AHLA Institutional Review Boards: A Primer (AHLA Members)
Institutional Review Boards: A Primer outlines the regulatory requirements and legal challenges associated with the evolving area of human subject research and the role of review boards.
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The new Third Edition explains the changes under the revised Common Rule requirements, providing solutions for both new and common problems that Institutional Review Boards (IRBs) face. Compliance with the revised Common Rule requires a close examination of IRB, facility, and research practices. This book provides full explanations of important changes such as:
- Changes in applicability and exemptions
- Collection, use, and storage of private information and bio specimens
- Use of broad consent
- And more
In addition, the Third Edition incorporates a number of all new chapters which address:
- Investigator Responsibilities including coverage of supervision, compliance, recordkeeping, and reporting
- IRB Compliance and Internal Audits addressing regulatory requirements, assignment of responsibility and delegation of duties, information collection, components of a compliance audit, elements of a compliance plan, common deficiencies, and areas of risk
- Secondary Findings in Genomic Research with analysis of the ethical, legal, and practical considerations involved in deciding whether to communicate findings to subjects
- Scientific Misconduct in Clinical Research including how to identify, investigate, and respond to allegations of misconduct
EDITORS: Gary W. Eiland, Richard G. Korman, Janet M. Lis, Teresa A. Williams
AUTHORS: Haley N. Bavasi, Valerie H. Bonham, Kate Bowen, Eve Brunts, Dale H. Cowan, Payal P. Cramer, Amy K. Dow, Heather L. Fields, Jennifer S. Geetter, Kimberly H. Gillespie, Gabrielle Goldstein, Michele R. Goodman, Igor Gorlach, Ann T. Hollenbeck, Jacqueline A. Holz, Beverly H. Lorell, Alice K. Marcee, Ernessa B. McKie, Melinda G. Murray, Katayoun (Kat) Neal, Laura M. Odwazny, David Peloquin, Mary Holloway Richard, Martha C. Romney,Chelsea M. Rutherford, Thomas D. Shrack, Lynn E. Smith, Katherine B. Steuer, Gelvina Rodriguez Stevenson, Sarah E. Swank, Leslie Thornton, Leah A. Voigt
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Authors / Contributors
Gary W. Eiland
Gary W. Eiland (Editor) has provided legal services to health care industry clients for more than 40 years, focusing on the special regulatory and organizational problems faced by academic medical centers and other health care providers. Mr. Eiland’s work includes handling sophisticated business transactions, government investigations, regulatory enforcement, clinical research compliance, self-disclosures, and pursuit of Office of Inspector General (OIG) Advisory Opinions.
Mr. Eiland is a past President of the American Health Lawyers Association, and speaks at national programs sponsored by AHLA and other health care trade associations, including serving as a frequent speaker at the Health Care Compliance Association's Annual Compliance Institute.
Richard G. Korman
Richard G. Korman (Editor) is Executive Vice President and General Counsel for Avera Health, located in Sioux Falls, SD. Mr. Korman is responsible for all legal, public policy, compliance, government relations, internal audit, insurance and risk management activities for Avera. Avera is the Catholic health ministry of the Benedictine Sisters of Yankton, SD and the Presentation of the Blessed Virgin Mary Sisters of Aberdeen, SD. Avera delivers health care services through more than 350
locations in a five-state region made up of South Dakota, Minnesota, Iowa, Nebraska and North Dakota.
Mr. Korman graduated from the University of Minnesota with a Bachelor’s degree in political science and from William Mitchell College of Law with a law degree. He is admitted to the South Dakota Bar, the Minnesota Bar and is a member of the American Health Lawyers Association, where he is currently on the planning committee for the annual In-House Counsel Program. He has spoken at numerous regional and national conferences related to healthcare law and compliance issues.
Janet M. Lis
Janet M. Lis (Editor) practices health care law in Media, Pennsylvania. For over 20 years, she has provided legal services to institutional review boards in the Philadelphia metropolitan area related to structure, function, policies and procedures, and legal/ regulatory compliance. Prior to practicing law, Ms. Lis worked as a registered nurse. Ms. Lis received undergraduate degrees from Bucknell University (B.A.) and Georgetown University (B.S.N.), and her law degree from Georgetown University Law Center (J.D.). She is admitted to the Pennsylvania Bar, and is a member of local and state bar associations, as well as the American Health Lawyers Association and Public Responsibility in Medicine and Research, which focuses on promotion of ethical standards in human subjects in research. She is a member of the Pennsylvania Bar Association Health Law Committee Bioethics Subcommittee and the Delaware County Health Literacy Coalition.
