Human Subject Research Compliance
The laws involved in human subject research can be confusing, yet violations can subject physician-investigators and institutions to significant risk and enforcement. We can help you navigate these complex requirements and assist in investigating and defending allegations of concern.
We have hands-on experience with:
- The Common Rule
- FDA requirements
- HIPAA and data integrity
- Informed consent and conflicts of interest
- Human Subject Research Protection
- Intellectual property issues
- Research integrity concerns and scientific misconduct
- Fraud and abuse laws
- Investigations involving non-compliance
- Research contracts including clinical trial agreements and study sponsor arrangements
Related Practices
- Certificate of Need
- Compliance with Federal and State Laws and Regulations
- Fraud and Abuse/Physician Self-Referral (Stark Law) and Anti-Kickback
- HIPAA/HITECH
- Licensing Issues
- Litigation Involving Physicians/Ancillary Healthcare Providers/Suppliers
- Physician/Ancillary Healthcare Provider/Supplier Entity Formation and Physician Group Structuring
- Third Party Payer Audit Defense