Approved September 2007
Updated June 2014
Institutional Review Board UT Southwestern Medical Center Use of Human Biological Specimens in Research Purpose Human biological specimens are a valuable resource for scientific inquiry. Their use can present risks to subjects. The purpose of this policy is to clarify the circumstances under which human biological specimens may be used for research purposes. This policy is based on Federal regulations governing human research and on UT Southwestern IRB policy, whose guiding principles revolve around the minimization of subject risk and the balancing of risk against the advancement of science and clinical care. Definitions Coded means that: (1) identifying information (such as name or social security number) that
would enable the investigator to ascertain readily 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 (2) a key to decipher the code exists, enabling linkage of
the identifying information to the specimens.
De-identified means no information is linked to the specimen that would allow the investigator
to identify the donor and no attempts will be made by the investigator to identify the donor using
genetic analysis technology, detailed demographic/clinical parameter matching or other means.
Exempt means human research that is not subject to the requirements of HHS regulations at 45
CFR part 46. Please note that at UT Southwestern, written confirmation of exempt status by the
IRB is required. Criteria can be found on the IRB website under Exempt Review.
Existing means data or specimens already have been collected and stored at the time the research
is proposed to the IRB for a determination of whether the research is exempt. Material collected
after the date of the initial submission to IRB is not “existing” for purposes of this policy.
Expedited means human subject research eligible for review by a subcommittee of the IRB.
Criteria can be found on the IRB website under Expedited Review.
A human subject is a living individual about whom an investigator (whether professional or
student) conducting research obtains either:
•
Data or specimens through intervention or interaction with the individual
•
Identifiable private information
An identifier is a piece of information that identifies a specific person or that could be used to
identify a specific person. In human research, identifiers are considered to be names, codes
linked to names, social security numbers, patient ID numbers and other such commonly used
data elements. However, the Health Insurance Portability and Accountability Act (HIPAA)
definition is broader, including a specific list of data elements. For more information about
HIPAA and its relationship to human research, please see HIPAA and the IRB.
Investigator means anyone involved in conducting the research. The IRB does not consider the
act of solely providing coded private information or specimens (for example, by a tissue
repository) to constitute involvement in the conduct of the research. Note that if the individuals
who provide coded information or specimens collaborate on other activities related to the
conduct of research with the investigators who receive such information or specimens, then the
IRB would consider such additional activities to constitute involvement in the conduct of the
research. Examples of such additional activities include, but are not limited to: (1) the study,
interpretation, or analysis of the data resulting from the coded information or specimens; and (2)
authorship of presentations or manuscripts related to the research.
Linked (see Coded).
Private information includes: 1) information that has been provided for specific purposes by an
individual and which the individual can reasonably expect will not be made public (e.g., a
medical record) and 2) information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place. For
information to be considered private, it must be individually identifiable (i.e., the identity of the
subject can be ascertained by the investigator or others associated with the information.)
Research that does not include generating, accessing, or recording private information is not
considered to be human subjects research (and usually does not require review by the IRB).
Research is a systematic investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge. Collection of information that is
not systematic (e.g., single case report), or is not collected with scholarly intent (e.g., internal
quality assurance review) is not considered research subject to regulation. Investigators should
consult with the IRB for assistance if having difficulty determining whether a project meets the
definition of research.
Secondary Use is defined for purposes of this policy as a purpose other than that for which the specimen originally was collected. Specimen is defined for purposes of this policy as any biological material obtained from or derived from patients or human research subjects. This includes, but is not limited to: fixed, frozen or fresh pathology or autopsy specimens; blood; urine; saliva; CSF; semen; breast milk; and any purified DNA, RNA, proteins, cell lines or clones. Policy Use of human specimens for research is regulated. At UT Southwestern, the Institutional Review Board (IRB) oversees all human subject research, including use of human specimens.
