TECHNOLOGY DEVELOPMENT FOR BIOMEDICAL APPLICATIONS
RELEASE DATE: January 20, 2004
RFA Number: RFA-RR-04-005 (This RFA has been reissued as RFA-RR-06-004)
(This RFA has been reissued, see RFA-RR-05-001)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.389
APPLICATION RECEIPT DATE: June 18, 2004 and October 15, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
This RFA replaces PAR-03-075.
The purpose of this request for applications (RFA) is to invite
innovative applications for (1) the development of new and improved
instruments or devices, (2) the development of new methodologies using
existing instruments, or (3) the development of software related to
instrumentation. Any of these projects should propose tools,
methodologies, or software that can be used by a wide range of
biomedical or clinical researchers. Projects that are focused on a
specific organ or disease will be returned without review; however,
proposals may use a specific organ or disease as a model system. Awards
made for applications received in response to this announcement will
employ the R21 and the R21/R33 mechanisms that are designed to support
high-risk applications for which few if any preliminary findings are
available. Investigators with substantial preliminary data should seek
an R01 grant by submitting an unsolicited application at the standard
receipt date or by responding to a particular program announcement.
Questions about the suitability of proposals should be addressed to
program staff listed in the "Where to Send Inquiries" section well
before submission. Proposals in the areas of biomedical imaging,
sensors, biomaterials, microelectromechanical systems (MEMS), tissue
engineering, and nanotechnology will be considered nonresponsive and
returned without review. Investigators considering research in these
areas may want to look at the NIBIB
(http://www.nibib1.nih.gov/research/investigators.htm) and BECON
(http://www.becon.nih.gov/becon_funding.htm) web pages for funding
opportunities in bioengineering research or biomedical imaging research.
In addition, proposals that are focused on a specific organ or disease
will be considered nonresponsive and also returned without review;
however, proposals may use a specific organ or disease as a model
system.
The proposed research may involve conceptualization, design,
fabrication, and/or testing of new instruments or devices. Applications
to develop new experimental techniques and protocols using existing
instrumentation are also welcome. Applications to develop new software
related to instrumentation are encouraged, with the exception of
proposals with a primary focus in the area of medical informatics. The
overall objective of applications for new instruments, techniques, or
software should be the development of more powerful and more precise
technology with broad applicability to biomedical research.
RESEARCH OBJECTIVES
The primary intent of this RFA is to stimulate the development of new
techniques for biomedical research that will allow scientists to achieve
biomedical breakthroughs. High-risk applications are encouraged, and
the innovative nature of the application will be part of the review
criteria.
For some high-risk applications, it may be appropriate to use the R21
mechanism alone to generate preliminary data. For applications with two
distinct phases where the high-risk portion of the research occurs
early, the R21/R33 mechanism is appropriate. As a simple example,
consider an applicant who had developed a new material that might be
used to fabricate a lens. The R21 portion of such a research plan would
be the fabrication and testing of the lens. In the R21 portion of the
application, the Principal Investigator would propose a set of
quantitative milestones that the new lens would have to achieve. Such
quantitative milestones might deal with the focal length, field of view,
and aberrations of the lens. Once the lens had been made, the R33 phase
of the research could be to incorporate this lens into a working
microscope. At the end of a successful R21/R33 award, it is expected
that there be a working instrument or new technique. Since the R21/R33
award cannot be renewed, it is not suitable for establishing a long-term
research project in a particular area. Investigators should not propose
to test a biological hypothesis as the R33 phase of an application.
Examples of new tools and techniques that are responsive to this RFA
include optical spectroscopy, mass spectrometry, electrophoresis and
other separation techniques, microscopy, lasers and optics, X-ray tools
and techniques, nuclear magnetic resonance spectroscopy, bioreactors and
other forms of cell culture, centrifugation, proteomics, genomic
sequencing, functional genomics, comparative genomics, microarrays, and
human sequence variation (e.g., genotyping). This list is not
exhaustive, but investigators outside of these areas are encouraged to
contact program staff to ensure that their applications are responsive.
