1.  Are Human Subjects Involved?

SBIR/STTR project work does not typically require the involvement of human subjects.  If activities involving human subjects are planned at any time during the proposed project at any performance site, check “Yes.” Check “Yes” even if the proposed project is exempt from Regulations for the Protection of Human Subjects.   

If activities involving human subjects are not planned at any time during the proposed project at a performance site, check “No” and skip the rest of block 1. 

1.a. If YES to Human Subjects:   

Is the project exempt from federal regulations?  Check Yes or No.   

If Yes, check the appropriate exemption number. If human subject activities are exempt from Federal regulations, provide the exemption numbers corresponding to one of more of the exemption categories.  The eight categories of research that qualify for exemption from coverage by the regulations are defined in the 45 CFR 46, Common Rule for the Protection of Human Subjects.  For more information on these exemptions, please visit 45 CFR 46, Exemptions, at Common Rule for the Protection of Human Subjects Research Exemptions. 

If No, is the IRB review pending?  Check Yes or No. 

IRB Approval Date 

Enter the latest Institutional Review Board (IRB) approval date, if available.  Leave blank if pending. 

Applicants should check “Yes” to the question “Is the IRB review pending?” even if the IRB review/approval process has not yet begun at the time of submission.  Also, note that an IRB Approval Date is not required at the time of submission.  This may be requested later in the pre-award cycle as a Just-in-Time requirement.   

Human Subject Assurance Number 

Enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available.  If the applicant has a FWA number, enter the 8-digit number.  Do not enter “FWA” before the number.  

2.  Are Vertebrate Animals Used?

If activities involving animals are planned at any time during the proposed project at any performance site, check “Yes.”  If no, skip the rest of block 2. 

Note that the generation of custom antibodies constitutes an activity involving vertebrate animals. 

2.a. If Yes to Vertebrate Animals 

SBIR/STTR projects do not typically require the involvement of vertebrate animals. 

Is the IACUC Review Pending? 

Indicate if an Institutional Animal Care and Use Committee (IACUC) review is pending.  Check “Yes” if a review is pending, check “No” if no review is pending.  

IACUC Approval Date 

Enter the latest IACUC approval date, if available.  Leave blank if pending. 

Animal Welfare Assurance Number 

Enter the Federally approved assurance number, if available.   

Helpful Tips: 
  • If human subjects are to be used in the proposed project and their activities have been determined exempt from Federal regulation, the applicant will need to provide the exemption numbers that correspond to the appropriate exemption categories. 
  • If their activities are not exempt, the applicant will need to provide the IRB pending or approval date, as well as the Human Subject Assurance Number. 
  • If animal subjects are to be used, the applicant will need to indicate whether an IACUC review has been conducted and the most recent approval date. 
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