Advances in medicine and clinical research as well as innovations related to the technology and tools used to treat humans have proliferated over the last two decades. The laws and regulations that govern research on humans (or the tissues, blood, specimens, and data from humans) and animals are very complex; the enforcement environment is quite aggressive. Academic medical centers, universities, hospitals and health systems, research institutes, and the individual scientists performing or overseeing research studies are at great risk. Those involved need to understand the regulatory requirements and best practices for the performance of clinical research. Some of the key enforcement areas include human research protections/informed consent; research billing; grants management/fiscal oversight of federal dollars; scientific misconduct; and conflicts of interest. These are particular areas of risk based upon the fines and penalties levied by the federal government as well as subject to whistleblower and plaintiff suits. Moreover, research organizations must ensure that their research operations are both effective and efficient in order to maintain the financial viability of their research enterprise.
Ankura’s research consulting team is well-known for its experience in all of the areas of risk noted above. Our team prides itself on creating client-specific solutions for any research need. One size does not fit all. Our research team understands the unique needs of large and small research organizations, including both research sites and the sponsors who fund research studies (e.g., pharmaceutical companies and device manufacturers, the federal and state governments, research foundations, etc.). Our research consulting team is highly specialized which allows us to provide our services in the most cost-efficient and timely manner.
Compliance with the laws and regulations governing human subject protections is critical to ensure that individuals understand the risks, alternative treatments, and the rewards of participation in research studies.
According to the Office for Research Integrity, allegations of research misconduct are on the rise and research organizations must have the necessary policies, procedures, and knowledgeable staff to investigate.
The Centers for Medicare and Medicaid Services require that research protocols be reviewed to ensure that only Medicare covered items and services are billed to government programs.
Obtaining federal research grants is often considered the gold star of a research enterprise, but request and accepting the money comes with numerous obligations.
Having a right-sized research administrative infrastructure is critical to ensure efficient and compliant conduct of research.
Given the complexity of scientific and clinical research, it is critical that research administration functions are staffed with knowledgeable staff to oversee and support research studies.
Evidence of a comprehensive research compliance program is not only recommended, it is expected.
Assessing the research compliance program again the elements is a key way for research enterprises to understand the risk oversight to the program.
Organizations should have a method for investigators to disclose relationships with sponsors and other commercial activities. A conflict of interest program should be a part of all research compliance initiatives.
Playing by the rules in research is not confined to the financial and scientific aspects of research studies but the subject enrolled in the studies should have priority with good clinical practices.
An organization should have a strategy that includes both the vision and goal for the research enterprise as well as a sound financial plan.