THE INTERNATIONAL BIOETHICS EDUCATION AND CAREER DEVELOPMENT AWARD

Release Date:  August 6, 2001

RFA:  RFA-TW-02-008

Fogarty International Center
 (http://www.nih.gov/fic)
National Institute of General Medical Sciences
 (http://www.nigms.nih.gov/)
National Institute of Environmental Health Sciences
 (http://www.niehs.nih.gov/)
National Center for Complementary and Alternative Medicine
 (http://nccam.nih.gov/)
National Institute of Dental and Craniofacial Research
 (http://www.nidr.nih.gov/)

Letter of Intent Receipt Date:  September 7, 2001
Application Receipt Date:       January 11, 2002

PURPOSE

The Fogarty International Center (FIC), in partnership with the National 
Institute of General Medical Sciences, the National Institute of 
Environmental Sciences, the National Center for Complementary and Alternative 
Medicine and the National Institute of Dental and Craniofacial Research, 
invites applications from nonprofit, private or public, domestic or 
international, educational and research institutions to develop or expand 
current graduate curricula and training opportunities in international 
bioethics related to performing research on acute and chronic diseases in 
low- and middle-income nations.  Applicant institutions can request up to 
four years support to create full curriculum development and training 
programs, or up to two years support for curriculum development alone in 
preparation to apply for full training program support in the future.  The 
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, particularly on scientific integrity and the protection 
of the interests of research participants.  Support will be provided for 
multi-disciplinary training for 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 included advanced degree and non-degree associated 
course work and practicums.  Support may also be included for the development 
and implementation of intensive short courses designed specifically for 
individuals directly involved in human subjects research ethical review and 
in conducting clinical trials in developing countries.

This RFA contributes to the FIC’s initiative to strengthen research bioethics 
training for individuals from developing countries.  The FIC recognizes that 
highly trained individuals from a number of disciplines are needed in order 
to provide guidance to the research community on ethical questions that arise 
during the conduct of research in settings where cultural differences may be 
relevant.  This RFA is intended to stimulate the development of new 
instructional programs in relevant aspects of 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.  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.  Trainees may also be supported to pursue culturally relevant 
studies on ethical practice in biomedical and behavioral research as part of 
their training.  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.  Upon completion of their 
training, developing country participants supported by this RFA are expected 
to pursue independent and productive careers, including expert training and 
consultation and/or research in bioethics within their home institutions.

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 Request for 
Applications (RFA), International Bioethics Education and Career Development 
Award, is related to the priority area of human resource development.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Institution:  Applications may be submitted by nonprofit public or private, 
international or domestic, non-Federal organizations, such as health 
professional schools or comparable higher education or research institutions 
that have strong, well-established graduate ethics training programs.  The 
applicant institution must have a faculty that is active in international 
ethics research, as evidenced by current research support and research 
publications.  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.  
Applicants are encouraged to develop consortia with other U.S. or 
international institutions to enhance the depth of their faculty and 
participant pool, and to improve the quality of the training provided.

Participants:  Developing country candidates for international bioethics 
training will be selected by the applicant institutions.  Since ethics is a 
multidisciplinary field, it is expected that trainees supported in each 
training program will represent diverse academic backgrounds.  Trainees may 
include post-doctoral behavioral or biomedical scientists, physicians, 
dentists, 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 
from the developing world. 

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) education project 
grant (R25) award mechanism that limits facilities and administrative (F & A) 
costs to eight percent.  F&A costs up to eight percent can be requested in 
applications submitted by foreign institutions or for a subcontract to a 
foreign institution.  Please see the web site 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more 
information on the F&A costs allowed for foreign institutions and 
international organizations.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
applicant organization must provide the necessary management for the transfer 
of funds and materials to the consortial institutions.  The total project 
period for an application for a full curriculum development and training 
program submitted in response to this RFA cannot exceed four years.  The 
total project period for an application for a curriculum development award 
without formal developing country training opportunities can not exceed two 
years.  Continued support during this period depends on satisfactory 
performance as judged by annual progress reports, site visits, meetings with 
program directors, career progress of trainees and the development of 
institutional capacity for international bioethics related training.  
Although the intent of this RFA is for long-term capacity development in 
research bioethics, at this time, the FIC has not determined whether this 
solicitation will be continued beyond the present RFA. 

