors  Consider secondary mentors or advisory groups  Include descriptions of previous trainees and their accomplishments

Chad Henry Washington University in St. Louis

T32 Award Management ► Statement of Appointment ► Institutional Allowance ► Training Related Expenses ► Tuition and Fees

T32: Regulatory Compliance ► Financial Conflict of Interest ► Biological Safety ► Human Subjects ► Training in Responsible Conduct of Research ► Minority Recruitment ► Animal Subjects

Recent Changes Institutional Training Grants AwardPredoctoralPostdoctoral CategoryOLDNEWOLDNEW Stipend$20,772 $36,996 - $51,036 Tuition/Fees$3, % above $3,000 (includes health insurance) 60% up to $16,000$3, % above $3,000 (includes health insurance) 60% up to $4,500 60% up to $21,000 for dual degree 60% up to $16,000 for additional degree Training Related Expenses$2,200$4,200$3,850$7,850 (includes health insurance) Trainee Travel$400 - $1,000 (typical range; varies by NIH awarding component) (per trainee) F&A (Old)8% (excludes tuition/fees/health insurance, equipment) F&A (New)8% (excludes, tuition/fees, equipment)

Award Management Help ► Consider roll up accounts to segregate costs by trainee and trainee-related expenses ► Centralized organization for trainees to know who to go to for appointment forms, questions, reimbursement, questions, etc.

Appointment Form

Diversity Recruitment ► Who  Under-represented Minorities  Individuals with disabilities  Individuals from disadvantaged backgrounds ► How  A single Diversity Recruitment Plan  A single Diversity Recruitment Review Criterion  Report on ALL dimensions of Diversity  Data tables, Appointment Forms, Trainee Reports ► Where  ALL Institutional T, K, and R25 mechanisms

Responsible Conduct of Research  Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects.  Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction.  The rationale for the proposed plan of instruction must be provided.  Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications.

T Table – NRSA Training Grant Funding Opportunities ► Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) This is the NIH omnibus Kirschstein-NRSA research training funding opportunity announcement. Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) ► Dental School Joint DDS or DMD/Masters Degree NRSA Research Training Program (T32) Dental School Joint DDS or DMD/Masters Degree NRSA Research Training Program (T32) Dental School Joint DDS or DMD/Masters Degree NRSA Research Training Program (T32) ► Human Genes and the Environment Research Training Program (T32) Human Genes and the Environment Research Training Program (T32) Human Genes and the Environment Research Training Program (T32) ► Predoctoral Training at the Interface of the Behavioral and Biomedical Sciences (T32) Predoctoral Training at the Interface of the Behavioral and Biomedical Sciences (T32) Predoctoral Training at the Interface of the Behavioral and Biomedical Sciences (T32) ► NICHD Institutional Predoctoral Training Program in Reproductive, Perinatal and Pediatric Epidemiology (T32) NICHD Institutional Predoctoral Training Program in Reproductive, Perinatal and Pediatric Epidemiology (T32) NICHD Institutional Predoctoral Training Program in Reproductive, Perinatal and Pediatric Epidemiology (T32)

“Overlapping” Appointment  An appointment period may overlap budget periods. For example: Year 9 Year 10 7/1/2005 – 6/30/2006 7/1/2006 – 6/30/2007 Stipend & Tuition $$ (6-months reported as unliquidated obligation ) Appointment Period 1/1/2006 – 12/31/2006

Compensation  Actual employment for services rendered  Examples: teaching assistant, lab assistant  In these cases, individual receives a salary and it is not considered stipend supplementation

Can compensation be provided from an NIH grant?  Yes, limited part-time basis  May not be same research that is part of planned experience  Fellowship sponsor or Training Grant Program Director must approve  May not interfere with, detract from, nor prolong the approved NRSA training

Stipend Taxability  IRS (not NIH) has domain over interpretation & implementation  Rules changed January 1, 1987; however interpretations seem to vary even among IRS offices  NIH Grants Policy Statement provide minimal guidance but individuals should really consult local IRS offices

Reporting and Closeout ► Annual progress reports ► Unobligated balance ► Publications ► Results ► Termination Notices ► Renewal/Competing Continuation Application

Lisa Moeller National Institutes of Health

FY2008 – What’s new? ► Electronic Submission – transition to SF 424 possible ► Revision of forms ► X-Train

Stipend Supplementation  Grantee determines amount according to formally established policies applied to all in similar training status  Non-Federal funds  Without additional effort or obligation to trainee/fellow

Employee Benefits  Since stipends are not provided as a condition of employment,  At this time, it is inappropriate and unallowable to charge NRSA grants for employee benefits—FICA, workman’s comp, unemployment insurance etc.  Note, new IRS ruling re: student exception to FICA taxes for student employees does not effect NRSA. (NRSA recipients are not considered employees) See Q&A:

Leave  VACATIONS & HOLIDAYS: Both Pre- and Postdoctoral Fellows & Trainees may receive same vacations and holidays available to individuals in comparable training positions at the grantee or sponsoring institution. Will continue to receive stipends.

Leave (cont.)  SICK LEAVE : May continue to receive stipends for up to 15 calendar days of sick leave per year.  PARENTAL LEAVE: May receive stipends for up to 30 calendar days of parental leave per year for the adoption or birth of a child. In case of individual fellowships, use of parental leave requires approval of sponsor.  See GUIDE notice NOT-OD

Leave (cont.)  Unpaid Leave: Approval for leave of absence must be requested in advance from awarding component.  Fellowship: award will be revised extending term date by number of months of leave.  Trainee (T32): terminate & reappoint  Stipends may not be reimbursed during leave of absence.