This program announcement is similar in spirit to the "Instrument
Development for Biological Research" program in the Directorate for
Biological Sciences at the National Science Foundation
(http://www.nsf.gov/cgi-bin/getpub?nsf98119). The major difference
between the two programs is that instrumentation for the conduct of
disease-oriented research is specifically excluded from the NSF program.
Some instrument development proposals could be considered either under
this program announcement or by NSF. Applicants are encouraged to
contact program staff at either NSF or NIH to identify the best program
for the application.
MECHANISM OF SUPPORT
This RFA will use NIH R21 and R21/R33 award mechanism(s). As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project.
Specific features of this mechanism include:
o Single submission and evaluation of both a feasibility/pilot phase
(R21) and an expanded development phase (R33) as one application.
o Expedited transition of the R21 feasibility phase to a R33
development phase for combined applications.
o Flexible budgets.
o Flexible staging of feasibility and development phases.
Applications under this program announcement will use either the
combined R21/R33 mechanism or the R21 mechanism alone. Applications
using just the R33 mechanism will not be considered. An application
using the R21 mechanism alone is appropriate when the possible outcomes
of the proposed research are unclear; under these conditions, it would
not be possible to propose quantitative milestones or describe the R33
phase of the research. Applicants are strongly encouraged to contact
program staff with any questions about the appropriate mechanism. Refer
to the "Where to Send Inquiries" section of this program announcement
for program staff contacts.
This RFA uses just-in-time concepts. It also uses only the non-modular
budgeting format. This program does not require cost sharing as defined
in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
NCRR intends to commit approximately $1 million in FY 2005 to fund five
to eight new grants in response to this RFA. Because the nature and
scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award
will vary. Although the financial plans at NCRR provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations, however applicants from for-
profit organizations should contact program staff prior to submitting an
application
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. The applicant
can choose to submit an independent R21 application, or a combined
R21/R33 application. The advantage of the combined R21/R33 mechanism is
that it offers a seamless transition between the exploratory phase and
the development phase of a project. Transition from the R21 to the R33
is dependent on completion of negotiated milestones. Once these
milestones have been achieved, the investigator will submit a progress
report to program staff. Upon determination that the milestones have
been accomplished, the R33 phase can begin.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Gregory K. Farber, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
TEL: (301) 435-0755
FAX: (301) 480-3659
Email: gf48a@nih.gov
o Direct your questions about peer review issues to:
Bo Hong, Ph.D.
Office of Review
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
TEL: (301) 435-0813
FAX: (301) 480-3660
Email: bh219i@nih.gov
o Direct your questions about financial or grants management matters to:
Mary Niemiec
Team Leader
Office of Grants Management
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
TEL: (301) 435-0842
FAX: (301) 480-3777
Email: mn20z@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must have
a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number
as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling (866)
705-5711 or through the web site at http://www.dunandbradstreet.com/.
The DUNS number should be entered on line 11 of the face page of the PHS
398 form. The PHS 398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted on June 18 and October 15. Both
new applications and revisions to previously reviewed applications are
due on the same date.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER
YEAR: Applications requesting $500,000 or more in direct costs for any
year must include a cover letter identifying the NIH staff member within
one of NIH institutes or centers who has agreed to accept assignment of
the application.
Applicants requesting more than $500,000 must carry out the following
steps:
Contact the IC program staff at least six weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff
member and IC who agreed to accept assignment of the application.
SPECIFIC INSTRUCTIONS FOR THE APPENDIX
The only items that may be included in the appendix are original glossy
photographs or color images of gels, micrographs, etc., provided that a
black and white photocopy of the same size is included within the
research plan.
SPECIFIC INSTRUCTIONS FOR PREPARING A COMBINED R21/R33 PHASED INNOVATION
AWARD APPLICATION
The combined R21/R33 application must include the specific aims for each
phase and the feasibility milestones that would justify transition to
the R33 phase. Applications must include a specific section labeled
Milestones following the Research Plan of the R21 phase. Milestones
should be well described, quantifiable and scientifically justified. A
discussion of the milestones relative to the progress of the R21 phase
and the implications of successful completion of the milestones for the
R33 phase should be included. The Milestone section should be indicated
in the Table of Contents. Applications lacking this information, as
determined by the NIH staff, will be returned to the applicant without
review.
