ANCILLARY STUDIES TO MAJOR ONGOING NIDDK CLINICAL RESEARCH STUDIES 

RELEASE DATE:  March 19, 2004

PA NUMBER:  PAR-04-078 (This PA has been modified, see PAR-06-216)

EXPIRATION DATE:  After March 2, 2007, unless reissued. 

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH)
 (http://www.niddk.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.847, 93.848, 93.849

THIS PAR CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PAR

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites investigator-initiated research project applications for ancillary 
studies to ongoing large-scale clinical trials, epidemiological studies and 
disease databases supported by the Institute.  These studies are focused on a 
wide range of diseases and conditions including diabetes, obesity, acute and 
chronic liver disease, chronic kidney disease, benign prostatic hyperplasia, 
among others.  The goal of these ancillary study proposals must complement 
but not overlap or interfere with the primary and secondary objectives of the 
parent study.  Each applicant must abide by the procedures for conducting 
ancillary studies established by the parent study group.  
  
RESEARCH OBJECTIVES

The NIDDK supports a large number of clinical trials in patients with 
diabetes, obesity, acute and chronic liver disease, chronic kidney disease, 
non-malignant urological conditions such as benign prostatic hyperplasia and 
other diseases/conditions within the purview of the Institute.  The Institute 
also conducts several large-scale epidemiological studies and disease 
databases to better characterize the treated natural history of type 1 and 
type 2 diabetes, chronic kidney disease, acute and chronic liver disease, a 
wide range of non-malignant urological conditions in men and women as well as 
other diseases.  Each of these studies represents a substantial financial 
commitment from the NIDDK to establish an infrastructure for participant 
recruitment and follow-up.  These studies offer unique opportunities to 
conduct additional investigations to fully exploit the research potential of 
each of these established cohorts.  

Each of the studies for which ancillary study proposals may be submitted has 
limitations on the type of investigations permissible and each has specific 
requirements for partnership with parent study investigators.  

You may not request support for activities that are part of the core protocol 
for the parent study.  Likewise, you may not seek funds for analysis of 
existing data or for studies that substantially duplicate ongoing ancillary 
studies to the parent studies.

In most cases, expansion of intervention protocols for clinical trials will 
not be permitted; however, in certain limited circumstances, this might be 
considered by the parent study.

The goal of this Program Announcement (PAR) is to support projects that are 
designed to provide additional information concerning the primary and 
secondary objectives of the parent study.  It is required that proposed 
ancillary studies be integrated with and complement the studies carried out 
by the parent study, and there be close collaboration between ancillary study 
and parent study investigators.  Applications proposing additional data 
collection and/or analyses of patient samples that do not clearly extend and 
enhance the stated major research objectives of the parent study will be 
considered non-responsive to this PAR.

Descriptions of the NIDDK supported clinical trials, epidemiological studies 
and disease databases eligible for ancillary studies in response to this PAR 
can be found at the following website: 
http://www.niddk.nih.gov/fund/ancillary-studies/.   For many of the studies 
eligible for this PAR, ancillary study policies are described at their 
websites, which are noted in these descriptions. For those studies without 
such a website, ancillary study policies may be found at the same website 
listing descriptions of eligible studies.  Note that some studies are 
undergoing protocol development.  As soon as ancillary study policies become 
available for these studies, they will be posted on the website noted above.  
In addition, the list of eligible consortia and networks will change over 
time.

MECHANISM OF SUPPORT 

This PAR will use the National Institutes of Health (NIH) research project 
grant (R01) award mechanism.  As an applicant, you will be solely responsible 
for planning, directing, and executing the proposed project. 

The total requested project period for an application submitted in response 
to this PAR may not exceed five years. 

This PAR uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm) as 
well as the non-modular budgeting formats.   Specifically, if you are 
submitting an application with direct costs in each year of $250,000 or less, 
use the modular budget format.  Otherwise, follow the instructions for non-
modular budget research grant applications.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  

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 Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS 

To be responsive to the requirements of this Program Announcement, you must 
propose studies using only the ongoing NIDDK supported clinical trials, 
epidemiological studies and disease databases found at the website 
established for this solicitation.

Ancillary studies associated with major clinical trials and epidemiological 
studies/disease databases provide a valuable opportunity to further extend 
the knowledge gained from these studies.  However, the potential value of 
such studies must be balanced against the need to ensure that the main 
clinical trial outcomes or objectives of the epidemiological studies/disease 
databases are not compromised by the burden of additional studies.  Hence, 
you must provide documentation at the time of grant submission that you have 
received approval from the appropriate governing body of the parent study to 
conduct your proposed ancillary study.  Each clinical trial, network or 
epidemiological study/disease database covered by this announcement has 
provided guidelines for which types of ancillary studies are currently 
acceptable and for the process of obtaining approval.  These study-specific 
guidelines are either currently posted on each study’s website or links will 
be provided as they become available via the website for this Program 
Announcement located at: http://www.niddk.nih.gov/fund/ancillary-studies/.
In addition, ancillary study policies for selected studies are posted at the 
website established for this PAR. Please note that study-specific 
restrictions may limit the types of ancillary proposals that are acceptable.

Applications not containing documentation of preliminary approval from the 
appropriate governing body (such as the Steering Committee) will be 
considered non-responsive to this announcement and will be returned to the 
Investigator, without having undergone peer review, by the NIDDK.

You must include a statement of your willingness to work collaboratively with 
the parent study and to abide by all parent study policies, publication 
restrictions, data access provisions, etc.

