kristoff@GENBANK.BIO.NET (Dave Kristofferson) (01/10/91)
NIH GUIDE - Vol. 20, No. 2, January 11, 1991
NOTICES
SCIENTIFIC MISCONDUCT: LIVING WITH THE NEW REGULATIONS: THE FIRST YEAR ... 1
National Institutes of Health (84/125)
Index: NATIONAL INSTITUTES OF HEALTH
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ...(128/249)........... 1
National Institutes of Health
Food and Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
CONFERENCE: SCIENTIFIC INTEGRITY: MAJOR ISSUES FACED BY RESEARCH
INSTITUTIONS ...........................................(252/282)........... 3
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH ......... 3
National Institutes of Health (285/313)
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
ARTIFICIAL LUNG RESEARCH AND DEVELOPMENT (RFP) .........(324/367)........... 4
National Heart, Lung, and Blood Institute
Index: HEART, LUNG, BLOOD
ROLE OF MONONUCLEAR PHAGOCYTES IN OPPORTUNISTIC INFECTIONS OF ORAL
MUCOSA AND OTHER TISSUES IN AIDS PATIENTS (RFP) ........(370/410)........... 4
National Institute of Dental Research
Index: DENTAL RESEARCH
EVALUATION OF TREATMENTS FOR CLEFT LIP AND/OR PALATE (RFA DE-91-04) ........ 5
National Institute of Dental Research (413/534, 1204/1561)
Index: DENTAL RESEARCH
RESEARCH CENTERS IN ORAL BIOLOGY (RFA DE-91-01) ..(537/663, 1564/1973)...... 6
National Institute of Dental Research
Index: DENTAL RESEARCH
ONGOING PROGRAM ANNOUNCEMENTS
INVESTIGATIONS INTO METHODS THAT REPLACE OR REDUCE VERTEBRATE ANIMALS
USED IN RESEARCH, OR LESSEN THEIR PAIN AND DISTRESS (PA-91-20) ............. 8
National Institutes of Health (669/925)
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
PREVENTION OF LOW BIRTH WEIGHT (PA-91-21) .........(928/1169)...............11
National Center for Nursing Research
National Institute of Child Health and Human Development
Index: NURSING RESEARCH, CHILD HEALTH, HUMAN DEVELOPMENT
NOTICES
SCIENTIFIC MISCONDUCT: LIVING WITH THE NEW REGULATIONS: THE FIRST YEAR
P.T. 42; K.W. 1014004, 1014006
National Institutes of Health
The Office of Scientific Integrity at the National Institutes of Health will
hold three regional symposia to share experiences related to implementing the
new regulations dealing with the Final Rule on "Responsibilities of Awardee
and Applicant Institutions for Dealing With and Reporting Possible Misconduct
in Science" (42 CFR Part 50, Subpart A). The symposia will feature open
discussion of problems and solutions associated with implementing and
operating under the new regulations. They will include sessions on assurance
and reporting requirements, conduct of inquiries and investigations from
development of the issues to resolution, jurisdictional issues, and due
process issues. The symposia are intended to be of special interest to
institutional officials responsible for instituting and overseeing the
university's response to allegations of scientific misconduct. The symposia
will be held in: Washington, DC on March 14-15; Seattle, WA on March 25-26;
and New Orleans, LA on April 15-16. Attendance will be limited to 200 with no
more than two representatives from each institution and will be on a first
come first served basis. There will be a $50 registration fee. To attend,
please provide your name, institution or company, and payment to:
Social & Scientific Integrity
7101 Wisconsin Avenue
Suite 610
Bethesda, MD 20814-4805
Telephone: (301) 986-4870
or
Dr. Clyde A. Watkins
Senior Scientist
Office of Scientific Integrity
National Institutes of Health
Building 31, Room B1C39
9000 Rockville Pike
Bethesda, MD 20892
Make check payable to Social & Scientific Systems. Additional information
will be sent upon request or upon receipt of reservation.
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS"
P.T. 42; K.W. 0783005
National Institutes of Health
Food and Drug Administration
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) are continuing to sponsor a series of workshops on responsibilities of
researchers, Institutional Review Boards (IRBs), and institutional officials
for the protection of human subjects in research. The workshops are open to
everyone with an interest in research involving human subjects. The meetings
should be of special interest to those persons currently serving or about to
begin serving as a member of an IRB. Issues discussed at these workshops are
relevant to all other Public Health Service agencies. The current schedule
includes the following:
I. SOUTHWEST WORKSHOP
DATES: February 4-5, 1991
WORKSHOP SITE:
Meridien Hotel
50 Third Street
San Francisco, CA 94103
SPONSOR:
University of California at San Francisco
Box 0400
San Francisco, CA 94143
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 1
REGISTRATION CONTACT:
Ms. Phyllis Colbert
Workshop Contact Person
University of California at San Francisco
Box 0400
San Francisco, CA 94143
Telephone: (415) 476-1881
TOPIC: "The Use of Human Subjects in Research: AIDS as a Model of
Complexity"
II. MIDEAST WORKSHOP
DATES: March 4-5, 1991
WORKSHOP SITE:
Friday Center
Laurel Hill Parkway
Chapel Hill, NC 27599-1020
SPONSORS:
University of North Carolina at Chapel Hill
300 Bynum Hall
Chapel Hill, NC 27599-4100
Shaw University
118 E. South Street
Raleigh, NC 27611
REGISTRATION CONTACT:
Mr. Al Dawson
Director
Friday Center
Laurel Hill Parkway
C. B. 1020
Chapel Hill, NC 27599-1020
Telephone: (919) 962-1106
TOPIC: "Interpreting the Federal Code for the Protection of Human Subjects"
III. MIDWEST WORKSHOP
DATES: April 11-12, 1991
WORKSHOP SITE:
Hyde Park Hilton
4900 Lake Shore Drive
Chicago, IL 60615
SPONSORS:
University of Chicago
970 East 58th Street
Chicago, IL 60637
Chicago State University
95th Street at King Drive
Chicago, IL 60628
REGISTRATION CONTACT:
Mr. Arnold L. Aronoff
Associate Director
Faculty and Administrative Services
University Research Administration
University of Chicago
970 East 58th Street
Chicago, IL 60637
Telephone: (312) 702-8669
TOPIC: "Cultural Diversity, Ethics, and Research: A Workshop on Human
Subject Protection"
NIH/FDA have planned national human subject protections workshops in other
parts of the United States. For further information regarding these workshops
contact:
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 2
Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Bldg. 31, Room 5B43B
Bethesda, MD 20892
Telephone: (301) 496-8101
CONFERENCE: SCIENTIFIC INTEGRITY: MAJOR ISSUES FACED BY RESEARCH
INSTITUTIONS
P.T. 42; K.W. 1014004, 1014006
National Institutes of Health
The National Institutes of Health, the Association of American Medical
Colleges, and Harvard Medical School are co-sponsoring a working conference
for scientists, administrators, and lawyers who have responsibility for
implementing policies and regulations designed to ensure scientific integrity.
The program is designed for maximum interaction between panelists and
attendees, and among attendees themselves. The goal is to generate new
perspectives for some of the most difficult problems faced by research
institutions in dealing with matters of scientific integrity. The moderators
and panelists will bring the perspectives of law, research, and administration
to the issues of due process for accused, accuser and institution; ownership
of research data; setting sanctions for misconduct; rehabilitation of
scientists found guilty of scientific misconduct; and prevention of scientific
misconduct. Samuel Thier, M.D., President, Institute of Medicine, will
address the conference on the balance between university and government
responsibilities for assurance of scientific integrity.
