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NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
EDUCATIONAL GUIDE
HUMAN BIOLOGICAL MATERIAL
TISSUE BANK
NOT ALL QUESTIONS WITHIN THE APPLICATION CONTAIN AN EDUCATIONAL NOTE.
THE NUMBERS AND LETTERS CORRESPOND WITH THE QUESTIONS ON THE APPLICATION.
SECTION I
4.
All research must have a source of funding. Examples of other funding may be departmental
funds or personal funding.
Other All research must have a specified source of funding
SECTION II
PURPOSE OF THE STUDY AND BACKGROUND (1)
1. This section should clearly support the purpose of the study, contain appropriate key literature
citation, and not exceed three pages in length.
METHODS AND PROCEDURES (2-6)
4. If genetic testing will be carried out, complete Addendum
5. YES
Both internal (e.g., UNMC TPF) and external sources (e.g., other institution, co-operative
group) must be specified.
In research involving existing HBM associated with PHI, written informed consent is
required from the subject or their legally authorized representative (LAR) unless: 1) all
subject identifiers (as defined by HIPAA) are stripped from the HBM sample(s) (i.e., the
HBM is de-identified by the investigator) upon initiation of the research, or 2) a waiver of
consent/authorization is granted by the IRB in accordance with the specific requirements of
45 CFR 46.116(d) and 45 CFR 160,164 (HIPAA). See Section II.12 for a list of the
identifiers.
6. Yes. A. If fresh tissue will be obtained directly from the UNMC Department of Pathology Gross
Cutting Room, a letter of approval from the Regional Pathology Services must be
submitted with this application. No tissue may be obtained directly from the O.R. or
procedure room unless, appropriate arrangements have been made with pathology
services. In most cases, the pathology exam must be complete before the tissue is
released
In research involving prospectively collected excess HBM written informed consent is
normally required unless waived by the IRB regardless of whether or not subject
identifiers are maintained in association with the HBM. It is the IRB’s position that the
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health care professional who performs the procedure to obtain the tissue has an
opportunity to obtain consent from the patient for the use of the excess (left-over) tissue
in research or can seek permission from the patient to allow the investigator to contact
the patient in order to obtain consent. Even if the health care professional referenced
above is not an investigator associated with the study and the investigator is provided
with tissue that has no identifiers, this does not negate a consent obligation unless the
IRB grants a waiver under 45 CFR 46.116(d).
It should also be noted that in order for excess tissue to be stored in the (blank), the
patient must have agreed to donate their tissue for research on the standard TNMC
consent for Surgery, Administration of Anesthetics, and/or Diagnostic/Therapeutic
Procedures. However, this is not sufficient to permit the use of the tissue in a specific
research project without the IRB granting a waiver of consent.
6. Yes. A. (4) A risk is a potential harm associated with the procedure that a reasonable person
would likely consider relevant in deciding whether or not to donate HBM for the
tissue bank.
6. Yes. A. (5) The investigator should determine the overall risk classification for the research
based upon the following factors: 1) nature of the research, 2) evaluation of subject
susceptibility and vulnerability to possible harm and discomfort, and 3) the steps
taken to minimize risk. The estimation of risk is, therefore, both procedure-specific
and population-dependent.
Minimal risk means "The probability (of occurrence) and magnitude (seriousness) of
harm or discomfort associated with the research are not greater than those
ordinarily encountered in daily life (of the average person in the general population)
or during the performance of routine physical or psychological examinations or
tests." Minimal risk, therefore, is used to define a relatively low threshold of
anticipated harm or discomfort associated with the research.
Greater than minimal risk means the possible harms and discomforts of the
research involving the proposed study population are greater than those ordinarily
encountered in the daily life of the average person in the general population or
during the performance of routine physical or psychological examinations or tests.
6. Yes. A. (11) If extra HBM is taken, written informed consent is required from the subject or LAR.
6. Yes. C. (4) A risk is a potential harm associated with the procedure that a reasonable person
would likely consider relevant in deciding whether or not to donate HBM for the
tissue bank.
6. Yes. C. (5)
The investigator should determine the overall risk classification for the research
based upon the following factors: 1) nature of the research, 2) evaluation of subject
susceptibility and vulnerability to possible harm and discomfort, and 3) the steps
taken to minimize risk. The estimation of risk is, therefore, both procedure-specific
and population-dependent.
Minimal risk means "The probability (of occurrence) and magnitude (seriousness) of
harm or discomfort associated with the research are not greater than those
ordinarily encountered in daily life (of the average person in the general population)
or during the performance of routine physical or psychological examinations or
tests." Minimal risk, therefore, is used to define a relatively low threshold of
anticipated harm or discomfort associated with the research.
