In April of this year, Notice NOT-HS-17-015 from the Agency for Healthcare Research and Quality (AHRQ) announced that all  applications with due dates on or after January 25, 2018.  This will These new application forms focus on two (2) major changes:

(1)   Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms.  These will include (listed by forms affected):

PHS 398 Career Development Award Supplemental Form

Removed Human Subjects Section, including the following attachments:

Protection of Human Subjects 

Data Safety Monitoring Plan

Inclusion of Women and Minorities

Inclusion of Children

                PHS 398 Cover Page Supplement

                Removed Human Subjects Section, including:

“Clinical Trial” question

“Agency Defined Phase III Clinical Trial” question

PHS 398 Research Plan

Removed Human Subjects Section, including the following attachments:

Protection of Human Subjects

Data Safety Monitoring Plan

Inclusion of Women and Minorities

Inclusion of Children

PHS Human Subjects and Clinical Trials Information Form (NEW!)

Introduced new form for consolidated human subjects, inclusion enrollment report and clinical trial information

PHS Inclusion Enrollment Report

Discontinued use (data collection moved to new PHS Human Subjects and Clinical Trials Information Form)

(2) Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms.  These will include:

Added “Agency to which you are applying” question with options for DOE, HHS, USDA and Other Added “SBC Control ID” field for the 9-digit code obtained from the Small Business Administration Added “Direct Phase II”, “Phase IIA”, “Phase IIB” and “Commercialization Readiness Program” as Application Type options

Added “Phase I Letter of Intent Number” field

Added “Agency Topic/Subtopic” field

Added two additional questions regarding eligibility

“1c. Is your small business majority owned by venture capital operating companies, hedge funds, or private equity firms?”

“1d. Is your small business a Faculty or Student-Owned entity?”

Added “DUNS Number of non-profit research partner for STTR” field

Minor text changes

Other changes to the forms include:

Updated OMB Expiration Date to 03/31/2020

Significant text edits throughout the application

Added new “Total Costs and Fee” calculation to budget periods and cumulative budget to R&R Budget and associated Subaward Attachment Form

All corrected forms should start appearing attached to FOA/RFAs no later than October 25, 2017. New FOAs posted before October 25, 2017 with initial due dates on or after January 25, 2018 will be posted without application forms. Application packages will be added to these FOAs by November 10, 2017.

Questions about these changes can be answered by your Sponsored Programs Analyst.