ACCEPTABILITY RESEARCH FOR HIV/STD PREVENTION

Release Date:  February 1, 2000

RFA:  HD-00-005

National Institute of Child Health and Human Development
National Institute for Mental Health

Letter of Intent Receipt Date:  April 10, 2000
Application Receipt Date:  May 12, 2000

THIS RFA USES THE “MODULAR GRANT” AND “JUST-IN-TIME” CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

This Request for Applications (RFA) invites research leading to an improved 
understanding of the acceptability of methods for the prevention of HIV and/or 
other STDs. The ultimate goal of the research is to gain insight into the 
acceptability of new prevention methods, including microbicidal methods 
currently undergoing development and testing.  Studies may examine the 
acceptability of specific products or classes of products, the processes and 
factors that influence acceptability in various populations, strategies to 
improve the acceptability of new products, and the development of improved 
methods for studying acceptability. It is hoped that such research will be 
useful in improving the methods, improving clinical trial design, and 
improving users' experiences with the methods. The National Institute of 
Mental Health (NIMH) is also interested in supporting applications on the 
identification of behavioral and social factors that encourage or discourage 
the initiation and maintenance of microbicide use and on the development of 
microbicides as alternative prevention strategies for HIV infection.

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 several priority 
areas.  Potential applicants may obtain "Healthy People 2010" at 
http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and non- 
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 
Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this RFA may 
not exceed five years.  This RFA is a one-time solicitation.  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated applications and be reviewed according to the customary 
peer review procedures.  The earliest anticipated award date is September 29, 
2000.

For all applications requesting up to $250,000 direct costs per year, specific 
application instructions have been modified to reflect "MODULAR GRANT" and 
"JUST IN TIME" streamlining efforts being examined by the NIH.  Complete and 
detailed instructions and information on modular grant applications can be 
found at http://grants.nih.gov/grants/funding/modular/modular.htm.  
Applications that request more than $250,000 in any year must use the standard 
PHS398 (rev. 4/98) application instructions.

FUNDS AVAILABLE

The NICHD intends to commit approximately $2 million total costs (direct plus 
Facilities and Administrative [F & A] costs) in FY 2000 to fund four to six 
new grants in response to this RFA. The NIMH intends to commit approximately 
$500,000 total costs in FY 2000 to fund one to two new grants.  An applicant 
may request a project period of up to five years; and any applicant 
considering the submission of a budget request that exceeds $500,000 in direct 
costs in any year is strongly encouraged to contact program staff listed under 
INQUIRIES prior to submission. Because the nature and scope of the research 
proposed may vary, it is anticipated that the size of awards also will vary.  
Although the financial plans of the NICHD and NIMH 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.

RESEARCH OBJECTIVES

Background

This RFA calls for research on the potential acceptability of new methods for 
HIV/STD protection. In the past several years, researchers and women’s health 
advocates have detailed the urgent need for the development of microbicides 
and other female-controlled methods that can prevent the spread of HIV and 
other STDs (Potts, 1994; Roddy, 1998).  As of April 1998, there were 54 
compounds and products in preclinical and clinical stages of development for 
possible use as microbicides (Alliance for Microbicide Development, 1998).  
New disease-prevention methods for men, including new forms of condoms and 
chemical barriers, also are needed and under development.  Future products and 
approaches may take a wide variety of forms.  They may not all consist of 
products for vaginal use.  There is interest in research targeting modalities 
such as gene therapies that alter permissiveness, monoclonal antibodies, 
natural product inhibitors, vaccines to stimulate local protection, agents 
that interfere with membrane fusion and attachment, cell adhesion factors, 
hormone or other receptors, and angiogenesis.  
There is, however, little work that can provide estimates of how a new method 
will be integrated into the "calculus of conscious choice" that individuals 
are purported to use when deciding upon protection.  For the purposes of this 
RFA, "acceptability" is defined as the probability that a method will be used 
in a defined population.  This moves beyond an older definition of 
acceptability as a "quality which makes an object, person, event or idea 
attractive, satisfactory, pleasing or welcome" (Marshall, 1977).  Method 
characteristics, user characteristics, partner characteristics, external 
influences such as the service delivery system and marketing, and the socio-
cultural context in which the potential users live, all work together to 
determine the actual initiation and the continued use of a method.   Actual 
use produces both feedback to the user and information into the socio-cultural 
context for other likely users.