This conference meets the criteria for 11 credit hours in Category 1 of the
Physician's Recognition Award of the AMA.
DATES: February 2-3, 1991
SITE: Hyatt Regency Hotel, Cambridge, MA
PROGRAM AND REGISTRATION INFORMATION: Telephone: (617) 432-1525
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH
P.T. 42; K.W. 1014004, 1014006
National Institutes of Health
The National Institutes of Health (NIH), the Association of American Medical
Colleges, and Washington University School of Medicine are co-sponsoring an
interactive conference for biomedical investigators, research administrators,
and university attorneys with an interest in fostering the integrity of
scientists. The goals of the workshop are to discuss the scope of the problem
of scientific misconduct; to identify perceived or real factors contributing
to misconduct; to discuss the roles of Congress, NIH, and institutions in
managing allegations of scientific misconduct; to examine how well specific
institutions have dealt with allegations of fraud, plagiarism or other
unacceptable scientific practices; to discuss any special ethical
considerations associated with Industry/University ties; and to discuss the
responsibilities of authors and collaborators in maintaining scientific
integrity in research. Several break-out sessions will address focussed
topics of particular concern.
This conference is approved for credit in AMA Category 1.
DATES: April 25-26, 1991
SITE: The Adams Mark Hotel, St. Louis, MO
PROGRAM AND REGISTRATION INFORMATION: Telephone: (800) 325-9862, interstate
(314) 362-6893, in Missouri
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 3
NOTICES OF AVAILABILITY (RFPs AND RFAs)
ARTIFICIAL LUNG RESEARCH AND DEVELOPMENT
RFP AVAILABLE: NHLBI-HR-91-02
P.T. 34; K.W. 0740070, 0705065, 0706040
National Heart, Lung, and Blood Institute
The National Heart, Lung, and Blood Institute (NHLBI) has a requirement for
the performance of research leading to the development of a new artificial
lung or improvement upon an existing artificial lung for eventual implantation
in pediatric or adult patients with acute or chronic respiratory failure. The
device should be highly efficient, biocompatible, and able to remain in
continuous use for more than 24 hours. The research will be performed in
three phases: design and development, in vitro testing, and in vivo (animal)
testing. Specifically, the implantable artificial lung should: 1) Exceed the
efficiency of current devices to support blood gas exchange; 2) Avoid
hemolysis, thrombosis, clots or emboli, and minimize or eliminate the need for
systemic anticoagulation; 3) Be compatible with the body (e.g., non-toxic,
non-corrosive, non-carcinogenic), impervious to body fluids, and stable in the
biologic environment; 4) Not cause a clinically intolerable inflammatory
response; 5) Not significantly compromise immunocompetence; 6) Be capable of
reliable continuous operation for longer than 24 hours; and 7) Avoid heat
build-up or obstruction of blood flow. THIS RFP EXCLUDES THE DEVELOPMENT OF
EXTRACORPOREAL LIFE SUPPORT SYSTEMS WHICH ARE NOT DIRECTLY RELATED TO
IMPLANTABLE SYSTEMS. RESEARCH ON MECHANICAL PROPERTIES AND BASIC MECHANISMS
OF BLOOD-MATERIAL INTERACTIONS PER SE NOT DIRECTLY RELATED TO THE ARTIFICIAL
LUNG IS EXCLUDED FROM THE RFP. DEVELOPMENT OF ANCILLARY COMPONENTS, CONTROL
OF THE SYSTEM, AND STUDY OF FAILURE MECHANISMS ARE EXCLUDED FROM THIS RFP.
This announcement is not a request for proposal (RFP). It is anticipated that
RFP NHLBI-HR-91-02 will be available on or about January 7, 1991, with
proposals due on March 11, 1991. Copies of the RFP may be obtained by
submitting a written request along with three (3) self-addressed mailing
labels to:
National Heart, Lung, and Blood Institute
Contracts Operations Branch, DEA
Westwood Building, Room 654
5333 Westbard Avenue
Bethesda, MD 20892
ATTN: Pamela S. Randall
The NHLBI expects to make two awards from this solicitation.
ROLE OF MONONUCLEAR PHAGOCYTES IN OPPORTUNISTIC INFECTIONS OF ORAL MUCOSA AND
OTHER TISSUES IN AIDS PATIENTS
RFP AVAILABLE: NIH-NIDR-1-91-1R
P.T. 34; K.W. 0715008, 0715125, 1002004, 0755010
National Institute of Dental Research
The National Institute of Dental Research (NIDR) has a requirement to define
the role of mononuclear phagocytes in opportunistic infections of oral mucosa
and other tissues in AIDS patients. Preliminary evidence indicates that
monocytes infected with replicating HIV-1 in vitro are unable to phagocytize
and/or kill certain pathogens that frequently cause life-threatening disease
and/or morbidity in AIDS patients. The contractor shall pursue the
significance and the mechanism of this defect by: 1) examining the impact of
HIV-1 infection in patients on the ability of macrophages to contain
opportunistic pathogens in the target organs, 2) determining whether HIV-1
infection is directly responsible for the mononuclear phagocyte abnormalities
in vitro, and 3) isolating mononuclear phagocytes from infected patients to
directly assay their microbicidal activity and/or infection with HIV. These
approaches require both patient materials obtained at autopsy and/or biopsy
and in vitro analyses. The contractor must have access to approved biohazard
facilities for working with HIV.
RFP NO. NIH-NIDR-1-91-1R will be available on or about January 21, 1991, with
proposals due on or about March 4, 1991. The RFP package will be available
upon written request to:
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 4
Marilyn R. Zuckerman
Contracting Officer
Contract Management Section
National Institute of Dental Research
National Institutes of Health
Westwood Building, Room 521
5333 Westbard Avenue
Bethesda, MD 20892
The NIDR expects to make one award from this solicitation.
EVALUATION OF TREATMENTS FOR CLEFT LIP AND/OR PALATE
RFA AVAILABLE: DE-91-04
P.T. 34; K.W. 0755015, 0715148, 0785210, 0795005
National Institute of Dental Research
Letter of Intent Receipt Date: November 1, 1991
Application Receipt Date: December 4, 1991
PURPOSE
The National Institute of Dental Research (NIDR) seeks research grant
applications from United States and foreign institutions to conduct
prospective and/or retrospective clinical trials evaluating treatment
procedures for nonsyndromic, unilateral left lip and palate. This Request for
Applications (RFA) is for a single competition with a receipt date of December
4, 1991.
RESEARCH OBJECTIVES
The objective of this RFA is to solicit applications for support of
prospective and/or retrospective clinical trials to evaluate procedures widely
used in the treatment of nonsyndromic, unilateral cleft lip and/or palate. It
is not intended to support studies on bilateral and syndromic clefts or other
major congenital or acquired craniofacial defects.
Examples of the types of issues that might be addressed include: effects of
neonatal treatment with orthopedic devices on maxillary arch morphology;
effects of alveolar bone grafting on the primary dentition; effects of timing
of palatal repair on speech development; evaluation of palatal management
procedures on velopharyngeal function; effects of palatal repair on middle ear
pathology; and retrospective evaluations of long-term effects of treatments.
