Heads-up: New Application Forms for Human Subjects Research

Does your research involve human specimens or data? If so, there are new questions you’ll need to address next time you apply for an NIH grant. Here’s what you need to know about that and other changes to NIH grant application procedures.

Effective for application due dates on or after January 25, 2018, all applicants will have to use the new FORMS-E application package. A major goal of the FORMS-E application package is to consolidate information about human subjects research and clinical trials into one place—the new PHS Human Subjects and Clinical Trials Information form. This form will use a variety of form fields to collect information on eligibility criteria, age limits, study timeline and design, and many other aspects of the proposed human subjects research/clinical trial. Comprehensive information is available at Clinical Trial Requirements for NIH Grants and Contracts.

Even if you indicate on the Research & Related Other Project Information form that human subjects are not involved in your project, you will need to address an additional question on the new PHS Human Subjects and Clinical Trials Information form:

If No to Human Subjects, Does the proposed research involve human specimens and/or data?
If the applicant answers YES to this question, an additional attachment describing why the proposed human specimens and/or data are not considered human subjects research must be included in the grant application.

Another change beginning with the January 25 application due date is that all applications involving one or more clinical trials must be submitted through a funding opportunity announcement (FOA) specifically designed for clinical trials. Accordingly, all new FOAs and all parent announcements will specify the allowability of clinical trials in the FOA title. Please see Clinical Trial-Specific Funding Opportunities for more information about the changes to FOAs.

It is a good idea to discuss the new Human Subjects and Clinical Trial form with your grants administrators and institutional business officials and to allow extra preparation time for your first FORMS-E grant submission. Your NIGMS program director will be able to help you identify the correct FOA for your proposed research. If you have any questions about human subjects policy or NIGMS’ support of clinical trials, please contact me.

FOA for Clinical Trial Planning Grants

NIGMS supports research in specific clinical areas that affect multiple organ systems. We recently reissued the funding opportunity announcement for clinical trial planning grants of high relevance to the NIGMS mission. We strongly encourage investigators to apply for a planning grant before submitting an application for a full clinical trial in one of the clinical areas that NIGMS supports. The next application deadline is August 7, with optional letters of intent due by July 7.

If you’re interested in applying for a clinical trial planning grant, we recommend that you consult with the appropriate NIGMS program staff  before you apply to determine whether the goal of the proposed trial aligns with the NIGMS mission and scientific priorities.

For more information, see our Clinical Studies and Trials webpage, which includes links to other useful resources like the NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials. In addition, please note that last year NIH announced a suite of policy changes known as Clinical Trial Stewardship Reforms that are designed to improve the clinical trial application and award process as well as the sharing of clinical trial data and results with other researchers and the public.

If you have any questions about NIGMS’ support of clinical trials, please contact me.

Apply for the IDeA States Pediatric Clinical Trials Network Program

NIH has launched a major new initiative called the Environmental Influences on Child Health Outcomes (ECHO) program to investigate environmental exposures on child health and development. An important component of the program will be the IDeA States Pediatric Clinical Trials Network (ISPCTN), which the Eunice Kennedy Shriver National Institute of Child Health and Human Development is leading in collaboration with us.

The ISPCTN will give medically underserved and rural populations access to state-of-the-art pediatric clinical trials. The network’s clinical trials sites, which will be located in states eligible for funding through our Institutional Development Award (IDeA) program, will receive support for the development of appropriate research infrastructure as well as supervised professional development in all aspects of clinical trials research and implementation. We expect the ISPCTN to help strengthen pediatric research opportunities and capacity in IDeA states, which historically have not received extensive NIH funding.

If you’re in an IDeA-eligible state (including Puerto Rico), we encourage you to apply to either or both of the ISPCTN FOAs:

Applications proposing studies on all pediatric diseases and conditions will be considered, but priority will be given to those on the focus areas and core elements of the ECHO program, which include upper and lower airway disease; obesity; pre-, peri-, and postnatal outcomes; and neurodevelopment. The application deadline for both announcements is April 15, 2016, with optional letters of intent due by March 15, 2016.

For more information about the ECHO program and its various FOAs, you can participate in webinars scheduled for January 14, 2016, and February 1, 2016, or contact one of us (douthardr@mail.nih.gov, gorospejr@mail.nih.gov).