Helpful Hints for
NHLBI Mentored Clinical Scientist
Development Award (K08)
Revised: February 2007
The following information is presented to applicants as advice and helpful
hints for preparing K08 applications for submission to the National Heart,
Lung, and Blood Institute (NHLBI). However, applicants MUST carefully
follow the NIH
K08 program guidelines at http://grants.nih.gov/grants/guide/pa-files/PA-06-512.html.
Candidate - Candidates must meet both the NIH and NHLBI eligibility
criteria. Some candidates may have completed as little as 2 postgraduate
years of clinical training with little research experience, whereas other
candidates may have completed subspecialty training that included 2 years
of postgraduate research training. A candidate's publications are an important
component of an application, although a set number of publications is
not specified. Though a range of previous research experience is accepted,
a candidate with no publications would be seen as a poor candidate. Occasionally,
candidates are seen as too senior in terms of research experience because
of the number of publications they have authored in the area proposed
for the K08 application. Candidates who may be perceived as too senior
should clearly identify the new directions and techniques they will learn
and consider requesting support of less than 5 years. Candidates with
significant research experience in the proposed field of study should
consider applying for independent research support (R01, etc.). The career
development plan for senior candidates should justify the need for additional
training and coursework or for an intensive research experience under
the guidance of an established scientist. K08 candidates may not hold
any other Federal or non-Federal equivalent salary award, such as the
American Heart Association Scientist Development Grant.
Career Development Plan - This section is a
major part of a career award application and weighs heavily in the
assignment of a priority score. Candidates should describe how the proposed
research project, coursework and other training experiences will provide the
best possible training experience for a candidate's progression toward an
independent research career. Courses, though not required, are usually expected
for candidates with limited research experience and should be completed in the
earlier stages of the career development plan. Candidates should specify the
courses to be taken, explain how they relate to career goals, and indicate
whether they will be taken for credit or audit (for credit is preferred). A
description of proposed seminars, journal clubs, and scientific conferences to
be attended as well as interactions with other scientists should also be
included. The career development plan should be "customized" for the candidate,
rather than a generic plan that would be used for other comparable trainees. A
timetable (graphic or text) that includes the coursework and the research
project is helpful, as is a plan for evaluating progress. The number of years
requested should be appropriate for the amount of research and training
proposed.
Mentor - Candidates must identify a primary
mentor who is an accomplished investigator in the proposed research area and
has experience in developing independent investigators. The mentor must provide
a statement of support, provide a plan for the development of the candidate,
and provide guidance during preparation of the research project. A list or
description of the mentor's prior trainees (from not more than the last 10
years) should be provided. The list or description should include their names,
the dates of mentored training, the title of the research project, and the
current positions. This information can be included in the bibliographic sketch
or in the mentor's letter of support. It is not required that mentor(s) have
NIH funding but this tends to weigh favorably in the review. A two-page
bibliographic sketch of the mentor must be included, along with information
describing their other support. Co-mentors are encouraged, but one person
should be identified as having primary responsibility for a candidate's
mentoring. Applications should also include information on the co-mentors'
prior trainees, as well as bibliographic sketches and other support.
Environment and Institutional Commitment - The
letters from the mentor and 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 mentor and institution
should provide statements concerning the protected time the candidate will
receive (minimum of 75% required), and if applicable, the duties from which
they will be relieved. 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.
Advisory Committee - The NHLBI strongly encourages K08
candidates to include an Advisory Committee composed of the candidate's
mentor(s) and two or three other senior faculty members. If the candidate
does not propose an Advisory Committee, she/he should document which individuals
are available to cover all areas of expertise that are required for the
research plan and career development. This Advisory Committee should meet
with the candidate to develop the career development plan and research
project prior to submission, review the plan after award, evaluate the
awardee's progress, and provide guidance for scientific career development.
Each Committee member should provide a biographical sketch, a letter of
commitment to participate actively in advising the candidate, and a description
of the method and frequency of interactions in the application. It is
not required that all Committee members be at the candidate's institution,
but if a member is at another institution, the method and frequency of
planned interactions should be described. Peer reviewers usually find
the lack of an Advisory Committee to be a weakness that negatively affects
the priority score.
Research Plan - The reviewers will look for
innovative approaches in the research, for proposals that are feasible and
realistic, for the necessary expertise of the persons involved, and for clarity
in the application. Candidates should clearly define the specific aims and
explain the rationale and long- and short-term objectives. Candidates are
strongly encouraged to submit preliminary data to demonstrate the feasibility
of the project. Candidates should address potential pitfalls in the research
proposal and present alternative approaches, including methods, sample size
justifications, and plans for data analysis.
