Subject: NIH GUIDE - Vol. 20, No. 10, March 8, 1991 - RFA CA9112
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 08 Mar 91 10:25 EST

Hi Paul,
   #l4  Please post to the listserver as: RFACA-91-12.910308
    Thanks.  dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA CA9112 CA-91-12 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
RFA:  CA-91-12
 
P.T. 34; K.W. 0715035, 0411005, 0715120, 0785055, 0785140, 0785210,
0745062
 
CLINICAL INVESTIGATOR AWARD FOR RESEARCH ON SPECIAL POPULATIONS
 
National Cancer Institute
 
Letter of Intent Receipt Date:  April 5, 1991
Application Receipt Date:  May 17, 1991
 
I.  PURPOSE AND BACKGROUND
 
The Comprehensive Minority Biomedical Research Program, Division of
Extramural Activities, National Cancer Institute (NCI) announces the
availability of Clinical Investigator Awards for Research on Special
Populations.  This program is intended to:
 
  o Encourage newly trained clinicians to develop research interests and
skills in the basic and applied sciences relevant to cancers and risks
for cancers that have a high prevalence or incidence in special
populations that may be underserved by limited access to current
knowledge and medical care.
 
  o Increase the pool of cancer physician-investigators in medical
oncology, epidemiology, nutrition, behavioral medicine, surgical
oncology, preventive oncology and diagnostic and therapeutic radiology
who are committed to investigation of the unique problems facing special
populations.
 
  o Provide the opportunity for clinically trained physicians with a
commitment to research to develop into independent biomedical research
investigators.
 
The term "special populations" refers to those population segments that
may experience or are known to experience high cancer rates and are
underserved in terms of:  cancer prevention and control programs (e.g.,
smoking or health screening programs); diagnostic and treatment
modalities; study for special risk factors or underlying biological
differences; and who may have limited access to regular medical care.
This definition is taken to include:  African Americans, Alaska Natives,
American Indians, Asian Americans, Pacific Islanders, Hispanics, the
elderly, and low-income groups.
 
HEALTHY PEOPLE FOR THE YEAR 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/RFA,
"Clinical Investigator Award for Research on Special Populations (K08)",
is related to the priority area of cancer research.  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, D.C. 20402-9325 (Telephone 202-783-3238).
 
II.  GOALS AND SCOPE
 
The award will enable candidates to undertake from three to five years
of special study and supervised research experience tailored to
individual needs with a sponsor (or sponsors) competent to provide
research guidance.  This award is intended to cover the transition
between postdoctoral experience and a career in independent
investigation, and to acquaint the candidate with the often unique
challenges and circumstances involved in designing research protocols
directed toward improving the health of groups comprising a significant
and often disproportional percentage of individuals at risk from high
cancer morbidity and mortality rates.
 
This award differs from the NIH Research Career Development Award (RCDA)
in that it seeks to develop research ability in individuals with a
clinical background early in the candidate's career rather than to
promote the further development of research skills of individuals
already demonstrating significant research achievement.  A major purpose
of this award is to increase the number of cancer-oriented research
physicians in the United States with research interests and experience
focused specifically on the unique needs of special populations and the
broad array of issues at the biological, behavioral, social, economic
and medical levels that render such populations at increased risk for
cancer and for mortality from cancer.
 
III.  MECHANISM OF SUPPORT
 
Support of this program will be through the National Institutes of
Health grant-in-aid (K08).  Applicants will be responsible for the
planning, direction, and execution of the proposed project.  Except as
otherwise stated in this Request for Applications (RFA), awards will be
administered under PHS grants policy as stated in the Public Health
Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000,
revised October 1, 1990.  Applicants may request three to five years of
support.  Awards are non-renewable and non-transferable from one awardee
to another.  Funding beyond the first year of the grant is contingent on
satisfactory progress during the preceding year.  Future program
interest in this initiative will be announced through the NIH program
announcement mechanism.
 
It is anticipated that the experience and results achieved by the
awardee from this special grants program, in the majority of cases, will
provide the basis for successful competition in the regular research
support programs of the NCI.
 
