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Helpful Hints for
Independent Scientist Award (K02)
Revised: October 2008
These Helpful Hints were written to assist potential candidates
who are planning to submit K02 applications to the National
Heart, Lung, and Blood Institute (NHLBI). This document clarifies
some of the NIH K02 program guidelines; it does not replace
those guidelines. Candidates MUST follow the
instructions in the NIH K02 Program Announcement (AKA guidelines)
found at http://grants.nih.gov/grants/guide/pa-files/PA-06-527.html,
and in the PHS Form 398, Part 1, Section 7, available
at http://www.grants.nih.gov/grants/forms.htm.
Summary of the K02 Goal - The K02 is a salary only
award which provides protected time for newly independent
investigators so they will be able to expand their research
commitment to at least a 75% effort. Newly independent scientists
often have non-research obligations such as heavy teaching
loads, clinical duties, committee assignments, service and
administrative duties that prevent them from having a period
of intensive research early in their independent research
career. The salary from the K02 will allow investigators to
be relieved of those other duties which provide a portion
of their income, and allow them to focus on their research
and career development.
Candidate - Eligibility: At the time of the
award, candidates must be citizens or non-citizen nationals
of the United States, or must have been lawfully admitted
to the United States for permanent residence. Candidates must
meet the U.S. citizenship requirements. Candidates must possess
a doctoral degree (i.e., Ph.D., Ph.D./M.D., M.D., D.V.M.,
PharmD., or an equivalent degree). Candidates should be newly
independent investigators who have peer-reviewed independent
support at the time of the award of the K02. NHLBI
requires K02 applicants to have national peer-reviewed support
(funding from state chapters of the American Heart Association
or American Lung Association is not acceptable). When in doubt
about eligibility, candidates are strongly encouraged to contact
the NHLBI program representative listed at the end of this
document prior to preparation of an application.
Candidates must describe their short and long-term career
objectives and explain how this award will contribute to them.
Candidates must clearly document that they have a relatively
small amount of time dedicated to research and have a need
for protected time which would allow them to focus on
research and research related activities. Candidates who are
well-established in their fields are considered ineligible.
Some indications of having achieved this status are tenure
or the equivalent, a substantial publication record or, considerable
research support that already requires commitment of a major
part of the candidate's time.
Career Development Plan - This section is an important
part of a career award application and weighs significantly
in the assignment of a priority score. Successful candidates
have a documented career development plan, which may
include didactic coursework and training in areas that would
promote multidisciplinary skills, and their potential to make
future contributions to their chosen field of research.
Candidates should specify the courses they will take, explain
how they relate to career goals, and indicate whether they
will be taken for credit or audited (for credit is preferred).
A description of proposed seminars, journal clubs, and scientific
conferences to be attended as well as opportunities for interactions
with other scientists should also be included. The career
development plan should be "customized" for the candidate,
based on clearly stated career goals and past experience.
The number of years requested should be appropriate for the
amount of research and training proposed. A timetable
(graphic or text) that includes the coursework and the research
projects is helpful, as are benchmarks and a schedule for
evaluating progress.
Environment and Institutional Commitment - The letters
from the institution should provide specific details
about the facilities and other resources that will be provided
to the candidate. In addition, letters of commitment from
the institution should provide statements concerning the protected
time the candidate will receive (at least 75 % required),
the duties from which they will be relieved, and the institutional
commitment to enhancing the candidate's ability as a productive,
independent investigator. Descriptions of the institution
should be sufficiently detailed so that reviewers can determine
if the environment is conducive to performing high quality
research. These letters are carefully reviewed by the peer
reviewers and carry substantial weight in the evaluation of
an application.
Research Plan - The reviewers evaluate the research
plan of an on-going independent project differently than they
would a proposed expansion of an existing project or a new
project. The NHLBI K02 is for newly independent investigators
whose research is in the areas of cardiovascular, pulmonary,
blood diseases or resources, transfusion medicine, or sleep
disorders. Applications submitted to the NHLBI must be in
one or more of these scientific areas. K02 applications will
be accepted by the NHLBI if the scientific focus is in one
of these areas even if the peer reviewed independent project
is supported by another NIH institute or a non-NIH entity.
1. Ongoing Research Project: The research in the peer reviewed
independent project has previously been reviewed and will
not be reviewed in depth as part of the K02 application. However,
the description of ongoing research should include a description
of its background and significance, specific aims, study design(s),
methods, and related information necessary for the reviewers
to understand the previously-funded research project. Applicants
should clearly identify their peer reviewed project in their
request for protected time.
2. Additional Research for the K02: The additional research
can be either an expansion of one or more of the aims of the
previously-funded research or a new project. Applicants should
propose additional work beyond expansion of previously-funded
research or new work. The reviewers will review the expanded
or new research project in depth. The research plan must be
as well documented as in an R01 application. The relationship
of the additional research to the original funded research
should be described. Candidates should explain new research
hypotheses, new techniques to be employed and new data related
to the original research.
