kristoff@GENBANK.BIO.NET (Dave Kristofferson) (11/06/90)
NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution. The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
----------------------------------------------------------------------
NIH GUIDE - Vol. 19, No. 39, November 2, 1990
NOTICES
PUBLIC HEALTH SERVICE - OPEN MEETING ON CONFLICTS OF INTEREST IN
CLINICAL EVALUATION OF COMMERCIAL PRODUCTS ................(84/313).......... 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
NATIONAL INSTITUTES OF HEALTH AND FOOD AND DRUG ADMINISTRATION NATIONAL
WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ...............(321/470)......... 4
National Institutes of Health
Food and Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
NOTICES OF AVAILABILITY (RFPs AND RFAs)
PRODUCTION AND DELIVERY OF SCHISTOSOMA MANSONI (RFP) ......(484/523)......... 6
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
PROTECTIVE EFFECTS OF PATTERNED ELECTRICAL STIMULATION ON THE
DEAFENED AUDITORY SYSTEM (RFP) ............................(526/587)......... 6
National Institute on Deafness and Other Communication Disorders
Index: DEAFNESS, COMMUNICATION DISORDERS
CLINICAL COORDINATING CENTER FOR A CHILDHOOD ASTHMA MANAGEMENT
PROGRAM (RFP) .............................................(590/652)......... 7
National Heart, Lung, and Blood Institute
Index: HEART, LUNG, BLOOD
MINORITY FELLOWSHIPS FOR DOCTORAL AND/OR POSTDOCTORAL TRAINING IN
NEUROSCIENCES (RFA MH-91-01) ..............................(655/693)......... 8
National Institute of Mental Health
Index: MENTAL HEALTH
MOLECULARLY TARGETED APPROACHES TO ANTIVIRAL THERAPY DEVELOPMENT
(RFA AI-91-01) ...................................(696/778, 1204/1655)....... 8
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
CARDIOVASCULAR DEVICE-CENTERED INFECTIONS (RFA HL-90-09-H) ..(781/843)....... 9
National Heart, Lung, and Blood Institute (1658/2096)
Index: HEART, LUNG, BLOOD
CLINICAL TRIAL PLANNING GRANT FOR DIGESTIVE AND NUTRITIONAL
DISEASES (RFA DK-91-02) ...........................(846/1008, 2099/2381).....10
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
ONGOING PROGRAM ANNOUNCEMENTS
MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM (PA-90-35) .........12
National Center for Research Resources (1014/1187)
Index: RESEARCH RESOURCES
NOTICES
PUBLIC HEALTH SERVICE - OPEN MEETING ON CONFLICTS OF INTEREST IN CLINICAL
EVALUATION OF COMMERCIAL PRODUCTS
P.T. 42; K.W. 1014004
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
SUMMARY: The Public Health Service (PHS) recognizes the need to issue
regulations addressing conflict-of-interest issues that arise when
investigators conducting PHS-supported clinical evaluations of commercial
products have financial interests in those products. before proceeding with
rulemaking, the PHS invites members of the public to attend a meeting to
discuss principles and questions relevant to such regulations.
DATE: November 30, 1990, 8:30 a.m. to 4:30 p.m.
ADDRESS: Masur Auditorium, Clinical Center, (Building 10)
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
FOR FURTHER INFORMATION CONTACT:
George Galasso, Ph.D.
Associate Director for Extramural Affairs
NIH, Building 1, Room 152
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-5356
SUPPLEMENTAL INFORMATION:
The PHS supports clinical trials that involve the evaluation of commercial
products such as drugs, vaccines, and devices. The efficient transfer of
these research results into commerce is essential to improve health care and
economic competitiveness. In generating new knowledge about a commercial
product, the PHS-supported research may affect the product's value either
favorably or adversely. To the extent that participating investigators have
financial interests related to commercial products they are evaluating in
clinical trials, the risk of apparent or actual conflicts of interest must be
addressed by the PHS and the research community it supports. Financial
holdings of investigators must not influence the design, conduct, or reporting
of such clinical trials.
The PHS has already issued regulations dealing with misconduct in science to
protect PHS-supported biomedical and behavioral research against
falsification, fabrication, plagiarism or other practices that seriously
deviate from commonly accepted practices within the scientific community. PHS
is considering issuance of additional rules to promote the integrity of
PHS-supported clinical trials where investigators may have financial interests
that could affect or give the appearance of affecting their objectivity.
Before doing so, the PHS and its component agencies, the National Institutes
of Health (NIH) and the Alcohol, Drug Abuse, and Mental Health Administration
(ADAMHA) will conduct a public meeting to discuss one approach to addressing
the issues involved, as well as other alternatives.
The proposed approach is outlined in this notice. In developing the outline,
NIH/ADAMHA have taken into consideration the comments received on the earlier
proposed Guidelines published in the NIH Guide for Grants and Contracts, Vol.
l8, No. 32, September l5, l989. The meeting will provide a forum for public
comments on the proposed approach and the various issues which it attampts to
address, as well as an opportunity for alternative suggestions.
