July 30, 2012 | Volume 2, Issue 3Institution BulletinLetter from the CEOThis summer marks the 21st anniversary of Quorum Review IRB.We are proud to have served this industry for over two decades andmarvel at the evolution IRB review has taken in this time. Walt andMarilyn Gearhart, founders of Quorum Review and my parents,believed that an IRB can provide high-quality ethics review and alsoprovide responsive, courteous service to researchers. I feel fortunatethat my family and our company continues to support these valuestoday.“Family businesses are guided by a long-term outlook,” says Mark J. Walter Gearhart, Jim Gearhart, Cami Gearhart, Marilyn GearhartGreen of Seattle University. “Instead of seeking quick money,traditional family businesses seek sustainable, long-lasting businessmodels.” This is certainly our philosophy at Quorum Review, and we begin our third decade with unlimited passion tocontinue our mission to support the ethical protection of research participants and provide exceptional customer service.We continue our commitment to maintaining the highest level of quality and professionalism. Earlier this summerQuorum’s Director of Regulatory Affairs, Linda Coleman, was recognized in the Puget Sound Region as the 2012Outstanding Corporate Counsel at a Small Company. Linda was recognized for her excellent work in building a team ofattorneys and regulatory staff who can effectively support our ethics review in multiple states and countries. I believe thatmuch of our customer satisfaction is due to the fact that our ethics boards render consistent, legally sound decisions – andthis is thanks in large part to the work of Linda and her teams.I am proud of the mission and values of Quorum Review, and I’m pleased we can share these values with you. To help youwith your mission, we have enclosed several articles regarding the ethics review of proposed clinical research. Please contactus if we can be of additional assistance.Sincerely,Cami Gearhart, CEOQuorum Review IRB
July 30, 2012 | Volume 2, Issue 3Chairperson Assessment ServiceDuring the development of a new study, questions or concerns may come up about the proposed study design orconsent process. Quorum Review offers a Chairperson Assessment to discuss such concerns or questions andprovide feedback about proposed studies. This service is offered free of charge to our clients.The Chairperson Assessment is designed to assist researchers, sponsors, orother parties involved with the research to address issues that may come Examples of research issuesup in the context of research and may pose a problem at the time of IRB appropriate for consideration forreview. Chairperson Assessment:Generally, a Chairperson Assessment is most helpful when a sponsor orresearch organization has specific questions about a proposed research Determining whether thestudy prior to the finalization of the study. Quorum requires the control arm is appropriatesubmission of a draft of the protocol or study plan, any supplementary in a given patient populationmaterials (i.e., investigator’s brochures, package inserts, or deviceliterature), and the informed consent. In addition, any specific questions Defining the appropriateshould be sent in advance to allow an opportunity to evaluate the age range of participantsquestions in the context of the proposed research. Developing an adequate description of the risksThe required documents and information should be submitted one week and/or benefits ofin advance of the scheduled Chairperson Assessment teleconference. The participation in the ICFrepresentatives from Quorum will be chosen based on the questions or Forming a uniqueconcerns identified, but generally include the IRB Chairperson or approach to obtaininganother experienced Board member, and a representative from Quorum’s consent, which may involveStudy Services and Regulatory Departments. During the teleconference, waivers or alterations of theQuorum’s Chairperson and members of the Quorum staff will answer consent or HIPAAquestions and provide feedback about the proposed study. authorization requirementsQuorum representatives can provide guidance based on our experienceserving a wide variety of clients across all therapeutic areas. The guidanceand opinions provided through a Chairperson Assessment are reflectiveof the individual Chairperson or Board member and Quorum staffmembers, and may not always represent the opinions of the fullyconvened Board. However, the guidance provided can often expedite thestudy start-up process, particularly if there are questions about whetherthe IRB will find a proposed aspect of the study to be acceptable.If you would like to schedule a Chairperson Assessment, please contact the Initial Study Support Team at:InitialStudySupport@quorumreview.com
