NIH Administration of the Clinical and Translational Science Awards Program

For all 38 Clinical and Translational Science Awards (CTSA) cooperative agreements awarded from 2006 through 2008, CTSA program staff did not document awardees' progress in compliance with NIH policy.

CTSA program staff must ensure that awardees submit annual progress reports and financial status reports, determine whether awardee progress remains satisfactory before awardees receive continued funding, and maintain official files in accordance with Department of Health and Human Services (HHS) policy. Additionally, under cooperative agreements, CTSA program staff provide assistance to awardees above and beyond the levels usually required for program stewardship of grants. This level of stewardship is known as substantial involvement. CTSA program staff assign NIH Project Scientists to awardees to provide this substantial involvement through technical assistance, advice, and coordination. Names of substantially involved staff and an annual summary of staff involvement should be documented in the official files.

CTSA program staff documented a comparison of accomplishments to research objectives for only 1 of 38 awardees throughout our review period. Although reviews for six awardees' files mentioned an inability to fulfill goals, only one file included a note from CTSA program staff regarding resolution. Also, most progress reports and half of financial status reports were late, yet the files contained no evidence that CTSA program staff took action to address timeliness of reports. CTSA program staff did not maintain files in accordance with HHS policy. Finally, no files contained evidence that CTSA program staff provided substantial involvement to awardees in accordance with Federal requirements and NIH policy.

We recommend that NIH ensure that CTSA program staff (1) document their monitoring of awardee progress; (2) ensure timely submission of required reports; (3) maintain official files in accordance with Federal policy; and (4) as required for cooperative agreements, provide substantial involvement to CTSA awardees. NIH concurred with our recommendations.