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Guidelines for IRB Review of Tissue Banking Proposals

Policy For Research Involving Collection And Storage Of Human Biological Specimens For Future Research

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1. Purpose: This policy is meant to provide guidance to the Tufts Health Sciences research community who are planning or conducting research that includes the collection of human biological specimens (specimens) for future research use and storing those specimens (with or without information about the source individual) in a repository referred to as a “tissue bank”. This policy also addresses protected health information (PHI) that could potentially accompany the stored specimens.

2. Scope: This policy applies to research studies in which specimens (with or without PHI) will be collected and stored for unspecified future research use.
The policy does not address the mandatory collection and transfer of specimens to a tissue bank as legally required under state law or regulation. The policy is limited to specimens collected from living persons and does not address the use of specimens obtained post-mortem. Additionally, this policy does not apply to specimens or data collected and stored as part of routine clinical care or hospital procedures, such as blood banks, medical records, or pathologic specimens.

3. Definitions: The following definitions will be used for the purposes of this policy.

3.1 Cell Line: cells that have been adapted to grow continuously in the laboratory and are used in research or industry.

3.2 Coded: identifying information or data (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

3.3 HIPAA3: is the Federal Health Insurance Portability and Accountability Act of 1996 that govern the use or disclosure of protected health information (PHI) by covered entities (i.e., health care providers, health plans, etc.)

3.4 Human Biological Specimen (specimen)1: includes any biological material that comes from a living human being, from molecules to subcellular structures and cell products such as proteins and DNA, to cells, tissues, and organs, including secretions, and waste (e.g., hair or nail clippings, urine, feces, sweat, tears, and shed skin cells).
Organisms, such as bacteria and viruses, isolated from human specimens are not human biological specimen

3.5 Identifiable: The identity of the subject is or may readily be ascertained by the investigator or associated with the information

3.5.1 (De-identified and coded) specimens and PHI whose HIPAA-defined identifiers have been replaced with a code that is linked to the specimen or PHI. Although readily recognizable information has been replaced by coded information, the presence of a link connecting the original specimens/PHI and its coded identification could allow a tissue bank or investigator who obtained the code to identify the Source Individual. Specimens/PHI from which identifiable information was permanently removed and cannot be retrieved by the tissue bank or an investigator is considered non-identifiable

3.5.2 Specimens/PHI whose identifiable information was replaced with a code is considered non-identifiable if the code was subsequently destroyed.

3.6 Protected Health Information (PHI)3: Individually identifiable health information maintained by a covered health care provider, health plan, or health care clearinghouse.

3.7 Source Individual: the individual from whom the specimens and/or PHI is collected.

3.8 Tissue Bank: an entity that collects, processes, stores, and distributes specimens (with or without associated PHI) for future research purposes.

3.8.1 Tissue Banking: refers to the receipt, processing, storage, and subsequent distribution or use of specimens (with or without associated PHI) to investigators for research purposes.

3.8.2 Storage for Batch Processing is not Tissue Banking: the Tufts Health Sciences Institutional Review Board (IRB) regularly reviews research protocols involving frequent or periodic collection and storage of specimens throughout the life of the study. These specimens are sometimes stored to allow for simultaneous or periodic pre-defined analysis throughout the course of the study or at the study’s conclusion. In this case, the plan for analysis is clearly described in the protocol and is designed to address specific aims of the study. These specimens are either destroyed during analysis or at the study’s end. This is not considered tissue banking since the specimens will not be stored for future unspecified research use, will not be subjected to testing outside the stated purpose and objectives of the original study, and will not be disseminated to investigators not associated with the original study.

3.8.3 Storage for Potential Repeat/Confirm Testing is not Tissue Banking: the collection, processing, cataloging, and storing (archiving) of specimens for future analyses described in the original study is not tissue banking. A research protocol may clearly explain that some of the specimens acquired for purposes of the study will be stored for subsequent testing at some future date. Typically, these stored samples will be used to repeat or confirm the result of previous analyses. These specimens will not be used for purposes beyond that of the original study, will not be used for future unspecified research, and will not be disseminated to investigators not associated with the original study.

4. PI Responsibilities:

4.1 Submit an Form 6 for Collection and Storage of Human Biological Specimens for Future Research to the IRB.

4.2 Informed Consent for tissue banking:

4.2.1 If the tissue banking is an optional component of a main research study, a separate informed consent form (ICF) to consent to this tissue banking is recommended.

4.2.2 Information from Tissue Banking ICF Worksheet must be included in the ICF.

4.2.3 Written informed consent will be obtained in accordance with the policy in the Tissue Banking ICF Worksheet.

4.3 Investigators should also refer to the following policies and guidance, as applicable:

5. IRB Review:

5.1 The IRB will review proposed tissue banking per IRB policies and procedures.

5.2 A subject’s decision to participate in the tissue banking component of a study cannot be a requirement for participation in the main study. The only exception to this is when the entire study is tissue banking for future use of stored specimens and there is no “main study” with a purpose other than tissue banking.

