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Asentral, Inc. IRB is a company answering the rapidly increasing demand for ethical review and oversight of clinical research in the community setting. Until recently such research was regarded as an adjunct to the 'real' research that occurred in the major academic and teaching hospital centers. Today, community based research has eclipsed institutions and hospitals in the progress of medical care with increasing participation by physicians who have chosen to practice in the community setting, with or without an academic affiliation. As with any research, there are unique, growing and ever-changing requirements, setting the stage for rigorous oversight. Asentral, an independent Institutional Review Board, provides such oversight. The primary function of Asentral is to ensure that no research protocol exposes subjects to unwarranted risks. Recognizing that some risk is inevitable, our second function is to assure that the risk is minimized, that any volunteer subject is well informed about the risks, and that the potential benefits, either to the patient or society, outweigh whatever risks may exist. We will also ensure that no volunteer is subjected to undue pressure to participate in any study. Asentral will determine that physicians undertaking research have the requisite credentials and expertise, and that all the data is gathered according to requirements of the research protocols. We will provide ongoing reviews and communication of relevant information between sites.
Because Asentral is affiliated with the Commonwealth of Massachusetts' Department of Public Health, a requirement for reviewing research in Massachusetts, Asentral is able to review studies in all states.
Asentral, Inc. IRB founders Peter Madras and Cynthia Owens, along with CEO Richard Clunie, are members of the Medical Development Group. Dr. Madras, Chairman of the Board at Asentral, Inc. IRB is also the President of the Medical Development Group Board of Directors.
Asentral, Inc. IRB is integrated with the clinical research efforts of Dana Farber Cancer Care Center (DFCCC). DFCCC participates in multiple clinical research studies sponsored by the National Cancer Institute (NCI) and the Pharmaceutical Industry. Asentral, Inc. IRB provides oversight for the majority of DFCCC’s pharmaceutical industry studies and has been designated by the NCI as the local Institutional Review Board for Dana Farber Cancer Care Center, working in collaboration with the NCI's Central Institutional Review Board (CIRB).