INFRASTRUCTURE FOR DATA SHARING AND ARCHIVING

RELEASE DATE: October 17, 2003

RFA Number:  RFA-HD-03-032 (Reissued as RFA-HD-08-020)

(see correction NOT-HD-04-003)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH) 
(http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS: 
National Institute of Child Health and Human Development (NICHD) 
(http://www.nichd.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.864

LETTER OF INTENT RECEIPT DATE:  December 15, 2003
APPLICATION RECEIPT DATE:  January 15, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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

The Demographic and Behavioral Sciences Branch (DBSB) of the Center for 
Population Research (CPR) of the National Institute of Child Health and Human 
Development (NICHD) invites applications to establish cooperative 
infrastructure to facilitate data sharing in population research.  The purpose 
of this request is to establish a capability to assist in making large-scale, 
complex datasets available to the population research community for secondary 
research analysis.  These datasets typically will be those collected with 
substantial DBSB support.  The desired capability to facilitate data sharing 
must have the following characteristics:  (1) the ability to use state-of-the-
art computer technology to store, document and access large-scale datasets, 
(2) the capability to advise the users about the technical aspects of the 
database, (3) the capability to implement appropriate data security measures 
to protect the privacy of human subjects in complex datasets, and (4) the 
ability to maintain effective outreach to maximize the usage of datasets by 
current and potential data users.

RESEARCH OBJECTIVES

The primary mission of DBSB is to advance population research by supporting 
investigations using the methodologies found in demography and allied fields.  
This research has necessarily featured the analysis of large-scale, 
population-based datasets.  Over time, many important studies have been 
supported by DBSB that both collect and analyze such data and the field has 
evolved a sophisticated, albeit informal, system of data sharing.  The onus of 
data sharing has been placed on the investigators and research centers 
fielding the studies.  Recently, this system has faced increasing challenges.  
The expense of maintaining effective and secure data sharing within the field 
has grown considerably as datasets have become more complex and more 
sensitive.  Some investigators and institutions lack the technical capability 
to provide access to data that is highly complex and sensitive with respect to 
human subjects protection.  Moreover, few institutions have the capability to 
support continued utilization of data after the base grant to collect them 
terminates.  DBSB convened a workshop to discuss these problems and a paper 
entitled "Data Access and Archiving: Options for the Demographic and 
Behavioral Sciences Branch" describes the deliberation and recommendations of 
the workshop.  The paper may be accessed at 
http://www.nichd.nih.gov/cpr/dbs/pubs.htm.  In a related development, the NIH 
has also published a policy of data sharing, 
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html, that 
reinforces the urgency to improve the system of data sharing within the 
population research community.  As a result, DBSB is seeking to create a 
capability that works cooperatively with and improves upon the current system 
of data sharing in population research. 

Currently, datasets created with NICHD funding are shared in a variety of 
ways.  Many investigators simply turn their data over to an existing archive 
or, if the demand for the data is expected to be minimal, provide data on a 
case-by-case basis.  However, for large, complex and/or sensitive datasets 
that have the potential for extensive secondary use, more complex systems of 
sharing have evolved in the population research community.  After the data are 
collected, the Principal Investigator creates and maintains a system to share 
the data with the research community.  During this time, the Principal 
Investigator usually conducts outreach efforts to help researchers outside of 
the investigative team and creates the documentation and help infrastructure 
to allow outside investigators reasonable access to the data.  Quite often an 
interactive system is set up to allow users to notify investigators of any 
problems with the data and this, in turn, helps the investigators improve the 
quality of the dataset.  Increasingly, data access is provided through the 
internet although many datasets are distributed via CD-ROM or equivalent 
media.  Often, a multi-tiered access system is used.  Data that are free of 
concerns about the protection of human subjects are circulated widely with a 
minimum of restrictions concerning research use.  Additional data that are 
sensitive in nature are available only through another tier of protection that 
usually involves contractual agreements between the investigator and the 
secondary user with respect to how the data are analyzed and published.  
Sometimes, the data are so sensitive that they may only be accessed through a 
supervised system.  

