National Cancer Institute (NCI)
The National Cancer Institute (NCI) coordinates the National Cancer Program,
which conducts and supports research, training, health information dissemination,
and other programs with respect to the cause, diagnosis, prevention, and treatment
of cancer, rehabilitation from cancer, and the continuing care of cancer patients
and the families of cancer patients.
The National Cancer Institute is interested in supporting research that fills
gaps in our knowledge and understanding of the many complex ethical issues facing
investigators, IRBs and participants in research. General topics of interest
include: 1) novel approaches to informed consent and assessment of the understanding
of research participants; 2) development of strategies for advance consent for
specimen collection; 3) evaluations to better understand the weighing of risks
and harms, in particular for children in early phase clinical trials; 4) assessment
of methods to ensure the privacy and confidentiality of research information
while conducting research, including assessment of understanding and provision
of new information to participants; 5) evaluation of the new challenges in conducting
population-based research including community and privacy issues; 6) strategies
that will enhance the effectiveness and efficiency of the IRB system; and 7)
development of strategies that will promote the ethical inclusion of minorities
and special populations in clinical research.
Direct your questions about scientific/research issues to:
Mary S. McCabe
National Cancer Institute
Bldg. 31 Room 3A-44
Bethesda, MD 20892
Telephone: (301) 496-6404
FAX: (301) 496-0826
Email: mccabem@mail.nih.gov
Direct your questions about financial or grants management matters to:
Kelly Oster
National Cancer Institute
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 (NHLBI)
The National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, fosters,
and supports research, clinical investigations and trials, observational studies,
and demonstration and education projects in diseases of the heart, blood vessels,
lung, and blood; sleep disorders; and the clinical use of blood and blood resources,
and transfusion medicine. Since October 1997, the NHLBI has also had administrative
responsibility for the NIH Woman's Health Initiative. For health professionals
and the public, the NHLBI conducts educational activities, including development
and dissemination of materials in the above areas, with an emphasis on prevention.
The NHLBI seeks to fund research in bioethics and medical research ethics that
addresses:
- Emerging technologies with the potential for clinical applications, for
example, cell-based therapies;
- Traditional bioethical issues that may need reassessment in light of changing
societal, cultural and political norms, for example informed decision-making
and the process leading to informed consent; children as research subjects
in clinical trials; the role of industry in research and conflict of interest;
research with communities and with socially disadvantaged populations; and
- Issues related to advances in medicine and technology, for example the speed
of translational research from the lab to beside and clinic; the use of repository
specimens for future tests of genetic mutations; data confidentiality and
privacy, especially for data on phenotype-genotype correlations; the social
constructs of race and ethnicity in relation to genetics; and adverse event
reporting.
The NHLBI welcomes other lines of bioethical inquiry that are consistent with
NHLBI’s scientific research mission.
Direct your questions about scientific/research issues to:
Ellen M. Werner, Ph.D.
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10156, MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0077
FAX: (301) 480-0868
Email: wernere@nhlbi.nih.gov
Direct your questions about financial or grants management issues to:
Marsha Mathis
National Heart, Lung, and Blood Institute
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 (NIHGRI)
The NHGRI, along with several other federal and private national and international
organizations, is currently engaged in a research effort known as the Human
Genome Project (HGP). This project’s primary goal is to map and sequence the
entire human genome. The HGP currently has several interrelated goals, among
them, the identification and analysis of the ethical, legal, and social implications
of this research. The Ethical, Legal, and Social Implications (ELSI) Research
Program of NHGRI is charged with administering program activities related to
this goal and as such has a number of related program announcements. They can
be viewed by touching the "Funding Opportunities button at: http://www.nhgri.nih.gov:80/About_NHGRI/Der/Elsi/
.
With regard to this Program Announcement, the NHGRI is interested in funding
a broad range of ethics issues research related to genetic topics. Examples
of research topics of interest are:
- How to design and conduct genetic and genomic research in an ethical manner,
taking into consideration issues of special concern to individuals from diverse
communities who traditionally have not been involved in this type of research,
or who may have been adversely affected in the past by genetic types of research;
- How best to provide information during the informed consent process for
participation in genetics research, particularly since many of the research
topics are complex, confusing, and not well understood. Further, this process
may be made more complicated by the fact that there may be no words into which
certain genetic research terms or concepts can be translated;
- How best to minimize potential risks associated with genetics research,
particularly when some of the research risks may remain unknown; and
- How best to protect the privacy and confidentiality of individuals, families,
and groups who participate in genetics research.
