MIDCAREER INVESTIGATOR AWARD IN PATIENT-ORIENTED RESEARCH (K24)

RELEASE DATE:  June 8, 2004

PA NUMBER:  PA-04-107  (Reissued as PA-08-151)

(See Notice NOT-OD-08-034 Extension of the Midcareer 
Investigator Award in Patient-Oriented Research)

(March 13, 2007 - See Notice (NOT-RR-07-006) NCRR will no longer participate in this PA.)

( See Notice NOT-OD-07-043 - Extension of 
Several NRSA Training (T), NRSA Fellowship (F), and Career Development (K) expiration dates.)

(See Notice NOT-DA-06-013 NIDA 
Policy Update Mentored and Career Development (K) Awards)

(See Notice NOT-OD-06-095 to clarify the 
eligibility of principal investigators for the Mid-Career 
Investigator Award in Patient Oriented Research (K24))
(See update, NOT-MH-05-008 and NOT-DA-05-005) 
(see update NOT-DA-05-001)

EXPIRATION DATE:  January 3, 2008

Department of Health and Human Services (DHHS)

NOTE TO APPLICANTS:  Applicants submitting competing renewals or amended 
applications for the July 1, 2004 receipt date should follow the guidelines 
in PA-00-005 http://grants.nih.gov/grants/guide/pa-files/PA-00-005.html 
This program announcement, PA-04-107, will supersede PA-00-005 and apply 
to all K24 applications submitted on or after the October 1, 2004 deadline.

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)
 
COMPONENTS OF PARTICIPATING ORGANIZATION:  
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 (http://www.niams.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://www.nccam.nih.gov)

The following NIH Institutes and Centers do not participate in this program:  
National Institute of General Medical Sciences (NIGMS); National Human Genome 
Research Institute (NHGRI); National Library of Medicine (NLM); National Center on 
Minority Health, Health Disparities (NCMHD); and the Fogarty International Center 
(FIC). 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.866; 93.271; 93.855, 93.856; 
93.846; 93.286; 93.398; 93.865; 93.173; 93.121; 93.847, 93.848, 93.849; 93.279; 
93.113, 93.114, 93.115; 93.361; 93.867; 93.233, 93.837, 93.838, 93.839; 93.281; 
93.853; 93.213; 93.389 

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Additional Requirements
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

SPECIAL NOTE: The participating NIH institutes and centers may have distinctive 
guidelines and requirements for this announcement in order to accommodate the career 
needs of researchers working in fields related to their specific research missions. 
Candidates are therefore encouraged to contact the staff person in the relevant 
institute or center listed under INQUIRIES prior to preparing an application to 
discuss issues of eligibility and review the specific provisions of this award.

PURPOSE OF THIS PA

The purpose of the Midcareer Investigator Award in Patient-Oriented Research is to 
provide support for clinician investigators to allow them protected time to devote 
to patient-oriented research (POR) and to act as research mentors primarily for 
clinical residents, clinical fellows and/or junior clinical faculty. This award is 
primarily intended for clinician investigators who are at the Associate Professor 
level or are functioning at that rank in an academic setting or equivalent non-
academic setting, and who have an established record of independent, peer-reviewed 
Federal or private research grant funding in POR.  This award is intended to advance 
both the research and the mentoring endeavors of outstanding patient-oriented 
investigators.  It is expected, for example, that investigators will obtain new or 
additional independent peer-reviewed funding as the PI for POR and establish and 
assume leadership roles in collaborative POR programs; and that there will be an 
increased effort and commitment to mentor beginning clinician investigators in POR 
to enhance the research productivity of the investigator and increase the pool of 
well-trained clinical researchers of the future.  With a view to achieving these 
objectives, the maximum level of allowable Research Development Costs has been 
increased in this announcement from $25,000 to $50,000 per year.

For the purposes of this award, and in agreement with the recommendations of the 
NIH Director’s Panel on Clinical Research, 
(http://www.nih.gov/news/crp/97report/index.htm), patient-oriented research is 
defined as research conducted with human subjects (or on material of human origin 
such as tissues, specimens and cognitive phenomena)for which an investigator 
directly interacts with human subjects.  This area of research includes 1) 
mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 
4) the development of new technologies.  Studies falling under Exemption 4 for 
human subjects research are not included in this definition.    