Teresa A. Williams
Teresa A. Williams (Editor) is Vice President of Regulatory Services at INTEGRIS Health, Inc. She oversees Legal Services, Corporate Compliance, and Legislative Affairs, also serving as the system Corporate Compliance and Privacy Officer. She is a graduate of Rose State College (A.A. 1986), the University of Central Oklahoma (B.B.A., cum laude, 1987) and the University of Oklahoma (J.D., with distinction, 1991). Ms. Williams was formerly a director in the Oklahoma City law firm of Crowe & Dunlevy. She is a former member of the Board of Directors of the American Health Lawyers Association (AHLA) and a past Chair of the AHLA In-Counsel Practice Group. She is a past President of both the Oklahoma Health Lawyers Association and Oklahoma Bar Association Health Law Section. Ms. Williams serves on the Board of Directors of The C.A.R.E. (Child Abuse Response and Evaluation) Center and the Financial Development Team for the Oklahoma General Assembly of the Church of God.
Ms. Williams is an adjunct professor at the University of Oklahoma College of Law in a Master of Legal Studies Program - Healthcare. She serves as an Advisory Committee Member at Mid-America Christian University and an Advisory Board Member for the Management Department at the University of Central Oklahoma. Ms. Williams is a frequent author and speaker on health law related topics at local and national seminars for continuing legal and compliance education.
Haley N. Bavasi
Haley N. Bavasi (Author) is an attorney in the Boston office of Wilson Sonsini Goodrich & Rosati, where she is a member of the firm's life sciences technology transactions practice. She brings to her current role regulatory and transactional experience from Ropes & Gray LLP, where she was a member of the firm’s health care and life sciences practices focused on advising clients in
the areas of clinical research and health data privacy, with an emphasis on these issues in a global context. She now represents life sciences companies in a variety of domestic and international engagements, including collaboration agreements, research and development agreements, clinical trial management, university licenses, and intellectual property licenses.
Ms. Bavasi attended law school at the University of California, Berkeley School of Law. Prior to attending law school, she worked as a research associate in HIV vaccine clinical trials in San Francisco. Ms. Bavasi co-authored Chapter 9, Understanding Research Informed Consent.
Valerie H. Bonham
Valerie H. Bonham (Author) is Senior Advisor in the Office of Legislative Policy and Analysis at the National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services. She previously served as Senior Attorney in the Office of General Counsel, DHHS/NIH, as well as Deputy Director of the NIH Office of Research Support and Compliance and Executive Director of the Presidential Commission for the Study of Bioethical Issues under President Obama. She advises on a range of issues, including clinical research and bioethics, Congressional oversight, investigations, statutory construction, federal grants, privacy, data sharing, risk management, and intragovernmental relations. She has published widely in all of these areas. She received her undergraduate degree from Rice University, and her law degree from the University of Virginia School of Law.
Kate Bowen (Author) is General Counsel at Texas Oncology, P.A., the nation’s largest independent, physician-led oncology practice, delivering leading-edge technology and treatment options through more than 420 physicians at over 175 sites in Texas. Her work involves Phase I through III oncology trials offered in the community setting, allowing patients to access innovative therapies close to home. She received her law degree from SMU Dedman School of Law.
Eve Brunts (Author) is a partner in the Health Care Practice at Ropes & Gray LLP. Her practice focuses on regulatory compliance and reimbursement issues. Ms. Brunts regularly advises research sponsors and clinical sites on clinical research compliance
and contracting issues, including human subjects protection requirements, FDA requirements for clinical trials, clinical trial funding, clinical trial agreements, and HIPAA research requirements. For research sponsors and clinical sites, Ms. Brunts has participated in research compliance reviews; assisted with the development of research policies, procedures, and template documents; negotiated research collaboration agreements and/or provided advice in connection with government investigations.
Ms. Brunts graduated from Yale University and Yale Law School and received a master in law from Cambridge University. She is listed in Chambers USA: America’s Leading Lawyers for Business (2006-2018) and LMG Life Sciences Star (2012-2017).
