Tissue Repository Management

1. Tissue Repository Management Ann Johnson IRB Administrator, IRB Member

2. Objectives • Identify the components necessary for management and oversight of tissue repositories used for research. • Understand regulatory requirements for managing tissue repositories used for research. • Preview the upcoming IRB requirements for new study applications involving tissue repositories.

3. 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

4. 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

5. 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): http://www.research.utah.edu/irb/forms/hipaa/word/tb_consent_lang.doc

6. 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

7. 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?

8. 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

9. 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.)?

10. Returning Research Results • Will any results be appropriate to return to participants for their benefit? • Genetic results • Disease information • How will participants be notified?

11. Governance and Oversight • May include • IRB • Steering and/or oversight committees

12. 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?

13. Tissue Banking Question in ERICA

17. Questions and Comments?