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?