NIAMS CLINICAL TRIAL OUTCOMES INSTRUMENT DEVELOPMENT GRANT PROGRAM 
 
RELEASE DATE:  October 27, 2003

RFA Number:  RFA-AR-04-005 
 
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 Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
 (http://www.niams.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S):  93.846
 
LETTER OF INTENT RECEIPT DATE:   December 13, 2003
APPLICATION RECEIPT DATE:        January 13, 2004   

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o 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

This announcement solicits research applications to develop, apply and 
evaluate new clinical trial outcomes measures of safety, efficacy and 
effectiveness of therapies for diseases, illnesses and injuries of 
interest to the NIAMS. Clinical trials in rheumatic, skin, bone and 
muscle diseases are often hampered by the lack of validated outcome 
measures or by outcome measures that are cumbersome, time-consuming and 
costly.  Increasing availability of computer modeling and statistical 
approaches, along with better understanding of disease natural history, 
have yielded new concepts and new models that may be relevant to the 
development of new and refined outcomes for clinical trials in diseases, 
illnesses and injuries of interest to the NIAMS.  This RFA is intended 
to accelerate the development and testing of new outcomes measures and 
instruments that could lead to improved trial designs or to the 
development of consensus about new instruments based on new or existing 
measures.    

RESEARCH OBJECTIVES
 
Background

The ability to conduct well-designed clinical studies to assess efficacy 
of new therapies depends on the identification of clinically relevant 
endpoints and development of sensitive and specific instruments that 
accurately reflect the course and stage of disease.  Except for the most 
common diseases (i.e., rheumatoid arthritis, osteoporosis), outcomes 
measures and benchmarks for comparison of clinical outcomes are sorely 
lacking in most areas of clinical research interest to NIAMS.  For some 
diseases, a number of outcome instruments exist but they are not used 
consistently. For example, in lupus, there are more than 20 
“instruments” that can be used in clinical trials to measure outcomes. 
Some measure disease activity, some measure organ damage, some are 
composite or index instruments that capture some, but not all, 
components/responses in disease. Often, lupus clinical trials are 
conducted using similar therapeutics but different outcomes instruments. 
This makes the comparison of results and the potential efficacy, 
toxicity, and complications of new therapeutic approaches very 
difficult. In addition, it hampers efforts by organizations, such as the 
FDA, to develop guidance documents for industry with benchmarks for 
approval of new agents.  The same applies to many other diseases, 
illnesses and injuries of interest to the NIAMS.  

In spite of the diversity of potential therapeutic approaches, trials in 
diseases, illnesses and injuries of interest to the NIAMS are difficult 
because many of the diseases are rare; the clinical manifestations are 
heterogeneous, requiring long-term follow-up; and the outcomes are often 
measured with "disease index/activity" measure instruments, which are a 
combination of many clinical parameters. The lack of proven therapies 
for other diseases of interest to the NIAMS such as muscular dystrophy, 
inflammatory myopathies, and other muscle and skin diseases is due in 
part to the rarity and heterogeneity of these diseases and in part to 
the lack of standardized and validated approaches for assessing disease 
activity and damage in patients. Skeletal muscle specific outcome 
measures or validated surrogate markers are not adequate for studies of 
treatments or systematic longitudinal assessments.  Common, chronic 
diseases such as lupus, rheumatoid arthritis or osteoarthritis, require 
long term follow up, and there may be no consensus about the best 
outcomes measures for trials aimed at structural change (i.e., 
prevention of erosion, delayed joint space narrowing, etc), single organ 
damage prevention (i.e., lung fibrosis in scleroderma), or surgical 
treatments. These factors contribute to clinical trial designs that 
frequently involve a large number of patients and are very costly. In a 
recent NIAMS-sponsored lupus conference, the private sector identified 
the lack of understandable, universal outcomes measures as the primary 
impediment to embarking more vigorously in clinical trials for this 
disease. (http://www.niams.nih.gov/ne/reports/sci_wrk/2002/summary.htm). 

