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of University Pennsylvania Institutional Review Boards Standard Operating Policies Section: SC 500 Reviews Requiring Special Considerations CATEGORIES OF RESEARCH REQUIRING SPECIAL POLICY SC 502 CONSIDERATION This policy pertains to: Responsibility for executing this policy Approval Authority Last Reviewed on Effective Date Approved by : Vice Provost for Research Director of the Office of Regulatory Affairs All research submitted to the IRBs HRP Director, IRB Administrators, Executive Chairperson, IRB Chairpersons Vice Provost for Research; Director of the Office of Regulatory Affairs 12/13/2006 Results: Changed Supersedes document dated: Version 4.0, April 2006 1. PURPOSE This section presents the policy concerning review of specific types of research that require additional considerations by the IRB. 2. POLICY Certain categories of research involve either methodologies that might require additional considerations or for which there are federally mandated determinations that IRBs are required to make and document. These categories of research include, but are not limited to: Clinical research involving devices Gene Transfer Research Prospective research in emergency settings Emergency use of an investigational article or product 3. SPECIFIC POLICIES 3.1 Review of Device studies In addition to the previous policy guidelines for IRB review, the IRB (or Executive chairperson if the review is expedited) will determine whether, in the context of the study or by the nature of the device (see list of significant risk devices), the study presents a significant risk (SR) or a non-significant risk (NSR) of harm to study subjects. This assessment will be based on the information provided by the investigator and/or the sponsor. The IRB s risk determination must be documented in the IRB meeting minutes. If an investigator submits a NSR research protocol that is determined by the IRB to be a SR study, the investigator and FDA will be notified in writing. No further action will be taken by the IRB on the research until the sponsor or investigator has met the requirements for a SR study described in 21 CFR 812. References Guide to Daily Operations SC 502 21 CFR 812 3.2 Humanitarian Use Devices (HUD) Humanitarian use devices are intended to benefit patients by providing treatment or diagnosis of diseases that affect fewer that 4,000 individuals in the US per year. The IRB will conduct both initial and continuing review and approve the local use of a HUD. 21 CFR 814 Page 1 of 4 University of Pennsylvania Institutional Review Boards Standard Operating Policies 3.3 Gene Transfer Research Gene Transfer Research may require special considerations. If the project involves gene transfer (administration of recombinant vectors) to human subjects for other than clinical purpose review by the Recombinant DNA Advisory Committee (RAC) may be required. The FDA must review any such study prior to final IRB approval. In addition, the protocol must be reviewed and approved by the University of Pennsylvania Biosafety Committee. Monitoring must be adequate, and a DSMB may be required. 3.4 FDA Regulated Prospective research in emergency settings (prospective review) 21 CFR 50.24 FR 61(192):5153151533 The IRB, with the concurrence of a licensed physician who is either a member of IRB or a consultant and who is not participating in the research being reviewed, may waive the requirement for informed consent in certain emergency research if it finds and documents the following: 1) The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions. 2) Obtaining informed consent is not feasible because: FDA Draft Guidance, March 2000: Exception from Informed Consent Requirements for Emergency Research The subjects will not be able to give their informed consent as a result of their medical condition; The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation. 3) Participation in the research holds out the prospect of direct benefit to the subjects because: Subjects are facing a life-threatening situation that necessitates intervention; Appropriate animal and other pre-clinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity. 4) The clinical investigation could not practicably be carried out without the waiver. 5) The proposed investigational or research plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review. 6) The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 21 CFR 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. Page 2 of 4 University of Pennsylvania Institutional Review Boards Standard Operating Policies The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with paragraph (7)(v) of this section. 7) Additional protections of the rights and welfare of the subjects will be provided, including, at least: Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which subjects the will be drawn; Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits; Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results; Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact, within the therapeutic window, the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review. The study plan must assure that, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document. The study plan must assure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible. 8) If the IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception provided above of this section or because of other relevant ethical concerns, the IRB will document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. 3.5 HHS Regulated Prospective research in emergency settings (prospective review) For research the is not FDA regulated, requests for waivers of informed consent will evaluated in accordance with 45 CFR 46.116 and 117. and the OHRP Guidance on Informed Consent Requirements in Emergency Research. 3.6 Emergency use of investigational article or product. An investigational article may be used in an emergency prior to IRB review, provided that the Page 3 of 4 FDA Information University of Pennsylvania Institutional Review Boards Standard Operating Policies patient is in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. Such emergency use is reported to the IRB within 5 working days, and any subsequent use of the test article is subject to IRB review. In such a situation, obtaining informed consent shall be considered feasible except in certain emergency situations where the investigator has adequately documented the necessary exception under the guidelines described in 21 CFR 50.23. The investigator must submit documentation to the IRB for review by the IRB Executive Chair within 5 working days after emergency use of the test-article. In review of the documentation, the IRB will ensure that the investigator and a physician not otherwise participating in the clinical investigation have adequately certified the following in writing prior to use of the test-article: Sheets 21 CFR 312 21 CFR 812 The human subject was confronted by a life-threatening situation necessitating the use of the test article. Informed consent could not be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject. Time was not sufficient to obtain consent from the subject's legal representative. There was available no alternative method of approved or generally recognized therapy that provided an equal or greater likelihood of saving the life of the subject. If immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject, and time is not sufficient, prior to administering the test-article, to obtain an independent physician's opinion, the determinations of the investigator must be reviewed in writing within 5 days after the use of the test article by a physician not otherwise participating in the clinical investigation. In this event, a copy of the independent review must be submitted to IRB within 7 working days after the use of the test article. 3.6.1 The IRB Executive Chair will review prior notifications to determine that the circumstances of the use follows FDA regulations. 3.6.2 Under FDA regulations, patients given emergency use test articles are considered research subjects and data from the emergency use may be used in research through reporting to the sponsor and the FDA. Under HHS regulations, whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered to be a research subject. and the data derived from use of the test article may not be used in a prospective systematic investigation designed to develop or contribute to generalizable knowledge. 3.7 Subjects of Genetic Research: At first consideration, much genetic research may appear to meet the criteria for expedited review. These include: Pedigree studies, which look for a pattern of inheritance of a gene; Positional cloning studies, which are conducted to identify particular genes; Diagnostic studies, which gather samples to develop techniques to determine the presence of specific DNA mutations; Data or gene banks and repositories. The IRB Executive Chair or designated reviewer shall determine whether sufficient assurances of privacy protection are provided. Otherwise, review by the full IRB is required. Page 4 of 4

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