1. Purpose
The policy and procedures for creating or using a WVU-approved data or tissue repository
utilizing clinical health information or authorized tissue specimens for purposes
of human subject research are outlined in this SOP. All research conducted on stored
human tissue at WVU must be obtained from a WVU IRB- approved tissue repository.
For purposes of this document,
tissue includes any cell tissue, fluid, or excreta from which measures
of normal or
pathologic human physiologic function can be obtained
Tissue includes, but is not limited to pathological specimens, diagnostic
specimens, hair and nail clippings,
deciduous and permanent teeth, dental plaque and calculus, sweat, uncannulated
saliva, placenta removed at
delivery, amniotic fluid, cerebrospinal fluid, genetic material, urine, blood,
and other bodily fluids.
This policy applies to:
- Tissue collected as part of an approved protocol, standard operating room procedure, or from a non- university affiliated institution that will be stored in a tissue repository for future research at WVU or its affiliates.
- First-trimester fetal tissue may be subject to additional requirements. (See SOP 048: Research Involving Pregnant Women, Fetuses, or Neonates).
- Clinical health information or authorized tissue specimens from decedents
This policy does not apply to:
- Tissue repositories that exist for purposes other than research, such as for quality improvement or State reporting.
- Research conducted using human tissue under established guidelines for IRB review if the tissue collected is used for the approved protocol or discarded.
2. Overview
Repositories housing human tissue and data about human subjects are used to collect, store, and distribute these materials for research purposes. Researchers wishing to create repositories are responsible for registration and adherence to institutional policies and procedures and applicable regulatory requirements. The WVU IRBs are responsible for the suspension/termination of research related to a registered tissue or data repository that does not comply with this policy. The WVU IRBs have the authority to suspend or terminate any or all research conducted using a tissue or data repository that is not in compliance with the guidelines set forth in this policy, and/or within the IRB approved protocol collecting, managing, or using the repository specimens or data.
3. Procedures for Creating a Data or Biospecimen Repository:
3.1 The researcher completes the HSC Onsite Data or Biospecimen Repository electronic form which initially goes to CTSI for review. The researcher then obtains the required approvals (see below). The following is a list of general steps taken to initiate the Onsite Tissue and Database Repository process:
- Submit HSC Onsite Data or Biospecimen Repository electronic form, which will include:
- Obtaining a Statistical Waiver Certification as per 45 CFR 164.514(b)(1) and signature
- Providing the names of those acting as Honest Brokers (if applicable)
- Obtaining Departmental Chair approval
- Submit IRB protocol with complete plan for repository creation (if the repository
or bank is being created
prospectively for research purposes and informed consent will be obtained from potential
donors) - Obtain IRB approval
- Obtain IBC approval (if applicable)
- Obtain CTSI Director approval (submit IRB approval letter for approval)
- CTSI facilitates the final approval of the HSC Onsite Data or Biospecimen Repository and communicates approval to the researcher.
All WVU tissue repositories must have biosafety approval from the Institutional Biosafety Committee (IBC) before the WVU IRB can provide approval. The researcher ensures that the required Informed Consent is obtained and submitted with the Onsite Tissue and Database Repository electronic form. Deposits of specimens into the tissue repository must conform to the IRB-approved guidelines for conducting research on human tissue. (See SOP 011: Human Subject Research Determination (NHSR)).
All specimens stored in a tissue repository must be accompanied by a copy of the
consent agreement signed by the donor. The table below outlines when additional
prospective informed consent is required in order to store specimens in a tissue
repository:
| Type |
Consent Requirements
|
| Decedents | Informed consent must be obtained from appropriate family members and submitted with the registration application. |
| Donor Consent | Human tissue, accompanied by a copy of an IRB approved consent agreement signed by the donor (see below for Approved IRB Protocols), can be placed into an approved tissue bank for unspecified research purposes. |
|
Approved IRB
Protocols |
Human tissue can be deposited as part of an IRB approved protocol for the following:
(1) Following standard operating or delivery room procedures. (2) Following standard diagnostic and treatment procedures (e.g., dental extraction, collection of bodily fluids). (3) From a non-affiliated institution that conforms to comparable standards for the protection of human subjects. |
| Surgical Consent | If human tissue obtained through standard operating or delivery room (non-research) procedures is to be placed into a tissue bank for potential research purposes, a separate consent form signed by the donor must be obtained in addition to the standard operating room consent form. |
| Type | Consent Requirements |
|
Non-Surgical
Consent
|
If tissue obtained for purposes of standard medical or dental diagnostic and
treatment (non-research) procedures is to be placed into a tissue bank for
potential research purposes, a separate consent form must be approved by
the IRB for this purpose.
For example, if a blood sample is obtained for standard clinical diagnostic purposes and then discarded without identifiers, no consent is required, unless the blood is analyzed as part of a research project prior to being discarded, in which case a signed IRB approved consent form is required. If the remaining blood or components of blood from a standard clinical diagnostic test are banked for potential research use, a signed IRB approved consent form is required. |
|
Tissue Acquired
from a Non-Affiliated Institution |
If identifiable human tissue is acquired from an institution, laboratory, or
company not affiliated with West Virginia University for the purpose of tissue
banking for research, the tissue must be accompanied by an approved consent
agreement signed by the tissue donor.