Inquiries about this PA are encouraged. The opportunity to clarify any issues
or questions from potential applicants is welcome.
Direct your questions about scientific/research issues to:
Elizabeth J. Thomson, MS, RN, CGC, FAAN
National Human Genome Research Institute
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
Direct your questions about financial or grants
management matters to:
Jean Cahill
Grants Management Officer
National Human Genome Research Institute
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 (NIA)
The NIA’s research mission is to support and conduct
high quality research on aging processes, age-related diseases, and special
problems and needs of the aged. Examples of research of ethical issues of interest
to the NIA include, but are not limited to:
- decision making and consent process in older persons
- end of life decisions
- comprehension of information necessary for informed
consent in light of impaired cognitive functioning and executive functions
in some older persons
- impact of degree and type of cognitive impairment
on decision making
- development of methods and instruments for assessing
capacity to comprehend and appreciate participation in research in older individuals
with and without diminished cognitive abilities
- education interventions for improving ability
of investigators to assess competency to give consent
- issues surrounding surrogate decision-makers for
frail elderly or older individuals with cognitive impairment
Direct your questions about scientific/research issues to:
Elisabeth Koss, Ph.D.
Alzheimer's Disease Centers Program
National Institute on Aging
Gateway Building, Suite 3C307
7201 Wisconsin Ave MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
E-mail: kosse@nia.nih.gov
Direct your questions about financial or grants management matters to:
Jeff Ball
Grants Management Specialist
National Institute on Aging
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 (NIAAA)
The National Institute on Alcohol Abuse and Alcoholism
(NIAAA) supports and conducts biomedical and behavioral research on the causes,
consequences, treatment, and prevention of alcoholism and alcohol-related problems.
NIAAA also provides leadership in the national effort to reduce the severe and
often fatal consequences of these problems.
- The ethics of administering alcohol as part of NIH-sponsored research, to
what patient groups and for how long:
- Is it ethical to give alcohol to alcoholics for the purpose of research,
and if so, under what circumstances?
- How much and for how long can alcohol be given to non-alcoholics?
- Informed consent issues:
- What types of consent procedures are needed for alcoholics who are impaired
due to current intoxication, withdrawal symptoms, or medically related cognitive
impairments?
- Appropriate procedures to inform alcoholics that insurance companies and
other agents may seek release of their medical records and may deny insurance
with out such a release.
- Research with minors:
- Under specific situations, IRB’s can waive the requirements to obtain active
parental consent. What aspects of research with children and adolescents influence
decisions about waiving active parental consent?
- Whether providing information on safer ways to drink (harm reduction) inadvertently
increases the risk that youth will engage in drinking (illegal behavior).
- Whether a strictly abstinence message increases youth vulnerability to engage
in drinking and other high-risk behaviors.
- Can one allow an alcoholic to continue their usual drinking pattern while
being studied or must treatment be given immediately?
- In genetic research, if genes that put people at risk for alcohol problems
are identified, then later statements about the population of people who have
those genetic factors may result in the stigmatization of persons who never
gave informed consent to participate in the study.
- What are the ethical issues pertaining to the design, development, and application
of summary measures of population health?
- Questions regarding the relationship of domestic violence to alcohol consumption
and protecting the privacy of both victims and perpetrators so that treatment
can be offered and research can be conducted.
- Financial compensation of alcoholics, particularly homeless and poverty-stricken
persons, for participation in research.
- What are appropriate levels of protection for subjects and researchers when
tissue is obtained for genetic studies?
- Ethical considerations in the treatment of HIV infected alcohol abusers.