The meeting will be held on November 30, 1990 in Masur Auditorium on the
campus of the NIH. Registration is requested as seatingis limited to
approximately 500 attendees. To assure that your comments will be considered
in the event that you may not be able to present them orally, written comments
may be submitted at the registration desk. Interested parties may register by
contacting:
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 1
Ms. Bonnie Kaps
National Institutes of Health
Building 31, Room 5B32
Bethesda, MD 20892
Telephone: (301) 402-0854
FAX: (301) 496-0166
DISCUSSION TOPICS - CLINICAL PRODUCT EVALUATION
General Principles
o Efficient transfer of research results into commerce is and will
continue to be essential if the United States is to maintain and
enhance health care and economic competitiveness.
o Pertinent Federal statutes provide generally that tax-financed
research institutions will give high priority to ensuring
commercialization of their scientists' results wherever
appropriate.
o The research community will not maintain public confidence without
rules that harmonize the national interest, institutional
interests, and individual interests.
o There is an apparent need for rules on conflict of interest that
will protect the integrity of PHS-sponsored clinical trials and
ensure that financial interests of investigators will not
compromise the conduct or reporting of such research.
o At the same time, the PHS must strive to ensure that procedures for
protection against conflict of interest do not stifle the
advancement of research and technology transfer, which are key
aspects of the PHS mission.
o The proposed approach is to address potential conflicts of interest
in clinical trials of commercial products because of the near term
significance for patient care.
Proposed Approach
o Require institutions to establish procedures that ensure that
clinical trials supported by PHS are not compromised by
inappropriate financial interests on the part of investigators.
o Covered individuals would include investigators responsible for
designing, conducting or reporting research and their spouses,
dependents and business partners.
o Institutions must solicit and review disclosures of financial
interests of investigators who will receive PHS funding for
clinical trials of commercial products and where necessary, take
action to eliminate or prevent inappropriate financial interests,
particularly financial interests in firms that manufacture, sell,
or otherwise have property rights in the product under study.
o A financial interest in the product under study may be approved by
the institution if it is judged unlikely to compromise the design,
conduct, or reporting of the study. The institution should impose
requirements to minimize even perceived conflict, for example, by
requiring disclosure of interests in resulting publications.
o Investigators/institutions must disclose to the PHS all sources of
support for the PHS-supported clinical trial (before the award of
PHS funds and after the award when changes occur).
Issues
o The overarching issue is how best to protect the integrity of
research while promoting technology transfer.
o Should the basic regulatory approach a) require disclosure and
allow flexibility for institutions to take appropriate action, b)
state specific prohibitions, or c) require disclosure and decisions
on appropriateness by the funding agency?
o To what extent should conflict of interest rules applicable to
Federal employees, including those applicable to NIH/ADAMHA study
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 2
section members, serve as a model in developing the proposed
requirements? (See 45 C.F.R. Part 73.)
o Are there regulatory frameworks not specific to PHS (e.g., Federal
Securities Laws) that are applicable to the topic? o Who are the
most appropriate parties to determine a conflict of interest?
o Should all forms of financial interests be reviewed, for example,
equity, salary, other payment for services, honoraria, and gifts?
o Are there minimal levels of financial interests which would not
create an actual or apparent conflict of interest?
o Should PHS require submission and approval of institutional
policies in order to ensure consistency and provide technical
assistance where necessary?
o Should PHS require disclosure to the funding agency of approved
financial interests, if any?
o Should there be a requirement for public disclosure of financial
interests, for example, in publications?
o Should there be disclosure of the investigators' financial
interests as part of the document seeking the research subjects'
informed consent to participation in clinical trials? (In this
regard, see the decision in Moore v. Regents of University of
California, 271 Cal. Rpt. l46, 793 P2d 475, l9 USPQ2d l753
California Supreme Court, July 9, 1990).
o Should institutional financial interests be considered?
o What should the remedies be for violations?
CONFLICT OF INTEREST
Clinical Evaluation of Products
November 30, 1990
Masur Auditorium, Clinical Center, NIH
Public Meeting
8:30-9:00 Introduction and Opening Remarks
9:00-10:30 Presentations
9:00-10:00 Four Presenters - 15 minutes each
10:00-10:30 General questions and answers
10:30-11:00 Coffee
11:00-12:30 Comments from the audience concerning all
aspects of this issue including, but not limited to:
General Policy - Basic regulatory approach; responsibilities of
PHS and institutions; reporting and disclosures of financial
interests; resolution of conflicts of interest.
Restrictions - Types of financial interests; minimal levels;
waivers.
Remedies and Sanctions - Federal oversight and role with respect
to institutions; enforcement against investigators.
Audience comments - 3-5 minutes each.
12:30-1:30 Lunch.
1:30-2:45 Comments continued.
2:45-3:15 Coffee.
3:15-4:15 Comments continued.
4:15 Conclusion.
