Institutional Review Board (IRB) s3

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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.

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

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 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.

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, 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 population-dependent.

16. Any statement concerning the prospect of direct subject benefit should be fully supported by the protocol.

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.