Clinical Research Law and Compliance Handbook
John E. Steiner, Jr., Esq., Chief Compliance Officer, The Cleveland Clinic Foundation
Softbound: 460 pages
Jones & Bartlett
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Avoid the hazards of legal and regulatory noncompliance in your clinical research programs.
As clinical research breakthroughs, as well as mishaps, continue to make headlines and regulatory oversight increases, compliance issues continue to mount.
Written in clear, practical language, the Clinical Research Law and Compliance Handbook will help you navigate the clinical research maze as it addresses critically important legal, operational, ethical, and business issues associated with clinical research trials. Written by leading experts in the field, this timely and comprehensive resource provides easy access and clear guidance for your clinical research questions and concerns. Key features of this book include:
- Clear, thorough coverage of the most significant risk areas including fraud and abuse, billing and conflicts of interest.
- Concise case summaries with detailed examples of litigated matters.
- Outstanding working tools include templates, checklists, forms and a complete model Master Research Agreement.
- Every chapter is packed with practical examples, relevant legal and regulatory authorities, suggested action steps and keen insights that will contribute to your effective clinical research compliance.
- Essential for those involved in academic research as well as clinical research in all settings.
- Edited by John E. Steiner, Jr., Esq., chief compliance officer and privacy official for the Cleveland Clinic Health System.
Contributed articles include:
- Key Compliance Issues for Academic Medical Centers -- Joan Booth, RN and Katherine Hammerhofer, RN, both of The Cleveland Clinic Foundation
- Contract Issues in Domestic Clinical Trials -- Donna J. Meyer, Esq., The Cleveland Clinic Foundation
- Clinical Research Billing: Process and Monitoring Issues -- John E. Steiner, Jr., Esq., The Cleveland Clinic Foundation, and F. Lisa Murtha, JD, Parente Randolph, LLC
- Clinical Research Trials: Operational and Budget Issues -- William A. Hunt and Sue O’Connell, both of Medcom Solutions, Inc.
- Fraud & Abuse in Clinical Research -- Karen Owen Dunlop, Esq. and William A. Sarraille, Esq., both of Sidley, Austin, Brown & Wood
- Identifiable Health Information in Clinical Research: National and International Issues -- M. Peter Adler, Esq., Foley & Lardner, and Jeffrey G. Micklos, Esq., Federation of American Hospitals
- Issues in Non-Registrational, Post-Marketing Studies -- Judith E. Beach, PhD, Esq. and Nancy Strehlow, Esq., both of Quintiles Transnational Corp.
- Key Compliance Issues for Institutional Review Boards -- Michael J. Meehan, Esq. and Marleina Thomas Davis, Esq., both of The Cleveland Clinic Foundation
- Conflicts of Interest in Clinical Research -- Kendra Dimond, Esq. and Joseph B. Clamon, Esq., both of Epstein, Becker & Green
- Data Integrity and Patient Safety in Clinical Trials -- Jeffrey Green, PhD, and Marc Shlaes, both of DataTrak International, Inc.
- Legal Issues in the Conduct of Multinational Clinical Trials by U.S. Entities -- Jan E. Murray, Esq.,
Squire, Sanders & Dempsey, L.L.P.
- Clinical Trials in the Courtroom -- Andrew Agati, Esq., Squire, Sanders & Dempsey, L.L.P.
John E. Steiner, Jr., Esq. is chief compliance officer and privacy official for the Cleveland Clinic Health System. He is responsible for the design, implementation and administration of the compliance programs for a multi-state, integrated delivery system that includes an academic medical center. The compliance programs include requirements of government and private payors, clinical research, and HIPAA. Steiner previously served as Senior Counsel for the American Hospital Association in Chicago where he led the effort on behalf of the hospital industry to create, in conjunction with the Office of Inspector General of the Department of Health and Human Services model voluntary compliance guidelines for hospitals. As Senior Counsel, he also addressed healthcare legal issues for 5,000 member hospitals and general corporate issues for the association and its subsidiaries. He also previously served as a member of the health law department of a national law firm headquartered in Chicago, Illinois. Steiner is a board member of the Health Care Compliance Association, the Chairman of the Council of Compliance Officers of the American Group Practice Association, a frequent speaker at national health law and compliance conferences, and has published numerous articles and books on health law and compliance topics.
(information from the publisher)
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