A fundamental part of one’s growth as a researcher is understanding how scientific investigation is practiced with integrity, and knowing when and how to apply professional norms and ethical principles throughout the research process. To promote research integrity, NIH-supported trainees, fellows, participants, and scholars must receive instruction in the responsible conduct of research (RCR).

NIH’s definition of a Phase III clinical trial is quite broad, including drug studies, device studies, behavioral interventions, epidemiological studies, community trials, and more. Phase III trials are usually large, prospective trails that compare two or more interventions against other standard or experimental interventions.

NIH expects that sex as a biological variable (SABV) will be factored into research designs, analyses, and reporting in pre-clinical and clinical studies. Accounting for SABV helps interpret and validate research findings, as well as enhances the rigor, reproducibility, and applicability of biomedical research. But how exactly do you account for SABV?

Institutions receiving funds from Public Health Service (PHS) agencies such as NIH must conduct research in accordance with the PHS Policy on Humane Care and Use of Laboratory Animals.

You may have heard that NIH can provide limited, interim research support for applications with creative and innovative approaches that fell just outside the payline. These “bridge awards” are helpful for researchers to gather additional data to revise their current application. But, how do we decide on which applications to support this way?

Inclusion plans. You have questions. We have answers. NIH’s Inclusion Policy Officer Dawn Corbett covers inclusion plans during peer review and post-award in Part 2 of this NIH All About Grants podcast miniseries. Want to know what is scientifically appropriate as it relates to inclusion, and how reviewers are looking at it? What about the ins and outs on progress reporting? And if you have concerns about enrollment in your funded study, what should you do? Well, as a start, put on your earbuds and listen.

Inclusion plans. You have questions. We have answers. What exactly are they? How do they relate to NIH’s policies requiring specific populations be included in NIH-supported clinical research? What do they mean for your application? And, what is an inclusion table anyway? In Part 1 of this NIH All About Grants podcast miniseries, NIH’s Inclusion Policy Officer Dawn Corbett tells us how to consider inclusion plans when putting together your application.