This list is not intended to be inclusive and applicants are free to propose
clinical trials concerning other issues in cleft treatment. It is essential
that the majority of the specific aims can be met during the initial period of
support (3-5 years).
It is likely that consortium arrangements will be required to assess
sufficiently large numbers of patients or patient records. Applications from
U.S. and foreign investigators and those including collaborative arrangements
between U.S. and foreign investigators are encouraged.
MECHANISM OF SUPPORT
Support for this program will be through research project grants (R01). It is
anticipated that up to four awards will be made, if a sufficient number of
high quality applications is received. Although funds have been allocated for
this program in NIDR's plans for Fiscal Years 1992 through 1996, award of
grants resulting from this RFA is contingent upon receipt of appropriated
funds for this purpose. Applicants may request up to five years of support.
Subsequent support will be contingent upon program needs and grantees'
performance, as determined by peer review. Policies that govern research
grant programs of the National Institutes of Health will prevail.
Applicants are encouraged to seek support from other public sources, as well
as private sector sources including foundations and industrial concerns, for
studies that will complement and expand the research supported by the NIDR. A
summary of the objectives and financial support for such studies must be
included in the application.
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 5
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided. Applications without such documentation will not be accepted for
review.
REVIEW PROCEDURES
Applications in response to this RFA will be reviewed by a Special Review
Committee convened by the NIDR's Scientific Review Branch. Secondary review
will be by the National Advisory Dental Research Council in May 1992.
Funding decisions will be based on the initial review group's and the National
Advisory Dental Research Council's recommendations concerning scientific
merit, program relevance and balance, total cost to the NIDR, and the
availability of appropriated funds. The earliest funding date is July 1,
1992.
APPLICATION PROCEDURES
It is recommended that prospective applicants contact program staff early in
the planning phase of application preparation and that they submit a letter of
intent no later than November 1, 1991. The letter should give a descriptive
title of the proposed research; the name, address, and telephone number of the
Principal Investigator; and names of other key personnel and collaborating
institutions. A letter of intent is not binding nor is it a prerequisite for
acceptance of an application but it will assist staff in planning for timely
review of applications.
Applications must be submitted on form PHS-398 (Rev. 10/88), available in the
business or grants office of most academic or research institutions or from
the Division of Research Grants, National Institutes of Health.
Requests for copies of the full RFA, enquiries and letters of intent should be
addressed to:
John D. Townsley, Ph.D.
Extramural Program
National Institute of Dental Research
Westwood Building, Room 506
Bethesda, MD 20892-4500
Telephone: (301) 496-7807
This program is described in the Catalog of Federal Domestic Assistance No.
93.122. Awards will be made under authorization of the 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 grants 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, April 6, 1988.
RESEARCH CENTERS IN ORAL BIOLOGY
RFA AVAILABLE: DE-91-01
P.T. 04; K.W. 0715148, 0710030, 0785035, 0710070, 1002027, 1002019, 0710095
National Institute of Dental Research
Letter of Intent Receipt Date: June 1, 1991
Application Receipt Date: September 16, 1991
PURPOSE
The National Institute of Dental Research (NIDR) invites applications from
United States institutions for support of Research Centers in Oral Biology
(RCOB). The primary goal of the RCOB program is to broaden and strengthen the
scientific base underlying the national capability to improve oral health.
The RCOBs bring teams of investigators into collaborative relationships to
conduct interdisciplinary and multidisciplinary research. Clinical research
will be supported only to the extent that it is a direct extension of the
basic research conducted by center investigators. The NIDR uses other
mechanisms, including categorical centers and clinical core centers, to
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 6
support clinical research focussing on the principal oral diseases and
conditions.
RESEARCH GOALS AND SCOPE
The RCOB program's primary goal is the expansion of the scientific base which
underlies the nation's capability to prevent and control oral diseases and
disorders and to improve oral health. The secondary goal is to create centers
of excellence that will attract investigators of high quality to dental
research, provide challenging opportunities for research training at all
levels of career development, and serve as magnet organizations to foster
productive research-related relationships with other institutions.
Support will be provided for interdisciplinary and multidisciplinary studies
in basic biomedical research areas relevant to the mission of the NIDR.
Examples of research areas that are particularly appropriate for study in a
RCOB include: immunology; microbiology and virology; genetics; developmental
biology; tissue structure and function; tissue repair and regeneration;
salivary glands and secretions; nutrition; and neurobiology. Clinical
research will be supported only to the extent that it is a direct extension of
the basic research conducted by center investigators. Support for substantial
clinical studies and clinical trials must be derived from other sources.
Support will not be provided for a research program that has as its single
focus a categorical or thematic area already targeted by NIDR for support.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided. Applications without such documentation will not be accepted for
review.
MECHANISM OF SUPPORT
RCOBs will be supported for five years with funding projected to start on
December 1, 1992. Renewal support will be contingent upon program needs and
an institution's ability to compete successfully in response to a Request for
Applications (RFA). Awards are contingent upon the availability of
appropriated funds. All policies and requirements that govern the research
grant programs of the PHS will apply to the awards. The NIDR anticipates
making four awards, not to exceed $750,000 each in direct costs for the first
year of the award if a sufficient number of applications of high scientific
merit are received. Applicants are encouraged to seek complementary support
from other federal government or nonfederal sources.
REVIEW PROCEDURES
Applications will be evaluated for scientific merit by a special review
committee convened by the NIDR Scientific Review Branch. Prior to the initial
review, a triage mechanism may be employed to screen out applications that are
noncompetitive or nonresponsive to the RFA. An applicant interview or site
visit may be included. Secondary review will be conducted by the National
Advisory Dental Research Council. Applications in response to this
announcement must be received by September 16, 1991, so they can be reviewed
and considered for funding in Fiscal Year 1993.
APPLICATION PROCEDURES
Prospective applicants should communicate with program and grants management
staff of the Institute's Extramural Program as early as possible in the
planning phase of application preparation. Advice and suggestions by staff
may materially assist applicants to ensure that the RCOB's objectives and
structure and the budget format are acceptable. At a minimum, prospective
applicants are urged to submit by June 1, 1991, a letter of intent that
identifies this RFA; includes a descriptive title for the RCOB, each component
and project; gives the name, address and telephone number of the Director, and
the names of other key personnel; and identifies participating institutions
and departments. It should be addressed to the Director, Extramural Program,
NIDR. The letter of intent is not binding nor is it a prerequisite for
acceptance of an application but it will assist staff in planning for the
timely review of applications.
Applications must be prepared on Form PHS 398 (Rev. 10/88), Application for
PHS Grant, which can be obtained from the Division of Research Grants, NIH, or
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 7
from the institution's Office of Research and Sponsored Programs. Detailed
instructions for preparing an application are included in the complete RFA.
INQUIRIES
Requests for copies of the complete RFA and for additional information should
be addressed to:
Director
Extramural Program
National Institute of Dental Research
National Institutes of Health
Westwood Building, Room 503
5333 Westbard Avenue
Bethesda, MD 20892-4500
Telephone: (301) 496-7723
This program is described in the Catalog of Federal Domestic Assistance No.
93.845. 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 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.
