The NIH program has recently experimented with a limited number of substantially larger awards. In itself, this could be a positive step, reflecting the flexibility in experimentation that characterizes an effective SBIR program.
Assessing the impact of the larger awards is challenging insofar as NIH has not developed a clearly articulated rationale for these awards, and no systematic effort has been made to determine the impact of extra large awards.
Thus while flexibility remains a laudable characteristic of the program, deviations from established program boundaries should be based on clear rationales and followed by equally clear assessment programs to determine whether such initiatives have been effective. This is especially important in this case because larger award size necessarily implies a smaller number of awards.
Understanding the impact of program change, e.g., the limits on venture funding. NIH is the agency most affected by the SBA ruling barring firms with 51 percent venture funding (or other nonindividual) ownership from the program. To better understand the ramifications of the ruling for the NIH SBIR Program, the NIH recently commissioned an empirical analysis by the National Academies. Timely assessment of the impact of major changes in the program should be a standard practice.26
Improving monitoring of awards to women and minorities. Program management resources to do not appear sufficient to permit effective monitoring of the program on a consistent basis, nor the development of appropriate databases to underpin this effort. These difficulties have been most apparent in relation to collecting data and monitoring the participation of women and minorities, one of the four primary congressional mandates for the program.27