Reminder of Policy Changes

For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.

NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects (NOT-OD-18-116)

Individuals of all ages are expected to be included in all NIH-defined clinical research unless there are scientific or ethical reasons not to include them. Applications for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals in the Inclusion of Women, Minorities, and Children section of the proposed research project.

Review Criteria Updates (Fellowship – NOT-OD-18-227; Research – NOT-OD-18-228; Career Development – NOT-OD-18-229)

We’ve updated application instructions and review criteria addressing rigor of prior research (formerly scientific premise); inclusion reporting and requirements; and protections for human subjects.

Recently published opportunities have the updated review criteria in the body of the announcement. Opportunities posted prior to the change have a link to the notice containing updated criteria at the top of the Application Review Information section.

Changes to the NIH Academic Research Enhancement Award (R15) Program (NOT-OD-19-015)

The R15 activity code is rebranded as “NIH Research Enhancement Award” and going forward will include two programs:

• Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions
• Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools

An institution letter verifying eligibility with the criteria listed in the funding opportunity announcement is required with each application and the ineligible institution list will no longer be maintained.

The NIH Academic Research Enhancement Award (AREA) Parent Announcement, PA-18-504, expires January 8, 2019 and will not be reissued.

Reinstatement of NIH SBIR Direct-to-Phase II Authority (NOT-OD-19-019)

Direct-to-Phase II is now an option for the SBIR Omnibus opportunities (see NOT-OD-19-019 for exceptions).

Other targeted SBIR opportunities issued by NIH Institutes and Centers have reinstated the Direct-to-Phase II option on an opportunity-by-opportunity basis.

New Funding Opportunity Announcements Targeting Basic Experimental Studies with Humans (NOT-OD-19-024)

We’ve issued new R01 Parent Announcements identified as Basic Experimental Studies with Humans. These opportunities focus on applications that propose clinical trials that also meet the definition of basic research. Pay close attention to participating Institutes and Centers and any restrictions posted in the Related Notices section of each opportunity. Applications proposing basic experimental studies involving humans may also be submitted to opportunities which allow clinical trials.

Harassment and Discrimination Protections in NIH Training Applications (NOT-OD-19-029)

The Letters of Support section of institutional training (T) applications must include a letter on institutional letterhead signed by a key institutional leader that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.

NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule; NOT-OD-19-050)

Several provisions in the Revised Common Rule resulted in changes to NIH policies and procedures. From an application submission perspective, the most notable changes are:

• Changes to categories of research qualifying for exemptions (FAQs)
• Use of new exemptions 7 and 8, when applicable

Application Instruction Updates

The application form instructions found on the How To Apply – Application Guide page include clarifications and policy updates (see Significant Changes).