RESEARCH OBJECTIVES

Background

In 1995, the NIH Director’s Panel on Clinical Research was convened by the former 
Director of NIH, Dr. Harold Varmus, to review the status of clinical research in the 
United States and to make recommendations about how to ensure it's effective 
continuance. The Panel first developed a three-part working definition of Clinical 
Research, breaking down Clinical Research into three categories: patient-oriented 
research (POR), epidemiologic and behavioral studies, outcomes research and health 
services research. The Panel then formulated 10 recommendations that were presented 
to the Advisory Council to the Director NIH in December, 1996.  In the area of 
training, the Panel recommended the initiation of new support mechanisms for mid-
career clinical investigators, providing protected time to stabilize their clinical 
research laboratories, continue mentoring of junior clinical researchers, and to 
enhance their clinical research careers.  

In response to the recommendations of the Advisory Council in the area of training, 
NIH in 1998 issued two program announcements (PA).  The first PA entitled Mentored 
Career Development Award in Patient-Oriented Research used the NIH K23 funding 
mechanism and was intended to provide junior clinical investigators protected time 
to initiate a research career in POR. The second PA entitled Midcareer Investigator 
Award in Patient-Oriented Research used the NIH K24 funding mechanism and was 
primarily intended to provide protected time to investigators with their own 
independent research support, i.e. PI’s, to mentor junior clinical investigators, 
particularly K23 grantees, in POR and to stabilize the careers of these 
investigators so that they could continue to be available as mentors in POR.  This 
award has formed an important part of the NIH initiative to attract and retain 
talented individuals to the challenges of patient-oriented research.

Objectives 

The specific objectives of the Midcareer Investigator Award in Patient-Oriented 
Research are to:

o encourage established, mid-career clinician scientists who are experienced in POR 
to devote more time to POR and enhance their clinical research skills in order to 
mentor new clinical investigators and to conduct meritorious patient-oriented 
research. 
o increase the pool of clinical researchers who can conduct patient-oriented 
research, who will be able to successfully compete for peer-reviewed grants, and 
mentor the next generation of clinical investigators.

MECHANISM OF SUPPORT

This Program Announcement will use the NIH K24 award mechanism.  Planning, 
direction, and execution of the proposed project and program will be the 
responsibility of the applicant. 

Applicants may request three to five years of support (at least three years are 
required).  This award may be renewed one-time if the K24 recipient continues to 
have independent peer-reviewed patient-oriented research support at the time of 
submission of the competing renewal application. Applicants requesting renewals must 
also meet all the remaining requirements of the original award. 

Funding beyond the first year is contingent upon satisfactory progress during
the preceding year, as documented in the required progress report (refer to
"Special Requirements G. Reporting Requirements"). The terms of the NIH Grants 
Policy Statement and the requirements of this PA apply to these awards.

This PA uses just-in-time procedures.  However, since this PA requires that the 
applicant have a track record of research support, independent or otherwise, current 
and past research support must be documented in the application as a part of the 
research support section of the biosketch. 

The modular budget format does not apply to the K24.  

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following 
characteristics: 

o For-profit or non-profit organizations; 
o Public or private institutions, such as universities, colleges, hospitals, and 
laboratories;  
o Domestic institutions/organizations;
o Foreign institutions are not eligible to apply  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Only U.S. citizens or noncitizen nationals, or an individual lawfully admitted 
for permanent residence who possesses an Alien Registration Receipt Card (I-151 
or I-551), or some other verification of legal admission as a permanent 
resident, are eligible to receive this award.  Candidates must meet this criterion 
prior to the time of award.  Noncitizen nationals, although not U.S. 
citizens, owe permanent allegiance to the U.S.  They are usually born in lands 
that are not states but are under U.S. sovereignty, jurisdiction, or 
administration.  Individuals on temporary or student visas are not eligible.