The goal of this RFA is to stimulate research to inform the development and 
dissemination of effective methods for disease protection that are acceptable 
to those whose sexual behavior places them in need of protection.  Research on 
acceptability of methods is different from research about the methods' safety 
and efficacy.  That which makes a product "acceptable" is typically more 
subjective and context-specific.  A demonstrably effective and safe product 
may find no market, or may encounter other, more subjective, obstacles to its 
actual adoption and use  (c.f. IUDs in the U.S.).  Users may be willing to 
accept a lower efficacy for a product that they can use covertly, or to accept 
an undesirable texture or unpleasant side effects for a product that works 
extremely well.  Sometimes, people feel forced to choose the "least worst 
alternative" (UNDP, 1995; Severy, 1998).  The actual product, its viscosity, 
color, smell, taste, application method, quantity necessary for efficacious 
use, and duration of effectiveness may influence acceptability.  Other aspects 
of the product, such as its actual or perceived effect on sexual pleasure, may 
have an impact.  Finally, there are many parties besides the person using the 
product who can have opinions that could influence adoption and continued use. 
 These include partners or potential partners, friends and family, health care 
providers, health system managers, and manufacturers of products.  The sexual 
beliefs, practices, and norms of a group may influence acceptability at the 
individual level as well.  The relative influence of these various parties and 
factors may vary among cultures, as well as among potential users of different 
ages and relationship statuses (Hardy et al., 1998).

Past research on acceptability has typically followed one of several models, 
appropriate to different stages of product development and introduction.  
Hypothetical product acceptability studies determine potential user responses 
to a product that is not yet developed and/or proven safe for use in the 
target population.  In some cases, these studies may employ existing products 
that are similar to the product under study.  Often, in such research women 
are asked to make hypothetical trade-offs between many features of a product, 
a number of which (such as effectiveness) are unknown.  This type of research 
provides the opportunity for early input from potential users about a new 
method; however, survey or focus group research asking individuals to evaluate 
their probable use of a hypothetical method generally has not been successful 
in predicting actual use of a method.  

Another common model of acceptability research is to embed behavioral studies 
within the clinical trials used to evaluate the safety and efficacy of new 
products.  This approach can provide valuable information about users’ actual 
experience with a method.  However, findings from such efforts are limited in 
their capacity to address use of a product in the larger population, once it 
is approved.  Selection bias into clinical trials, and the participant 
"buy-in" that may develop as a result of intensive follow up, skew the ability 
of such studies to predict acceptability outside the experimental situation.  
 

A third model, often referred to as post-marketing research, tracks the 
adoption and use of a method in actual population settings, studying how the 
interplay of the individual user, product characteristics, the health system, 
and the larger social and cultural setting influences use.  This model offers 
the advantages of generalization to larger populations, but suffers from the 
obvious disadvantage that it cannot be done before an approved product is 
available.  An extension of this model studies diffusion processes within 
populations and potentially could lead to improved communication strategies 
tied to the introduction of new methods.   

Although each of these models of acceptability research is flawed in some 
ways, research designs that combine models in creative ways may yield more 
robust results about the acceptability of new products and the factors that 
influence acceptability.  Approaches to the improvement of models for 
acceptability research might include strengthening the attention to user 
perspectives and/or to provider perspectives about users, combining 
qualitative and quantitative methods, and using existing products to model 
products-in-development.

Studies of acceptability also should attend to the full range of factors that 
influence the ultimate, consistent, and continued use of a product, including 
the motivation of the individual and the couple to avoid unwanted consequences 
of their sexual behavior, the context in which the individual or couple are 
living, and the medical/health care service delivery they expect to encounter 
in their daily lives.  The placement and timing of acceptability studies 
within the development of new methods need further efforts to adequately 
address these issues. 

Research Scope

This RFA invites research that will contribute to an improved understanding of 
the acceptability of methods to prevent HIV and other STDs.  The ultimate goal 
of the research is to gain insight into the acceptability of new prevention 
methods, including microbicidal methods currently undergoing development and 
testing.  Studies may examine acceptability directly, through acceptability 
studies on new methods in development or testing, or indirectly, through 
studies of the acceptability of potential methods using existing methods as 
models.  The choice of models for potential methods must be theoretically 
informed, but may include contraceptive methods as well as existing STD/AIDS 
prevention methods, such as the female condom.  The inclusion of 
methodological sub-studies aimed at improving measurement and research design 
in acceptability research may be appropriate in the context of a study 
addressing one of the other questions posed under this RFA.

