Research and Innovation Development Office
Category: Research news
31 August 2017
Funding secured through the National Institutes of Health (NIH), a major governemental source of funding in the USA, will be subject to different rules in future, particularly where that work involves human subjects.
We have been alerted to this change, as NIH says it could affect how we:
- select the right NIH funding opportunity announcement
- write the research strategy and human subjects sections of your application
- comply with appropriate policies and regulations.
Applications submitted for calls closing on or after 25 January 2018 will be required to satisfy the new raft of forms, including revised human subject and clinical trials forms. Study level information will be required, so that the funder can understand properly what you propose.
The NIH asks us (and our researchers) to consider:
- 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 you answer yes to all these questions, the NIH will understand your work is a clinical trial. The definition of a clinical trial has been broadened in recent years, and will affect the proposed project.
Finally, the NIH has changed its policies relating to the stewardship of clinical trials. The changes are:
- the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning 25 January 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 25 January 2018, and contract solicitations published as of 25 January 2018
- use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after 25 January 2018.
- expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.
The funder says, "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. our attention to detail will be critical to ensuring successful funding of your clinical trial awards."