Direct your questions about scientific/research issues to:
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
Direct your questions about financial or grants management matters to:
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 (NIAID)
NIAID provides the major support for scientists conducting research aimed at
developing better ways to diagnose, treat and prevent the many infectious, immunologic
and allergic diseases that afflict people worldwide. Examples include gene transfer
research, xenotransplantation, and HIV vaccine trials. These advances in biomedical
and behavioral research by NIAID and their application to medicine have highlighted
the importance of ethical issues in these areas. Thus, NIAID encourages
research of an operational nature, such as development of tools to demonstrate
that research participants are in fact informed when they consent, or analysis
of ethical obligations when basic principles differ between sponsor and host
country or other subject areas germane to NIAID's mission.
Direct your questions about scientific/research issues to:
Lawrence J. Prograis, Jr., M.D.
DAIT
NIAID
6700 B Rockledge, Room 5134
Bethesda, MD 20892
Telephone: (301) 496-1886
FAX: (301) 402-2571
Email: LPROGRAIS@niaid.nih.gov
Direct your questions about financial or grants
management matters to:
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 (NIAMS)
The mission of the National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS) is to support research into the causes, treatment, and
prevention of arthritis and musculoskeletal and skin diseases, the training
of basic and clinical scientists to carry out this research, and the dissemination
of information on research progress in these diseases.
NIAMS is aware of the many complex ethical issues encompassing clinical research.
In order to enhance our knowledge and understanding, we are interested in supporting
research that addresses these issues. Examples include: 1) informed consent;
2) advance consent for specimen collection and long term storage/use; 3) assessment
of comprehension and by participants; 4) assessment of methods to ensure the
privacy and confidentiality of research information; 5) IRB-related issues;
and 6) development of strategies that will promote the ethical inclusion of
minorities and children in clinical research.
Direct your questions about scientific/research issues to:
Christine L. Densmore, M.S.
Clinical Coordinator
NIAMS
Building 45, Rm 5AS19B
Bethesda, MD 20892-6500
Telephone: (301) 594-5052
FAX: (301) 480-4543
Email: densmorc@mail.nih.gov
Direct your questions about financial or grants management matters to:
Melinda Nelson
Grants Management Officer
NIAMS
Building 45, Rm 5AS49F
Bethesda, MD 20892-6500
Telephone: (301) 594-3535
FAX: (301) 480-5450
The National Institute of Child Health and Human Development (NICHD)
The National Institute of Child Health and Human
Development (NICHD) has dedicated its research to understanding the dynamic
biological, behavioral, and social processes that dictate physical, emotional,
and cognitive growth. The NICHD seeks the knowledge to understand the complex
interplay of processes that transform cells into healthy functioning individuals,
free of disease and disabilities. When this goal is not achieved, or achieved
unequally by different groups, the NICHD mission is to understand why, and to
develop remedies to ensure the healthy functioning of all infants, children,
youth, and families.
NICHD has interest in supporting research that will
increase our understanding of the complex ethical issues and potential risks
and benefits that are involved when research protocols include children, pregnant
females, couples or individuals attempting to conceive as participants, or individuals
with developmental disabilities.
- Investigate the conditions, which influence children and adolescents to
participate in research with focus on the child’s relationship with parent(s,)
developmental stage, physical health or health history, communication with
peers, and life experiences.
- Investigate children's or families’ of individuals with development disabilities
understanding of research risks, the value of research, and the consent process
as it influences their participation in research.
- Investigate the practices and consequences of obtaining "assent"
from children or individuals with developmental disabilities.
- Investigate pregnant female’s understanding of research risks to her fetus,
the value of research to her and her fetus and the consent process as it influences
her participation in research. At what point do potential research benefits
outweigh potential risks and how much risk is too much risk for a pregnant
female and her fetus.
- Investigate the understanding of the risks and benefits of fertility research
on the part of couples attempting to conceive. Investigate the practices and
consequences of obtaining "assent" for fertility research from couples
or individuals attempting to conceive.
- Investigate ethical issues surrounding the potential conflict between cultural
norms in countries where we do research and US research policies.
- Investigate the concept of "community" in the context of research. Identify
optimal ways in which: (a) a community could be consulted when considered
the sampling frame of a research protocol; (b) researchers can determine who
represents the interests of a community and how to obtain input from community
representatives; (c) researchers can minimize group harms that may result
as a consequence of the study.