Allowable Costs

All expenses related to trainee participation in the program should be 
itemized on the PHS Form 398 (NRSA substitute budget pages OO and PP) in the 
categories listed in the RFA.  All expenses related to faculty participation 
in the program should be itemized on the PHS Form 398 budget pages DD and EE 
in the categories listed in the RFA.  Total training expenses should be 
identified on PHS Form 398 (NRSA substitute page DD) under the “Other” 
category.  Developmental proposal budgets may include costs for curriculum 
and faculty development but not for trainee related expenses.  Allowable 
costs requested for training at international institutions should follow the 
guidelines specified for U.S. institutions.

Stipend/Salary/Consultant Fees

Program Director:  The program director may receive salary and fringe 
benefits compensation for up to 25% professional effort devoted to the 
international bioethics curriculum and training program creation during the 
first year of the award.  Salary must not exceed the annual salary cap level 
(currently $161,200 plus fringe benefits) from federal sources 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-013.html).  (Use 
PHS 398 form page DD.)

Faculty:  Faculty at the applicant institution who provide critical design, 
development, implementation and refinement of essential components of the 
international bioethics curriculum or extended long-term training or conduct 
collaborative research with the trainees may receive salary and fringe 
benefits.  The total amount of salary and fringe benefits requested for all 
faculty, including the program director in the second and subsequent years of 
the award, may not exceed $56,000 for full curriculum and training program 
application budgets.  The total amount of salary and fringe benefits 
requested for all faculty, including the program director in the second year, 
for a curriculum development alone award without formal developing country 
training may not exceed $9,250.  The responsibilities and time commitment for 
faculty receiving salary should be thoroughly described.  (Use PHS 398 form 
page DD.)

o  Faculty from consortia institutions involved in curriculum development and 
training, and invited speakers and consultants who provide essential 
programmatic functions may receive consultant fees not to exceed $2,000 per 
faculty member per year, in accordance with the applicant’s institutional 
policies.  No more than ten percent of the direct costs in the budget may be 
used for consultant fees.  The teaching responsibilities and time commitment 
for faculty receiving consultant fees should be thoroughly described.  (Use 
PHS 398 form page DD.)

o  Developing country trainees may be paid a stipend comparable to their 
professional experience similar to other equivalent trainees at the grantee 
institution but not exceeding $45,000 per year in accordance with the grantee 
institutional policies while involved in long-term training.  Applicants may 
wish to refer to the NRSA stipend levels as a guide.  These are described on 
the web site http://www.nih.gov/fic/opportunities/index.html.  (Use PHS 398 
form substitute page OO.)

o  Up to $28,000 may be requested in the budget of full curriculum and 
training program applications to provide salary and fringe benefits for 
support staff for the program at the grantee institution.  Up to $4,625 may 
be requested in the budget of applications for the curriculum development 
alone without developing country training awards to provide salary and fringe 
benefits for support staff for the program at the grantee institution.  The 
responsibilities and time commitment for personnel receiving salary support 
should be thoroughly described.  (Use PHS 398 form page DD.)

Tuition, Fees and Insurance

o  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.  (Use PHS 398 form substitute page OO.)

Trainee Travel

o  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 may be 
requested for appropriate per diem and lodging for developing country 
trainees to participate in short courses or attend bioethics conferences.  
(Use PHS 398 form substitute page OO.)