Up to $300,000 has been set-aside in FY 1991 to fund meritorious
applications received in response to this competition.  Depending on the
merit and distribution of applications received, approximately 1 to 3
Clinical Investigators will be funded with a start date of September 30,
1991.  Meritorious applications received for this competition that
cannot be funded at that time may be held over for possible funding in
Fiscal Year 1991.
 
IV.  PROVISIONS FOR THE AWARD
 
The Clinical Investigator Award for Research on Special Populations will
be funded for a minimum of three and a maximum of five years.  All funds
must be used to support the original awardee.  Support is based on a
full-time, twelve-month appointment.  The awardee will be provided
salary support of up to $50,000 each year, plus fringe benefits.  The
actual salary must be consistent with the established salary structure
of the institution for persons of equivalent qualifications, experience,
and rank.
 
Up to a total of $10,000 annually will be provided in years 01 and 02
and up to $20,000 annually in succeeding years for supplies, equipment,
travel, and other expenses that are necessary for pursuit of the
awardee's research program.  An appropriate sponsor must assume
responsibility and provide guidance for the development of the
candidate's research program, and for maintaining the focus of the award
and the awardee's time commitments on special populations.
 
Institutions may apply for awards on behalf of named individuals meeting
the criteria for this award.  Evidence of the commitment of the
institution and sponsors to the candidate's research and career
development is to be included in the applications.  Access to sufficient
numbers of patients and subjects meeting the above cited definition of
"special populations" must be documented.
 
The grant will be made annually to the awardee's parent institution for
each of the annual budget periods.  Costs allowed include:
 
  o Awardee's Salary - A maximum of $50,000 per year for full-time
support; in addition, fringe benefits will be provided.  Institutional
supplementation is permitted.
 
  o Research Support - A maximum of $10,000 annually for years 01 and 02
and $20,000 annually for succeeding years for the categories listed
below:
 
Equipment:  specialized research equipment essential to the proposed
program (the available facilities should include most of the necessary
equipment); Supplies:  consumable supplies essential to the proposed
program;
 
Travel:  domestic travel essential to the proposed program;
 
Tuition for Training Courses:  if essential to the awardee's individual
research development program; and
 
Other:  publication costs, patient costs, and other expenses necessary
for the research program.
 
  o Indirect Costs - The indirect cost rate may not exceed 8 percent of
the total allowable direct costs.  The grantee institution's share of
the fringe benefits may be paid as a direct cost (if not treated as an
indirect cost) on that portion of the salary provided by the Clinical
Investigator Award.
 
V. ELIGIBILITY
 
  o The award is designed to provide intensive, supervised research
experience on the above designated topics for physicians.  Although the
award is primarily for those holding the M.D. degree, applications will
be accepted from M.D.'s and D.O.'s already holding the Ph.D. or an
equivalent research degree if special circumstances can be shown, such
as a Ph.D. in unrelated field or an intervening period of clinical
training since the completion of the Ph.D. These applications will be
considered on a case by case basis.
 
If the candidate has less than three or more than seven years of
postdoctoral experience at the time of application, a strong
justification for an exception must be included in the application and
must be clearly indicated as such.
 
Candidates should have completed their clinical training, should have
documented competence in clinical activities, and should show research
experience in the chosen area of interest.  Candidates must provide
evidence of a serious intent for research and academic careers, and for
an interest in medical issues associated with special populations.
 
  o Applicants for this Clinical Investigator Award may not submit a
concurrent application for an NIH Research Career Development Award,
Academic Award, or First Independent Research Support and Transition
Award or a research project grant.  However, an Awardee of this program
may apply subsequently for a research project grant.
 
  o The grantee institution must be a domestic nonprofit research
institution, school, or comparable institution with strong,
well-established research and training programs, adequate numbers of
highly trained faculty in clinical and basic science departments, and
commitment to providing guidance to new medical scientists in the
development of independent research careers.
 
  o Candidates must be nominated by an institution on the basis of
qualifications, interests, accomplishments, motivation, and potential
for a research career.
 
  o Candidates must have one or more sponsors or advisors who are
recognized as accomplished investigators in the research proposed at the
applicant's institution.
 
  o NIH and ADAMHA policy is that applicants for clinical research
grants, cooperative agreements, and contracts 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, because
of the emphasis of this award, such populations must be included if
human subjects are to be employed in the proposed research.  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.
 
