A-0

Application Type

New, Resubmission, Renewal, Continuation, Revision

B. Research training plan section

B-1

Intro to Application- (resubmissions only)

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PHS_Fellow_IntroductionToApplication

B-2

Specific Aims

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PHS_Fellow_SpecificAims

B-3

Research Strategy

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PHS_Fellow_ResearchStrategy

B-6

Inclusion Enrollment Report (renewals only)

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PHS_Fellow_InclusionEnrollmentRpt

B7

Progress Report Publication List (renewals only)

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PHS_Fellow_ProgressReport_PubList

B-8-1 Human Subjects Section

B-8.2 – 8.5

Are Human Subjects Involved?

Special Review

If Human Subjects special review is added, the form will check the Yes box.

B-8.6 – 8.8

Human Subjects involvement indefinite?

Questionnaire

Q ID 1

A Yes or No answer is required. See Explanation, below. 

Explanation:  If at the time of application, plans to involve human subjects are unknown, please check "Yes".  In rare situations, applications are submitted with the knowledge that human subjects will be involved during the period of support, but plans are so indefinite that it is not possible to describe the involvement of human subjects in the application. The kinds of activities that lack definite plans are often institutional awards where the selection of specific projects is the institution's responsibility, research training grants, and projects in which the involvement of human subjects depends upon completion of instruments, animal studies, or purification of compounds. The Protection of Human Subjects upload is still required.

Policy:  NIH Office of Extramural Research Human Subjects Website. This site provides, in one place, DHHS and NIH requirements and resources for the extramural community involved in human subjects research http://grants.nih.gov/grants/policy/hs/index.htm

B-9.1-9.3

Is the project a Clinical Trial?

Questionnaire

Q ID 2

Check the “Yes” or “No” to indicate whether the project is a clinical trial. See Explanation, below.

Explanation:  The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subject research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits this definition of a clinical trial. Human subject research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or the test itself imposes more than minimal risk for subjects.

Policy:  Clinical Trials Registration in ClincialTrials.gov (Public Law 110-85):  Competing Applications and Non-Competing Progress Reports NOTICE OD-08-023  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html

B-10.1-10.3

Is this an NIH-defined Phase III clinical trial?

Questionnaire

Q ID 3

Check the “Yes” or “No” to indicate whether the project is an NIH-defined Phase III clinical trial. See Explanation, below.

Explanation:   An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Policy: Clinical Trials Registration in ClincialTrials.gov (Public Law 110-85):  Competing Applications and Non-Competing Progress Reports. NOTICE OD-08-023  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html

b-11

Protection of Human Subjects

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PHS_Fellow_ProtectionOfHumanSubjects

b-12

Inclusion of Women and Minorities

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PHS_Fellow_InclusionOfWomenAndMinorities

b-13

Targeted/Planned Enrollment

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PHS_Fellow_TargetedPlannedEnrollment

B-14

Inclusion of Children

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PHS_Fellow_InclusionOfChildren

Other Research Training Plan section

B-15.3-5

Are Vertebrate Animals Used?

Special Review

If an Animal Usage special review is added, the form will check the Yes box.

B-15.6-8

Will the inclusion of vertebrate animals use be indefinite?

Questionnaire

Q ID 4

A Yes or No answer is required. See Explanation, below.

Explanation:   If animal involvement is anticipated within the period of award but plans are indefinite and it is not possible to describe the use of animals, check "Yes" and in the Research Training Plan: Vertebrate Animals narrative, provide an explanation and indicate when it is anticipated that animals will be used.

Policy: Refer to PHS Policy on Humane Care and Use of Laboratory Animals

B-16

Vertebrate Animals

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PHS_Fellow_VertebrateAnimals

B-17

Select Agent Research

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PHS_Fellow_SelectAgentResearch

B-18

Resource Sharing Plan

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PHS_Fellow_ResourceSharingPlan

B-19

Respective Contributions

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PHS_Fellow_RespectiveContributions

B-20

Selection of Sponsor and Institution

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PHS_Fellow_SelectionSponsorInstitution

B-21

Responsible Conduct of Research

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PHS_Fellow_ResponsibleConductResearch

C.  Additional Information

C-1.2-4

Does the proposed project involve human embryonic stem cells?

Questionnaire

Q ID 5

Indicate “Yes” if the proposed research involves human embryonic stem cells.

Explanation:  See http://stemcells.nih.gov/index.asp for a definition of human embryonic stem cells.

