Complying with the applicable rules and regulations related to clinical research can be overwhelming, particularly for health systems with multiple hospitals serving as research sites. While health systems typically have internal regulatory affairs, ethics and legal professionals to help them navigate these complex landscapes, clinical research issues can be idiosyncratic and evolving–and these in-house functions can often benefit greatly from support from a trusted external partner.
Whatever we may think, the agencies imposing these complex rules believe they are important in protecting the rights and welfare of subjects and assuring sound, reliable research. Health systems that conduct research are required to assure compliance, and when they fail, they face monetary fines, civil penalties, cessation of human research activities, potential negative licensure implications and bad PR. With dual licensed legal and medical professionals deeply experienced in human subject research, Hancock Daniel’s Clinical Research Practice Group can help your organization ensure the safe and ethical conduct of all clinical trials in accordance with the appropriate ethical, scientific, legal, and regulatory standards.
CLINICAL RESEARCH REGULATORY OVERSIGHT
Keeping abreast of the rules, regulations and compliance issues related to clinical research can be a daunting task. Clinical research regulatory oversight is the responsibility of two main governmental agencies: The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). Both FDA and OHRP are agencies under the Department of Health and Human Services (HHS). The FDA enforces the Food Drug and Cosmetic Act, which regulates foods, drugs, devices, and cosmetics, and OHRP regulates any research that is federally funded. The Joint Commission on the Accreditation of Healthcare Organizations now also reviews aspects of clinical research activities during site assessment visits.
Additional oversight implications exist for:
• Studies funded by National Institutes of Health – Grants Policy Statement, etc.
• Research Misconduct – Office of Research Integrity
• Health Fraud and Other Violations and Crimes – HHS Office of Inspector General and Department of Justice
Key enforcement considerations include:
• Professional negligence/malpractice exposure
• Privacy/HIPAA
• Billing/reimbursement compliance
• Fraud and Misrepresentation
• “Common Law” (private citizens, government prosecutors)
• Mail Fraud, Wire Fraud, Health Fraud Statutes (DOJ)
• False Statements (DOJ)
• False Claims (DOJ and qui tam relators)
• Anti-Kickback Law (HHS OIG and DOJ)
• Anti-Self-Referral Law (HHS OIG and DOJ)
HOW CAN HOSPITALS AND HEALTH SYSTEMS PROTECT THEMSELVES?
The root causes of noncompliance can be found in uninformed contracting practices, poor record keeping, poor financial planning and general lack of training. An external partner like Hancock Daniel can help avoid the costly pitfalls of noncompliance through:
• Training across all research functions,
• Internal research inventory and coordination support,
• Contractual review and negotiation of terms with sponsors, vendors and collaborators,
• Process coordination and standardization to improve efficiency.
• Going-forward coverage analyses including compliance safeguards,
• Third-party payors billing models,
• Research personnel and investigator education on key risk issues,
• Auditing and monitoring programs to ensure safeguards are working,
• Scope of Practice considerations, and
• Monitoring of CMS, DOJ and other enforcement developments.
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