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Compliance, integrity issues focus of reports
Recent OIG reports cover research issues
By J. Mark Waxman, JD
CareGroup Healthcare System
It is difficult for those receiving federal dollars for research to avoid continuing interest by the Office of the Inspector General (OIG) in compliance efforts. In the last few months, two federal reports have included discussions of human subject protections.
The Department of Health and Human Services/OIG Fiscal Year 2004 Work Plan, which can be found at http://OIG.hhs.gov, acknowledges a U.S. Food and Drug Administration (FDA) request to review the effectiveness of FDA’s own corrective actions designed to provide better control and oversights of FDA’s clinical trials. Integrity issues with FDA’s trials have led FDA itself to initiate an inventory of clinical trials, and a mandatory educational and certification program, which will include ethical issues, for all FDA clinical investigators. The OIG will take steps to determine whether the FDA’s program is sufficient to avoid the unnamed integrity issues.
A second effort responsive to FDA’s request will determine whether a specific FDA trial followed procedures on safeguarding participant records and other confidential information and documents. The trial involved a nutritional supplement designed to increase bone density. Reports on both projects are anticipated in 2004.
OIG also will review the National Institutes of Health’s (NIH) research grants to ascertain the extent to which awards are made for noncompeting continuation grants and whether NIH closes out grants on time. While this effort will likely lead to greater diligence by NIH, its impact on providers only is indirect.
More direct will be the OIG effort to evaluate whether selected NIH grantees have themselves followed all the applicable rules. That effort, which is anticipated to be completed in FY 2005, will assess performance against not only the specific laws and regulation, but also more particularly whether actual expenditures were in line with and consistent with achievement of the grant objectives. The key focus group identified is grantees of the Human Genome Research Institute.
This latter effort could raise a series of interesting questions not usually subject to intense review, starting with: Were the objectives and structures desired by the grant achieved, as opposed to whether the expenditures were within budget and met broad general category requirements?
More specifically, the following types of questions could be asked: 1) If structures such as an advisory group were envisioned, was it actually created; did it meet regularly, and make recommendations; or 2) Was the knowledge envisioned to be developed through the grant actually reviewed and the subject of publications or educations programs?
The OIG also will review NIH practices with respect to ensuring compliance with adverse event reporting and processing, and the use of data safety monitoring boards. This activity could provide guidelines, or even regulations, about the definitions and processes surrounding adverse events. Currently, there are concerns over not reporting every potential adverse event and questions over whether trial participants are well served in large multicenter trial efforts when essentially every event can be perceived as adverse and, thereby, should be reported to the IRB.
Finally, OIG will evaluate compliance with federal regulations on reporting inventions and to what extent NIH monitors this process. As part of this effort, OIG will investigate whether NIH has received the required royalty-free licenses to inventions. A third element in this area will be an assessment of the extent to which NIH receives royalty income on all products to which it is entitled. This series of efforts, to be the product of reports in FY 2005, signal a desire to examine and tighten up the commercial side of research development.
Grantees should see this as a signal to review their own processes and procedures ahead of government audits, and subsequent claims. Indeed, one can envision sizable where years of grants lending to products and royalties are at issue and books and records have not reflected appropriate notifications, accounting, and payment.
A second area reflecting OIG interest is an effort that began in September 2003 (68 Fed Reg 52,783) to develop compliance program guidance (CPG) for recipients of extramural research and cooperative agreement awards from NIH. Noting that the primary recipients of such grant funds are nonprofit and university entities that have initiated their own sponsored research compliance programs, OIG, nevertheless, seeks to create its own model.
As has been the case with other CPG efforts, the OIG notes that the resulting guidance will include the standard seven elements for such plans (which should be a part of any provider’s compliance plan):
1. Written policies and procedures with respect to compliance.
2. A designated compliance officer and compliance committee.
3. Effective training and education.
4. Effective lines of communication.
5. Internal monitoring and auditing.
6. Disciplinary guidelines.
7. Prompt responses to problems, including corrective action and reporting.
OIG indicates it also is considering an eighth element — "Defining roles and responsibilities and assigning oversight responsibility." This element would "include a discussion of the importance of effectively delegating oversight authority."
There is a concern that this will, in effect, create an entire new set of regulatory requirements under the guise of guidance, with attendant new costs not likely to be included in any reimbursement or grant system of payment.
The notice of this effort also identifies specific areas of concern based upon the OIG’s fraud investigations. In listing these areas, the OIG is alerting grantees to exposure areas for review:
Those seeking to avoid problems should review each of these areas to check their own processes and their underlying results.