What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?

July 5, 2018

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 be provided on the Cumulative Inclusion Enrollment Report. You should provide the sex/gender, race, and … Continue reading “What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?”

New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review

July 5, 2018

Have you ever wondered why your grant application must undergo a separate round of peer review—even after a panel of experts initially weighed in on its scientific merit and provided a score to consider when making funding decisions? A new All About Grants podcast delves more into the second round of peer review at NIH … Continue reading “New Podcast on NIH Advisory Councils: Understanding What Happens During the Second Round of Peer Review”

The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You

July 3, 2018

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.

Rigorous Resources for Rigorous Research

July 2, 2018

Over two years ago, NIH rolled out a policy to enhance reproducibility of its supported research through rigor and transparency. Applicants and reviewers were required to devote more attention to four areas: the rigor of the prior research (scientific premise), the rigor of the proposed research (scientific rigor), consideration of biological variables including sex, and the authentication of key biological and/or chemical resources.
When the 21st Century Cures Act was passed later that same year, we were required, amongst other things, to assemble a working group of the Advisory Council to the NIH Director (ACD). These experts were charged with recommending ways to further enhance reproducibility of the research we fund, while being informed by the current policy.