Part-time Training  Allowed in unusual and pressing personal circumstances (e.g., medical conditions, disability, child or elder care)  NIH prior approval required  Program Director/Sponsor must submit written request, countersigned by trainee/fellow & authorized institutional official  Must continue to be at least 50%. Less than 50% would require leave-of-absence from NRSA support

Rebudgeting FROM TuitionStipendsTravelTRE INTO Tuition-YesYesYes StipendsYes-YesYes TravelNoNo-Yes TRENoNoYes-

Forms: Payback Agreement (PHS 6031)  Required only for postdocs, entering their first 12-months of postdoctoral NRSA support

Financial Status Report (SF 269)  Required annually within 90 days of budget end date  Unliquidated obligations can be used to report any stipends and tuition charges for “overlapping” appointments  Automatic Carryover of an unobligated balance is not generally allowed but awards are footnoted either way

Payback Requirements Predoctoral Trainees and Fellows:  Eliminated payback for any Predoc appointed on or after June 10, 1993  Any Predoc with an obligation prior to June 10, 1993 retains that obligation Postdoctoral Trainees and Fellows:  Incur obligation in first 12 months of Postdoc NRSA support  The 13 th and subsequent months of Postdoc NRSA support can satisfy the Postdoc obligation  Normally, individuals with two years of NRSA postdoctoral support have no further obligation  Postdoc NRSA cannot be used to repay a Predoc obligation

Acceptable Payback Service  Health-related biomedical or behavioral research  Health-related teaching  Direct administration or review of health-related research  Any combination of these activities

Payback Reporting Requirements  Annual Payback Activities Certification (APAC) (PHS Form )  Mailed annually on the anniversary of termination of support  Report reflects activities performed during last 12 months  Service must begin within 2 years of termination

Financial Payback  Can be voluntary or involuntary  Amount owed is total stipend received (plus interest when applicable)  Most people pay back with service  Less that 2 percent of all NRSA recipients with obligations (more than 110,000 individuals) have had waivers or have engaged in financial payback

Waiver   Rare & requires NIH Director approval   Permanent or Total Disability   Substantial hardship & against equity   Any remaining obligation is cancelled upon death

Dr. Paula Flicker National Institutes of Health

NIH Program Official ► Responsibilities:  Programmatic  Scientific  Technical ► Roles  Scientist  Administrator ► Identify Opportunities ► Communicate:  Program Announcements (PA)  Requests for Applications (RFA)

More about the Program Official ► Liaison between the PI and the NIH ► Most important contact for the PI ► Respond to PI questions/concerns ► Help applicants ► Oversee review ► Evaluate applications ► Make Funding recommendations ► Report on program accomplishments ► Review annual progress reports

Training Grant News ► Kirschstein-NRSA Institutional Training Grants ► PA June 12, ► Pre/Post/Short Term ► Web Table of IC Contacts and Interests ► What’s New  Diversity Recruitment Plans  Responsible Conduct of Research  Professional Skills & Career Guidance  Evaluation and Tracking  Multiple PIs on Training Grants ► New Receipt Dates – Jan, May, Sept 25 ► PHS 398 Revision expected in September, 2007 ► Electronic Receipt delayed to at least January, 2008.

Responsible Conduct of Research All T32 grants must have a responsible conduct of research component that is assessed by the Review Committee for adequacy. It is mandatory that every trainee complete this assignment. An award will not be made until an adequate plan for training in responsible conduct of research has been submitted.

Responsible Conduct of Research Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. ORI supports several programs designed to promote education and training in the responsible conduct of research (RCR) that covers the following nine instructional areas: ► Data Acquisition, Management, Sharing and Ownership ► Conflict of Interest and Commitment ► Human Subjects ► Animal Welfare ► Research Misconduct ► Publication Practices and Responsible Authorship ► Mentor / Trainee Responsibilities ► Peer Review ► Collaborative Science ntro.pdf

Minority Recruitment Plan The focus of the requirement is on the plans and successes of training grants in the recruitment and graduation of trainees from underrepresented minority groups.  Underrepresented racial & ethnic groups  Individuals with disabilities  Individuals from socially, culturally or educationally disadvantaged backgrounds All applicants are expected to demonstrate commitment and proactive recruitment efforts.

Minority Recruitment Plan Who has been underrepresented in health- related science on a national basis? ► National Science Foundation data: ► Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007:

NRSA Data Tables ► Depends on the type of application ► Membership of Participating Depts/Programs ► Participating Faculty Members ► Grant Support Available ► Pre- and Postdoctoral Trainees ► Publications ► Admissions ► Qualifications of Applicants and Trainees

NRSA Data Tables Sample table formats available: ► NHLBI: rFormat rFormat rFormat ► NIGMS: m m m ► NINDS:

Useful Information ► Offer trainees opportunities for:  Teaching  Outside internships  Organize seminars  Interact with trainees from a variety of different science backgrounds ► Include a cover letter requesting specific institute ► Check institute-specific guidelines for help with tables

Peer Review: Evaluation Areas ► Program Direction/ Administrative Structure ► Training Faculty ► Training Program ► Applicant Pool ► Trainees and Candidates ► Outcomes ► Environment

Frequent Reviewer Comments ► Insufficient time commitment of Program Director ► Large number of faculty may preclude unity and collaboration ► Pre-doctoral and post-doctoral programs not given equal attention in preparation ► Weak integration among faculty, tracks, and departments

More Reviewer Comments ► Majority of trainees with one or two faculty ► Proposed faculty must have successful research support ► Overlap with other training grants at the same institution

Questions?

Thank you.