INTERNATIONAL BIOETHICS EDUCATION AND CAREER DEVELOPMENT AWARD

RELEASE DATE:  August 5, 2003

RFA Number:  RFA-TW-04-001 (This RFA has been modified, see RFA-TW-06-003)

Fogarty International Center (FIC)
 (http://www.fic.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) 
 (http://www.nccam.nih.gov) 
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI) 
 (http://www.nhgri.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) 
 (http://www.niehs.nih.gov)
National Institute of General Medical Sciences (NIGMS) 
 (http://www.nigms.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.989, 93.213, 93.233, 
93.837, 93.838, 93.839, 93.172, 93.856, 93.121, 93.277, 93.894, 93.862

LETTER OF INTENT RECEIPT DATE:  November 17, 2003

APPLICATION RECEIPT DATE:  December 16, 2003

EXPIRATION DATE: December 17, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Training 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 Fogarty International Center (FIC), in partnership with the 
National Center for Complementary and Alternative Medicine (NCCAM), the 
National Heart Lung and Blood Institute (NHLBI), the National Human 
Genome Research Institute (NHGRI), the National Institute of Allergy 
and Infectious Diseases (NIAID), the National Institute of Dental and 
Craniofacial Research (NIDCR), the National Institute on Drug Abuse 
(NIDA), the National Institute of Environmental Health Sciences 
(NIEHS), and the National Institute of General Medical Sciences 
(NIGMS), invites applications to develop or expand current graduate 
level curricula and training opportunities in international bioethics 
related to performing research involving human subjects in low- and 
middle-income nations.  Since current programs provide training for 
participants from the Asian, African and Latin American regions (for 
descriptions of current programs, see 
http://www.fic.nih.gov/programs/bioethics/bioethicsaward.html), new 
applications focusing on countries of the Middle East, North, East and 
West Africa, Eastern Europe and the former Soviet Union are encouraged.  
Applicant institutions can request up to four years of support to 
create comprehensive curriculum development and training programs.  
Developing country institutions can request up to two years of support 
for program planning and curriculum development in preparation to apply 
for comprehensive training program support in the future.  In addition, 
current International Bioethics Education and Career Development 
awardees may apply for competing supplements to their award to 
collaborate with other Fogarty International Center programs (for 
descriptions of other programs see the FIC web site 
http://www.fic.nih.gov/programs.html).  Proposed curricula should 
provide a core set of advanced study courses that primarily focus on 
the internationally relevant aspects of the ethical, legal and social 
principles guiding the responsible conduct of research in developing 
countries.  Support will be provided for training developing country 
health professionals working at institutions conducting biomedical, 
behavioral or public health research involving human subjects, and for 
ethicists or philosophers from developing countries with an interest in 
biomedical/clinical research.  Appropriate training may include 
advanced degree and non-degree associated course work and practicum 
experiences such as participation in ethical review committees, 
development of intensive short courses designed for human subjects 
research ethical review committee members, analysis of ethical review 
guidelines or processes and research on ethical practices in biomedical 
or behavioral research in the trainees' countries.  

This RFA contributes to the Fogarty International Center's initiative 
to strengthen research bioethics expertise in developing countries.  
This RFA is intended to stimulate the development of new instructional 
programs in international bioethics at institutions that do not 
currently offer such programs or to expand existing instructional 
programs in international bioethics to include a major focus on issues 
relevant to developing countries.  The goal of this initiative is to 
increase the cadre of developing country biomedical and behavioral 
scientists, clinical investigators, nurses and other health 
professionals and relevant academics with state-of-the-art knowledge of 
ethical considerations, concepts and methods in research involving 
human subjects.  It is expected that such advanced training will 
enhance the career development of individuals from developing countries 
as well as strengthen bioethical expertise at the trainees' host 
institutions.  

TRAINING OBJECTIVES

Background:  Few developing country institutions provide formal training 
in bioethics, and few developed country programs for advanced bioethics 
training focus in depth on the internationally relevant aspects of 
bioethics, particularly those related to clinical investigations and 
traditional medical interventions in developing countries.  Therefore, 
few developing country health professionals conducting laboratory or 
clinical investigations have received extensive training in the 
principles of bioethics, codes and legal aspects of ethical research, 
ethical experimentation on vertebrate animals, informed consent, 
decision-making related to collaborative agreements between host and 
sponsors of clinical research, elements of study design that affect the 
ethical conduct of clinical trials, or interventions that should be 
provided to study participants.  

