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.

Comment on Proposed Rules for Protection of Human Subjects

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 exit icon, 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.