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.
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.
UPDATE: The proposed rulemaking comment period has been extended to January 6, 2016.
I would like to draw your attention to proposed revisions to the federal policy for the protection of human subjects , often referred to as the Common Rule. Even if you’re not currently involved in human subjects research activities, your research might be affected by the proposed changes.
The modifications are intended to enhance the ability of individuals to make informed decisions about participating in clinical research and also to modernize and streamline the regulatory approval process. One of the major reforms would expand the definition of human subjects research to include the secondary use of human biospecimens, regardless of identifiability. Some of the other proposed changes would affect the processes for obtaining informed consent and for determining the exemption status of human subjects research activities.
I encourage you to review the notice of proposed rulemaking and submit comments by the December 7, 2015, deadline. Please note that each proposed change described in the document includes specific questions for public comment.
NIGMS supports research in certain clinical areas, primarily those that affect multiple organ systems. To help investigators plan and prepare for clinical research projects, we offer planning grants for clinical trials of high relevance to the NIGMS mission. These planning grants, which we discussed in an earlier Feedback Loop post, can be used to develop management strategies and assemble regulatory documents for large-scale clinical trials.
We recently reissued the funding opportunity announcement for these planning grants. The next application deadline is December 18, with optional letters of intent due by November 18.
If you’re interested in applying for a clinical trial planning grant, we strongly 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 Web page, which includes links to other useful resources like the NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials. In addition, please note that NIH recently revised its definition of “clinical trial” to make a clearer distinction between clinical trials and clinical research studies and to enhance the precision of the clinical trial information NIH collects, tracks and reports.
If you have any questions about NIGMS’ support of clinical trials, please contact me.
In addition to their systems-level studies of complex biological phenomena, the NIGMS-supported National Centers for Systems Biology engage in a variety of training and outreach activities. One recent example is a curriculum for first-year graduate students created by the New York Center for Systems Biology. This material introduces computational principles and approaches that are becoming increasingly important across the biomedical sciences.
If you would like to know more about this course and/or download materials such as lecture slides or problem sets, please see the Teaching Resources section (no longer available) of the September 13, 20 and 27 issues of Science Signaling.
To learn more about the systems biology centers and their offerings, visit the systems biology portal (no longer available).
One of my activities is representing NIGMS on the NIH Financial Conflict of Interest Panel. This group has put substantial time and effort into updating the financial conflict of interest regulations that apply to NIH grant applicants. The proposed changes to the regulations are reflected in a recently released notice of proposed rulemaking (link no longer available) that is now open for comment. You may submit comments electronically or by mail as long as they are received by July 20, 2010.
Although responsibility for reporting and managing financial conflicts of interest would remain with the grantee institution, several of the proposed changes would affect individual investigators. For example, investigator disclosure requirements would be expanded to include all significant financial interests related to the investigator’s institutional responsibilities. In addition, the dollar threshold for disclosure of significant financial interests would be $5,000 (it’s currently $10,000), and this amount would apply to both payments and equity interests. Equity interest of any amount in non-publicly traded entities is considered a significant financial interest and would have to be disclosed.
Investigators would also be required to complete financial conflict of interest training before engaging in NIH-funded research and every 2 years thereafter.
I encourage you to look over the proposed rulemaking document as well as to learn how your institution will be implementing the new financial conflict of interest policy.
UPDATE: The comment period on the proposed changes to financial conflict of interest regulations has been extended to August 19. For more details, see the NIH Guide.