RESEARCH ON ETHICAL ISSUES IN HUMAN STUDIES

Release Date:  March 31, 1999

PA NUMBER:  PA-99-079

P.T.

National Cancer Institute
National Heart, Lung, and Blood Institute
National Human Genome Research Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
Centers for Disease Control and Prevention
Fogarty International Center
National Center for Complementary and Alternative Medicine
National Center for Research Resources
Office of Research on Women"s Health

Application receipt dates:  June 1, October 1, February 1

THIS PROGRAM ANNOUNCEMENT (PA) USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. 
THE PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT
MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

The National Institutes of Health (NIH) and the Centers for Disease Control and
Prevention invite research grant applications (R01) for support to conduct
research on ethical issues that arise with research involving human participants.

The sponsoring organizations are jointly offering this Program Announcement (PA). 
Although this PA applies to several agencies, it will be administered according
to National Institutes of Health (NIH) policies and procedures.  This PA is one
of the steps the NIH is taking to develop an on-going, multi-agency,
comprehensive program in research ethics.  Other steps include the "Short-Term
Courses in Research Ethics" (T15), PA-99-051 (http://www.nih.gov/grants/guide/pa-files/PA-99-051.html), 
and the "Mentored Scientist Development Award in Research
Ethics" (K01), PA-99-050 (http://www.nih.gov/grants/guide/pa-files/PA-99-050.html), both
published in the NIH Guide for Grants and Contracts, January 22, 1999 and, for
those particularly interested in genetic research ethics, "Ethical, Legal, and
Social Implications of Human Genetics Research," PA-96-042
(http://www.nih.gov/grants/guide/pa-files/PA-96-042.html), published April 26, 1996.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS led national
activity for setting priority areas.  This PA, Research on Ethical Issues in
Human Studies, is related to one or more of the priority areas.  Potential
applicants may obtain a copy of "Healthy People 2000" at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by any domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, research institutions, 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 PA will use the NIH individual research project grant (R01) award mechanism.
However, specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts.  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. 
Complete and detailed instructions and information on Modular Grants can be found
at http://www.nih.gov/grants/funding/modular/modular.htm.

Applications will request direct costs in $25,000 modules, up to a total direct
cost of $250,000 per year for three to five years.  A typical modular grant
application will request the same number of modules in each year.  Grants that
include a request for more than $250,000 in direct costs will use the usual
application process.  The cost of equipment and Consortium/Contractual agreements
is included in the budget limitation.  Application budgets will be simplified. 
Detailed categorical budget information will not be submitted with the
application, budget form pages of the application kits will not be used. 
Instead, total direct costs requested for each year will be presented. 
Information, in narrative form, will be provided only for Personnel and, when
applicable, for Consortium/Contractual Costs.  See section on APPLICATION
PROCEDURES below.

There will be no routine escalation for future years.  In determining the total
for each budget year, applicants should first consider the direct cost of the
entire project period. Well-justified modular increments or decrements in the
total direct costs for any year of the project that reflect substantial changes
in expected future activities may be requested. For example, purchase of major
equipment in the first year may justify a higher overall budget in the first, but
not in succeeding years.

Other Support pages of the PHS 398 will not be submitted with the application.

Information on research projects ongoing or completed during the last three years
of the principal investigator and key personnel will be provided as part of the
"Biographical Sketch." This information will include the specific aims, overall
goals and responsibilities, and should include Federal and non-Federal support.
This information will be used by reviewers in the assessment of each individual"s
qualifications for a specific role in the proposed project.

Following peer review, information about Other Research Support will be requested
by NIH from the applicant for applications being considered for award.

Additional budget information will be requested only under special circumstances.

Responsibility for the planning, direction, and execution of the proposed project
will be solely that of the applicant.

RESEARCH OBJECTIVES

This is a promising time for research because the prospect for advancing
generalizable knowledge is so great.  These advances, however, stretch our
ethical limits, generate new dilemmas, and demand constant vigilance to ensure
that researchers do not jeopardize the rights and welfare of their research
participants.

Because of the rapid advances and complexity of the research enterprise, more
empirical work is needed to guide researchers and Institutional Review Board
(IRB) members towards selecting optimal ways that promote appropriate protections
for research participants.  Few studies, for example, have been conducted on how
best to provide information about a study"s methods and procedures to improve
participants" comprehension, the effect of different recruitment strategies on
retention of study participants, methods to assess the risk/benefit calculus, or
the effects investigator characteristics and behavior have on levels of
recruitment, retention, and withdrawal.