Candidates for this award must have a health-professional doctoral degree or its 
equivalent.  Such degrees include but are not limited to the M.D., D.O., D.D.S., 
D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), as well as a doctoral 
degree in nursing. Candidates with Ph.D. degrees are eligible for this award if the 
degree is in a clinical field and they usually perform clinical duties.  This may 
include clinical psychologists, clinical geneticists, speech and language 
pathologists.  Applicants should be at the Associate Professor level, or are 
functioning at that rank in an academic setting or equivalent non-academic setting 
and must have an established record of independent, peer-reviewed patient-oriented 
research grant funding and record of publications.  This award is intended for 
individuals who are at a mid-career stage and have a record of supervising and 
mentoring patient oriented researchers.    Candidates are advised to discuss their 
eligibility with the institute contacts listed in the INQUIRIES section of this 
program announcement.  

Candidates must be able to demonstrate the need for a period of intensive research 
focus as a means of enhancing their clinical research career and a need for 
protected time to enhance their mentoring activities.

Candidates must commit 25 to 50 percent effort to conducting patient-oriented 
research and mentoring. 

Candidates for the K24 award may not have pending or concurrently apply for any 
other PHS career award.  

(Please note that NIH encourages applications for educational loan repayment from 
qualified health professionals who have made a commitment to pursue a research 
career involving clinical, pediatric, contraception, infertility, and health 
disparities related areas.  The LRP is an important component of NIH's efforts to 
recruit and retain the next generation of researchers by providing the means for 
developing a research career unfettered by the burden of student loan debt.  Note 
that an NIH grant is not required for eligibility and concurrent career award and 
LRP applications are encouraged.  The periods of career award and LRP award may 
overlap providing the LRP recipient with the required commitment of time and effort, 
as LRP awardees must commit at least 50% of their time (at least 20 hours per week 
based on a 40 hour week) for two years to the research.  For further information, 
please see: www.lrp.nih.gov)
 
SPECIAL REQUIREMENTS

A. Program 

The K24 award provides three to five years of support.  Twenty-five to fifty percent 
of full-time professional effort must be devoted to the patient-oriented research 
program and mentoring that are part of the award.  The remainder may be devoted to 
other clinical, teaching, or research pursuits consonant with the objectives of the 
award.
 
B. Research Support

o  Candidates are expected to continue to hold independent peer-reviewed support 
during the period of this award. Candidates losing this support during the award 
period must document in their annual Progress Reports efforts to replace this 
support and demonstrate that they continue to meet all other requirements of the K24 
award. 

o Candidates may not receive additional compensation from another HHS award 
(specifically, AHRQ or SAMHSA) that exceeds the maximum allowable salary 
compensation (See details on current salary limitations at 
http://grants.nih.gov/grants/policy/salcap_summary.htm ). 

C. Environment

The institution must be able to demonstrate a commitment to the applicant as a 
productive, independent investigator.  The application must describe a program that 
will use the relevant research and educational resources available and the 
institution must certify that the candidate will be released from other duties and 
be able to devote 25 to 50 percent effort(at least 25 percent effort)to a patient-
oriented research program. 

The applicant institution must document the availability of beginning clinical 
investigators (including junior clinical faculty) to be mentored. 

If there is an NIH (K30) Clinical Research Curriculum Award at the sponsoring 
institution, a plan should be described for integrating the proposed mentoring 
activities with the K30 curriculum.

D. Allowable Costs

Salary: The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) will 
provide salary for levels of effort between 25 and 50 percent.  The actual salary 
provided by the award is based on a full-time, 12-month institutional salary and the 
level of effort requested up to the maximum legislated salary rate in effect at the 
time of award.  In all cases, the salary requested must be consistent both with the 
established salary structure at the institution and with salaries actually provided 
by the institution from its own funds to other staff members of equivalent 
qualifications, rank, and responsibilities in the department concerned.  If full-
time, 12-month salaries are not currently paid to comparable staff members, the 
salary proposed must be appropriately related to the existing salary structure.  The 
award will also provide fringe benefits on the calculated base salary at the 
established institutional rate.

The institution may supplement the NIH salary contribution up to a level that is 
consistent with the institution's salary scale. Institutional supplementation of 
salary must not require extra duties or responsibilities that would interfere with 
the purpose of the K24 award.  

In addition, the candidate may derive additional compensation for effort associated 
with other Federal sources or awards provided the total salary derived from all 
Federal sources does not exceed the maximum legislated salary rate and the total 
percent effort does not exceed 100 percent. 

