Michael S. Lauer, MD, Deputy Director for Extramural Research, National Institutes of Health, sent the following message to NIH grant applicants/awardees, contractors, researchers and research administrators.
If you are conducting NIH-funded research that involves human
subjects, or are considering applying to NIH for support of such
research, we want to call your attention to important changes that may
affect how you:
First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form
- select the right NIH funding opportunity announcement
- write the research strategy and human subjects sections of your application
- comply with appropriate policies and regulations
For application due dates of January 25, 2018, and beyond, you will
be required to use an updated application forms package (FORMS-E),
which includes the new human subject and clinical trial form. This
form requests human subject and clinical trials information at the
study level using discrete form fields, which is a change from current
practice. Contract proposals will also require this information. Learn about the new form here
Second, take a moment to answer these four questions about your current or proposed research:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial
Clarified and broadened in 2014, the definition encompasses a wide
range of trial types: mechanistic, exploratory/developmental,
pilot/feasibility, behavioral, and more. NIH expanded the clinical trial
definition in response to widespread calls from diverse stakeholders
for improved reporting of research milestones and outcomes, and for
assuring maximal transparency.
Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition
that includes case studies, FAQs and other resources that can help.
Still unsure? Contact your NIH program official or the scientific point
of contact listed on the funding opportunity announcement to which
you are applying.
Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials
NIH made a number of policy changes to improve the stewardship of
clinical trials across the life cycle of the trial. We encourage you
to familiarize yourself with all that is changing, including:
- the requirement to apply to an FOA that specifically allows for
the submission of clinical trial applications for due dates beginning
January 25, 2018.
- Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
- updated peer review criteria that will be included in FOAs for
clinical trial applications and solicitations for due dates on/after
January 25, 2018.
- new Human Subject Information form requirements for clinical
trials that will be included in updated application forms (FORMS-E)
for due dates on/after January 25, 2018, and contract solicitations
published as of January 25, 2018.
- use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
- expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.
Improving the design, efficiency, and transparency of clinical trials is important because it:
- respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
- facilitates design of clinical trials while reducing unnecessary duplication
- promotes broad, timely, and responsible dissemination of research information and results
- fosters responsible stewardship of the public’s investment in biomedical research
We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page
to bring together all the information you need to know. Please review
this information carefully. Your attention to detail will be critical
to ensuring successful funding of your clinical trial awards.
We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts
, in the NIH Extramural Nexus
, and on my blog
The success of clinical trials relies on the public trust in
scientific rigor and ethical oversight. We all play a critical role
in this process. We are most grateful to you for your help and