and Human Services (HHS)
EXPIRED
Department of Health and Human Services (DHHS)
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Agency
for Health Research and Quality (AHRQ), (http://www.ahrq.gov)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov)
Title: Cancer Surveillance Using Health Claims-Based Data (R01)
Announcement Type
This is a
reissue of PA-04-012,
which was previously released October 20, 2003, and now is divided into separate FOAs for the R01 (this
FOA) and R21 (PA-06-386)
grant funding mechanisms.
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific FOAs will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PA-06-385
Catalog of Federal Domestic Assistance Number(s)
93.399,
93.226
Key Dates
Release
Date: May 4, 2006
Letters of Intent
Receipt Date(s): Not applicable.
Application Receipt/Submission Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Receipt Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council
Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest
Anticipated Start Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional
Information To Be Available Date (URL Activation Date): Not Applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable.
Additional Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Background
There is increasing interest in the use of secondary data such as health claims to assess priorities in cancer research as well as cancer screening, treatment, and outcomes. The 1998 Institute of Medicine report on Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the NIH (http://www.nap.edu/readingroom/books/nih/ ) recommends that, "In setting priorities, NIH should strengthen its analysis and use of health data, such as on burdens and costs of diseases, and of data on the impact of research on the health of the public." Increasing the use of these types of data to assess the quality of cancer care has also been identified as a priority by the Institute of Medicine (http://search.nap.edu/html/enhancing_data_systems ). Studies using claims-based data are usually population-based and have the potential to address a number of priority questions including disparities in health care based on demographic characteristics and the quality of cancer care.
Claims offer an advantage in that they can be used to assess care for large, usually population-based cohorts of people. Examples of health claims include secondary data sources include: the linked SEER-Medicare data (http://healthservices.cancer.gov/seermedicare/ ); databases with multiple payers, such as the Healthcare Cost and Utilization Project (HCUP) database (http://www.ahrq.gov/data/hcup/ ); fee-for-service insurance bills for medical, rehabilitative, and/or other health care services; managed care encounter data; and discharge summaries.
Research Goals and Scope
Cancer is a heterogeneous chronic disease that requires innovations in treatment and care approaches. This funding opportunity announcement (FOA) is intended to support research directed at the use of health claims data for cancer surveillance, including studies of cancer detection, treatment, and/or outcomes. Research topics that would be relevant to this FOA include, but are not limited to, the following examples:
Examples of some of the types of projects that have been funded under earlier releases of this FOA include:
See Section
VIII, Other Information - Required Federal Citations for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This FOA will
use the NIH Research Project Grant (R01) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This FOA uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise, follow the instructions for non-modular research grant applications.
NOTE: Because AHRQ does not use the NIH modular budget format, applicants requesting funding from AHRQ (i.e., submitting applications to AHRQ) must use the detailed Research and Related (R&R) Budget (even for applications with direct costs in each year of $250,000 or less).
2. Funds Available
Applications received in response to this funding opportunity will compete for funds in the general funding pool of the NIH Institutes and Centers (ICs). No specific funds have been set aside. The number of awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research. Applicants may request up to 5 years of support for R01 awards with costs appropriately tailored to the proposed work. No limit is set on the costs requested by R01 applicants.
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 also vary. Although the financial plans of the NIH IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
The earliest anticipated start dates for any awards made in conjunction with this FOA would be in April 2007.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
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 support.
2. Cost Sharing or Matching
Cost sharing is not required for this funding opportunity.
The
most current NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided they are scientifically distinct.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance, contact GrantsInfo; Telephone: (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Proposed research should provide special opportunities for furthering
research programs through the use of unusual talent, resources, populations, or
environmental conditions in other countries that are not readily available in
the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review, and Anticipated Start Dates
Letter of Intent Receipt Date: Not applicable.
Application
Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS
Application Receipt Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review
Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest
Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of
Intent
A letter of intent is
not required for the funding opportunity.
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
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 (for U.S. Postal Service express
or regular mail)
Bethesda, MD 20817 (for express/courier delivery;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be submitted on or before the application
receipt/submission dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH 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 application already reviewed, but
such application must include an Introduction addressing the previous critique.
Information on the status of an
application should be checked by the Principal Investigator (PI) in the NIH
electronic Research Administration (eRA) Commons at https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps:
1) Contact the NIH IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
2) Obtain agreement
from the NIH IC staff that the IC will accept your application for
consideration for award; and
3) Include a cover letter with the application that
identifies the NIH staff member who and NIH IC that agreed to accept assignment
of the application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research Data
The precise content
of the data-sharing plan will vary, depending on the data being collected and
how the investigator is planning to share the data. Applicants who are planning
to share data may wish to describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation to be provided,
whether or not any analytic tools also will be provided, whether or not a
data-sharing agreement will be required and, if so, a brief description of such
an agreement (including the criteria for deciding who can receive the data and
whether or not any conditions will be placed on their use), and the mode of
data sharing (e.g., under their own auspices by mailing a disk or posting data
on their institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants requesting
more than $500,000 in direct costs in any year of the proposed research must
include a plan for sharing research data in their application. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
Not applicable.
Section V. Application
Review Information
1. Criteria
Only the review criteria
described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the NIH ICs on the
basis of established U.S. Public Health Service (PHS) referral guidelines.
Appropriate
scientific review groups convened in accordance with the standard NIH peer
review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
The following will be considered in making funding decisions:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an 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 or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to progress
in the field? Does the project develop and/or employ novel concepts,
approaches, methodologies, tools, and/or technologies for this area?
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 PI and other researchers?
Does the investigative team bring complementary and integrated expertise to the
project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional
Review Criteria
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing).
2.D. Sharing Research
Resources
Not applicable.
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
After the
peer review of the application is completed, the PD/PI will be able to access
his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the NoA
are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590,
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Joan Warren, Ph.D.
Applied
Research Program
Division
of Cancer Control and Population Sciences
National
Cancer Institute
6130
Executive Boulevard, EPN Room 4004, MSC 7344
Bethesda, MD 20892-7344 (for U.S. Postal
Service express or regular mail)
Rockville, MD 20852 (for express/courier
delivery)
Telephone:
(301) 496-5184
Fax:
(301) 435-3710
Email: [email protected]
Bernard
Friedman, Ph.D.
Agency
for Healthcare Research and Quality
540
Gaither Road,
Room 5000
Rockville, MD 20850
Telephone:
(301) 427-1404
Email: [email protected]
2. Peer Review Contacts:
Not
applicable.
3. Financial or Grants Management Contacts:
Crystal
Wolfrey
Office
of Grants Administration
National
Cancer Institute
6120
Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal
Service express or regular mail)
Rockville, MD 20852 (for express/courier
delivery)
Telephone:
(301) 496-8634
Fax:
(301) 496-8601
Email: [email protected]
Joan
Metcalfe
Agency
for Healthcare Research and Quality
540
Gaither Road,
Room 4000
Rockville, MD 20850
Telephone:
(301) 427-1450
Email: [email protected]
Section VIII. Other Information
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); and efficacy,
effectiveness, and comparative trials (Phase III). Monitoring should be
commensurate with risk. The establishment of data and safety monitoring boards
(DSMBs) is required for multi-site clinical trials involving interventions that
entail potential risks to the participants (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
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 and local institutional
review board (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.
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 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 funding opportunity 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.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
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 (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 applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from: 1) currently funded NIH research
projects; or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process, please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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).
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 PA 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.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for 2 years to the research. For further information,
please see http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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