FELLOWSHIP AND CAREER AWARDS IN SICKLE CELL DISEASE RESEARCH

NIH GUIDE, Volume 23, Number 9, March 4, 1994



PAR NUMBER:  PAR-94-042



P.T. 22



Keywords:

  Blood Diseases 



National Heart, Lung, and Blood Institute



PURPOSE



The objective of this program announcement is to encourage the

submission of applications for Fellowship and Clinical Investigator

Development Awards in Sickle Cell Disease research in order to

support the training and professional development of individuals who

can serve the expanding research, teaching, and clinical requirements

in the area of sickle cell disease.  This program announcement

emphasizes the need for increased research training and career

development in this area and encourages individuals at varying levels

of experience to submit applications for support by using three

existing research training and career development mechanisms that are

sponsored by the NHLBI.



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,

Fellowship and Clinical Investigator Development Awards in Sickle

Cell Disease Research, is related to the priority areas of clinical

prevention services, chronic disabling conditions, and maternal and

infant health.  Potential applicants may obtain a copy of "Health

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 20402-9325 (telephone 202-782-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign, for-profit and

non-profit organizations, public and private, such as universities

colleges, hospitals, laboratories, units of State and local

governments and eligible agencies of the Federal government.  Only

domestic institutions are eligible for K awards.  At the time of

application for a fellowship or K award, individuals must be either

citizens or noncitizen nationals of the United States or have been

lawfully admitted to the United States for permanent residence.  An

individual lawfully admitted for permanent residence must submit with

the application a notarized statement indicating possession of the

alien Registration Receipt Card (1-151 or 1-551).  Individuals on

temporary or student visas are not eligible.MECHANISM OF SUPPORT



The mechanisms of support available for this program announcement are

the NRSA Individual Fellowship (F32), NRSA Senior Fellowship (F33)

and the Clinical Investigator Development Award (CIDA) (K08).



The three support mechanisms for Fellowship and Clinical Investigator

Development Awards in Sickle Cell Disease provide a wide range of

training and career development opportunities to obtain research

experience in sickle cell disease.  A brief description of these

mechanisms is listed below.



NSRA Individual Fellowship Award (F32)



Provides support for individuals at the postdoctoral level who wish

to gain experience in biomedical and behavioral research related to

sickle cell disease.  Upon completion of this training, individuals

are encouraged to consider other mechanisms to support further

research experience.



NRSA for Senior Fellows (F33)



Provides support to experienced scientists who have at least seven

years of relevant postdoctoral research or professional experience

and wish to make major changes in the direction of their scientific

careers, or enhance and enlarge their capabilities to conduct

biomedical and behavioral research on problems related to sickle cell

disease.



Clinical Investigator Development Award (K08)



Provides support to physicians with varying levels of research

experience to prepare them for research careers as independent

investigators.  Candidates' development programs are based on

scholastic background, previous research experience, past

achievements, and identified skills needed to become an independent

scientist.  The objective is to develop clinical investigators whose

basic and clinical research interests are grounded in the advanced

methods and experimental approaches needed to solve problems in

sickle cell disease.



Detailed guidelines for each of the support mechanisms can be

obtained from most institutional offices of sponsored research; the

Office of Grants Information, Division of Research Grants, National

Institutes of Health, telephone (301) 435-0714; and Dr. Fann Harding,

Division of Blood Diseases and Resources, telephone (301) 496-1817.



RESEARCH OBJECTIVES



Background



Sickle cell anemia is a major health problem characterized by

recurrent episodes of pain called "crises," a chronic anemia related

to accelerated destruction of red blood cells, increased

susceptibility to certain infections, and acute and chronic damage to

various organs.  This blood disorder results from the presence of

genes for sickle hemoglobin inherited from both parents.  In the

United States, sickle cell anemia is predominantly, but not

exclusively, found in persons of African ancestry.  The prevalence of

sickle cell anemia within this group is about 1 in 500 at birth,

affecting more than 50,000 individuals in this country.  This

disorder is also found in Greeks, Southern Italians, Eti-Turks,

Arabs, Egyptians, Southern Iranians and Asiatic Indians at incidence

rates often equal to or greater than that found in African-Americans.

In addition, sickle cell hemoglobin also occurs in combination with

other abnormal hemoglobins and thalassemia, bringing the total number

of individuals affected with various forms of sickle cell disease to

over 70,000 in the United States.  Thus, sickle cell anemia and

related hemoglobinopathies are among the most common genetic blood

disorders seen in this country.



During the past two decades, there has been a quantum leap in basic

and clinical research leading to significant advances at the

molecular and cellular levels.  This progress embraces a number of

important research areas, including the molecular structure of the

sickle hemoglobin fiber, kinetics of polymerization, adherence of

sickle cells to vascular endothelium, alterations in blood flow,

regulation, and control of globin gene expression, development of

animal models, abnormalities of the red cell membrane, and

identification of genetic modifiers.  At the clinical level, there

appears to be a new era of therapeutic optimism, especially with

agents that increase fetal hemoglobin, which are now undergoing

clinical trials.  Patients are living longer and more productive

lives.  Mortality from infection, the major cause of early death in

infants and young children, has been significantly reduced with early

identification of newborns with sickle cell disease and adding

prophylactic penicillin to the management regimen.  In spite of this

progress to date, an effective therapy remains elusive.