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has 
further complicated data sharing.  The Department of Health and Human Services 
(DHHS) has issued the regulation, "Standards for Privacy of Individually 
Identifiable Health Information," applicable to entities covered by HIPAA, 
http://www.hhs.gov/ocr/hipaa/.  As population research evolves to embrace some 
aspects of clinical research or combines traditional population data with 
health records that are HIPAA regulated, the field must learn to deal with 
data security as mandated by this law.

Objectives and Scope

DBSB wishes to preserve this system of data sharing in which the investigators 
have control of the data through the active life of the project and have the 
initial burden of creating a data-sharing system that is appropriate for their 
data.  However, DBSB recognizes that investigators need help in designing 
appropriate systems of data sharing; they may need assistance in improving or 
augmenting data sharing capability during the project period and they need a 
mechanism for ensuring data access after their project funding ends.  The 
cooperative infrastructure created by this initiative will provide this help.

This initiative will support one or more cooperative agreements to assist 
Principal Investigators to develop infrastructure and/or to directly provide 
infrastructure to facilitate the sharing of large-scale datasets in population 
research.  The infrastructure will provide help to investigators in creating 
and operating an effective and innovative data-sharing system and will be 
capable of assuming the primary responsibility for maintaining access to the 
data after the grant support for collecting the data has expired.

Specific Objectives

Applicants must propose to work cooperatively with DBSB and other grantees 
supported by this initiative to provide data-sharing infrastructure to support 
the access of population researchers to data that have, are and will be 
collected by selected studies.  Applicants may request five years of support 
to provide the following infrastructure:

o Consultation infrastructure that will help investigators set up an 
innovative system of data sharing that is tailored both to provide efficient 
data access and provide adequate protection to human subjects. 

o Data access infrastructure that will provide access to data from complex 
and/or sensitive population research studies.  This infrastructure will 
provide full service access to data that are valuable to the research 
community but can no longer be provided through the investigator.  It may also 
augment data-sharing infrastructure for ongoing studies, e.g., in cases where 
highly specialized services are required.  The intent of this infrastructure 
is to improve upon the efforts of individual investigators rather than to 
substitute for their efforts to share data that are supported through the 
project grant or related infrastructure or center grant.

Applicants may propose to offer the full range of desired infrastructure or 
may propose to provide a specialized type of infrastructure, e.g., for a 
particular kind of data or a particular technique for sharing sensitive data. 
The applicants must propose to work cooperatively with DBSB and other grantees 
funded through this solicitation to accomplish the goals of the project. 

For purposes of this RFA, population research is defined as any research 
relevant to the mission of the DBSB.  See 
http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm for details about DBSB.  The 
types of complex datasets to be serviced by the infrastructure include:  The 
National Survey Of Families And Households (NSFH) 
(http://www.ssc.wisc.edu/nsfh/home.htm), The Los Angeles Family and 
Neighborhood survey (LAFANS) (http://www.lasurvey.rand.org/), the National 
Longitudinal Study of Adolescent Health (Add Health)  
(http://www.cpc.unc.edu/projects/addhealth/), The Welfare, Children and 
Families: A Three City Study (Three City Study) 
(http://www.jhu.edu/~welfare/), The Fragile Families and Child Well-being 
Study (Fragile Families Study) (http://crcw.princeton.edu/fragilefamilies/), 
or The New Immigrant Survey (NIS) (http://www.pop.upenn.edu/nis/).  In 
addition, the branch is developing a portfolio of research in the field of 
population health that is expected to yield complex data for future research.  
See the Community Child Health RFA (RFA-HD-02-008) for an example of such a 
development 
(http://grants2.nih.gov/grants/guide/rfa-files/RFA-HD-02-008.html).

MECHANISM OF SUPPORT

This RFA will use the NIH Resource-Related Research Project - Cooperative 
Agreement (U24) award mechanism.  As an applicant you will be solely 
responsible for planning, directing, and executing the proposed project.    
The anticipated award date is July 01, 2004.  

