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.