- Research the challenges in the ethical design and conduct of cross-cultural
studies, especially research conducted in low- and middle- income nations,
with an emphasis on 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.
- 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.
Direct your questions about scientific/research issues to:
Lisa Freund, Ph.D.
NICHD
Building 6100, Room 6B05D MSC7510
Bethesda, MD 20892
Telephone: (301) 435-6879
FAX: (301) 408-0230
Email: freundl@mail.nih.gov
Direct your questions about financial or grants management matters to:
Mary Daley
NICHD
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 (NIDCD)
The NIDCD supports biomedical and behavioral research and research training
in the normal and disordered processes of hearing, balance, smell, taste, voice,
speech, and language. The Institute also conducts and supports research and
research training related to disease prevention and health promotion; addresses
special biomedical and behavioral problems associated with people who have communication
impairments or disorders; and supports efforts to create devices which substitute
for lost and impaired sensory and communication function.
The NIDCD in interested in supporting research related to ethical issues in
research in human communication for all individuals, whether the primary communication
mode is spoken, signed, or an augmentative/alternative device.
These include:
- Novel approaches to informed consent and assessment of the understanding
of research participants with deafness/hearing impairment; strategies to better
promote the ethical inclusion of children and minorities in research studies;
issues related to conflicts of interest and study outcomes; and understanding
how health care delivery policies or practices have an impact on research
in NIDCD mission areas.
- Issues specific to advances in genetics. These include: the development
of adequate informed consent procedures about the use of DNA specimens for
genetic testing related to hearing impairment; advance consent/reconsenting
for the use of repository specimens for future genetic studies; novel approaches
to facilitate comprehension of genetic information and subsequent informed
decision making for various cultural groups as well as for individuals with
hearing impairment; and, novel ways to include individuals with hearing impairment
and individuals who are deaf, as well as related organizations representing
the spectrum of communities of deaf or hearing impaired people, in the research
enterprise.
Direct your questions about scientific/research issues to:
Amy M. Donahue, Ph.D.
Chief, Hearing and Balance/Vestibular Section
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
Direct your questions about financial management to:
Sara Stone
Grants Management Office, Division of Extramural Research
NIDCD
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 (NIDCR)
The mission of the NIDCR is to promote general health through supporting research
to improve oral, dental, and craniofacial health. Prevention, diagnosis, and
treatment of conditions such as inherited and acquired craniofacial deformities,
salivary disorders, acute and chronic orofacial pain conditions, oral infectious
diseases including dental caries and periodontal diseases, and oral aspects
of systemic diseases all fall with the scope of NIDCR’s interests. Studies addressing
ethical issues related to oral/craniofacial conditions, oral-systemic disease
linkages, and public health or health care delivery policies or practices influencing
oral health are of specific interest to NIDCR.
Direct your questions about scientific/research issues to:
Patricia S. Bryant, Ph.D.
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN24E
Bethesda, MD 20892
Telephone: (301) 594-2095
FAX: (301) 480-8318
Email: BryantP@de45.nidr.nih.gov
Direct your questions about financial or grants management matters to:
H. George Hausch, Ph.D.
Acting Director
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
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 (NIDDK)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
conducts and supports research encompassing a broad spectrum of metabolic diseases
such as diabetes, inborn errors of metabolism, endocrine disorders, mineral
metabolism, digestive diseases, nutrition, obesity, urology and renal disease,
and hematology. The NIDDK is interested in supporting research that will enhance
the knowledge and understanding of the many complex ethical issues facing investigators,
IRBs and participants in research. General topics of interest include: 1) development
of methodology to assure research subjects possess the cognitive ability to
differentiate between research and standard treatment and to distinguish between
discretionary and obligatory activities; 2) investigation of factors that would
lead individuals to participate in studies that present significant risk with
little or no prospect of direct benefit; 3) definition, measurement, and understanding
of social harms that might be associated with research participation; 4) assessment
of methods to ensure the privacy and confidentiality of research information
while conducting research, including provision of new information to participants
and future access to medical records; 5) study the challenges in the ethical
design and conduct of cross-cultural studies, especially research conducted
in low- and middle- income nations; 6) development of strategies associated
with re-consenting patients to allow for extended storage of blood and tissue
samples in repositories for use at a later time and for presently unidentified
studies; 7) strategies in the ethical design and conduct of studies involving
special populations such as the homeless and drug abuse populations; 8) development
of methodologies for ensuring informed consent and confidentiality with internet
or web based questionnaires or computer driven questionnaires; 9) development
of novel strategies for obtaining and evaluating alternate methods of informed
consent such as the use of videos and interactive computer prompts in the informed
consent process.
