WORKSHEET: Tissue Banking Informed Consent Form (ICF)
NUMBER
HRP-350
DATE
05/13/2015
PAGE
1 of 2
The purpose of this worksheet is to provide support for Investigators and research teams as well as IRB members reviewing research.
A. Tissue banking considerations (Check all that apply.)
1. Is there optional specimen banking as part of this study (or is this a specimen banking study)?
2. Are all fields in the Tissue Banking Form 6 complete?
3. Is Form 6, question # 9 completely answered (or a copy of the tissue bank’s policies submitted)?
4. Is there an optional banking ICF or optional banking section of the main ICF (for a specimen banking study, the banking ICF = the main
ICF)
5. Does the ICF contain all elements of consent?
B. The following information must be included in the ICF regarding tissue banking (Check all that apply.)
1. A description of the samples (human biological material) to be collected.
2. A description of the manner in which the samples will be collected. In particular, whether the involvement of the tissue bank will
necessitate the performance of procedures in addition to, or taking of samples in a greater volume than that which would otherwise be
done as part of the underlying clinical trial.
3. A place for subjects to record their choices about participating in tissue banking.
4. If the collection of samples involves the performance of procedures in addition to those that would be performed as part of the
underlying clinical trial, or involves the collection of samples in a greater volume than would be collected as part of the underlying clinical
trial, an explanation of the associated risks, if any.
5. If associated medical record information will also be collected, a detailed description of the specific information involved as well as the
frequency of its collection and transfer to the tissue bank.
6. A statement that the subject’s agreement to collection of samples (and medical record information, if applicable) for transfer to a tissue
bank is not a condition for enrollment in any research study or for future care or treatment at Tufts Medical Center or Tufts University.
7. A description of the measures that will be taken to guard against loss of confidentiality.
8. Does the ICF state that a subject can participate in the main study and not be part of the optional banking?
9. A description of:
(a) The types of investigators/entities to whom the samples (and medical record information, if applicable) may be distributed, and
(b) The purposes for which the samples (and medical record information, if applicable) may be used.
The ICF is to describe the intended purposes for the future use of the materials with as much specificity as possible.
10. If the samples (and medical record information, if applicable) will be coded, a statement that the subject is able to withdraw consent at
any time to future use, except where it is impossible to achieve the withdrawal because the tissue bank has already distributed the
samples (and medical record information, if applicable), the samples have been completely exhausted, or the code to match the sample
to the subject is no longer available.
11. If the samples (and medical record information, if applicable) will be coded, a statement indicating that the PI is the person to contact if
the subject wishes to withdraw consent to the future use of the samples (and medical record information, if applicable).
NOTE: the mechanism used to withdraw consent to the research use of samples (and medical record information, if applicable) should
not be limited to written communication. The following example is usually adequate:
You may withdraw your consent to allow the use of your banked tissue at any time by calling Dr. ______________, the Principal
Investigator, at tel. # (XXX) XXX-XXXX or by making your request in writing and sending it to Dr. ______________ at Street Address;
City, State, Zip Code.
12. A statement that a risk of participation includes possible loss of confidentiality and, if genetic testing is part of the protocol, a statement
to the effect that the results of genetic tests, if inadvertently disclosed, could negatively affect access to insurance or employment, or
could have an impact upon family or social relationships.
13. A statement that the subject will not be contacted by the tissue bank or by secondary recipients of samples (and medical record
information, if applicable) distributed by the tissue bank. If the IRB allows such contact, the ICF must state the circumstances under
which such contact may occur.
14. A statement, if applicable, that the samples will or may be used in the development of commercial products, including the development
of cell lines and whether the subject will receive any benefit or monetary gain from such development.
15. A statement addressing whether or not the subject will receive any direct benefit from participation in the tissue banking component of
the research protocol.
16. A statement describing whether or not, once the subject’s samples have been transferred to the tissue bank, the results of research
performed on those materials will be communicated to the subject or to the subject’s study doctor, primary care doctor, and/or placed in
the subject’s medical record.
17. If research results are to be communicated to the subject’s study doctor, the subject’s primary care doctor, or placed in the subject’s
medical record, the potential benefits and risks of such transfer and placement of information must be described in the ICF.
18. An explanation, if applicable, that Tufts Medical Center, Tufts University, or a member of the research team will receive money or other
remuneration from the tissue bank for the collection or use of the samples. No explanation is necessary if the payment is intended solely
WORKSHEET: Tissue Banking Informed Consent Form (ICF)
NUMBER
HRP-350
DATE
05/13/2015
PAGE
2 of 2
as reimbursement for the direct costs of the collection of the materials and transfer to the tissue bank.
19. Will identifiable medical record information accompany the specimen supplied to a tissue bank?
If so, the ICF must include:
An expiration date or expiration event for the potential research to be performed on the subject’s samples and medical record
information;
A statement that once medical record information is disclosed to the tissue bank, subsequent release of medical record information
by the tissue bank may not be protected by the federal privacy rule;
A statement that the subject may inspect or copy the medical record information to be disclosed to the tissue bank; and
A statement describing the particular identifiers that will be disclosed to the tissue bank (for example, date of birth, date of sample,
zip code, etc.).
20. Will the subject’s medical record information be supplied to the tissue bank on an ongoing basis?
If so, the ICF must:
Explicitly disclose that medical record information will continue to be collected from future medical records on an ongoing basis and
transferred to the tissue bank;
State any risks associated with supplying the subject’s medical record to the tissue bank on an ongoing basis;
Describe the specific information to be disclosed, the frequency of its disclosure, and the time period during which it will be
disclosed;
State that the ongoing disclosure of medical record information will terminate once all research on the individual’s samples have
been completed;
State that the individual can, at any time, revoke permission for the ongoing collection of information from his or her medical records
and include the mechanism for doing so.