About HRP Consulting
HRP Consulting Group (HRP) has been in the business of research ethics and compliance for over 10 years.
HRP Consulting Group has over 100 years of combined hands-on experience in the fields of human research protections, animal care and use, biosafety, research integrity, conflict of interest, and other areas of research ethics and compliance. We use our experience to provide expert support to research professionals throughout the world. Services include, but are not limited to, program evaluations, development of policies and procedures, accreditation assistance, training and education, auditing, HRPP and IRB administration, temporary staffing support for HRPPs and IRBs, expert opinions, and “on-call” consulting.
Relationships are the core of our business. Our internationally recognized experts take a personalized approach to develop customized solutions for the challenges you face. HRP prides itself on being there for our clients as an ongoing source of support.
For more information, or if you just have a question you are hoping we may be able to help with, please call or email us at any time: 347-862-9321 or email@example.com.
Cheryl Savini | Senior Vice President
Cheryl has over 30 years’ experience in human research protections, in both biomedical and social, behavioral, and educational research, and co-founded the HRP Consulting Group in 2009. With field experience in both civilian and military arenas, her professional experience ranges from IRB administration to program oversight. Cheryl has held a number of leadership positions throughout her career, has served as an IRB member, and has personal experience as a research subject. Cheryl is currently serving as a member of the SACHRP Subcommittee on Harmonization, charged with developing recommendations for SACHRP regarding the harmonization and simplification of HHS regulations and guidelines for the protection of human research subjects.
Cheryl has been a member of the nationally and internationally acclaimed Collaborative Institutional Training Initiative (CITI) training program since 2002, serving as a member of the developers, editors, and contributors’ groups. She is and has been an invited speaker at numerous conferences both domestic and international, such as PRIM&R (Public Responsibility in Medicine and Research) AER Conference, and contributed content to the 3rd edition of IRB Management and Function.
Cheryl has also been honored with several distinguished awards, including the University Presidential Award at the University at Albany, the State University of New York Chancellor’s Award for Professional Service; and the Initiatives for Women Award.
Karen Christianson, RN, BSN | Associate Vice President
Ms. Christianson’s passion for research was ignited by her experience as a pregnant subject in a clinical trial. Following this experience, Ms. Christianson became a Research Nurse at a large academic medical center and spent a number of years managing a broad portfolio of investigator-initiated, industry, and NIH-supported research.
Ms. Christianson eventually transitioned into a role in Academic Affairs and was responsible for establishing a human research QA/QI program, training programs, and establishing a comprehensive Human Research Protection Program of which she was named Director. Ms. Christianson led the program through a successful application for AAHRPP accreditation in 2010 and was subsequently invited to become an AAHRPP site visitor. Her dedication to best practices in research was honored at the 2011 PRIM&R AER conference when she was presented with IRBNet’s Ethics in Human Subject Protection Award.
Ms. Christianson joined HRP Consulting Group in 2013 and has since successfully partnered with a number of clients to evaluate, improve, and support their HRPP, IRB, and Research Integrity functions. Her specialties include program and process evaluations, HRPP development and accreditation, IRB management and operations, research misconduct, research compliance, and FDA inspections.
Gary L. Chadwick, PharmD, MPH, CIP | Senior Consultant Emeritus
Professor Chadwick was a Commissioned Officer with the U.S. Public Health Service for over 26 years. Among other postings, he served in the FDA Commissioner’s Office as the Associate Director for Human Subject Protection and also in the Health and Human Service (HHS) Office for Human Research Protection (OHRP).
Gary has been a member of several national commissions and organizations including: the Council for Certification of IRB Professionals and the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP). In the recent past he has been a site visitor and on the Accreditation Council of AAHRPP.
Dr. Chadwick is the co-author of the widely used investigator training book, “Protecting Study Volunteers in Research,” now in its fourth edition.
He earned his Bachelor’s degree in Pharmacy from the Ohio State University, his PharmD from the University of Tennessee, and his MPH from the Uniformed Services University.
Dean Gallant | Senior Consultant
Dean R. Gallant retired in 2013 as Assistant Dean for Research Policy and Administration in the Faculty of Arts and Sciences at Harvard University. In that capacity, he was responsible for the oversight of human subjects and animal research, professional conduct, and general issues of research policy.
Mr. Gallant has a background in social psychology and worked at the Alcohol and Drug Abuse Research Center at McLean Hospital before moving to the Center for Behavioral Sciences at Harvard University, where he long served as Assistant Director. He was Director of the Harvard University Science Center for 10 years and, for 35 years, Mr. Gallant was a member of Harvard University’s Committee on the Use of Human Subjects in Research, where he served as Executive Officer.
He is an active member of PRIM&R and has spoken and written on human subjects research issues for many years. From 2010 to 2019 he served as a member of the Subcommittee on Harmonization of the DHHS Secretary’s Advisory Committee on Human Research Protections (SACHRP).
