Helpful Hints for Independent Scientist
Award (K02)
Revised: August 2006
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-00-020.html,
and in the PHS Form 398, Section III, 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 new investigators who have peer
reviewed independent support at the time of the award of the K02. 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 currently are devoting approximately 75% of
their time to research projects are viewed as not needing protected time.
Further, the K02 is not intended for investigators who already have full time
available to conduct research, or who have publication records or considerable
research support indicating that they are well established in their fields, or
who have achieved tenure or its equivalent.
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 - New
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 new 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 (see the
Public Health
Service policy on RCR at:
http://ori.dhhs.gov/multimedia/acrobat/rcrpolicy.pdf). This document describes
nine core instructional areas that comprise RCR: data acquisition, management,
sharing, and ownership; mentor/trainee relationships; publication practices and
responsible authorship; peer review; collaborative science; human subjects;
research involving animals; research misconduct; and conflict of interest and
commitment. 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 bioethics for
resources and information on
this topic at: http://www.nih.gov/sigs/bioethics.
Human Subjects - Prior to preparing an
application, candidates should read the definition and clarification of Human
Subjects in PHS 398 (rev. 5/01) sections IIIA. - Definition and IIIG. -
Assurances and Certification.
Required Education in the Protection of Human Research
Participants: As of October 1, 2000, 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-00-039.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
revised PHS 398 (rev. 5/01) application kit (in PDF) 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 (rev. 5/01) 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 Roy White, Ph.D. Dr.
White may be reached at the Review Branch, Division of Extramural Affairs,
NHLBI, by telephone at (301) 435-0287, or by
e-mail at
whiter@nhlbi.nih.gov. Candidates intending to include color or detailed
photographs in their applications should contact Dr. White, 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-00-020.html) and the PHS form
398, "Additional Instructions to Preparing Individual Research Career Award
Applications - the 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 Affairs
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 with 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: February 1, June 1, and October
1
Resubmission/Amended
NHLBI K02 Career Development Award applications are to be
submitted for the Standard NIH Receipt Dates, which
are included in the following notice: http://grants.nih.gov/grants/guide/notice-files/NOT-HL-06-133.html.
This notice is effective immediately and supercedes earlier
instructions and includes dates for submitting Letters of
Intent.
NHLBI Staff Contact:
For further information regarding NHLBI K02
applications, please contact the NHLBI Program Official:
Traci Heath Mondoro, Ph.D. |
Health Scientist Administrator |
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 10182 and use zip code 20817) |
Telephone: 301-435-0052 |
FAX: 301-480-1060 |
Email:
mondorot@nhlbi.nih.gov |
|