5.3 The IRB will consider whether standard clinical care might be affected by participation in the proposed tissue banking and will review the procedure for choosing the specimens to be sent for standard clinical testing versus tissue banking for future research use. For example:

5.3.1 If the proposed research involves “leftover” specimens after performance of diagnostic tests on a surgically procedure, the IRB may guard against removal of more than the usual amount of tissue by requiring that the surgeon not know if the subject has consented to the research use of any surplus materials.

5.4 The IRB will consider how specimens are identified, de-identified, and coded, or rendered no longer identifiable.

5.4.1 In most cases, specimens or PHI will be de-identified and coded before being stored at the tissue bank.

5.4.2 The key to the code is to remain within the exclusive possession and control of the PI or designee at Tufts Medical Center or Tufts University. This should be described in the protocol and/or Site-Specific Appendix.
NOTE: It may be necessary for a tissue bank to re-code specimens or PHI upon receipt to further protect privacy and confidentiality of the source individual. For example, if an Investigator who submits specimens or PHI to a tissue bank needs to also request specimens or PHI from the tissue bank for future research.

5.5 In specific circumstances in which the specimens or PHI must retain certain HIPAA identifiers (for example, date of collection), the following requirements must also be met:

5.5.1 The IRB is to grant a waiver of research authorization, release as a limited data set, and/or the research authorization language in the ICF must specify the HIPAA identifiers that will accompany the specimens or PHI to the tissue bank.

5.5.2 All other identifiers must be removed from the specimens or PHI. For example, if the tissue bank only needs the date of collection of the specimens, the subject’s name should still be removed and the specimens should be de-identified and coded.

5.6 Future use of specimens or PHI might require further IRB review and approval as well as additional HIPAA determinations.

5.7. When PHI accompanies the specimens to the tissue bank, the IRB will consider whether the PHI exists at the time of specimen collection and if future PHI will be transferred to the tissue bank.

5.7.1. If PHI will be collected and transferred to the tissue bank in the future, the protocol must describe the duration, frequency, and rationale for the future transfer of PHI to the bank.

Appendix

HIPAA Identifiers:

A HIPAA identifier is any one of the following types of information about the individual (or the relatives, employers, or household members of the individual) from whom the SPECIMENS are collected:3
1. Names
2. Geographic subdivisions smaller than a state (except the first three digits of a zip code if the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people and the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000)
3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death and all ages over 89 and all elements of dates (including year) indicative of such age (except that such ages and elements may be aggregated into a single category of age 90 or older)
4. Telephone numbers
5. Fax numbers
6. Electronic mail addresses
7. Social security numbers
8. Medical record numbers
9. Health plan beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers, including license plate numbers
13. Device identifiers and serial numbers
14. Web Universal Resource Locators (URLs)
15. Internet Protocol (IP) address numbers
16. Biometric identifiers, including finger and voice prints
17. Full face photographic images and any comparable images
18. Any other unique identifying number, characteristic, or code (excluding a random identifier code for the subject that is not related to or derived from any existing identifier).

References

  1. Note: This definition is adapted from the 1999 report of the National Bioethics Advisory Commission entitled “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance.”https://bioethicsarchive.georgetown.edu/nbac/hbm.pdf
  2. Response of the Department of Health and Human Services to NBAC’s Report Research Involving Human Biological Materials: Ethical Issues and Policy Guidance
    http://aspe.hhs.gov/sp/specimens/specimens.pdf
  3. Health Insurance Portability and Accountability Act (“HIPAA”). http://www.hhs.gov/hipaa/
  4. Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule, Department of Health and Human Services, NIH Publication Number 03-5388, 2003.
  5. OHRP Issues to Consider in the Research Use of Stored Data or Tissues.http://www.hhs.gov/ohrp/policy/reposit.html
  6. OHRP Guidance on Research Involving Coded Private Information or Biological Specimens (2008).http://www.hhs.gov/ohrp/policy/cdebiol.html
  7. NIH Genomic Data Sharing (GDS) Policy. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.htmland http://gds.nih.gov/pdf/supplemental_info_GDS_Policy.pdf
  8. Supplemental Information to the National Institutes of Health Genomic Data Sharing Policy.http://gds.nih.gov/pdf/supplemental_info_GDS_Policy.pdf
  9. NIH Points to Consider for IRBs and Institutions in their Review of Data Submission Plans for Institutional Certifications.  https://gds.nih.gov/pdf/PTC_for_IRBs_and_Institutions.pdf