RESEARCH ON ETHICAL ISSUES IN HUMAN STUDIES

RELEASE DATE:  May 1, 2002

PA NUMBER: PA-02-103 (Notice of intent to reissue, see NOT-OD-06-043)
                     (Expiration date extended, see NOT-OD-05-026)

EXPIRATION DATE:  April 2006 

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI)
 (http://www.nhgri.nih.gov/)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov/default.htm)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 (http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://www.nccam.nih.gov)
Fogarty International Center (FIC) 
 (http://www.nih.gov/fic/)
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

This PA replaces PA-99-079.

The National Institutes of Health (NIH) invite research grant applications 
(R01) to investigate ethical issues in human subjects research. The Code of 
Federal Regulations - Protection of Human Subjects (45 CFR, Part 46) provides 
a regulatory framework that all NIH-supported researchers must follow.  
Recent developments in biomedical and behavioral research, however, including 
the rapid growth of new interventions and technologies (e.g., stem cells, 
genetics research), increasing involvement of foreign populations in clinical 
research, and concerns about financial conflicts of interest among 
researchers, challenge investigators' abilities to interpret and apply the 
regulations. Other situations (e.g., research with vulnerable populations, 
the use of data banks or archives, research on stigmatizing diseases or 
conditions) may present difficulties for identifying strategies, procedures, 
and/or techniques that will enhance/ensure the ethical involvement of human 
participants in research.  The purpose of this program announcement is to 
solicit research addressing the ethical challenges of involving human 
participants in research in order to inform and optimize protections for 
human participation in research.

RESEARCH OBJECTIVES

In pursuing NIH-funded human research, investigators, institutions, and IRB 
members must adhere to several general ethical principles, including: Respect 
for Persons - individuals should be treated as autonomous agents and persons 
with diminished autonomy are entitled to additional protections; Beneficence 
- efforts must be made to maximize possible benefits and minimize possible 
harms; and Justice - individuals or groups of individuals should not be 
unduly burdened as a result of participating in research and individuals or 
groups of individuals should not disproportionately benefit as a result of 
participating in research 
(http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm).  

Interpreting and applying these ethical principles, however, can present 
questions or dilemmas for investigators. For example, in some circumstances, 
it may be difficult for investigators and members of Institutional Review 
Boards (IRBs) to: identify and minimize all forms of risks or harms; know how 
best to inform potential human participants in order that they comprehend 
research risks and voluntarily consent to participate; or, identify and then 
implement procedures that will safeguard the rights and welfare of 
participants considered vulnerable to undue influence. Ensuring consistency 
with stated principles may be particularly challenging when working with non-
Western cultures or in foreign countries where the very concepts and meaning 
of "individual," "risks," "benefits," "informed consent," etc. may be very 
different and/or where the standards for conducting research may be at odds 
with US standards. In addition, constant advances in communication and 
information technologies affect how research data are defined, recorded, 
stored, and maintained, thereby providing new challenges for maintaining 
privacy and confidentiality. 

In conducting research on ethical issues in human subjects research, several 
different conceptual frameworks for ethics (e.g., principlism, deontology, 
utilitarianism, ethics of rights, ethics of care, etc.) exist and may provide 
presuppositions and theoretical foundations from which bioethical questions 
can be formulated and tested. It is important to remember that the questions 
and strategies for testing these issues must be consistent with existing 
federal requirements. Currently, research supported by the Department of 
Health and Human Services (DHHS – which includes NIH) follows the Code of 
Federal Regulations (45 CFR, Part 46) – Protection of Human Subjects 
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). For 
research conducted internationally, alternative guidelines that are 
consistent with 45 CFR 46 may be used 
(http://www.hhs.gov/ohrp/humansubjects/assurance/filasur.htm), such as 
those developed by the World Health Organization, the Council for 
International Organizations of Medical Sciences, and other internationally 
recognized groups.

In addition, the research design for conducting research on ethical issues in 
human studies should be appropriate to the nature of the project(s) proposed 
and the disciplines involved. Given the conceptual and methodological 
complexity of many of these research questions, interdisciplinary and 
collaborative projects are encouraged, particularly those involving clinical 
researchers, ethicists, and behavioral/social scientists. 

