The Human Subjects Office (HSO) provides the following guidance for investigators planning to provide specimens and/or associated data to individuals who are not part of the original research team that collected the specimens/data.

In accordance with the University of Iowa (UI) Copyright Policy, the UI generally owns the research data generated from all research, development, and related activities conducted under its oversight. Therefore, investigators proposing to share such specimens/data must determine if:

1. the data transfer is permissible and
2. if a usage agreement for sharing with other UI investigators is sufficient or 
3. if a data use agreement (DUA) or a Material Transfer Agreement (MTA) is necessary for sharing data/specimens outside of the University of Iowa - contact Division of Sponsored Programs (DSP) 

Research Repositories 

Human Tissue Repositories

Human Tissue Repositories collect, store, and distribute human tissue materials for research purposes. Research repository activities involve three components: 

1. Repository PI or ‘Collector investigators’ – researchers who collect the tissue samples
2. Repository storage and data management center 
3. ‘Recipient investigators’ – those with whom PI intends to share the specimens/data

Repository Purpose

1. Gives the “Collector investigator” authority and responsibility for distributing specimens or data from the repository if certain pre-determined guidelines are met 
2. Minimizes the paperwork burden on “Recipient investigators” (those individuals with whom the PI intends to share the specimens or data)

Repository PI (“collector”) responsibilities:

1. Determine the conditions under which s/he will share specimens/data from the repository with Recipient Investigators 
2. Develop a “Usage Agreement” describing the conditions.  A Usage Agreement template can be found in the dropdown menu in the Miscellaneous attachments section on the HawkIRB attachments page. 
3. Identify the storage and data management site 
4. Obtain IRB approval for establishing and maintaining the repository (see below)
5. Maintain a copy of the signed Usage Agreements 
6. If applicable, obtain a Certificate of Confidentiality from NIH to protect the confidentiality of repository specimens and data.

Recipient Investigator responsibilities:

1. Sign the Usage Agreement and abide by the conditions listed.
2. If the Recipient Investigator determines s/he cannot proceed without exceeding the terms of the Usage Agreement (e.g., must have access to subject identifiers in order to obtain additional data items from medical records):
   1. Notify the Repository PI
   2. Submit an IRB application to appropriate IRB (prior to receiving specimens)

IRB Review and Approval

Repository PI (collector)

As the “Repository PI (collector)”, UI investigators must obtain IRB approval prior to sharing specimens/data with investigators who are not part of the original research team that collected the specimens/data. The HawkIRB application must include/address the following:

• Section VII.B1 – Project Description
  1. Select repository
•  Section VII.E.6 – Procedures
  1. Describe the specimen/data sharing
• Section X – Privacy & Confidentiality 
  1. X.4 – Describe how data & specimens will be stored to protect subject confidentiality
     • How data is labeled - Data is NOT deidentified if a link exists between the ID code and subject identifying information, so describe if the link will/will not be shared 
     • Location of specimen/data management site – storage site
     • The individual responsible for the specimens/data 
  2. X.5 – Select ‘No’ if non-research team members will have access to the study data. 
  3. X.6 - Identify all non-UI research team members that will have access to data/with whom data will be shared (commercial entity or colleague at another institution)
     1. Describe how they will have access to data/specimens.
• Section XII –Future Use
  1. XII.4 – Select whether storage for future use is mandatory or optional
     (When either of these is selected, appropriate language is inserted in the Informed Consent Document- see 3 below)
     1. If optional, describe
        1. Method to track subjects’ wishes 
        2. Method to ensure the subjects’ wishes are honored.
     2. FYI - If you say no, then only the research team members have permission to use the data/tissue/specimens for the study described as in the HawkIRB application.
• Informed Consent Document (ICD)
  1. WHAT WILL HAPPEN DURING THE STUDY? – Specify everyone with whom the data will be shared, including future investigators, commercial entity or colleague at another institution
  2. WHAT ABOUT CONFIDENTIALITY? – Include limits on how and where data will be stored (e.g., stored only on the UI campus, stored somewhere off-campus, etc.)
• Other Attachments 
  1. When a UI investigator (Repository PI) plans to share specimens/data within the institution with other UI investigators not on the research team (Recipient Investigators), a Usage agreement template is required and attached to the Miscellaneous Category of the HawkIRB application. 
  2. If the UI investigator will share specimens/data with investigators outside the UI, the investigator must contact Division of Sponsored Programs (DSP) about a Data Use Agreement (DUA). The PI does not need to attach the DUA, but the PI must attach documentation (an email) from DSP to the Miscellaneous category- verifying a DUA exists 
  3. If the UI investigator (Repository PI) will share identifiable specimens/data with investigators not on the research team, the Recipient investigators may need IRB approval for their project.  UI Recipient investigators should submit a Human Subjects Determination (HSRD) Form. For researchers outside the UI, check with the local IRB office. 
  4. If UI investigator (Repository PI) plans to share specimen/data externally with an outside organization, contact DSP for guidance about a data usage agreement (DUA). 

Modification to existing project

If an investigator decides to share data/specimens with outside entities after subjects have been consented and data collected, contact DSP about a usage agreement and submit a modification form for IRB approval.  If subjects have not agreed to allowing their data &\or specimens to be stored in a repository to share for sharing with an outside entity, reconsent will likely be required prior to sharing of any data or specimens.  The modification should include the PI’s plan to reconsent subjects enrolled in the study.

Recipient Investigator

The UI Recipient Investigator generally DOES NOT need IRB approval if:

• S/He agrees to the Usage Agreement conditions to keep data de-identified and not attempt to reidentify identifiable data, and 
• The Repository PI and Recipient Investigator both sign the Usage Agreement

A UI Recipient Investigator DOES need IRB approval in the following circumstances: 

• 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., access subject identifiers so that additional data items can be obtained from medical records).
  1. Recipient Investigator must submit an IRB application for review and approval. 
  2. Describe specifically why the Recipient Investigator cannot do his/her study without going beyond the terms of use in the Usage Agreement. 
• If the Recipient Investigator’s funding source requires evidence of IRB approval (e.g., NIH), the Recipient Investigator should submit an IRB application for review and approval. 
  1. Include a copy of the funding agency grant, and 
  2. a copy of the signed Usage Agreement so that the IRB knows that the terms of the Usage Agreement will be followed. 
  3. IRB approval of the Recipient’s use of the specimens or data will be classified as exempt from the federal regulations. 
     1. DSP will notify the funding agency (via the DHHS 310 form) that the PI has obtained IRB approval for an exempt project.
     2. Because the project is exempt, the recipient PI will not have to submit continuing review applications for the duration of that grant.