Policy:  See http://stemcells.nih.gov/policy/guidelines.asp for Federal policy on federally funded stem cell research.

C-1.6

Can a specific stem cell line be referenced at this time?

Questionnaire

Q ID 6

“N” answer affirms that an undefined registry cell line will be used.  “Y” answer will require entering the cell IDs in the next question.

Explanation:  See http://stemcells.nih.gov/research/registry/eligibilityCriteria.asp for additional information on stem cells.

Policy:  See http://stemcells.nih.gov/policy/guidelines.asp for Federal policy on federally funded stem cell research.

C-1.5

List the registration number of the specific cell line(s) from the stem cell registry.

Questionnaire

Q ID 7

List the registration numbers of the cell lines in the spaces provided. The maximum allowed length of each registration number is four (4).

Explanation: List the registration numbers of the cell lines in the spaces provided. The maximum allowed length of each registration number is four (4). 

Policy:  See the stem cell registry found at: http://stemcells.nih.gov/registry/index.asp

C-2.1

Candidates Alternate Phone Number

Person Details

Secondary Work Phone - Enter an alternate number (e.g., cell phone); field will be left blank if null.

C-4.0

Degree Sought During Proposed Award:

Questionnaire

Q ID 42

Are you seeking a degree during the proposed award?

“N” will proceed to Field of Training; “Y” requires degree date and type.

C-4.3

Expected Completion Date

Questionnaire

Q ID 35

Enter the date the degree was earned in month/day/year format (MM/DD/YYYY).  The specific date of the month is not important. The Month and Year data will be formatted to meet NIH requirements

C-4.0

Degree Sought

Questionnaire

Q ID 99

If Yes, select the type of degree sought during the proposed award, from the list provided. If the degree being sought does not appear on the list, please select the most appropriate "other" degree type from the list.  (List detailed in Appendix.)

C-4.2

Other Degree Type

Questionnaire

Q ID’s 16, 17, 18, 19, 100, 21

If you have selected an "other" type as your degree sought, please provide the specific degree type here.

C-5

Field of Training for Current Proposal:

Questionnaire

Q ID 22

Select subcategory field of training that best applies to the proposed award from the list; otherwise select “Subcategory Not Found”.

Field of Training (broad)

Questionnaire

Q ID 23.

Sponsor discourages use of the broader category descriptions, unless it’s truly the best fit; i.e. suitable subcategory cannot be found on list

The form allows for up to four (4) current and prior support entries. The questionnaire asks the respondent if they had prior support; a “Yes” answer asks a series of questions to provide the form data. These series can repeat to supply the four detailed lines. A “No” response to current/prior support will present the next required question.

C-6.1 - 3

Current Or Prior Kirschstein-NRSA Support?

Questionnaire

Q ID 24

If yes, please identify current and prior Kirschstein-NRSA support in the following questions. Up to 4 awards can be identified.

C-6.4

Level

Questionnaire

Q ID 32

Select from list:

Predoctoral or Postdoctoral

C-6.5

Type

Questionnaire

Q ID 33

Select from List:

Individual or Institutional

C-6.6

Start Date

Questionnaire

Q ID 43

Q ID 44

If known, enter the start date of this support in the format MM/DD/YYYY.

C-6.7

End Date

Questionnaire

Q ID 49

Q ID 45

If known, enter the end date of this support in the format MM/DD/YYYY.

C-6.8

Grant Number

Questionnaire

Q ID 46

Q ID 27

If known, enter the grant number for this support.

Do you have another current or prior Kirschstein-NRSA support award to report?

Questionnaire

Q ID 31

Answer “Yes” to supply the required fields in the questions that follow. Answer “No” to proceed to the next required question.

C-7.1

Applications for Concurrent Support?

Defaults to No unless defined narrative is uploaded.

Are there applications for other concurrent support for this candidate? If yes, upload the Concurrent Support narrative.

Explanation:    If the candidate has applied or will be applying for other support that would run concurrently with the period covered by this application check “Yes” and include the type, dates, source(s) and amount in the uploaded attachment. The candidate must promptly report to the NIH IC to which this application is assigned any support resulting from other such applications.

