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://ohrp.osophs.dhhs.gov/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:
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 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 301-435-0714, email:
[log in to unmask] 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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
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: [log in to unmask]
*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: [log in to unmask]
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: [log in to unmask]
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.
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