The NIH U24 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."  

FUNDS AVAILABLE

The NICHD intends to commit approximately $750,000 in total costs [Direct plus 
Facilities and Administrative (F & A) costs] in FY 2004 to support one to four 
new and/or competing continuation grants in response to this RFA.  An 
applicant may request a project period of up to five years and a budget for 
direct costs of up to $600,000 per year.  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 NICHD 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 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 Faith-based or community-based organizations 
o Domestic institutions/organizations
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 his/her 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

Cooperative Agreement Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the award 
statement.  They are to be followed in addition to, and not in lieu of, 
otherwise applicable OMB administrative guidelines, HHS grant administration 
regulations at 45 CFR Parts 74 and 92, and other HHS and NIH grant 
administration policies.

The administrative and funding instrument used for this program will be the 
U24, an "assistance" mechanism (rather than an "acquisition" mechanism), in 
which substantial NIH scientific and/or programmatic involvement with the PI 
is anticipated during performance of the activities. Under the cooperative 
agreement, the NIH purpose is to support and/or stimulate the PI's activities 
by involvement in and otherwise working jointly with the PI in a partnership 
role; it is not to assume direction, prime responsibility, or a dominant role 
in the activities.  Consistent with this concept, the dominant role and prime 
responsibility resides with the PI for the project as a whole, although 
specific tasks and activities may be shared between the awardee and the NICHD 
Project Coordinator.  Facilities and Administrative cost (formerly called 
indirect cost) award procedures apply to cooperative agreements in the same 
manner as for grants.  Business management aspects of these awards will be 
administered by the NICHD Grants Management Branch in accordance with HHS and 
NIH grant administrative requirements.

1.  Awardee Rights and Responsibilities

Awardees have primary authorities and responsibilities to define objectives 
and approaches, and to plan, conduct, analyze, and publish results, 
interpretations, and conclusions of their studies.  The primary 
responsibilities of awardees are to:

o Define the objectives of the plan to create and provide infrastructure;

o Design the necessary strategies and approaches for creating and providing 
the infrastructure;

o Conduct specific studies and operate infrastructure;

o Analyze and interpret data and needs of the population research community;

o Modify plans and operations as required;

o Provide information to the NICHD Project Coordinator concerning progress.

Awardees will retain custody of and have primary rights to the data developed 
under these awards, subject to Government rights of access consistent with 
current HHS, PHS, and NIH policies.

2. NIH Responsibilities

NICHD Project Coordinator:

An NICHD Project Coordinator will have substantial programmatic involvement, 
above and beyond normal program stewardship.  The NICHD Project Coordinator 
will represent the government's interests on the Steering Committee.  The 
Project Coordinator will provide information on datasets that are candidates 
for support through the cooperative agreement and will provide an assessment 
of priority of each dataset in regard to potential support through the 
cooperative agreement.  The Project Coordinator will work to reconcile the 
capacity of the awardee(s) with the needs of individual investigators who wish 
to share data, population research centers that are supporting data sharing 
and the population research community that uses shared data.  The Project 
Coordinator will establish a time and place for each Steering Committee 
meeting. 

NICHD Project Officer:

The NICHD will appoint a Project Officer, apart from the Project Coordinator, 
who will:

o Carry out continuous review of all activities to ensure that the objectives 
are being met and that all regulatory, fiscal, and administrative matters are 
handled according to NIH guidelines.

o Have the option to withhold support to a participating institution if 
technical performance requirements are not met.

o Perform other duties required for normal program stewardship of grants.

3. Collaborative Responsibilities

Grantees will be expected to cooperate with NICHD and the population research 
community to ensure that the infrastructure to share data is adequate to meet 
the needs of population research.  This will involve working to support the 
efforts of individual investigators, providing services directly to the 
population research community and innovating new solutions as technology 
permits. 

