Department of the navy (don) 6. Small Business Innovation Research (sbir) Proposal Submission Instructions introduction

ADDITIONAL NOTES
Due to the short timeframe associated with Phase I of the SBIR process, the DON does not recommend the submission of Phase I proposals that require the use of Human Subjects, Animal Testing, or Recombinant DNA.  For example, the ability to obtain Institutional Review Board (IRB) approval for proposals that involve human subjects can take 6-12 months, and that lengthy process can be at odds with the Phase I goal for time to award.  Before the DON makes any award that involves an IRB or similar approval requirement, the proposer must demonstrate compliance with relevant regulatory approval requirements that pertain to proposals involving human, animal, or recombinant DNA protocols.  It will not impact the DON’s evaluation, but requiring IRB approval may delay the start time of the Phase I award and if approvals are not obtained within two months of notification of selection, the decision to award may be terminated. If the use of human, animal, and recombinant DNA use is included under a Phase I or Phase II proposal, please carefully review the requirements at: http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protections/Human-Subject-Research.aspx. This webpage provides guidance and lists approvals that may be required before contract/work can begin.
Due to the typical lengthy time for approval to obtain Government Furnished Equipment (GFE), it is recommended that GFE is not proposed as part of the Phase I proposal. If GFE is proposed and it is determined during the proposal evaluation process to be unavailable, proposed GFE may be considered a weakness in the proposal.
For topics indicating ITAR restrictions or the potential for classified work, there are generally limitations placed on disclosure of information involving topics of a classified nature or those involving export control restrictions, which may curtail or preclude the involvement of universities and certain non-profit institutions beyond the basic research level. Small businesses must structure their proposals to clearly identify the work that will be performed that is of a basic research nature and how it can be segregated from work that falls under the classification and export control restrictions. As a result, information must also be provided on how efforts can be performed in later Phases if the university/research institution is the source of critical knowledge, effort, or infrastructure (facilities and equipment).