The Horizon Health Network became the first health authority in Canada to receive national accreditation of its human research protection program (HRPP) via the Human Research Accreditation Canada (HRA Canada). The HRPP is the system through which all research studies in Horizon are reviewed for methodology, regulatory compliance and approved for ethical conduct by their Research Ethics Board (recognized as a leading practice in 2010).
TrialSite News offers our breakdown of this important news for the research world. Research accreditation represents a timely and important topic.
Who is the Horizon Health Network?
One of two health authorities in the Canadian province of New Brunswick, Horizon Health Network delivers medical care on behalf of the Government of New Brunswick to the central and southern portions of the province through 12 hospitals and 28 health centers/clinics while providing a variety of programs and services. Representing one of the largest employers in New Brunswick, the $1+ billion organization employs about 13,000 staff and 1,000 doctors. With over 100 facilities, clinics and offices the authority also represents a major clinical research presence in this part of Canada.
What is accreditation?
Accreditation offers a form of external review which demonstrates a provider’s processes for research administration and oversight meet all the regulatory requirements, industry standards and best practices for health research involving human participation.
Is Accreditation easy to Achieve?
No. In fact, it represents a lengthy, challenging process that involves first and foremost self-reflection of the leadership and management as well as all groups throughout the health enterprise. The process of accreditation requires the development of new policies and operational procedures but ultimately it serves to improve the quality of the support their office provides to patients, staff and sponsors not to mention more certainty for regulators.
Does it help establish research site competitive differentiation?
Absolutely. The achievement of certain accreditation levels can truly differentiate the provider’s role as a clinical investigational site. Enhancing the confidence of patients and research partners. Accreditation evidences the voluntary effort of subjecting the organization to the goal of meeting rigorous standards which provide the highest level of scientifically and ethnically sound human participant research. Hence raising the bar, a fully accredited site may be more attractive to a major industry sponsor—such as a biopharmaceutical company.
What are some Key value drivers associated with this accreditation?
Well, Horizon Health Network can now ensure their HRPP processes confirm to the normative documents governing the conduct of human participants research. Now this Canadian provider and research site can project the confidence that the research being conducted adheres to the guidelines, laws and regulations governing research involving humans. This makes for overall better research and potentially better outcomes for those living in this provincial region of Canada, e.g. “New Brunswickers.”
Who lead’s Horizon Health Network’s Research efforts?
Barry Strack, Regional Director of Research Services
What is HRA Canada?
An independent, not-for-profit accrediting body for human research in Canada. This organization known as HRA Canada accredits Human Research Protection Programs (HRPPs) on Canadian public and private organizations through a bilingual, voluntary, peer-driven program based on education and excellence. The organization is led by Janice E. Parente while accreditations are driven by Clarissa Fleck.
What are some recent activities of Horizon Health Network?
They are sponsoring an upcoming webinar to co-resent on Horizon’s HRPP and accreditation process to the Canadian Association of Research Administrators (CARA)—the national organization for research administrators in Canada.
Moreover, like research sites worldwide, the Canadian group has pivoted to support a number of COVID-19 based clinical trials. What follows are some example studies centering on COVID-19:
- COVID-19 Global Rheumatology Alliance Protocol
- Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in a New Brunswick, Canada Cohort of Patient (TripleC-NB)
Are there other accreditation bodies relevant to clinical research?
Yes. Probably the most well known is AAHRPP or the Association for the Accreditation of Human Research Programs. Based in Washington DC, AAHRPP accreditation exists to help research sites strengthen protection for research participants. Hundreds of research sites have earned AAHRPP accreditations. There are other specialized or niche accreditations in research.
An interesting and timely new entrant to the field of research site accreditation—one with tremendous potential—SASI or the Site Accreditation and Standards Institute focuses more broadly on underlying research site systems and processes, not to mention culture and leadership, implementing the “SASI-QMS: 2020-1” a Standard for Clinical Research Site Quality Management Systems. Pursuing a “culture of competence and conscience,” this accreditation body seeks a more systemic transformation of research sites to drive improved safety, quality and importantly, productivity. The initiative is led by high-profile biopharma physician turned executive and investor Briggs Morrison quality guru Larry Kennedy and an elite team of research professionals covering disciplines of quality and regulatory, operational efficiency and pharmaceutical drug development.
Call to Action: Are you interested in research site accreditation? If you are in Canada, visit HRA Canada for more information. AAHRPP is the leading site accreditation body centering on human protection. Involved with cell or gene therapies? Check out the Foundation for the Accreditation of Cellular Therapy at the University of Nebraska Medical Center. Seeking a more systemic review of your entire research organization? Join some major academic medical centers doing just that with SASI—see their contact information.Source: Horizon Health Network