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All prospective collection of human specimens for research requires prior written IRB approval
and informed consent from the subject (unless consent is waived by the IRB – see requirements
for consent waiver on WAIVER AND ALTERATION (LINK NEEDED)
The secondary use of existing human specimens for research purposes can be permitted under certain circumstances. Some types of secondary use require prior review and authorization (approval or confirmation of exempt status) by the IRB and also may require informed consent from subjects. (A consent waiver may be applicable in certain circumstances.) In those circumstances for which prior IRB authorization is required, investigators are responsible to seek IRB review before initiating a secondary use of existing human specimens for research. IV. Applicability This section reviews oversight requirements for the various ways in which human specimens may be used in research. A. Prospective Collection and Use of Human Specimens for Research Purposes 1. Research on human specimens obtained prospectively for research within UT Southwestern and its affiliated hospitals UT Southwestern IRB approval is required for the prospective collection and research use of human specimens obtained explicitly for research purposes. Examples include extra blood taken for a research project at the time of a clinical blood draw, or additional biopsies performed for research purposes during a clinically indicated procedure. The IRB will require written consent/authorization of each research participant (unless a waiver of consent is approved). This is not considered a “secondary use” because the express (primary) purpose of the collection is the intended study. 2. Research on human specimens obtained prospectively for research outside of UT Southwestern and its affiliated hospitals UT Southwestern IRB approval is required for the prospective collection and research use of human specimens obtained explicitly for UT Southwestern research purposes, even if the work is done off campus. An example would be samples collected by an investigator who travels to a remote site to collect specimens from members of an extended family. This is not considered a “secondary use” because the express (primary) purpose of the collection is the intended study. B. Use of Existing Human Specimens that DOES NOT Require UT Southwestern IRB Review 1. Laboratory research on de-­‐identified commercially available human cells or cell lines when acquired from established vendors government tissue banks UTSW Institutional Review Board
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UT Southwestern IRB review is not required for laboratory research on human cells obtained from commercial or governmental entities because the release of these samples to investigators does not meet the regulatory definition of human-­‐subjects research. When human cells are obtained from one of these repositories, investigators are reminded to review the contract or purchase agreement carefully to ensure that the planned use of the specimens will be in accordance with the vendor’s or supplier’s terms and conditions. Exception: permission is required for use of human embryonic stem cells, regardless of source (see D.1. below). 2. Research on de-­‐identified human specimens obtained from IRB-­‐approved Tissue Repositories within UT Southwestern UT Southwestern IRB review is not required for research on (1) non-­‐identifiable specimens or (2) coded specimens that are provided to the investigator without linked identifiable information, when the specimens are obtained from IRB-­‐approved Tissue Repositories within UT Southwestern. In such cases, the UT Southwestern IRB has approved the Tissue Repository’s procedures for distribution to investigators of non-­‐identifiable or coded specimens without linked identifiable information. Each Tissue Repository is responsible for complying with the procedures described in its IRB-­‐approved protocol. 3. Analyses of human specimens obtained from outside of UT Southwestern when the analysis is performed as a fee-­‐for-­‐service for other investigators (or as other genuinely non-­‐collaborative services meriting neither professional recognition nor publication privileges) UT Southwestern IRB review is not required for activities limited to the performance of analyses on human specimens as a commercial or genuinely non-­‐collaborative service. For example, appropriately qualified laboratory staff may perform analyses of blood samples for investigators outside UT Southwestern solely on a commercial (non-­‐collaborative) basis. In such situations, UT Southwestern personnel performing the analyses are not considered to be “engaged in the research,” but still must adhere to the commonly recognized professional standards for maintaining privacy and confidentiality. [Note: for research collaborations involving receipt of human specimens from collaborators outside of UT Southwestern and its affiliated hospitals, see Section C3.] C. Use of Existing Human Specimens that DOES Require Prior UT Southwestern IRB Review 1. Laboratory research on identifiable human specimens when acquired from established vendors and government tissue banks UT Southwestern IRB review is required for laboratory research on identifiable human
specimens obtained from commercial or governmental entities. When human cells are obtained
from one of these repositories, the project may qualify for exemption under category 4,
“Research involving the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or if the information
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is recorded by the investigator in such a manner that subjects cannot be identified, directly or
through identifiers linked to the subjects.”
2. Secondary use of identifiable previously collected excess (i.e., otherwise discardable) clinical specimens from within UT Southwestern and its affiliated hospitals UT Southwestern IRB review is required for any proposed research use of excess clinical specimens obtained from Clinical Pathology and related services within UT Southwestern and its affiliated hospitals. Examples include specimens collected for diagnostic purposes or during surgery in the clinical laboratories (including pathology) or in clinical care areas, such as the operating suites. The IRB will determine whether the proposed research is: •
Not regulated human-subjects research under 45 CFR 46;
•
Human-­‐subjects research exempt from the requirements in 45 CFR 46; •
Research that may be reviewed by an IRB through an expedited review procedure; or •