Furthermore, the importance or consequences of the myriad aspects of the research
process on research participants, researchers, and IRB members need to be
investigated.  Of interest are topics including: (1) the identity of the sponsor
of the study and the appearance of conflict of interests, (2) purposes for which
the research is being conducted, (3) the study"s methods that might include
perilous procedures or interventions, (4) inducements to participate and the
relative risks and benefits (including medical, financial, legal, and social) of
deciding to consent to or refuse participation, (5) ensuring justice in the
selection of participants as well as in the conduct of the research, (6)
consequences for the participant as well as for the integrity of the research
study when the participant withdraws from a study, (7) privacy and
confidentiality and when there might be exceptions to either or both, (8) planned
and possible future use of collected tissues or cells (e.g., blood, cell
cultures, DNA, saliva, skin, organs, and tumor biopsies), and (9) planned and
future uses of data collected from a completed study.

This PA is designed to encourage empirical studies that are expected to fill many
gaps in our knowledge and understanding of the complex ethical issues that arise
when involving human participants in research. The PA does not solicit essays,
editorials, literature or historical reviews of science, conferences, or
speculative, theoretical, or policy analyses.  Research may or may not be linked
to a particular disease, disorder, or population.  Applicants are encouraged to
link to the Institutes" or Centers" home pages to learn more about their specific
interests.

The focus can be on potential, current, or former research participants,
investigators, and/or institutional review boards (IRBs).  Possible research
topics are listed below in no order of priority. This list of topics should not
be considered exhaustive and the selection of topic by the applicant need not be
limited to those provided below.

o  Evaluate the cognitive ability required to comprehend, appreciate, and reason
in order to consent to specific experimental procedures and risks (e.g., a
placebo controlled trial, phase I study, sham surgery, pain inducement, symptom-
provocation or exacerbation study, stored tissue repository), to differentiate
between research and standard treatment (e.g., therapeutic misconception), and
to distinguish between discretionary and obligatory activities (e.g., quid pro
quo add-on studies or wrap-around studies).

o  Develop and test new means of sustaining autonomy to be used in situations of
declining or loss of capacity, means can include current yet untested advance
directives for research, and consent programs for organ donation (e.g., durable
power of attorney, proxy, legally authorized representative) and especially novel
and innovative approaches.

o  Investigate how potential participants weigh risks and benefits e.g., what
factors would lead individuals to participate in studies that present significant
risk with little or no prospect of direct benefit.

o  Develop and evaluate the concept and working definition of "community" in the
context of research.  Identify optimal ways in which: (1) a community could be
consulted when considered the sampling frame of a research protocol, (2)
researchers can determine who represents the interests of a community and how to
obtain input from community representatives, (3) researchers can minimize group
harms that may result as a consequence of the study.  For example, how does
"community" apply when a waiver of consent has been granted to conduct emergency
research* and the consent process includes setting up and assessing community
consultation and consent process strategies or programs [* References:  "Informed
Consent Requirements in Emergency Research," OPRR Reports, No. 97-01, Oct. 31,
1996 available on the web at the following URL address:
{http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc97-01.htm}, Also:
"Protection of Human Subjects: Informed Consent and Waiver of Informed Consent
Requirements in Certain Emergency Research, Final Rules" in the Federal Register
of October 2, 1996 (Vol. 61, 51498-51531)].

o  Apply existing knowledge from cognitive, behavioral, social, and educational
fields to develop practical, reliable, valid, and efficient methods and
instruments for assessing capacity to comprehend, appreciate and/or reason in a
research setting, especially when individuals with cognitive, psychiatric, and
developmental disorders are involved, the focus should be on functional abilities
rather than on clinical diagnosis.

o  Research the determining factors and consequences for:
(1) participation (e.g., the impact of escalating monetary incentives on
potential subjects from varied socioeconomic groups to determine the threshold
for interest and consent, perception of fairness, and coercion to remain in the
study),
(2) retention and satisfaction in research (e.g., altruism, wanting to help
family members or future generations, free care, research burden, adverse events,
researcher behavior),
(3) participant withdrawal (e.g., for the participant, the researcher, and the
integrity of the research study).

o  Research the definition, measurement, and understanding of social harms that
might be associated with research participation (e.g., discrimination by
insurance companies or employers that results from participation in HIV/AIDS or
drug abuse studies, vaccine research, or genetic research using identifiable
tissue samples, novel re-contact or opt-out strategies and certificates of
confidentiality could be considered).