Direct your questions about scientific/research issues to:
Patricia R. Robuck, Ph.D., M.P.H.
Division of Digestive Diseases and Nutrition
NIDDK
6707 Democracy Blvd., Room 659
Bethesda, MD 20817
Telephone: (301) 594-8879
FAX: (301) 480-8300
Email: pr132q@nih.gov
Direct your questions about financial or grants
management matters to:
Sharon T. Bourque
Senior Grants Management Specialist
NIDDK/NIH
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 (NIDA)
NIDA’s mission is to lead the nation in bringing
the power of science to bear on drug abuse and addiction. This charge has two
critical components: The first is the strategic support and conduct of research
across a broad range of disciplines. The second is to ensure the rapid and effective
dissemination and use of the results of that research to significantly improve
drug abuse and addiction prevention, treatment, and policy.
NIDA supports research of ethical issues related
to the definition, measurement, and understanding of social harms that might
be associated with participation in drug abuse and addiction research. Examples
of such issues include, but are not limited to, the following:
- Discrimination by insurance companies or employers
that may results from participation in HIV/AIDS or drug abuse studies;
- Vaccine research;
- Genetic research using identifiable tissue samples;
- Novel re-contact or opt-out strategies;
- Certificates of confidentiality.
Other ethical issues related to drug abuse research
will also be considered.
Direct your questions about scientific/research issues to:
Lucinda Miner, Ph.D.
Chief, Office of Science Policy
National Institute on Drug Abuse
6001 Executive Blvd., Room 5231, MSC 9195
Bethesda, Maryland 20892
Telephone: (301) 443-6071
FAX: (301) 443-6277
Email: cminer@nida.nih.gov
Angela M. Martinelli, DNSc, RN
Office of Science Policy
National Institute on Drug Abuse
6001 Executive Blvd., Rm. 5232
Bethesda, MD 20892-9591
Telephone: (301) 443-6071
FAX: (301) 480-2485
Email: amartine@mail.nih.gov
Direct your questions about financial or grants
management matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
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 (NIEHS)
The National Institute of Environmental Health Sciences
is interested in supporting research and educational efforts that promote public
understanding of the social, ethical, and legal implications of conducting environmental
health research involving human subjects in areas such as gene-environment interactions,
environmental health hazards, disease susceptibility, and social stressors.
Specifically, NIEHS is interested in those research and education projects that
involve translational research endeavors that foster community-university partnerships
and also address:
- Developing innovative methods for obtaining informed
consent, especially in minority and at-risk communities.
- Limitations of proxy consent, especially for children,
physically and mentally challenged or incapacitated individuals.
- Methods of communicating issues relating to risk
and benefits to the individual and the community of participation in research
projects.
- Individual, family and community rights in access
to information and the materials generated from the research. Role of certificates
of confidentiality.
- Challenges in researching and identifying environmental
hazards long before effective and acceptable medical, ecological, or policy
interventions are available.
- Issues relating to confidentiality, such as, limitations
and challenges of reusing the data or information (stored data, banked samples)
by other researchers/ communities.
- Issues relating to conflict of interest, benefits
of the process and outcome of research and interventions.
- Challenges and guidelines for ensuring equal representation
or selection of participants and communities.
- Methods of disseminating or creating greater public
awareness on consent procedures, role of IRBs, and the process of voluntary
disclosures.
- Ownership of the data. The role of the community
in community based participatory research programs.
- Challenges in developing and conducting community,
institutional and societal level interventions.
- Issues relating to stigmatization, discrimination
in employment and health care, and in community.