ONGOING PROGRAM ANNOUNCEMENTS
INVESTIGATIONS INTO METHODS THAT REPLACE OR REDUCE VERTEBRATE
ANIMALS USED IN RESEARCH, OR LESSEN THEIR PAIN AND DISTRESS
PA: PA-91-20
P.T. 34; K.W. 0755020, 0780010, 0780015, 0780020
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
BACKGROUND
The National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and
Mental Health Administration (ADAMHA) invite grant applications for
investigations into research methods that do not use vertebrate animals, use
fewer vertebrate animals, or produce less pain and distress in vertebrate
animals used for research.
Biomedical research will be most effectively advanced by the continuous use of
a combination of models in a complementary and interactive manner, rather than
by concentrating on any one or a few kinds of model systems. Each system,
whether mammalian or nonmammalian, has its own unique advantages and
limitations. Because of a continued, wide interest in the development of
nonmammalian models for biomedical research, this ongoing NIH/ADAMHA-wide
Program Announcement (PA) is being reissued to encourage the submission of
applications in this area.
Proposals for the study of invertebrates, lower vertebrates, microorganisms,
cell and tissue culture systems, or mathematical approaches should be regarded
as having the same potential relevance to biomedical research as proposals for
work on systems that are phylogenetically more closely related to humans.
Experience indicates that information yielded by such systems can increase
substantially the knowledge of human function.
Animals are essential to the advancement of knowledge in the biomedical
sciences. Non-animal research methods can, and do, provide additional
opportunities to advance our understanding of biological processes. For
example, biological models or model systems derived from, or consisting of,
nonmammalian organisms, or cell and tissue culture systems, may provide
valuable insights into mechanisms of biological functions that are more
difficult to obtain from studies of whole vertebrate animals. Mathematical
modeling is another useful investigational strategy when closely coupled to
biological experimentation, and there are opportunities for mathematical
modeling in many areas of biomedical research. Non-invasive experimental
techniques, permitting studies of biological processes in intact animals, can
reduce the number of experimental animals since multi-step phenomena can be
observed in a single subject. Such technologies often permit studies
otherwise impossible to perform.
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 8
Many strategies are currently in place to reduce the pain and distress of
laboratory animals; however, new methods and technologies are encouraged.
RESEARCH GOALS
Grant applications are requested for projects that will increase the extent
and depth of knowledge needed to develop methods of biomedical research that:
o do not require the use of vertebrate animals
o reduce the number of vertebrate animals used in research
o produce less pain and distress in vertebrate animals than methods
currently used
o validate or demonstrate the reliability of non-animal methods
o expand non-vertebrate animal research methods that have been found
valid and reliable
MECHANISM OF SUPPORT
The support mechanisms for this program include the individual
investigator-initiated research project grant (R01), the FIRST award (R29),
small grants program (R03), program project grants (P01), and small business
innovation research (SBIR) grants (R43, R44). Under these mechanisms, the
applicant will plan, direct, and carry out the research program. The project
period during which the research will be conducted should adequately reflect
the time required to accomplish the stated goals and be consistent with the
policy for grant support. Support will be provided for up to five years
(renewable for subsequent periods) subject to the availability of funds and
progress achieved.
Research grant applications may be submitted by both nonprofit and
profit-making organizations and institutions, State or local governments and
their agencies, and eligible agencies of the Federal Government.
APPLICATIONS AND REVIEW PROCEDURES
Applications in response to this solicitation will be peer reviewed for
scientific and technical merit. They will be judged on the overall scientific
merit of the proposed research, potential significance of the research
findings, adequacy of methodology, availability of necessary facilities, and
the qualifications of the research team. A secondary review for policy and
program relevance to the research needs and missions of the Institute or
Center to which the proposal is assigned will be made by the respective
National Advisory Council or Board.
Applications for other than SBIR support must use PHS Form 398 (rev. 10/88),
"Application for Public Health Service Grant". SBIR applicants must use the
form PHS-6246-1. Send the original and six copies of the application to the
Division of Research Grants, NIH as described in the PHS application kit.
Applicants should check the box marked "yes" in item 2 of the PHS 398 face
page, and enter the PA number and title on line 2.
Applicants are encouraged to contact Dr. Ramm at the address below prior to
submitting an application:
Dr. Louise E. Ramm
Director, Biological Models and Materials Research Program
National Center for Research Resources, NIH
Westwood Building, Room 8A07
Bethesda, MD 20892
Telephone: (301) 402-0630
Program staff in other participating NIH and ADAMHA Institutes and Centers may
also be contacted:
National Cancer Institute
Dr. J.A.R. Mead
Chief, Grants and Contracts Operations Branch
Developmental Therapeutics Program
Division of Cancer Treatment
Executive Plaza North, Room 832
Bethesda, MD 20892
Telephone: (301) 496-8783
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 9
National Center for Nursing Research
Dr. Jan Heinrich
Director, Extramural Programs
Building 31, Room 5B03
Bethesda, MD 20892
Telephone: (301) 496-0523
National Eye Institute
Dr. Ralph J. Helmsen
Research Training and Resources Officer
Building 31, Room 6A48
Bethesda, MD 20892
Telephone: (301) 496-5983
National Institute of Allergy and Infectious Diseases
Dr. Luz A. Froehlich
Deputy Director
Westwood Building, Room 703
Bethesda, MD 20892
Telephone: (301) 496-7688
National Institute on Aging
Dr. DeWitt Hazzard
Head, Resource Development
Biology of Aging Program
Building 31, Room 5C21
Bethesda, MD 20892
Telephone: (301) 496-6402
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Dr. Michael Lockshin
Director, Extramural Program
Building 31, Room 4C32
Bethesda, MD 20892
Telephone: (301) 496-0802
National Institute of Child Health and Human Development
Ms. Hildegard P. Topper
Special Assistant to the Deputy Director
Building 31, Room 2A-03
Bethesda, MD 20892
Telephone: (301) 496-0104
National Institute on Deafness and Other Communication Disorders
Dr. Ralph F. Naunton
Acting Director, Extramural Programs
Executive Plaza South
Room 750
6120 Executive Boulevard
Rockville, MD 20892
Telephone: (301) 496-1804
National Institute of Dental Research
Dr. G. Wayne Wray
Deputy Director, Extramural Program
Westwood Building, Room 503
Bethesda, MD 20892
Telephone: (301) 496-7723
National Institute of Diabetes and
Digestive and Kidney Diseases
Dr. Walter Stolz
Director, Division of Extramural Activities
Westwood Building, Room 657
Bethesda, MD 20892
Telephone: (301) 496-7277
National Institute of Environmental Health Services
Dr. Jerry Robinson
Scientific Programs Branch
Division of Extramural Research and Training
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-7724
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 10
National Institute of General Medical Sciences
Dr. Joyce Jones
Deputy Associate Director for Program Activities
Westwood Building, Room 955
Bethesda, MD 20892
Telephone: (301) 496-7063
National Heart, Lung, and Blood Institute
Dr. Henry G. Roscoe
Deputy Director, Division of Extramural Affairs
Westwood Building, Room 7A17
Bethesda, MD 20892
Telephone: (301) 496-7225
National Institute of Neurological Disorders and Stroke
Dr. Eugene Streicher
Director, Division of Fundamental Neurosciences
Federal Building, Room 916
Bethesda, MD 20892
Telephone: (301) 496-5745
National Institute on Alcohol Abuse and Alcoholism
Dr. Helen Chao
Deputy Director, Division of Basic Research
Parklawn Building, Room 16C-06
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-2530
National Institute on Drug Abuse
Dr. Roger Brown
Chief, Neuroscience Research Branch
Division of Preclinical Research
Parklawn Building, Room 10A-31
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-6975
National Institute of Mental Health
Dr. Ronald I. Schoenfeld
Acting Deputy Director
Division of Basic Brain and Behavioral Sciences
5600 Fishers Lane, Room 11-103
Rockville, MD 20857
Telephone: (301) 443-3563
PREVENTION OF LOW BIRTH WEIGHT
PA: PA-91-21
P.T. 34; K.W. 0785035, 0775015, 0404004, 0403020
National Center for Nursing Research
National Institute of Child Health and Human Development
PURPOSE
This program announcement is designed to stimulate clinical research in the
area of prevention of low birth weight (LBW) infants. Applications that
examine the psychosocial and/or biobehavioral mechanisms of premature labor or
intrauterine growth retardation and the effectiveness of interventions to
prevent LBW are of high priority. Interdisciplinary, collaborative projects
between nurses, physicians, physiologists, and behavioral scientists are
encouraged.