Research Development Support: The NIH will provide up to $50,000 per year for the 
following expenses:  (a) research expenses, such as supplies, equipment and 
technical personnel for the PI and the mentees; (b) travel to research meetings or 
training; (c) statistical services including personnel and computer time.

Ancillary Personnel Support: Salary for secretarial and administrative assistance, 
etc. is not allowed.

Facilities and Administrative Costs:  These costs will be reimbursed at 8
percent of modified total direct costs.

E. Evaluation

In carrying out its stewardship of human resource related programs, the NIH may 
request information essential to an assessment of the effectiveness of this program. 
Accordingly, recipients are hereby notified that they may be contacted after the 
completion of this award for periodic updates on various aspects of their employment 
history, publications, support from research grants or contracts, honors and awards, 
professional activities, and other information helpful in evaluating the impact of 
the program.

F. Other Income

Awardees may retain royalties and fees for activities such as scholarly writing, 
service on advisory groups, honoraria from other institutions for lectures or 
seminars, fees resulting from clinical practice, professional consultation or other 
comparable activities, provided these activities remain incidental, are not required 
by the research and research-related activities of this award, and provided that the 
retention of such pay is consistent with the policies and practices of the grantee 
institution.

All other income and fees, not included in the preceding paragraph as retainable, 
may not be retained by the career award recipient.  Such fees must be assigned to 
the grantee institution for disposition by any of the following methods:

o  The funds may be expended by the grantee institution in accordance with the NIH 
policy on supplementation of career award salaries and to provide fringe benefits in 
proportion to such supplementation.  Such salary supplementation and fringe benefit 
payments must be within the established policies of the grantee institution.

o  The funds may be used for health-related research purposes.

o  The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks 
should be made payable to the Department of Health and Human Services, NIH and 
forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 
20892.  Checks must identify the relevant award account and reason for 
the payment.

Usually, funds budgeted in an NIH supported research or research training
grant for the salaries or fringe benefits of individuals, but freed as a
result of a career award, may not be rebudgeted.  The awarding component will
give consideration to approval for the use of released funds only under
unusual circumstances.  Any proposed retention of funds released as a result
of a career award must receive prior written approval of the NIH awarding
component.

G. Special Leave

Leave to another institution, including a foreign laboratory, may be permitted if 
the proposed experience is directly related to the purpose of the award. Only local 
institutional approval is required if such leave does not exceed three months.  For 
longer periods, prior written approval of the NIH awarding institute is required.  
Details on the process for submission of prior approval requests can be founds in 
the NIHGPS (rev. 12/03), Requests for Prior Approval, at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600130.”  
Due to the special nature of the K24, this letter must include a description of 
the plans to continue meeting the effort commitments of both the research and 
mentoring components of the K24 award. A copy of a letter or other evidence 
from the institution where the leave is to be taken must be submitted to assure 
that satisfactory arrangements have been made.  Support from the K24 award 
will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the
prior written approval of the NIH funding institute and may be granted only in 
unusual situations.

Support from other sources is permissible during the period of leave.  Such
leave does not reduce the total number of months of program support for which
an individual is eligible.

H. Termination or Change of Institution

When a grantee institution plans to terminate an award, the NIH awarding institute 
must be notified in writing at the earliest possible time so that appropriate 
instructions can be given for termination. The Director of the NIH may terminate an 
award upon determination that the purpose or terms of the award are not being 
fulfilled.  In the event an award is terminated, NIH shall notify the grantee 
institution in writing of this determination, the reasons therefore, the effective 
date, and the right to appeal the decision.

If the grantee is moving to another eligible institution, career award support may 
be continued provided:

o A relinquishing statement is submitted by the original institution and a transfer 
application is submitted by the new institution at least three months prior to the 
transfer in order to allow the necessary time for administrative review by the NIH 
awarding institute.
 
o All conditions of the award are met at the new institution.

o The period of support requested is no more than the time remaining within the 
existing award period. 

o A change of grantee request normally will be permitted only when all of the 
benefits attributable to the original grant can be transferred, including equipment 
purchased in whole or in part with grant funds. In reviewing a request to transfer a 
grant, NIH will consider whether there is a continued need for the grant-supported 
project or activity and the impact of any proposed changes in the scope of the 
project. A change may be made without peer review, provided the PI plans no 
significant change in research and career development objectives and the facilities 
and resources at the new organization will allow for successful performance of the 
project. If these conditions or other programmatic or administrative requirements 
are not met, the NIH awarding office may require peer review or may disapprove the 
request and, if appropriate, terminate the award.