Prior to funding an application, the Program Director will contact the
applicant to discuss the proposed milestones and any changes suggested
by the review panel as indicated in the Summary Statement. The Program
Director and the applicant will negotiate and agree on a final set of
milestones. These will be the basis for judging the success of the R21
work. For funded applications, the Principal Investigator will submit a
progress report to the program upon completion of the R21 milestones.
Receipt of this progress report will trigger a review that will
determine whether or not the R33 should be awarded. The release of R33
funds will be based on successful completion of negotiated scientific
milestones, program priorities, and on the availability of funds.
The R21/R33 Phased Innovation Award application must be submitted as a
single application with one face page. Although it is submitted as a
single application, it should be clearly organized into two phases. To
accomplish a clear distinction between the two phases, applicants should
submit Sections a-d (Specific Aims, Background and Significance,
Preliminary Studies, Research Design) for the R21 phase, then the
milestones, and then sections a and d (Specific Aims, Research Design)
for the R33 phase. The Form 398 Table of Contents should be modified to
show the sections for each phase as well as the milestones. There is a
page limit of 25 pages for the composite research plan. Section a-d of
the R21 research plan must not be longer than 15 pages. The milestones,
and the a and d sections for the R33 application can take, at most, an
additional 10 pages. The clarity and completeness of the R21/R33
application with regard to specific goals and feasibility milestones are
critical. The presentation of milestones that are not sufficiently
scientifically rigorous to be valid for assessing progress in the R21
phase will reflect upon the approach as proposed by the investigator and
may affect the priority score.
1. Face Page of the application:
Item 2. Check the box marked "YES" and type the number and title of
this program announcement.
Items 7 and 8: Costs Requested
For the R21 phase of the application, direct costs are limited to a
maximum of $125,000 per year for no more than three years. R21 budgets
can only exceed this cap to accommodate F&A costs of subcontracts to the
project. The combined R21/R33 application is limited to five years in
duration, and the R33 phase may not exceed three years in duration.
2. Page 2 - Description: As part of the description, identify
concisely the fundamental research and/or technology or tool to be
developed, its innovative nature, its relationship to presently
available capabilities, and its expected impact on biomedical research.
3. Budget: The application should provide a detailed budget for Initial
Budget Period (form page 4) for the first year of the R21 phase and a
second detailed budget (form page 4) for the first year of the R33
phase. Form page 5 should be used to provide a budget for the entire
proposed period of support. Form pages should indicate which years are
R21 and which are R33. All budgets should include a written
justification. The modular budget format should not be used.
4. Research Plan:
Item a: Specific Aims.
Specific aims must be presented which the applicant considers to be
scientifically appropriate for the relevant phases of the project.
Research that develops new technologies or tools is likely to require
application of principles from fields such as analytical chemistry,
mathematics, physics, and engineering. Clear statements of the
underlying principles should be made within this section.
Item b: Background and Significance
Elaborate on the innovative nature of the proposed research. Clarify
how the fundamental tools or technologies to be developed will result in
a significant improvement over existing approaches. Explain the
potential of the proposed technology for having an impact on a
compelling area of biomedical research. Clearly identify how the
project, if successful, will result in new capabilities for biomedical
research, the immediacy of the opportunity, and how any proposed
technologies or tools differ from existing technologies or tools. This
item should not be included in the R33 portion of the application.
Item c: Preliminary Studies
While preliminary data are not required for submission of the R21 phase,
this section should provide current thinking or evidence in the field to
substantiate feasibility of the R21 phase. If the applicant does have
preliminary data, it should be presented in this section. This item
should not be included in the R33 portion of the application.
Item d: Research Design and Methods
Follow the instructions in the PHS 398 form. Applicants should also
address plans to make the products, tools, or technologies forthcoming
from this research available to the relevant biomedical research user
community.
5. Milestones:
For combined R21/R33 applications, a specific section labeled Milestones
must be included following the Research Design and Methods of the R21
phase. Milestones should be well described, quantifiable, and
scientifically justified. Applicants should write the milestones
assuming that a scientifically literate non-expert will use them to
evaluate the progress that has been achieved. Milestones should not be
simply a restatement of the specific aims or a timeline. The milestones
section should be indicated in the Table of Contents. Applications
lacking this information will be returned to the applicant without
review.
