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Advice to
Investigators Submitting Clinical Research
Applications*
Clinical
investigation is vital to the mission of NIH. The
following guidelines are provided to assist
investigators in the preparation of clinical
applications. These suggestions are an extension, not a
replacement, of instructions for completing the PHS 398
from. "Clinical studies" encompass a wide range of
methodologies, and not all of these suggestions will be
applicable to all clinical studies.
Specific Aims: Clearly
articulate the hypotheses or objectives and specific aims of the
study.
Background and Significance: Describe the scientific basis and
rationale for the study. Address the following: a) the
significance of the project in the context of the field;
b) the clinical importance of the problem; c) the need
for a clinical study; d) the potential impact of the
proposed study on the understanding of the
pathophysiology, etiology, or outcome of the disease; e)
the potential impact on clinical
practice.
Research Design and
Methods: Describe the overall study design. Study groups (subjects,
populations) and the rationale for their selection should be described.
Description of study groups should include inclusion and exclusion
criteria, potentially confounding variables, estimates of availability and
accessibility, as well as recruitment strategies and the likelihood of
subject accrual. Primary and secondary endpoints should be clearly
defined, clinically important, and measurable. For clinical trials, if it
is not included within the body of the grant application, the detailed
study protocol might be submitted in the Appendix. Description of
statistical analyses should include justification of sample size and power
calculations. Phase III clinical trials must also include a description of
plans to conduct analyses by sex/gender, racial/ethnic groups, and
relevant subpopulations, when applicable. Procedures for data flow, data
management, data quality, and database integrity and security should be
described. If appropriate, a plan for data sharing should be
included.
Human Subjects Research Section: Incomplete information
concerning the use of human subjects may affect the
scientific merit rating. Unless your proposed clinical
studies are described by one or more of the exemptions
in the human subjects regulations (45 CFR46 101 (b): see
also PHS 398),the following should be addressed in a
section entitled "protection of human subjects": risks
to the subjects; adequacy of protection against risks;
potential benefits of the proposed research to the
subjects and others; importance of the knowledge to be
gained. If your proposed studies are described by one or
more of the exemptions, address the following in the
"protection of human subjects" section: specify and
justify the exemption(s) claimed; population sample;
sources. Note: Prospective collection of data and/or
samples does not qualify for Exemption 4. Careful
attention must be paid to NIH policies on inclusion of
children, women, and minority populations. Plans for
inclusion and recruitment of children, women, and
minorities should be addressed, and excluded populations
should be justified. If the proposal involves a clinical
trial, it must include a description of a Data and
Safety Monitoring Plan (DSMP).
Investigators: Clinical
projects often require a multidisciplinary team of
investigators. The involvement and contribution of the
investigators to the clinical aspects of the project
should be described. The expertise of the investigators
should mach the study population, e.g., investigators
with pediatric expertise should be included if the study
involves a pediatric population.
Environment: Describe the
clinical, data management, and statistical resources
that are available for the study.
Additional Resources:
Investigators are encouraged to contact program staff
prior to submitting an application. Additional
information that may be useful is available on the
following NIH web sites:
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Institute/Center Contacts and Online Resources:
| NCCAM: |
Web site: http://nccam.nih.gov/research/policies/index.htm |
| NCI: |
Web site: http://www.nci.nih.gov/clinicaltrials/conducting/ |
| NCRR: |
Web site: http://www.ncrr.nih.gov/clinical_rsrch.asp
- clinicalrsrch |
| NEI: |
Donald F. Everett
Program Director, Collaborative Clinical Research
National Eye Institute
Tel: (301) 451-2020
Email: deverett@nei.nih.gov
Web site: http://www.nei.nih.gov/funding/special.htm |
| NHBLI: |
Robert Musson, Ph.D.
Deputy Director DEA
National Heart, Lung, and Blood Institute
Tel: (301) 435-0266
Email:
mussonr@nhlbi.nih.gov
Web site: http://www.nhlbi.nih.gov/funding/policies/index.htm
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| NIA: |
Web site: http://www.nia.nih.gov/funding/policy/humint.htm |
| NIAID: |
Web site: http://www.niaid.nih.gov/ncn/clinical/humansubjects/default.htm |
| NIAMS: |
Web site: http://www.niams.nih.gov/rtac/clinical/index.htm |
| NIBIB: |
Meredith D. Temple-O'Connor, Ph.D.
Acting Director, Division of Interdisciplinary
Training
National Institute of Biomedical Imaging and
Bioengineering
Tel: (301) 451-4792
Email: templem@mail.nih.gov |
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NIDA: |
Ivan Montoya, M.D., M.P.H.
Medications Research Grants Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
Tel: (301) 443-8639
Email: imontoya@nih.gov
Web site:
http://www.nida.nih.gov/Funding/CTI.html
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| NIDCD: |
A. Julianna Gulya, M.D.
Division of Extramural Research
National Institute on Deafness and
Other Communication Disorders
Tel: (301) 435-4085
Email: gulyaj@mail.nih.gov
Web site: http://www.nidcd.nih.gov/research/clinicaltrials/index.asp |
| NIDCR: |
Richard L. Mowery, Ph.D.
Chief, Clinical, Epidemiology, and Behavioral
Research Branch
National Institute of Dental and Craniofacial
Research
Tel: (301) 594-4841
Email: rm33a@nih.gov
Website: http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp |
| NIDDK: |
Joyce A. Hunter, Ph.D.
Deputy Director, Division of Extramural Activities
National Institute of Diabetes and Digestive
and Kidney Diseases
Tel: (301) 594-0056
Email: hunterj@extra.niddk.nih.gov
Web site: http://www.niddk.nih.gov/patient/patient.htm |
| NIEHS: |
Kimberly Gray, Ph.D.
Health Science Administrator, Susceptibility
and Population Health Branch
Division of Extramural Research and Training
National Institute of Environmental Health
Sciences
Tel: (919) 541-0293
Email: kg89o@nih.gov |
| NIGMS: |
Alison E. Cole, Ph.D.
Program Director
National Institute of General Medical Sciences
Tel: (301) 594-3349
Email: colea@nigms.nih.gov |
| NIMH: |
David Shore, M.D.
Associate Director for Clinical Research
National Institute of Mental Health
Tel: (301) 443-6776
Email: DShore@mail.nih.gov
Web site: http://www.nimh.nih.gov/grants/index.cfm |
| NINDS: |
Scott Janis, Ph.D.
Clinical Trials
National Institute of Neurological Disorders
and Stroke
Tel: (301) 496-9135
Email: sj151t@nih.gov
Web site:
http://www.ninds.nih.gov/funding/clinical_trials/clinical_research.htm |
| NINR: |
Claudette G. Varricchio DSN, RN, FAAN
Chief, Office of Extramural Programs
National Institute of Nursing Research
Tel: (301) 402-6423
Email: varriccc@mail.nih.gov
Website: http://www.nih.gov/ninr/research/dea/applicationprocess.html
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* NIH Definition of Clinical Research
1.
Patient-oriented research. Research conducted with
human subjects (or on material of human origin
such as tissues, specimens, and cognitive
phenomena) for which an investigator (or
colleague) directly interacts with human subjects.
Excluded from this definition are in vitro studies
that utilize human tissues that cannot be linked
to a living individual. Patient-oriented research
includes: (a) mechanisms of human disease, (b)
therapeutic interventions, (c) clinical trials, or
(d) development of new technologies.
2.
Epidemiologic and behavioral studies,
3.
Outcomes research and health services
research.
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