Objectives of Training Program:  This initiative is to train academics, 
health professionals and researchers from developing countries in 
culturally relevant bioethics related to research.  Proposed training 
programs should equip them with the critical skills that are needed to 
provide bioethics expertise and leadership to their institutions, 
national governments and international bodies and potentially, to pursue 
studies on ethical practice in biomedical and behavioral research in 
developing countries.  The specific objectives are:  

1) Curriculum Development:  To improve the quality of international 
ethics training by supporting the development of courses in fundamental 
areas needed to provide skills for teaching and research related to 
bioethics and the ethical review of research on acute and chronic 
diseases in developing countries.  Curriculum should include topics most 
relevant to the bioethics issues widely experienced in conducting 
research involving human subjects in resource poor settings in 
developing countries including voluntary informed consent, standards of 
medical care, sensitivity to cultural differences, research on 
vulnerable populations, benefits sharing, use of human biological 
materials, human rights, conflict of interest, equivalent protections 
and harmonization of international guidelines.  Applicants are 
encouraged to develop training modules including topics related to the 
specific research interests of the participating NIH Institutes and 
Centers listed above, for example, research on vulnerable populations 
related to drug use and abuse.

2) Training:  To support appropriate advanced training for a cadre of 
developing country professionals who could assume the expert roles and 
leadership responsibilities when involved in ethics review, clinical 
trials and epidemiological studies in their countries.  Applications 
that provide training for participants from the Middle East, North, East 
and West Africa, Eastern Europe and the former Soviet Union are 
encouraged.

Training Program:  Applications should propose programs for up to two 
years and no less than 12 months of advanced bioethics training for 
developing country trainees through an appropriate combination of 
instructional and practical experiences at the grantee, consortium or 
home country institutions.  Applicants should provide a detailed 
description of the proposed courses and practicum opportunities 
currently available or to be developed along with explicit educational 
goals of each program component.  Curriculum developed in comprehensive 
programs must be offered to trainees after a maximum of one year of the 
award.  Training should be initiated in comprehensive programs during 
the first year of support, if feasible.

Faculty:  The Principal Investigator will direct the training program 
and, with associated faculty, design, implement, evaluate and refine, as 
needed, an international bioethics curriculum.  The Program Director 
should possess the international bioethics expertise, leadership 
experience and the administrative capabilities required to create an 
interdisciplinary instructional program.  He or she should be currently 
engaged in international ethics research as well as in mentoring 
international students.  Proposed faculty should be actively engaged in 
the design and conduct of bioethical research, and have a record in 
obtaining funding for these activities.  Faculty trained in ethics, 
philosophy, law, clinical research and public health are recommended.  
Faculty should also be accomplished research investigators and graduate 
training mentors.  The capability of the participating faculty to 
develop bioethics curricula, instruct and mentor individuals to pursue 
careers in international bioethics must be documented.  Applicants are 
encouraged to include faculty from developing countries.  The role(s) of 
each proposed faculty member in course development, instruction and 
mentoring trainees should be described.

Trainees:  Applicants should describe how potential participants from 
diverse professional backgrounds (postdoctoral behavioral and biomedical 
scientists, physicians, nurses, midwives, traditional medicine 
practitioners, ethics review committee members, hospital directors and 
health policy-makers, as well as ethicists or philosophers, with an 
interest in biomedical/clinical research) will be recruited and selected 
as trainees including descriptions of selection criteria and selection 
committee members.  Applicants should include strategies for recruiting 
and retaining adequate representation of women and ethnic minorities in 
the home countries of the developing country trainees.  Individuals 
selected for training should demonstrate a high level of interest in 
bioethics, the immediate potential to provide bioethics expertise to 
their host institutions, national governments and international bodies 
and pursue studies on ethical practice in biomedical and behavioral 
research in their countries.  A faculty mentor with appropriate research 
and training experience in ethical issues related to biomedical or 
behavioral research should be provided for each trainee during their 
training period.  Applicants are encouraged to include plans for 
enabling trainees to develop and sustain bioethics programs on return to 
their home country.  It is expected that, upon completion of their 
training, developing country participants supported by this RFA pursue 
independent and productive careers, including expert training and 
consultation and/or research in bioethics within their home 
institutions.

MECHANISM OF SUPPORT

This RFA will use the NIH R25 award mechanism that limits facilities and 
administrative (F & A) costs to eight percent of direct costs (less 
equipment).  Applicants that request funding for subcontracts to foreign 
organizations may also include F & A costs up to eight percent of direct 
costs (less equipment).  More information on the F & A costs allowed for 
foreign institutions and international organizations can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html.  As 
an applicant, you will be solely responsible for planning, directing, 
and executing the proposed project.  This RFA is a one-time 
solicitation.  The anticipated award date is June 2004.  Under this RFA: 
o  U.S. applicants can submit a new or competitive renewal award 
application for a comprehensive curriculum development and training 
program; 
o  A developing country applicant may apply for a two-year program 
planning and curriculum development grant or a comprehensive curriculum 
development and training award; or
o  Current grantees of comprehensive curriculum development and training 
program awards can submit a competing supplement application.