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Greater than minimal risk means the possible harms and discomforts of the
research involving the proposed study population are greater than those ordinarily
encountered in the daily life of the average person in the general population or
during the performance of routine physical or psychological examinations or tests.
6. Yes. C. (12) Subjects should not and third party payors cannot be held financially responsible for
the costs of procedures for collection of HBM solely for research purposes.
Subjects who may be vulnerable to coercion, undue influence or increased risk must
be provided with appropriate additional safeguards. Depending upon the nature of
the study, the IRB may require completion of an addendum to this application.
CONFIDENTIALITY OF HBM DONOR DATA (7-10)
8. In accordance with HIPAA, the listed identifiers pertain to a) the individual subject, and b)
relatives, employers, or household members of the individual subject.
9.
In order to help protect confidentiality, the least number of HIPAA specified identifiers should be
recorded.
In order to protect confidentiality, subject identifiers should be deleted ASAP in consideration of
the scientific objectives of the research.
10. Research data must be stored and secured in a manner which fully protects confidentiality. This
section should describe how data is stored and secured at all stages of collection and analysis,
including hard copy and/or electronically on local computers or shared secure drives. For
example, hard copies must be stored in a secure location (e.g., locked room and file cabinet) and
all electronic copies, which include PHI, must be protected in accordance with UNMC Computer
Use and Electronic Information Security Policy 6051. This policy requires that all mobile devices
(e.g., laptops, flash drives) which contain PHI must be encrypted in order to minimize the
potential for breach. In addition, all research data should be stored with a backup system.
RELEASE OF HBM FROM THE TISSUE BANK (11-15)
11. For HBM that will be released to external investigators or organizations, a Material Transfer
Agreement (MTA) must be in place. In addition, the PI must have a copy of the external IRB
Approval letter for the external investigator’s research and if PHI will be included with the HBM, a
limited data set use agreement must be in place. For more information regarding the MTA,
please contact Russell Nelsen, J.D at 559-2468.
12. This section must describe 1) the person or group who has authority to grant access to HBM in
the bank (e.g., the PI of this protocol, an independent committee), 2) the procedure that is
followed for submitting a request to the bank, 3) the criteria for distributing tissue (e.g., scientific
merit, presence of external funding), and 4) the requirement for IRB approvalNote: If HBM is
released with any of the 18 subject identifiers specified by HIPAA Privacy and Security Rule,
verification of IRB approval must be obtained from the PI. Copies of IRB approval letters for
those projects should be maintained on file.
13. When HBM is released from the tissue bank, the PI must assure that confidentiality will be
protected and a data use agreement is in effect if required by the HIPAA Privacy and Security
Rule.
14. A record must be maintained which specifies: a) what HBM and data were released, b) the format
of data release (e.g., electronic), c) the associated HIPAA identifiers linked to the HBM and data,
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d) the date of release, e) the recipient(s) of the HBM and data, and f) evidence of IRB approval (if
required) for release of HBM and data with associated HIPAA identifiers. The above specified
documentation must be maintained for at least six years from the date of data release in
compliance with UNMC policy #6057. Random documentation reviews will be conducted to
verify compliance.
Note: A record must maintained which specifies: a) what HBM was released, b) the associated
HIPAA identifiers, c) the date of release, d) the recipient of the HBM, e) evidence of IRB approval
(if required), f) obtainment of a signed investigator agreement under HIPAA for use of a limited
data set (if required).
15. Every HBM donor has the right to withdraw their HBM from the tissue bank if there are
associated identifiers. The tissue bank must have a procedure for destroying the HBM should
the HBM donor request that it be removed from the bank.
Every donor has the right to withdraw any unused HBM from the tissue bank. The tissue
bank must have a procedure for destroying the tissue unless the HBM donor consents for the
tissue to be anonymized.
Consent is required from donors in order to store HBM in a tissue bank for use in future
research. This consent (i.e., the standard TNMC consent or a protocol specific tissue banking
consent) only authorizes the storage of HBM and not its use in research. Note: Based on
current case law, subjects do not retain any proprietary interests in their HBM once it has
been donated under legally valid consent. However, every donor has the right to withdraw
any unused HBM from the tissue bank. In this case, the tissue must be destroyed unless the
subject consents for the tissue to be anonymized.
POTENTIAL BENEFITS (16-17)
If extra HBM will be obtained (Section II.6b) or procedures will be performed solely for research
purposes (Section II.7c), then specifically describe any risks associated with obtaining HBM. The use
of HBM associated with PHI always carries a potential risk of loss of confidentiality.
A risk is a potential harm associated with the research that a reasonable person would likely consider
relevant in deciding whether or not to participate in research.