Research that requires review by the IRB at a convened meeting (full board review). These determinations are based upon the nature of the research, the source of the specimens, the use and/or disclosure of identifiable health information, privacy and confidentiality protections, what patients were told at the time of clinical consent, and whether informed consent/authorization of subjects should be required for the research, among other factors. [Note: typically such studies will qualify for exempt status or approval via the expedited procedure and also often meet the standard for waiver of informed consent. However, if obtaining consent from subjects is practicable, consent will be required. The consent determination is made by the IRB based upon the overall level of feasibility, the risks posed by loss of confidentiality, and the nature of the information to be obtained.] To propose the use of excess human materials for research, investigators should complete and submit a request to conduct Exempt research. If an IRB Chair should determine that the study requires a more rigorous review, the investigator will be notified promptly. Instructions for submitting Exempt research requests can be found on the IRB website under, ”Electronic Application (eIRB).” 3. Research on human specimens obtained from collaborators outside of UT Southwestern and its affiliated hospitals UT Southwestern IRB review is required for any research on human materials provided to investigators by collaborators outside of UT Southwestern. The IRB will determine whether the proposed research is: UTSW Institutional Review Board
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•
Not regulated human-subjects research under 45 CFR 46;
•
Human-­‐subjects research exempt from the requirements in 45 CFR 46; •
Research that may be reviewed by an IRB through an expedited review procedure; or •
Research that requires review by the IRB at a convened meeting (full board review). These determinations are based upon the nature of the research, the source of the specimens, the use and/or disclosure of identifiable health information, privacy and confidentiality protections, and whether informed consent/authorization of subjects should be required, among other factors. To propose the use of specimens obtained from collaborators outside of UT Southwestern and its affiliated hospitals for research, investigators should complete and submit a request to conduct Exempt research. If an IRB Chair should determine that the study requires a more rigorous review, the investigator will be notified promptly. Instructions for submitting Exempt research requests can be found on the IRB website under Electronic Application (eIRB).” Secondary use of previously-­‐collected research samples from within UT Southwestern and its affiliated hospitals or from UT Southwestern IRB-­‐approved Tissue Repositories UT Southwestern IRB review is required for any proposed secondary use of existing samples collected previously for research. The IRB will take into consideration the scope/intent of the original research project, as well as the language in the consent form the subjects signed when the sample was provided for the initial research use. The IRB will determine whether the proposed research is: •
Not regulated human-subjects research under 45 CFR 46;
•
Human-­‐subjects research exempt from the requirements in 45 CFR 46; •
Research that may be reviewed by an IRB through an expedited review procedure; or •
Research that requires review by the IRB at a convened meeting (full board review). These determinations are based upon the nature of the research, the source of the specimens, the use and/or disclosure of identifiable health information, privacy and confidentiality protections, and whether informed consent/authorization of subjects should be required, among other factors. [Note: typically such studies will qualify for exempt status or approval via the expedited procedure and also often meet the standard for waiver of informed consent. However, if obtaining consent from subjects is practicable, consent will be required. The consent UTSW Institutional Review Board
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determination is made by the IRB based upon the overall level of feasibility, the risks posed by loss of confidentiality, and the nature of the information to be obtained.] To propose the secondary use of existing human specimens for research, investigators should complete and submit a request to conduct Exempt research. If an IRB Chair should determine that the study requires a more rigorous review, the investigator will be notified promptly. . Instructions for submitting Exempt research requests can be found on Electronic Application (eIRB) page. Note: It may be possible to convert previously collected research samples to a UT Southwestern IRB-­‐approved Tissue Repository. Investigators are encouraged to pursue this option if they envision using the samples multiple times. Special Samples Human embryonic stem cells (hESC) UT Southwestern permission is required for research on existing hESC lines and IRB approval is required for the derivation of new hESC lines. In addition, there are other special ethical, legal, financial, and institutional issues related to the research use of hESC. Investigators are asked to contact the IRB prior to any use of hESC cells or any derivation of new hESC lines at UT Southwestern or its affiliated hospitals. Fetal Tissue Specimens UT Southwestern IRB review is required for research on fetal tissue. Note: federal law prohibits the sale of fetal tissue for profit. Transfer of samples to research collaborators outside of UT Southwestern and its affiliated hospitals The UT Southwestern IRB must review any plan to transfer human specimens to outside collaborators (academic or commercial) for research. Other requirements also may apply (see “a.” below). Exception: The transfer of non-­‐identifiable human specimens from an IRB-­‐approved UT Southwestern Tissue Repository to another investigator, if approved by the IRB as one of the procedures of the tissue bank, does NOT require separate IRB review and approval. This is because the IRB already will have reviewed and approved the procedures of the Tissue Repository, which describe such transfers. Note: Investigators should address in any Tissue Repository protocol submissions to the IRB whether or not there are plans to transfer specimens outside UT Southwestern. Whenever plans to transfer specimens outside of UT Southwestern arise after initial IRB approval, a protocol modification should be submitted to the IRB for review and approval. Materials Transfer Agreements (MTAs) UTSW Institutional Review Board
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In addition to IRB permission for sharing of specimens, UT Southwestern’s Office of
Technology Development must negotiate a Materials Transfer Agreement (MTA) or License
Agreement with the recipient entity. For more information, please contact Office of Technology
Development at 214-648-4459 or at technologydevelopment@utsouthwestern.edu.
This applied to transfer of human specimens: a) To an academic or non-­‐profit entity or collaborator and/or use in collaboration with an academic or non-­‐profit entity. b) To for-­‐profit or commercial entities or collaborators and/or use in collaboration with a commercial entity. c) For purposes other than genuine research collaborations. UTSW Institutional Review Board
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