The purpose of this PA is to support empirical research addressing the 
ethical challenges of involving human participants in research in order to 
inform and optimize protections for human participation in research. Examples 
of the types of topics that would be appropriate for applications submitted 
under this announcement include, but are not limited to, the following:

MINIMIZING RISKS in HUMAN RESEARCH

o Assess how features of the research and research setting affect 
evaluations of risks versus potential benefits of different types of 
research (e.g., use of placebo, Phase I, II, III clinical trials) for 
investigators, IRB members, and potential participants/ groups/ 
communities. Examples of features of the research or research setting 
may include:
-  Characteristics of the participant (e.g., age, health status and 
stage of disease, ethnic/cultural background, cognitive capacity, 
social status, gender, incarceration);
-  Aspects of the condition/disease (e.g., prevalence, severity, 
chronicity, degree of disability);
-  Nation or culture in which the study will take place.

o Identify potential social, psychological, and/or economic harms (e.g., 
stigma, discrimination, personal distress, loss of insurance coverage, 
loss of employment) that may be associated with recruitment, 
participation, self-determined or study-determined withdrawal from 
research. Evaluate strategies or procedures for minimizing these harms 
in regard to individuals/groups/communities/populations' willingness to 
participate in different types of research.

o Assess the conditions and assumptions under which IRB evaluation of 
risk vs. potential benefits is similar or different from the evaluation 
of risks vs. potential benefits by 
individuals/groups/communities/populations.

o Assess the impact of obtaining a Certificate of Confidentiality on 
perceptions of IRB members and/or participants in terms of evaluation 
of risks, understanding of the research, and/or understanding of the 
rights to privacy.

o Identify and evaluate strategies for protecting and minimizing 
disclosure of private information when identifiable data are:
-  Collected via the internet
-  Preserved for secondary analysis, e.g., a tissue or gene bank, data 
archive or warehouse;
-  Collected about third parties in research, e.g., network studies.

ISSUES in INFORMED CONSENT

o Determine how features of the informed consent process affect 
participants' comprehension and/or willingness to participate in 
research. Examples of these features include:
-  Variations in the style of presentation (e.g. oral, written, 
graphic, video);
-  Readability, complexity, and or format of the consent document;
-  Characteristics of the participant (e.g. language preference, 
age, health status, education, cultural/ethnic background, personal 
motivations, cognitive capacity);
-  Contextual features or circumstances in which informed consent 
takes place (e.g., characteristics of the research staff, location 
such as research hospital vs. private office vs. home, 
presence/involvement of family members, presence/involvement of 
patient advocates). 

o Evaluate different methods and identify best-practice strategies for 
consulting with communities in the United States and/or other countries 
regarding comprehension, willingness to participate, and/or willingness 
to continue with research at the individual, group/community, and/or 
population level.

o Assess how re-contacting participants to obtain informed consent for 
additional uses of their data affects participant comprehension, 
willingness to participate, and sense of coercion.

o Identify and evaluate strategies, procedures, and/or techniques for 
improving comprehension of research by individuals, groups/communities, 
and /or populations at the time of initial consent, during, and/or 
after completion of the study. Also, determining how these strategies 
may differ depending on age, health status, ethnic/cultural background, 
cognitive capacity, social status, and/or gender of the target 
audience.

o Assess how participants' willingness to participate versus sense of 
coercion, may be affected by:
-  Use of different types of incentives, remuneration, and/or provision 
of medical care;
-  Different features of the research setting, e.g., personal physician 
as recruiter and/or researcher, private funding versus federal funding;
-  Characteristics of the participant, e.g., health status, age, 
ethnic/cultural background, education, gender.

o Assess the impact of communicating or not communicating individual test 
results, study progress, and/or study results on participants' 
willingness to continue with the protocol and/or participate in 
research again.