If an applicant is planning to move to a new eligible institution prior to or 
immediately after the issuance of an award, the contacts listed in the INQUIRIES 
section of this program announcement should be contacted prior to the preparation of 
an application to discuss this situation.  

A final progress report, invention statement, and Financial Status Report are
required upon either termination of an award or when an award is relinquished as a 
recipient changes institutions. 

I. Additional reporting requirements: 
   (for non-competing and competing renewal applications)

If the application is funded, additional reporting requirements for
NON-COMPETING Grant Progress Report (PHS Form 2590) and for competitive renewal 
applications are as follows:

o A description of how the K24 award has contributed to the recipient’s immediate 
and long-term career objectives.

o Updated listing of active and pending research support using the OTHER SUPPORT 
pages from PHS Form 398.  Clearly denote the recipient’s role in each of these 
grants or projects. Asterisk those active/pending sources of support that are a 
result of the protected time provided by the K24 award. Describe plans for obtaining 
patient-oriented research support during the next funding period. 

o A description of the research activities conducted during the reporting period.  
This description should clearly distinguish research activities utilizing the 
protected time provided by the K24 award from other research activities.   

o A description of the mentoring activities during the prior award period directly 
resulting from the protected time provided by the K24 award. Include the names of 
the individuals mentored; degree(s), professional specialty(ies) and staff 
positions; publications resulting directly from the K24-supported mentoring; current 
positions; and mentoring activities for each of these individuals. Describe plans 
for mentoring during the next funding period.

WHERE TO SEND INQURIRIES

Refer to INQUIRIES AND NIH STAFF CONTACTS

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet 
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when 
applying for Federal grants or cooperative agreements. The DUNS number can be 
obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of 
the face page of the PHS 398 form. The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS: The instructions in the Form PHS 398 do not fully apply 
to the special needs of this grant application. Letters of Reference, information 
about the Career Development/Training Activities During Award Period, and Statements 
by Sponsor(s) are NOT REQUIRED.  Therefore, in addition to the required information 
listed in the instructions for Research Career Awards in the PHS 398, all 
applications MUST include the following information in the respective sections:

BIOGRAPHICAL SKETCH: A biographical sketch should be provided for the candidate only 
using the Biographical Sketch Format Page. Candidates must list both current and 
pending research support following the format of the BIOGRAPHICAL SKETCH Format Page 
in the PHS Form 398 format and clearly define their specific role on each of the 
listed research projects/ grants.  For competing renewal applications, identify 
those research projects resulting directly from the support provided by the prior 
K24 award. 

CANDIDATE
 
o The candidate’s immediate and long-term career objectives in POR and in mentoring 
beginning clinician investigators. 
 
o A summary of the research career of the candidate, documenting the ability of the 
candidate to conduct high quality POR and commitment to a career in POR. 

o Documentation of the ability to provide mentoring to beginning clinician 
investigators. Provide the number of years of mentoring experience, mentoring role 
(i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, 
the specialties of the individual mentees and the stages in their professional 
career. In addition, describe the types of research that were conducted by the 
individuals mentored, and the proportion of mentored individuals currently in 
academic medicine and/or directly participating in POR. 

o An explanation as to how the relief from patient care or administrative 
responsibilities through the protected time provided by this award will contribute 
to the development or expansion of the candidate’s POR program and increased level 
of commitment to mentoring beginning clinician investigators.  It is important to 
convey to the reviewers the reasons for needing protected time to continue a vital 
research program and continue to engage in the mentoring of new scientists. It 
should be clear that this award will permit the candidate to spend more time on 
research and mentoring and less time on administrative and clinical responsibilities 
for the institution. 
ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE
o A description of the facilities and other resources that will be provided to the 
candidate. 

o Letter of commitment from the institution.  This letter should provide statements 
concerning the amount of protected time the candidate will receive (25 to 50% 
required); the duties from which he/she will be relieved (if clinical duties the 
institution should describe specific steps that will be taken to cover these duties, 
such as hiring clinical staff); and the institutional commitment to enhancing the 
candidate's ability to be 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 POR. This information will 
be evaluated very carefully by the peer reviewers and carry substantial weight in 
the evaluation of an application. 

