Speakers for this Event:

Barry Mangum, Pharm.D., FCP, Director Clinical Pharmacology, Duke Clinical Research
    Unit  

Yvonne Higgins, A.B., CIP, Director Quality Management, Copernicus Group IRB

In a recent announcement of the proposed revisions to existing federal regulations governing human research subjects, the US Department of Health and Human Services (HHS) acknowledged, “There is very little evidence that having multiple IRBs review the same study is increasing protections to subjects,” according to an HHS publication on the recent proposed changes to the review and conduct of human. “By diffusing responsibility for that review, it might actually be leading to weakened protections.”

Goals:

The goals of this presentation are to provide clarity on the rationale for this proposed change to the federal regulations; to discuss the potential impact on sponsors, CROs, and academic institutions; to dispel some of the myths regarding the independent review board model and to provide a case study of the collaborative relationship between the Duke University and Copernicus Group IRB in the review and conduct of clinical trials.

Barry Mangum, Pharm.D., FCP, Director Clinical Pharmacology, Duke Clinical Research Unit will present an academic institution’s perspectives of the IRB Process in Phase I Clinical Trials. Dr. Mangum will describe key barriers and solutions for success in an academic model for Phase I clinical trials including:

• IRB review
• Contract negotiation
• Intellectual property
• The cost of conducting Phase I clinical trials

Yvonne Higgins, A.B., CIP, Director Quality Management, Copernicus Group IRB will describe some of the perceived barriers and real solutions to reliance on an independent IRB and will describe the use of independent IRBs as an alternative to the traditional institutional review board model. Key challenges and suggested strategies for success will include:

• Quality of IRB review
• An IRB’s knowledge of local and cultural concerns
• Institutional and individual liability
• Control, accountability and regulatory oversight of the clinical trial
• Concerns about potential loss of revenue

Individuals from pharmaceutical companies, CROs and site management organizations with the following job responsibilities:

• Clinical operations, study start up, clinical trial managers, regulatory, informed consent, site recruitment, clinical project managers, therapeutic heads, clinical development and medical directors

Dr. Mangum is a Associate Professor, Clinical Pharmacology and Assistant Professor, Pediatrics at Duke University Medical Center. He is a graduate of The Medical University of South Carolina where he received his Doctorate in Pharmacy with special thesis emphasis on neonatal/pediatric pharmacology. Currently, Dr. Mangum is working at the Duke Clinical Research Institute as Senior Pediatrics Faculty in pediatric clinical trials focusing on providing strategic planning and coordination of specialty pediatric population clinical research. Additionally, Dr. Mangum is the Director of Clinical Pharmacology for the Duke Clinical Research Unit, an academic early phase clinical pharmacology unit designed to explore new therapies for diseases in children and adult patients.

Dr. Mangum has an extensive background in neonatal and pediatric pharmacology and is the co-author and co-publisher of the leading drug dosing manual, NeoFax®: A Manual of Drugs Used in Neonatal Care. NeoFax® is in the twenty-second year of publication as a source for neonatal drug dosing information. The NeoFax® content has been integrated into varying intranet and handheld device application used globally to aid in drug information and dose calculations (e.g. NeoFax-EM, NeoFax-Rx, and NeoFax-PN). Dr. Mangum has been strategically involved with the design and the implementation of all clinical and business decisions related to the NeoFax® endeavors.

Dr. Mangum continues to be active in national and global leadership of pediatric clinical research as an educator and committee member of academic and pharmaceutical industry organizations. He has represented the interest of pediatric patients by chairing and speaking at meetings globally on the topic of neonatal pharmacology and legislative issues to support clinical research in children. Currently, Dr. Mangum is serving a four- year appointment to the World Health Organization’s Expert Committee on the Selection and Use of Essential Medicines.

As Director of Quality Management for Copernicus Group IRB (CGIRB), Ms. Higgins is responsible for overseeing CGIRB’s Human Research Protection Program. She earned her A.B. in Biology from Hood College and a Certificate in Human Research Ethics from the University of Washington School of Medicine. In 2001, she became among the first to earn certification as an Institutional Review Board Professional (CIP), from the Council for Certification of IRB Professionals. Additionally, she earned a Level II Certification in Quality Assurance from the Defense Acquisition University.

The recipient of many awards, Ms. Higgins’ most recent achievement was the Distinguished Service Award bestowed by Public Responsibility in Medicine and Research (PRIM&R), which is awarded to a member of the organization who has made valuable and unique contributions to the field of research ethics, and who has attained distinction in promoting PRIM&R’s purpose and ideas through writing, teaching or research.

It is especially noteworthy that Ms. Higgins has been an Association for the Accreditation of Human Research Protection Programs (AAHRPP) site auditor since 2007and a member of AAHRPP’s Council since 2009.

Ms. Higgins has contributed to the cause of ethics and responsibility in human research protections for more than 15 years. During that time she has been a highly respected leader in several roles, notably: as an employee of the Office for Human Research Protections (OHRP), where she served as a public health analyst; as the executive director of the human research protections office at the University of Pennsylvania; and, in her "spare time," as co-chair of the Workshop and Didactic Subcommittee for PRIM&R's AER Conferences for three years, and as faculty at many more PRIM&R conferences.

Copernicus Group IRB (CGIRB) is an independent institutional review board (IRB) whose primary responsibility is to ensure that the rights and welfare of human research subjects are protected.

The CGIRB Board reviews research protocols and study-related information, as well as investigator qualifications and resources to assure regulatory compliance. CGIRB provides:

• Multiple weekly CGIRB Board meetings
• Initial, continuing and expedited reviews
• Promptly communicated Board decisions
• Online submission and tracking via CGIRB Connexus®
• Continuing review reminders
• Education and training resources

Copernicus Group IRB may review studies for a single investigator or serve as a central IRB for multi-center trials involving upwards of several thousand investigators. Additionally, CGIRB may function as the IRB of record for studies conducted at hospitals or academic institutions. CGIRB was inspected by the FDA in 1999, 2005 and again in 2010 with no Form FDA 483 issued. CGIRB’s human research protection program has maintained full accreditation by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc., since 2004. In 2010, CGIRB became the first central IRB to achieve ISO 9001:2008 certification.