Format for Letters - Letters submitted with an application
must be addressed to the "NHLBI K02 Review Committee" and
be written on institutional letterhead stationery. Revised
applications must include new letters, since letters
submitted with previous applications are not retained by NIH.
Budget - Career awards use the JUST IN TIME process,
but do not use modular budgets.
The salary requested and awarded may not exceed $75,000 per
year plus fringe benefits. Facilities and Administrative Costs
are 8% of direct costs. The K02 has an award period of 3 to
5 years and is not renewable.
Other Salary Support - NIH policy permits supplementation
of salary from non-Federal funds. Supplementation from
other Federal funds is not permitted unless
explicitly authorized by both the program from which the funds
are derived and the NHLBI.
Research Support - The research support is that provided
by the peer reviewed, independent research project (e.g.,
R01) and any other research projects that will be ongoing
at the time of an award. It is important to list all
the research projects that will be ongoing during the K02's
project period. Each research support entry should include
the inclusive dates of the project period, the percent effort,
and the dollar amount of support.
Funds for Research Support - Because the K02 is a
salary only award, it does not provide funds for research
support. Salary support from a pre-existing NIH grant is relinquished
prior to receiving a career award. Usually, the funds budgeted
in the NIH grant (R01) for salary may not be re-budgeted.
However, it may be possible to rebudget salary funds within
an R01 to support the cost of research support (including
tuition, fees, and books) with the prior approval of the NIH.
Documenting the Need for Protected Time - Newly independent
investigators just starting their independent research often
have a small percentage of their time allocated to their research-related
endeavors. Institutions may require candidates to earn the
remainder of their salary by assuming teaching assignments,
by working on committees, by performing clinical duties, or
by performing other duties that take newly independent investigators
away from their research. In order to demonstrate their need
for protected research time, candidates must clearly outline
the percentage of time devoted to their research project and
the percentage of time devoted to other duties. The following
points are suggested:
1. List all current duties and the percentage of time devoted
to each.
2. Include a letter on institutional letterhead addressed
to the "NHLBI K02 Review Committee" from the individual having
the authority to protect a candidate's time, such as the Department
Chair. The letter should state that, if the K02 is awarded,
the candidate will be relieved of the duties requiring some
specified percent effort and the candidate will have 75% (or
more) protected time. The percentages should be consistent
with those listed by the candidate.
3. Candidates must clearly document that the requested period
of salary support and protected time will foster their career
as a highly productive scientist.
Need For Independent Support At the Time of the Award
- K02 applications may be submitted on the next receipt date
after the submission of an R01 or concurrently with an R01
application for the same receipt date. However, applicants
must have on-going peer reviewed support at the time of
the award of a K02.
A K02 may be awarded for three to five years. Therefore,
enough time should remain on an on-going independently funded
project so the K02 will provide support for at least two or
more years concurrently with the independent support. If the
K02 project period will exceed the project period of funded
independent support, the candidate should provide information
about proposed continuing research. Documentation of PENDING
applications or proposed PENDING applications is recommended.
Research Ethics: Research ethics training for
NIH career award candidates consists of: training in
the responsible conduct of research; and education in the
protection of human subjects. The latter is addressed in the
section that follows on Human Subjects.
Training in the Responsible Conduct of Research (RCR): Candidates
must describe plans to receive instruction in the responsible
conduct of research. Although 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,
policies regarding the use of human and animal subjects, and
data management. Plans for RCR training must be described
in a single paragraph that addresses the proposed subject
matter, format, frequency and duration of instruction and
includes an explicit statement that a candidate has taken
the course, or will take it at a specific date. No award will
be made if an application lacks this component. See the NIH
website for
information on this topic at: http://www.nih.gov/sigs/bioethics/researchethics.html.
Human Subjects - Prior to preparing an application,
candidates should read the definition and clarification of
Human Subjects in PHS 398.
Required Education in the Protection of Human Research Participants:
The NIH requires all investigators submitting NIH grant applications
for research involving human subjects to complete education
in the protection of human research participants. An NIH
Web page contains links to the NIH web-based tutorial and
frequently-asked-questions at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.html.
Before the NIH can issue awards for research involving human
subjects, candidates must provide a letter that includes
the names of the key personnel who are responsible for the
design and conduct of the study, the title of the education
program completed by each named person, and a one sentence
description of the program. The letter must be signed by an
authorized institutional official.
If this requirement has been fulfilled for ongoing independent
support, it need not be duplicated. However, if human
subject use will be added, either by expansion of a current
project or initiation of a new project, then this requirement
must be satisfied and documented.
Women and Minority Inclusion in Clinical Research Policy
- Candidates must list the expected number of human subjects,
their gender, and the number of minority group members expected
to be involved in the proposed research.
The NIH requirements for the inclusion of women and minorities
in study populations are detailed at: http://www.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html.
The
NIH requirements for reporting race and ethnicity data
are detailed at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.