For funded proposals, peer review is not likely between the two phases
of the project. When the R21 milestones have been achieved, the
Principal Investigator must submit a progress report to program staff.
Receipt of this progress report will elicit a review to determine
whether or not the R33 should be awarded. The release of R33 funds will
be based on successful completion of milestones, program priorities, and
on the availability of funds.
SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R21 APPLICATION WHEN
SUBMITTED WITHOUT THE R33 PHASE
1. Face Page of the application:
Item 2. Check the box marked "YES" and type the number and title of
this program announcement.
Item 7a: DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT
For the R21 application, direct costs are limited to a maximum of
$125,000 per year for a maximum of three years. R21 budgets can only
exceed this cap to accommodate F&A costs of subcontracts to the project.
2. Page 2 - Description: As part of the description, identify
concisely the fundamental research and/or technology or tool to be
developed, its innovative nature, its relationship to presently
available capabilities, and its expected impact on biomedical research.
3. Budget: The application should provide a detailed budget for Initial
Budget Period (form page 4), as well as a budget for the entire proposed
period of support (form page 5). All budgets should include a written
justification. The modular budget format is not to be used.
4. Research Plan:
The research plan for an R21 application is limited to 15 pages.
Item a: Specific Aims.
Specific aims that the applicant considers to be scientifically
appropriate for the relevant phases of the project must be presented.
Research that develops new technologies or tools is likely to require
the application of principles from fields such as analytical chemistry,
mathematics, physics, and engineering. Clear statements of the
underlying principles should be made within this section.
Item b: Background and Significance
Elaborate on the innovative nature of the proposed research. Clarify
how the fundamental tools or technologies to be developed in this
project will result in a significant improvement over existing
approaches. Explain the potential of the proposed technology for having
an impact on a compelling area of biomedical research. Clearly identify
how the project, if successful, would result in new capabilities for
biomedical research, the immediacy of the opportunity, and how any
proposed technologies or tools would differ from existing technologies
or tools.
Item c: Preliminary Studies
While preliminary data are not required for submission of the R21 phase,
this section should provide current thinking or evidence in the field to
substantiate feasibility of the R21 phase. If the applicant does have
preliminary data, it should be presented in this section.
Item d: Research Design and Methods
Follow the instructions in the PHS 398 form.
5. Milestones:
Applications using the R21 mechanism without the R33 phase do not need
to include milestones.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original
of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all five copies of the appendix material must be sent to:
Office of Review
National Center for Research Resources
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially
the same as one already reviewed. This does not preclude the submission
of a substantial revision of an unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NCRR. Incomplete applications will not be
reviewed. Applications that are complete and responsive to the RFA will
be evaluated for scientific and technical merit by an appropriate peer
review group convened by NCRR in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Research
Resources Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them as
appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers (if
any)?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
o To what degree does the research or development of technologies or
tools support the needs of the targeted biomedical research community?
o What is the time frame for developing the proposed approaches, tools,
or technologies? Is this time frame suitable for meeting the relevant
biomedical research community's needs?
o For R21/R33 proposals, are the proposed milestones appropriate for
judging the success of the R21 work?
o For R21/R33 proposals, are the proposed milestones appropriate in
determining whether the R33 phase should be awarded?
o For R21/R33 proposals, are the milestones quantitative? Will a
scientifically literate non-expert be able to determine whether the
milestones have been achieved?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections
on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in
direct costs in any year of the proposed research must include a data
sharing plan in their application. The reasonableness of the data
sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the
proposed data sharing plan into the determination of scientific merit or
priority score. http://grants.nih.gov/grants/policy/data_sharing
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Application Receipt Date: June 18, 2004 and October 15, 2004
Peer Review Date: October 2004 and February 2005
Council Review: January 2005 and May 2005
Earliest Anticipated Start Date: April 1, 2005 and July 1, 2005
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be
gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for research
involving human subjects. You will find this policy announcement in the
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate the official NIH identifier(s) for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information , the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can
be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or
early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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