RESEARCH PLAN  

A Research Plan that establishes goals both for the individual’s research career and 
for mentoring. These goals should be appropriate to the experience level of the 
candidate, and to the research and training environment. The Research Plan should be 
presented in two separate parts.

o Currently supported research: There is no need to provide extensive detail with 
regard to ongoing, funded research. Enough information should, however, be provided 
in the areas of Hypotheses and Specific Aims; Background, Significance and 
Rationale; Preliminary Studies and Results; and Research Design and Methods to 
permit the peer reviewers to evaluate the extent, special features and general 
quality of the candidate's research activities and opportunities for mentoring. 

o New research to be specifically supported by this grant: Describe how this award 
will be used to help refine the candidate’s research skills and/or develop new 
directions in POR. This description should include a Statement of Hypothesis and 
Specific Aims; Background, Preliminary Studies and Aims; Significance and Rationale; 
and Research Design and Methods. Although it is not expected that this description 
should be as detailed as an application for an investigator-initiated research grant 
(e.g., R01), it is expected that sufficient detail be provided to permit an 
evaluation of the scientific merit of the research, and to clearly show research 
opportunities for mentoring. Documentation must be provided that appropriate and 
adequate resources, both in terms of support and facilities, are available to the 
candidate to conduct the research program(s).  This is an important part of the 
application because it will provide the main rationale and justification needing 
protected time for research. The candidate must ensure that the inclusion of women, 
members of minority groups and their subpopulations, and children, has been 
addressed in the development of the design for all proposed patient-oriented 
research.  The candidate must provide for each new research project proposed the 
information described in the General Instructions in Form PHS 398 on Human Subjects 
and Vertebrate Animals. Candidates must provide plans for ensuring continuing 
support of their POR programs preferably as the PI.

o Percent effort committed to the research plan. 

MENTORING PLAN 

o The Mentoring Plan is a required component of the application. 

o The plan should include a description of the availability of beginning clinician 
investigators for mentoring; their previous training and specialization; plans for 
recruitment, selection and supervision; the types of educational and research 
experiences that will be provided; and the capacity in which the candidate for the 
K24 award will serve as a mentor. If there is an existing clinical research 
curriculum, e.g. an NIH K30, describe how the mentoring plan will be integrated with 
the curriculum. Candidates must also describe a plan for supporting the research of 
their mentees during the period of the K24 award. This plan should include active 
support for POR at the time of application for a K24 Award, and may include the K24 
Research Development Support.  

o The proposed percent effort committed to the mentoring plan. 

APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm.  Application
deadlines are also indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, five signed photocopies in one package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not
accept any application in response to this PA that is essentially the same as
one currently pending initial review unless the applicant withdraws the
pending application.  The CSR will not accept any application that is
essentially the same as one already reviewed.  This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.

Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established PHS 
referral guidelines.  An appropriate scientific review group convened in accordance 
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) 
will evaluate applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council or 
board.

REVIEW CRITERIA

In the written comments, reviewers will be asked to evaluate the following
aspects of the application:

o Candidate
o Research Plan
o Mentoring Plan
o Progress Assessment (competing renewal applications only)
o Environment and Institutional Commitment to the Candidate

The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application.  The application does not need to be strong in all
categories to deserve a high priority score. The review criteria are listed in 
logical order, not in order of priority.

CANDIDATE

o Evidence of ongoing high quality patient-oriented research and the
relationship of that research to this program.  

o Evidence of the candidate's capabilities and commitment to serve as a mentor for 
patient-oriented research.

o Demonstration that the proposed program and protected time will relieve the
candidate from non-research patient care and administrative duties and allow
him/her to devote additional time to patient-oriented research.

o Record of financial support for patient-oriented research.