SCIENTIFIC BACKGROUND
Although the decline in U.S. infant mortality (the number of deaths in
children under one year of age per 1,000 live births) in a given year has
dropped dramatically from 21.8 in 1968 to 9.73 per 1,000 live births in 1989,
the decline has leveled off since the late 1970s. Low birth weight infants
(LBW=<2.5 kg) account for 6.9 percent of all U.S. live births or more than
250,000 LBW infants and 50,000 VLBW (<1.5 kg) infants per year. Of particular
concern is the increased LBW rate in the black population where the disparity
between black and white infant LBW rates and mortality is roughly double.
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 11
LBW represents a major source of U.S. infant morbidity and mortality. LBW is
the second leading cause of death of infants, after birth defects. LBW
infants are 40 times more likely to die during their first month of life and
two to three times more likely to suffer from chronic handicapping conditions
such as blindness, mental retardation, and deafness.
Risk factors associated with LBW include maternal age, poverty, race, low
education levels, multiparity, and inadequate prenatal care. Maternal
behaviors such as substance abuse, smoking, alcohol consumption, and excessive
exercise or standing increase the incidence of premature labor and/or
intrauterine growth retardation. Maternal smoking cessation is a very
effective means to improve birth weight. However, it is a behavioral change
that is hard to maintain.
Although less common than alcohol and smoking, substance abuse is a problem of
epidemic proportions among pregnant women: it has quadrupeled between 1985
and 1989. Estimates of the number of infants exposed to crack cocaine range
from 100,000 to 350,000. Concomitant increases in AIDS, syphilis, inadequate
nutrition, violence, and physical abuse have accompanied the dramatic
increases in substance abuse in pregnant women.
Our information base on other potential contributors to premature labor and/or
intrauterine growth retardation, such as environmental factors, strenuous
physical activity, high levels of anxiety, stress, depression, and genetic
factors, is limited.
Recent evidence suggests that prenatal care is beneficial to all women, and
particularly to those minority and low-income women who are at highest risk
for delivering LBW infants. Despite evidence of increased benefit from
prenatal care, the percentage of pregnant black women who had no prenatal care
increased disproportionately between 1980 and 1987 compared to white women.
Interventions by nurses and other health-care providers are key components of
prenatal care, as described in the recent report of the Public Health Service
Expert Panel on the Content of Prenatal Care, Caring for Our Future: The
Content of Prenatal Care. This report suggested that access to prenatal care
should be improved and that prenatal care should be expanded to include (1)
early and continuing risk assessment, (2) health promotion, and (3) medical
and psychosocial interventions and followup. The recommendations suggest a
number of promising strategies for future intervention trials designed to
recognize cultural and ethnic differences.
AREAS OF INTEREST
o Studies that increase the understanding of factors that help women
assume healthy life styles versus risk-taking behavior
o Development of intervention models for reducing risk-taking
behavior, including smoking cessation, reduced alcohol consumption,
and improved nutrition
o Studies that determine the effects of stress, anxiety, depression,
fatigue, and adverse home and work environments on birth weight
outcome
o Development of effective intervention models (including home
visits) for reducing the impact of significant adverse
psychological and environmental effects on low birth weight
outcomes
o Studies that assess both the efficacy of biological monitoring
techniques in preventing preterm delivery and the effects of
self-monitoring on pregnant women
o Studies that assess the efficacy of new modes of delivery of
prenatal care.
PROGRAMMATIC BACKGROUND
This initiative was developed to study factors that may be effective in
preventing preterm delivery, particularly those related to nursing practice.
An interdisciplinary expert panel convened by the National Center for Nursing
Research has defined gaps in existing knowledge related to the prevention of
preterm delivery and has identified research opportunities in two major areas:
the prevention of premature labor and intrauterine growth retardation. These
areas should be approached through innovative intervention studies related to
maternal behavior and life style, environmental risks, and the biobehavioral
interface.
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 12
Prospective, longitudinal, interdisciplinary studies are encouraged. This
initiative is part of a series of initiatives related to the prevention and
care of LBW infants.
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 Section 2, A-D of the Research Plan
AND summarized in Section 2, E, Human Subjects. Applicants/offerors 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 (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 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.
For foreign awards, the policy on inclusion of women applies fully; since the
definition of minority differs in other countries, the applicant must discuss
the relevance of research involving foreign population groups to the United
States' populations, including minorities.
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.
MECHANISMS OF SUPPORT
All policies and requirements that usually govern the research grant programs
of the Public Health Service apply. The particular research grant mechanisms
for this announcement are the traditional research grant award (R01) and the
First Independent Research Support and Transition (FIRST) award (R29).
APPLICATION PROCEDURES AND REVIEW CRITERIA
Applications should be submitted on the standard PHS Form 398 (rev. 10/88).
Application forms are available at most institutional business offices or from
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 13
the Division of Research Grants, NIH, telephone (301) 496-7441. In order to
expedite the application routing within NIH, please (1) check the box #2 on
the face page indicating that your application is in response to this
announcement and (2) print (next to the checked box) "Prevention of LBW,
PA-91-21." Mail the completed application and six copies to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Receipt dates for applications are February 1, June 1, and October 1.
Applications will be reviewed for scientific and technical merit by an
appropriate study section in the Division of Research Grants. Second level
review will be conducted by a National Advisory Council.
Applications compete on the basis of scientific merit with all other
applications. Researchers considering an application in response to this
announcement are encouraged to discuss their project and the range of the
grant mechanisms available with NCNR staff in advance of formal submission.
Correspondence and inquiries should be directed to:
Dr. Sharlene Weiss
Health Promotion/Disease Prevention Branch
National Center for Nursing Research
Building 31, Room 5B09
Bethesda, MD 20892
Telephone: (301) 496-0523
or
Dr. Linda Wright
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North
6130 Executive Boulevard
Rockville, MD 20892
Telephone: (301) 496-5575
This program is described in the Catalog of Federal Domestic Assistance No.
93.361, Nursing Research and No. 93-865, Research for Mothers and Children.
Awards are under authorization of the 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 to Health Systems Agency
review, April 6, 1988.
