About HRP Consulting

HRP Consulting Group (HRP) has been in the business of research ethics and compliance for over 10 years.

 

With over 100 combined years of hands-on experience as HRPP, IRB and Research Compliance professionals, federal regulators and AAHRPP representatives, we use our experience to provide expert support to research professionals throughout the world. In addition to our in-house expertise, HRP has developed a network of highly experienced associates who can be called upon when assisting clients.

 

Relationships are the core of our business. We take a personalized hands on approach to develop customized solutions to the challenges you face. HRP prides itself on being there for you as an ongoing source of support.

 

Cheryl Savini, CIP | Senior Vice President / Managing Director

Cheryl SaviniAs Senior Vice President of HRP Consulting Group, Ms. Savini has over 25 years’ experience in human research protections, in both the biomedical and social and behavioral fields.

Serving both the civilian and military arenas, Ms. Savini’s experience ranges from IRB administration and policy development to program oversight and monitoring.

She has held positions of Acting Research Compliance Officer at the University at Albany for both human research protections and the animal welfare programs; Director, Human Subjects Research Office at the University of Miami; and Quality Assurance Manager for the Human Subjects Research Office for the U.S. Department of the Navy.

In addition, Ms. Savini has worked for an independent IRB and medical academic institutions, and has served as an IRB member. She has been a member of the nationally and internationally acclaimed Collaborative Institutional Training Initiative (CITI) web-based training program since 2002, serving on the social and behavioral developers, editors, and contributors groups.

Ms. Savini is a Certified IRB Professional (CIP) and has 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, CCRP | Associate Vice President
Karen ChristiansonMs. 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 mix 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 quality assurance/improvement program, training and on-going education programs, and building the foundation for 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 evaluation and enhancement, process evaluation and enhancement, accreditation support, policy development, training, and management of compliance issues.

Christina Palleschi, MA | Director of Operations / Consultant Assistant
Jeffrey M. Cohen, Ph.D. | Senior Advisor

As Senior Advisor of HRP Consulting Group, Dr. Cohen has over 35 years’ experience in human research protections. Dr. Cohen was also the founder of HRP Associates in 2005.

For 20 years, Dr. Cohen served in the Office for Research at the University at Albany, State University of New York as the Associate Director for Research Compliance and Information Management. In this role, Dr. Cohen was responsible for the administration of the Institutional Review Board (IRB) as well as the Institutional Animal Care and Use Committee (IACUC).

He then served as Director, Division of Education and Development in the Office for Human Research Protections (OHRP) in the US Department of Health and Human Services for four years. Following his service at OHRP, Dr. Cohen served as Associate Dean, Responsible Conduct of Research at Weill Medical College of Cornell University. Since leaving Cornell, Dr. Cohen has been an independent consultant.

Dr. Cohen has been an active contributor to national discussions of human subjects issues since 1979, is a highly visible participant at national meetings such as those sponsored by PRIM&R (Public Responsibility in Medicine and Research) and is past president of ARENA (The Applied Research Ethics National Association).

Dr. Cohen is a Certified IRB Professional (CIP) and in 2009 won the prestigious ARENA Legacy award for his contribution to human research protections.

Gary L. Chadwick, PharmD, MPH, CIP | Senior Consultant

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. He also serves 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.

Mary Adams, MTS | Consultant

Mary AdamsMs. Adams has worked in the field of human research protection for over 25 years. Her experience encompasses both biomedical and behavioral research.

For 12 years Ms. Adams served as the director of the IRB at the University of Rochester, where she was responsible for developing and implementing policy and procedures to ensure compliance with federal and state research regulations and to achieve AAHRPP accreditation. She has conducted audits of human research protection programs for private hospitals, university medical centers, and the Department of the Navy.

Ms. Adams has both published and presented on various topics in human research protections. She has been a speaker at both PRIM&R and the Society of Research Administrators International and is the former Chair of the Manuscript Editorial Board for SRA’s Journal of Research Administration.

Eric Allen, MLS, CIP, CPIA | Consultant

As a Consultant with HRP Consulting Group, Mr. Allen has more than a decade of successful experience in human research protections and research ethics.

In his previous position as the Director for the Office of Research Compliance at the University of North Carolina at Greensboro, Mr. Allen served in many capacities including but not limited to serving as the Research Integrity Officer (RIO), Institutional Official designee, overseeing seeing the IRB, IACUC, IBC, and developing education programs for the campus community for all respective committees. He also created a training curriculum to satisfy both NIH and NSF Responsible Conduct of Research requirements.

Prior to his position at the University of North Carolina at Greensboro, Mr. Allen served as a Research Associate at North Carolina A&T State University. In this role, he developed a compliance program inclusive of Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC) and also managed the pre- and post- award process for various federal agencies.

Mr. Allen is active with PRIM&R (Public Responsibility in Medicine and Research) as a conference presenter, mentor, and member of the Diversity Task Force. He is a Certified IRB Professional (CIP) and Certified Professional IACUC Administrator (CPIA). He combines his professional experience with Bachelor’s Degree in Exercise and Sports Science from Greensboro College and holds a Master’s degree in Liberal Studies from the University of North Carolina at Greensboro.

Lisandra González, MPH, CIP, CCRP | Consultant

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 KennedyMs. Kennedy has over fourteen years of experience managing human subject protection programs and overseeing IRB operations. Starting as a Research Associate at the University of Miami, Ms. Kennedy managed NIH-funded studies involving pregnant women and premature infants. Interactions with the IRB spurred an interest in joining the University of Miami Human Subject Research Office, first as an IRB Administrator for both a medical and social science IRBs and then as the Director of Regulatory Affairs and Educational Initiatives. In addition, Ms. Kennedy was responsible for special projects in the Office of Research targeting the long-term improvement of the University’s research-related activities. She also served as the Institutional Biosafety Committee Administrator.

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.

Joyce Plaza, MBE, CIP | Consultant

Joyce PlazaJoyce Plaza has worked in the field of bioethics and human research protections for over 14 years. She has over 35 years’ experience teaching various subjects from high school students to graduate and medical school students.

For nine years, Joyce served as the Manager of the Morningside campus Human Research Protection Office (HRPO) at Columbia University. This included managing the IRB and administrative staff. She was responsible for developing and implementing the Morningside campus HRPO education for faculty and students. Joyce worked closely with social science researchers, both faculty and student, across various departments; and also served on the Policy and Education committees of the Columbia HRPO.

Ms. Plaza holds a Master of Bioethics degree from the University of Pennsylvania and is a Certified IRB Professional (CIP). She has served on a National Institute of Drug Addiction (NIDA) DSMB, and as an unaffiliated member of The Center for Addiction and Substance Abuse (CASA) IRB and Good Samaritan Hospital IRB, Phoenix, AZ.

Daniel Voss, JD, CIP | Consultant

Daniel VossMr. Voss has over ten years of experience in human subject research compliance in behavioral and biomedical research protection programs.

Previously, Mr. Voss supported the social and behavioral IRB at the University of Missouri in Columbia, Missouri. He then served as the Assistant Director of the HRPP at the University of Kansas Medical Center for almost ten years.

Mr. Voss holds the CIP designation, has experience with AAHRPP accreditation and has also previously served on the Council for Certification of IRB Professionals. He earned his Bachelor’s degree in Physics from Southern Illinois University at Edwardsville, and earned both a Master’s degree in Physics and Juris Doctorate from the University of Missouri-Columbia.

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Address
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Phone: 347-862-9321
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info@thehrpconsultinggroup.com