Earlier this fall, the Office of Inspector General (OIG) in both the Department of Health and Human Services (HHS) and the National Science Foundation (NSF) published their respective annual audit work plans for FY 2009. In the current fiscal year, both the HHS and NSF OIG will continue to audit grantee compliance with federal cost principles to determine whether charges to HHS and NSF awards are allowable, reasonable, and properly allocated. The OIGs also plan to review agency oversight of and grantee compliance with select rules and regulations, including conflicts of interest, monitoring of clinical trials, and restrictions on access to select agents. The following are summaries of the research-related HHS and NSF OIG reviews planned for FY 2009.
HHS OIG Work Plan
The HHS OIG will continue its review of the National Institutes of Health’s (NIH) management of grantee compliance with conflict of interest requirements. The OIG review comes on the heels of increased Congressional attention on conflicts of interest in research, spearheaded by Senator Grassley. The review also follows a prior OIG review of NIH’s oversight of conflict of interest, in which the OIG determined that NIH’s oversight of grantees was inadequate. This finding was based primarily on NIH’s failure to obtain sufficient information from grantees to assess the types of financial interests identified by the grantee institutions.1 As a result of the prior review, the OIG recommended that NIH: (1) require grantees to disclose detailed information on the nature of identified conflicting interests and how the institution is managing, reducing, or eliminating those interests; and (2) increase its oversight of grantees to ensure compliance with the federal conflict of interest regulations.
Under the current Public Health Service (PHS) regulations on conflict of interest, located at 42 C.F.R. part 50, subpart F, grantees are required to notify the PHS awarding component of the existence of a conflicting interest and assure that the interest has been managed, reduced, or eliminated, but are not required to disclose the details of the interest or the specific steps taken by the grantee to manage, reduce, or eliminate the interest.2 This could soon change. NIH is preparing an Advance Notice of Proposed Rulemaking (ANPRM) that will consider changes to the PHS conflict of interest regulations. One of the changes that NIH is considering is an increase in the level of information grantees will be required to provide to NIH when reporting an identified conflicting interest. The ANPRM is expected to be issued before the end of the calendar year.
Consistent with prior years, the OIG plans to continue its review of colleges’ and universities’ compliance with select Office of Management and Budget (OMB) Circular A-21 cost principles. Schools will be selected for review based on level of grant funding and input from select HHS operating divisions and offices.
The effectiveness of data and safety monitoring boards (DSMBs) in monitoring data in clinical trials is another area of focus in the OIG work plan. In June 1998, NIH issued a policy on data and safety monitoring mandating that some form of data and safety monitoring be implemented for all NIH funded clinical trials. The purpose of the DSMB is to monitor both the integrity of trial data and the safety of trial participants. The level of monitoring necessary depends on the size, complexity and potential risk of the trial. For small, low risk studies, monitoring by the principal investigator may be appropriate, whereas for higher risk or multi-site site trials, an independent DSMB may be necessary. A subpart of the OIG review will include an evaluation of NIH’s oversight of grantee compliance with the NIH policy for DSMBs in multi-site clinical trials.
In response to its previous reviews of university, state, and private laboratory compliance with select agent regulations, the HHS OIG plans to review compliance with rules on the transfer of select agents. Under 42 C.F.R. part 73, the HHS regulations on select agents, access to select agents must be restricted to individuals approved by the HHS Secretary or Administrator, following a security risk assessment by the Attorney General.3 The OIG review will focus on access to select agents during transfers at laboratories registered with the Centers for Disease Control and Prevention (CDC). The OIG will also continue its review of the implementation of select agent regulations at the CDC, NIH, and the Food and Drug Administration (FDA).
Additional HHS OIG reviews include:
- Examining the degree to which drug manufacturers are using foreign clinical trial data to support new drug applications (NDA) submitted to the FDA. An earlier OIG review revealed that the FDA often did not have knowledge that foreign clinical trials had been conducted until after the NDA was submitted.
- Testing the NIH National Institutes of Environmental Health Science’s (NIEHS) grant award process for compliance with the HHS grants manual. The OIG also plans to review expenses incurred by the NIEHS Director’s office for compliance with NIH policies.
- Evaluating the NIH National Center for Research Resources’ oversight of Clinical and Translational Science Award (CTSA) grantees and the information sharing techniques developed by CTSA consortium institutions.
NSF OIG Work Plan
The NSF OIG plans to continue its effort reporting reviews at selected universities. During FY 2008, the OIG completed five audits of labor-effort reporting systems at NSF grantee institutions. The most common findings of these audits were untimely certification of effort reports and a lack of “suitable means of verification” that the work charged to NSF awards had been performed. Additional findings included: (1) incorrect charging of administrative time directly to grants; (2) the absence of appointment letters documenting employee institutional base salary; and (3) charging for activities that did not benefit the NSF grant. The OIG anticipates initiating an additional six reviews at NSF top-funded universities and performing similar audits at up to five other universities.
As in past years, the OIG plans to continue its desk reviews of grantee A-133 audit reports for findings and questioned costs related to NSF awards. The OIG will also evaluate whether NSF has taken effective corrective action on past A-133 audit findings and recommendations relating to NSF awards.
Given NSF’s extensive reliance on A-133 audits to assess potential risk to NSF award funds, the OIG plans to continue its quality control reviews of A-133 audit reports. NSF OIG personnel are also working with the OMB to revise the audit checklists used by federal agencies to conduct initial reviews and quality control reviews of A-133 audits.
Additional NSF OIG reviews include:
- Assessing whether NSF has adequate policies and procedures to test the financial capabilities of grantees prior to issuing awards.
- Evaluating the adequacy of internal control systems at universities, non-profits and for-profit entities to safeguard and properly account for the expenditure of NSF funds.