Institution Newsletter Volume 2, Issue 1

The Quorum Review: Institutional EditionLetter from the CEOHow can we help each research site initiate clinical trials as effectively aspossible? A recent article by researchers at Duke University1 concludes thatU.S. researchers face impediments from many sources, including:  Aging regulations  Broad risk management by trial sponsors  Layers of oversight by institutions  Health system incentives that do not favor researchThe researchers describe the current clinical trials process as “unsustainablyburdensome, threatening to deprive patients and health-care providers ofnew therapies and new evidence to guide the use of existing treatments.”As this article makes clear, there is no easy fix to streamline the clinicaltrials process. Even so, here at Quorum Review we will continue to do oursmall part – to provide ethics review carefully, promptly, accurately andcourteously.To help you with your mission, we’ve enclosed several articles regarding theethics review of proposed clinical research. Please contact us if we can be of additional assistance.Sincerely,Cami Gearhart, CEOQuorum Review IRB1 Kramer, Smith & Califf, Impediments to Clinical Research in the United States, Clinical Pharmacology & Therapeutics (February 2012), http://www.nature.com/clpt/journal/v91/n3/full/clpt2011341a.html

February 24, 2012 | Volume 2, Issue 1New Draft Guidance on “Exculpatory Language” from FDA and OHRPOn August 19, 2011, OHRP and FDA issued a joint Draft Guidance document: “Guidance on Exculpatory Language inInformed Consent.” When finalized, the Guidance will replace guidance on this topic from both OHRP2 and FDA3.The Draft Guidance provides an updated interpretation of the regulatory restriction on “exculpatory language” in informedconsent documents.4 The Draft Guidance specifically addresses the issue of a subject’s rights with respect to a biospecimenprovided for research purposes, stating: “a subject’s waiver of any rights…with respect to a biospecimen…would not beexculpatory.” This conclusion is based on two factors: (1) the practice of not compensating research subjects who providebiospecimens for research purposes, and (2) the absence of federal or state laws or policies that recognize a legal right tocompensation if a subject has voluntarily signed an informed consent form stating they would not be paid for biospecimens.The position is a departure from previous guidance documents, which will be replaced when this Draft Guidance isfinalized. The 1998 Frequently Asked Questions Guidance from FDA advised that it was acceptable “for [a] consent to saythat specimens are to be used for research purposes” but not to say that they were donated because “the word ‘donation’implies abandonment of rights to the property [and] 21 CFR 50.20 prohibits requiring subjects to waive or appear to waiveany rights as a condition for participation in the study.”5 The 1996 Guidance from OHRP took the same position withrespect to sample ownership, providing the following examples of “exculpatory” language:  By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances.  I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items.  By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.6In contrast with the position taken in the previous guidance documents, the Draft Guidance provides several examples of“acceptable language” as follows:  By agreeing to this use, you are giving up all claims to any money obtained by the researchers from commercial or other use of these specimens.  I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name of research institution] and hereby relinquish all property rights, title, and interest I may have in those samples.  By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples collected during this research.7Quorum Review’s practice, based on the existing guidance, has been to modify language that explicitly or implicitlyindicated subjects were “donating” samples or otherwise giving up ownership rights with respect to samples. Given theupdated interpretation of “exculpatory language”, Quorum Review anticipates making a change to our policies. QuorumReview will not make a formal change until the Final Guidance is issued; however, please feel free to contact us withquestions about consent language addressing sample ownership in the interim. Questions can be addressed to your studymanager or sent to our Site Support Team at sitesupport@quorumreview.com.2 Exculpatory Language in Informed Consent, OHRP (November 15, 1996).3 Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998).4 45 CFR 45.116 and 21 CFR 50.20 state: “No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear towaive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.”5 Question 52, Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, FDA (1998).6 Exculpatory Language in Informed Consent, OHRP (November 15, 1996).7 Draft Guidance, Guidance on Exculpatory Language in Informed Consent, DHHS (August 19, 2011).

February 24, 2012 | Volume 2, Issue 1  method for maintenance of confidentiality of dataThe Importance of Addressing Local  language(s) understood by prospective subjectsResearch Context  method for minimizing the possibility of coercion or undue influence in seeking consent, and,  safeguards to protect the rights and welfare of vulnerableAn important consideration for the IRB is commonly subjects10referred to as the “local research context.” Local research The OHRP memorandum includes a number of methodscontext may include community attitudes towards research, by which an IRB may obtain necessary information,the literacy rate, subject recruitment, or other community including personal knowledge of the research context byfactors, such as: geographic, socioeconomic, gender, one or more IRB members, consultants, and an exchange ofcultural, and moral backgrounds of the proposed human information between the IRB and the research site.subject population. Quorum Review IRB recognizes the importance of the localIn January, 2010, the Office for Human Research research context for institutions. We have incorporated aProtections (OHRP) withdrew two policy documents number of steps within our standard process to obtainsuggesting that OHRP favored local IRB review over review knowledge about the research context in your community.by a non-local IRB.8 OHRP has clarified that it no longer Quorum solicits information about the local population,holds this position.9 Although OHRP’s policy has shifted, site privacy and confidentiality practices, and local laws andthe reviewing IRB, whether local or central, still must requirements from investigators on our requiredobtain appropriate knowledge of the local research context. submission forms. In addition, Quorum maintains information about unique local requirements related toThe OHRP policy memorandum “IRB Knowledge of Local research, such as state law, or institution-specificResearch Context” outlines the necessary information an requirements. Quorum’s IRB members come from a varietyIRB should obtain as follows: of backgrounds, professions, and geographic regions. If needed, our specialty consultants are available to field  the anticipated scope of the institutions research activities questions for the IRB members regarding specific scientific  the types of subject populations likely to be involved and local context issues.  the size and complexity of the institution  institutional commitments and regulations For further information or to obtain a copy of Quorum’s  applicable law Institutional Start-Up Package, please contact Quorum’s  standards of professional conduct and practice Business Development Team at  method for equitable selection of subjects busdev@quorumreview.com.  method for protection of privacy of subjects8 (Archived) OPRR Policy Memorandum, Local Institutional Review Board (IRB) of Multicenter ClinicalTrials Sponsored by the Division of Aids (DAIDS) Nat’l Institute of Allergy and Infectious Diseases(NIAID), Sept.13,’93,, http://www.hhs.gov/ohrp/archive/humansubjects/guidance/hsdcsep93.htm (Archived) OPRR Policy Memorandum, Local IRB Review of Multicenter Clinical Trials, Nov.9, ‘92,93-01, http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-01.htm.9 10 OHRP April 30, 2010 Response, Use of a Central Institutional Review Board, OPRR Policy Memorandum, IRB Knowledge of Local Research Context, August 27, 1998 (updatedhttp://www.hhs.gov/ohrp/policy/Correspondence/mcdeavitt20100430letter.html 2000), http://www.hhs.gov/ohrp/policy/local.html

Institution Newsletter Volume 2, Issue 1

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