Completing the "Collection and/or use of Biological Specimens" Section
What is the purpose of the Biological Specimens section?
Guidance for completing the Biological Specimens section of the ARROW application
The Biological Specimens section of the initial review application needs to be filled out any time biological specimens (tissue, blood, urine, etc.) will be collected, received or analyzed for research purposes. This section describes the type and source of the sample, as well as what will be done with the sample at the UW.
The Biological Specimens section is separated into the following pages:
- Collection and/or Use of Biological Specimens: General
- Collection and/or Use of Biological Specimens: General, Continued
- Collection of Biological Specimens Directly From Subjects
- Residual Biological Specimens
- Existing Biological Specimens
- Banking Specimens for Future Use
- Clinically Relevant Information and Reporting
- Genetic Analysis
- HIV Testing/Illegal Drug Use
- Collection and/or Use of Fetal Tissue
- Collection and/or Use of Biological Specimens: VA
- Collection and/or Use of Biological Specimens: VA Continued
Q1.1 Select the types of biological specimens to be used for this study. Select all that apply.
Study teams should select which of the types of specimens listed they will be using for research. If the sample is not blood or urine (i.e. tissue or other), the specific type of sample should be listed in response to question 1.1.1.Q1.2 Select from where you are obtaining biological specimens. Select all that apply.
- If a specimen is collected directly from the subject as part of a research procedure specifically for that purpose (i.e. it is not being collected as part of clinical care already), “Obtained directly from subjects for the purpose of this research (i.e., not obtained for clinical purposes)” should be selected. This can include collection of additional biopsy tissue, blood or bone marrow that wouldn’t normally be collected during that same procedure for clinical purposes.
- If a specimen was originally (or will be) collected for clinical purposes or for a different research study, and is considered to be left over tissue (to be destroyed) (i.e. it does not need to be analyzed in the future), “Residual (to be discarded) biological specimens from a clinical or research procedure (i.e., prospectively obtained)” should be selected.
- If a specimen is already in existence (i.e. it was already collected for a different purpose and is now archived or stored), “Existing biological specimens” should be selected.
NOTE: More than one option can be selected. For example, you can have specimens that are left-over from clinical care (residual) AND specimens that are already in existence, both being used in the same study. In this case, the second and third options would be selected.Q1.3 Are you banking specimens for future research purpose (i.e., research beyond the scope of the current study)?
If the study team plans on storing the samples after their research is complete (in order to possibly use for a future study), this is considered banking of the samples. If the study team does not plan on banking the samples, the plan for destroying the specimens should be described in 1.3.1, such as “The samples will be depleted when analyzed” or “The samples will be destroyed once analysis is complete”. If you are cutting a section of a larger tissue block, you should describe what will happen to your section (e.g. destroyed or deplete) and the larger tissue block (e.g. returned to archives).Q1.4 Will results of any testing performed on the samples be released to subjects?
If this question is answered "yes", the “Banking Specimens for Future Use” page will appear in this section. These questions should be answered if your study team plans to bank the samples you receive, not if you are receiving them from a tissue bank. Guidance on banking of samples can be found here:
Guidance for Completing IRB Applications for Recruitment Registries or Repositories that Store Data and/or Tissue
If this question is answered "yes", the “Clinically Relevant Information and Reporting ” page will appear in this section. If the study team will be running any tests on samples which will then be given to the subjects, the questions on this page need to be completed. Guidance on releasing test results to subjects can be found here:Q1.5 Are you performing genetic analysis on specimens?
Clinically Relevant Information and Reporting Guidance
If this question is answered "yes", the “Genetic Analysis ” page will appear in this section. Any time genetic testing will be completed on the samples, these questions should describe if the subjects can opt-in/opt-out of the genetic testing. Guidance on different genetic testing and template consent form language for genetic testing can be found here:Q1.6 Are you testing for HIV or other infectious diseases (e.eg., hepatitis) and/or screening for illegal drug use?