o  Identify and develop ways to address special issues related to research and
medical records (e.g., allowing participants access to their research records,
protection of privacy and confidentiality while providing a mechanism for future
notification of unanticipated benefits or risks resulting from study
participation).

o  Research the ethical issues within the context of a specific disease/disorder,
or a group of diseases/disorders, or identified vulnerable populations (e.g., by
age, gender, economic status, race/ethnicity/culture).

o  Research the challenges in the ethical design and conduct of cross-cultural
studies, especially research conducted in low- and middle- income nations. 
Topics for investigation could include: translating ethical procedures to local
environments such as risk/benefit assessment, informed consent, privacy and
confidentiality, and appropriate material inducements, considerations arising
from the methodological design and conduct of cross-cultural protocols, such as
placebo control and randomization, community involvement at different levels of
study design, conduct and recruitment, and broader issues of "distributive
justice" including clinical obligations to the study participants and allocation
of intellectual property and other benefits.

o  Develop and evaluate best practice outcome measures for IRBs to use in
monitoring protocol review (e.g., extent of sponsors contributing funds to cover
costs of protocol review, recruitment and signing bonuses), the on-going consent
process (e.g., consent monitor, Research Intermediary), and conduct of the study
(e.g., number and type of procedural reviews, aggregation of adverse events,
measures to reduce exposure to unwarranted risk, data safety and monitoring
boards, educational strategies).

ANNUAL MEETINGS AND COLLABORATION

Successful applicants will be asked to participate in yearly meetings to report
progress, discuss problems, and share information related to the conduct of their
grants. Previous experience with meetings of this kind has shown that they can
provide an opportunity for grantees to work collaboratively with other
investigators on various issues, which might include common core instruments,
joint publication, sharing of protocols and data, or other avenues of
collaboration that may arise. Meetings may be held in the Washington, D.C. area,
in conjunction with a professional meeting [e.g., PRIM&R/ARENA (Public
Responsibility in Medicine and Research/Applied Research Ethics National
Association Conferences)], or another mutually agreed upon site. It is
recommended that costs associated with attendance of the principal investigator
and one collaborator at these meetings be included as part of the budget
proposal.

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 is 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," which have been 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 on the web at the following URL address:
https://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 the 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 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 was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research, or may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email:
Grantsinfo@od.nih.gov. Applications are also available on the World Wide Web at:
http://www.nih.gov/grants/forms.htm

Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct costs
for any year are advised that he or she must contact the Institute and Center
(IC) program staff before submitting the application, i.e., as plans for the
study are being developed.  Furthermore, the applicant must obtain agreement from
the IC staff that the IC will accept the application for consideration for award. 
Finally, the applicant must identify, in a cover letter sent with the
application, the staff member who, and the Institute or Center that, agreed to
accept assignment of the application.  This policy requires an applicant to
obtain agreement for acceptance of both any such application and any such
subsequent amendment.  Refer to the NIH Guide for Grants and Contracts, March 20,
1998. {http://www.nih.gov/grants/guide/notice-files/not98-030.html}.

BUDGET INSTRUCTIONS

For applications requesting $250,000 or less, 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:

PHS 398

o  FACE PAGE- Item 2 should be completed as noted above.  Items 7a and 7b should
be completed to indicate Modular Direct Costs (in $25,000 increments up to a
maximum of $250,000) and Total Costs [Modular 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 (rev 4/98).  It is not required and will not be accepted at the
time of application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form. It is not
required and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See {http://www.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.

o  Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct plus
facilities and administrative) 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.

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://www.nih.gov/grants/funding/modular/modular.htm}

- Complete the educational block at the top of the form page,
- List current position(s) and then previous positions,
- List selected peer-reviewed publications, with full citations,
- Provide information, including overall goals and responsibilities, on research
projects ongoing or completed during the last three years.

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. It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

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

APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE
TO THIS PA AND WILL BE RETURNED WITHOUT FURTHER REVIEW.

The PA title and number must be typed on item 2 of the face page of the
application form, and the "YES" box must be marked.

Submit a signed, typewritten original of the application 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)

The Center for Scientific Review (CSR) will not accept any application in
response to this PA 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 assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the top
half of applications under review, will be discussed, assigned a priority score,
and receive a second level review by the appropriate national advisory council
or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments, reviewers will be asked to 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? Does the proposed research take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional or other support
that will contribute to the success of the research?

