October 18, 2012 | Volume 2, Issue 4Institution BulletinLetter from the CEOThis month, two researchers were honored for basic research conductedin academic settings. The Nobel Assembly awarded the 2012 Nobel Prizein Physiology or Medicine to John B. Gurdon and Shinya Yamanaka,investigators who discovered a way to develop stem cells from adult skincells—thus removing the need to use and destroy human embryos.The work of these two scientists illustrates the importance of basicresearch conducted every day in institutions across the country. In 1962,Dr. Gurdon’s work was revolutionary in opening the door to cloning.When coupled with the work of Dr. Yamanaka and other scientists, hiswork now may pave the way for radical advances in medicine that allowdamaged or diseased tissues to be regenerated in the lab - or even inside CEO Cami Gearhart , JDpatients bodies.Here at Quorum Review, we are privileged to review clinical research made possible by the tenacity and ingenuityof researchers in hospitals and universities across the country. When an institution is ready to use a central IRB,we are committed to supporting the organization with a high quality review and strong staff support. Today’snewsletter delves more deeply into how to work with Quorum Review, from waiving jurisdiction to developing aconsent form. We look forward to an opportunity to work with you.Sincerely,Cami Gearhart, CEOQuorum Review IRB
October 18, 2012 | Volume 2, Issue 4Quorum Services: Custom Consent Form ServiceQuorum Review offers a Custom Consent Form service to clients who would prefer to have Quorum develop theconsent document. Quorum draws on the combined expertise of legal, medical, and consent form developmentstaff to produce the consent forms needed for a given study.When clients elect to use the Custom Consent Form service, they canexpect consent documents to include: An accurate summary of relevant information about the presented in language that is understandable to the lay reader Elements required by Quorum Review standards, which include regulations in the United States and Canada, and relevant U.S. state and Canadian provincial law HIPAA statements for U.S. consent forms and PIPEDA statements for Canadian consents Quorum Review’s preferred style and standardsIn general, documents produced through the Custom Consent Form service will be based on Quorum Review’sinternal consent form templates. These templates can be modified to be appropriate for a wide variety of researchstudies. In addition, upon request, the documents can incorporate relevant client template language betweenQuorum Review and the client.The time needed to create consent documents depends on the complexity of the study and the number of consentforms that may be required. In general, most Custom Consent Form service requests can be fulfilled within fourto seven business days after the request submitted to Quorum. Upon receipt of a Custom Consent Form servicerequest, clients will be provided with a quote containing estimated costs and delivery times for the client’s reviewand approval.Clients will be asked to provide some information with a Custom Consent Form service request, including: Descriptions of the risks of study-related products, including the study drug or device, rescue medications, prophylactic drugs, and other products specifically indicated in the protocol Risks of protocol procedures Alternative treatments The plan for compensating subjects in the event of illness or injuryIf a client is not able to provide the information described above, this may extend the time needed to create theconsent documents and additional development charges may be incurred.
October 18, 2012 | Volume 2, Issue 4Waiving Jurisdiction to Another IRBFor various reasons, a hospital, academic medical center, or other research organization may need to waiverjurisdiction to an outside IRB. Institutions with a Federal Wide Assurances (FWA) from the Office of HumanResearch Protections (OHRP) must ensure that the arrangements made with the outside IRB are documented in awritten agreement between the institution and the IRB if the research is covered by the FWA1. Although thisagreement is only required for research covered by an FWA, it is a best practice to ensure that arrangements forIRB review of a study by an outside IRB are always documented in writing, regardless of whether the researchwould fall under an institution’s FWA. The agreement should cover the following points: Outline the relationship between the Institution and the organization or institution operating the IRB Include a commitment that the IRB will adhere to the requirements of the institution’s FWA.OHRP provides a sample authorization agreement that includes the required language but Institutions may havegood reason to expand upon this language and develop their own agreement. The agreement must be kept on fileby both organizations and must be made available to OHRP or any U.S. federal department or agency conductingor supporting research covered by the FWA upon request. If an institution will rely on multiple external IRBs, theinstitution must ensure that its FWA designates the external IRB that reviews the largest percentage of theresearch covered by the FWA. The institution should also ensure that any IRB that will be reviewing researchcovered by their FWA is registered with OHRP2.Quorum Review solicits information with each new study submission to determine whether the investigator isaffiliated with an institution that has jurisdiction over the study. If so, the investigator is instructed to obtainpermission from the institution to rely on Quorum Review as the IRB for the study. It is important to note thatinstitutions must still authorize the jurisdiction to an outside IRB even if the institution does not maintain itsown internal IRB. An institution can waive jurisdiction to an outside IRB for a single study or multiple studies.Quorum Review has an Institutional Jurisdiction Waiver Form and Institutional Authorization Agreement (IAA)that can be used by institutions waiving to jurisdiction to Quorum. Quorum will also accept the templateauthorization agreement developed by OHRP.1 Assurance Process - FAQs, U.S. Department of Health & Human Services, Office of Human Research Protections, available at:http://answers.hhs.gov/ohrp/categories/1563, accessed 09/25/2012.2 2 Id.