Dale H. Cowan
Dale H. Cowan (Author) is retired from the practice of medicine and health law in Cleveland, Ohio. During the course of his 45 years of practice in hematology and medical oncology he was affiliated with MetroHealth Medical Center, University Hospitals of Cleveland, the Cleveland Clinic, and Case Western Reserve School of Medicine. He served as Chair of the Institutional Review of MetroHealth Medical Center. Additionally he served as Chair of the Ethics Advisory Committee of the Eastern Cooperative Oncology Group during which time he drafted the Conflict of Interest policies for the Group. Dr. Cowan also served on the faculty of the Case Western Reserve Law School at which institution he initiated the first courses in health care regulation. Dr. Cowan authored an article on IRBs in the Spring, 1975, issue of the Case Western Reserve Law Review, several articles on the ethics of research with human subjects with cancer and alcoholism, and a book chapter on the issues of reviewing clinical trials by IRBs. Dr. Cowan also served on the Editorial Board of the journal IRB published by the Hastings Center. He is a Fellow of the American College of Physicians, the American College of Legal Medicine where he served on the
Board of Governors and as President, and the American Health Lawyers Association (AHLA) where he served two terms on the Board of Directors. He is a recipient of the David J. Greenburg Service Award from the AHLA.
Dr. Cowan is a graduate of Harvard College, Harvard Medical School, and Case Western Reserve School of Law. He is licensed in medicine in California, Florida, and Ohio, and is a member of the Bar in Ohio. Dr. Cowan authored Chapter 12, Conflict of Interest Issues.
Payal P. Cramer
Payal P. Cramer (Author) is counsel in the law firm of Baker Hostetler LLP. She focuses her practice on health care and regulatory compliance. She counsels clients on matters related to clinical research programs, including human subject protection and institutional review boards, contract negotiation, Food and Drug Administration (FDA) compliance, research-related billing, and federal grant compliance. She has significant experience advising clients on matters related to data use in research, including HIPAA compliance. She received her undergraduate degree from Emory University, her Master’s in Public Health from Boston University, and her law degree from Emory University School of Law.
Amy K. Dow
Amy K. Dow (Author) is in private practice with the Health Care and Life Sciences Practice of Epstein Becker & Green, P.C. She advises entities engaged in clinical and preclinical research activities, including health systems, IRBs, sponsors and contract research organizations. Ms. Dow also counsels clients regarding the manufacture, sale and promotion of pharmaceuticals, biologics and medical devices, including topics relating to fraud and abuse, FDA compliance, corporate compliance and state law issues, and drafts and negotiates clinical research, consulting, and other services agreements.
Ms. Dow received her undergraduate degree from the University of Arizona and her law degree from Northwestern University School of Law. Ms. Dow co-authored Chapter 12, Payment to Research Subjects.
Heather L. Fields
Heather L. Fields (Author) is a shareholder at the Chicago, IL and Milwaukee, WI offices of Reinhart Boerner Van Deuren SC, where she chairs the firm’s Hospitals and Health Care Systems group. She is also a member of the firm’s Corporate Compliance and White Collar Litigation and Hospice and Palliative Care and Tax-Exempt Organizations groups. For more than 20 years, Ms. Fields has assisted clients with a wide variety of regulatory, transactional and compliance-related matters. She has extensive experience conducting internal investigations and advising clients in connection with compliance and fraud and abuse issues that arise in the context of operations and various health care provider relationships and transactions. Ms. Fields also deals regularly with patient safety and quality-of-care issues, peer review matters and medical staff issues, including investigations, corrective actions, fair hearings and drafting and review of medical staff bylaws and other governance documents. She advises clients on designing and implementing corporate compliance programs and assessing compliance program effectiveness, all aspects of HIPAA compliance, and clinical research compliance.
Ms. Fields has served as interim associate general counsel on an in-house basis for extended periods for clients, and is Certified in Healthcare Compliance (CHC), as well as a Certified Compliance and Ethics Professional (CCEP). Ms. Fields co-authored Chapter 11, HIPAA Compliance in Clinical Trials.
Jennifer S. Geetter
Jennifer S. Geetter (Author) is a Partner in the law firm of McDermott Will & Emery LLP. Ms. Geetter advises global life sciences, health care, and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws.
Ms. Geetter represents a broad range of clients, including pharmaceutical, device, and biologics companies; health plans institutional health care providers, and other enterprises; mobile app, mHealth, and other digital health technology companies and platform providers; research institutes; and informatics, data broker, and data aggregator companies. She assists these clients with a range of projects, including Health Insurance Portability and Accountability Act (HIPAA), Federal Trade Commission (FTC), and state and federal privacy, security and breach response preparedness and response; research compliance, research program structure, and operational and compliance infrastructure; complex research affiliation agreements and arrangements; scientific review and research misconduct proceedings and investigations; biobanking and registry development and compliance, including emerging issues in the future, unspecified use of biospecimens, and genomic data; development and implementation of data-sharing strategies and platforms to achieve business objectives, particularly in connection with biomedical innovation, health care reform, electronic health record implementation, and quality assurance requirements; and data privacy, data mapping, and data use strategies for mobile apps and other mHealth and digital technologies. Ms. Geetter co-authored Chapter 1, Distinguishing Research from Other Activities.
