This Law Note, focused on the interests of clinical researchers, is an addendum to the Law Note published last month, "The Office of Inspector General's 2013 Work Plan: New Projects Relevant to Health Care Providers".
Earlier this Fall, the U.S. Department of Health and Human Services ("HHS") Office of Inspector General (the "OIG") issued its Fiscal Year 2013 Work Plan (the "Work Plan"). The Work Plan sets forth projects planned with respect to HHS programs and operations, including the Centers for Medicare and Medicaid Services ("CMS"). This Law Note summarizes new projects and continuing projects we believe are most relevant to researchers. Researchers and those who advise them should use the Work Plan to inform their compliance efforts, as it highlights the specific areas on which the OIG intends to focus its legal and investigative activity.
The OIG assists the Department of Justice ("DOJ") in developing and pursuing Federal False Claims Act cases against institutions that receive grants from the National Institutes of Health and other public health service agencies. The following new and continuing projects, categorized by public health agency, emphasize the OIG's continued focus on resolving civil and administrative fraud cases and promoting compliance of HHS grantees.
- Agency for Healthcare Research and Quality ("AHRQ").
- Early Implementation of Patient Safety Organizations ("PSO"). The OIG will review the policies and activities of PSOs to determine the extent of participation among hospitals, PSO's practices in receiving and analyzing adverse event reports, and the extent to which PSOs provide information to health care providers and the Network of Patient Safety Databases maintained by AHRQ. The OIG will evaluate PSOs' efforts to identify and resolve patient safety problems in hospitals and identify any barriers to the full and effective implementation of the PSO program. PSOs are nongovernmental entities certified by HHS to collect and analyze reports of adverse events from hospitals and other health care settings. (Patient Safety and Quality Improvement Act of 2005.) Adverse events are harm caused to patients during medical care, such as infections or injury. A prior OIG review found that hospitals did not identify all serious adverse events, suggesting that hospital incident-report systems may be an unreliable source of information for PSOs. See https://oig.hhs.gov/oei/reports/oei-06-09-00092.pdf.
- Food and Drug Administration (the "FDA").
- Oversight of Investigational New Drug Applications. To begin clinical studies on a new drug product for human use, the sponsor must submit to the FDA an investigational new drug ("IND") application with all the known information about the new drug and a description of how the proposed human clinical trials will be conducted. The OIG continues to review the FDA's process for evaluating IND applications. It will carry on assessing the FDA's timeliness and identifying challenges in the IND review process. The FDA has 30 days from receipt of the applications to review them, after which the sponsors may start clinical trials without the FDA's approval.
- National Institutes of Health ("NIH").
- Extramural Construction Grants at NIH Grantees (New). The American Recovery and Reinvestment Act of 2009 ("Recovery Act") provided $1 billion to be invested in extramural construction projects to build, renovate, or repair non-Federal biomedical and behavioral research facilities. The OIG will perform reviews at facilities that received extramural construction grants to determine whether Recovery Act funds were spent in accordance with Federal requirements, specifically, whether appropriate bidding procedures were followed and whether expenditures were appropriate. The OIG will also review NIH's internal controls for awarding such grants and, as part of its oversight role in preventing fraud, waste, and abuse, will determine whether these controls monitoring Recovery Act grants are effective and efficient.
- Human Subjects Protection Practices of National Cancer Institute Extramural Grantees Collecting Biospecimens (New). Although regulations at 45 CFR Part 46, subpart A address human subject protections (including informed consent for HHS-funded research), no current regulations directly address human subjects' protections in research that includes the collection of human biospecimens. The OIG will determine the extent to which informed consent documents for research that includes the collection of biospecimens comply with existing human subjects protection regulations. Further, the OIG will determine the extent to which Institutional Review Boards ("IRB") overseeing this type of research comply with regulations. The OIG will also determine the extent to which the principal investigators and IRBs take measures to address unique risks associated with this type of research. Biospecimens are biological materials (i.e. blood, plasma, tissue) taken from clinical trial human subjects or remaining from a clinical procedure. With research involving the collection of biospecimens, informational risks, such as a breach of privacy, are magnified because of the long-term electronic storage of the subjects' personally identifiable information and the potential for the biospecimens to be used in research not specified at the time of collection. Again, no current regulations directly address human subjects' protections with such research.
- Use of Data and Safety Monitoring Boards ("DSMB") in Clinical Trials. NIH requires that all NIH-funded clinical trials establish data- and safety-monitoring plans. (NIH's "Policy for Data and Safety Monitoring," June 1998.) This requirement sets minimum responsibilities that sponsoring institutes and centers must meet to ensure and oversee data and safety monitoring. The OIG will continue to review and determine the extent to which DSMBs monitor data in clinical trials. It will also carry on determining how and to what extent NIH is ensuring that grantees comply with NIH policy for DSMBs in multistate clinical trials.
- Awardee Eligibility for Small Business Innovation Research ("SBIR") Awards. The SBIR Program, created by the Small Business Innovation Development Act of 1982, is a highly competitive, three-phase award system providing qualified small businesses with opportunities to propose innovative ideas that meet the specific research and development needs of the Federal Government. The OIG will continue to determine the extent to which HHS ensures that SBIR awardees meet eligibility requirements and awards are not duplicative. The OIG will carry on determining the extent to which SBIR award amounts comply with program guidance and whether HHS assesses the commercialization success of SBIR-funded projects.
- Other Public Health-Related Reviews.
- Protections of Human Research Subjects (New). As a follow-up to a series of OIG reports issued in 1998 that identified vulnerabilities in Federal oversight of human research subjects, the OIG will review the Office for Human Research Protections' ("OHRP") oversight of institutional compliance with Federal requirements designed to protect human research subjects. OHRP, a component of the HHS Office of the Assistant Secretary for Health, provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS. OHRP derives compliance authority from the Public Health Service Act, § 289, and 45 CFR part 46. Currently, OHRP evaluates written substantive indications of noncompliance with 45 CFR part 46 at its own discretion.
- Oversight of Laboratory-Developed Tests (New). The Medical Devices Amendments Act of 1976 provided the FDA with the authority to regulate all medical devices, including in vitro diagnostics, for clinical effectiveness. Laboratory-developed tests ("LDT"), a category of in vitro diagnostics, have traditionally been used in research settings only and, because of this limited use, the FDA has chosen to use regulatory discretion with respect to these tests and does not oversee them. In a new initiative, the OIG will determine HHS agencies' oversight of the clinical effectiveness of laboratory-developed tests. It will determine the extent and nature of LDT use for health care decisions and describe the challenges in regulating LDTs.
The complete 2013 OIG Work Plan is available at https://oig.hhs.gov/reports-and-publications/archives/workplan/2013/Work-Plan-2013.pdf.