Industries & Practices
Clinical Research
We help health care providers that participate in clinical research trials to maintain compliance while engaging in innovative and lifesaving work.
Health care providers engaged in clinical research face a complex set of regulatory hurdles, ethical issues and operational concerns. We help clinical trial participants manage their legal obligations, including HIPAA and patient privacy, billing and reimbursement issues, regulatory compliance and contracting. Our clients include hospitals and health systems, as well as academic medical centers and research staff that participate in sponsored research and investigator initiated studies. We also have experience representing principal investigators, institutional review boards and laboratories.
We provide counsel on:
- Clinical research contracting, including clinical trial agreements, material transfer agreements, data use agreements, confidentiality agreements and facility use agreements
- Regulatory compliance, including human subject protection
- FDA and OHRP requirements
- Physician Payments Sunshine Act
- Reporting obligations
- Fraud and abuse issues, including compensation arrangements with physician investigators
- Informed consent, waivers and IRB review
- Preparation, review and approval of policies and procedures, informed consent and child assent forms and HIPAA authorizations
- Misconduct allegations and investigations
- Integration of research and clinical care
- Clinical trial budgets and reimbursement
- Insurance coverage and billing for clinical trial services
- Medicare/Medicaid coverage policies
Clinical research informed consent
Advise a health system-affiliated IRB on requirements for obtaining informed consent from research subjects.
MoreClinical trial compensation arrangements
Advise health care system affiliated IRB on fraud and abuse considerations when structuring compensation arrangements with principal investigators.
MoreClinical trial documents
Negotiated clinical trial documents on behalf of a nonprofit health system.
MoreClinical research budgeting
Advise health system on fraud and abuse considerations in developing a budget for clinical trials.
MoreClinical research fraud and abuse
Advise a health system on fraud and abuse considerations related to a non-employed physician as the principal investigator.
MoreAcademic medical center clinical research
Represented a large academic medical center with a comprehensive cancer center that participated in sponsored research and investigator initiated studies.
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