Kimberly Gillespie (Author) is Chief Legal Counsel for University of California San Diego Health (UCSDH). In this capacity, Ms. Gillespie is responsible for managing the legal affairs of the UCSDH and advising leadership in all aspects of health care law. Areas of specialty for Ms. Gillespie include corporate governance, health care compliance, health care fraud and abuse laws (Stark, Anti-Kickback Statute, the Civil Monetary Penalties Statute, and the False Claims Act), state and federal privacy laws, medical staff and peer review matters, hospital and physician transactions, regulatory affairs, research compliance, and conflict of interest. Ms. Gillespie also oversees the UCSDH Risk Management Office.
Prior to serving as Chief Legal Counsel, Ms. Gillespie served as Principal Counsel in the UC Office of the General Counsel, Chief Compliance, Privacy and Risk Officer at UCSDH, and in-house counsel for UCSDH and Virginia Commonwealth University Health System. Ms. Gillespie earned her undergraduate and master’s degree from Virginia Commonwealth University (B.A. 1992, M.P.A. 1994) and her law degree from the University of Richmond, T.C. Williams School of Law (J.D. 2003). She is licensed to practice in California, North Carolina, and Virginia. Ms. Gillespie previously served as a member of the Virginia State Bar, Health Law Section, Board of Governors and writes on a variety of health law topics. Ms. Gillespie co-authored Chapter 11, HIPAA Compliance in Clinical Trials.
Gabrielle Goldstein (Author) is Counsel at Nixon Peabody, where she provides regulatory and transactional advice to IRBs, hospitals, research institutions, academic medical centers and biotechnology companies. Her practice includes a wide range of issues, including federal and state requirements for the protection of human subjects, stem cell research, storage and use of biospecimens, research misconduct and financial conflicts of interest in research. She also provides transactional support to her clients through structuring collaborative arrangements between industry, government and health care institutions.
Ms. Goldstein is currently completing her PhD in Health Policy at UC Berkeley, where her dissertation explores variation in biomedical research oversight operations in the U.S. and Canada. Ms. Goldstein has a B.A. from UC Berkeley, a J.D. from Boston University School of Law, and is a PhD Candidate at UC Berkeley. She is a frequent lecturer and author on issues relating to domestic and international clinical research regulation. Ms. Goldstein co-authored Chapter 15, Tissue and Data Repositories for Research.
Michele R. Goodman
Michele R. Goodman (Author) is an Associate in the Health Care and Life Sciences Practice of Jones Day. She advises clients on compliance, regulatory, and transactional matters throughout the health care and life sciences industries. Ms. Goodman counsels clients on fraud and abuse and transparency laws, and a diverse range of federal and state regulatory compliance issues. She also focuses on clinical trials and research programs and collaborations, including negotiating agreements, reviewing informed consent forms, and advising on regulatory and ethical issues.
Prior to her legal career, Ms. Goodman was a certified clinical research professional at the National Cell Repository for Alzheimer's Disease, where she coordinated the participation of over thirty academic medical centers, including the collection of biospecimens and data from participating families and the distribution thereof to researchers across the country. She received her undergraduate degree from Indiana University and her law degree from the Maurer School of Law at Indiana University. Ms. Goodman co-authored Chapter 15, Tissue and Data Repositories for Research.
Igor Gorlach (Author) is a health care associate at King & Spalding LLP. He advises health systems, life sciences companies, pharmacies, laboratories, and device suppliers on complex Medicare and Medicaid compliance and reimbursement issues as well as privacy and data protection. Prior to joining King & Spalding, Mr. Gorlach served in various legal and policy positions in Washington, DC, and Boston, MA. During 2014-2015, he served on the George Washington University institutional review board. Igor received his JD degree from Harvard Law School and his MPH degree Harvard School of Public Health. Mr. Gorlach co-authored Chapter 7, Investigator Responsibilities.
Ann T. Hollenbeck
Ann T. Hollenbeck (Author) is a Partner in the Health Care and Life Sciences Practice of Jones Day. She advises entities engaged in clinical research activities, including health systems, IRBs, sponsors, research consortia, and unique research collaborations. Ms. Hollenbeck provides legal advice on a wide range of issues including research compliance, governance and corporate law, reimbursement and funding, and fraud and abuse. She received her undergraduate degree from Butler University and her law degree from Indiana University School of Law, and is licensed to practice law in Michigan, Indiana, and Illinois. Ms. Hollenbeck authored Chapter 16, Incidental Findings in Genomic Research: Ethics, Law, and Practicality.