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816
NIH GUIDE - Vol. 20, No. 2, January 11, 1991 - Page 14
------------------------- Full text of RFAs -------------------------
EVALUATION OF TREATMENTS FOR CLEFT LIP AND/OR PALATE
National Institute of Dental Research
Letter of Intent Receipt Date: November 1, 1991
Application Receipt Date: December 4, 1991
RFA: DE-91-04
P.T. 34; K.W. 0755015, 0715148, 0785210, 0795005
PURPOSE
The National Institute of Dental Research (NIDR) seeks research
grant applications from United States and foreign institutions to
conduct prospective and/or retrospective clinical trials
evaluating treatment procedures for nonsyndromic, unilateral
cleft lip and palate. This Request for Applications (RFA) is for
a single competition with a receipt date of December 4, 1991.
The RFA may be reissued at a later date.
BACKGROUND INFORMATION
The incidence of cleft lip and palate in the United States is
difficult to determine. According to the latest estimate, based
on 1982-85 data, 5354 new cases occur each year, making it the
most common craniofacial birth defect. There is a racial
gradient in incidence; Orientals and American Indians have the
highest incidence, blacks the lowest, and whites intermediate.
More males than females are born with cleft lip or cleft lip and
palate, more unilateral clefts occur on the left side, and the
severity is greatest among males. Clefts are often associated
with other congenital anomalies.
The objective of treatment is to correct the facial disfigurement
and improve oral function to allow normal speech, mastication,
hearin,g and psychosocial interactions. Comprehensive treatment
calls for a multidisciplinary team approach, often involving
specialists in pediatrics, plastic and reconstructive surgery,
oral surgery, orthodontics, pediatric dentistry, speech
pathology, audiology, prosthodontics, otolaryngology, psychology,
and genetics.
The treatment sequence, timing, methods, and surgical techniques
are all controversial. The long-term impact on maxillofacial
growth and speech production are primary considerations but
numerous other factors enter into treatment decisions. Lip
repair is commonly performed at four to ten weeks of age but many
surgical teams wait until later while others prefer the perinatal
period. Either active or passive presurgical orthopedic
procedures to improve the form of the maxillary arch are used in
about 60 percent of centers. Alveolar bone grafting is utilized
in many centers but the timing of grafting and the source of
grafted bone differ. Repair of the soft and hard palate is
commonly, though by no means always, performed synchronously
between six and 18 months of age. Surgical closure of the hard
palate is sometimes delayed until the preschool years or even the
mid-teens. Secondary palatal surgery may be required to achieve
velopharyngeal competence and lip and nose revision is often
performed in late adolescence. Numerous orthopedic, orthodontic,
and surgical treatment techniques have been advocated. There is
suggestive evidence that the skill of the surgeon may be more
important than the specific technique in determining outcomes.
Minimal standards for reporting the results of surgery on
patients with cleft lip and palate have been proposed to address
the anatomic and functional integrity of the affected structures
and facial aesthetics, over time. Assessments may involve visual
examinations, still and video photography, instrumental
assessments of airway patency and mode of breathing,
cephalometric and panoramic radiography, impressions for dental
casts, evaluation of feeding and speech including dynamic
assessment of velopharyngeal function, auditory function, and
psychosocial adjustment. Developments in methodology and
instrumentation allow quantitation of some of these parameters
and can permit reporting of the efficacy of certain procedures
with reasonable confidence.
Most evaluations of cleft treatments consist of anecdotal reports
or case series. Numerous retrospective comparisons of two or
more treatments have been conducted but observer bias and the
equivalency of the pretreatment characteristics of the different
treatment groups are major concerns. When detailed and durable
records are available, retrospective matching might alleviate
some of these concerns. Changes in surgical technique and
personnel over time are additional causes for concern. Only
rarely have prospectively controlled clinical trials been
attempted to evaluate treatments for clefts. Long-term follow-up
is needed for many types of studies, during which time treatment
methods evolve and undergo modification.
Assessment of treatment outcomes with respect to growth and
several functions demands a well orchestrated team approach.
Widely accepted assessment and analytical methods have not been
available. There is great diversity in surgical methods and
treatment management within and between centers. The small
number of cases of any particular cleft sub-type treated at any
one center generally precludes hypothesis testing, unless sound
consortial arrangements can be made. Ethical concerns in
randomized designs and the desirability of maintaining operator
anonymity may be significant impediments to conducting trials.
Nevertheless, it appears likely that several clinically
significant aspects of cleft treatments could be evaluated
prospectively. The existence of several extensive, cleft
treatment data bases, in the U.S. and abroad, suggests that
retrospective analyses also may prove fruitful.
RESEARCH GOALS AND SCOPE
The objective of this RFA is to solicit applications for support
of clinical trials to evaluate procedures widely used in the
treatment of nonsyndromic, unilateral cleft lip and/or palate.
It is not intended to support studies on bilateral isolated
clefts and syndromic clefts or other major congenital or acquired
craniofacial defects.
The following list provides examples of the types of issues that
might be addressed. The list is not intended to be inclusive and
applicants are free to propose clinical trials concerning other
issues in cleft treatment.
1 The effect of various surgical techniques used for lip closure
on the alignment of palatal segments.
2 The effect of neonatal treatment with passive and/or active
orthopedic devices in correcting and maintaining acceptable
maxillary arch morphology.
3 The effect of early alveolar bone grafting on the position and
quality of the primary dentition.
4 Comparison of iliac crest, rib, mandible, and calvaria as
sources for alveolar bone grafts.
5 The effect of timing of palatal repair on early speech and
language development.
6 Comparison of the effects of different palatoplasty techniques
on velopharyngeal function.
7 The efficacy of secondary palatal management procedures for
velopharyngeal incompetence.
8 The effect of surgical repair of cleft palate on middle ear
pathology.
9 Retrospective comparisons of surgical and related procedures
for primary treatment of unilateral clefts.
10 Retrospective, multidisciplinary evaluations of long-term
outcomes of cleft treatments.
It is essential that the majority of the specific aims can be met
during the initial period of support (3-5 years). It is likely
that consortium arrangements will be required to assess
sufficiently large numbers of patients or patient records. This
also may reduce the effects of differences in patient management.
Applications from U.S. and foreign investigators and those
including collaborative arrangements between U.S. and foreign
investigators are encouraged; studies involving non-U.S.
populations may facilitate standardization of treatments and
record keeping and provide large, homogeneous study populations.
Experiences with responses to other RFAs for related clinical
trials indicate the desirability of proposing very focused
studies, often designed to answer a single or very few questions
presented in the form of a hypothesis(es). Significant input
from an experienced biostatistician during preparation of the
application and the conduct of the trial is mandatory.
Statistical power calculations, inclusion-exclusion criteria,
recruitment procedures, attrition rate determinations, methods
for randomization, treatment regimens, outcome measures, and data
processing procedures must be clearly defined. The use of
appropriate controls or normative data bases and ethical aspects
of design of the trial must be addressed. Consortial
arrangements designed to ensure successful conduct and completion
of the trial must be documented.
Consideration might be given to archiving raw data and the
physical records from which they are derived and making them
accessible to qualified investigators, while assuring the privacy
of patients and clinicians. The development of such a shared
data base could be an important outcome.
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 Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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 (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.
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
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.
MECHANISM OF SUPPORT
Support for this program will be through research project grants
(R01). It is anticipated that up to four awards will be made, if
a sufficient number of high quality applications is received.
Although funds have been allocated for this initiative in NIDR's
plans for Fiscal Years 1992 through 1996, award of grants
resulting from this RFA is contingent upon receipt of
appropriated funds for this purpose. Applicants may request up
to five years of support. Subsequent support will be contingent
upon program needs and grantees' performance, as determined by
peer review. Policies that govern research grant programs of the
National Institutes of Health will prevail.