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 3
NATIONAL INSTITUTES OF HEALTH AND THE FOOD AND DRUG ADMINISTRATION 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. SOUTHEAST WORKSHOP
DATES: December 6-7, 1990
WORKSHOP SITE:
The Hotel Nikko Atlanta
3300 Peachtree Road
Atlanta, GA 30305
SPONSORS:
Emory University School of Medicine
1440 Clifton Road
Atlanta, GA 30322
Moorehouse School of Medicine
720 Westview Drive, S.W.
Atlanta, GA 30310
REGISTRATION CONTACT:
Office of Continuing Medical Education
Emory University School of Medicine
1440 Clifton Road, N.E.
(107 WHSCAB)
Atlanta, GA 30322
Telephone: (404) 727-5695
TOPIC: "Protection of Human Subjects in Research: Difficult Bioethical
Issues"
II. 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
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"
III. MIDEAST WORKSHOP
DATES: March 4-5, 1991
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 4
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: "Problems in Interpreting the Federal Code for the Protection of Human
Subjects"
IV. 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 Protections"
NIH/FDA have planned national human subject protections workshops in other
parts of the United States. For further information regarding these workshops
contact:
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
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 5
NOTICES OF AVAILABILITY (RFPs AND RFAs)
PRODUCTION AND DELIVERY OF SCHISTOSOMA MANSONI
RFP AVAILABLE: RFP-NIH-NIAID-DIR-91-24
P.T. 34; K.W. 0780005
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases has a requirement
for the production and delivery of adult worms, sporcysts, and cercariae of
Schistosoma mansoni. The successful offeror must be able to deliver worms and
cercariae to the NIH campus within one hour after they have been harvested.
Approximately 6,000 mature S. mansoni shall be required each week. When
different isolates are requested at the same time, the total number of worms
and/or mice perfused per week for the worms will not exceed 6,000 worms or the
number of mice needed to obtain 6,000 adult worms (60 mice). Approximately
1,000,000 cercariae shall be required each week. Cercariae, eggs, and
sporocysts shall be live upon receipt. One fixed-priced award is
contemplated. It is anticipated that this contract will be awarded for one
year with four one-year options to continue this contract. Any contract
awarded will be subject to DHHS regulations regarding the use of animals in
research. Any responsible source may submit a proposal which shall be
considered by the Government.
RFP-NIH-NIAID-DIR-91-24 will be issued on or about October 29, 1990.
Proposals will be due forty-five days thereafter.
To receive a copy of this RFP, please supply this office with a request in
writing and two self-addressed mailing labels addressed to the office listed
below:
Ms. Grace A. Bruce
Contract Specialist
Contract Management Branch, NIAID
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 707
5333 Westbard Avenue
Bethesda, MD 20892
This advertisement does not commit the Government to make an award.
PROTECTIVE EFFECTS OF PATTERNED ELECTRICAL STIMULATION ON THE DEAFENED
AUDITORY SYSTEM
RFP AVAILABLE: NIH-NIDCD-91-01
P.T. 34; K.W. 0715050, 0745047
National Institute on Deafness and Other Communication Disorders
The National Institute of Deafness and Other Communication Disorders (NIDCD),
NIH, has a requirement to evaluate the possibility that chronic electrical
stimulation of selected portions of the auditory system can maintain the
anatomical and physiological viability of deafferented auditory nerve axons
and their cell bodies in a manner compatible with future implantation of a
functional auditory prosthesis.
Past studies supported by NIDCD and its predecessor, the National Institute of
Neurological and Communicative Disorders and Stroke, have supported the
development of essentially all aspects of auditory prostheses. These have
included the evaluation of the safety of chronic implantation and electrical
stimulation of the cochlea. For the most part, these components were designed
for permanent implantation in adults. Recently the NIDCD, through the Neural
Prosthesis Program, has supported studies of problems that are unique to
implants in children. Specifically, the effects of head growth and recurrent
otitis media have been evaluated in young animals.
Recently, research in deafened kittens has suggested that spatially and
temporally patterned electrical stimulation with multielectrode cochlear
implants does indeed provide selective protection to auditory ganglion cells
and their axons in the cochlea. The purpose of this proposed study is to
confirm this effect and, if real, to optimize it. It is possible that this
could lead to a method of extracochlear stimulation for protection of the deaf
human cochlea in the period between the diagnosis of deafness and the
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 6
implantation of a cochlear implant. This is especially appealing in the young
deaf child where a delay in implantation may be desirable.
The contractor will be required to come to Bethesda yearly to present progress
on their work at the Neural Prosthesis Workshop sponsored by the Neural
Prosthesis Program.
It is anticipated that one award will be made under this RFP for a three-year
period.
This is not a Request for Proposals. RFP No. NIH-NIDCD-91-01 will be issued
on or about October 26, 1990, with responses due December 21, 1990.
