Instructions for Submitting IRB Applications for Research that Involves Biological Specimens
These instructions cover any prospective collection of human tissue, blood, urine, saliva, semen, other body fluid, or stool for research purposes. Use this guidance to complete the regular initial IRB application form: Application for IRB Approval of Human Subjects Research.
I. Specimens collected for use in the current study only.
In this scenario, no specimens will be stored for tests to be done after this immediate study is complete.
The IRB application, the protocol and the consent form must disclose, as specifically as possible, the type of information, including genetic information, which will be sought from the specimens, how the specimens will be collected and how and when the specimens will be disposed. If there is genetic testing, include whether the information may be of value to the individual subject and, if so, provide opportunity in the consent form for the subject to choose whether (s)he wishes to receive the test results and appropriate genetic counseling.
For this case, you should not use one of the consent form templates for stored specimens because all relevant information should be included in the consent form for this study as a whole.
Again, this presumes you will be destroying all specimens at the end of the current study; if this is not the case, then you must submit an additional application as described in section II, below.
II. Specimens collected and stored for future unspecified research.
In some cases this may be the entire purpose of the study; in other cases the repository is an adjunct to another study and will continue after that study has ended. In the latter case, a separate IRB application is needed to establish the repository and should be submitted with the application describing the parent study.
Note that there are two options for consent form templates in these circumstances:
- If any personal identifiers or codes are retained with the specimens, use the template for “Consent for Storing Biological Specimens With Identifying Information.”
- If no personal identifiers or codes linking the specimen to any subject are retained, use the template for “Consent for Storing Biological Specimens Without Identifying Information.”
Include the following information in the IRB application:
- How the specimens will be collected.
- What will happen to the specimens? Will the specimens be processed for storage, catalogued and placed in a secured facility? At what site? Will the specimens be identified or not?
- Who will have access to the specimens?
- Will research records and personal information be kept private?
- Is there any cost to the subject for storage of the specimens?
- Who owns the specimens? Include any grant, sponsor or contract language related to ownership of the specimens in the application and in the consent form.
- How will the specimens be used in the future? Who can access? Will IRB approval be required? Will identifiers be released? Do any contracts to release include language that explicitly states that no identifiers will ever be released?
- Will researchers re-contact subjects in the future to seek consent for additional studies involving the specimens? (This is only possible if there are identifiers.)
- Will results of research involving specimens be released to subjects? If so, how will you find subjects in the future?
- Will the specimens be shared with other institutions? Be specific in both the application and the consent form about how specimens are released, to whom, for what, and any other pertinent details.
- How long will the specimens be stored? How and when will they be destroyed? Can they be withdrawn?
