WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical solutions for clinical research, announced that its New England Institutional Review Board (IRB) has been reaccredited by the Association for the Accreditation of Human Research Protection Programmes (AAHRPP).
This association serves to protect the rights and welfare of clinical research participants, and also to build public trust and confidence in research.
“At WCG, we endeavour to attain the highest quality and efficiency standards in all our business operations and we have our work reviewed regularly by external experts,” said WCG chairman and chief executive officer Donald A. Deieso, Ph.D.
“As a result, all of our 14 review panels are AAHRPP accredited; our Western IRB and Copernicus Group IRB are the only two IRBs certified to ISO 9001:2008; and we have also achieved Lean Six Sigma certification.”
“New England IRB’s AAHRPP reaccreditation underscores WCG’s commitment to championing scientifically and ethically sound research, safeguarding clinical trial participants, and demonstrating continuous improvement,” said AAHRPP president and chief executive officer Elyse Summers, J.D.
“WCG has always been a strong proponent of the AAHRPP accreditation process and we consider it to be an important validation of the high quality of our clinical reviews,” said WCG chief compliance officer David Forster, JD, MA, CIP.
“In addition to ensuring that all our IRBs are AAHRPP accredited, we also help other institutions to achieve that milestone through our WCG Consulting division.”
Founded in 1988, New England IRB is one of the original independent IRBs established to meet the review needs of sponsors, contract research organisations, and investigators across the United States. First accredited by AAHRPP in 2003, New England IRB was among the first cohort of central IRBs to achieve AAHRPP accreditation.
AAHRPP accreditation is an intensive process. AAHRPP reviews an IRB’s records, policies, procedures and other materials. It also performs an on-site inspection of the organisation’s minutes, sample protocols and consent forms, and conducts employee interviews. In addition, AAHRPP requires the IRB to demonstrate an ongoing commitment to process improvement. AAHRPP accreditation has to be renewed after three years the first time and then every five years after that.
New England IRB provides high-quality, full-service, independent ethical review services to New England’s fast-growing biopharmaceutical industry, which now accounts for more than 10 per cent of the U.S. drug development pipeline.