Faculty Travel

o  Funds may be requested for round trip economy airfare year on U.S. 
carriers (to the maximum extent possible) per diem and lodging for consortia 
faculty participants to travel to the applicant institutions and sites of 
short courses once per year.  (Use PHS 398 form page DD.)

o  Funds should be requested for airfare, per diem and lodging for two-three 
days comparable to U.S. government rates 
(http://www.gsa.gov/Portal/gsa/ep/contentView.do?contentId=17943&contentType=GSA_BASIC) for 
the Program Director, foreign co-PIs, if appropriate, and selected trainees 
to attend an annual bioethics network meeting in the Washington, D.C. area.  
(Use PHS 398 form page DD.)

Training related expenses

o  Funds to support curriculum development related costs at the applicant 
institution (such as books, printed materials, audiovisual materials, 
computer software, etc.) as well as administrative expenses (such as 
photocopying, long distance phone and shipping costs, etc.) may be requested.  
(Use PHS 398 form substitute page OO.)

o  No more than $56,000 per year may be requested to support intensive short 
courses in full curriculum and training program application budgets.

o  One time, one-year project support of up to $10,000 may be requested for 
trainees when returning to their home country institutions.  The amount of 
salary support at the home institution for returning trainees may not exceed 
20% of their full-time salary.  The application should describe in detail how 
proposals for reentry projects monitored by appropriate faculty will be 
selected by a competitive peer review process examining merit and potential 
impact in the trainee’s home country.

FUNDS AVAILABLE

FIC and partners have committed approximately $1,500,000 in FY 2002 to fund 
an estimated 6 new training program awards and 3 developmental program awards 
in response to this RFA.  A full curriculum development and training program 
applicant may request a project period of up to four years and a budget for 
total costs (which includes eight percent F & A costs) of up to $250,000 per 
year maximum.  A curriculum development alone program without developing 
country training applicant may request a project period of up to two years 
and a budget for total costs (which includes eight percent F & A costs) of up 
to $25,000 per year maximum. 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 curriculum development and training proposed may vary, it is anticipated 
that the size of each award will also vary.  Although the financial plans of 
the FIC 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.

TRAINING OBJECTIVES

This award provides support for up to four years to allow institutions to 
develop a comprehensive ethics curriculum with a focus on the ethics of 
conducting research in developing countries and to train a cohort of 
developing country participants.  Curriculum development awards provide up to 
two years support for curriculum and faculty development alone in preparation 
for offering full training programs in the future.  Applications may be 
submitted from educational and research institutions that do not currently 
provide such a instructional program, as well as to those that propose to 
expand well-established international ethics training programs to include 
developing country participation.

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.  While other NIH programs support some 
short-term training courses in research bioethics, only a few trainees are 
from the developing world.  In addition, 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.  

This initiative is intended to involve talented, interested individuals in 
developing countries in the challenges of culturally relevant bioethics.  
Proposed training programs should equip them with the critical skills that 
are needed to provide expertise and leadership to their institutions, 
national governments and international bodies and potentially, to pursue 
culturally relevant studies on ethical practice in biomedical and behavioral 
research.  The specific objectives are:  

1) 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 conduct of research on 
acute and chronic diseases in developing countries.

2) 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 or clinical trials and 
epidemiological studies involving academic, laboratory, clinical or public 
health settings of research and clinical investigations in their 
countries.

A) Program:  The applicant must provide an explicit set of goals/objectives 
for the proposed program that address the specific needs for bioethics 
training in the developing countries or regions of origin for prospective 
trainees.  Applicants must provide a detailed description of the proposed 
program including courses offered, frequency of classes, selection criteria 
for participants entering the program, and target goal of enrollment into the 
program.  If planned activities include short courses, applicants should 
provide detailed descriptions of well-justified, specifically targeted, 
intensive curricula designed for individuals directly involved in human 
subjects research ethical review or in conducting clinical trials in 
developing countries.

B) Program Director: The award will support the Principal 
Investigator/Program Director to manage, coordinate and evaluate the program 
and, with associated faculty, to design, develop, implement and refine as 
needed, an international bioethics curriculum.  The Program Director should 
possess the international bioethics expertise, leadership 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 the mentoring of new 
investigators.  A minimum of 10-25% of the program director’s professional 
effort is required during the first year.

