Recent policy changes requiring clinical trial applications to be submitted to FOAs that specifically allow clinical trials, first announced in fall of 2016, impact how all NIH applicants choose a FOA, whether you are submitting a clinical trial or not.
A new “All About Grants” podcast is now available! In “Understanding the Definition of a Clinical Trial and What That Means for You” (mp3, transcript), Dr. Mike Lauer, NIH deputy director for extramural research, discusses the changes to clinical trial policies, addresses community questions, and speaks to how these changes will impact applicants and grantees. All About Grants podcast episodes are produced by the NIH Office of Extramural Research, and ….
We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.
The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms ….
Experiments, including clinical trials, differ in the methods used to assign participants to study conditions or arms and to deliver interventions. Thanks to the Office of Disease Prevention, the NIH has a new website that provides resources on research methods related to experiments that randomize groups or clusters or that deliver interventions to groups. The information is … Continue reading “New NIH Resource for Studies that Randomize Groups or Clusters or that Deliver Interventions to Groups”
Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on … Continue reading “4 Questions For Researchers and Institutions Involved In Human Subjects Research”
Are you an investigator or research administrator new to working with the NIH grants process? If so, then don’t let the 2017 NIH Regional Seminars pass you by. Registration is underway for the Spring seminar in New Orleans, LA (May 3-5). If these dates or location don’t work for you, consider the Fall seminar in Baltimore, MD (October 25-27, 2017). Here are our top five ….
Do you remember walking into the person’s office down the hall from you when you needed to ask a question, instead of “popping” them an email, instant message, or text? There’s no disputing that the digital age definitely has its advantages – making information sharing faster, cheaper, and more convenient, and allowing us to communicate locally and abroad in seconds. But in this fast paced world of instant communication – the internet, email, and all of our social media choices – sometimes we forget how valuable face-to-face interactions can be. That is exactly one of the reasons I love the NIH Regional Seminars on Grant Funding and Program Administration. The seminars give me the opportunity to join over 60 of my fellow NIH and HHS faculty in sharing our knowledge and perspectives to ….
A number of NIH policies became effective in January. Here’s a brief recap:
On this blog we previously discussed ways to measure the value returned from research funding. Several of my colleagues and I, led by NIGMS director Jon Lorsch – chair of an NIH Working Group on Policies for Efficient and Stable Funding – conceived of a “Research Commitment Index,” or “RCI.” We focus on the grant activity code (R01, R21, P01, etc) and ask ourselves about the kind of personal commitment it entails for the investigator(s). We start with the most common type of award, the R01, and assign it an RCI value of 7 points. And then, in consultation with our NIH colleagues, we assigned RCI values to other activity codes: fewer points for R03 and R21 grants, more points P01 grants.
Institutions need not regard the NIH Good Clinical Practice (GCP) policy’s effective date as a deadline by which we expect NIH-funded investigators and clinical trial staff involved in the design, conduct, oversight, or management of clinical trials to complete GCP training. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the effective date. For more information, ….