Topics of particular interest include, but are not limited to: 

1.  Studies of the acceptability of specific products or classes of products, 
and the product characteristics that influence acceptability among various 
populations, especially adolescents and young adults, as well as persons with 
severe mental illness.

o  Expansion of our understanding of the acceptability of method delivery 
systems (e.g., insertion, ingestion, injection) and formulations (e.g., gel, 
film, foam) in different cultures and populations.

o  Examination of the extent to which dual protection against pregnancy and 
disease enhances or deters acceptability of any new method.

2.  Studies of the processes and factors that influence acceptability in 
various populations. 

o  Exploration of health care providers' understandings of acceptability and 
the impact of health care delivery approaches on acceptability.

o  Improvement of our understanding concerning how and when external factors 
(e.g., friends, family, community, media) influence the acceptability of 
methods, and how, when, and with whom individuals communicate about methods 
and method use. 

o  How individuals and couples make tradeoffs among factors such as efficacy, 
side effects, mechanics of use, etc. in making choices about use and continued 
use.

o Calibration of the influence of individuals' past history of contraceptive 
and prophylaxis use upon their acceptance of new methods

o  Examination of individual behavioral characteristics (e.g., attitudes, 
cognitive and decision making influences, belief in invulnerability), 
psychosexual factors (e.g., sexual experience, perception of control over 
sexual behavior or health), psychosocial characteristics (e.g., family 
environment, peer use, cultural values), and cultural or contextual factors 
(e.g., gender rules and roles, perceived sociosexual climate in which personal 
and public contraceptive health care decisions are made) that influence 
microbicide acceptance and use

3.  Research leading to strategies to improve the acceptability of new 
products.

o  Exploration of the types of messages and delivery modalities most effective 
for different groups to facilitate their understanding, acceptance and use of 
methods.

o  Expansion of how messages concerning the risk of exposure to disease and 
negative outcomes are understood and balanced against desires for pleasure or 
pleasing a partner.

4.  Development of improved methods for studying acceptability.

o  Development of better measures of hypothetical acceptability and testing 
them against actual use.  This could include the design and testing of 
questions concerning acceptability included within Phase III clinical trials

o  Measurement issues related to self-report of sexual behaviors and use of 
methods.

o  Development and testing of measures of couple acceptability in situations 
where clandestine use is either not an option or not desired.

o  Gender/race/age/ethnicity/cultural differences in responding to questions 
that deal with hypothetical constructs and choices, as well as such 
differences in actual acceptability of a given product.

Applications may propose research designs that encompass any or all of the 
models described under “Background,” or may propose new models for research.  
Applications may propose research in the context of clinical trials, general 
clinical or population samples, or a combination of these.  Acceptability 
research is properly not the concern of Phase I clinical trials, where the 
safety of the product is tested among a highly select group.  However, Phase 
II and Phase III trials may, in some cases, be  appropriate locations for such 
work. 

Proposed methodologies should be appropriate to the questions under study, and 
may consist of qualitative or quantitative approaches or a mix.  Qualitative 
research may be particularly appropriate for some questions, especially those 
requiring exploration of sensitive and complex issues.  Such research could 
reveal user perspectives on the salient attributes of new products and 
attitudes towards the health delivery system.  In all cases, strict attention 
must be paid to the ethical considerations related to the potential for 
respondents' exposure to any possible negative consequences of participation 
in research.  

Collaborations among clinical trial investigators, product developers, service 
providers, and social and behavioral science researchers are strongly 
encouraged. 

Selected References:

Alliance for Microbicide Development.  8701 Georgia Avenue, Suite 804, Silver 
Spring, MD, 20910.

DeZoysa, I., Elias C.J., Bentley, M. 1998.  Ethical challenges in efficacy 
trials of vaginal microbicides for HIV Prevention.  American Journal of Public 
Health, 88:571-575.

Forrest, J.E., Frost J.J. 1999. Women's interest in vaginal microbicides.  
Family Planning Perspectives. 31(1):16-24.

Gross, M., Buchbinder, S.P., Celum, C., Heagerty, P., Seage, G.R. 1998.  
Rectal microbicides for U.S. gay men: Are clinical trials needed? Are they 
feasible?  Sexually Transmitted Diseases. 25:296-302.

Hardy, E., De Padua, K.S., Jiminez, A.L., Zaneveld, L.J.D. 1998.  Women's 
preferences for vaginal microbicidal contraceptives I, II.  Contraception. 
58:233-249.