C) Faculty:  Sufficient numbers of faculty should be involved in the proposed 
curriculum development and training who have a record of providing the type 
of instruction required under this award.  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 proposed faculty should be actively engaged in the 
design and conduct of bioethical research, and also have demonstrated a 
successful record in obtaining peer reviewed funding for such activities.  
The capability of the participating faculty to develop advanced curricula, 
instruct and fully train individuals to pursue careers in international 
bioethics must be documented.  Applicants are encouraged to include senior 
faculty from developing countries with expertise in conducting research 
involving human subjects or who participates in ethics review procedures in 
their home countries as program consultants or training faculty.  Training 
faculty should also include individuals from the grantee or consortium 
institutions with experience in the design of biomedical (including clinical) 
or behavioral research involving human subjects in developing countries.  The 
percent of faculty effort planned for course development, instruction and 
mentoring trainees should be described.

D) Curriculum:  The curriculum should be designed to provide a maximum of two 
years, master’s degree level graduate training but may also accommodate 
shorter term training for non-degree seeking participants with other 
professional degrees and different levels of experience in bioethics.  The 
core curriculum developed may include an array of bioethics-related topics of 
general interest such as the history and principles of human and animal 
subjects’ research, ethical perspectives on the use of human biological 
materials in research, the ethics of designing clinical research protocols 
and ethical considerations in performing research in vulnerable populations 
with an emphasis on culturally relevant research.  Other topics may include 
international codes, laws and guidelines, informed consent, intellectual 
property, collaborative agreements between host and sponsor countries, the 
role of ethics review committees in the developing world and in cross-
cultural research and ethnographic research.  The curriculum may include 
training in the methodology used in culturally relevant studies of ethical 
theory and practice in biomedical and behavioral research.  The scope and 
format for presenting the core curriculum can be flexible to meet the 
perceived needs of the trainees and faculty.  The program may also include 
advanced, specialized courses in ethics related to human genetics, 
epidemiology, public health, traditional medical practice, human rights, 
justice and economics.  The detailed description of the content of proposed 
courses and the potential benefit to developing country trainees should be 
included in the training plan.  The curriculum developed must begin to be 
offered to trainees within one year of the award and should be initiated 
during the first year of support, if feasible.

E) Training:  The award provides support 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.  In addition, 
institutions may propose providing support for appropriate candidates to earn 
a master's degree in a relevant area - e.g., public health research 
bioethics, clinical research.  The proposed program should also have the 
flexibility to accommodate participants with different levels of experience.  
Individuals selected for training should demonstrate a high level of interest 
and the potential to become leaders and provide expertise to their host 
institutions, national governments and international bodies and possibly, 
pursue culturally relevant studies on ethical practice in biomedical and 
behavioral research.  Applicants should describe how the proposed training 
will advance the career development of prospective trainees.  Candidates 
selected for training should document in their applications to the grantee 
program that they can return to a position in their country of origin that 
will permit them to pursue an independent and productive career that includes 
training, consultation and/or research on bioethics.  Grantees are encouraged 
to include plans for enabling the trainees to develop and sustain bioethics 
programs on return to their home country.  Applicants are encouraged to 
select candidates already involved with international research efforts 
involving human subjects. 

Plans for recruiting and the process and criteria for selecting participants 
to enter the program and the countries to be involved should be described.  
Applicants should describe the criteria for selecting particular developing 
countries or developing country institutions for recruiting trainees.  
Applicants should describe how 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 participants in both long-and short-term training.

A faculty mentor with appropriate research and training experience in ethical 
issues related to biomedical or behavioral research must be identified for 
each potential long-term trainee.  Trainees cannot receive concurrent salary 
support from any other PHS sources while being supported by this award and 
must be willing to commit at least 75% of their full-time professional effort 
to training activities for the entire period of support.

