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irb@kdhcd.org
Email subject line must
have the study’s IRB #
Tissue and Biological Sample Use and Storage
PI Name: Click here to enter text.
Date: Click here to enter a date.
Project Title: Click here to enter text.
Appendix G – Tissue and Biological Sample Use and Storage
Section 1: Use of Existing Samples
1.1 Are you using existing samples?
☐ No – Section 1 Complete, go to Section 2
☐Yes
1.2 What type(s) of sample will be used
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1.3 Explain how the PI has legitimate access to the samples
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1.4 Where will the sample physically reside?
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Section 2: use of Samples Collected Prospectively
2.1 Does the research require prospective collection of samples?
☐ No – Section 2 Complete, go to Section 3
☐Yes
2.2 What type(s) of sample will be collected (e.g. blood, urine, bone marrow)
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2.3 What volume(s) will be collected?
Appendix G
Tissue and Biological Sample Use and Storage
Page 1 of 4
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Email subject line must
have the study’s IRB #
Tissue and Biological Sample Use and Storage
Click here to enter text.
2.4 What is the frequency of collections?
☐ Once
☐ Multiple Collections
2.5 List anticipated schedule, amount per collection and indicate if the collection is for research
purposes only. IF multiple collections, indicate if the collection amount will vary.
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2.6 Specify the sample collection group
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Section 3: Diagnostic & Genetic Testing, Incidental Findings and Returning Results
3.1 Does the research include genetic testing?
☐No
☐Yes. If “YES”, Complete Appendix F: Genetic Testing
3.2 Will the results of this research or future tests be communicated to subjects?
☐No
☐Yes
3.3 Will subjects be allowed to opt out of receiving results?
☐No
☐Yes
Section 4: Sample Storage and Future Use
4.2 Is the Principal Investigator (PI) the sole custodian of the samples?
☐No. Who, other than the PI, is a custodian?
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☐Yes
Appendix G
Tissue and Biological Sample Use and Storage
Page 2 of 4
Electronic Submissions Only
irb@kdhcd.org
Email subject line must
have the study’s IRB #
Tissue and Biological Sample Use and Storage
4.2 Does the PI intend to store samples for purposes other than those specifically related to the
study?
☐No
☐ Yes. For what purpose(s) will the samples be stored?
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4.3 Where will the samples be stored?
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4.4 How long will the samples be stored?
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Section 5: Sharing Samples
5.1 Will any portion of the samples be sent outside of Kaweah Delta Health Care District?
☐ No – Section 5 Complete, go to Section 6
☐Yes
5.2 For what purpose will samples be shared/sent outside of Kaweah Delta Health Care District?
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5.3 Indicate where and to whom the samples will be sent.
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5.4 What volume(s) will be shared?
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Appendix G
Tissue and Biological Sample Use and Storage
Page 3 of 4
Electronic Submissions Only
irb@kdhcd.org
Email subject line must
have the study’s IRB #
Tissue and Biological Sample Use and Storage
5.5 Will samples include indirect identifiers or codes when released outside of Kaweah Delta Health
Care District?
☐No
☐Yes. Provide details below
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5.6 Are written agreements or policies in place to protect the confidentiality of subjects’ date (data
use agreement)
☐No
☐Yes
Section 6: Identifiers
6.1 What identifiers will be on the sample(s)?
☐No Identifiers
☐Indirect Identifiers
☐Identifying
Information
Appendix G
No one, including the investigator, can identify a subject based on any
information on the sample
A unique code that can be used to identify the subject but is not immediately
transparent
Will the investigator have a link to the identifiers?
☐Yes ☐No
Explain what the identifying information will be on the sample(s)
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Tissue and Biological Sample Use and Storage
Page 4 of 4