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 info@thehrpconsultinggroup.com.

Karen Christianson | Vice President

Karen has over 25 years of experience in human research protections and other areas of research ethics and compliance.  Karen’s passion for research was ignited by her experience as a pregnant subject in a clinical trial.  She then went on to hold a wide range of positions in research, from Research Nurse to HRPP Director, before joining HRP Consulting Group in 2013.   

Karen has served as an AAHRPP Site Visitor, has presented extensively, is a member of the CITI Program GCP Working Group, has authored content for CITI Program courses, and contributed content to Institutional Review Board: Management and Function.  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. 

Gary L. Chadwick, PharmD, MPH, CIP | Senior Consultant Emeritus
Dr. Gary Chadwick holds a faculty appointment at the University of Rochester School of Medicine and Dentistry as Emeritus Professor of Medical Humanities and Bioethics. For 16 years, he was Director of the Office for Human Subject Protection at UR. He has been with the HRP Consulting Group for the past three years.

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 GallantDean 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
Wayne PattersonBefore joining the HRP Consulting Group, Dr. Wayne Patterson was the Associate Vice President for Research and Director of the Office of Research Support at the University of Texas in Austin, with oversight responsibility for the Institutional Review Board, Institutional Animal Care and Use Committee, Institutional Bio-Safety Committee and research-related Conflict of Interest administration. He also served as a member and protocol reviewer for the IACUC, IBC and IRB and as the Conflict of Interest Official for the University.

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

Lisandra GonzalezMs. 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

Julia Kennedy

Ms. Kennedy has been working in the field of human research protections since 2001. Prior to joining HRP Consulting Group in 2016, Ms. Kennedy served in various roles, including IRB Administrator and Director of Regulatory Affairs and Educational Initiatives at the University of Miami, IRB Manager at the Medical College of Wisconsin, Director of the Human Research Protection Program at Wheaton Franciscan Healthcare, and Research Integrity Manager at Children’s Hospital of Wisconsin. Her experience includes establishing processes and  infrastructure to better support IRB and HRPP operations, developing quality improvement and education programs, and implementing electronic IRB submission and review systems.

Ms. Kennedy has a Master’s Degree in Public Administration from the University of Miami, a Bachelor’s Degree in Psychology from the University of Wisconsin-Madison, 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.

Teresa Toyfair | Consultant

 

Ms. Toyfair has worked in the field of human research protections since 2009 and has worked with the HRP Consulting Group since 2016.  While with HRP, Ms. Toyfair has provided clients with high-quality support of IRB operations when their programs are under stress. Her experience encompasses both biomedical and social behavioral research.  Prior to joining HRP, Ms. Toyfair worked at Baystate Medical Center in Springfield, MA as an IRB Analyst.  In this role she provided oversight and management of an Institutional Review Board while providing guidance to IRB members, clinical research staff, and principal investigators on regulatory processes. While at Baystate, Ms. Toyfair also served as an IRB member.  Ms. Toyfair is a Certified IRB Professional (CIP) and a Certified IRB Manager (CIM).

Maribel Martinez | Consultant

Maribel has 10 years of experience in Human Subjects Research. She has experience with Biomedical and Social Behavioral Science Research. Her experience includes working with minimal risk and greater than minimal risk IRB submissions. She has worked with institutional leadership to develop institutional policies on Human Subject Protections. Furthermore, Maribel has tested and participated in implementing IRB electronic systems. She is customer oriented and works with IRB staff, IRB leadership, and study personnel to provide an efficient and effective process to study reviews.

Meghan Hammock | Consultant

Prior to my working in the human subject research area, I worked at the University of Texas Medical Branch in Galveston Texas in sponsored programs administration in various capacities.  In 2011, I moved to Austin and began my IRB career at the University of Texas at Austin where I worked for 8 years. After completing training at UT Austin, I was assigned to review exempt studies and, within a short period of time, I was given the responsibility for processing and reviewing all exempt studies at the university from submission through closure.  Then , in addition to being the sole exempt study reviewer, I was assigned pre-review of studies that were submitted for expedited review.  During that time, I also began attending IRB meetings to learn the full board process and assist in taking meeting minutes.   After gaining experience with  review of expedited studies, I was appointed as an IRB member, completed expedited reviews and began processing and pre-reviewing full board studies.  In 2019, after leaving UT Austin, I began working for HRP as temporary staff for several clients performing exempts and expedited reviews.

Contact Us

Address
1981 Marcus Avenue,
Suite 210
Lake Success, New York 11042

Phone: 347-862-9321
Fax: 347-862-9323
info@thehrpconsultinggroup.com

IND Safety Reports and IRBs

HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...