May 7, 2024
To avoid the pitfalls that inconsistent use of terms can lead to, NIH and FDA developed a glossary of terms related to clinical research that could be used to assist the research community in effectively communicating about clinical trials. NIH and FDA are most interested in hearing community feedback on the utility of the glossary in its goal of promoting effective communications. Comments will be accepted until June 24, 2024.
October 31, 2023
I often hear concerns raised that NIH does not fund enough basic research, or enough applied research for that matter. Basically, the concerns center around what is the correct balance. It is an important point to consider, as a better understanding of these wider research areas can shed light on NIH’s approach to higher-level priority setting and funding decisions. To get at this question, we leveraged the Research, Condition, and Disease Classification (RCDC) system and looked at trends in NIH funding of these areas between fiscal years (FYs) 2009 and 2022.
September 28, 2020
NIH has received many inquiries from recipients regarding their ability to direct charge personal protective equipment (PPE) costs to their clinical trials and clinical research awards. In this recent Guide Notice, NIH provides criteria for applicants/recipients on when it is appropriate to direct charge PPE costs.
October 12, 2018
NIH encourages fellows supported on NIH NRSA Fellowship awards and trainees supported on NIH NRSA Training awards to receive training in clinical research, including in the conduct of clinical trials. Under a mentor’s guidance, fellows and trainees can gain experience in the wide variety of research skills specific to clinical trials including, but not limited to: developing a clinical trial protocol; applying the principles of informed consent and requirements for human subjects research; learning about random assignment of participants to different intervention arms; analyzing trial endpoints; and/or implementing quality control standards.
October 10, 2018
Want to gain knowledge in clinical research and pharmacology? Start learning now through the FREE self-paced courses offered by the NIH Office of Clinical Research.
April 18, 2016
Precise and clear communication across biological and clinical research disciplines supports efficient translation of results from basic research into applied therapeutics and interventions. Both the NIH and FDA are keenly interested in working together to help the biological and clinical research communities speak a common language, so that research results can be clearly understood by both groups. This is especially true in considering the vocabulary used to describe measures of health, disease, or physiological processes…..
December 3, 2014
For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. ….
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