F)  Environment:  The institution should develop an innovative, 
multidisciplinary program to maximize the available research and educational 
resources.  The opportunities for trainees to participate in research and 
other activities related to the institution’s clinical research portfolio and 
with faculty conducting significant biomedical or behavioral research in 
developing countries should be described in detail.  The opportunities for 
trainees to participate in activities through consortia established with 
other U.S. or international institutions to enhance the depth of their 
faculty or to improve the quality of the educational experience should be 
described.  Applicant institutions must describe the pool of trainees and 
their career development that previously received bioethics training in 
existing programs.

SPECIAL REQUIREMENTS

1) Advisory Committee: The Program Director must establish an Advisory 
Committee for this program to provide ongoing assessment and monitoring.  
Members of bioethics divisions in the School of Public Health, Medicine or 
Nursing, as well as members of institutional ethics review committees 
should be considered for such committees.  Committees should include 
representatives of potential trainee countries or regions.  The 
committee's responsibilities might include recruitment and selection of 
faculty, selecting trainees, evaluating trainee progress, and monitoring 
and evaluation of the overall effectiveness of the instructional program 
and suggesting revisions as needed.  A detailed description should be 
provided of the committee's composition, function, and organizational 
structure.

2) Evaluation:  A plan must be provided for the evaluation of the curriculum 
developed and training provided.  Benchmarks should be specified as well as 
detailed plans and procedures to identify, analyze and report results to the 
FIC program staff.

3) Dissemination:  Grantees are encouraged to share educational tools and 
curricula and to make them publicly accessible.

4) Trainee Tracking System:  Applicants should describe their plan to monitor 
the short- and long-term impact of research bioethics training on their 
trainees.  Awardees will be required to implement a system to track and 
document the long-term impact of this training program on:  (1) the careers 
of all trainees; (2) the research capacity at the collaborating developing 
country institution of trainees; (3) positions trainees assume upon 
completion of training; (4) the contributions of trainees to future NIH-
supported and other international research and intervention trial efforts.  
Examples of training impact include: how training affects research bioethics 
training, review or policies at the home institution, how training enabled 
participants to assume more responsible positions upon returning home, how 
collaborations with former trainees resulted in the funding of collaborative 
research projects for which trainees were either Principal Investigators or 
co-Investigators, and publications of research results authored by trainees 
supported by this program.  During the first year after the awards are made, 
program staff at the FIC will work with grantees to standardize evaluation 
among programs for annual progress reporting based on the ideas presented in 
their applications and experience with similar programs.  It is expected that 
the standardized evaluation approach developed will be implemented in all 
programs.  The impact of training resulting from each program will be an 
important criteria considered in determining whether this RFA will be 
recompeted.

5) Program Directors will attend an annual meeting organized by the FIC of 
all directors and selected trainees supported by this RFA in the Washington 
D.C. area.  Applicants should allow for these travel expenses in their 
proposed budgets.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:  
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 throuh 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., 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 applicant should 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.  

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed program, the name, address, telephone and 
fax numbers, and E-mail address of the Program Director, the names, titles 
and institutions of other key personnel, the participating institutions and 
the number and title of the RFA in response to which the application may be 
submitted.  Although a letter of intent is not required, is not binding, and 
does not affect the review of the application submitted, the information that 
it contains permits the NIH to estimate the potential application review 
workload and avoid conflict of interest during the review of applications.

The letter of intent is to be sent by the letter of intent receipt date 
listed in the heading of this RFA to the program staff listed under 
INQUIRIES.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable PDF format.  The NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email:  GrantsInfo@nih.gov.

It is strongly recommended that prospective applicants contact the staff 
person listed under INQUIRIES early in the planning phase of the application.  
Such contact will help ensure that applications are responsive to the overall 
intent of this award.

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.

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)

Applications must be received by 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.

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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the CSR and responsiveness 
by FIC.  Incomplete applications will be returned to the applicant without 
further consideration.  Applications that are complete and responsive will be 
evaluated for scientific and technical merit by a peer review group convened 
by CSR in accordance with the standard NIH peer review procedures.