Jacqueline A. Holz
Jacqueline A. Holz (Author) currently is a Contract Specialist providing legal support to U.S. Oncology Research within McKesson Specialty Health for patient participation in community based oncology research and clinical trials. Prior to arriving at McKesson Specialty Health in January 2017, she received a Masters of Law degree from Loyola University, Chicago School of Law while serving as senior legal advisor and U.S. compliance officer at Chugai Pharma. At Chugai starting in 2008, she provided for the legal counsel and management associated with both the corporate and the clinical research portions of a global pharmaceutical company. She received her Bachelor’s Degree from Rutgers University and her Juris Doctor degree from Touro College, Jacob D. Fuchsburg Law Center. Ms. Holz edited and expanded Chapter 17, Typical Areas of IRB Noncompliance.
Beverly Lorell is the Senior Medical and Policy Advisor for the FDA and Life Sciences group at King & Spalding in Washington, D.C. Dr. Lorell was a Professor of Medicine at Harvard University, interventional cardiologist, and heart failure specialist. She was a clinical investigator in many pharmaceutical and medical device clinical trials. She also served on FDA Cardiovascular and Renal Drugs Advisory Committee. Before joining King & Spalding, she was vice president and the global chief medical and science officer of Guidant Corporation.
In her practice at King & Spalding, she advises many manufacturers as well as health care systems on issues regarding clinical trial conduct, data integrity, and the protection of human subjects—including IRB matters— related to the Common Rule and FDA regulations. Dr. Lorell represents King & Spalding’s membership in the Clinical Trials Transformation Initiative (CTTI), a public-private partnership with FDA, and she was the lead author of a recent publication on the reform of informed consent. Ms. Lorell co-authored Chapter 7, Investigator Responsibilities.
Alice K. Marcee
Alice K. Marcee (Author) is an Assistant Vice Chancellor & Counsel for Academic and Health Affairs at the University of Texas System (UTS). Dr. Marcee provides strategic, legal, and operational advice regarding the development of two new medical schools in UTS and health care matters that include physician alignment and aggregation, governance, public-private partnerships, and value-based care models. While serving as in-house counsel at The University of Texas Southwestern Medical Center (UTSW), she was a non-voting, ex-officio member of the institution’s IRB panels for approximately four years. Prior to law school, Dr. Marcee was on faculty in the Department of Family & Community Medicine at UTSW, engaged in health services research, supporting physicians with the integration of electronic health records into practice, and telemedicine program development and implementation.
Dr. Marcee received a Doctor of Veterinary Medicine, magna cum laude, from the Texas A&M College of Veterinary Medicine and a Juris Doctor from Southern Methodist University Dedmen School of Law. Ms. Marcee co-authored Chapter 9, Special Categories of Review and Chapter 15, Tissue and Data Repositories for Research.
Ernessa McKie (Author) is an associate at BakerHostetler in Atlanta. She focuses her health care practice on licensure applications and recovery audit work. She has a wealth of previous experience in working with the Centers for Medicare and Medicaid Services and in assisting hospitals in quality reporting, regulatory drafting, and reconsideration requests for quality reporting programs, as well as working with clients in litigation. Ms. McKie serves as an advisor to institutional review boards on a variety of matters, including but not limited to informed consent review, policy and procedure review, and operational guidance. Well-versed in government policy, analysis, and alternative dispute resolution, Ms. McKie also has experience working as a pharmaceutical sales representative, which provides her with additional insight regarding the pharmaceutical and health care industry.
Melinda G. Murray
Melinda G. Murray (Author) is Associate General Counsel at Holy Cross Health in Silver Spring, MD where she advises on regulatory matters, contracts, privacy issues, clinical research and bioethics, medical staff, risk, and compliance issues. Prior to 2008, she served as In-House Counsel to several hospitals and hospital systems. She served for 3 years on the Health Law Steering Committee for the D.C. Bar and has presented and written on a variety of health care issues for health care groups and the community. She received her undergraduate degree from Wheaton College (MA), and her law degree from Georgetown University Law School. Ms. Murray co-authored Chapter 11, HIPAA Compliance in Clinical Trials.
