and Human Services (HHS)
EXPIRED
EXPLORATORY CENTERS (P20) FOR INTERDISCIPLINARY RESEARCH
RELEASE DATE: September 30, 2003
RFA Number: RFA-RM-04-004 (formerly RFA-RR-04-002, see NOT-RM-05-006 and NOT-OD-04-008)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
This RFA is developed as a roadmap initiative. All NIH Institutes and
Centers participate in roadmap initiatives.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.389
LETTER OF INTENT RECEIPT DATE: January 30, 2004
APPLICATION RECEIPT DATE: February 24, 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
In addition to the biological sciences, biomedical research encompasses
a large number of scientific disciplines, including the behavioral,
quantitative, engineering and computer sciences. Distinct disciplinary
perspectives represent significant sources of strength to the overall
research enterprise because each discipline has its own intellectual
history, experimental and analytic approaches, and theoretical context
that produce a unique way of thinking about a problem. Nevertheless,
as scientific capabilities move forward, increasingly complex questions
arise, and these often require the convergence of perspectives from
multiple disciplines. Over the years, the Institutes and Centers (ICs)
of the National Institutes of Health (NIH) have developed many
initiatives, mechanisms and programs to support multidisciplinary
research--that is, research that brings together researchers from
different disciplines to focus on a circumscribed problem.
It is becoming apparent that, in some cases, the collaborative nature
of disciplines that characterizes multidisciplinary research is not
sufficiently sustained to address, in a comprehensive and effective
way, challenging problems in biomedical and behavioral research.
Rather, interdisciplinary research, which integrates several
disciplinary approaches in a more sustained and systematic fashion, may
be required to tackle these more complex problems. Integrating
different disciplines in this way holds the promise of opening up
currently unimagined scientific avenues of inquiry, and in the process,
may form whole new disciplines. Historical examples include the
development of genomics, which was formed from genetics, molecular
biology, analytical chemistry, and informatics. Another example in
which multiple disciplines have, in a less directed way, blended and
evolved into a new discipline is neuroscience. Thirty years ago,
students of the brain might have identified themselves as anatomists,
physiologists, or psychobiologists, but today they would consider
themselves neuroscientists.
Combining particular aspects of different disciplines to develop
entirely new ways to approach biomedical and behavioral research
problems is daunting in many ways. In recognition of the difficulty of
establishing interdisciplinary research efforts, this Request for
Applications (RFA) solicits applications for P20 planning grants that
will support planning activities for groups of researchers to develop
interdisciplinary research strategies to solve significant biomedical
and/or behavioral research problems. Activities supported will include
study design and, perhaps, pilot research to demonstrate the approach
to be pursued. Whatever the approach, it must integrate aspects of
multiple disciplines, which will be specified by the applicants.
Planning activities are intended to lay the foundation and prepare
investigators for submitting a subsequent application for more
substantial and longer duration support through an Interdisciplinary
Research Consortium. In recognition of the need to bring several
disciplines together as equal partners, this RFA allows the research
team to submit separate, but related applications that will be reviewed
as a unit.
RESEARCH OBJECTIVES
This RFA invites applications for planning grants using the P20
(exploratory center) mechanism that will focus on developing new
approaches to solving significant and complex biomedical problems,
particularly those that have been resistant to more traditional
approaches. These new approaches must hold the promise of leading to
new research approaches to improving human health.
These planning grants are expected to identify a biomedically relevant
problem, evaluate why previous approaches have not worked, justify why
the proposed interdisciplinary approach will work, identify the
planning approach, and propose a timeline. The planning approach could
include holding workshops or conducting feasibility studies, but these
are only examples of possible planning approaches.
It is expected that the outcome of these planning centers will
demonstrate that the proposed interdisciplinary approach is likely to
be successful. Success is defined as combining aspects of individual
disciplines to provide a new approach to solving a problem that is
likely to yield insights that could not have been achieved by an
isolated laboratory or using a multi-disciplinary approach. The
planning grant should request three years of funding.
