As highlighted in many previous blog posts and the recent National Academies of Sciences, Engineering, and Medicine (NASEM) report, promoting a strong biomedical workforce is a top priority for the NIH. In 2017, NIH launched the Next Generation Researchers Initiative, which is a multi-pronged approach to increase the number of NIH-funded early stage investigators. An important component of this initiative is the call for increased transparency and availability of data about the make-up of the biomedical research workforce. More complete data will allow NIH leadership to best understand and address the needs of our emerging workforce. Continue reading
As you may recall, NIH issued guidance for implementing the burden-reducing provisions of the 2018 Common Rule (NOT-OD-18-211). Subsequently on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions Continue reading
A few weeks ago, we touted the value of the NIH’s Research, Condition, and Disease Classification (RCDC) system to give us consistent annual reporting on official research budget categories and the ability to see trends in spending over time. RCDC’s robust scientific validation process, which allows for such consistency, provides public transparency into over 280 different NIH budget categories.
RCDC categories do not encompass all types of biomedical research. So, how can we get this type of data for other research areas that are not encompassed in RCDC categories, especially those which are newly emerging fields? Are we able to use the same thesaurus-based classification system to explore other research trends?
We recognize that it may be difficult to determine whether two or more closely related protocols should be considered a single study. Generally, if you have research activities that use the same human subjects population, follow the same core research … Continue reading
Did you know that grant funds can expire? A recent interview with NIH experts on the topic of “Expiring Appropriations” addresses how you know if you have expiring funds, what to do if you find yourself in this situation, and whether money can be restored. This 10 minute conversation is available as both a video and a podcast. Continue reading
In just a few months, approximately 65 NIH & HHS grants process and policy experts will be bringing their expertise to the San Francisco Bay area for the NIH Regional Seminar on Program Funding and Grants Administration. Plan to meet, share, and learn with us over the course of 2-3 days, October 17-19, 2018! Continue reading
If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited. The existing dataset sample can … Continue reading
If the study is considered human subjects’ research and meets the NIH definition of clinical research, then it is subject to the NIH inclusion policy.
Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive. Continue reading
Looking for a grant award you heard about? Go here! Perhaps how many trainees NIH supported? You got it! Research spending on a certain disease? Done! Comparing NIH to another federal funder? Look no further! As you can see, NIH shares a quite diverse array of data associated with our funded grants in a transparent way. But, that does not mean we share everything. Continue reading