To receive a copy of the RFP, please submit a written request to the following
address, and supply this office with two (2) self-addressed mailing labels:
Contracting Officer
Contracts Management Branch, DEA
National Institute of Neurological Disorders and Stroke, NIH
Federal Building, Room 901
7550 Wisconsin Avenue
Bethesda, MD 20892
Attention: RFP No. NIH-NIDCD-91-01
All responsible sources may submit a proposal which shall be considered by the
Government.
CLINICAL COORDINATING CENTER FOR A CHILDHOOD ASTHMA MANAGEMENT PROGRAM
RFP AVAILABLE: NHLBI-HR-90-12
P.T. 34, AA; K.W. 0715013, 0785035, 0755018
National Heart, Lung, and Blood Institute
The purpose of this solicitation is to establish a clinical coordinating
center for a collaborative study of a Childhood Asthma Management Program
(CAMP). The objective of this program is to determine, in a population of 5-9
year old children with asthma, if regular use of either of two types of
anti-inflammatory medications (inhaled corticosteroids or cromolyn sodium),
compared to regular bronchodilator medication and to each other, results in
greater lung function and less bronchial hyperresponsiveness over a five-year
period. The program will require a clinical coordinating center (CCC) to
collect data from approximately 8 participating clinical centers, each
studying a minimum of 132 children with asthma aged 5-9 years, including 44
from minority groups, e.g., Blacks, Hispanics and Native Americans, over a 6
1/2 year period. The coordinating center will be responsible for: (1)
coordinating and participating in the development, preparation, and
maintenance of the study protocol, reporting forms, and manual of operations,
and printing and distribution of these documents; (2) designing a system for
collection and management of data with feedback systems for quality control;
(3) arranging and attending meetings of the principal investigators from each
clinical center, and taking and distributing minutes of the meetings; (4)
developing procedures for standardization of pulmonary function testing; (5)
coordinating and training appropriate staff in implementing study
interventions, including administration of medications, health education
protocols, and procedures for measurement of pulmonary function; (6) training
clinical center staff in entering data through a distributed data entry
system, if appropriate, and completion of study forms; (7) randomizing
subjects to treatment groups and monitoring subject recruitment; (8) assuring
prompt accumulation, entry, and editing of study data; (9) communicating with
the clinical centers concerning missing, delayed, incomplete, or erroneous
data; (10) obtaining and processing laboratory reports, if appropriate; (11)
storing blood samples from subjects and obtaining appropriate analyses; (12)
preparing statistical reports on a quarterly basis and, as needed, to monitor
study progress, quality of data, clinical center performance; (13) submission
of weekly recruitment reports to the Project Officer; (14) interacting with
the Project Officer on issues relating to study design, study conduct, and
data analysis; (15) analyzing data from the beginning of data collection
through the end of the study; (16) completing analysis of study data; and (17)
assisting in the preparation of scientific reports for publication and
presentation.
This announcement is not a request for proposal (RFP). It is anticipated that
RFP NHLBI-HR-90-12 will be available on or about November 1, 1990, with
proposals due on February 28, 1991. Copies of the RFP may be obtained by
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 7
submitting a written request along with three (3) self-addressed mailing
labels to:
Pamela S. Randall
National Heart, Lung and Blood Institute, NIH
Contracts Operations Branch, DEA
Westwood Building, Room 654
5333 Westbard Avenue
Bethesda, MD 20892
Telephone: (301) 496-7334
The Institute expects to make one award from this solicitation.
MINORITY FELLOWSHIPS FOR DOCTORAL AND/OR POSTDOCTORAL TRAINING IN
NEUROSCIENCES
RFA AVAILABLE: MH-91-01
P.T. 22, FF; K.W. 0720005, 1002030
National Institute of Mental Health
Application Receipt Date: January 10, 1991
The Minority Fellowship Program (MFP) of the National Institute of Mental
Health is designed to facilitate the entry of minority students into mental
health careers with the long-term goal of increasing the number of minority
scientists trained at the doctoral and postdoctoral levels to conduct research
and teach in the neurosciences.
Three awards will be made for national programs to be administered by
professional associations, academic institutions, or other eligible
organizations, or by any combination of the foregoing. Domestic public or
private nonprofit institutions and professional and scientific organizations
may apply.
The National Institute of Mental Health will accept applications on the
receipt date of January 10, 1991. Applications received after this date will
be returned without review. It is estimated that approximately $750,000 is
available in fiscal year 1992 for three MFPs for Doctoral and Postdoctoral
Training in the Neurosciences.
Applicants are encouraged to contact Institute staff before applying for an
award:
Stanley F. Schneider, Ph.D.
Associate Director for Research Training and Career Development
Division of Basic Brain and Behavior Sciences
National Institute of Mental Health
5600 Fishers Lane
Rockville, MD 20852
Telephone: (301) 443-4347
MOLECULARLY TARGETED APPROACHES TO ANTIVIRAL THERAPY DEVELOPMENT
RFA AVAILABLE: AI-91-01
P.T. 34; K.W. 0740012, 1002008, 1002045
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: November 28, 1990
Application Receipt Date: January 17, 1991
The National Institute of Allergy and Infectious Diseases (NIAID) invites
grant applications for research that applies an understanding of the molecular
biology of virus replication and pathogenesis to the development of antiviral
agents that are targeted to inhibit specific viral functions. Therapeutic and
prophylactic agents (other than vaccines) that specifically inhibit virus
replicative functions without interfering with normal cellular processes are
likely to provide significant clinical benefits with minimal toxicity.