Guidelines for Genetic Research and the Use of Storable Tissues
Genetic Information and Nondiscrimination Act (GINA) Guidance
If this question is answered "yes", the “HIV Testing/Illegal Drug Use ” page will appear in this section. HIV status or illicit drug use status is considered stigmatizing information, and has additional requirements to protect subjects legally, as well as their reputations. Guidance on HIV testing (as well as other communicable diseases) and drug use can be found here:1.7 Does this study involve collection and/or use of fetal tissue?
Communicable Disease Guidance
Guidance Regarding Research that Involves the Collection of Information about Illegal Substance or Alcohol Abuse
If this question is answered "yes", the “Collection and/or use of Fetal Tissue ” page will appear in this section. The use of fetal tissue (including use of cell lines derived from fetal tissue) for research purposes brings into effect additional institutional, state and federal regulations. For assistance with regulations for the use of fetal tissue, please see the following FAQ:To the top
What if my research involves the use of fetal tissue?
How do study teams complete the “Collection and/or Use of Biological Specimens: General, Continued” page?
Q2.1 Describe the purpose of collecting the specimens.
For specimens collected for research purposes, the study team should state why collection of the specimens will further the research goals. For specimens collected for clinical purposes, the study team should state the clinical reason for collecting the samples.Q2.2 Describe the information that will be associated with the specimens (e.g., clinical information such as diagnosis, date of collection, lab results).
This response should summarize the nature of the data that will be associated with the specimens either directly or indirectly via a code. If the specimens are labeled with a code that can be linked to any additional data (within a spreadsheet or database), this should also be stated here.Q2.3 Describe how specimens will be labeled (e.g., name, initials, coded ID number linked to identifiers, anonymous).
This response should state exactly what will be included on the specimen labels, e.g. study code, date of collection, etc.To the top
How do study teams complete the “Collection of Biological Specimens Directly From Subjects” page?
This section is meant to elicit information about how and when specimens are collected directly from subjects. The answers should describe what procedure is being used to collect specimens (Q3.1), how often/at which visit the specimens are collected (Q3.2), and if the subjects can participate in the study if they decide they do not want their specimens collected (Q3.3).
How do study teams complete the “Residual Biological Specimens” page?
Q4.1 Describe the source of the residual specimens (e.g., surgical pathology).
When a specimen is considered “leftover” from a clinical or research procedure, the original source of the sample should be described. Examples of this could be “surgical pathology” or "leftover specimens, such as urine or blood, from a clinical lab".Q4.2 Describe the study team's arrangements for obtaining the samples and ensuring that a sufficient sample has been secured to fulfill any non-research objectives for collection (i.e., clinical testing). NOTE: Any samples obtained during surgery that will not be first processed by pathology will require special permission from pathology.
When using residual samples, the study team must ensure that all clinical testing is complete or can be completed on remaining tissue once it has been given to the study team for research. This question asks the study team to verify that participant care will not be impacted by the receipt of the samples. If the study team plans to obtain fresh tissue prior to processing by pathology, documentation of permission from pathology that this is acceptable is required. This documentation can be uploaded to the Supplemental Information section of the application.To the top
How do study teams complete the “Existing Biological Specimens” page?
Q5.1 What was the original purpose for the collection of these biological specimens?
If the specimens are currently in existence, this indicates they are being stored or archived. This answer is meant to describe why those specimens were originally collected and stored (clinical testing and archive, research tissue bank, etc.).Q5.1-5.5
These questions ask for information about the source of the existing samples. Each grouping of questions should be completed in its entirety. For example, if 5.2 is selected “yes”, it is also required that the UW IRB submission number be provided.
What is the purpose of the “Collection and/or Use of Biological Specimens: VA” pages?
When research being conducted at the VA includes the use of biological specimens, additional requirements apply. Please visit our VA page for assistance with these studies: VA Research - Overview