FUNDS AVAILABLE

The participating ICs intend to commit approximately $1.8 million in 
fiscal year 2004 (FY04) to fund seven or eight new and/or competitive 
continuation awards and planning and curriculum development grants in 
response to this RFA.  

Comprehensive curriculum development and training program award:  An 
applicant may request a project period of up to four years and a budget 
for total costs of up to $250,000 per year maximum (including eight 
percent F & A costs).  

Planning and curriculum development grant:  Developing country 
applicants can request up to two years support for a program for up to 
$25,000 total costs (including eight percent F & A costs) per year.  

Competing supplement:  Principal Investigators of active International 
Bioethics Education and Career Development awards may request a 
supplement of up to $25,000 per year total costs (including eight 
percent F & A costs) for the number of years remaining in the project 
period of the parent award.  For application instructions, see the 
"Special Requirements" section below.

The National Institute of Dental and Craniofacial Research will provide 
supplements to grantee institutions to cover the training related costs 
for oral health professionals or researchers per year up to a total of 
$200,000 per year.

Because the nature and scope of the proposed training 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 ICs 
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 all of the 
following characteristics:  

o  Non-profit
o  Public or private
o  International or domestic  
o  Non-Federal agencies, such as health professional schools or 
comparable higher education or research institutions. 

Eligible developing foreign countries include those low- and middle-
income countries in the following regions:  Africa, Asia (except Japan, 
Singapore, South Korea and Taiwan), Central and Eastern Europe 
(Hungary, Poland, the Czech and Slovak Republics, Romania, Bulgaria, 
Albania, Turkey and the countries of the former Yugoslavia), Russia and 
the Newly Independent States of the former Soviet Union, Latin America 
and the Caribbean, the Middle East (except Israel), and the Pacific 
Ocean region (except Australia and New Zealand).

Applicant institutions should also have a substantial biomedical and 
clinical research portfolio including faculty conducting significant 
biomedical or behavioral research involving human subjects in developing 
countries.  An institution may submit only one application and only one 
new or existing program will be supported at an institution.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed training is invited to work with their 
institution to develop an application for support (see the "Special 
Requirements" section for additional instructions).  Consultants from 
other U.S. or international institutions may be supported to serve as 
faculty in the proposed program.  Individuals from underrepresented 
racial and ethnic groups, as well as individuals with disabilities, are 
always encouraged to apply for NIH programs.  

SPECIAL REQUIREMENTS 

Competing Supplements:  Principal Investigators of current comprehensive 
International Bioethics Education and Career Development awards may 
apply for one competing supplement annually to an active International 
Bioethics Education and Career Development Award to expand their 
programs to collaborate with other FIC research and research training 
programs (http://www.fic.nih.gov/programs.html) for the following 
purposes: 
o  To provide international bioethics training to developing country 
participants in the other FIC-supported research and research training 
programs; 
o  To provide international bioethics training to the ethics review 
committee members at the collaborating developing country institutions 
of other FIC research or research training programs; and
o  To support bioethics practicum experiences for trainees associated 
with the human subjects research conducted by the other FIC research or 
research training program participants in developing countries.

Competing supplement applications should include a needs assessment for 
the proposed training expansion and detailed plans for the proposed 
collaborative activities.  Competing supplement applications should also 
include plans to administer the joint activities and a letter of 
collaboration from the Principal Investigator of the other collaborating 
FIC program.

Principal Investigator:  A minimum of 25percent of professional effort 
is required in the first year of the award.

Advisory Committee:  The Program Director should establish an Advisory 
Committee for the proposed program.  It is recommended that the 
committee include representatives of potential trainee countries or 
regions.  The committee's responsibilities may include recruitment and 
selection of faculty, selecting trainees, evaluating trainee progress, 
and monitoring and evaluation of the overall effectiveness of the 
instructional program.  Applicants should provide a detailed description 
of the committee's composition, function, and organizational structure.

Evaluation:  A plan must be provided for the evaluation of the 
curriculum developed and training provided.

Dissemination:  FIC strongly encourages grantees to make the educational 
tools and curricula developed publicly accessible on a web site or by 
other means.

