Clinical Trials / Human Subjects Research
Clinical research implicates an overwhelming number of legal and ethical issues, including contract considerations, informed consent, patient privacy and HIPAA concerns, budgeting and billing compliance, and financial disclosures.
Frier Levitt understands the unique challenges facing physician-investigators, who often lack administrative support and whose primary focus is on substantive care for patients. The regulations governing human subject research are multifaceted and complex and the missteps can result in severe consequences.
Frier Levitt attorneys have an in depth knowledge of the rules and FDA regulations surrounding human subjects research and regularly counsel physicians and academic institutions on the controversial and complex legal issues intertwined with scientific development. We can help you or your institution navigate the broad range of topics that arise in the clinical trials setting and develop processes and procedures to ensure that your clinical trial, or your participation in a sponsored trial, is fully compliant with applicable laws and regulations.
Our multidisciplinary team of attorneys understands not only the rules and FDA regulations governing clinical research, but is also well versed in Federal and State anti-kickback and fraud and abuse laws that are often, and sometimes unknowingly, implicated in the clinical research setting. We assist clinical researchers with all facets of a clinical trial including:
- Negotiating and drafting clinical trial agreements and other contracts with study sponsors to ensure compliance with Federal and State law
- Assistance with budget development and establishing procedures to ensure billing compliance with Medicare and other third-party payor requirements
- Preparing Institutional Review Board (IRB) submissions
- Drafting Patient Informed Consent Forms and HIPAA Agreements
- Patient Recruitment
- Conflict of Interest Disclosures
- Data Integrity
- Intellectual Property
- Ensuring adherence to the principles of Good Clinical Practices (GCPs)
Contact Frier Levitt today for assistance with your clinical research needs.