You may be required by specific trials, networks, or epidemiological 
studies/disease databases to include funds in your application to travel to 
national Steering Committee meetings and/or to cover the cost of access to 
samples and data held by the parent study Data Coordinating Center or by 
central repositories.

Data Sharing Plan

Due to the collaborative nature of the parent studies, all applicants will be 
required to submit a data sharing plan, regardless of the dollar amount of 
their application.  Reviewers will assess the adequacy of the proposed plan.  
Ancillary studies will also be required to abide by the data sharing policies 
of the parent study.

NIH policy requires that investigators make unique research resources readily 
available for research purposes to qualified individuals within the 
scientific community after publication (Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts on Obtaining and 
Disseminating Biomedical Research Resources:  Final Notice 
(http://www.ott.nih.gov/policy/rt_guide_final.html).  Therefore, it is 
expected that the specimens and data collected in projects funded by the PAR 
will be made available to the broader scientific community, after a 
proprietary period, at no charge other than the costs of reproduction and 
distribution. 

This PAR has a special requirement that applicants include a “Sharing Plan” 
in the application that describes how they will share the specimens and data 
collected with the wider scientific community.  The Plan must include the 
eventual transfer of these materials to the NIDDK Central Biosample and Data 
Repositories or another archival storage facility designated by NIDDK.  
Approval of the data sharing plan will be a condition of the award.  The 
effectiveness of the resource sharing will be evaluated as part of the 
administrative review of each Non-competing Grant Progress Report (PHS 2590).

Data and Safety Monitoring Plan

All applicants must include a data and safety monitoring plan for the 
ancillary study activities even when the parent trial already has a central 
Data and Safety Monitoring Board and even if the study is of minimal risk.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PAR 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:

Barbara Harrison, M.S.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 661
Bethesda, MD 20892-5450
Telephone:  301-594-8858
Fax:  301-480-8300
E-mail:  bh72k@nih.gov

John W. Kusek, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 617
Bethesda, MD  20892-5458
Telephone:  301-594-7735
FAX:  301-480-3510
Email: jk61x@nih.gov  

Sanford A. Garfield, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 685
Bethesda, MD 20892-5460
Telephone:  301-594-8803
Fax:  301-480-6271
E-mail: sg50o@nih.gov

Scientific/research questions on a specific study should be directed to the 
contact listed on the website for that study.

o Direct your questions about peer review issues to: 

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752 
Bethesda, MD  20892-5452
Telephone: (301) 594-8897
FAX: (310) 480-3505
Email: fc15y@nih.gov 

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

Sharon Bourque
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 719
Bethesda, MD 20892-5456
Telephone: 301-594-8846
Fax:  301-480-3504
Email: sb114m@nih.gov

Helen Ling
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 732
Bethesda, MD  20892-5456
Telephone:  301-594-8857
FAX:  301-480-3504
Email: hl12d@nih.gov 

Florence Danshes
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 734
Bethesda, MD 20892-5456
Telephone:  301-594-8861
Fax:  301-480-3504
Email: fd39j@nih.gov 

Financial/grants management questions on a specific study should be directed 
to the contact listed on the website for that study.

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.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS 

You must submit a letter documenting the preliminary approval of your 
proposed ancillary study by the parent trial, network or epidemiological 
study/disease database.  The required documentation varies somewhat between 
the parent studies, so be sure to follow the procedures provided by the 
parent trial, network, or epidemiological study of interest to you.

In addition, you must explicitly state your willingness to abide by the 
policies of the parent trial, network, or epidemiological study.  It is 
strongly advised that the letter documenting the preliminary approval be sent 
to the NIDDK Programmatic contact (see "Where to Send Inquires") at an early 
stage of application development. NIDDK's receipt of the letter of 
preliminary approval, signed by the representatives of the consortium/network 
Steering Committee, will allow NIDDK Staff to plan for the Referral and 
Review of the application.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant 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 
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the 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 IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

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. 

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
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and all 
appendices must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752 
Bethesda, MD  20892-5452
(Courier use ZIP 20817)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PAR that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

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.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIDDK.  Incomplete or non-responsive applications will 
be returned to the applicant without further consideration.  Applications 
that are complete and responsive to this PAR will be evaluated for scientific 
and technical merit by an appropriate peer review group convened by the NIDDK 
in accordance with the review criteria stated below.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of 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 Diabetes and Digestive and 
Kidney Diseases Advisory Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

SIGNIFICANCE: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive 
this field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

Justification of the need for access to the clinical trial, network of 
epidemiological study/disease database.

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). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data  

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score 
(http://grants.nih.gov/grants/policy/data_sharing)

Data and Safety Monitoring Plan

The adequacy of a data and safety monitoring plan for the ancillary study 
will be assessed by the reviewers.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PAR will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Programmatic priorities:  Only very meritorious applications within the 
scientific interests and scope of the NIDDK mission will be supported
o Cumulative burden to the parent study:  The cumulative burden to the parent 
study of all ancillary studies ongoing and proposed for funding under this 
PAR may be a limiting factor.  For example, if small quantities of biological 
samples are available, not all studies rated as highly meritorious may be 
able to access them.  Likewise, the cumulative burden of studies already 
approved for funding may be such that those of lower priority cannot be 
funded, regardless of priority score.

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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).  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.  

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PAR 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 
PAR is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Bethesda, Maryland 20892
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and Human Services (HHS)
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