Direct your questions about scientific/research issues to:
Shobha Srinivasan, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
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
Direct your questions about financial or grants management matters to:
Jackie Russell
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
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 (NIGMS)
NIGMS supports research in Genetics, Pharmacogenetics, Clinical Pharmacology,
Anesthesia, and Trauma and Burn Injury.
Genetic studies are aimed at understanding the fundamental mechanisms of inheritance
and development including chromosome organization and mechanics, control of
gene expression, developmental genetics, extrachromosomal inheritance, mechanisms
of mutagenesis, neurogenetics and the genetics of behavior; population genetics,
evolution, and the genetics of complex traits, including SNPs and haplotypes.
NIGMS supports a focus in pharmacogenetics on understanding individual variations
in drug responses and identifying the responsible receptors and enzymes, as
well as discovering variants and their altered functions; the emphasis is on
linking phenotype to genotype in humans. Studies in clinical pharmacology and
anesthesiology include the effects of drugs on the body and the body's effects
on drugs, such as absorption, transport, distribution, metabolism, and excretion,
as well as drug interactions with receptors, signal transduction mechanisms,
and drug delivery strategies. Studies in trauma and burn injury are directed
towards an improved understanding of the physiological responses to injury,
including shock, compensatory mechanisms, adverse consequences (including sepsis
and multiple organ failure), and restoration of tissue integrity.
NIGMS’ interests in research on ethical issues includes:
- Issues associated with sharing stored samples
- Strategies for posting clinical data to web sites
- Issues related to the content of informed consents
- Conveying benefits to groups that participate in research
- Giving indirect consent when incapacitated
- Promoting dialogue with communities and giving feedback to research participants
- Maintaining privacy of individuals and groups for stored data
Direct your questions about scientific/research issues to:
Rochelle M. Long, Ph.D.
Pharmacology, Physiology, and Biological Chemistry Division
NIGMS, NIH
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
Direct your questions about financial or grants management matters to:
Antoinette Holland
Grants Administration Branch
NIGMS, NIH
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 (NIMH)
The mission of the National Institute of Mental Health (NIMH) is to reduce
the burden of mental illness through research on the mind, brain, and behavior.
NIMH supports the scientific investigation of various topics related to research
ethics, including the ongoing process of informed consent in studies involving
research participants with mental disorders, the use of surrogate decision-makers
(legally authorized representatives), and factors that influence IRB decisions
regarding additional safeguards for participants in research on mental disorders,
symptoms, and related disability. Of particular interest are empirical studies
that apply the theories, findings, and methods of basic behavioral and neuroscience
research to understand (a) research subjects’ "capacity" to understand
relevant information, to appreciate the nature and consequences of participation
options, to manipulate information rationally while making decisions, and to
employ means for improving such decisions; (b) ethical decision-making (consideration
of risks, benefits, and alternatives) by investigators studying mental disorders;
and (c) IRB reviews of applications that involve participants with mental disorders.
Direct your questions about scientific/research issues to:
Timothy Cuerdon, Ph.D.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6190, MSC 9615
Bethesda, MD 20892-9625
Telephone: (301) 435-0301
FAX: (301) 480-2920
Email: tcuerdon@mail.nih.gov
Direct your questions about financial or grants management matters to:
Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
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: DTrunnell@mail.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke encourages submission
of research proposals addressing ways of meeting the ethical challenges encountered
in performing well-controlled clinical studies of neurological and cerebrovascular
disorders. Examples of topics of interest to NINDS include:
- Ethical issues associated with the use of placebo treatment, with or without
standard care, in studies of acute and chronic neurological conditions: New,
alternative research designs are needed to reconcile conflicting scientific
and ethical requirements.
- Consent issues: To date, little is known about the extent to which patients
with acute or chronic neurological disorders can provide informed consent.
There is an urgent need to develop instruments for assessment of decision-making
capacity in these vulnerable patients, and to develop methods of assisting
such patients or their caretakers in decision-making concerning clinical trial
enrollment decisions. There is a need for continued research on waiver-of-consent
issues for studies on decisionally-impaired patients with traumatic brain
injuries and other neurological disorders.
