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The High-Risk, High-Reward Research program welcomes any project relevant to the NIH mission , including clinical trials . Though technical and conceptual risks are expected in highly innovative projects, clinical research must also contend with potential risks to human subjects. Because awards are administered by the most topic-relevant NIH Institute or Center (IC), applicants proposing NIH-defined clinical trials should contact program staff at the appropriate IC to ensure their applications conform to NIH and IC-specific policies for clinical trials.
| C | More Information | Contact |
|---|---|---|
| NCATS | See NCATS's Clinical & Health Services Research page. | ncatsinfo@nih.gov |
| NCCIH | See NCCIH's Clinical Trials page. | Contact by research area |
| NCI | See NCI's Clinical Trials Resources for Grants and Contracts page. | Lori Henderson, PhD Phone: (240) 276-5930 Email: hendersonlori@mail.nih.gov |
| NEI | NEI will not support clinical trials that are greater than minimal risk on this funding opportunity (Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests). See NEI's Guidelines for Clinical Trials page. | Donald Everett, MA Phone: (301) 451-2020 Email: dfe@nei.nih.gov |
| NHGRI | See NHGRI's Clinical Studies page. | Simona Volpi, PharmD, PhD Phone: (301) 480-3480 Email: volpis@mail.nih.gov |
| NHLBI | See NHLBI's Clinical Trial Development Continuum page. | Katherine Kavounis Phone: (301) 594-1369 Email: Katherine.Kavounis@nih.gov |
| NIA | Applications proposing to conduct non-pharmacological intervention research must define the stage of intervention development proposed as defined by the NIH Stage Model . Applications should adhere to NIA Guidance on Clinical Trials . | Contact the NIA Office of Clinical Research |
| NIAAA | Policies and guidance established by the US Food and Drug Administration (FDA), NIH, and NIAAA should be reviewed by researchers prior to applying for support or initiating studies involving human subjects research or clinical trials. See NIAAA Human Subjects Research and Clinical Trials webpage for more information on NIAAA Clinical Trial policies. | Megan Ryan, MBA Email: mryan1@mail.nih.gov |
| NIAID | See NIAID's Clinical Trial Research resource page. | Maria Powell, PhD Email: maria.powell@nih.gov |
| NIAMS | See NIAMS's Conducting Clinical Research resource page. | NIAMSclinicaltrials@mail.nih.gov |
| NICHD | See NICHD's Policies on Clinical Research and Related Issues . | Joseph Gindhart, PhD Email: gindhartjg@mail.nih.gov Keith Rivers Email: riverskt@mail.nih.gov |
| NIDA | The mission of the National Institute on Drug Abuse (NIDA) is to advance science on the causes and consequences of substance use and substance use disorders (SUD) and to apply that knowledge to improve individual and public health. In this regard, NIDA addresses the most fundamental and essential questions about substance use and SUD — from detecting and responding to emerging trends and understanding how substances work in the brain and body, to developing and testing new approaches to treatment and prevention. NIDA is interested in supporting mechanistic clinical trials* and Basic Experimental Studies with Humans (BESH) that aim to aid these processes. *A mechanistic clinical trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, biomarkers for a disease or response to treatment, or the mechanism of action of an intervention. It is not designed to test the safety or demonstrate the efficacy/effectiveness of an intervention. | Katia Howlett, PhD, MPP, MBA Phone: (301) 443-4877 Email: katia.delrahim-howlett@nih.gov Roger Little, PhD Email: alittle@mail.nih.gov |
| NIDCD | See NIDCD Clinical Trials page. | Trinh Ly, MD Phone: (301) 435-4085 Email: trinh.ly@nih.gov |
| NIDCR | See NIDCR's resources on Conducting Clinical Research . Toolkit for interventional studies | Dena Fischer, DDS, MSD, MS Email: dena.fischer@nih.gov |
| NIDDK | See NOT-DK-21-004 for more information on clinical trials at NIDDK. | Minnjuan Flournoy Floyd, PhD, MPH, MBA Email: Minnjuan.flournoyfloyd@nih.gov |
| NIEHS | See NIEHS's Clinical Research Branch . | Michelle Campbell, MB Phone: (984) 287-3972 Email: campbel5@niehs.nih.gov |
| NIGMS | NIGMS supports basic biomedical research that contributes to the understanding of fundamental cellular and physiological principles. General areas of interest include cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, biomedical technology, bioinformatics and computational biology. The Institute also supports research in certain clinical areas, primarily those that affect multiple organ systems. Additional information is available on the NIGMS website about research interests (including staff contact information) and clinical studies and trials . | Della White, PhD Email: whitede@mail.nih.gov |
| NIMH | See NOT-MH-19-006 for more information on clinical trials at NIMH. | Contact by research area |
| NIMHD | See NIMHD's Clinical & Health Services Research page. | NIMHDDCHSRinquiries@mail.nih.gov |
| NINDS | See NINDS's Clinical Research resource page. | Carlos Faraco, PhD Email: carlos.faraco@nih.gov |
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