| Hospitals (Representative
Clients/ Legal Projects, Attorneys)
What hospital or other research institution policies or protocols should be evaluated in addition to IRB approval to monitor human subject research?
If an adverse event occurs during a human subject research study or trial conducted by an institution or its employees or agents, the institution may face primary or vicarious liability for the adverse event. Institutions should track and monitor all human subject research; obtain, where appropriate, representation on IRBs reviewing research conducted at the institution; and adopt policies and procedures to permit research approval, patient tracking and cost assessment by the hospital or institution. Such institutions should consider regularly monitoring and auditing their research compliance, their agents’ and employees’ compliance, and their affiliated IRB’s compliance with the federal Common Rule and FDA regulations. Hospitals and research institutions should also consider adopting their own policies and procedures regarding the conduct of human subject research.
What steps should § 501(c)(3) entities, such as tax exempt hospitals, consider taking to avoid excise taxes on individuals for excess benefit transactions with disqualified persons?
Section 501(c)(3) entities should (1) identify as part of a comprehensive tax compliance program “disqualified persons,” (2) determine what remuneration has or will be paid to such disqualified persons, (3) determine if such transaction constituted or will constitute an “excess benefit transaction,” (4) not engage in excess benefit transactions or correct all excess benefit transactions, and (5) follow the process described in the IRS Regulations to shift the burden of proof to the IRS.
Representative
Clients/ Legal Projects, Attorneys
Multi-Hospital System
- Administrative and Legislative Matters – State
- Civil and Criminal Health Care Investigations
- Corporate Law and Business Organization
- Corporate Restructuring and Mergers
- Employment/HR
- EMTALA
- EEOC and CCRD Defense
- Fraud and Abuse
- Hospital and Health Care Facility Representation
- Human Resources Law
- Human Subject Research/Clinical Trials
- IRB Audits and Reviewü Intellectual Property Law
- Joint Ventures
- Litigation
- Long Term Care and Retirement Housing
- Medical Director Contracts
- Medical Records Management
- Medical Staff Bylaws
- Medical Staff Peer Review/HCQIA
- Medicare Anti-Kickbackü Noncompete Analysis and Enforcement
- OHRP Assurance Filing and Compliance
- Operational Issues
- Patient Consults
- Privacy/HIPAA
- Real Estate Law
- Regulatory Compliance
- Restraint and Seclusion Policies
- Physician Recruitment and Retention
- Risk Management/Professional and General Liability
- Stark Law
- Tax Law Issues – Health Care
- Third Party Payor, Licensing Issues, Credentialing and Certification Issues
Metro-Denver Area Hospital (Unaffiliated Hospital)
- Call Issues and Disputes
- EEOC and CCRD Defenseü Employment/HR
- EMTALA
- Hospital and Health Care Facility Representation
- IRS Intermediate Sanctions
- Medical Records Management
- Medical Staff Bylaws
- Medical Staff Peer Review and HCQIA
- Medicare Fraud and Abuse/Anti-Kickback
- Nonprofit Issues
- NPDB Reporting and Compliance
- Physician Recruitment and Retention
- Privacy/HIPAA
- Restraint and Seclusion Policies
- Stark Law
- Tax Exempt Fiduciary
- Tax Exemption and Unrelated Business Income Tax Analysis
Hospitals Outside Metro-Denver Area
- Same General Hospital Legal Services Listed Above
- Special Emphasis on Rural Hospital and Outlier Issues, Physician Recruitment, HR, and Telemedicine
Hospital Districts
- Bond Financing – Health Care
- Contracting Issues
- Defense of claims under 42 U.S.C. § 1983
- General Litigation
- Hospital and Health Care Facility Representation
- Issues Unique to Hospital Districts
- Open Records
- Operational Issues
- Same General Legal Services Listed Above
Academic Medical Centers
- Same General Hospital Issues Listed Above, with Special Emphasis on Faculty Practice Plans, Joint Ventures, Federal and State Tax Exemption Issues, UBIT and IRS Intermediate Sanctions, Litigation, Human Subject Research, Federal Assurance and IRB Issues
Attorneys practicing in this
area: Wallis S.
Stromberg, Henry C. Cleveland,
III, Barbara L. Crawford, Michael M.
Schmidt, Paul D. Godec, Taylor T.
Pollock, Peter C. Middleton
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