Format for Letters - Letters submitted with an
application must be addressed to the "NHLBI K08 Review Committee" and be
written on institutional letterhead stationery. Applications with fewer than
three reference letters will be returned without review. These letters should
be from individuals in addition to/other than those directly involved in the
application (i.e., not from sponsors, cosponsors, and collaborators). Neither
sponsor/mentor and sponsors of this application, nor collaborators, can be
counted as a reference. Revised applications must include new letters of
reference, since letters submitted with previous applications are not retained
by NIH. See the PHS 398 instructions for more details on requirements for
letters of reference.
Budget - The NHLBI K08 requires that
recipients devote a minimum of 75% effort to the research plan supported by the
career development award. The remaining 25% effort may be devoted to research
and research-related activities such as teaching, patient care, or other
research-related clinical activities. The salary that may be requested and
awarded for a career development award can be 100% of the recipient's
institutional salary, exclusive of fringe benefits, up to the $75,000 maximum
allowed by the program. Fringe benefits are requested separately from the
salary and are based on the salary requested. A maximum of $25,000 is allowed
for Research and Development Support. If it is clear that the $25,000 will be
insufficient to support the project, the candidate should explain what other
financial resources will be available to cover the expenses.
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.
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/researchethics.html.
Candidates are encouraged to consider instruction in the following areas:
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.
Human Subjects - Prior to preparing an application, candidates
should read the definition and clarification of Human Subjects in PHS
398, Part II.
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 PHS 398 application
form (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 K08
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 human 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://grants1.nih.gov/grants/guide/notice-files/not98-024.html.
Data and Safety Monitoring Plan - If the research project
will include a clinical trial (i.e., biomedical or behavioral
intervention studies), the application 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.
NHLBI suggests that K08 applications include biographical sketches of
the collaborators and consultants.
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) about submitting this additional material prior to the review. The
NHLBI SRA for K08 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 email 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.
NHLBI requires documentation of the candidate's professional clinical
licensure in the United States. This document may be placed after the
candidate's biosketch.
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.
Links
to NIH Application Forms, Including the PHS 398: http://grants.nih.gov/grants/forms.htm
Note: NIH is in the process of converting to SF424 (Research and Related
[R&R]) forms and electronic submission through Grants.gov. Information
on this plan (SF424) and on registering for electronic submission
is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html.
Updates
regarding the transition process are at http://era.nih.gov/ElectronicReceipt/.
Link to
the NHLBI Model K08 Application:
http://www.nhlbi.nih.gov/funding/training/redbook/k08model.htm
Link to Documents Providing
Advice on the Preparation of a Grant Application:
http://grants.nih.gov/grants/grant_tips.htm
Application Procedures - Submit a signed, typewritten original
of the application, including the checklist, and three
signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service, non-USPS service)
Note that new and revised applications must include at least three sealed
letters of reference attached to the face page of the original application.
Applications submitted without the required number of reference letters
will be considered incomplete and will be returned without review.
Personal
deliveries of applications are no longer permitted
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of
the application and all five collated sets of the appendix
material must be sent to:
Chief, Review Branch
Division of Extramural Research Activities, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhblichiefreviewbranch@nhlbi.nih.gov
Application Receipt Dates: February 12, June 12, and October 12 -
new applications;
March 12, July 12, and November 12 - resubmission applications. Letters
of intent (LOI) are requested from applicants who are planning to submit
resubmission applications. The LOIs should be submitted one month in advance
of the resubmission receipt due 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
Bethesda, MD 20817(for express mail)
Telephone: (301) 435-0270 FAX: (301) 480-0730
Email: Chief,
Review Branch
Additional information on application receipt dates is located in
the notice, "Change
in Standing Receipt Dates for NIH/AHRQ/NIOSH Beginning in January 2007,"
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-001.html. The
new receipt dates are effective as of January 2007 and will apply to both
paper and electronic applications.
NHLBI Staff Contact:
For further information regarding NHLBI K08 applications, please contact
the NHLBI Program Director:
Lorraine M. Silsbee, M.H.S. |
National Heart, Lung, and Blood Institute |
6701 Rockledge Drive, MSC 7934 |
Bethesda, MD 20892-7934 |
Telephone: (301) 435-0709 |
FAX: (301)480-1455 |
Email:
SilsbeeL@nhlbi.nih.gov |
|