OVERSIGHT OF RESEARCH and RESEARCH DATA

o Identify and evaluate strategies to improve the oversight of human 
participants protection by Institutional Review Boards (IRB), Data and 
Safety Monitoring Boards (DSMB), Conflict of Interest (COI) committees, 
etc. Examples may include:
-  Develop and evaluate best practice outcome measures for decision-
making about the acceptability of research protocols;
-  Assess the consistency of protocol review decisions within DSMBs, 
IRBs, or COI Committees;
-  Assess the impact of conflicts of interest among members of 
oversight committees on decision-making about the acceptability of 
research protocols, interpretations of adverse events, and/or 
perceptions of "independence of review" by the research community.
-  Assess the impact of disclosing varying degrees of financial 
conflicts of interest involving the principal investigator, members of 
oversight committees, sponsor, institution, etc. on research 
participant willingness to participate and/or continue with research, 
and/or participant understanding of the research.

o Compare and evaluate different methods and strategies for identifying, 
reporting, and handling adverse events based on the perspectives of 
individual participants, institutions, DSMBs, and/or IRBs. 

MECHANISM OF SUPPORT 

This PA will use the NIH R01 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.
 
This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs. 

Also, new investigators are encouraged to apply. They may wish to develop 
small, focused research projects that provide initial findings for larger 
research proposals in the future. It would be expected that such applications 
also would have smaller budgets reflecting the scope of the research 
proposed.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants. Since this PA involves a number 
of NIH Institutes, we are providing: (a) a General NIH Contact, to assist 
with general questions about the PA and help direct applicants to relevant 
Institute/Office Contacts; and (b) Specific NIH Institute/Office Contacts to 
answer questions about Institute/Office specific scientific/research issues 
and financial or grants management issues. We strongly encourage you to 
identify and correspond with Institute/Office Contacts prior to submitting 
your application. 

o Direct your general questions about this program announcement to:

OER, OD, NIH 1 Rockledge Centre, Suite 350 Room  3531 
6705 Rockledge Drive MSC 7963 Bethesda,MD 20892-7963  e-mail: OERMailbox@mail.nih.gov

To assist in identifying which Institute/Office most closely matches your 
research topic, the following web site provides additional information about 
Institute/Office specific research interests that will be supported by this 
PA http://grants.nih.gov/grants/funding/ethics_contacts.htm.

o  Direct your questions about scientific/research issues to (be sure to 
identify the Institute/Office that most closely matches your topic):

National Cancer Institute
Kim Witherspoon
Clinical Grants and Contracts Branch
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Blvd (EPN), Rm 7009
MSC 7432
Bethesda, MD 20892-7432 
National Institutes of Health
Phone: 301-496-8866
Fax: 301-480-4663
Email: withersk@ctep.nci.nih.gov

National Heart, Lung, and Blood Institute
Ellen M. Werner, Ph.D 
6701 Rockledge Drive, Room 10156, MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0077
FAX: (301) 480-0868
Email: wernere@nhlbi.nih.gov

National Human Genome Research Institute
Elizabeth J. Thomson, MS, RN, CGC, FAAN 
Building 31, Room B2B07
31 Center Drive, MSC 2033
National Institutes of Health 
Bethesda, MD 20892-2033
Telephone: (301) 402-4997 
FAX: (301) 402-1950 
Email: et22s@nih.gov

National Institute on Aging
Neil Buckholtz, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 3C307 7201
Wisconsin Avenue Bethesda, MD 20892-9205
Telephone: (301) 496-9350
Email: buckholn@nia.nih.gov

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

National Institute on Allergy and Infectious Diseases
Lawrence J. Prograis, Jr., M.D.
DAIT
6700 B Rockledge, Room 5134
Bethesda, MD 20892
Telephone: (301) 496-1886
FAX: (301) 402-2571
Email: LPROGRAIS@niaid.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases
Christine L. Densmore, M.S.
Clinical Coordinator
Building 45, Rm 5AS19B
Bethesda, MD 20892-6500
Telephone:  (301) 594-5052
FAX: (301) 480-4543
Email: densmorc@mail.nih.gov

National Institute of Child Health and Human Development
Lisa Freund, Ph.D.
Building 6100, Room 6B05D MSC7510
Bethesda, MD  20892
Telephone:  (301) 435-6879
FAX:  (301) 408-0230
Email: freundl@mail.nih.gov