Applicants are encouraged to seek support from other public
sources as well as private sector sources, including foundations
and industrial concerns, for studies that will complement and
expand the research supported by the NIDR. A summary of the
objectives and financial support for such studies must be
included in the application.
REVIEW PROCEDURES AND CRITERIA
Applications in response to this RFA will be reviewed by a
Special Review Committee convened by the NIDR's Scientific Review
Branch. Secondary review will be by the National Advisory Dental
Research Council in May 1992. Review criteria include the
significance and originality of the research goals and
approaches; feasibility of the research and the adequacy of the
study design; availability and appropriateness of the study
populations or clinical data, including efforts to include
females and minorities in study populations; training, experience,
and research competence of the investigator(s); adequacy of
facilities; provisions for protection of human subjects; and the
appropriateness of the requested budget for the work proposed.
Funding decisions will be based on the initial review group's and
the National Advisory Dental Research Council's recommendations
concerning scientific merit, program relevance and balance, total
cost to the NIDR, and the availability of appropriated funds.
The earliest funding date is July 1, 1992.
METHOD OF APPLYING
It is recommended that prospective applicants contact program
staff early in the planning phase of application preparation.
Such contact may help ensure that applications are responsive to
this RFA. It is suggested that prospective applicants submit a
letter of intent as soon as possible, but no later than November
1, 1991, giving a descriptive title of the proposed research; the
name, address, and telephone number of the Principal Investigator;
and names of other key personnel and collaborating institutions.
A letter of intent is not binding nor is it a prerequisite for
acceptance of an application but it will assist staff in planning
for timely review of applications.
Applications must be submitted on form PHS-398 (Rev. 10/88),
available in the business or grants office of most academic or
research institutions or from the Division of Research Grants,
National Institutes of Health. Applications received after
December 4, 1991 and those that are deemed nonresponsive to the
RFA will be assigned to a Division of Research Grants Study
Section for initial review and will be considered with other
nonsolicited grant applications.
To identify the application as a response to this RFA,
check "yes" on item 2 of page 1 of the application and enter
"RFA: DE-91-04, EVALUATION OF TREATMENTS FOR CLEFT LIP AND/OR
PALATE." 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.
The original and four copies must be received by December 4,
1991, at:
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892-4500**
At the time of submission two (2) additional copies of the
application must be sent to:
John D. Townsley, Ph.D.
Extramural Program
National Institute of Dental Research
Westwood Building, Room 506
Bethesda, MD 20892-4500
Telephone: (301) 496-7807
Inquiries concerning this RFA and letters of intent may be
addressed to Dr. Townsley.
This program is described in the Catalog of Federal Domestic
Assistance No. 93.122. Awards will be made under authorization
of the 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 grants 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, April 6, 1988.
RESEARCH CENTERS IN ORAL BIOLOGY
RFA AVAILABLE: DE-91-01
P.T. 04; K.W. 0715148, 0710030, 0785035, 0710070, 1002027, 1002019, 0710095
National Institute of Dental Research
Letter of Intent Receipt Date: June 1, 1991
Application Receipt Date: September 16, 1991
PURPOSE
The National Institute of Dental Research (NIDR) invites
applications from United States institutions for support of
Research Centers in Oral Biology (RCOB). The primary goal of the
RCOB program is to broaden and strengthen the scientific base
underlying the national capability to improve oral health. The
RCOBs bring teams of investigators into collaborative
relationships to conduct interdisciplinary and multidisciplinary
research. Clinical research will be supported only to the
extent that it is a direct extension of the basic research
conducted by center investigators. The NIDR uses other
mechanisms, including categorical centers and clinical core
centers, to support clinical research focussing on the principal
oral diseases and conditions.
BACKGROUND INFORMATION
During the late 1960's, the NIDR initiated a program of Dental
Research Institutes and Centers to strengthen the inadequate
scientific base of dental research. This program was highly
successful in achieving this objective.
In the mid-1970's, advisors recommended that NIDR utilize the
research center support mechanism to focus on specific oral
health problems. This recommendation was based on the need for a
coordinated attack on these problems, combining basic and
clinical research approaches. As a result, NIDR developed a
categorical research centers program and initiated centers on
periodontal diseases and caries research. Subsequently,
categorical and thematic centers were funded, which focussed on
orofacial pain, craniofacial anomalies, materials science, and
oral health and aging.
The National Advisory Dental Research Council recommended
instituting the RCOB program to provide support for
multidisciplinary research centers that bring together the
diverse resources of an institution to apply emerging
technologies to investigate important basic science problems
relevant to oral health and diseases. This program was initiated
in 1987 by a Request for Applications (RFA) that resulted in
four RCOBs being funded. The present RFA announces the first
recompetition of the RCOB program.
RESEARCH GOALS AND SCOPE
The RCOB program's primary goal is the expansion of the
scientific base which underlies the nation's capability to
prevent and control oral diseases and disorders and to improve
oral health. The secondary goal is to create centers of
excellence that will attract investigators of high quality to
dental research, provide challenging opportunities for research
training at all levels of career development, and serve as magnet
organizations to foster productive research-related relationships
with other institutions.
Support will be provided for interdisciplinary and
multidisciplinary studies in basic biomedical research areas
relevant to the mission of the NIDR. Examples of research areas
that are particularly appropriate for study in a RCOB include:
immunology; microbiology and virology; genetics; developmental
biology; tissue structure and function; tissue repair and
regeneration; salivary glands and secretions; nutrition; and
neurobiology. Clinical research will be supported only to the
extent that it is a direct extension of the basic research
conducted by center investigators. Support for substantial
clinical studies and clinical trials must be derived from other
sources.
Support will not be provided for a research program that has as
its single focus a categorical or thematic area already targeted
by NIDR for support.
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 Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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 (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.
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
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.
MECHANISM OF SUPPORT
RCOBs will be supported for five years with funding projected to
start on December 1, 1992. Renewal support will be contingent
upon program needs and an institution's ability to compete
successfully in response to an RFA. Awards are contingent upon
the availability of appropriated funds. All policies and
requirements that govern the research grant programs of the PHS
will apply to the awards.
The NIDR anticipates
making four awards, not to exceed $750,000 each in direct costs
for the first year of the award
if a sufficient number of applications
of high scientific merit are received.
Applicants are encouraged to
seek complementary support from other federal government or
nonfederal sources.
DIRECTION AND LEADERSHIP
Strong and effective scientific leadership must be provided.
RCOB directors will be responsible for the organization and
operation of the program and for communication with NIDR on
scientific and administrative matters. Directors will be
responsible for maintaining high quality research and for
ensuring effective collaboration among individual investigators.
It is essential that the research components and projects be
interrelated; they should not constitute a collection of
individual projects more appropriately supported by individual
research project grants.
REVIEW PROCEDURES AND CRITERIA
Applications will be evaluated by a special review committee
convened by the NIDR Scientific Review Branch. Prior to the
initial review, a triage mechanism may be employed to screen out
applications that are noncompetitive or nonresponsive to the RFA.