In addition to established therapies, new agents and approaches are 
being developed in laboratories and tested in experimental animals for 
repair/replacement and preventive interventions of diseases, illnesses 
and injuries of interest to the NIAMS. Trials for these 
agents/technologies are also difficult because the primary outcome 
measure may be distant to the therapeutic target.  For example, the 
prevention of lupus nephritis with a tolerogenic dose of a very specific 
agent is difficult to evaluate when the outcome is changes in a disease 
activity index that combines indicators of many organ systems and 
overall disease activity. 

New technologies are being applied rapidly to the development of 
biomarkers of disease for identification of patient subsets, evaluation 
of disease outcomes, evaluation of response to therapies and the 
identification of predictors of outcomes. However, it is unclear how 
these potentially valuable biomarkers (i.e., array data) can be 
incorporated into disease outcome measure instruments in a meaningful 
way. Thus, there is a great need to refine existing instruments to 
incorporate biomarkers and to test biomarkers together with other 
outcomes in large cohorts. New techniques in the areas of clinimetrics, 
statistical analysis, computer simulation, etc. may help improve the 
design of relevant outcome variables that include biomarkers to be used 
in smaller, more cost-effective trials. 
  
Scope

This RFA encourages projects that propose to design, evaluate, validate, 
and test new and/or improved outcome measures for clinical trials in 
diseases, illnesses and injuries of interest to the NIAMS (see 
http://www.niams.nih.gov/rtac/funding/faq.htm).  The experimental design 
of a project may include, for example, consensus development approaches, 
meetings of experts, collection of data, beta testing of new 
instruments, mathematical and computer modeling, validation studies. The 
proposal should include plans to disseminate information and have input 
from relevant scientific communities and professional organizations on 
the scientific merit and applicability of new and improved outcomes. 
Approaches that take advantage of bioinformatics to speed up data 
collection, analysis, dissemination and updates are encouraged. 

Suggested topics may include, but are not limited to:

o The use of the preliminary definitions of improvement for adult and 
juvenile disease as primary or secondary endpoints.

o New outcomes to evaluate disease damage and their 
interaction/combination with other disease outcomes. 

o New outcomes (i.e., biomarkers, imaging modalities) to functionally 
assess the early progress/success of interventions such as tissue-
engineered repairs.

o Outcomes tools that includes biomarkers, new imaging and other 
technologies in the evaluation of responses to diagnostic procedures and 
non-operative and operative treatments.

o Uses of health-related quality of life measures in the context of 
chronic rheumatic, musculoskeletal, muscle and skin diseases, illnesses 
and injuries in adult and pediatric patients.  

o Development of new methods for collection of a common core set of 
measures that could be used in different trials that would ensure more 
uniform reporting of outcome measures. 
   
o Approaches that allow the combination of the data from trials in which 
all measures have been collected to confirm the validity of the 
preliminary definition of improvement (DOI) and attempt to derive 
improved DOIs.  

o Approaches to facilitate the updating, sharing and disseminating of 
trial data, current core set measure forms, and uniform data collection 
procedures.

o Identification, access and use of existing databases to analyze and 
test new or combined outcomes measures.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) R01 
(investigator-initiated research project grant). Responsibility for the 
planning, direction, and execution of the proposed project will be 
solely that of the applicant.  Before making an award for an 
investigator-initiated clinical trial outcomes instrument development 
project, the NIAMS will consider the desirability of substantial 
continued staff involvement in an assistance mode. If such involvement 
is deemed appropriate by the Institute, the award mechanism will be a 
cooperative agreement. Regardless of the mechanism of support, NIAMS 
staff will closely monitor progress during the award. This monitoring 
may include regular communications with the principal investigator and 
staff, the request to develop mutually agreeable milestones for the work 
to be done, and attendance at the steering committee and other project-
related meetings. The Terms and Conditions for an award will include 
milestones expected to be met by projects at specific time periods, any 
requirements regarding minimum effort of specific investigators, and any 
other identified requirements for completion of the approved research. 
As with any award, continuation, even during the period recommended for 
support, is conditional upon satisfactory progress.  Applicants may 
request up to $150,000 (direct costs) per year for up to three years.  
These awards are not renewable.