National Institute on Deafness and Other Communication Disorders
Amy M. Donahue, Ph.D.
6120 Executive Blvd EPS Room 400C MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402 3458
Fax: (301) 402 6251
Email: amy_donahue@nih.gov

National Institute of Dental and Craniofacial Research
Patricia S. Bryant, Ph.D.
Division of Population and Health Promotion Sciences
45 Center Drive, Room 4AN24E
Bethesda, MD 20892
Telephone: (301) 594-2095
FAX: (301) 480-8318
Email: BryantP@de45.nidr.nih.gov

National Institute of Diabetes and Digestive Kidney Diseases 
Patricia R. Robuck, Ph.D., M.P.H.
Division of Digestive Diseases and Nutrition
6707 Democracy Blvd., Room 659
Bethesda, MD  20817
Telephone:  (301) 594-8879
FAX:  (301) 480-8300
Email:  pr132q@nih.gov

National Institute on Drug Abuse
Dr. Susan Weiss,  
Chief, Science Policy Branch, 
Office of Science Policy and Communications, NIDA.
Phone: 301 594-6126
Email: sweiss@nida.nih.gov

National Institute of Environmental Health Sciences
Shobha Srinivasan, Ph.D.
Division of Extramural Research and Training
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
RTP, NC  27709
Telephone: (919) 541-2506
FAX: (919) 316-4606
Email: sriniva2@niehs.nih.gov

National Institute of General Medical Sciences
Rochelle M. Long, Ph.D.
Pharmacology, Physiology, and Biological Chemistry Division
Building 45, Room 2AS.49G, MSC 6200
(45 Center Drive for express/courier service)
Bethesda, MD  20892-6200
Telephone:  (301) 594-1826
FAX:  (301) 480-2802
Email: longr@nigms.nih.gov

National Institute of Mental Health
Timothy Cuerdon, Ph.D.  
Division of Mental Disorders, Behavioral Research, and AIDS
6001 Executive Boulevard, Room 6190, MSC 9615
Bethesda, MD 20892-9625
Telephone:  (301) 435-0301
FAX: (301) 480-2920
Email: tcuerdon@mail.nih.gov

National Institute of Neurological Disorders and Stroke
Barbara Radziszewska, Ph.D., M.P.H.
Clinical Research Project Manager
Clinical Trials Cluster
6001 Executive Blvd., Room 2216
Bethesda, MD 20892-9520
Telephone:  (301) 496-2076
FAX:  (301) 480-1080
Email: br94h@nih.gov

National Institute of Nursing Research
Karin F. Helmers, PhD
Building 45, Room 3AN12
Bethesda, MD  20892
Telephone:  (301) 594-2177
FAX: (301) 480-8260
Email: Karin.helmers@nih.gov

National Center on Complementary and Alternative Medicine
Joana Rosario, MD, MPH
6707 Democracy Blvd, Suite 401
Bethesda, MD 20892-5475   For courier use: 20817                             
Telephone: (301) 594-9986       
Fax: (301) 480-3621       
Email: jr69z@nih.gov

Fogarty International Center 
Barbara Sina Ph.D.
Division of Training and Research
Building 31 Room B2C39
Telephone: 301-402-9467
FAX: 301-402-0779
Email: sinab@mail.nih.gov

Office of Behavioral and Social Sciences Research 
Deborah H. Olster, Ph.D.
Senior Advisor
Office of Behavioral and Social Sciences Research (OBSSR)
National Institutes of Health
Bldg. 1, Room 256
One Center Drive
Bethesda, MD 20892-0183
Phone: (301) 451-4286
FAX: (301) 402-1150
Email: olsterd@od.nih.gov

Office of Research on Women's Health
Joyce Rudick 
Building 1, Room 201
Bethesda, MD 20892
Telephone: (301) 402-1770
FAX:   (301) 402-1798
Email: rudickj@od.nih.gov

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

National Cancer Institute
Kelly Oster
Executive Plaza South Room 243
Bethesda, MD 20892
Telephone:  (301) 496-8627
FAX: (301) 496-8601
Email: osterk@mail.nih.gov

