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Tackling The Issue of Expertise:
Quorum's Use of Medical Consultants to Assist with the Review of Research

Quorum reviews a diverse range of drug, device, and biologics research. One of the questions frequently asked of our staff is "how does Quorum address the need for medical expertise across such a vast and diverse expanse of therapeutic areas?" To ensure thorough, accurate, and efficient ethics review of an ever expanding range of study products, Quorum utilizes medical consultants. These consultants are a compliment to Quorum's knowledgeable Board members and IRB infrastructure keeping Quorum a leader in the IRB field. Due to Quorum's use of consultants, a researcher is able to submit a study in virtually any therapeutic area and be assured that it will be reviewed with expertise.

Consultants are expressly permitted, if not advised, in applicable federal regulations. These regulations exist because the federal government understood that IRBs could not maintain a Board comprised of members knowledgeable about every possible type of research. At Quorum, medical consultants provide that additional expertise necessary to permit the Board to review all types of research in a manner that protects the human research subject.

Quorum's medical consultants have expertise in fields ranging from cardiology to oncology. These consultants review research protocols and related documents with the keen eye of an expert in the field who is current with the standard of care within their given area, but also with knowledge of human subject protection. The job of Quorum's consultants is two-fold. First, they review research to determine whether in their opinion the research's risk to benefit ratio is acceptable. This is accomplished through considering the science and procedures involved and considering human subject protection issues. Second, they review and present the research to Quorum's Board members in a manner that members can understand, so that each member is able to formulate their own decision on whether to approve the research.

Consistent with the regulations, Quorum's medical consultants do not vote. Instead, Quorum's Board members vote after considering the consultant's presentation of the research and their own independent examination of the research. Independently, Quorum's Board members are experts themselves in various fields and experienced in human subject protection review. Due to the composition of Quorum's Board members, consultants are not always necessary and are used only when additional expertise is needed.

When necessary, Quorum's use of medical consultants combined with its Board members ensures the right combination of expertise able to produce a thorough, accurate, and efficient review of research. Such research that is crucial to the development of a diverse range of products critical to improving health care.