ࡱ> g #bjbjVV r<r<6 6 8D DC(dzL'''''''$),|'1"11''1F'1'VP$@%p_w^$ '(0C($x-H-%%Z-n&@>,&$J''C(1111-6 V: REPOSITORY / BANK and DATA USAGE This guidance document applies to any situation where an individual wants to collect and save any type of samples or data for future use in different research protocols. This includes saving standard of care information when the intention is to establish a setting where those items may be accessed at a later date for research purposes. The individual must have IRB approval to intentionally save samples or data for possible future research use. This is accomplished by establishing a repository, or bank. Samples: biological items such as tissue, blood, body fluids Data: information that is either stored by hard copy or electronically Protocol A repository allows an investigator to collect and deposit the item into savings. The protocol for a repository must describe how the samples will be collected as well as adequate protective measures for: Storage and maintenance of the items. Maintaining confidentiality. The level of security should be commensurate with the expected level of risk the subject is exposed to by allowing their samples/data to be maintained. For example, identified samples require more stringent measures than completely de-identified samples; samples for identified genetic testing require more protection than identified data on surveys of non-sensitive matters. Allowing/granting access to the repository / bank. A description of how the samples/data will be withdrawn for research purposes. Includes use by the investigator themselves, as well as provisions to supply to a third party if anticipated. If the consent allowed for multiple uses (e.g., restricting use to diabetes research only or more expanded usage such as with other illnesses or diseases), a description of how those authorizations will be tracked to ensure that the samples/data are only available for the use(s) that the patient is approving? Collaborative Efforts If the protocol is a collaborative effort between EVMS and other institutions, and EVMS is the repository site, the EVMS investigator should develop a sample collection protocol and informed consent document for distribution to collector-investigators and their local IRBs. For a site to collect samples/data, a written submittal agreement should require written informed consent from the donor-subjects utilizing an informed consent form (ICF) approved by the local IRB. Any site receiving samples/data for research use must have IRB approval for access to the identities of donor-subjects or to information through which the identities of donor-subjects may readily be ascertained. Such approval would only be granted in extraordinary circumstances. A written recipient usage agreement for recipient-investigators should be part of the protocol submission and include the following: "Recipient acknowledges that the conditions for use of this research material are governed by the repository Institutional Review Board (IRB) in accordance with Department of Health and Human Services regulations at HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm"45 CFR 46. Recipient agrees to comply fully with all such conditions and to report promptly to the repository any proposed changes in the research project and any unanticipated problems involving risks to subjects or others. Recipient remains subject to applicable State or local laws or regulations and institutional policies which provide additional protections for human subjects. This research material may only be utilized in accordance with the conditions stipulated by the repository IRB. Any additional use of this material requires prior review and approval by the repository IRB and, where appropriate, by an IRB at the recipient site, which must be convened under an applicable OPRR-approved Assurance." OPRR recommends that a Certificate of Confidentiality be obtained to protect confidentiality of human repository specimens and data. In general, a protocol for the repository/bank will not have any procedures outlined for using the samples/data after withdrawal from the bank. It is strictly a description and purpose for how the items will be accumulated, saved, and distributed when use is needed. Submissions that describe both creating a bank of samples and a particular use of the samples most often need to be split into two separate IRB proposals BEFORE presentation to the IRB. However, if the intention is to only use the samples/data for one specific research protocol, then a bank is most likely not necessary. More specific guidance can be provided by the IRB office. Collection, storage, management and use: Tissue Collector (EVMS or Collaborator)Repository/Bank Storage and Data Management CenterRecipient Investigator (EVMS or Collaborator) IRB Review Informed Consent Submittal Agreement Assurance of ComplianceIRB Review Sample Informed Consent Certificate of Confidentiality Assurance of ComplianceRecipient (Usage) Agreement IRB Review Other State or Local Policies Consent Form(s) to Collect Samples or Act as a Repository/Bank Site In addition to the basic elements included in the EVMS template consent, the consent form to collect the samples should address the following items: The operation of the repository. The specific types of research to be conducted (choices may be provided to the subject for the samples to be used in various ways) Description of the nature and purposes of the research should be as specific as possible. Where human genetic research is anticipated, informed consent information should include information about the consequences of DNA typing (e.g., regarding possible paternity determinations). Conditions under which data and specimens will be released to recipient-investigators. Procedures for protecting the privacy of subjects and maintaining the confidentiality of data. USE OF DATA / SAMPLES FROM THE REPOSITORY / BANK In order to conduct any research that will retrieve the data/samples from a repository, the investigator must first obtain IRB approval to use (withdraw) the samples for a particular study. Besides the standard requirements for a complete protocol, this protocol needs to include the following items: How the samples/data came into existence. Copies of either: the study consent(s), the approved waiver of consent, and/or a new waiver of consent request. For biological samples, will all or part of the sample be used? If part, what will happen to the leftover portion? If the subject was consented for the samples/data to be saved, is the current request within the context that the subject approved on the approved consent form. And, How will subject confidentiality be maintained in the new study? Will there be any need to link back to the repository/bank? If so, provide justification for this needed link.     PAGE  PAGE 3 OF  NUMPAGES 3 FWA #00003956 October 2012 Version 1.0 EVMS Institutional Review Board GUIDANCE DOCUMENT PAGE  PAGE 1 OF  NUMPAGES 3  !"  ! " # * , 7 ` e P a b v H M     ŵɉɅɁ}ɁɁyɅɅɅɅɅɅh ihzZho"h hdtchdtc5>*hyaCJaJhyahyaCJaJhyahya56>*CJaJhya56>*CJaJhQhyahnL"hP'hw5>*CJ$OJQJaJ$ht{5>*CJ$OJQJaJ$"hP'hnL5>*CJ$OJQJaJ$/!"! 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