National Heart, Lung, and Blood Institute
Marsha Mathis
6701 Rockledge Drive, Room 7158, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0170
FAX: (301) 480-3310
Email: mathism@nhlbi.nih.gov

National Human Genome Research Institute 
Jean Cahill
Grants Management Officer
Building 31, Room B2B34 
31 Center Drive, MSC 2031
Bethesda, MD 20892-2031
Telephone: (301) 435-7858
FAX: (301) 402-1951
Email: jc166o@nih.gov

National Institute on Aging
Jeff Ball
Grants Management Specialist
7201 Wisconsin Avenue
Gateway Building, Suite 2N212
Bethesda, MD  20892-9205
Telephone: (301) 402-7732
FAX: (301) 402-3672
E-Mail: ballj@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism
Ms. Judy Fox Simons
6000 Executive Boulevard, Suite 504
Bethesda, MD  20892-7003
Telephone: (301) 443-4706
FAX: (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

National Institute on Allergy and Infectious Diseases
Barbara Huffman
Division of Extramural Activities
6700-B Rockledge Drive, Room 2132
Bethesda, MD 20892
Telephone: (301) 496-3821
FAX:  (301) 402-2571
Email: bh23q@nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases
Melinda Nelson
Grants Management Officer
Building 45, Rm 5AS49F
Bethesda, MD 20892-6500
Telephone: (301) 594-3535 
FAX: (301) 480-5450
Email:  nelsonm@mail.nih.gov

National Institute of Child Health and Human Development
Mary Daley
Building 6100, Room  8A07D MSC7510
Bethesda, MD  20892
Telephone:  (301) 496-1305
FAX:  (301) 402-0915
Email: daleym@mail.nih.gov

National Institute on Deafness and Other Communication Disorders
Sara Stone
6120 Executive Blvd EPS Room 400B MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402 0909
Fax: (301) 402 1758
Email: sara_stone@nih.gov

National Institute of Dental and Craniofacial Research 
H. George Hausch, Ph.D.
Acting Director
Division of Extramural Activities
45 Center Drive, Room 4AN-44F
Bethesda, MD 20892-2904
Phone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

National Institute of Diabetes and Digestive Kidney Diseases
Sharon T. Bourque
Senior Grants Management Specialist
6707 Democracy Blvd. Room 719
Bethesda, MD 20892
Telephone: (301) 594-8846 
FAX: (301) 480-3504 
Email: bourques@extra.niddk.nih.gov

National Institute on Drug Abuse
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 443-6847
E-mail:  gfleming@nida.nih.gov

National Institute of Environmental Health Sciences
Jackie Russell
Grants Management Branch
Division of Extramural Research and Training
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-0751
FAX:  (919) 541-2860
Email:  russell@niehs.nih.gov

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

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

National Institute of Neurological Disorders and Stroke 
Gladys Melendez
Senior Grants Management Specialist
NIH/NINDS/GMB/Suite 3290
6001 Executive Blvd.
Rockville, MD 20892
Telephone: (301) 496-9231
FAX:  (301) 402-0219
Email:  bohlerg@ninds.nih.gov

National Institute of Nursing Research
Sally York
Building 45, Room 3AN12
Bethesda, MD  20892
Telephone:  (301) 594-2154
FAX: (301) 480-8260
Email: Sally.York@nih.gov

National Center for Complementary and Alternative Medicine
Ms. Andra A. Standberry
6707 Democracy Blvd.
Democracy Two, Suite 401
Bethesda, MD  20892-5475
Telephone:  (301) 594-3788
Fax:  (301) 480-3621
Email:  standbea@mail.nih.gov

Fogarty International Center 
Bruce Butrum
Office of the Director
Building 31 Room B2C39
Telephone: 301-496-1670
FAX: 301-594-1211
Email: butrumb@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

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

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o 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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

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

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

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

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html)
; a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.  
Awards are made under authorization of Sections 301 and 405 of the Public 
Health Service Act as amended (42 USC 241 and 284) and administered under NIH 
grants policies described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people. http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.

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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