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 (American
Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,
Hispanics).  The rationale for studies on single minority population
groups should be provided.
 
Applicants must include a description of the composition of the proposed
study population in terms of gender and racial/ethnic group and a
rationale for its choice.  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 Section 2, A-D of
the Research Plan AND summarized on Section 2, E, Human Subjects.
 
Applications must employ a study design with gender and/or minority
representation (by age distribution, risk factors, incidence/prevalence,
or other) appropriate to the scientific objectives of the disease,
disorder, or condition, or condition being studied.
 
It is not an automatic requirement for the study design to provide
statistical power to answer the questions posed for men and women and
racial/ethnic groups separately; however, whenever there are scientific
reasons to anticipate differences between men and women with regard to
the hypothesis under investigation, applicants should include an
evaluation of gender and minority group differences in the proposed
study.
 
  o Awardees and their sponsors will be required to submit a
non-competing continuation report at the end of each year of support.
This report is to contain specific information concerning progress,
accomplishments and plans for the next year.
 
  o Candidates must agree to inform the NCI annually for ten years
subsequent to completion of the award about academic status,
publications, and research grants or contracts received.
 
  o Candidates for an award must be citizens or non-citizen nationals of
the United States or its possessions and territories or must have been
lawfully admitted to the United States for permanent residence at the
time of application.
 
Applications not meeting the above criteria will be returned without
review.
 
  VI.  REVIEW PROCEDURES AND CRITERIA
 
  A. PROCEDURES
 
  Upon receipt, applications will be reviewed initially by the Division
  of Research Grants (DRG) for completeness.  Incomplete applications
  will be returned to the applicant without further consideration.
  Evaluation for responsiveness to the program requirements and
  criteria stated in the RFA is an NCI program staff function.
  Applications which are judged non-responsive will be returned
  to the applicant.  Questions concerning the relevance of proposed
  research to the RFA should be directed to program staff as described
in the
  INQUIRIES section.
 
  In cases where the number of applications is large compared to the
  number of awards to be made, the NCI may conduct a preliminary
  scientific peer review to eliminate those applications that are
  clearly not competitive.  The NCI will remove from competition
  those applications judged to be non-competitive for award and
  notify the applicant and institutional business official.
 
  Those applications judged to be both competitive and responsive will
  be further evaluated according to the review criteria stated below
  for scientific and technical merit by an appropriate peer review
  group convened by the Division of Extramural Activities, NCI.  The
  second level of review by the National Cancer Advisory Board
  considers the special needs of the Institute and the priorities of
  the National Cancer Program.
 
  B. REVIEW CRITERIA
 
  o  The candidate's potential for a career in independent research.
 
  o  The candidate's commitment to a research career.
 
  o  The overall merit of the candidate's plan for research and the
     development of research skills.
 
  o  The quality of the candidate's clinical training and experience.
 
  o  The institution's ability to provide quality facilities, resources,
     and opportunities necessary to the candidate's research
     development.
 
  o  Presence of highly trained faculty in clinical and basic science
     departments relative to the area of study.
 
  o  The ability and plans of the sponsor (or sponsors) who will provide
     the candidate with the guidance necessary for career development in
     research.
 
  o  The candidate's conformance to the eligibility requirements.
 
  The review group will recommend an appropriate budget for each
  approved application.
 
  VII.  METHOD OF APPLYING
 
  The research grant application form PHS 398 (revised 10/88)
  must be used in applying for these grants.  These forms are available
  at most institutional business offices; from the Office of
  Grants Inquiries, Division of Research Grants, National Institute
  of Health, Room 449, Westwood Building, 5333 Westbard Avenue,
  Bethesda, MD  20892; and from the NCI Program Director below.
 