An applicant interview or site visit may be included. Secondary
review will be conducted by the National Advisory Dental Research
Council. Applications in response to this announcement must be
received by September 16, 1991, so they can be reviewed and
considered for funding in Fiscal Year 1993. Noncompetitive or
nonresponsive applications and those received after September 16,
1991 or that exceed the budget limitation will be returned to
the applicant. Waivers of the receipt deadline and budget
limitation will not be granted.
Major factors to be considered in the evaluation of applications
include:
1 The scientific merit of each proposed project, including its
significance, originality, feasibility, and experimental design.
2 The combination of the various components, projects, core
units, and pilot projects into an effective and cohesive program,
and the adequacy of plans to ensure efficient collaboration,
interaction, and dissemination of information among
investigators.
3 The competence of the investigators and their commitment to
the accomplishment of the proposed research goals.
4 The availability of statistical and data analysis resources
and evidence of their use in developing research protocols.
5 The qualifications, experience, and commitment of the director,
including the ability to provide effective leadership of the
project. Provisions for selection of a replacement director if
it should be necessary.
6 The scientific and administrative structure of the program,
including provisions for quality control during development of
the application; procedures for monitoring the research; and
mechanisms for reviewing potential pilot projects. The
composition and use of internal and external advisory committees.
7 The institution's commitment to the program; the adequacy of
its facilities, resources, and administrative capabilities.
8 The appropriateness of the period of support and budget
requested for each component, project, core, and for the entire
center. The extent to which complementary projects, supported
from non-NIDR funds, will contribute to the cost effectiveness of
the proposed RCOB.
9 If clinical studies are proposed, the availability and
appropriateness of study populations and the utilization of
minorities and women as study subjects.
10 Ethical aspects, including the provisions for the protection
of human subjects and for the humane treatment of animals.
ADDITIONAL INFORMATION AND GUIDELINES
1 Applicants may request up to $750,000 in direct costs for the
first year with no more than four percent increases in each
subsequent year. Where indirect costs are assigned to a
subcontract and counted as direct costs, the allowable direct
cost maximum of $750,000 may be exceeded by the amount of the
indirect cost assigned to the subcontract. Applications that
exceed these limits will be returned to the applicant.
Applicants are encouraged to seek support from other sources,
including foundations and industrial concerns, for studies that
will complement and expand the program supported by the NIDR. A
summary of the objectives and financial support for such studies
and an explanation of how they will further the goals of the RCOB
and make it more cost effective should be included in the
application.
2 A typical RCOB consists of 5-7 projects distributed among 2-3
major components and served by 2-3 core units. Each core unit
must be utilized by at least two projects. Limited support
($35,000 per year) will be provided for pilot or feasibility
projects.
3 RCOB directors will meet once a year with each other and with
NIDR staff and consultants to exchange information and ideas,
assess progress, resolve actual or potential problems, and explore
opportunities for collaboration. The funds for these meetings
must be included in the budget.
4 An interim review may be conducted by NIDR to evaluate
progress. The funding for subsequent years may be contingent on
a successful outcome of this review.
5 The inclusion of projects that are deemed to have only
adequate or no scientific merit or that are considered
peripheral to the RCOB's objectives may be considered a
reflection of the Director's judgement and may affect the rating
of the application. Component projects devoid of merit will be
disapproved. Projects with only adequate merit that are not
deemed essential to the success of the RCOB may be recommended
for deletion. Each component and project recommended for
approval will receive its own priority score.
6 Applicants should be aware that, in addition to scientific
merit, program priorities and program balance, the total cost of
an RCOB to the NIDR will be considered by NIDR staff and the
Council in making funding recommendations. An additional
consideration will be the extent to which complementary projects,
supported from non-NIDR funds, will contribute to the cost
effectiveness of the proposed RCOB.
TIMETABLE
Letter of Intent.........................June 1, 1991
Receipt of Applications............September 16, 1991
Advisory Council Review.....................May 1992
Projected Award Date...................December 1992
METHOD OF APPLICATION
Prospective applicants should communicate with program and grants
management staff of the Institute's Extramural Program as early
as possible in the planning phase of application preparation.
Advice and suggestions by staff may materially assist applicants
to ensure that the RCOB's objectives and structure and the budget
format are acceptable. At a minimum, prospective applicants are
urged to submit, by June 1, 1991, a letter of intent that
identifies this RFA; includes a descriptive title for the RCOB,
each component and project; gives the name, address, and telephone
number of the Director and the names of other key personnel; and
identifies participating institutions and departments. It should
be addressed to the Director, Extramural Program, NIDR. The
letter of intent is not binding nor is it a prerequisite for
acceptance of an application but it will assist staff in planning
for the timely review of applications.
Applications must be prepared on Form PHS 398 (Rev. 10/88),
Application for PHS Grant, which can be obtained from the
Division of Research Grants, NIH, or from the institution's
Office of Research and Sponsored Programs. To identify the
application as a response to this RFA, check "yes" on Item 2 of
page 1 of the application and enter the title "Research Centers
in Oral Biology" and the RFA number DE-91-01. Use the RFA label
provided in the PHS-398 application package.
The instructions accompanying Form PHS-398 must be followed as
far as possible but some modification will be necessary. For
example, a new Table of Contents must be prepared giving page
numbers for all items in the application. Pagination must be
consecutive throughout the application. Each component, project
and core must be identified by number and investigator. A
consolidated budget for the complete RCOB for the entire project
period must be presented (use page 5, PHS-398). Separate
detailed, annual and total budgets for the entire project period
for each project and core must be presented (use pages 4-5, form
PHS-398). Present a table giving the budget totals for each
project and core and for the entire program, for all years of
support. Direct and indirect costs are to be given. Funds may
be requested for professional, technical, and administrative
personnel; consultant services; equipment; supplies; travel;
patient costs directly related to the research; minor renovations
and other costs. Detailed justification of the budget requests
will be required. Not more than $35,000 each year may be
requested for a group of pilot or feasibility projects.
Provide a summary of financial support from non-NIDR sources for
studies that will complement and expand the program supported by
the NIDR. Explain how these studies will further the goals of
the RCOB and make it more cost effective.
Under Section 2, Research Plans, describe the goals of the RCOB
and discuss the background and significance of the topics being
addressed. Explain how each component, project, core, and the
pilot projects will contribute to achieving those goals.
Describe the administrative structure, the responsibilities of
the Director, individual investigators, and the proposed
mechanisms for monitoring scientific progress. Describe the
relationship of all existing and pending institutional research
projects that may be relevant to the RCOB regardless of funding
source.
Each project must be presented as in a research project grant
application, that is, the instruction pages 19-23 of Form PHS-398
should be followed. The 20-page limitation will apply to each
project. Describe the core units and explain how they will
relate to the projects that will utilize their resources. Each
pilot project to be conducted during the first 2 years of the
award must be presented as a concept in 200 words or less.
Concepts for pilot projects to be conducted in subsequent years
must be submitted later in noncompeting continuation applications
(Form PHS 2590), prior to their initiation. Abstracts (page 2,
Form 398) must be completed for the entire application, each
component, project, and core.
The original and four copies of the complete application must
be received by September 16, 1991, at:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892-4500**
Two copies of the application, letters of intent, and all
inquiries should be directed to:
Director
Extramural Program
National Institute of Dental Research
National Institutes of Health
5333 Westbard Avenue, Room 503
Bethesda, MD 20892-4500
Telephone: (301) 496-7723
This program is described in the Catalog of Federal Domestic
Assistance No. 93.845.
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 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.