RESEARCH CAREER DEVELOPMENT IN MYCOBACTERIUM TUBERCULOSIS

NIH GUIDE, Volume 21, Number 29, August 14, 1992



PA NUMBER:  PA-92-96



P.T. 34



Keywords:

  Infectious Diseases/Agents 

  Pulmonary Diseases 

  Biology, Molecular 

  Immunology 

  Vaccine 

  Diagnosis, Medical 



National Institute of Allergy and Infectious Diseases



PURPOSE



The Department of Health and Human Services (DHHS) National Action Plan

to Combat Multidrug-Resistant Tuberculosis (April 1992) has listed the

training of tuberculosis researchers as a high priority item necessary

to achieve tuberculosis control.  Individuals trained as

physician-investigators and basic scientists are essential to expansion

of high quality research programs in the area of tuberculosis.  There

is an urgent need to promote research training in basic and clinical

aspects of tuberculosis including improved diagnosis, molecular

biology, therapeutics, patient compliance, immunology, and vaccine

development.  Many laboratory techniques for the diagnosis of

tuberculosis and for the identification of drug resistance were

developed in the 1950s and 1960s.  Although more accurate, rapid, and

sophisticated methods are available, they have not been implemented for

tuberculosis.  The increasing incidence of both tuberculosis and drug-

resistant tuberculosis makes it imperative to apply current

technologies to the fullest capacity.



This Program Announcement (PA) emphasizes the commitment of the

National Institute of Allergy and Infectious Diseases (NIAID) to

support Clinical Investigator Awards (K08), Physician Scientist Awards

(K11), and Research Career Development Awards (K04) to increase the

number of biomedical investigators conducting high-quality research in

the area of Mycobacterium tuberculosis (Mtb).  The NIAID encourages

eligible individuals, including underrepresented minorities and women,

to submit applications.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This PA,

Research Career Development in Mycobacterium Tuberculosis, is related

to the priority areas of immunization and infectious diseases, and HIV

infection.  Potential applicants may obtain a copy of "Healthy People

2000" (Full Report:  Stock No. 017-001-00474-0) or "Healthy People

2000" (Summary Report:  Stock No. 017-001-00473-1) through the

Superintendent of Documents, Government Printing Office, Washington, DC

20402-9935 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



The PSA-K11 award is designed to encourage newly trained clinicians to

develop independent research skills and experience in a fundamental

science.  Applicants for the PSA must hold an M.D. or other health

professional degree.  Ordinarily, candidates holding both a medical

degree and a Ph.D. degree in the biomedical sciences are ineligible.



The CIA-K08 award seeks to provide clinically trained individuals with

demonstrated aptitude in research to develop into independent

investigators.  Applicants for the K08 award must hold an M.D. or other

health professional degree, have had three to five years of clinical

and research postdoctoral experience by the projected start of the

award and not have been a Principal Investigator on a Public Health

Service-supported research project grant (R01, R29, R15).



The RCDA-K04 award is designed to foster the development of young

scientists with outstanding research potential for careers of

independent research in health related sciences. The salary support

provided is intended to allow release time from most of the teaching,

clinical, and administrative duties to permit nearly full time

involvement in research efforts.  Applicants for the RCDA must hold a

doctoral degree or equivalent and have at least five years postdoctoral

research experience which can include two years as the Principal

Investigator of a peer reviewed research grant, prior to the requested

beginning date of the award.



MECHANISMS OF SUPPORT



Each of the career development mechanisms is tailored to a particular

stage of an investigator's career.  Existing mechanisms supported by

the NIAID include:  the Physician Scientist Award (PSA-K11), the

Clinical Investigator Award (CIA-K08), and the Research Career

Development Award (RCDA-K04).  Physician investigators are encouraged

to use the PSA and CIA to develop expertise in basic and clinical

research.  Only U.S. citizens or non-citizens lawfully admitted for

permanent residence at the time of application are eligible to apply.

The distinguishing features of each of the "K" mechanisms are

summarized above.  The booklet, The K Awards, is available from the

Office of Grants Inquiries, Division of Research Grants, National

Institutes of Health, Westwood Building, Room 449, Bethesda, MD  20892-

9912, (telephone: (301) 496-7441).



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements will be required to include

minorities and women in study populations so that research findings can

be of benefit to all persons at risk of the disease, disorder or

condition under study; special emphasis should be placed on the need

for inclusion of minorities and women in studies of diseases, disorders

and conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale should be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information should be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.  Applicants are urged to assess carefully the feasibility of

including the broadest possible representation of minority groups.

However, the NIH recognizes that it may not be feasible or appropriate

in all research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans (including American Indians or Alaskan Natives),

Asian/Pacific Islanders, Blacks, Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies. If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.  All applications for

clinical research submitted to NIH are required to address these

policies. NIH funding components will not award grants or cooperative

agreements that do not comply with these policies.