In addition, the NHLBI expects participation of women and
racial/ethnic minorities in study populations to reflect their
representation in the U.S. population unless a compelling
justification to the contrary is provided. Applications proposing
research studies with human subjects that differ materially
from this standard will not be funded. The PHS 398 application
kit ) contains
a table for listing the targeted/planned enrollment of the
study population (http://grants.nih.gov/grants/funding/phs398/enrollment.pdf).
All K02 applications involving human subjects must
include a completed table.
Inclusion of Children Policy - This NIH policy
defines children as "individuals under the age of 21". Children
must be included in all human subjects research conducted
or supported by the NIH unless there are scientific or ethical
reasons not to include them. This policy applies to all NIH
conducted or supported research involving humans subjects,
including research that is otherwise "exempt" in accordance
with Sections 101(b) and 401(b) of 45 CFR 46 - Federal Policy
for the Protection of Human Subjects. If children will be
excluded from the research, the application must present an
acceptable justification for the exclusion. In the research
plan, the investigator should create a section titled "Participation
of Children".
The full instructions, including the list of allowable justifications
for exclusion of children, are found at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Data and Safety Monitoring Plan - NIH has a new requirement
for competing applications. Applications for research
projects that include clinical trials (i.e., biomedical
or behavioral intervention studies) must contain a
section entitled "Data and Safety Monitoring Plan".
See the PHS 398 for details.
Miscellaneous - Applications should be reviewed by
an editor or proofreader and a trusted colleague. Poorly written
applications are generally viewed as evidence of lack of attention
to details and often receive a poor priority score.
Candidates should reread the program announcement and check
that sufficient information is provided in their application
for reviewers to evaluate all listed review criteria.
If, after submitting an application, candidates obtain additional
preliminary data or publications relevant to the project,
or they obtain additional grant support, they should contact
the NHLBI Scientific Review Administrator (SRA) regarding
inclusion of the additional material in the review. The NHLBI
SRA for K02 applications is Rina Das, Ph.D. Dr. Das
may be reached at the Review Branch, Division of Extramural
Research Activities, NHLBI, by telephone at (301) 435-0297,
or by e-mail at
dasr2@nhlbi.nih.gov. Candidates intending to include
color or detailed photographs in their applications should
contact Dr. Das, the Scientific Review Administrator, to arrange
for them to be available to reviewers.
Font Size: The Center for Scientific Review has standards
for font size and spacing. Applications that do not adhere
to the rules are being returned to candidates unreviewed.
The PHS 398 preparation instructions contain detailed information
on the standards.
Review Criteria - A panel of reviewers will judge
the merit of applications by the review criteria stated in
the NIH program announcement and by the following criteria:
Career Development Plan - Likelihood that an award
will contribute substantially to continued scientific development,
productivity, and independence of an applicant.
Research Plan - Quality of the proposed research plan
and potential for strengthening an investigator's independence.
Scientific and technical merit of the research proposed for
the augmented time provided by a K02 award.
Link
to NIH Application Forms, Including the PHS 398: http://grants.nih.gov/grants/forms.htm
Applicants should use both the
NIH program announcement (http://grants.nih.gov/grants/guide/pa-files/PA-06-527.html)
and the PHS form 398, "Instructions to Preparing an Individual
Research Career Award Application (CDA) - K Series," and the
information in this "Helpful Hints" in completing
their applications. Consultation with program staff, identified
under "NHLBI Staff Contact," is also recommended before submitting
an application.
Letter of Intent - Applicants are asked to submit
a Letter of Intent at least one month before the announced
receipt date to:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive Two Rockledge Centre,
Room 7214, MSC 7924
Bethesda , MD 20892-7924
Telephone: (301) 435-0270 FAX: (301) 480-0730
Email: Chief,
Review Branch
Application Procedures - Submit a signed, typewritten
original of the application, including the Checklist, and
five signed photocopies in one package to:
| CENTER FOR SCIENTIFIC REVIEW |
| NATIONAL INSTITUTES OF HEALTH |
| 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 |
| BETHESDA, MARYLAND 20892-7710 |
| (For express/courier service use Bethesda,
Maryland 20817-7710) |
One additional copy of the completed application should be
sent to the Chief, Review Branch at the address listed under
the Letter of Intent.
Application Receipt Dates:
New applications due: February 12, June 12, and October 12
Resubmitted applications due: March 12, July 12, and November
12
NHLBI Staff Contact:
For further information regarding NHLBI K02 applications,
please contact the NHLBI Program Official:
| Traci Heath Mondoro, Ph.D. |
| Program Director |
| Division of Blood Diseases and Resources |
| National Heart, Lung, and Blood Institute |
| National Institutes of Health |
| 6701 Rockledge Drive MSC 7950 |
| Bethesda, Maryland 20892-7950 (for overnight
delivery, insert Room 9140 and use zip code 20817) |
| Telephone: 301-435-0052 |
| FAX: 301-480-0187 |
| Email:
mondorot@nhlbi.nih.gov |
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