Katayoun (Kat) Neal
Katayoun (Kat) Neal (Author) is Staff Counsel at McKesson Corporation, headquartered in The Woodlands, TX. Ms. Neal supports McKesson’s specialty pharmacy businesses focusing on health care contracting, legal, and regulatory matters. Prior to focusing on specialty pharmacies, Ms. Neal supported the U.S. Oncology Research clinical trial program. She dedicated eight years to the clinical trial research program, where she managed clinical trials, assisted with process improvements, and negotiated clinical trial agreements. She received her undergraduate degree from the University of Houston, and her law degree from the University of Houston Law Center.
Laura M. Odwazny
Laura M. Odwazny is a Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services, where she is a subject matter expert in human subject protections, research compliance, and administrative law pertaining to rulemaking. Ms. Odwazny’s primary client is the Office for Human Research Protections, which interprets and enforces the HHS regulations that provide protections for human research subjects. Ms. Odwazny also currently advises the HHS Office of Global Affairs. Throughout her 18 years with the Office of the General Counsel, Ms. Odwazny has provided legal advice to various other agencies within HHS, including the Presidential Commission for the Study of Bioethical Issues, the Office of the Assistant Secretary for Health, the Program Support Center Division of FOIA Services, the Health Resources and Services Administration, and the Substance Abuse and Mental Health Administration. Prior to her employment with HHS, Ms. Odwazny served as a law clerk to the Superior Court of Pennsylvania and the Supreme Court of Pennsylvania. Ms. Odwazny is a graduate of the University of Chicago and the University of Pittsburgh School of Law, and received a M.A. in Bioethics through the History and Philosophy of Science Department at the University of Pittsburgh.
Ms. Odwazny speaks frequently on issues of human subjects research protection as applied to biomedical and behavioral research. Ms. Odwazny served as an adjunct professor at American University Washington College of Law, teaching “The Law and Ethics of Human Subjects Research,” and currently teaches “Compliance in Research” at the University of Pittsburgh School of Law Health Care Compliance Certificate program. Ms. Odwazny serves as a member of the IRB for the Walter Reed Army Institute of Research (WRAIR), U.S. Department of Defense. Ms. Odwazny has served on the Core Conference Planning Committee of the Public Responsibility in Medicine & Research (PRIM&R) Advancing Ethical Research conference since 2013 and is the past committee co-chair (2015-17). Ms. Odwazny also serves as a member of the Model Agreements and Guidelines International (MAGI) Advisory Board. Ms. Odwazny co-authored Chapter 10, Understanding Research Informed Consent.
David Peloquin is an attorney at Ropes & Gray LLP where he practices in the firm’s health care group. He focuses his practice on advising academic medical centers, life sciences companies, and information technology companies on issues related to human subjects and animal research, Medicare/Medicaid and other third-party payer reimbursement, and data privacy. Mr. Peloquin frequently writes and speaks on topics related to each of these areas. He also serves as a community member of the Institutional Review Board at Partners Healthcare in Boston.
Mr. Peloquin received his undergraduate degree from Carleton College and his law degree from the Yale Law School. He clerked for the Honorable Diana E. Murphy of the United States Court of Appeals for the Eighth Circuit. Before attending law school, Mr. Peloquin worked as a project manager for Epic Systems, a leading provider of electronic medical records.
Mary Holloway Richard
Mary Holloway Richard (Author), of Counsel with Phillips Murrah PC in Oklahoma City, represents hospitals, clinics, group practices and individual providers across Oklahoma on a broad range of issues-- transactions, reimbursement audits and appeals, OIG investigations, and compliance. She works with clients to develop business strategies in this highly regulated industry and to minimize their exposure to risks. She lectures and publishes on topics including nonprofit operations, responses to the opioid epidemic, clinical research, telehealth, HIPAA, employment and management agreements, and behavioral health law topics. She was formerly in house counsel assigned to the system’s IRB.
Mary has been in leadership of the American Health Lawyers Association’s Behavioral Health Task Force since its inception. She is past Chair of the Health Law Section of the Oklahoma Bar Association where she inaugurated a vulnerable population webcast series for state lawyers and is past president of the Oklahoma Health Lawyers Association. She is a graduate of George Washington University law school and teaches at Oklahoma City University School of Law.
Martha C. Romney
Martha C. Romney (Author) is an Assistant Professor at the Jefferson College of Population Health (JCPH), Thomas Jefferson University. Ms. Romney’s research focuses on issues related to obesity, cancer, population health, employee wellness, and health disparities in research and implications for policy, which has been disseminated through publications and presentations. Ms. Romney teaches Public Health Policy and Advocacy, Cultural Humility & Competency in Population Health and Bioethics, as well as lectures on legal/regulatory, ethical and policy issues in the JCPH Master of Public Health (MPH) and Doctoral Population Health Sciences programs, in the University and at professional conferences. Ms. Romney also has pharmaceutical product litigation support and regulatory policy experience.