Note: The investigator should review each research intervention and determine the overall risk
classification for the study based upon the following factors: 1) existing data concerning risk, 2)
evaluation of subject susceptibility and vulnerability to possible harm and discomfort, and 3) the steps
taken to minimize risk. The estimation of risk is, therefore, both procedure-specific and populationdependent.
Minimal risk means "The probability (of occurrence) and magnitude (seriousness) of harm or
discomfort associated with the research are not greater than those ordinarily encountered in daily life
(of the average person in the general population) or during the performance of routine physical or
psychological examinations or tests." Minimal risk, therefore, is used to define a relatively low
threshold of anticipated harm or discomfort associated with the research.
Greater than minimal risk means the possible harms and discomforts of the research involving the
proposed study population are greater than those ordinarily encountered in the daily life of the
average person in the general population or during the performance of routine physical or
psychological examinations or tests.
16. Any statement concerning the prospect of direct subject benefit should be fully supported by the
protocol.
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17. Societal benefit generally refers to the advancement of knowledge which may lead to new
discoveries. For example, research may ultimately result in the development of new or improved
treatments or diagnostic tests which may benefit future patients.
COMPENSATION (18)
18. Yes. Compensation may be monetary or, depending on the nature of the research, may consist
of other forms of compensation such as gift cards, free goods, or other items. Any
compensation must be justified and not constitute undue inducement of the subject to
participate in the research. A prorated system of financial compensation is required in
most circumstances. The IRB has a policy generally limiting financial compensation,
particularly in consideration of the possibility that economically disadvantaged subjects
may be vulnerable to coercion or undue influence.
Compensation may be monetary or may consist of other forms of compensation such as
gift cards, free goods, or other items. Any compensation must be justified and not
constitute undue inducement to donate HBM to the tissue bank. The IRB has a policy
generally limiting financial compensation, particularly in consideration of the possibility that
economically disadvantaged participants may be vulnerable to coercion or undue
influence.
INFORMED CONSENT (19-20)
19. No. Obtainment of informed consent is required for donation of 1) extra HBM, 2) obtainment of
HBM solely for the purpose of tissue banking. The use of excess HBM (existing or
prospectively collected) with associated donor identifiers may, however, qualify for an IRB
Waiver of consent. In some cases, prospectively collected HBM even without donor
identifiers may require consent. Complete Addendum for Waiver of Consent if needed.
19. Yes. B. The environment where informed consent will be obtained should be conducive to
discussion and thoughtful consideration by the prospective subject with consideration
given to the need to minimize the possibility of coercion or undue influence.
19. Yes. C. The amount of time allotted to the process of consent is dependent upon the nature and
complexity of the study and the need to minimize the possibility of coercion or undue
influence.
19. Yes. D. All investigators have a legal and ethical obligation to ensure that the prospective HBM
donor has sufficient knowledge and comprehension of all of the elements of informed
consent to enable him/her to make an informed and enlightened decision whether or not
to participate or allow their HBM to be stored in the tissue bank. Some investigators,
therefore, choose to determine the level of a donor’s comprehension by questioning the
individual concerning their understanding of all the elements of informed consent. This
section should clearly document that the investigator has an adequate plan in place to
assure existence of an acceptable level of comprehension of all the elements of consent
19. Yes. E. Any individual who is authorized by the IRB to document the obtainment of informed
consent from the subject/subject's LAR must have the necessary clinical expertise as
well as sufficient knowledge about the protocol and IRB consent requirements. In
addition, the IRB may determine that under certain circumstances, obtainment and
documentation of informed consent by a physician will be required for some research
projects. In any case, the principal investigator is ultimately responsible for ensuring the
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obtainment of valid consent from all subjects or their LAR. Only individuals who are
listed in this section and approved by the IRB are authorized to document consent and
assent.
20. Other: Depending upon the nature of the research project, the IRB will consider whether a
waiver of consent can be granted in accordance with the criteria in the HHS regulations
for the protection of human subjects [45 CFR 46.116(d)] and HIPAA (45 CFR 160, 164).
If a waiver of consent is requested, the Addendum for Waiver or Alteration of Informed
Consent must be submitted with this application (available on the IRB website,
http://unmc.edu/irb). There are separate forms for adults and parent/guardian
permission/child assent.
Utilization of a separate youth or child assent form is not required for research involving
use of HBM. However, subjects aged 13-18 must sign the parental consent form.
Assent from subjects 7-12 must be obtained verbally and documented in the record.
The IRB understands that the full protocol may contain a very extensive listing of
references. However, to assure that the full IRB has sufficient information to complete
their review this application must contain at least the key references.
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