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Appendix M
STORAGE OF DATA AND/OR SPECIMENS FOR FUTURE RESEARCH
University of California, Irvine
Institutional Review Board
Operation of a repository and/or a data management center is subject to oversight by the IRB when it contains information from or about living individuals. The IRB must approve the conditions under which data and specimens may be accepted and shared, while ensuring adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
If your study involves the creation of a research database or specimen repository, please answer the following questions. Note: If your study involves genetic data /specimens, Appendix N is also required.
1.Describe the type of data/specimens to be stored:
2.Describe for what purpose the data/specimens will be stored:
3.Indicate who will have access to the stored data/specimens:
- Indicate which of the following statements will be included in the informed consent document used to collect the data/specimens (check all that apply):
Information about storage of their data/specimens for future studies
Information about the type(s) of research that could be performed with their data/specimens
Information about the conditions under which data/specimens will be shared with others
Information about the confidentiality measures taken to protect their privacy
Information about the approximate length of time data/specimen will be stored
Information about the potential risk for a breach of confidentiality associated with the storage of data/specimens with subject identifiers
Information about whether the subjects will be given the option to withdraw their data/specimens
Other (specify here):
- Will the data/specimens be destroyed after the study concludes?
Yes – Indicate (or estimate) when the study will end:
No – Explain how long data/specimens will be stored:
- Will any of the data/specimens be shared with collaborators or sent to a central repository or data center?
Yes – provide details here:
No – data/specimens will not be shared with others and they will remain at UCI.
7.Indicate how samples will be shared with others (check all that apply):
No Subject Identifiers or Code
(i.e., the data/specimens will be shared anonymously; collaborators will not be able to identify a subject from the data/specimens)
Coded Data/Specimens with access to the key code
(i.e., the data/specimens are coded and the key code (if one exists) will be made available to collaborators)
Coded Data/Specimens with no access to the key code
(i.e., the data/specimens are coded and the key code (if one exists) will not be made available to collaborators)
Data/Specimens with Subject Identifiers
(i.e., the data/specimens are shared with personal or private information attached)
Identify the direct subject identifiers and justify why they are necessary:
Data/specimens will be shared as a HIPAA Limited Data Set
(Note: The recipient must sign a UCI data use agreement. Contact the IRB office for details.)