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (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.  This 
program does not require cost sharing as defined in the current NIH 
Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

Specifically, when an application is submitted with direct costs in each 
year of $250,000 or less, the modular format should be used. The 
anticipated award date is December 2004.  Applications that are not 
funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated applications using the standard receipt dates 
for NEW applications described in the instructions to the PHS 398 
application. This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE

The NIAMS intends to commit approximately $1.0 million in FY 2004 to 
fund four or five new grants in response to this RFA. An applicant may 
request a project period of up to three years and a budget for direct 
costs of up to $150,000 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 NIAMS provide support for this 
program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications. 

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:
         
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government 
o Faith-based or community–based organizations 
o Domestic or foreign institutions/organizations
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

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:

Susana Serrate-Sztein, M.D. 
Director, Genetics and Clinical Studies Program, NIAMS, NIH
One Democracy Plaza 
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD  20872-4872
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: szteins@mail.nih.gov

Alan Moshell, M.D.
Director, Skin Diseases Program, NIAMS, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD  20872-4872
Telephone: (301) 594-5017
FAX: (301) 480-4543
Email: moshella@mail.nih.gov

Joan McGowan, Ph.D.
Director, Bone Diseases Program, NIAMS, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD  20872-4872
Telephone: (301) 594-5055
FAX: (301) 480-4543
Email: mcgowanj@mail.nih.gov 

James S. Panagis, M.D.
Director, Orthopaedics Program, NIAMS, NIH 
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD  20872-4872
Telephone: (301) 594-5055
FAX: (301) 480-4543
Email: panagisj@mail.nih.gov

Gayle E. Lester, Ph.D.
Program Director, Osteoarthritis Initiative & Diagnostic Imaging, NIAMS, 
NIH
One Democracy Plaza 
6701 Democracy Boulevard Suite 800, MSC 4872 
Bethesda, Maryland 20892-4872 
Telephone: (301) 594-3511 
FAX:  (301) 480-4543
Email:  lester1@mail.nih.gov
                                                                        
o Direct your questions about peer review issues to:

Teresa Nesbitt, D.V.M., Ph.D.
Chief, Review Branch, NIAMS, NIH
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-5032
Telephone:  (301) 594-4953
FAX:  (301) 480-4543
Email:  nesbittt@mail.nih.gov
 
o Direct your questions about financial or grants management matters to: 

Mr. Michael G. Morse
Deputy Chief, Grants Management Branch, NIAMS, NIH 
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD  20872-4872
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email: morsem@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 IC staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Susana Serrate-Sztein, M.D. 
Director, Genetics and Clinical Studies Program, NIAMS, NIH 
One Democracy Plaza 
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD  20872-4872
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: szteins@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must have 
a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number 
as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling (866) 
705-5711 or through the web site at http://www.dunandbradstreet.com/. 
The DUNS number should be entered on line 11 of the face page of the PHS 
398 form. The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular 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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original 
of the application, including the Checklist and three signed 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

Teresa Nesbitt, D.V.M., Ph.D.
Chief, Review Branch
NIAMS
One Democracy Plaza
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20872-5032
Telephone:  (301) 594-4953
FAX:  (301) 480-4543
Email:  nesbittt@mail.nih.gov
 
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes 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 and 
responsiveness by the CSR and the NIAMS. Incomplete and/or nonresponsive 
applications will not be reviewed.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIAMS 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 Arthritis and 
Musculoskeletal and Skin 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 the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them as 
appropriate for each application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

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

SIGNIFICANCE: Does this study address an important problem? If the aims 
of the application are achieved, how will clinical trials 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:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections 
on Federal Citations, below).

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

ADDITIONAL REVIEW CONSIDERATIONS 

SHARING RESEARCH DATA:  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. 

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 13, 2003
Application Receipt Date:        January 13, 2004
Peer Review Date:                July 2004
Council Review:                  December 2004
Earliest Anticipated Start Date: December 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to be 
gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the Internet 
sites.   Furthermore, we caution reviewers that their anonymity may be 
compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

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

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


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