January 29, 2013 | Volume 3, Issue 1Institution BulletinLetter from the CEODid you have an opportunity to attend the Decem...
January 29, 2013 | Volume 3, Issue 1FDA’s Draft Guidance for IRBs, Clinical Investigators,and SponsorsThe FDA announced th...
January 29, 2013 | Volume 3, Issue 1Finally, FDA recommends that IRBs routinely review        Research Studies Can be Cond...
January 29, 2013 | Volume 3, Issue 1Screening Subjects: To Consent or Not?Quorum frequently receives questions from       ...
January 29, 2013 | Volume 3, Issue 1statement that is read to subjects over the phone,            •    How paper copies/re...
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Quorum Review Institution Bulletin v3, iss1

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Quorum Review's Institution Bulletin includes Letter from CEO, Cami Gearhart, JD, on Tuskegee Syphilis Experiment as a leading key component of today's subject protection requirements, as well as Quorum's insights on two recent FDA draft guidances: The first addresses specific IRB responsibilities and explains how an IRB may efficiently fulfill them and the second explains that researchers must obtain informed consent before initiating clinical screening for eligibility.

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Quorum Review Institution Bulletin v3, iss1

  1. 1. January 29, 2013 | Volume 3, Issue 1Institution BulletinLetter from the CEODid you have an opportunity to attend the December PRIM&R meeting inSan Diego? If so, I hope you saw the exhibit on the Tuskegee SyphilisExperiment by photographer Tony Hooker. The exhibit featured historicphotographic images superimposed on contemporary images, as well aspersonal quotes from individuals involved in the study.The haunting images of the exhibit made me think of ghosts – the ghosts ofthe individuals who died and suffered during the trial before it was exposedby a whistleblower. It is believed that of the 400 African-American men whostarted the study, 28 died directly of syphilis, 100 died of relatedcomplications, 40 wives were infected and 19 children were born with CEO Cami Gearhart , JDcongenital syphilis.The abuses of that trial prompted regulatory action and led to the key components of today’s subject protectionrequirements, including review by an independent committee, informed consent, and regular continuing reviewof the merit of the study. It’s vital that those of us involved in the research enterprise revisit Tuskegee regularly toremember the importance of the protections of ethics review.As the research enterprise has grown and become more complex, so have the requirements and obligations for ahuman research protection program. Enclosed are two articles to assist your institution in its mission to protectresearch participants. One article describes the use of screening consent and the other summarizes recent FDAdraft guidance on IRB review responsibilities.Quorum Review is honored to have the privilege to work with you and your institution research teams. Please letus know if we can be of further assistance.Sincerely,Cami Gearhart, CEOQuorum Review IRB
  2. 2. January 29, 2013 | Volume 3, Issue 1FDA’s Draft Guidance for IRBs, Clinical Investigators,and SponsorsThe FDA announced the availability of a new draft guidance explains that when an IRB has previousguidance entitled Guidance for IRBs, Clinical experience with an investigator or institution, it mayInvestigators, and Sponsors: IRB Responsibilities for easily determine the investigator is appropriatelyReviewing the Qualifications of Investigators, Adequacy of qualified and the site is suitable for the research.Research Sites, and the Determination of Whether anIND/IDE is Needed.i The draft guidance addresses With respect to investigators, the draft guidancespecific IRB responsibilities and explains how an suggests that the IRB could rely on documentationIRB may efficiently fulfill them. or a statement from an office at an institution regarding the qualifications of a particularIRB Review of Qualifications of Clinical investigator. It is suggested that review ofInvestigators and Adequacy of Site information such as the curriculum vitae of the investigator andThe draft guidance discusses review of an research staff andinvestigator’s qualifications and the research site verification ofunder two complementary regulatory provisions. professional association and • First, the IRB is obligated to “ascertain the medical licensure acceptability of the proposed research in may only be terms of institutional commitments and necessary when regulations, applicable law, and standards of the IRB has no professional conduct and practice.” 1 knowledge of the • Second, the IRB is required to find that risks investigator or to subjects are minimized and reasonable in the institution. relation to anticipated benefits, if any, to subjects. 2 The FDA did identify threeThe FDA indicates that the IRB should consider the possible scenariosnature and risks of the proposed research as well as that warrant additional attention from the IRB whenthe relationship with the investigator or institution determining whether an investigator is appropriatelywhere the research will be conducted when qualified:evaluating investigator qualifications and theadequacy of a proposed research site. The draft 1. Sponsor-investigator studies 2. A study outside the investigator’s area of expertisei Available at: www.regulations.gov/#!documentDetail;D=FDA-2012-D-0847-0001. 3. Any study design features or other1 characteristic(s) that may significantly 21 CFR 56.107(a).2 increase potential risk to subjects 21 CFR 56.111.
  3. 3. January 29, 2013 | Volume 3, Issue 1Finally, FDA recommends that IRBs routinely review Research Studies Can be Conducted Without an IND 1,lists on FDA-hosted websites for investigators that which when finalized will represent FDA’s currenthave been the subject of investigations and warning thinking on this topic. Similarly, with device studies,letters, investigators that have been notified of the IRB must review studies that do not have an IDEinitiation of a disqualification proceeding, and also to determine whether they are appropriatelydisqualified investigators. categorized as non-significant risk or exempt by a sponsor. The draft guidance indicates that the FDAWith respect to evaluation of the site, FDA suggests is available to assist sponsors, investigators and IRBsthat the IRB could simply note that a particular in making NSR or SR determinations, and suggestsinstitution has adequate resources such as emergency review of the guidance Procedures for Handlingor specialized care, rather than requiring the Inquiries Regarding the Need for an Investigational Deviceinvestigator to provide an explanation of such Exemptions Application