RESEARCH OBJECTIVES



Studies that are encouraged include, but are not limited to, the

following research areas:



o  Basic Biology:  Studies on the growth, physiology, biochemistry,

genetics, and molecular biology of Mtb.



o  Pathogenesis:  Clinical and basic research on the pathogenesis of

Mtb including physiology, biochemistry, and structural biology;

identification and characterization of virulence factors; genetic

exchange, and the development of physical and genetic maps; mechanisms

of drug resistance; role of cytokines in disease progression; and the

mechanism of latency and reactivation of infection, especially

characterization of the cellular and molecular components of the

immune-mediated mechanisms involved in the development of active and

latent disease and in protection.



o  Improved Diagnostic Procedures:  Development and evaluation of new

technologies to rapidly and reliably diagnose tuberculosis and identify

drug susceptibility patterns.  Research in further innovation and

application of diagnostic tests to distinguish between active and

latent tuberculosis in patients with compromised immune systems.



o  Drug Discovery and Development:  Development of new in vitro assays,

culture systems, and animal models to assess the safety and efficacy of

potential compounds to treat tuberculosis.  Research in the development

and evaluation of new drugs and modalities to treat and prevent

multi-drug resistant tuberculosis.  Research to reduce the duration of

therapy required to treat drug-susceptible infections. Research on

timed controlled-release drugs and the administration or means to

increase compliance with therapy.



o  Vaccine Development:  New and improved vaccines to prevent Mtb

infection.  Development of novel vaccine vectors.  Research on the

regulation of responses by immunomodulators and identification of the

antigens involved in protection.  Development of animal models to

correlate immune responses with protection.



APPLICATION PROCEDURES



Application receipt dates for all competing career development awards

(K series) are February 1, June 1, and October 1.  Institute assignment

decisions will be governed by the program considerations as specified

in the PHS Referral Guidelines.  Earliest possible funding dates are

approximately ten months after the receipt dates.  The special

instructions for the PSA and CIA are found in the publication entitled

"The K Awards," revised October 1991.  Application form PHS 398 (rev.

9/91) and "The K Awards" are available from the Office of Grants

Inquires, Division of Research Grants, National Institutes of Health,

Westwood Building, Room 449, Bethesda, MD  20892-9912.  Applications

submitted in response to this program announcement must be identified

by typing "PA-92-96, Research Career Development In Mycobacterium

Tuberculosis" on line 2a of the face page of the PHS 398 form that is

available from the applicant institution's office of sponsored research

and from the Office of Grants Inquiries, National Institutes of Health,

Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-

7441.



Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research Resources

may wish to identify the GCRC as a resource for conducting the proposed

activity.  In such a case, a letter of agreement from either the GCRC

program director or Principal Investigator must be included with the

application.



REVIEW CONSIDERATIONS



Applications in response to this announcement will receive initial peer

review on the basis of standard NIH review criteria and guidelines.

Applications for the Clinical Investigator Award (K08) and the

Physician Scientist Award (K11) will be reviewed for scientific merit

by scientific review groups (SRGs) convened by the concerned institute.

Applications for Research Career Development Awards (K04) will be

reviewed for scientific merit by initial review group(s) (IRGs)

convened by the Division of Research Grants, NIH.  Applicants are

referred to the NIH brochure, The K Awards (October 1991 edition),

which details the qualifications, eligibility, etc., for the K08, K11,

and K04 candidates, as well as the review criteria.  This brochure

should be available at the institution's business office, or a copy may

be requested from the Grants Inquiries Office, Division of research

Grants, National Institutes of Health, Bethesda, MD 20892, telephone

(301) 496-7441.  Award criteria will be the overall merit of the

application as determined by the IRG, relevance of the application to

the research objectives as outlined in this PA, and availability of

funds.



AWARD CRITERIA



The award of grants pursuant to this announcement is contingent upon

availability of appropriated funds.  The following criteria will be

used in making funding decisions: overall merit of the proposed project

as determined by peer review, availability of funds, relevance to the

research priorities of the awarding institute, and program balance

among research areas of the announcement.



INQUIRIES



For further information about NIAID career development awards, contact:



Dr. Milton J. Hernandez

Director, Office of Science Training and Manpower Development

National Institute of Allergy and Infectious Diseases

Solar Building 4C-10

6003 Executive Blvd.

Bethesda, MD  20892

Telephone:  (301) 496-7291



For inquiries regarding fiscal and business matters, contact:



Ms. Barbara A. Huffman

Special Assistant for Operations

Grants Management Branch

Director of Extramural Affairs

National Institute of Allergy and Infectious Diseases

Solar Building 4C-26

6003 Executive Blvd.

Bethesda, MD  20892

Telephone:  (301) 496-7075



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.855, Allergy, Immunology and Transplantation Research, and No.

93.856, Microbiology and Infectious Diseases Research.  Awards will be

made under the authority of the Public Health Service Act, Title III,

Section 301 (Public Law 78-410, as amended; 42 USC 241) and

administered under PHS grants policies and Federal Regulations 42 CFR

Part 74.  This program is not subject to the intergovernmental review

requirements of Executive Order 12372 or Health Systems Agency review.



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