Starting January 29, 2019, NIH will begin implementing the Inclusion Across the Lifespan policy, which requires the consideration of age, along with sex/gender and race/ethnicity, in applications that involve human participants. What does this policy mean for you and your study?
Are you submitting a K application? Check out some new frequently asked questions (FAQs).
It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial.
The Glossary of NIH terms now contains definitions for Ancillary Study, Child, Clinical Trial Research Experience, Independent Clinical Trial, and Older Adult.
The Human Subjects System (HSS) system was launched in June 2018 and replaced the Inclusion Management System (IMS). Learn about HSS at a glance by viewing the new graphic on the HSS page. The graphic orients users at different stages of the grants process to how and when they can use HSS to update study information on human subjects and clinical trials to NIH.
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.
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on July 20, 2018, the HHS Office for Human Research Protections (OHRP) has announced the availability of three draft guidance documents that relate to three burden-reducing provisions
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?
How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?
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 protocol and procedures, and intend to combine the data for analysis in aggregate, this would … Continue reading “How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form?”
NIH’s resubmission policy has not changed, but the policy notice highlights some important points: only a single resubmission (A1) of an original application (A0) will be accepted, an A0 application may be submitted following an unsuccessful A0 or A1 application (with a few exceptions), what happens when switching FOAs between the A0 and A1 applications, and generally a change of activity code (e.g., R01) between the A0 and A1 is not allowed, with one exception.