UCSF COMMITTEE ON HUMAN RESEARCH
APPLICATION SUPPLEMENT
HUMAN BIOLOGIC SPECIMEN COLLECTING
AND/OR BANKING FOR FUTURE RESEARCH
Instructions:
 Complete this form only if you are engaged in collecting and/or retaining specimens for future research in a bank,
repository, or private collection.

Do not complete this form if you are only obtaining specimens from another source for analysis described in your
application. The research may qualify for exempt certification, expedited review or full committee review depending on
the breadth of the study.
Note: There are 3 sections on this form
 If this is a study and the specimens will be shipped to a bank at another institution, only sections A and B apply.
 If this application is for a repository that is not involved in the collection process but only receives specimens from other
sources, sections A and C should be completed.

If this application involves retaining specimens that are collected under this study, complete sections A, B and C.
Section A: General Information
Principal Investigator of CHR Application:
CHR # (if issued):
Study Title (may not exceed 500 characters):
1. This protocol involves (check all that apply):
2. Approximately how many specimens do you expect to
collect or bank each year (best estimate)?
3. What types of specimens will be collected and/or banked
for future research? (check all that apply)
[ ] Specimen collection
[ ] Specimen banking and/or repository administration
[ ] 1-99
[ ] 100-999
[ ] 1000-9,999 [ ] 10,000 or more
[ ] Blood
[ ] DNA/RNA
[ ] Cell cultures
[ ] Tissue (please describe): ______
[ ] Existing/archival materials (name source): ______
[ ] Other (please describe): ________
Reminders




Specimens should not be collected, received or distributed without evidence of IRB approval
Personal identifiers should not be released to specimen recipients
Testing of specimens should be consistent with the uses described in the specimen donor consent form
Specimen donation should not be mandatory for treatment studies
Section B: Specimen Collection and Informed Consent Process: This section applies only to investigators who are
engaged in the actual collection process from research subjects.
1. Specimens are (check all that apply):
[ ] Surplus clinical specimens from a diagnostic or therapeutic
procedure
[ ] Specimens collected for research purposes only
[ ] Other (explain briefly):_______
2. How will consent be obtained?
[ ] Specimen banking consent form
[ ] Separate specimen banking section within a research study
consent form
[ ] Surgical consent form with tissue donation brochure
[ ] Other (explain briefly): _____
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3. Specimen Preparation Methods (check all that apply):
[ ] Paraffin embedded (blocks)
[ ] Frozen
[ ] Other (please specify): _____
4. Where will the specimens ultimately be stored (check all At UCSF (complete Section C below):
that apply)?
[ ] UCSF repository (includes departmental collections,
established tissues banks and new banks)
[ ] Private collection
Transferred to an external group (Check and specify name of
all that apply):
[ ] Cooperative Group Bank: _____
[ ] NIH (name branch): _____
[ ] Other University: ______
[ ] Industry sponsor: _____
[ ] Other (please describe):______
5. Confidentiality: The primary risk to subjects who donate specimens to be banked for future research is the risk of loss
of confidentiality and/or privacy. Most banks need to maintain a link between the identities of donors and coded
specimens to be able to collect valuable clinical follow-up information about the donor. On the other hand, if you are
stripping the specimens of all identifiers (other terms used for this are de-identifying and anonymizing), there is no way to
trace who the specimen came from.
a. How will the identities of the specimen donors be
[ ] Neither the researcher nor the specimen repository/bank
protected? (check applicable box at right)
possess donor identifiers.
[ ] The identifiers are maintained at the repository/bank only.
There is a firewall between the source and the researcher so
that the protected health identifiers are never given to the
researcher
[ ] Identifiers may be released to (UCSF) researchers with
CHR approval under certain circumstances. Please explain
below.
b. DHHS/OHRP recommends that specimen repositories obtain a Certificate of Confidentiality to protect donor-subjects
from attempts at gaining access to samples to support denial of insurance or employment or for paternity testing. If you are
obtaining a Certificate of Confidentiality, list the name of the issuing agency below. If not, please explain why one is not
necessary:
c. If specimens will not be anonymized, explain the process by which subjects may have their specimens removed from the
bank and destroyed if they choose to do so later. Please note that instructions should also be in the consent form.
d. Will clinical follow-up data be linked to the specimens?
e. If yes, for how long will follow-up data be collected?
[ ] Yes [ ] No
[ ] Indefinitely
[ ] ______ years
f. Who will collect the follow-up data and perform the data entry?
[ ] Until death
[ ] Other (please explain): _______
g. Please provide a list of the data points that will be collected. (Use the space below or attach a list)
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Section C: Administration of UCSF-Based Repository: Bank administration applies only to entities involved in
specimen storage, inventory management and distribution to investigators.
1. [ ] Bank is administered under a separate CHR Approval (provide name of bank and CHR approval number):
___________ (Skip the rest of the section)
[ ] Bank will be administered under this protocol
[ ] Other (please explain): ________
2. Where is the bank physically located (address and room number)? (Provide all locations if specimens are housed in
multiple locations.)
3. Data Security: Please indicate how repository data are kept secure. Check all that apply:
[ ] Data are coded; data key is destroyed at end of study or provide date:
[ ] Data are coded; data key is kept separately and securely
[ ] Data are kept in locked file cabinet
[ ] Electronic data are protected with a password
[ ] Data are kept in locked office or suite
[ ] Data are stored on a secure network
4. Specimen Distribution (complete this section only if bank will be administered under this protocol)
a. Is there a formal utilization review process? If so, please describe the process.
b. Specimens banked at UCSF may be made available to
(check all that apply):
[ ] UCSF researchers (requires separate CHR approval or
exempt certification for use)
[ ] Non-UCSF researchers* (requires local IRB approval)
[ ] Industry researchers*
* Please contact the Office of Technology Management (OTM) regarding the possible need for a Material Transfer
Agreement (MTA), 353-4445.
c. Banks should not release specimens to other investigators unless they have already received IRB approval for their use.
Please describe how IRB approval will be verified prior to release of the samples.
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