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 curricula and training will have a substantial impact on 
the ethical pursuit of these goals.  Each of these criteria will be addressed 
and considered in assigning the overall score, weighting them as appropriate 
for each application.  Note that 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 training that by its nature is not innovative but is 
essential to move a field forward.

Significance

1.  The need for the specific 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 
curriculum and training to developing country institutions, national 
governments or an 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 overall curriculum that provides 
balance and breadth in all critical areas while providing focussed training 
opportunities to fill recognized gaps in trainee expertise;

o  If short courses or non-degree training are proposed, the adequacy of the 
mixture of long- and short-term training opportunities within the program as 
a means to achieve the overall objectives stated;

o  A trainee recruiting, application and selection process that captures the 
most qualified individuals with a variety of professional backgrounds from 
developing countries who could most benefit from the training proposed 
including the potential impact of training on their developing country 
institution.  (The proposed qualifications of potential candidates should be 
well described in terms of academic status and previous accomplishments 
and/or experience in bioethics.)

o  The process for determining appropriate trainee skill development plans, 
ethical research or review participation and mentorship;

o  Appropriate assessment and enhancement of background skills needed by each 
trainee in areas such as bioethics research methodology, technical writing, 
statistical methods, clinical practice, medical informatics and English as a 
second language (if necessary);

o  Process for periodic evaluation and revision of curriculum developed;

o  Process for periodic evaluation of trainee progress and mentoring 
activities;

o  Methods to monitor the long-term impact of the training experience on the 
subsequent careers of the trainees and capacity for ethical review of 
research in the trainees’ home countries;

o  Plans to include an adequate representation of women and ethnic minorities 
in the home countries among the developing country trainees.

Innovation

o  Innovation in the international bioethics curriculum designed for 
developing country trainees;

o  Innovation in training participants for active involvement in the ethical 
design and review of laboratory, clinical or public health research or 
intervention trials conducted at their home countries;

o  Creativity of plans to include modern information technology training to 
facilitate trainee access to electronic information resources, distance 
learning and collaborative interaction.

Investigators

o  Qualifications of the program director to lead, and other faculty to 
participate in, the proposed curriculum development and training program.  
(The bioethics research experience and training accomplishments should be 
included in addition to Biographical Sketch and Other Support forms for each 
faculty participant.)

o  The applicant’s record and experience in developing bioethics-training 
programs to support biomedical and behavioral research efforts.

Environment

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

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research;

o  The adequacy of the proposed plan to share data. 

Schedule
Letter of Intent Receipt Date:    September 7, 2001
Application Receipt Date:         January 11, 2002
Peer Review Date:                 March-April 2002
Council Review:                   May 21, 2002
Earliest Anticipated Start Date:  June 1, 2002

AWARD CRITERIA

In addition to the outcome of the initial scientific peer review, the 
following may also be considered in making funding decisions:

o  The extent to which proposed training programs support and complement 
other FIC or NIH efforts in international bioethics.

o  The availability of funds.

o  Program balance among critical research and public health training areas 
of emphasis.

o  The geographic distribution among proposed trainees included in 
applications under consideration.

INQUIRIES

Written and telephone inquiries concerning this RFA are strongly encouraged.  
The opportunity to clarify any issues or questions from potential applicants 
is welcome.  FIC will hold a workshop for prospective applicants associated 
with the Global Forum on Bioethics in Research in the Gambia November 8-10, 
2001.  All potential applicants who wish to attend the workshop should submit 
a letter of intent to apply for the RFA by the deadline stated above 
expressing this interest in order to obtain information about the workshop.  
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.nih.gov/fic/programs/bioethics.html) subsequent to the workshop.  
Direct inquiries regarding the workshop and other programmatic 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
E-mail:  barbara_sina@nih.gov

Direct inquiries regarding fiscal 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
E-mail:  butrumb@mail.nih.gov

AUTHORITY AND REGULATIONS

Awards are made under authorization of Sections 301 and 405 and Title IV, 
Part A, (42 USC 241, 284 and 287) of the Public Health Services Act, as 
amended, and administered under NIH grants policies and Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92s.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or to Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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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