Research on any virus that is a human pathogen or that serves as a model for a
human pathogen, except for human immunodeficiency virus (HIV) and/or other
retroviruses, is an appropriate subject for a proposal. Research on HIV
antiviral agents is the subject of a separate initiative.
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 8
RESEARCH GOALS AND SCOPE
The purpose of this Request for Applications (RFA) is to stimulate research in
the development of novel molecularly targeted approaches to antiviral therapy.
This includes strategies for both the design of novel specific agents and
development of methods for selective drug delivery. The strategies proposed
should involve a molecular rationale for anticipated antiviral activity
without significant concomitant cellular and/or organism toxicity. The
preparation and testing of derivatives of previously identified nucleoside
analogue antiviral agents does not constitute a novel approach. Investigators
will choose the virus and system they prefer for these studies, but the
selected virus should either be a clinically important human pathogen or serve
as a model for a human viral pathogen. Possible choices include, but are not
limited to: hepatitis B, C, and D virus, papillomavirus, cytomegalovirus,
herpes simplex virus, varicella zoster virus, influenza viruses, respiratory
syncytial virus, parainfluenza, rotavirus, coxsackievirus, and rhinovirus.
The development of agents inhibitory to HIV and other retroviruses is the
focus of a separate RFA and, therefore, proposals to target HIV will not be
accepted in response to this initiative.
MECHANISM OF SUPPORT
Award(s) will be made as Cooperative Agreements. These are assistance
relationships with substantial involvement of NIAID staff. Universities,
medical colleges, hospitals, and laboratories or other public, private, or
for-profit institutions are eligible.
This RFA is a one-time solicitation. NIAID anticipates making ten to fifteen
awards as a result of this RFA. However these anticipated awards are
dependent upon receipt of a sufficient number of applications of high
scientific merit and upon the availability of funds. The earliest possible
award date is June 1, 1991. It is the intent of NIAID to fund a group of
proposals that will ensure that a variety of approaches and virus systems will
be investigated.
INQUIRIES
Investigators seeking information relevant to this RFA should contact Dr.
Catherine Laughlin at the address below. Requests for copies of the complete
RFA and questions regarding review procedures should be addressed to Dr.
Preble at the address below.
Dr. Olivia Preble
Chief, Microbiology and Immunology Review Section
Program and Project Review Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 3A10
Bethesda, MD 20892
Telephone: (301) 496-8208
Dr. Catherine Laughlin
Chief, Antiviral Research Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 753
Bethesda, MD 20892
Telephone: (301) 496-8285
CARDIOVASCULAR DEVICE-CENTERED INFECTIONS
RFA AVAILABLE: HL-90-09-H
P.T. 34; K.W. 0715040, 0740035, 0715125
National Heart, Lung, and Blood Institute
Letter of Intent Receipt Date: December 3, 1990
Application Receipt Date: January 14, 1991
The Devices and Technology Branch of the Division of Heart and Vascular
Diseases, National Heart, Lung, and Blood Institute (NHLBI), NIH, and the
Section of Bioengineering and Environmental Systems, National Science
Foundation (NSF), announce the availability of a Request for Applications
(RFA) on the above subject. Applications are invited for support of
interdisciplinary research on the mechanisms, prevention, and treatment of
infections developing in and around permanently implanted cardiovascular
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 9
devices such as total artificial hearts, ventricular assist devices, and
prosthetic heart valves.
Molecular approaches to the life sciences and medical sciences and new
engineering techniques are encouraged. These may deal with the nature of the
molecular interaction between bacterial surface components, the biomaterial
surface, and molecules mediating bacterial adhesion, growth, and colonization
on biomaterials. Other approaches based on recent advances in molecular and
computational biology are encouraged. Research utilizing NSF support must
have a substantive bioengineering component. The engineering contribution may
include mathematical modeling, instrumentation, tissue engineering, or any
other engineering approach that may relate to cardiovascular device-centered
infections. Research projects involving human subjects, animal models, or
other experimental approaches may be focused on: (1) the etiology,
pathogenesis, and natural history of device-centered infections, including the
relationship to thromboembolism; (2) elucidation of possible predisposing
factors for their development; and/or (3) potential approaches to improved
prevention and treatment of such infections.
In any studies involving human subjects, women and minority individuals should
be included in the study population; otherwise a clear rationale for their
exclusion must be provided in the application. Minority institutions are
encouraged to apply, and other institutions are encouraged to establish
collaborative arrangements with minority institutions.