  The RFA label available in the 10/88 revision of application form 398
  must be affixed to the bottom of the face page.  Failure to use
  this label could result in delayed processing of your application
  such that it may not reach the review committee in time for review.
  In addition, the RFA number and title must be typed on line 2 of
  the face page of the application form.
 
  In Section 2 of the application under the heading "Research Plan" note
  the following:
 
  Candidates must provide a description of the proposed research and
  career development plan for the period of the award.  The candidate
  must be prepared to commit full-time effort to the objectives of
  this award.  It is required that a minimum of 75 percent effort be
  devoted to the research program.  The remaining 25 percent may be
  divided among other activities such as teaching and clinical
  training pursuits only if they are consonant with the program
  goals, i.e., the awardee's development into an independent
  biomedical research investigator.  The reasons for a commitment to
  research in the problems facing special populations with respect to
  cancer must be indicated.
 
  The sponsor must provide:
 
  o  His/her concept of a development and research plan for the awardee.
 
  o  His/her curriculum vitae (updated) with complete bibliography and
     research support.
 
  o  A letter indicating his/her evaluation of the proposed awardee and
     his/her willingness to provide guidance and support.
 
Evidence of the commitment of the institution to the candidate's
research and development must be provided.
 
Adequate access to populations comprised of one or more of the groups
targeted by this award must be demonstrated.
 
Submit a signed, typewritten original of the application, including
Checklist, and four (4) signed, exact photocopies, in one package to DRG
at the address below.  The photocopies must be clear and single sided.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At time of submission, send two (2) additional copies of the
application to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 848
5333 Westbard Avenue
Bethesda, MD  20892
 
If the applicant has an approved assurance covering the research
(multiple project assurance for human subjects/full assurance of
compliance for animal subjects), the applicant should provide with
the application, certification of institutional review board (IRB)
approval if humans are involved and verification of the
institutional animal care and use committee (IACUC) approval if
animals are involved.  These reviews and approvals should occur
PRIOR TO SUBMISSION of the applications for award and the
certifications and verifications should be SUBMITTED WITH the
applications.  Failure to provide required certifications and
verifications within applications could result in deferral or
rejection.  If animals or humans will be subjects of the research
at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION, the
applicants must identify, within the application, the assurance
status of each participant.  Failure to provide this information
within applications could result in deferral or rejection.
 
Applications must be received by May 17, 1991.  If an application is
received after that date, it will be returned.  If the application
submitted in response to this RFA is substantially similar to a
research grant application already submitted to the NIH for review,
but has not yet been reviewed, the applicant will be asked to
withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be
allowed, nor will essentially identical applications be reviewed by
different review committees.  Therefore, an application cannot be
submitted in response to this RFA which is essentially identical to
one that has already been reviewed.
This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
 
VIII.  LETTER OF INTENT
 
Prospective applicants are asked to submit, by April 5, 1991, a letter
of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the
names of other key personnel, the participating institutions, and
the number and title of the RFA in response to which the
application is being submitted.  The letter of intent is of great
benefit to the NCI in planning and implementing the review
process although the letter is not required, is not binding, and does
not enter into the review of subsequent applications.
 
The letter of intent should be sent to the NCI Program Director:
 
Dr. Lemuel Evans
Division of Extramural Activities
Comprehensive Minority Biomedical Program
National Cancer Institute
NIH, Building 31, Room 10A04
Bethesda, MD  20892
Telephone:  (301) 496-7344
FAX:  (301) 402-0062
 
IX.  INQUIRIES
 
Written or telephone inquiries concerning the objectives and scope of
this RFA or inquiries about whether or not specific proposed
research would be responsive are encouraged and should be directed
to Dr. Lemuel Evans at the above address.  The Program Director
welcomes the opportunity to clarify any issues or questions from
potential applicants.
 
For information regarding budgetary/administrative issues related to
this RFA, please contact:
 
Mr. Leo Buscher, Jr.
Chief, Grants Administration Branch
National Cancer Institute
National Institutes of Health
Executive Plaza South, Room 216
Bethesda, MD  20892
Telephone:  (301) 496-7753
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93-398, Cancer Research Manpower.  Awards are under
the authority of Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grant policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not
Subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.