for Research Involving Medicalresources if the facility were part of a major medical Devices 2 for information on how to requestinstitution. The draft guidance indicates that a assistance.statement from an appropriate person at a researchsite stating the facilities are adequate could be used The draft guidance proposes some flexibility for IRBsin lieu of a statement from an investigator describing in evaluating investigators and proposed researchthe facility, staffing and resources where the research sites in circumstances where the IRB is familiar withwill take place. the institution and/or investigator and the nature of the study does not warrant additional scrutiny. As toIRB Determination of Necessity of an the IRB determination of necessity of an IND orIND or IDE IDE, the FDA re-iterates the IRB’s responsibility ofThe draft guidance indicates that IRBs should evaluating a sponsor’s determination as to whetherevaluate the sponsor’s explanation if they have the IND or IDE regulations apply to a particulardetermined that an IND or IDE is not necessary for study. The draft guidance indicates that FDA expectsa particular study. If the IRB questions whether an the IRB to obtain and evaluate an explanation as toIND is necessary and the explanation is not why the sponsor would not seek an IND or IDE for satisfactory, the research involving FDA-regulated products. IRB should delay Comments on the draft guidance were due January 22, 2013. approval of the To see the proposed draft Guidance, please visit study until the www.regulations.gov. matter is resolved. The draft guidance suggests reviewing another guidance: 1 Available at: Draft Guidance for http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryI nformation/Guidances/UCM229175.pdf . Industry: 2 Available at: Investigational New http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Gui Drug Applications danceDocuments/ucm126598.htm. (INDs) –Determining Whether Human
  4. 4. January 29, 2013 | Volume 3, Issue 1Screening Subjects: To Consent or Not?Quorum frequently receives questions from A common scenario, as part of screening for ainvestigators and study staff about whether a consent clinical trial, is an individual patient being asked toform is necessary for the screening process for a fast prior to coming in for a visit. If that individualgiven study. The FDA has issued guidance on this would not otherwise be asked to fast for their clinicquestion, indicating that informed consent must be visit, they should be consented before they are askedobtained prior to initiation of any clinical to fast. This request may occur over the phone, andprocedures that are performed solely for the purpose therefore the researcher is not able to obtain a signedof determining eligibility for research.1 consent form prior to requesting that the patient be fasting when they come in for their next visit.The FDA provides some examples of “procedures”that could be performed solely for the purpose of In this scenario,determining research eligibility, such as: withdrawal the researcherfrom medication (or wash-out) and diagnosis or can request thattreatment of a disease or medical condition. the IRB waive the requirementBecause clinical screening procedures for research for a signedeligibility are considered part of the subject selection consent form.and recruitment process, the FDA indicates they This is alsorequire IRB oversight, and recommends that the IRB known as areceive the following information regarding the “waiver of documentation of consent.” The criteriascreening process that will be conducted by an that must be met in order to waive documentation ofinvestigator: consent are defined in the FDA and HHS regulations as follows:  An outline of the screening procedure to be followed “The IRB may, for some or all subjects, waive the requirement [of a] sign[ed] written consent form if it  A description of how consent for screening finds that the research presents no more than will be obtained minimal risk of harm to subjects and involves no  A screening consent form including a brief procedures for which written consent is normally summary description of the study in which required outside of the research context.”3 they may be asked to participate OR request for a waiver of consent for the screening Although a screening procedure or processes may procedures (if appropriate)21 qualify for a waiver of documentation of consent, the IRB can still require that the investigator provide individuals with a written statement regarding the research. In the case of a phone-based consent1 FDA Information Sheet, Screening Tests Prior to Study Enrollment, availableat: process for screening procedures this may be ahttp://www.fda.gov/RegulatoryInformation/Guidances/ucm126430.htm ,accessed 12/26/2012.2 3 Id. 45 CFR 46.117(c)(2); 21 CFR 56.109(c)(1).
  5. 5. January 29, 2013 | Volume 3, Issue 1statement that is read to subjects over the phone, • How paper copies/records related to theoften described as a “screening” or “receptionist” screening are handled (shredded, readable copiesscript. Typically, the IRB would require the elements put out as trash)1of consent to be covered in this statement. Generally, Quorum would recommend sites developThe FDA has also provided guidance covering a standard operating procedure (SOP) or other policyoversight of the use of such scripts. Specifically, the document describing the use of screening scripts andFDA has identified several issues that are appropriate addressing the points of concern outlined by FDAfor an IRB to consider when evaluating the use of a when a screening script is used.script for screening purposes: • A description of what happens to personal 1 information if the caller ends the interview or FDA Information Sheet, Recruiting Study Subjects, available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.ht simply hangs up m, accessed 12/26/2012. • Whether the data is gathered by a marketing company • How the data will be used, if it is sold, etc. • Whether names of non-eligible individuals are maintained in case they would qualify for Contact Quorum Review another study Interested in learning more about Quorum Review? Our Institutional Team is ready to answer your inquiries regarding your organization’s specific“ Although a screening institutional IRB needs. Nancy Jane Earnhardt procedure or processes Institutional Specialist may qualify for a waiver nearnhardt@quorumreview.com T | 919-930-5198 of documentation of The Institution Bulletin is a special publication of consent, the IRB can the Quorum Forum, and brought to you by the still require that the Institution Team at Quorum Review IRB. investigator provide individuals with a written statement regarding the research.”

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