PI Name: / IRB#:
Protocol/Project Title:
Appendix T - Tissue and Biological Sample Use and Storage

A. Use of Existing Samples

1. Are you using existing samples?

Yes / If yes, go to next question
No / If no, section A is complete, go to Section B

2. What type(s) of samples will be used?

3. Explain how the PI has legitimate access to the samples:

4. If using a biosample repository (e.g. NIDDK), please list here:

5. Where will the samples physically reside?

B. Use of Samples to be Collected Prospectively

1. Does the research require prospective (new) collection of samples?

Yes / If yes, go to next question
No / If no, section B is complete, go to Section C

2. What type(s) of samples will be collected (blood, urine, etc.)?

3. What volume(s) will be collected? What is the frequency of collection (one or multiple)? If multiple collections will be done, indicate the schedule and if the collection amounts will vary.

4. Specify if the collection is for research purposes only, or if other applications exist.

C. Diagnostic & Genetic Testing, Incidental Findings and Returning Results

1. Does the research include genetic testing?

Yes / If yes, go to next question
No / If no, section C is complete, go to Section D

2. Will the results of this research or future tests be communicated to subjects? Will subjects be allowed to “opt out” of receiving results?

D. Sample Storage and Future Use

1. Does the PI intend to store samples for purposes other than those specifically related to this study?

Yes / If yes, go to next question
No / If no, section D is complete, go to Section E

2. For what purpose(s) will the samples be stored?

3. Where will the samples be stored and how long will the samples be stored?

4. If the PI is not the sole custodian of the samples, who else will be a custodian?

E. Sharing Samples

1. Will any portion of the samples be sent outside of the Rosalind Franklin University?

Yes / If yes, go to next question
No / If no, section D is complete, go to Section F

2. For what purpose will samples be shared/sent outside of the Rosalind Franklin University?

3. Indicate where and to whom the samples will be sent as well as the amounts (e.g. volumes) to be shared:

4. Will samples include indirect identifiers or coding when released outside of the Rosalind Franklin University?

5. Are written agreements or policies in place to protect the confidentiality of subjects’ data? (e.g. data use agreement)?

F. Identifiers

1. What identifiers will be on the sample(s)?

None / This only applies if no one, including the PI, can identify a subject based on any information on the sample (completely anonymous samples)
Coded Information / Samples will be labeled with a unique code such that the identity of the subject is not transparent. If checked answer question 2 below.
Direct Identifiers / This would include names, or other information that would readily allow identification. If checked answer question 3 below

2. If samples are coded, describe this and include who/where the coding is done and whether or not the PI have the key to the code (to enable reidentification):

3. If samples will have identifiers, please describe the nature of those:

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Form Version: 1/15/17