In most cases, it is expected that the proposed centers will have
leaders from more than one discipline. In order to recognize the
intellectual input from scientists from more than one discipline and
potentially from separate institutions, this RFA will allow
contributing scientists to submit separate, but related, applications
that address the same research problem. In addition to describing the
research to be accomplished, these linked applications must address the
nature of the collaboration. Whether applicants choose to submit one
or multiple linked P20 applications, the development of interactions
across disciplines must be specifically addressed. This innovative
approach should allow each of the intellectual leaders to achieve
appropriate credit for their contribution to this interdisciplinary
project. This RFA also allows applications from single principal
investigators who propose an interdisciplinary approach.
MECHANISM OF SUPPORT
This RFA will use NIH P20 award mechanism. As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. The anticipated award
date is September 2004.
This RFA uses just-in-time concepts. 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
The participating ICs intend to commit approximately $9 million in FY
2004 to fund roughly fifteen new planning grants in response to this
RFA. An applicant must request a project period of three years and a
budget for direct costs of up to $400,000 per year. The F&A costs
(often called indirect costs) for any subcontracts will not count
toward this $400,000 cap. For linked applications, the total direct
costs for all of the grants is limited to $400,000; that is, the
$400,000 maximum budget will need to be distributed across the
multiple, linked applications. Because the nature and scope of the
proposed research will vary from application to application, it is
anticipated that the size also will vary. Although the financial plans
of the IC(s) 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
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 Foreign institutions are not eligible to apply
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 or to
partner with principal investigators from other institutions to develop
a responsive application.
SPECIAL REQUIREMENTS
This RFA demonstrates the interest of NIH in supporting
interdisciplinary research efforts as new pathways of discovery, but
support by NIH is not sufficient for such research to prosper. More
important is the commitment by research institutions to foster and
accommodate interdisciplinary research.
Therefore, applicant organizations must describe their plans to
facilitate interdisciplinary research as it relates to the P20 planning
grant. Among the issues that should be addressed are: 1) how the
institution will distribute credit for direct (and indirect) costs to
reflect the contributions of different components, 2) how the
institution will recognize the contributions of the research team
beyond the Principal Investigator, and 3) how the institution attends
to the careers of "interstitial" team members who play important roles
in interdisciplinary research, but who are not tenure track or
eligible/appropriate to be principal investigators on research grants.
Applicant institutions are encouraged to describe how interdisciplinary
research will be facilitated beyond these three issues.
This description of institutional commitment should be included as a
letter from an appropriate representative of the applicant institution.
It is likely that the appropriate institutional representative will
have authority beyond a single department.
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:
Greg Farber, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, Room 960
Bethesda, MD 20892-4874
Telephone: (301) 435-0778
FAX: (301) 480-3659
Email: [email protected]
Michael F. Huerta, Ph.D.
Associate Director, Scientific Technology and Research
National Institute of Mental Health
6001 Executive Blvd., Room 7202
Bethesda, MD 20892-9645
Telephone: (301) 443-3563
FAX: (301) 443-4822
Email: [email protected]
o Direct your questions about peer review issues to:
Sheryl Brining, Ph.D.
Director, Office of Review
National Center for Research Resources
6701 Democracy Blvd, Rm 1074
Bethesda MD 20892-4868
Telephone: (301) 435-0809
FAX: (301) 480-3660
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Mary Niemiec
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd, Rm 1046
Bethesda, MD 20892-4874
Telephone: (301) 435-0842
FAX: (301) 480-3777
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Name, address, and telephone number of collaborating Principal
Investigators if a linked application is submitted.
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Greg Farber, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
6701 Democracy Boulevard, Room 960
Bethesda, MD 20892-4874
Telephone: (301) 435-0778
FAX: 301-480-3659
Email: [email protected]
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: [email protected].
SPECIFIC INSTRUCTIONS FOR ALL APPLICATIONS
Required information, in addition to that requested in the PHS 398 Form
Instructions, is listed below.
1) Timeline
A specific section labeled Timeline must be included following the
Research Design and Methods section. The timeline should show the
planned actions over the three-year period of the award. The timeline
section must be contained within the 25-page limit.
2) Meeting
All awardees should plan to attend a meeting in the Washington, DC area
in the second year of the award. Awardees will be expected to present
their results at the meeting and will help NIH staff plan for future
programs to support interdisciplinary research at NIH. The budget
should contain support for travel for the project leaders for this
meeting.