Ms. Romney earned her BSN from Duke University, MS in Nursing from Columbia University, JD from the Antioch School of Law, MPH from Drexel University School of Public Health. Ms. Romney edited and co-authored Chapter 3, Understanding the Clinical Trial Process.
Chelsea M. Rutherford
Chelsea M. Rutherford (Author) is an associate in McDermott Will & Emery’s Washington, DC office. Ms. Rutherford advises health care clients on a wide range of transactional and regulatory issues, including physician practice management, fraud and abuse enforcement and investigations, and research compliance. Prior to law school, she worked in clinical genetics laboratories and co-authored peer-reviewed research in the field. Ms. Rutherford received a Bachelor of Arts in Human Biology from the University of Virginia, a Masters of Bioethics from Columbia University, and a Juris Doctor from Boston University, where she also served as the editor in chief of the American Journal of Law and Medicine. Ms. Rutherford co-authored Chapter 1, Distinguishing Research from Other Activities.
Thomas D. Shrack
Thomas D. Shrack (Author) is the Practice Area Senior Attorney-Clinical Research for Ascension, in Indianapolis, Indiana. Ascension is the largest non-profit health system in the U.S. and the world's largest Catholic health system and operates more than 2,600 sites of care in 22 states and the District of Columbia. Previously, Mr. Shrack was a shareholder at Hall, Render, Killian Heath & Lyman, P.C., where he focused his practice on the legal and ethical issues involved in clinical research activities and clinical research compliance, as well as on general clinical services, patient care issues, corporate counsel services, medical staff relations, and general regulatory and compliance issues. Mr. Shrack has served as a voting member on two hospital institutional review boards and, prior to practicing law, participated in clinical research as ultrasonographer for a group of peripheral vascular surgeons.
Mr. Shrack received his undergraduate degree from Miami University in Oxford, Ohio, law degree from Indiana University School of Law, Indianapolis, and is a member of the Indiana Bar. Mr. Shrack authored Chapter 19, Scientific Misconduct In Clinical Research.
Lynn E. Smith
Lynn E. Smith (Author) is a Director with Huron Consulting Group and has 20+ years of experience in research administration and regulatory compliance. Her areas of expertise include transformation of Human Research Protection Programs (HRPP), Institutional Review Boards (IRB) and assisting clients achieve accreditation of their HRPP. Other areas of expertise include research compliance assessments, investigations of investigator non-compliance, management of research compliance and clinical trial offices, conflicts of interest (COI), scientific misconduct, and export controls.
Katherine B. Steuer
Katherine B. Steuer is Senior Associate Counsel at St. Jude Children’s Research Hospital, in Memphis, Tennessee. Ms. Steuer advises the institution and its clinical departments and committees on legal, regulatory, and strategic matters, including clinical research, bioethics, genomics, pathology and pharmaceutical regulation, medical staff, graduate medical education, managed care, compliance, reimbursement, and fraud and abuse. She is counsel to the IRB and the human subjects’ protection program, and also drafts healthcare and affiliation agreements, consent forms, and policies and procedures. Ms. Steuer is a member of the board and past chair of the Memphis Bar Association Health Law Section, and a member of state and federal bar associations.
Having graduated from Wesleyan University in Connecticut, she obtained her law degree from Harvard Law School. More recently, Ms. Steuer obtained a Certificate in Pediatric Bioethics from Children’s Mercy Bioethics Center, Children’s Mercy Hospital in affiliation with the University of Missouri – Kansas City. Ms. Steuer co-authored Chapter 16, Incidental Findings in Genomic Research: Ethics, Law, and Practicality.
Gelvina Rodriguez Stevenson
Gelvina Rodriguez Stevenson (Author) is an Associate General Counsel at the Children’s Hospital of Philadelphia. In her role at CHOP, Ms. Stevenson advises the hospital on the legal aspects of medical research and scientific innovation. Ms. Stevenson also provides legal support in the areas of privacy, contract negotiation, conflicts of interests, controlled substances and other matters. Prior to working at CHOP, Ms. Stevenson was an Associate University Counsel at Weill Cornell Medical College, a Legislative Attorney for the New York City Council, an associate at Chadbourne & Parke LLP and a law clerk to The Honorable Audrey B. Collins, U.S. District Court, Central District of California. Ms. Stevenson holds a JD from New York University School of Law, a Master’s degree from the Woodrow Wilson School at Princeton University and a Bachelor of Arts from New York University. Ms. Stevenson serves as a Vice Chair of the AHLA Teaching Hospitals and Academic Medical Centers practice group and as Co-chair of the Hispanic National Bar Association Health and Life Sciences Committee.
