i. Data\Specimen Use Agreements

If a University of Iowa researcher stores human specimens for the specific purpose of providing specimens and/or associated data to others who are not members of the original “specimen collection” research team, the IRB may require that the researcher provide additional information to the IRB for establishing a formal repository.  The IRB has developed these procedures based on guidance from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (DHHS).

Purpose for Establishing a Formal Repository:

1. To give the “collector investigator” authority and responsibility for distributing specimens or data from the repository if certain pre-determined guidelines are met
2. To minimize the paperwork burden on “recipient investigators” (those individuals with whom the PI intends to share the specimens or data)
3. Features of a Formalized Repository:
4. Repository PI (“collector”) obtains IRB approval for establishing and maintaining the repository
5. Repository PI determines the conditions under which s/he will share specimens or data from the repository with Recipient Investigators
6. Repository PI develops a “Usage Agreement” that describes those conditions
7. Repository PI is responsible for maintaining a copy of the signed Usage Agreements

If Recipient Investigator agrees to those conditions, and the Repository PI and Recipient Investigator both sign the Usage Agreement, the Recipient Investigator does NOT need IRB approval – the Repository PI may provide the specimens or data based on the signed Usage Agreement alone.

The Recipient Investigator DOES need IRB approval in the following circumstances:

1. If the Recipient Investigator wants to use the specimens or data in a manner that goes beyond what is described in the Usage Agreement (e.g., get subject identifiers so that additional data items can be obtained from medical records), the Recipient Investigator must submit an IRB application for review and approval.  The IRB application should specifically describe why the Recipient Investigator cannot do his/her study without going beyond the terms of use in the Usage Agreement.
2. If the Recipient Investigator is being funded by a funding source that requires evidence of IRB approval (e.g., NIH), the Recipient Investigator should submit an IRB application for review and approval.  The Recipient Investigator should include with his/her IRB application a copy of the funding agency grant, and a copy of the signed Usage Agreement so that the IRB knows that the terms of the Usage Agreement will be followed.  IRB approval of the Recipient’s use of the specimens or data will be classified as exempt from the federal regulations.  The funding agency will be notified by the Division of Sponsored Programs (via the DHHS 310 form) that the PI has obtained IRB approval for an exempt project, and the PI will not have to submit continuing review applications for the duration of that grant.

Further information about establishing a formal specimen repository, along with sample usage agreements and additional information required by the IRB, may be found in a document called "Specimen/Data Repository Procedures at UI" on the HSO website.  Investigators are encouraged to contact the Human Subjects Office for assistance before submitting an application to establish a formal registry.