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) 710-0267,
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.
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