Helpful Hints for
Independent Scientist Award (K02)
Revised: December 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)
(http://grants.nih.gov/grants/guide/pa-files/PA-09-038.html).
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 -The involvement of human subjects
and protections from research risk relating to their participation
in the proposed research will be assessed. See the "Human
Subjects Sections" of the PHS 398 Research Plan component
of the SF 424 (R&R), part I, 5.5.
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
- The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children
as appropriate for the scientific goals of the research will
be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the "Human Subjects Sections"
of the PHS 398 Research Plan component of the SF 424 (R&R)
part I, 5.5.
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.
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".
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".
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.
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.
Link
to NIH Application Forms, Including the SF 424 (R&R)
Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov
(http://www.grants.gov) using the SF 424 Research and Related
(R&R) forms and the SF 424 (R&R) Application Guide.
The SF
424 (R&R) Application Guide for NIH and Other PHS Agencies,
now includes Part 1.7 Supplemental Instructions to the SF
424 (R&R) for Preparing an Individual Research Career
Development Award (CDA) Application ("K" series).
Note in particular that the "Candidate" and "Research
Plan" (sections A-D) combined may not exceed 25 pages.
Please note that this new Application Guide is to be used
with all Adobe application packages, including those for the
K programs.
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 |
|