Ms. Stevenson is Adjunct Clinical Faculty at Drexel University School of Medicine Masters in Clinical Research Program. Ms. Stevenson co-authored Chapter 8, Children in Research.
Sarah E. Swank
Sarah E. Swank is an experienced attorney who has worked as in house counsel in two national health care systems and as a Shareholder in a nationally recognized law firm. Ms. Swank was Senior Counsel at Dignity Health in Pasadena, California supporting five hospitals, laboratory services and six CINs and a Shareholder in Ober|Kaler's Health Law Group in the Washington, DC office providing advice and guidance on health care transactions, governance, ACOs, telehealth, compliance, EMTALA, clinical research, IRBs and health care reform.
Before joining Ober|Kaler, Sarah was an Associate General Counsel for Trinity Health in the metro-DC area, where she managed the local legal team and assisted in system-wide initiatives. She started her career as a managed care attorney and government affairs associate in New York State. Sarah works with clients to navigate the complex legal framework facing the health care industry today and to promote access to high quality and safe care by breaking down silos through innovation, technology, clinical research and patient-centeredness.
Leslie Thornton (Author) is an attorney at Ropes & Gray LLP, practicing in the firm’s health care group. Dr. Thornton advises academic medical centers, pharmaceutical and device manufacturers, research institutes, health technology companies, and other health care organizations on a broad range of research issues, including preclinical and clinical matters, federal grants and contracts, research misconduct, and government audits and investigations. She also advises her clients regarding health care privacy and security matters, both U.S. and ex-U.S.
Before law school, Dr. Thornton gained experience as an academic researcher in both public health and psychiatric settings, including extensive training in advanced statistical and epidemiologic methods. She received her J.D. from the University of California, Berkeley School of Law, her Ph.D. from the Johns Hopkins Bloomberg School of Public Health, and her undergraduate degrees from the University of California, Los Angeles.
Leah A. Voigt
Leah A. Voigt is Chief Privacy & Research Integrity Officer at Spectrum Health System in Grand Rapids, Michigan. Prior to joining Spectrum Health, Ms. Voigt was an attorney in private practice in the Washington, DC office of the global firm, Squire Sanders & Dempsey (now Squire Patton Boggs). She was a member of both the Health Care and Life Sciences practice groups, and her clients included a diverse range of organizations, from large academic medical centers, health systems, and health insurance companies, to start-up health information technology companies and global medical device and pharmaceutical manufacturers.
Before graduate school, Ms. Voigt served as an administrator for a biomedical research institute in Los Angeles, California. Ms. Voigt is currently Chair of the Academic Medical Centers & Teaching Hospitals Practice Group of the American Health Lawyers Association. She received a Bachelor of Arts from Smith College, a Masters of Health Policy from University of Michigan, and her Juris Doctor from Loyola Law School in Los Angeles. Ms. Voigt co-authored Chapter 8, Children in Research.
Table of Contents
Chapter 1 Distinguishing Research from Other Activities
Chapter 2 Regulations that Govern Clinical Research in the United States
Chapter 3 Understanding the Clinical Trial Process
Chapter 4 Introduction to Institutional Review Boards
Chapter 5 The IRB Review Process
Chapter 6 Roles and Responsibilities of Investigators
Chapter 7 Children in Research
Chapter 8 Special Categories of Review
Chapter 9 Understanding Research Informed Consent
Chapter 10 HIPAA Compliance in Clinical Trials
Chapter 11 Payment to Research Subjects
Chapter 12 Conflict of Interest Issues
Chapter 13 Billing for Clinical Trial Services: General Overview
Chapter 14 Use of Biospecimens and Private Information in Research and Research Repositories
Chapter 15 Secondary Findings in Genomic Research: Ethics, Law, and Practicality
Chapter 16 Typical Areas of IRB Noncompliance
Chapter 17 IRB Compliance and Internal Audits
Chapter 18 Scientific Misconduct in Clinical Research
PLUS downloadable Exhibits & Sample Forms
The revised Common Rule takes effect on January 21, 2019, implementing fundamental changes to the rules surrounding human subjects research. Are you prepared to comply?