It is anticipated that up to five awards will be made under this program. The
specific number to be funded will, however, depend on the merit and scope of
the applications received and on the availability of funds. A letter of
intent is requested by December 3, 1990, and the deadline for receipt of
applications is January 14, 1991. The earliest award date for successful
applicants will be in July 1, 1991. Awards will be made to foreign
institutions only for research of very unusual merit, need, and promise.
Potential applicants should contact either of the individuals designated below
for the full RFA document, which includes instructions for the submission of
applications:
Paul Didisheim, M.D. Norman Caplan
National Heart, Lung, and National Science Foundation
Blood Institute 1800 G Street
Federal Building, Room 312 Washington, D.C. 20550
7550 Wisconsin Avenue Telephone: (202) 357-7955
Bethesda, MD 20892
Telephone: (301) 496-1586
CLINICAL TRIAL PLANNING GRANT FOR DIGESTIVE AND NUTRITIONAL DISEASES
RFA AVAILABLE: DK-91-02
P.T. 34; K.W. 0755015, 0715085, 0715135, 0710095
National Institute of Diabetes and Digestive and Kidney Diseases
Application Receipt Date: January 22, 1991
PURPOSE
The Division of Digestive Diseases and Nutrition of the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for
Planning Grants (R21) to support the development of single center or
multicenter clinical trials in digestive and nutritional diseases. Areas of
particular importance include obesity, inflammatory bowel disease, irritable
bowel syndrome, helicobacter pylori, primary biliary cirrhosis, and sclerosing
cholangitis. It is anticipated that three planning grant awards will be made.
BACKGROUND
Recent advances in basic biomedical research have provided new insights into
the pathogenesis of many nutritional and digestive diseases. These advances
have led to new possibilities for therapeutic interventions in these diseases.
New therapies or interventions are best evaluated in prospective, randomized
controlled clinical trials. However, the planning, design, conduct, and
analysis of clinical trials are difficult. Each step in the process requires
major commitment of effort and time, financial support, and multidisciplinary
expertise. As a consequence, opportunities can be lost to identify and
rigorously evaluate important new therapeutic possibilities.
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In the area of digestive diseases and nutrition there are several diseases or
conditions that warrant studies of new therapeutic interventions. Digestive
and nutritional diseases or conditions of importance for which there are
currently no satisfactory long-term therapies include severe obesity,
inflammatory bowel disease, irritable bowel syndrome, primary biliary
cirrhosis, and sclerosing cholangitis. These are important conditions that
affect many Americans and cause considerable morbidity and mortality. Primary
biliary cirrhosis, for example, is an autoimmune disease of the liver that
largely affects women and leads slowly but inexorably to cirrhosis and death
from liver failure. Primary biliary cirrhosis is the leading single
indication for liver transplantation in adults. Despite these features, there
is currently no therapy of proven benefit for primary biliary cirrhosis. In
recent years, several small clinical trials in primary biliary cirrhosis have
reported some benefit of several agents including ursodeoxycholic acid,
chlorambucil, cyclosporine A, methotrexate, prednisone, and colchicine. While
results from several of these studies have been promising, they have not been
convincing enough to provide firm guidance for therapy of patients with this
important disease. It is obvious, however, that one or several of these
agents could be adequately evaluated in a proper, large, multicenter
randomized controlled trial.
Clinical Trial Planning Grants have been designed to aid investigators in
designing clinical trials in important areas of digestive and nutritional
diseases. These Planning Grants will support the development of a clinical
trial research plan. This grant also provides a means for early peer review
of the rationale and need for the trial.
OBJECTIVES AND SCOPE
The overall goal of this Request for Applications (RFA) is to encourage
experienced clinical investigators in digestive diseases to undertake
prospective, randomized, controlled, single-center or multicenter trials in
the treatment of digestive and nutritional diseases.
The NIDDK Clinical Trial Planning Grant has been designed to help support the
extensive planning that should precede any well-designed single-center or
multicenter trial. The grant provides a mechanism for early peer review of
the rationale and need for the trial as well as support for the development of
a detailed Manual of Procedures. In addition, a limited number of patients
can be recruited to test the operational aspects of the trial.
It is expected that this Planning Grant RFA will be followed by a program
announcement within twelve months from the funding of grants in response to
this initial RFA, for applications to perform single-center or multicenter
clinical trials. Applications in response to this latter announcement will be
required to provide detailed information regarding the rationale, experimental
design, protocols and procedures, analytical techniques, facilities and
environment, adequacy of the proposed administrative procedures, and
collaborative arrangements for the trial. A well documented Manual of
Procedures will also need to be part of the latter submission. The actual
funding of a single or multicenter clinical trial will be contingent in part
on the excellence and feasibility of the proposed trial, programmatic needs,
and on the availability of designated funds.
ELIGIBILITY REQUIREMENTS
All applicants must be qualified nutritionists, gastroenterologists,
hepatologists, or surgeons with the demonstrated ability to recruit adequate
numbers of patients. Applicants for a Planning Grant for a multicenter
clinical trial must have demonstrated expertise in the many complex features
of conducting a multicenter study. All applicants are responsible for
obtaining and maintaining the appropriate Investigational New Drug Application
from the Food and Drug Administration and the appropriate assurance and
certification from their Institutional Review Boards for Human Subjects. Only
costs that are not usual costs for the normal care of patients entered in the
trial may be requested as research costs to the grant application.