- Withdrawal of treatment issues: Clinical trials on neurological disorders
often employ symptomatic treatment withdrawal in order to ascertain the "natural"
state of the disease. The withdrawal of treatment is not well tolerated by
patients, and its safety has not been established. In order to minimize discomfort
and risk to patients, investigators curtail the withdrawal period, to the
extent that the ascertainment of the natural state of the disease may not
be valid. A question arises: how can novel treatments of neurological disorders
be evaluated while addressing these ethical and methodological concerns?
- Issues associated with genetic risk studies: Linkage disequilibrium studies
can lead to identification of disease genes towards a goal of helping to ameliorate
or cure those diseases. Conversely, these studies can be used to characterize
individuals, or even entire populations, in terms of their ultimate risk for
developing disease, with potential, adverse consequences to those involved.
Consequently, linkage disequilibrium studies pose numerous ethical challenges.
Studies are needed to identify the risks posed by this research and the methods
of minimizing those risks. While those kinds of risks are not unique to genetic
studies of neurological disorders, the late onset of some neurological disorders
leads to some special ethical issues.
Direct your inquiries about scientific/research issues to:
Barbara Radziszewska, Ph.D., M.P.H.
Clinical Research Project Manager
Clinical Trials Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2216
Bethesda, MD 20892-9520
Telephone: (301) 496-2076
FAX: (301) 480-1080
Email: br94h@nih.gov
Direct your questions about financial or grants management matters to:
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 (NINR)
The National Institute of Nursing Research supports clinical and basic research
to establish a scientific basis for the care of individuals across the life
span-from management of patients during illness and recovery to the reduction
of risks for disease and disability, the promotion of healthy lifestyles, promoting
quality of life in those with chronic illness, and care for individuals at the
end of life.
NINR is interested in research that addresses the ethical conduct of research.
Ethical issues of interest to NINR include studies to improve the understanding
of the informed consent process and to determine when secondary gains may become
coercive (i.e., amount of remuneration, free health care). The factors that
influence the decision making process in clinical trials with varying risks
and benefits needs to be identified. Studies are needed to determine the capacity
of consent in vulnerable populations (i.e., cognitively impaired, severely mentally
ill, low literacy), and to identify cultural and ethnic factors that influence
the recruitment, consent process and the participation in research studies.
NINR is interested in the best practices of the participation of children in
clinical trials, of patient and family considerations for participating in genetic
studies and organ transplantation. Interventions are needed to improve the patients’
comprehension of participation in a clinical research trial and to enhance autonomy
in the informed consent process of all populations. Lastly, NINR is interested
in studies investigating ethical issues surrounding end of life research.
Direct your questions about scientific/research issues to:
Karin F. Helmers, PhD
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD 20892
Telephone: (301) 594-2177
FAX: (301) 480-8260
Email: Karin.helmers@nih.gov
Direct your questions about financial or grants management matters to:
Sally York
National Institute of Nursing Research
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 (NCCAM)
NCCAM is interested in supporting research regarding the ethical treatment
of human subjects who participate in studies that utilize complementary and
alternative medical practices. Studies of CAM practices share the same challenges
as all clinical trials, but there are unique additional issues that incur potential
ethical risks, issues than when well studied and better understood will considerably
elevate the quality of future CAM research. CAM practices, by definition, are
unproven and often poorly characterized or standardized. Thus, for example,
NCCAM is interested in studies of informed consent regarding the choices research
subjects might face in considering whether to receive a CAM treatment instead
of, or in addition to, a proven conventional treatment. In developing nations,
the only widely available practices might involve traditional healing methods.
Thus, NCCAM is interested in ethical issues raised by studies that explore ancient
local healing practices in populations that have no usual access to proven medications
and who are unaccustomed to being research subjects.
Direct your questions about scientific/research issues to:
Joana Rosario, MD, MPH
Director, Office of International Health Research
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
Direct your questions about financial or grants management matters to:
Ms. Andra A. Standberry
Grants Administration Branch
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 (FIC)
The Fogarty International Center is primarily interested in supporting international
bioethics research related to performing research on acute and chronic diseases
in
low- and middle-income nations. Studies should focus on the internationally
relevant aspects of the ethical, legal and social principles guiding the responsible
conduct of research in developing countries, particularly on scientific integrity
and the protection of the interests of research participants. Research areas
may include ethical perspectives on the use of human biological materials in
research, the ethics of designing clinical research protocols and ethical considerations
in performing research in vulnerable populations with an emphasis on culturally
relevant research. Other topics may include the impact of international codes,
laws and guidelines and ethical issues related to informed consent, intellectual
property, collaborative agreements between host and sponsor countries, the role
of ethics review committees in the developing world and in cross-cultural research
and ethnographic research.