The approved consent agreement must contain comparable language to the approved WVU tissue banking language, providing assurance that the tissue can be used without additional consent as long as donor confidentiality is maintained, that the tissue can be used with subject identification with additional consent, and that the financial considerations regarding the cost and potential financial advantage to institutions are enumerated. |
| CORE (Center for Organ Recovery and Education) | The CORE consent form may be substituted for the WVU form. |
3.2 The researcher submits the form electronically via an automated
submission system, where it is received by the CTSI Director of Research Analytics
or their approved designee.
3.3 Upon review, the CTSI Director asks for additional information and
as necessary, collaborates with WVU
OHRP/IRB to ensure the form meets criteria for approval without IRB review or approval.
3.4 If an IRB approved protocol is needed prior to creating a new repository
for research purposes, the
researcher is informed that they must first submit a protocol application to the
IRB prior to initiation of
the repository.
4. Maintaining a Data or Biospecimen Repository
Storage of tissue must be conducted in a manner conforming to the appropriate care and handling of biological specimens as outlined within the IBC Guidelines. Disposal of tissue must be conducted in a manner conforming to the appropriate care and handling of biological specimens as outlined through the IBC Guidelines. Information provided by the Institutional Biosafety Committee and Biosafety unit of Environmental Health and Safety at West Virginia University may be found on the WVU Biosafety website. Identification numbers assigned by the tissue bank will be the only method of linking the specimen. The Specimen Record, the Donor Record. Donor Record, and the Specimen Record will be stored in separatefiles. The Specimen Record - Include demographic and medical information from the patient’s medical or research record which does not identify the patient. Variables like age (< 90), medical diagnosis, and laboratory values can be included in the Specimen Record. The Donor Record - Include information dentifying the donor, such as a copy of the approved consent agreement signed by the donor. All files containing Protected Health Information (PHI) must be stored according to HSC ITS guidelines in an approved storage location, such as the HSC Secure Network Drive or Virtual Desktop Infrastructure.
5. Types of IRB Approval for Secondary Research or Existing Data on Biospecimens That Have Been Stored in an Approved On-Site Repository
|
Protocol Type
|
Description
|
|
NHSR
|
If human tissue is de-identified (stripped of all 18 Protected Health Information Identifiers) so that the researcher cannot trace the tissue back to the donor, then the project is considered to be not human subjects’ research (NHSR). |
| Exempt | If identifiable human tissue is removed from a bank for research purposes,
but the researcher
records the data without identifiers, the project is considered Exempt research." |
|
Expedited or Full Board Review
|
If identifiable human tissue is removed from a tissue bank for research purposes
and information
is provided to the PI in a manner that human subjects can be or are identified, and the researcher uses the identifiers, the project must follow the procedures for Expedited Review or Full Board Review |
| Tissue Sent to a Non-Affiliated Institution | If identifiable human tissue is removed from an approved tissue bank at West
Virginia University and sent to an institution, laboratory, or company not
affiliated with West Virginia University for purposes of research, the PI
must conform to the IRB Guidelines for the Protection of Human Subjects
by obtaining approval through an approved protocol
from their institution. A Data Use Agreement for Limited Data Sets form must be submitted following approval. |
6. Conducting Secondary Research Using Existing Data or Biospecimens That Have Been Stored in Approved On-Site Repository
Removal of human tissue from a repository for research purposes: All researchers must apply for an IRB approval for each individual research project utilizing tissue from a tissue bank. Tissue deposited and/or removed from a tissue bank must be logged using a Tissue Bank Log which will include date and time of deposit or removal, specimen number, the approved IRB protocol number, name(s)
Pre-Existing Specimens: The WVU IRB acknowledges that there may be specimens that were collected prior to the development and enforcement of the approved policy for conducting research on human tissue, and that records accompanying these specimens may not be in compliance with current WVU IRB policy. Whenever possible, it is the duty of the tissue bank to bring records from pre- existing specimens into compliance with current IRB policy (e.g., obtaining copies of consent forms to accompany specimens, separating the Specimen Record from the Donor Record, completing a Tissue Bank Development Application to register an on-site Tissue Bank).
Grandfather Clause: All tissue deposited or removed from a tissue bank after 1 January 2011 must conform to this policy. Any tissue banked after 1 January 2011 must conform to this policy. As it may be impractical to obtain consent for many specimens deposited before 1 January 2011, the tissue bank will not be required to demonstrate evidence of informed consent for specimens collected prior to this date.
7. References
WVU Policies:
SOP 011: Human Subject Research Determination (NHSR)
SOP 048: Research Involving Pregnant Women, Fetuses, or Neonates
WVU HSC and WVU Medicine Information Security Policies
IBC Guidelines