Steering Committee

A Steering Committee will be established that will create a set of operating 
procedures that will be published as a manual of operations and the 
cooperative agreement will be bound by these procedures.  The Steering 
Committee will be the decision-making body for determining which datasets to 
serve and what help to provide.  It will balance available resources with the 
importance of the dataset to the field and the needs and capabilities of the 
investigator.  The Steering Committee will comprise the Project Coordinator 
for the grant(s) and the Principal Investigator(s) of the grant(s).  Each will 
have one vote in situations requiring a vote. 

There will be semi-annual face-to-face one and one-half day meetings of the 
Steering Committee and other meetings as needed through telephone or internet 
connections.  One face-to-face meeting will occur in Bethesda, MD and the 
other at the annual meeting of the Population Association of America.  

Advisory Committee

In addition, NICHD will appoint an advisory committee that will meet at least 
once a year with the Steering Committee to advise on issues such as data 
security, data access, and priorities for resource allocation.

4.  Arbitration Process

Any disagreements that may arise in scientific or programmatic matters within 
the scope of the award between grantees and the NIH may be brought to 
arbitration.  This special arbitration procedure in no way affects the 
awardee's right to appeal an adverse action that is otherwise appealable in 
accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulation 
at 45 CFR Part 16.  An Arbitration Panel will help resolve both scientific and 
programmatic issues that develop during the course of work that restrict 
progress.  The Arbitration Panel will be composed of three members:  a member 
selected by the Steering Committee without NIH staff voting, a member selected 
by NICHD, and a member with expertise in the relevant area selected by the 
other two members.

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:  

Jeffery Evans Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1176
FAX:  (301) 496-0962
Email:  je30m@nih.gov

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104
Email:  stretchr@mail.nih.gov

o Direct your questions about financial or grants management matters to:  

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  hancockk@mail.nih.gov 

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 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 NICHD 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:  

Jeffery Evans Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1176
FAX:  (301) 496-0962
Email:  je30m@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 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:  Applicants should include funds in their budget 
requests to allow the Principal Investigator to attend two Steering Committee 
meetings per year, each for one and one-half days.

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/label-bk.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 
copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (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 eight 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 and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  Incomplete and/or non-responsive 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 NICHD 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 Child Health and 
Human Development Council.

REVIEW CRITERIA

The goals of DBSB-supported research are to advance our understanding of human 
population processes, understand the causes and consequences of population 
change and enhance the general child health and human development mission of 
NICHD.  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 Quality and potential impact of proposed infrastructure program:  Reviewers 
will examine the overall quality, scientific merit, and innovation of the 
activities to be supported.  Reviewers will consider the likelihood, based on 
existing capabilities and proposed activities, that the proposed program will 
facilitate data sharing in population research.

o Technical competence of key personnel:  Reviewers will consider the 
capability and credentials of the Principal Investigator to direct the 
infrastructure and maintain high standards of collaboration with the 
population research community and the specific technical qualifications of key 
support personnel.

o Institutional commitment and environment:  Reviewers will assess the nature 
and level of resource commitment from the institution in which the 
infrastructure is housed and any cooperating institutions, taking into account 
the institutional context.  Reviewers also will consider the academic and 
physical environment as it bears on the potential for interaction with 
scientists from the population research community and allied fields.

o Capacity to support the number and variety of datasets vital to the field of 
population research:  Reviewers will assess the applicant's ability to support 
the number and variety of datasets that are considered vital to population 
research.

o The ability to work cooperatively with individual investigators, population 
research centers and the NICHD to achieve the goals of the RFA.

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:

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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

ADDITIONAL REVIEW 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:  December 15, 2003
Application Receipt Date:  January 15, 2004
Peer Review Date:  February/March 2004
Council Review:  June 2004
Earliest Anticipated Start Date:  July 01, 2004

AWARD CRITERIA

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
o Balance of data sharing capabilities available to the cooperative project

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 

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 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 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.

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://grants1.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


H H S Department of Health
and Human Services

 
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