Direct your questions about scientific/research issues to:
Barbara Sina Ph.D.
Division of Training and Research
Fogarty International Center
Building 31 Room B2C39
Telephone: 301-402-9467
FAX: 301-402-0779
Email: sinab@mail.nih.gov
Direct your questions about financial or grants management matters to:
Bruce Butrum
Office of the Director
Fogarty International Center
Building 31 Room B2C39
Telephone: 301-496-1670
FAX: 301-594-1211
Email: butrumb@mail.nih.gov
Office of Behavioral and Social Sciences Research (OBSSR)
One mission of the Office of Behavioral and Social Sciences Research (OBSSR)
is to promote research regarding the ethical treatment of human subjects in
the behavioral and social sciences. In this mission we work with the various
Institutes and Centers at NIH to insure that such research is appreciated and
supported. While OBSSR provides no direct funding to applicants for ethics research,
we do serve as a potential sounding board for applicants with interests in ethics
topics in the behavioral and social sciences – with an interest in directing
such applicants to the appropriate NIH Institute or Center. As such, we encourage
applicants with questions regarding behavioral and social science ethics topics
to contact OBBSR.
Direct your questions about scientific/research issues to:
Stephen Drigotas, Ph.D.
Office of Behavioral and Social Sciences Research
1 Center Drive, Room 255
Bethesda, MD 20892
Telephone: (301) 402-3930
Fax: (301) 402-1150
Email: Drigotas@od.nih.gov
Office of Research on Women’s Health (ORWH)
The mission of the Office of Research on Women's Health (ORWH) is to: (a) advise
the NIH Director and staff on matters relating to research on women's health;
(b) strengthen and enhance research related to diseases, disorders, and conditions
that affect women; (c) ensure that research conducted and supported by NIH adequately
addresses issues regarding women's health; (d) ensure that women are appropriately
represented in biomedical and biobehavioral research studies supported by NIH;
(e) develop opportunities for and supports recruitment, retention, re-entry,
and advancement of women in biomedical careers; and (f) support research on
women's health issues. ORWH works in partnership with the NIH institutes and
centers to ensure that women's health research is part of the scientific framework
at NIH and throughout the scientific community.
ORWH is interested in ethical issues surrounding the inclusion of women in
clinical studies and women as subjects in research studies, including the role
and scope of IRBs. While ORWH provides no direct funding to applicants for ethics
research, we do serve as a potential sounding board for applicants with interests
in ethics topics in the issues related to women with an interest in directing
such applicants to the appropriate NIH Institute or Center. ORWH is interested
in research to identify the best strategies for explaining immediate and longer-term
risks and benefits for women participating in research, particularly research
involving screening (e.g., genetic screening, or screening for evidence of disease.)
In addition, ORWH is interested in ethical issues surrounding inclusion of all
populations of women in clinical trials and, especially women of reproductive
age and pregnant women, the elderly. Priorities include:
- Ethical issues in recruitment and retention, defining usual care, issues
of privacy, cognitively impaired patients,
- Ramifications of pregnant women in research enrollment,
- Enrollment of non-English speaking minorities,
- Enrollment of minorities in percentages appropriate for the disease being
studied,
- Use of cognitively impaired women as in those with dementia,
- Use of incarcerated women, women under the influence of licit and illicit
psychoactive agents,
- Enrollment of women in experimental therapies - risk-benefit issues.
- Use of tissue specimens from surgical and/or autopsy for research such as
genetic basis for breast cancer and other cancers.
- Direct your questions about scientific/research issues to:
Joyce Rudick
Office of Research on Women’s Health, Office of the Director
Building 1, Room 201
Bethesda, MD 20892
Telephone: (301) 402-1770
FAX: (301) 402-1798
Email: rudickj@od.nih.gov |