Some of the factors upon which review of single center or multicenter Planning
Grant applications will be evaluated are the following: rationale for the
proposed clinical trial; experimental design including identification of
appropriate primary and secondary outcomes of the trial; preliminary
experimental procedures and plans for patient participation; preliminary plans
for quality control and data analysis; and patient recruitment potential.
Planned preliminary studies and the professional credentials of the organizers
and participating centers should be included. Estimates of patient numbers
have to be based on the best estimates of the expected differences in measured
end points between control and treatment groups.
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 11
The NIH places special emphasis on the need for inclusion of minorities and
women in studies of diseases which disproportionately affect them and also
requires that applicants give added attention, where feasible and appropriate,
to their inclusion in other clinical studies. For proposed population-based
studies that include neither women nor minorities, a clear rationale for not
including them must be provided. In attempting to include either group in a
particular study, attention must be paid to such issues as research design and
sample size.
TERMS OF THE AWARD
Applications for single or multicenter clinical trial Planning Grants should
request up to 1 year duration and a maximum of $50,000 in direct cost.
Examples of the allowed uses of these funds include: paying travel expenses
of clinicians, biostatisticians, epidemiologists, and other essential
personnel who assist in the preparation of the Manual of Procedures;
supporting preliminary studies to refine trial procedures and document
recruitment potential; paying for secretarial assistance and office supplies;
and providing consultant fees for biostatisticians, but not generally for
other scientific personnel. Three Planning Grants may be awarded. Funding
decisions will be based in part on relative merit recommendation of the
Initial Review Group (IRG) and in part on programmatic needs as determined by
the National Diabetes and Digestive and Kidney Diseases Advisory Council and
by the staff of the Division of Digestive Diseases and Nutrition. The award
of applications submitted in response to this RFA is contingent on the actual
availability of funds and receipt of applications deemed worthy of support by
the accepted NIH peer review process.
REVIEW PROCEDURES
All applications submitted in response to this RFA will be evaluated for
scientific and technical merit by an IRG convened for this purpose by the
Division of Extramural Activities, NIDDK. There will be a single receipt date
of January 22, 1991. Applications received after that date will be returned.
Earliest funding will be December 1991.
METHOD OF APPLYING
Potential applicants should write or phone the individual listed below for the
full RFA document.
Tommie S. Tralka
Director, Clinical Trials Program
Division of Digestive Diseases and Nutrition
Westwood Bldg., Rm 3A-15
5333 Westbard Ave.
Bethesda, MD 20892
Telephone: (301) 496-9717
ONGOING PROGRAM ANNOUNCEMENTS
MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM
PA: PA-90-35
P.T. 44, FF; K.W. 0710030
National Center for Research Resources
Application Receipt Date: November 30, 1990
This is a re-issuance of the announcement published in the NIH Guide for
Grants and Contracts dated September 18, 1990, Vol. 19, No. 35.
BACKGROUND AND OBJECTIVES
The National Center for Research Resources (NCRR), National Institutes of
Health (NIH), currently plans to continue and expand the Minority High School
Student Research Apprentice Program in 1991. The purpose of the program is to
provide minority high school students with a meaningful experience in various
aspects of health-related research in order to stimulate their interest in
careers in science.
In FY 1991, in addition to encouraging institutions to apply for an increased
number of apprentices, the program is including a high school science teacher
initiative. This new program extension will allow teachers who are members of
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 12
a minority group, or who teach a significant number of minority students, to
participate in a summer research project in order to update their knowledge
and skills in modern research tools and techniques. Such a hands-on research
experience should strengthen teaching skills and provide teachers the
opportunity to bring back to the classroom a sense of the excitement of
research, which should stimulate students to pursue scientific careers. A
longer range goal is to establish year round links between science teachers,
secondary school students, and biomedical researchers.
Please note, however, that expansion of the program in FY 1991 is contingent
on the availability of appropriated funds. Thus, allocations may be reduced
below the requested amount. Upon recommendation of the National Advisory
Research Resources Council, the Center will give preference in making awards
to those institutions that can support a summer program having a "critical
mass" of at least five or six students.
ELIGIBILITY
Eligible institutions are those that were awarded grants during the latest
complete Federal fiscal year 1990 from either the Biomedical Research Support
Grant (BRSG) Program or the Minority Biomedical Research Support (MBRS)
Program. ALL ELIGIBLE INSTITUTIONS, INCLUDING THOSE NOT CURRENTLY FUNDED, ARE
STRONGLY ENCOURAGED TO APPLY. Only one application for the Apprentice Program
may be submitted by a component of an institution that is the recipient of
both the BRSG and MBRS awards.