RESEARCH PLAN

Although it is understood that currently funded research described in K24 
applications do not require the level of detail necessary in regular research grant 
applications, a fundamentally sound research plan must be provided.  New research 
proposed in the K24 application that is not currently funded by a peer-reviewed 
grant should include a Statement of Hypothesis and Specific Aims; Background, 
Preliminary Studies and Aims. The application should outline the general goals for 
the later years and sufficient detail should be provided to permit evaluation of the 
scientific merit of the plan.

o Appropriateness of the research plan as a vehicle for demonstrating and developing 
skills and capabilities in patient-oriented research to prospective mentees.

o Scientific and technical merit of the proposed research.

o Relevance of the proposed research to the candidate's career objectives.

o Availability of adequate resources to conduct the research program.  This includes 
adequacy of plans for continued support of the research during the funding period of 
the grant.   

o Adequacy of the plan's attention to gender and minority issues associated
with projects involving human subjects.

o Adequacy of plans for including children as appropriate for the scientific
goals of the research, or justification for exclusion.

MENTORING PLAN

o Adequacy of the plans for mentoring or supervising beginning clinicians in
patient oriented research.

o Adequacy of plans to integrate appropriate clinical research curricula, such as 
those offered by available K30 programs at the institution, into the mentoring 
plans.

o Appropriateness of the proposed level of effort committed to the mentoring
component.

PROGRESS ASSESSMENT(Additional criteria for competing renewal applications)

o Extent to which the career, research and mentoring objectives of the previous 
award have been achieved.
 
o Justification of the need for an additional 3 to 5 years of support.

o Evidence of leadership in patient-oriented research such as through being 
principal investigator on independent peer-reviewed research grants and providing 
high quality mentorship.
 
ENVIRONMENT AND INSTITUTIONAL COMMITMENT

o Applicant institution's commitment to the scientific development of the
candidate and assurances that the institution intends the candidate to be an
integral part of its research program.  

o Adequacy of research facilities and the availability of appropriate
educational opportunities;

o Quality and relevance of the environment for continuing the scientific and 
professional development of the candidate and for others pursuing patient-oriented 
research;

o Applicant institution's commitment to provide adequate protected time for the 
candidate to conduct the research and mentoring program.

o Applicant institution’s commitment to the career development in patient-oriented 
research of individuals mentored by the candidate.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 Inclusion Criteria in the sections on
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested period
of support in relation to the career development plan and proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds
with all other recommended applications.  The following will be considered in
making funding decisions:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities involving live, 
vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory 
Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal 
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as 
applicable.

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding studies 
(phase I); efficacy studies (phase II), efficacy, effectiveness and comparative 
trials (phase III). The establishment of data and safety monitoring boards (DSMBs) 
is required for multi-site clinical trials involving interventions that entail 
potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community.  The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. 

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects.  You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  A
continuing education program in the protection of human participants in
research is available online at: http://cme.nci.nih.gov/

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project description and 
elsewhere in the application as appropriate, the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances.  Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA.  It is important for applicants to understand the basic scope
of this amendment.  NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time.  If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). 

Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites.   Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.398 at http://www.cfda.gov/, and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.  Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

INQUIRIES AND NIH STAFF CONTACTS

Applicants are encouraged to contact the individuals designated below, in advance of 
preparing an application, for additional information concerning the areas of 
research, receipt dates, and other types of pre-application instructions.

National Institute on Aging (NIA)
Dr. Robin Barr
Telephone: 301-496-9322
Email:  BarrR@mail.nih.gov

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Dr. Robert B. Huebner
Telephone:  301-443-4344
E-mail:  bhuebner@mail.nih.gov 

National Institute of Allergy and Infectious Diseases (NIAID)
Dr. Milton Hernandez
Telephone: 301-496-3775
Email: mh35c@nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Dr. Richard Lymn
Telephone: 301-594-5128
Email: rl28b@nih.gov

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Note: Please refer to the NIBIB website for specific guidance on NIBIB policies and 
procedures for K-awards (http://www.nibib.nih.gov/Training)
Zeynep Erim, Ph.D.
Program Director
Division of Interdisciplinary Training
National Institute of Biomedical Imaging and Bioengineering
Democracy II, Suite 200
6707 Democracy Boulevard
Bethesda, MD 20892-5477
Telephone: (301) 435-6686 
Fax: (301) 480-1614 
Email: erimz@mail.nih.gov

