Ann Johnson IRB Administrator, IRB Member. Objectives 1. Identify the components necessary for management and oversight of tissue repositories used for.

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Presentation transcript:

Ann Johnson IRB Administrator, IRB Member

Objectives 1. 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 Management Must follow the regulations for establishing a tissue repository AND managing a repository HIPAA requirements for future research HIPAA requirements for de-identification and limited data sets DHHS definition of human subject research FDA regulations for in vitro diagnostic devices

Tissue Repository Management Protocol Description of the consent process for collecting the specimens Description 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 Collection Waivers 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): _consent_lang.doc

Privacy and Confidentiality De-identification procedures Timing of de-identification is important Sample coding procedures Who maintains the code? Who has access to the code? Encryption of data Limited access to the data Confidentiality agreements between investigators and research staff

Future Access to Specimens Agreements 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 Specimens Agreements 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 Specimens Who 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 Results Will any results be appropriate to return to participants for their benefit? Genetic results Disease information How will participants be notified?

Governance and Oversight May include IRB Steering and/or oversight committees

Custodianship of Specimens/Data What 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?