Annual Meeting:  Program Directors will be invited to attend an annual 
networking meeting in the Washington D.C. area, organized by the Fogarty 
International Center, of all directors and selected trainees supported 
by this RFA.  Applicants should include travel expenses for this meeting 
in their proposed budgets.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  FIC will hold a workshop 
for prospective applicants October 31, 2003 associated with the annual 
network meeting of the Principal Investigators of the current 
International Bioethics Educational and Career Development awards 
October 28-30, 2003.  All potential applicants who wish to attend the 
workshop should contact the training program staff listed below by 
September 30, 2003.  Support will be available for a limited number of 
potential developing country applicants to attend the workshop.  All 
documents distributed at this workshop and a summary of questions and 
answers regarding this RFA raised at the workshop will be posted on the 
FIC website (http://www.fic.nih.gov/programs/bioethics.html) subsequent 
to the workshop.  Additional inquiries may fall into three areas:  
training and research, peer review, and financial or grants management 
issues. 

o Direct your questions about training program issues to:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 402-9467
Fax:  (301) 402-0779
Email:  sinab@mail.nih.gov

o Direct your questions about peer review issues to:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD  20892-7840
Telephone:  (301) 435-1021
Fax:  (301) 480-3567
Email:  duperes@csr.nih.gov

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

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1670
Fax:  (301) 594-1211
Email:  butrumb@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, email 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 NIH 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:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 402-9467
Fax:  (301) 402-0779
Email:  sinab@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  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.

SUPPLEMENTAL INSTRUCTIONS:

Budget:  The program director may receive salary and fringe benefits 
compensation for up to 25 percent professional effort (salary must not 
exceed the annual salary cap level from federal sources) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-013.html).  
Developing country trainees may be paid a stipend comparable to their 
professional experience similar to other equivalent trainees at the 
grantee institution in accordance with the grantee institutional 
policies.  Applicants may wish to refer to the NRSA stipend levels as a 
guide (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-036.html).
Funds for tuition, academic fees and self-only or family 
medical insurance for developing country trainees at the applicant and 
consortia institutions may be requested.  Funds may be requested for one 
round trip economy class airfare per year on U.S. carriers (to the 
maximum extent possible) and local ground transportation for each long-
term developing country trainee to travel to the applicant institution 
and return to their home country.  Funds should be requested for 
airfare, per diem and lodging for three days comparable to U.S. 
government rates for the Program Director to attend an annual bioethics 
network meeting in the Washington, D.C. area.  Support of up to $10,000 
per developing country trainee may be requested in the "Other Expenses 
Category" for bioethics practicum projects of up to one year upon return 
to their countries after didactic training.

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 five signed, 
photocopies, in one package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within eight weeks.

The Center for Scientific Review 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 in 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.  While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the FIC.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.

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 Center for Scientific Review in accordance 
with the review criteria stated below.  As part of the review, all 
applications will:

o Receive a written critique 
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 second level review by the Fogarty International Center 
Advisory Board. 

REVIEW CRITERIA

The goals of NIH-supported research and training 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 discuss the following aspects of the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals: 

o Significance
o Approach
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.  The application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a meritorious priority score.  For 
example, an investigator may propose to carry out important training 
that by its nature is not innovative but is essential to move a field 
forward.

SIGNIFICANCE:

1.  The need for the international bioethics curriculum and training 
proposed to fill specific gaps in expertise for prospective developing 
country trainees.
2.  The expected contributions of the proposed international bioethics 
training to developing country institutions, national governments or 
international institutions.

APPROACH: 

1.  The clarity and feasibility of the curriculum development and 
training objectives.
2.  Adequacy of the program plan to achieve the proposed curriculum 
development and training objectives including:
o  Strong and appropriate courses and curriculum that provides balance 
and breadth in all critical areas in addition to providing practicum 
opportunities to fill recognized gaps in trainee expertise;
o  A trainee recruiting, application and selection process that captures 
the most qualified individuals with a variety of professional 
backgrounds from developing country institutions who could most benefit 
from the training proposed.
o  Appropriate assessment and enhancement of additional background 
skills needed by each trainee in areas such as research design 
methodology, technical writing, statistical methods, informatics and 
English as a second language;
o  Process for periodic evaluation of curriculum, trainee progress and 
faculty mentoring;
o  Plans to recruit an adequate representation of women and ethnic 
minorities in the home countries of the developing country trainees.

INNOVATION: 

1.  Innovation in the international bioethics curriculum designed for 
developing country trainees;
2.  Innovation in providing practicum opportunities for trainee 
involvement in the ethical design and review of laboratory, clinical or 
public health research, developing short courses or other education 
resources or analyzing ethical guidelines or practices.

INVESTIGATOR:

Qualifications of the program director to lead, and other faculty to 
participate in, the proposed curriculum development and training 
program.  

ENVIRONMENT: 

The adequacy of the teaching facilities and other training resources 
including possible research bioethics related opportunities and the 
overall training environment at the applicant institution.

ADDITIONAL CONSIDERATIONS

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  November 17, 2003
Application Receipt Date:  December 16, 2003
Peer Review Date:  March 2004
Council Review:  May 2004
Earliest Anticipated Start Date:  June 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 including geographic balance
o Interests of co-funding organizations

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 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.

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

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution.  The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on "Am 
I a covered entity?"  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 287b) 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 (also cite 
other relevant policies)

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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