Heise, L., McCrory, E., Wood, S. 1998.  Ethical Dilemmas in the Clinical 
Testing of Microbicides: A Report on a Symposium. NY: International Women's 
Health Coalition.

Mastroianni, F., Donaldson, P.J., Kane, T.K. (eds.) 1990.  Developing New 
Contraceptives: Obstacles and Opportunities. Washington DC:  National Academy 
Press.

Potts, M. 1994.  The urgent need for a vaginal microbicide in the prevention 
of HIV transmission (editorial) American Journal of Public Health. 84(6):890-
891.

Roddy, R.E., Schultz, K.F., Cates, W. 1998. Microbicides, meta-analysis, and 
the N-9 question:  Where's the research?  Sexually Transmitted Diseases. 
25(3):151-153.

Rosenthal, S.L., Cohen, S.S., Stanberry, L.R. 1998.  Topical microbicides:  
Current status and research considerations for adolescent girls. Sexually 
Transmitted Diseases. 25(7):368-377.

Severy, L.J. 1999.  Acceptability as a critical component of clinical trials. 
 Advances in Population. V3:103.122. Jessica Kingsley Publishers, Ltd.

UNDP/UNFPA/WHO/World Bank Special Program of Research, Development and 
Research Training in Human Reproduction. 1995. Women's and men's perspectives 
on fertility regulation methods and services. Report of a meeting, Geneva, 29 
November – 1 December.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 research involving human subjects should read the 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research," published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 
18, 1994, available at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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/or 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," published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and available at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy. 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of this RFA.  
Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NICHD staff to estimate the potential review workload and 
avoid conflict of interest in the review.  

The letter of intent is to be sent to Dr. Susan Newcomer at the address listed 
under INQUIRIES by April 10, 2000.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these  grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division 
of Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301-435-0714, E-mail: Grantsinfo@nih.gov.

Application Instructions

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year.  (Applications that request 
more than $250,000 direct costs in any year must follow the traditional PHS 
398 application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form Page.

Under Personnel, list key project personnel, including their names, percent of 
effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus F & A) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of key personnel, and the role on the 
project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the Form Page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and telephone number of the individual 
to contact concerning fiscal and administrative issues if additional 
information is necessary following initial review.

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-00-003. A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in the pdf format.  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.

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 should be 
sent to:

Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)

Applications must be received by May 12, 2000.  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

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness to this RFA by NICHD and NIMH staff.  Incomplete 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 
NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will receive a written critique and may 
undergo a process in which only those applications deemed to have the highest 
scientific merit will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Council of NICHD or NIMH.

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 
their 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.  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 work that by its 
nature is not innovative, but is essential to move a field forward.

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

(2) 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?

(3) 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?

(4) 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)?

(5) 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?

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

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects also will be 
evaluated.

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

o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

The scientific review group also will examine the provisions for the 
protection of human subjects and the safety of the research environment.

Schedule

Letter of Intent Receipt Date:  April 10, 2000 
Application Receipt Date:  May 12, 2000       
Council Review:  September 2000               
Earliest Anticipated Start Date:  September 29, 2000

AWARD CRITERIA

Awards will be made based on scientific merit as determined by peer review, on 
programmatic priorities, and on the availability of funds.

INQUIRIES

Written, E-mail, and telephone inquiries concerning this RFA are encouraged. 
The opportunity to clarify any issues or questions from potential applicants 
is welcome.

Direct inquiries regarding NICHD programmatic issues to:

Susan F. Newcomer, Ph.D.
Demographic and Behavioral Science Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07
Bethesda, MD  20892
Telephone:  (301) 435-6981
FAX:  (301) 496-0962
E-mail:  sn19y@nih.gov

Direct inquiries regarding NIMH programmatic matters to:

David M. Stoff, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-4625
FAX:  (301) 443-9719
E-mail:  dstoff@nih.gov

Direct inquiries regarding NICHD fiscal matters to:

Michael Loewe
Grants Management Office
National Institute of Child Health and Human Development
Building 61E, Room 8A17K
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
E-mail:  loewem@nih.gov

Direct inquiries regarding NIMH fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
E-mail:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.864, 93.121, and 93.242.  Awards are made under authorization of the Public 
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public 
Law 99-158, 42 USC 241 and 285) and administered under NIH grant policies and 
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive Order 
12372 or 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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