C-7.4

Concurrent Support

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PHS_Fellow_ConcurrentSupport

C-8

Goals for Fellowship Training and Career

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PHS_Fellow_Goals_FellowshipTrainingCareer

C-9

Activities Planned Under This Award

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PHS_Fellow_ActivitiesPlanned

C-10

Doctoral Dissertation and Other Research Experience

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PHS_Fellow_DocDissertOtherResExperience

Parameter 'PI_CITIZENSHIP_FROM_CUSTOM_DATA' supports this data element. Default value is 1.  If the value is set to 1, uses field Citizenship Type in Person Extended Attributes table

C-11.1

Citizenship:

Person Extended Attributes >

Citizenship Type

Select from a look-up value provided:

A: Non-U.S Citizen with Temporary Visa

C: U.S. Citizen or noncitizen national

N: Permanent Resident of the U.S.

P: Permanent Resident of the U.S. - PENDING

C-12.1

Change of Sponsoring Institution

Questionnaire

Q ID 28

Has this application been previously submitted by a different institution?

Check YES, if this application reflects a change in grantee institution from that indicated on a previous application.

C-12.2

Name of Former Institution

Questionnaire

Q ID 29

Enter the name of the former institution.

Explanation:   Per NIH, a former institution is not generally applicable to a "New" application. If you check YES, you will be prompted to provide the name in a follow-up question.

Additional Narrative type for this form version 1-2. (prior instructions uploaded this file to the Other Project Info form.)

Consult the instructions provided in the Application Guide regarding the content of the Sponsor(s) and Co-Sponsor(s) section.

D-1

Sponsor(s) and Co-Sponsor(s) Information

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PHS_Fellow_Sponsor_CoSponsor_Info

E.  BUDGET

E-1 section

If you are not requesting any tuition or fees in the detailed budget, "None Requested" will be selected.  If you do have added Tuition in detailed budget "Funds Requested" will be selected and detail will map for each applicable year of support, in the fields provided.

Budget:

Cost Element: 422311

Description: Tuition- Other– Not MTDC

Line Item expense entered per budget period in the Cost Element defined for Tuition for this form.

To populate this form the tuition must be budgeted using the parameterized cost element in Tuition_Cost _Elements.

If Tuition is not budgeted, the “None Requested” box will be checked.

Parameter: Tuition_Cost _Elements

To maintain parameter: enter cost element in this method: (‘XXXXXX‘) e.g. parenthetical statement, single quote at start end of CE,  Example:

Warning: If Tuition is incorrectly budgeted (wrong cost element for this form), None Requested box will be checked.

*current parameter default cost element is Tuition – Other – Not MTDC (422311) found in the Other Direct panel of Non-Personnel tab.

Senior Fellowship Applicant section

These questions will only appear upon “Yes” to the question “Is this a senior Fellowship Application.

Senior Fellowship

Questionnaire

Q ID 36

Is this a Senior Fellowship Application?

E-1-11

Present Institutional Base Salary Amount:

Questionnaire

Q ID 47

Please enter the dollar amount of your present institutional base salary

E-1-13

Academic Period

Questionnaire

Q ID 48

Indicate the period of time on which the salary is determined (e.g., academic year of 9 months, full-time 12 months, etc.  Select a value from the list presented:
6-month, 9-month, 10-month, 12-month

E-1-14

Number of Months

Questionnaire

Q ID 50

Please enter the number of months you will receive the salary.  Fractions of months (using two decimal places) may be expressed.

E-2

Stipends/Salary During First Year of Proposed Fellowship

Budget: Period 1

Cost Element : 400315

Description: Fellows- Non-Student– Not MTDC

To populate the Stipend Amount and Number of Months, this Fellow/Personnel expense must be in the Period 1 budget using the defined cost element. The amount and months are mapped from the Personnel Budget Details.

If Stipend is not budgeted, the form fields will be zero.

Parameter: Stipend_Cost _Elements

Warning: If Stipend is incorrectly budgeted (wrong cost element or no person details), the values will not publish.

* current parameter default cost element is Fellows-Non-Student-Not MTDC (400315) found in the Personnel tab.

E-2 a1

Supplemental Amount

Questionnaire 

Q ID 38

Are you receiving any supplementation from other sources? (Numeric value, no commas or non-numeric characters).

E-2 a2

Supplemental Number of Months

Questionnaire 

Q ID 39

Enter the number of months receiving the supplemental funds. (Numeric value, no commas/non-numeric characters).

E-2b-1

Supplemental Type

Questionnaire  Q40

What is the type of the supplemental funding?

E-2b-2

Sources:

Questionnaire  Q41

What is the source of the supplemental funding??

E-0

Appendix

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PHS_Fellow_Appendix

This narrative type requires a Description/Title.