3) Management Plan
A plan should be presented for how the team will collaborate and how
the efforts of the individual investigators will be coordinated. This
concise management plan should be presented in a separate section
following the Research Design and Methods section and must be contained
within the 25-page limit.
4) Institutional Barriers to Interdisciplinary Research
The items mentioned in the Special Requirements section should be
addressed in a letter from the appropriate institutional official.
This letter should follow the Management Plan in the application.
5) Budget
The modular budget format should not be used.
SPECIFIC INSTRUCTIONS FOR SEPARATE APPLICATIONS FROM RESEARCH A TEAM
(LINKED APPLICATIONS)
It is important that applicants who wish to submit linked applications
announce their intentions clearly and early. Linked applications must
mention the linkage in 4 separate areas of the application: the letter
of intent, the cover letter included with the application, the title of
the proposal, and in the abstract.
1) Letter of Intent
Linked applications should be clearly identified in letters of intent.
Each Principal Investigator for the linked proposals should send a
separate letter as detailed above. In the letter, the name and
institution of the other members of the team should be identified
clearly.
2) Cover Letter
To aid the Division of Receipt and Referral in making appropriate
assignments, it is essential that the other members of a linked group
be identified in the cover letter of the application. The cover letter
should mention that this is a linked application and give the title(s),
PI name(s), and originating institution(s) of application(s) that are
linked.
3) Title
Linked applications must have identical titles followed by the phrase
(number of number). An appropriate title would be "Plans for
Interdisciplinary Studies of Obesity (1 of 2)".
4) Abstract
The fact that this is a linked application should be specified in the
abstract of the application. The names and institutions of the other
"linked" Principal Investigators should be in the abstract.
5) Budget
Linked applications can request, at most, $400,000 in total direct
costs for ALL awards (e.g., if two applications are linked, and if one
requests $250,000, the other linked application could only request up
to $150,000). The modular budget format should not be used.
6) Research Plan and Common Text
The PHS 398 form instructs applicants to divide the Research Plan
section of the application into four parts (A-D) to answer the
following questions:
A) What do you intend to do?
B) Why is the work important?
C) What has already been done?
D) How are you going to do the work?
For linked applications, it is expected that sections A, and B will be
the same in each linked application. Section C may or may not have
common text between linked applications. Section D should be different
for each of the components of a linked application.
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
five copies of the appendix material must be sent to:
Office of Review
National Center For Research Resources
6701 Democracy Boulevard, 10th floor
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. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes from the previous unfounded version
of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the (IC). Incomplete and/or nonresponsive
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 the 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 an appropriate National Advisory
Council or Board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
bio-medical and behavioral systems, improve the control of disease, and
enhance health. In the written comments, reviewers will be asked to
discuss the following aspects of the application in order to judge the
likelihood that the proposed research will have a substantial impact on
the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning the application's overall score, weighting them
as appropriate for each application. 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? Do the applicants acknowledge potential problem areas and
consider alternative tactics? Are the appropriate disciplines
adequately represented and well integrated to approach this complex
research question?
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?
INVESTIGATORS: Are the investigators appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigators 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
and technical merit and in the determination of the priority score:
1) Is the proposed approach interdisciplinary? Are the appropriate
disciplines included to provide a unified approach to the problem?
2) Does the proposed interdisciplinary approach have the potential to
significantly change the way research on this topic is pursued?
3) Is there a plan in place to ensure that the collaboration runs
smoothly? Does the management plan ensure that there will be
sufficient coordination and collaboration among the members of the
research team?
4) Will the proposed timeline allow the research team and NIH program
staff to assess the impact of the anticipated interdisciplinary
approach to solving a biomedical problem by the end of the award?
5) Will this interdisciplinary approach accomplish more than what would
be accomplished by individuals working separately on the same problem,
i.e. is the whole greater than the sum of the parts?
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 CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: January 30, 2004
Application Receipt Date: February 24, 2004
Peer Review Date: July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 2004
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH
Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 PA 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.health.gov/healthypeople.
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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||