Wayne Patterson | Senior Consultant
Prior to his position at the University of Texas at Austin, Dr. Patterson was the Senior Assistant Vice President for Research at the University of Texas Medical Branch in Galveston from 1994 – 2009. Before joining the University of Texas System, he served over 20 years in the United States Air Force in clinical laboratory management, core research laboratory management and as Deputy Director of the Air Force’s largest research facility.
In addition, he was an AAHRPP site visitor from 2006 – 2016, a member of AAHRPP Council from 2008-2016 and served as Council chair from 2010-2012. He also was a member of the Board of Directors of the Texas Society for Biomedical Research from 1994 – 2016.
Lisandra González, MPH, CIP, CCRP | Consultant | Manager -- Temporary Staffing Services
Ms. Gonzalez has worked in the field of human research protections for over ten years. Her experience encompasses both biomedical and social behavioral research.
For six years, Ms. Gonzalez worked at the University of Connecticut Health Center (UCHC) as part of a team of researchers engaged in Community Participatory Research. While at UCHC, Ms. Gonzalez was also an IRB Member, which sparked her career in human subjects protection.
Most recently, Ms. Gonzalez was an HRPP Education and Compliance Specialist at Baystate Medical Center in Springfield, MA. In that role she served as a liaison between the IRB office and the research community, providing training in the various aspects of review and conduct of human subjects research in support of best practices and adherence to research regulations, policies, and guidelines. Ms. Gonzalez also mentored researchers, research staff, residents and fellow physicians through the process of study development, IRB submission and study conduct. She assisted in the development and implementation of HRPP educational programs. Most notably, Ms. Gonzalez monitored IRB compliance with institutional and national regulations, policies, and guidelines for human subjects research.
Ms. Gonzalez holds a Master’s Degree in Public Health (MPH) from the University of Connecticut and is a Certified IRB Professional (CIP).
Julia Kennedy, MPA, CIP | Consultant
Ms. Kennedy has also functioned as an IRB Manager at the Medical College of Wisconsin, Research Integrity Manager at Children’s Hospital of Wisconsin, and the Director of the Human Research Protection Program for Wheaton Franciscan Healthcare. Each position adding to her expertise in a wide range of knowledge from high volume clinical research involving children to assuring compliance consistent with the ethical and regulatory framework of a Catholic healthcare system. She has a proven ability to build and lead highly successful teams and programs. Achievements include establishing operational IRBs and infrastructure to support IRB function, developing quality improvement and education programs, and implementing electronic IRB submission and review systems.
Ms. Kennedy has a Bachelor’s Degree in Psychology from the University of Wisconsin-Madison, a Master’s Degree in Public Administration from the University of Miami and is a Certified IRB Professional.
Cassandra Myers | Consultant
Cassandra (Cassie) Myers has over 20 years of experience in health care, with over 14 of those years in the field of human research protections in varying roles. Her experiences encompasses leadership, process improvement, project management and operations.
Most recently, Cassie was Director of Human Research Ethics at University of North Carolina-Chapel Hill and oversaw a major structural reorganization to better support the staff and research community, the implementations of the revised common rule, and numerous quality and system improvement projects. During her time as Director, Cassie also oversaw the transition of the institution’s IRBs and research community during the COVID-19 pandemic to safely continue human subject research programs and was a liaison with study teams to provide consultation and guidance. Prior to her time at UNC-Chapel Hill, Cassie served as IRB Manager at Allina Health and Park Nicollet, and as IRB staff at Mayo Clinic and Children’s Hospitals and Clinics of Minnesota.
Cassie has a Bachelor’s Degree in Health Management from the University of Minnesota.
Mike Bingham | Consultant
Michael (Mike) Bingham has over 15 years of experience working in the field of human research protections. His experience includes both biomedical & social behavioral research, as well as IRB reliance.
Most recently, Mr. Bingham was a part of the University of Wisconsin-Madison’s IRB Reliance Team, one of the first teams in the country devoted specifically to IRB reliance issues. In this role he worked as a liaison between UW-Madison study teams, UW-Madison IRBs and external IRBs on reliance related issues. These issues included executing reliance agreements, as well as guiding IRBs and study teams through single IRB regulations and best practices. During his tenure at UW-Madison, Mr. Bingham served as a Regulatory Operations Manager and Ambassador for SMART IRB. In this role he worked with institutions nationwide to ensure regulatory requirements were met in order to join SMART IRB. Also, during his time at UW-Madison, he served as the lead IRB representative for the Greater Plains Collaborative PCORnet network, which included coordinating and leading their annual conference. Prior to his position at UW-Madison, Mr. Bingham served as the lone IRB Coordinator for ProHealth Care in Waukesha, WI, Assistant Director of the Education IRB at UW-Madison, and on the IRB staff at both Wheaton Franciscan Healthcare and the Medical College of Wisconsin.
Mr. Bingham earned his Juris Doctorate (J.D.) from Suffolk University Law School in Boston, MA.
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...