July 30, 2012 | Volume 2, Issue 3Training for Principal Investigators and Study StaffA quick internet search will turn up an astonishing number of “hits” for clinical research training. This can bediscouraging when trying to choose appropriate training for Principal Investigators and study staff. It is importantto consider the reason training is required, aside from the obvious benefit of increased knowledge and expertise.HHS RequirementsThe HHS regulations related to protection of human Most granting agencies will specify the trainingsubjects do not require investigators to obtain program that has been designated to meet thetraining in the protection of human subjects in requirements of the grant or contract. Allresearch. However, an institution holding an investigators receiving funding from the NationalOHRP-approved Federal wide Assurance (FWA) is Institutes of Health (NIH) after October 1, 2000, forresponsible for ensuring that its investigators projects involving human subjects, must provide aconducting HHS-conducted or supported human description of education completed in the protectionsubject research understand and act in accordance of human subjects for each individual identified aswith the requirements of the HHS regulations for "key personnel" in the proposed research. 2 “Keythe protection of human subjects. OHRP does personnel” include all individuals who are directlystrongly recommend that institutions and their responsible for the design and conduct of the humandesignated IRBs establish training and oversight subjects part of the research. Although NIH does notmechanisms (appropriate to the nature and volume require a specific course, they do provide an onlineof their research) to ensure that investigators web-based tutorial. 3maintain continuing knowledge of, and comply with,the following: FDA Requirements The Food and Drug Administration (FDA) • relevant ethical principles; requirements related to investigator training and • relevant federal regulations; education are set forth in the FDA Form 1572. This • written IRB procedures; form is signed by the investigator prior to the • OHRP guidance; initiation of any clinical study under FDA • other applicable guidance; jurisdiction. The Form lists the responsibilities of • state and local laws; and the investigator—specifically that the investigator will • Institutional policies for the protection of human be knowledgeable about the conduct of clinical trials subjects. and the sponsor’s expectations as well as the federal expectations pertaining to conducting trials.OHRP explicitly recommends that investigatorscomplete appropriate institutional educationaltraining before conducting human subject research.11 OHRP Frequent Questions, Must investigators obtain training of human 2 NIH Notice OD-00-039.subjects?, available at: http://answers.hhs.gov/ohrp/questions/7224, accessed 3July 6, 2012. See http://phrp.nihtraining.com/users/login.php, accessed July 6, 2012.
July 30, 2012 | Volume 2, Issue 3AAHRPP RequirementsFacilities with accreditation through the Association One well-accepted online program is theof Accreditation of Human Research Protection Collaborative Initiative Training Program (CITI)Programs (AAHRPP) must follow the standards which is a subscription program that individuals andestablished for achieving and maintaining institutions can use to provide training to staff andaccreditation. These standards emphasize investigators. CITI offers a wide range of topics.responsibility on the part of individuals and Categories of staff can be directed to specific topicsinstitutional officials for education, process to fulfill training requirements. Quorum actuallyimprovement and communication that stresses offers the CITI program to its clients free of charge.human subject protection. Specifically, the AAHRPP The NIH and its many institutes also have onlineaccreditation instrument states: “The Organization training programs that are free to the public.has an education program that contributes to theimprovement of the qualifications and expertise of Training programs for corrective action, auditindividuals responsible for protecting the rights and responses and other remedial responseswelfare of research participants.” 1 While most auditors are not permitted to suggest training programs or specific trainers fromInstitutional or Local Requirements companies specializing in education and qualityAcademic institutions may also impose requirements improvement, it is possible to network with otherrelated to training for investigators and staff. Often sites and institutions to obtain recommendationsthese requirements are more specific and may give about companies and independent contractors whoinvestigators and their staff more direction as to what provide such services. Blogs such as the onetypes of training are considered appropriate. Some available as a member of ACRP and Linked Inhave developed programs of their own. interest groups are useful forums for referrals for these types of programs.Training OptionsProfessional associations such as the Association of SummaryClinical Research Professionals (ACRP) offer No matter the reason or motivation for trainingtraining opportunities to investigators, clinical programs at any clinical research site or institution,research coordinators and clinical research monitors. the necessity of such programs is indisputable.Others, such as the Society of Clinical Research Protecting human subjects should be of paramountAssociates (SOCRA) offer training to coordinators concern for anyone involved in research—andand monitors. Both organizations offer certification training of investigators and study staff can be anopportunities. important step in preventing issues or addressing them as they arise.Professional associations for physicians, such as theAmerican Association of Pharmaceutical Scientistsand specialty societies and the American Associationof Psychology provide training and educationopportunities for its membership.1 AAHRPP Standards, Organizations, Element I.1.E.