Students eligible for support under this program are those who (1) identify
themselves as minority (i.e., Black, Hispanic, American Indian, Alaskan
Native, Pacific Islander, or Asian); (2) are U.S. citizens or have a permanent
visa; and (3) are enrolled in high school during the 1990-91 academic year.
(Students who will graduate from high school in 1991 are eligible, as is a
student who participated in a previous year provided he/she is still enrolled
at the high school level.)
MECHANISM OF SUPPORT
The mechanism of support for this program will be the NIH grant-in-aid (S03).
Awards will be for one year. Awards will be effective March 1, 1991,
contingent upon availability of appropriated funds. Support will be provided
at a level of $2,000 for each student apprentice and $5,000 for each high
school science teacher. Funds for ONE high school science teacher may be
requested for EACH FIVE students requested and multiples thereof. No indirect
costs will be paid. Direct support must be as salary; stipends are not
allowed. Funds allocated may also be utilized for supplies, extending the
research experience, or if adequate funds exist, for the addition of a student
apprentice. However, funds from these grants may only be used for the costs
of the apprentice program. The Program Director is responsible for the
recruitment and selection of the apprentices, as well as the high school
science teachers, and assignment of each to an appropriate investigator.
Students:
Recruitment and selection of students should emphasize factors including the
students' motivation, ability, scholastic aptitude, and accomplishments. In
addition, consideration should be given to science teachers' recommendations
and, where possible, the degree of parental commitment. Assignments should be
made to investigators involved in health-related research who are committed to
increasing the high school student's understanding of research and the
technical skills needed.
Teachers:
Recruitment and selection criteria should include: experience and teaching
responsibilities, level of interest in participating in a research program,
expected impact on their teaching programs, ability to stimulate minority
students to pursue scientific careers, and future plans for continued
interaction with the research institution.
METHOD OF APPLYING
Eligible institutions should submit an application consisting of no more than
(a) a letter stating the justification for the number of student and teacher
positions requested (preference will be given to those institutions with a
demonstrated commitment and a documented history of encouraging students to
pursue scientific careers); together with (b) the original and one signed and
completed copy of the Grant Application Form, PHS 398 (Rev. 10/88) face page,
page 4 "Detailed Budget for First 12-Month Budget Period Direct Costs Only,"
and checklist page only. The required pages of the PHS 398 application form
NIH GUIDE - Vol. 19, No. 39, November 2, 1990 - Page 13
should be completed according to instructions provided in the PHS 398 (Rev.
10/88) kit except for the following:
Face Page:
Item 1 - Leave blank.
Item 2 - Check the box marked "YES" and indicate the announcement title as
"Minority High School Student Research Apprentice Program, PA-90-35."
Items 4, 5, 7b, 8, and 10 - Not applicable; do not complete.
Item 6, Dates of entire proposed project period - Enter 91-03-31 through
92-02-29.
Item 7a - Insert the total dollar amount of the request, which is the sum,
from application page 4, of the number of student positions requested times
$2,000 per student and $5,000 per teacher.
Item 14, Organizational component to receive credit towards a Biomedical
Research Support Grant - Use this space to enter the code and the BRSG
component and/or MBRS grant numbers on which eligibility for this Minority
High School Student Research Apprentice Program application are based (no
credit will be given for the S03 application).
Page 4, "Detailed Budget for First 12-Month Budget Period Direct Costs Only" -
Using ONLY the Other Expenses category, enter on separate lines the number of
students requested at $2,000 per student and the number of high school science
teachers requested at $5,000 per teacher. Not more than one teacher position
may be requested for each five student positions requested. Enter the sum of
the amounts requested for each under the "TOTALS" column for the Other
Expenses category and under "Total Direct Costs for First 12-Month Budget
Period" at the bottom of the page.
The original and one copy of the signed Program Director's report and each
student and teacher report should be submitted with the renewal application by
November 30 in order that the data contained in these reports can be used by
NCRR to decide about policies and future funding for the Minority High School
Student Research Apprentice Program. These reports should also be submitted
at the same time even if renewal support is not requested.
In any event, all reports including the Financial Status Report must be
submitted to the NIH by the grantee institution no later than May 31, 1991,
unless an extension of the budget period end date has been authorized in
writing.
Mail the completed application by the November 30, 1990, firm deadline for
receipt of applications to:
Office of Grants and Contracts Management
National Center for Research Resources
National Institutes of Health
Westwood Building, Room 849
5333 Westbard Avenue
Bethesda, MD 20892**
Inquiries can be made of Dr. Marjorie A. Tingle at the above address or by
calling (301) 496-6743.
This program is described in the Catalog of Federal Domestic Assistance, No.
13.337, Biomedical Research Support. Grants will be awarded under the
authority of the Public Health Service Act, Section 301 (a)(3); Public Law
78-410 (42 USC 241) as amended, and administered under PHS grant policies and
Federal Regulations 45 CFR 74 and the Guidelines for Minority High School
Student Research Apprentice Program. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
**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. 19, No. 39, November 2, 1990 - Page 14