These major advances in basic and clinical understanding of sickle

cell disease provide an unprecedented opportunity for further

improvements in patient management.  In addition, the enormous health

and economic impact of sickle cell disease, estimated to be more than

$705 million per year, argues strongly for increased attention to

this disorder.  A particular emphasis is placed on training due to

the paucity of qualified investigators to carry out basic and

clinical research as well as patient care in sickle cell disease.

This need was reaffirmed by the NHLBI Sickle Cell Task Force convened

to investigate the significant decline noted in

investigator-initiated research in sickle cell disease.  Although the

Task Force was unable to ascribe the decline to any single factor, it

made several recommendations to remedy this problem.  These

recommendations included the initiation of strategies to augment the

availability of training and career development programs devoted to

sickle cell disease.  This Program Announcement is a direct response

to that recommendation.  The "Sickle Cell Task Force Report on

Investigator-Initiated Research" was published in May, 1993.



Areas of Interest



The integration of a broad range of disciplines is required to

further elucidate the basic pathophysiology of the disease and

achieve the goals of treatment, prevention, and management.  Thus,

sickle cell disease is an especially exciting research area,

encompassing a wide spectrum of scientific interactions with

important behavioral and humanistic components.  Potential research

areas include cell biology, biochemistry, genetics, molecular

biology, physiology, and psychology.  Individual programs that offer

research training and career development opportunities in all areas

related to sickle cell disease are encouraged.  The past training of

candidates applying for these programs may have been in the basic

sciences or in the clinical disciplines.  If candidates do not

possess skills in research design and biostatistics, the applicant

should consider including these areas in his/her training or career

development plan.



Candidates submitting applications in response to this program

announcement should focus on topics exemplified by those listed

below.  These topics are examples only and should not be viewed as

inclusive.  Applicants are encouraged to consider other related

topics and innovative approaches.



o  Basic research projects that lead to a better understanding of the

pathophysiology and clinical manifestations of sickle cell disease.



o  Basic and applied research projects that lead to the development

of effective therapeutic approaches for the treatment of sickle cell

disease.



o  Clinical research projects that will improve the identification of

patients at risk for severe disease and the development of methods

and therapies to prevent sequelae.



o  Studies that deal with the psychosocial and behavioral aspects of

sickle cell disease.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH 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 must be included in the form PHS 398

(rev. 9/91) 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, 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, Blacks, and 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, (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 deferred until the information is provided.



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.



APPLICATION PROCEDURES



Applications for NRSA Individual Fellowships (F32) and Senior

Fellowships (F33) are to be submitted on the grant application form

PHS 416-1 (rev. 10/91) and will be accepted at the standard

application deadlines as indicated in the application kit.

Applications for Clinical Investigator Development Awards (K08) are

to be submitted on PHS 398 (rev. 9/91) and will be accepted at the

standard application deadlines as indicated in the application kit.

Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grants

Information, Division of Research Grants, National Institutes of

Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone

(301) 435-0714.  The title and number of the program announcement

must be typed in Section 2a on the face page of the application.



The completed original application, for a Clinical Investigator

Development Award, and three legible copies must be sent or delivered

to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established Public

Health Service referral guidelines.  Applications for NRSA

Fellowships will be reviewed for scientific and technical merit by

study sections of the Division of Research Grants, NIH.  Applications

for Clinical Investigator Development Awards, assigned to the NHLBI,

will be reviewed by the appropriate initial review group managed by

the Division of Extramural Affairs, NHLBI.  All reviews will be

conducted in accordance with the standard NIH peer review procedures.

Following scientific-technical review, the applications will receive

a second-level review by the appropriate national advisory council.



The review criteria are set forth in the guidelines for each support

mechanism.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to the ICD.  The following will be considered

in making funding decisions:



o  Quality of the proposed project as determined by peer review.

o  Availability of funds

o  Program balance among research areas of the announcement.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Inquiries regarding programmatic issues may be directed to:



Fann Harding, Ph.D.

Division of Blood Diseases and Resources

National Heart, Lung, and Blood Institute

Federal Building, Room 5A08

Bethesda, MD  20892

Telephone:  (301) 496-1817



For fiscal and administrative matters, contact:



Ms. Jane R. Davis

Blood Division Grants Management Section

National Heart, Lung, and Blood Institute

Westwood Building, Room 4A15

Bethesda, MD  20892

Telephone:  (301) 594-7436



AUTHORITY AND REGULATIONS



The programs of the Division of Blood Diseases and Resources of the

National Heart, Lung, and Blood Institute are identified in the

Catalog of Federal Domestic Assistance, number 93.839.  Awards will

be made under the authority of the Public Health Service Act, Section

301 (42 USC 241) and administered under PHS grant policies and

Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part

74.  This program is not subject to the intergovernmental review

requirements of Executive Order 12372, or to Health Systems Agency

review.



.

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