National Cancer Institute (NCI)
Note:  The NCI has special policies and requirements for their K24 
grants.  
Refer to the following URL for this information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-CA-00-020.html
Dr. Lester Gorelic 
Telephone: 301-496-8580
Email: lg2h@nih.gov 

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Susan Taymans, Ph.D. 
6100 Executive Boulevard, Room 8B01
Bethesda, MD   20892 
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone:  301-496-6517
Email:  taymanss@mail.nih.gov
 
National Institute on Deafness and Other Communication Disorders 
(NIDCD)
Dr. Daniel Sklare
Telephone: 301-496-1804
Email: ds104i@nih.gov

National Institute of Dental and Craniofacial Research (NIDCR)
Dr. Sharon M. Gordon
Telephone: 301-402-0799
Email: NIDCRtraining@mail.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK)
Division of Diabetes, Endocrinology, and Metabolic Diseases
Dr. James Hyde
Telephone: 301- 594-7692
Email: jh486z@nih.gov 

Division of Digestive Diseases and Nutrition
Dr. Judith Podskalny
Telephone: 301-594-8876
Email: jp53s@nih.gov

Division of Kidney, Urologic, and Hematologic Diseases
Dr. Terry Rogers Bishop
Telephone: 301-594-7717
Email: tb232j@nih.gov 

National Institute on Drug Abuse (NIDA)
Office of Science Policy and Communications
Dr. Lucinda L. Miner
Telephone:  (301) 443-6071
Email: CM171W@NIH.GOV

Division of Neuroscience and Behavioral Research
Dr. Charles Sharp
Telephone: 301-443-1887
Email: cs107m@nih.gov

Division of Epidemiology, Services and Prevention Research
Dr. Kathy Etz
Telephone: 301-443-1514887
Email: ke25p@nih.gov

Division of Treatment Research and Development
Dr. Jamie Biswas
Telephone: 301-443-5280
Email: jb168r@nih.gov

National Institute of Environmental Health Sciences (NIEHS)
Dr. Carol Shreffler
Telephone:  919 - 541- 1445    
Email:  shreffl1@niehs.nih.gov
 
National Eye Institute (NEI)
Dr. Chyren Hunter
Telephone: 301-496-2020
Email: CLH@nei.nih.gov 
http://www.nei.nih.gov/funding/t32.htm 

National Heart, Lung, and Blood Institute (NHLBI)
Dr. Ellen M. Werner
Telephone: 301-435-0061
Email: wernere@nhlbi.nih.gov
http://www.nhlbi.nih.gov/funding/training/redbook/estk24.htm

National Institute of Mental Health (NIMH)
Dr. Mark Chavez
Division of Mental Disorders, Behavioral Research, and AIDS
Telephone: 301-443-8942
Email: mchavez1@mail.nih.gov

Dr. Nancy Desmond
Division of Neuroscience and Basic Behavioral Science
Telephone: (301) 443-3563
Email: ndesmond@mail.nih.gov

Dr. Enid Light
Division of Services and Intervention Research
Telephone: (301) 443-1185
Email: elight@mail.nih.gov

National Institute of Neurological Disorders and Stroke (NINDS)
Margaret Jacobs
Telephone: 301-496-4188
Email: nindstrainingoffice@ninds.nih.gov

National Institute of Nursing Research (NINR) 
Dr. Nell Armstrong
Telephone:  (301) 594-5973
Email: armstrongn@nih.gov 

National Center for Complementary and Alternative Medicine (NCCAM)
Dr. Nancy J. Pearson
Telephone: 301-594-0519
Email: pearsonn@mail.nih.gov

National Center for Research Resources (NCRR)

Note: To be eligible for K24 support from the NCRR, an applicant must be affiliated 
with an institution that hosts a General Clinical Research Center (GCRC) and 
must include with their application a letter of commitment from the GCRC Program 
Director or the Principal Investigator to use GCRC resources.

Dr. David Wilde
Telephone: 301-435-0799 
Email: wilded@mail.nih.gov


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NIH Funding Opportunities and Notices


H H S Department of Health
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