In addition to the above criteria, in accordance with NIH policy, all
applications will also 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 will also 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.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program priority

INQUIRIES

Written and telephone inquiries are encouraged. Additional information, including
sample budget narratives and biographical sketch, may be found at this site:
{http://www.nih.gov/grants/funding/modular/modular.htm}. The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding general programmatic issues to:

Ruth L. Fischbach, Ph.D., M.P.E.
Senior Advisor for Biomedical Ethics
Office of Extramural Research
1 Center Drive, Room 144, MSC 0152
Bethesda, MD  20892-0152
Telephone:  (301) 496-1414
FAX:  (301) 402-7062
Email:  rlfisch@nih.gov

Programmatic inquiries related to a specific Institute or Center may be directed
as follows:

Mary S. McCabe, R.N.
Office of Clinical Research Promotion
National Cancer Institute
31 Center Drive, Room 3A44, MSC-2440
Bethesda, MD  20892-2440
Telephone:  (301) 496-6404
FAX:  (301) 496-0826
Email:  mm95z@nih.gov

Eleanor Schron, M.S., R.N., FAAN
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, Room 8144
Bethesda, MD  20892-7952
Telephone:  (301) 435-0399
FAX:  (301) 480-3667
Email:  es41u@nih.gov

Elizabeth Thomson, R.N., M.S., C.G.C.
Ethical, Legal, and Social Implications Research
National Human Genome Research Institute, NIH
38 Library Drive, Room 617, MSC 6050
Bethesda, MD  20892-6050
Telephone:  (301) 402-4997
FAX:  (301) 402-1950
Email:  et22s@nih.gov

Miriam Kelty, Ph.D.
Associate Director, Extramural Affairs
National Institute on Aging
7201 Wisconsin Avenue, Room 218C
Bethesda, MD  20892-9205
Telephone: (301) 496-9322
FAX:  (301) 402-2945
Email: mk46u@nih.gov

Harold Perl, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0788
FAX:  (301) 443-8774
Email:  hperl@willco.niaaa.nih.gov

Milton J. Hernandez, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C21
Bethesda, MD  20892-7640
Telephone: (301) 496-3775
FAX: (301) 402-0369
Email: mh35c@nih.gov

Dr. Steven J. Hausman
Director, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 45, Room 5AS-13F
45 Center Drive, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-2463
FAX:  (301) 480-4543
Email:  sh41g@nih.gov

Marian Willinger Ph.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03D, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
FAX:  (301) 496-3790
Email:  mw75q@nih.gov

Norman Braveman, Ph.D.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN24
Bethesda, MD  20892-6402
Telephone:  (301) 594-2089
FAX:  (301) 480-8318
Email:  Norman.Braveman@nih.gov

Judith Fradkin, M.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 5AN-12E
Bethesda, MD  20892-6600
Telephone:  (301) 594-8814
FAX:  (301) 480-3503
Email:  JF58S@nih.gov

Andrea Baruchin, Ph.D.
Office of Science Policy and Communications
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5230, MSC 9591
Bethesda, MD  20892-9591
Telephone:  (301) 443-6071
FAX:  (301) 443-6277
Email:  ab47j@nih.gov

Michael E. McClure, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive
P.O. Box 12233, Mail Drop EC-23
Building 4401, Room 3417
Research Triangle Park, NC  27709
Telephone:  (919) 541-5327
FAX:  (919) 541-5064
Email:  mm461n@nih.gov

Rochelle M. Long, Ph.D.
Pharmacology, Physiology, and Biological Chemistry Division
National Institute of General Medical Sciences
45 Center Drive, Room 2AS-49H
Bethesda, MD  20892-6200
Telephone:  (301) 594-1826
FAX:  (301) 480-2802
Email:  rochelle_long@nih.gov

Peter Muehrer, Ph.D.
Chief, Health and Behavioral Science Research Branch
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health, National Institutes of Health
6001 Executive Boulevard, Room 6189, MSC 9615
Bethesda, MD  20892-9615
Telephone:  301/443-4708
FAX:  301/480-4415
Email:  pmuehrer@mail.nih.gov

Joseph S. Drage, M.D.
Training and Special Programs Officer
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3309, MSC 9531
Bethesda, MD  20892-9531
Telephone:  (301) 496-4188
FAX:  (301) 402-4370
Email:  jd66x@nih.gov

Dr. June Lunney
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  June_Lunney@nih.gov

Marjorie A. Speers, Ph.D.
Deputy Associate Director for Science
Centers for Disease Control and Prevention (MS-D50)
1600 Clifton Road
Atlanta, GA  30333
Telephone: (404) 639-7260
FAX: (404) 639-7341
Email:  mas4@cdc.gov

