May 2, 2011 | Volume 1, Issue 1The Quorum Review: Institutional EditionLetter from the CEOWelcome to the first issue of Quorum Review’s Institutional Newsletter!Quorum works with over two hundred institutions, and we know thatinstitutions have special needs and interests in ethics oversight. Thisnewsletter is intended to help you – our institutional clients – feel betterprepared to deal with the day-to-day challenges of research ethics.In today’s research environment, more and more sponsoringorganizations are seeking to place their studies in institutional settings.At the same time, pressure is building to centralize the ethics oversight ofmulti-site studies. Here at Quorum, we realize that local review isimportant in many situations. When an institution is ready to use acentral IRB, however, we are committed to supporting the institutionwith a high quality review and strong staff support.We are honored to have the privilege to work with you and otherinstitutions to provide ethics review of important research. Today’snewsletter will delve more deeply into recent FDA guidance as well as theimportance of specialty expertise to an ethics board. Welcome to theworld of Quorum Review!Sincerely,CamiCami Gearhart, CEOQuorum Review IRB
May 2, 2011 | Volume 1, Issue 1Tackling the Issue of Expertise: documents with the keen eye of an expert in the field who is current with the standard of careQuorum’s Use of Medical within their given area, but also with knowledgeConsultants to Assist with the of human subject protection. The job of Quorums consultants is two-fold. First, theyReview of Research review research to determine whether in their opinion the researchs risk to benefit ratio isQuorum reviews a diverse range of drug, device, acceptable. This is accomplished throughand biologics research. One of the questions considering the science and procedures involvedfrequently asked of our staff is "how does Quorum and considering human subject protection issues.address the need for medical expertise across such Second, they review and present the research toa vast and diverse expanse of therapeutic areas?" Quorums Board members in a manner thatTo ensure thorough, accurate, and efficient ethics members can understand, so that each member isreview of an ever expanding range of study able to formulate their own decision on whetherproducts, Quorum utilizes medical consultants. to approve the research.These consultants are a compliment to Quorumsknowledgeable Board members and IRB Consistent with the regulations, Quorumsinfrastructure keeping Quorum a leader in the medical consultants do not vote. Instead,IRB field. Due to Quorums use of consultants, a Quorums Board members vote after consideringresearcher is able to submit a study in virtually any the consultants presentation of the research andtherapeutic area and be assured that it will be their own independent examination of thereviewed with expertise. research. Independently, Quorums Board members are experts themselves in various fieldsConsultants are expressly permitted, if not and experienced in human subject protectionadvised, in applicable federal regulations. These review. Due to the composition of Quorumsregulations exist because the federal government Board members, consultants are not alwaysunderstood that IRBs could not maintain a Board necessary and are used only when additionalcomprised of members knowledgeable about every expertise is needed.possible type of research. At Quorum, medicalconsultants provide that additional expertise When necessary, Quorums use of medicalnecessary to permit the Board to review all types consultants combined with its Board membersof research in a manner that protects the human ensures the right combination of expertise able toresearch subject. produce a thorough, accurate, and efficient review of research. Such research that is crucial to theQuorums medical consultants have expertise in development of a diverse range of products criticalfields ranging from cardiology to oncology. These to improving health care.consultants review research protocols and related
May 2, 2011 | Volume 1, Issue 1Regulatory Recap: Changes to to the databank. Quorum intends to apply this change to new consent forms by the effective dateU.S. FDA Regulations of March 7, 2011. Although it is not required byRegarding Consent the FDA or Quorum, clients that request an update to existing consent forms to include theOn January 4, 2011, the Food and Drug statement may submit a request to their StudyAdministration (FDA) published a rule revising Manager. It is important to note a few thingsthe current informed consent regulations to regarding this change.include a new requirement for informed consentdocuments and processes. This rule applies to The exact statement must be included. While the other elements of consent included in the FDAspecified drug and device trials and requires the regulations allow the sponsor, site, and IRB flexibilityinclusion of a statement indicating that to craft language to address each required element,information from the trial will be included in a this requirement does not. The FDA clearly statesdatabank. The databank is maintained by the that the exact statement quoted above must beNational Institutes of Health/National Library of included in consent forms and that processes must beMedicine (NIH/NLM). Submission of in place to ensure compliance with the newinformation to the databank is required by U.S. requirement.law for specified drug and device trials. The new This requirement only applies to some types ofrequired statement will be found in a new studies. The requirement only applies to anparagraph of the FDA regulations at 21 CFR § "applicable clinical trial" as defined in FDAAA, 4250.25(c). The effective date of this rule is March 7, U.S.C. 282(j)(I)(A), section 402(j)(I(A) of the PHS2011, and the compliance date is one year after Act, and any relevant regulation. Quorum will rely onthe effective date, on March 7, 2012. The required the sponsor to make an assessment of whether astatement is: clinical trial is "an applicable trial" and therefore whether this statement is required.A description of this clinical trial will be available on This requirement will only be applied to newhttp://www.ClinicalTrials.gov, as required by U.S. Law. studies. It only applies to clinical trials that areThis Web site will not include information that can initiated on or after the compliance date of March 7,identify you. At most, the Web site will include a summary 2012. Quorum is proactively updating its proceduresof the results. You can search this Web site at any time. to include the statement by the effective date to ensure compliance by the required date.In response to this regulatory change, Quorum This change will not require re-consent ofReview IRB (Quorum) is updating consent form participants. The FDA indicated that re-consent,templates and procedures to ensure that this based solely on the new requirement, of clinical trialrequired statement is included in consent forms participants in clinical investigations that werefor drug and device trials that must provide data initiated before the compliance date will not be required.
May 2, 2011 | Volume 1, Issue 1A Warm WelcomeQuorum extends a warm welcome to the 19 research Forsyth Memorial Hospital, Inc.,organizations, academic medical centers, hospitals, Winston-Salem, NCand universities that added Quorum to their Federal Affiliated Clinical Research, Inc.,Wide Assurances in the first quarter of 2011: Las Vegas, NV The Christ Hospital, Cincinnati, OH NDI Medical, LLC, Cleveland, OH Sanford, Sioux Falls, SD St. Francis Hospital & Health Centers, Diex Research Sherbrooke Inc., Beech Grove, IN Sherbrooke, QC, Canada Community AIDS Resource DBA Cardiology Associates of Mobile, Inc., Care Resource, Miami, FL Mobile, AL Public Hospital District No. 1 King Co, Bon Secours Richmond Health System, Renton, WA Richmond, VA Froedtert Physician Partners, Inc., Main Line Hospitals, Wynnewood, PA Menomonee Falls, WI Medica Research Foundation (d/b/a Medical Central Utah Clinic, Provo, UT Research Institute), Minnetonka, MN Sentara Leigh Hosp, Norfolk, VA Planned Parenthood League of Sentara Bayside Hosp, Virginia Beach, VA Massachusetts, Boston, MA West Coast Clinical Trials, Cypress, CA