tissue repository management
Post on 25-Feb-2016
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Tissue Repository Management
Ann JohnsonIRB Administrator, IRB Member
Objectives1. Identify the components necessary for
management and oversight of tissue repositories used for research.
2. Understand regulatory requirements for managing tissue repositories used for research.
3. Preview the upcoming IRB requirements for new study applications involving tissue repositories.
Need for Tissue Repository ManagementMust follow the regulations for establishing a
tissue repository AND managing a repositoryHIPAA requirements for “future research”HIPAA requirements for de-identification and
limited data setsDHHS definition of human subject researchFDA regulations for in vitro diagnostic devices
Tissue Repository Management ProtocolDescription of the consent process for collecting the
specimensDescription of the procedures for protecting the privacy
and confidentiality of the data associated with the specimens
Description of the process investigators will used to gain access to the specimens and data for use in future research
Description of the procedures for returning research results to participants and benefits sharing
Description of the governance and oversight of the specimen collection
Description of the process for custodianship of the specimens and associated data
Consent Process and Specimen CollectionWaivers of consent and authorization
If tissues are prospectively collected vs. retrospectively obtained?
If tissues are identifiable?If tissues were collected for other purposes not
related to the research?Informed consent document
Standard tissue banking language (11 points of light): http://www.research.utah.edu/irb/forms/hipaa/word/tb_consent_lang.doc
Privacy and ConfidentialityDe-identification procedures
Timing of de-identification is importantSample coding procedures
Who maintains the code? Who has access to the code?
Encryption of dataLimited access to the dataConfidentiality agreements between
investigators and research staff
Future Access to SpecimensAgreements between investigators*Who will be involved in the process for
gaining access to specimens/data?**Who must give approval in order to access
the specimens/data?How will requests for access be prioritized?How will specimen sharing be tracked?
Future Access to SpecimensAgreements between investigators
Types: Data use/transfer agreements Material transfer agreements
Agreements should address Acceptable uses of specimens/data and any restrictions on
use How human subject protection will be ensured Sharing of specimens with third parties Commercial use of specimens
Must be in accordance with the terms of informed consent or the approved waiver of consent/authorization
Future Access to SpecimensWho will be involved in the process for
gaining access to the specimens?What information must be provided in a
request to access specimens/data?How are requests submitted?Who will receive the requests?How will specimens/data be prepared before
sharing (e.g., de-identification, coding, physical preparation/storage, etc.)?
Returning Research ResultsWill any results be appropriate to return to
participants for their benefit?Genetic resultsDisease information
How will participants be notified?
Governance and OversightMay include
IRBSteering and/or oversight committees
Custodianship of Specimens/DataWhat is the process for transfer or
destruction of the specimens/data if the repository closes?
What is the process for maintaining the specimens/data if the custodian/investigator leaves the institution?
Tissue Banking Question in ERICA
Questions and Comments?
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