Kenneth Bridbord, M.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: ken_bridbord@nih.gov

Dr. Geoffrey Cheung
Deputy Director
National Center Complementary and Alternative Medicine
Building 31, Room 5B-36
Bethesda, MD  20892-2182
Telephone:  (301) 594-2013
FAX:  (301) 594-6757
Email:  CheungG@OD.NIH.GOV

Richard Knazek, M.D.
Clinical Research Area
National Center for Research Resources
6705 Rockledge Drive, Room 6128
Bethesda, MD  20892-7965
Telephone:  (301) 435-0792
FAX: (301) 480-3661
Email:  RichardK@NCRR.nih.gov

Joyce Rudick, Ph.D.
Office of Research on Women"s Health
National Institutes of Health
Building 1, Room 201, MSC-0161
Bethesda, MD 20892-0161
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  rucickj@od.nih.gov

Address inquiries regarding fiscal matters to:

Dena Solomon
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 263
FAX:  (301) 496-8601
Email:  solomond@gab.nci.nih.gov

William Darby
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7160
Bethesda, MD  20892-7952
Telephone:  (301) 435-0144
FAX:  (301) 480-3310
Email:  wd8u@nih.gov

Jean Cahill
Division of Extramural Research
National Human Genome Research Institute
38 Library Drive, MSC 6050, Room 613
Bethesda, MD  20892-6050
Telephone:  (301) 402-0733
FAX:  (301) 402-1951
Email:  jcl66o@nih.gov

Joseph Ellis
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, 2N212
Bethesda, MD  20892-9205
Telephone: (301) 496-1472
FAX:  (301) 402-3672
Email:  EllisJ@exmur.nia.nih.gov

Judy Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2434
FAX:  (301) 443-3891
Email:  js182a@nih.gov

Barbara Huffman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C25
Bethesda, MD  20892-7640
Telephone: (301) 496-3821
FAX: (301) 402-0369
Email:  bh23q@nih.gov

Sally A. Nichols
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-49F, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email: sn21q@nih.gov

Doug Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17F, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6999
FAX:  (301) 402-0915
Email:  shawverd@exchange.nih.gov

Martin R. Rubinstein
Grants Management Officer
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN44A
Bethesda, MD  20892
Telephone:  (301) 594-4800
FAX:  (301) 402-1517
Email:  mr49c@nih.gov

Nancy Dixon
Grants Management Officer
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 6AN44C
Bethesda, MD  20892-6600
Telephone:  (301) 594-8854
FAX:  (301) 480-3504
Email:  dixonn@extra.niddk.nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone: (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

David Mineo
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
111 T.W. Alexander Drive, East Campus
Research Triangle Park, NC 27709
Telephone:  (919) 541-1373
FAX:  (919) 541-2860
Email:  mineo@niehs.nih.gov

Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences
Building 45, Room 2AN.50B
Bethesda, MD  20892-6200
Telephone:  (301) 594-5132
FAX:  (301) 480-3423
Email:  HOLLANDA@nigms.nih.gov

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
Email:  Diana_Trunnell@nih.gov

Dawn Richardson
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3254, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  da8h@nih.gov

Jeff Carow
Grants and Contracts Management Office
National Institute of Nursing Research
Building 45, 3AN-12, MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email:  jeff_carow@nih.gov

Scott Bowen
Operations Officer
Centers for Disease Control and Prevention (MS-D41)
1600 Clifton Road
Atlanta, GA  30333
Telephone: (404) 639-7046
FAX: (404) 639-7114
Email:  msb4@cdc.gov

Silvia Mandes
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email:  silvia_mandes@nih.gov

Marie Willett
Grants Management Branch
National Heart, Lung, and Blood Institute*
6701 Rockledge Drive, Suite 7156, MSC 7926
Bethesda, MD  20892-7952
Telephone:  (301) 435-0144
FAX:  (301) 480-3310
Email:  WillettM@gwgate.nhlbi.nih.gov
*NOTE: NCCAM uses NHLBI as a service center for all grants management activities.

Joellen M. Harper
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6086
Bethesda, MD  20892-7965
Telephone:  (301) 435-0844
FAX:  (301) 480-3777
Email:  jh41m@nih.gov

Terri Kendrix
Office of Research on Women"s Health
Building 1, Room 201
Bethesda, MD 20892
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  kendrixt@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance.  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 PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74. 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, and 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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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