Off-Campus Research

Off-campus research includes any human subjects research that is conducted in locations that are outside of the UI campus, UI Health Care (UIHC), or the VA Health Care System (VAHCS). This includes research conducted outside of the United States. The UI IRB must review and approve all human subjects research that occurs off-campus.

For research activities that will be conducted in the U.S. but outside of the state of Iowa, the investigator must follow the laws of that state or U.S. territory. Similarly, for research activities conducted outside the United States, investigators must comply with local norms, customs, laws and regulations of that country. There are additional requirements and guidance for International Research.

Completing the HawkIRB Application for Off-Campus Research 

UI investigators must submit a HawkIRB application for any project that meets the regulatory definition of human subjects research, even if it occurs off-campus or outside the United States. Investigators must design the project in accordance with laws and regulations from states, territories or countries.

Relevant Sections of the HawkIRB Application

Provide specific information regarding off-campus research in the following sections:

  • Section II.2: Investigators may need to add a non-UI research team member if they are collaborating with someone who is engaged in the research.
  • Section VII.A.1: Investigators must indicate all locations where study activities will take place both on- or off-campus. Study procedures include recruitment, consent procedures, all study activities, data storage and data analyses.
  • Section X.4: Provide a thorough, detailed description of the plan to protect subject privacy and confidentiality. Additional confidentiality protections may be necessary when collecting, storing, transmitting or transporting research data from off-campus sites. The level of protection will depend on the sensitivity of the data and risks to subjects in the event there is a breach of confidentiality. In most cases, storing electronic data on a password-protected laptop is not adequate for off-campus research. The most common data security related clarifications requested by the IRB are:
    • Describe plans to maintain data security for paper records while at the off-campus site and when traveling back to the UI campus.
    • Describe physical protections for any devices holding electronic data.
    • Describe plans to save electronic data in a UI supported location (i.e., OneDrive) as soon as possible.
    • For more sensitive data, submit a data security review form to the UI IT Research Services office for review and approval before submitting the HawkIRB application.
    • Establish a mechanism to educate all research team members about the data security plan and make sure they follow the procedures outlined in the plan.

More information is available in the Data Security Educational Tool.

Additional Documentation for Off-Campus Research

When conducting off-campus human subjects research, the UI IRB may require additional documentation to be attached to the HawkIRB application before the study will be approved. The Principal Investigator should start a draft HawkIRB New Project form to access template documents on the Attachment Page.

Letter of Agreement

When you indicate in Section VII.A.1 that research-related activities will be conducted at an off-campus site, such as a school, nursing home, social service organization, etc., investigators must provide documentation that the site agrees to allow the research activities to occur at their site. Additional information is available on the web page about Attachments.

If research activities will be conducted in a setting where formal approval is not required (i.e. in a public place or in someone’s home), the ‘Letter of Agreement’ section of the attachments page can remain empty.

HIPAA Letter for Research Involving the Collection of PHI

When an off-campus research study involves the collection or use of protected health information (PHI), investigators must provide a Health Insurance Portability and Accountability Act (HIPAA) letter from the Privacy Officer or Board at the organization/site. The HIPAA letter must indicate the Privacy Officer’s or Board’s understanding of their responsibilities related to HIPAA and how it may relate to the research study being conducted by the UI investigator. Additional information is available on the web page about Attachments.

Research Conducted in Iowa Public Schools

Investigators who wish to conduct research involving students, their families, and/or the staff of K-12 public schools in Iowa are required to first obtain permission through the appropriate K-12 administrator(s). The UI IRB strongly recommends that investigators contact the Cooperating Schools Program in the College of Education when planning to conduct human subjects research in schools in Iowa. The Cooperating Schools Program is a university-wide service that helps to facilitate research by providing information to researchers about obtaining permission to conduct their research in public schools throughout Iowa.

Attach documentation of the formal approval from each appropriate school administrator in the ‘Letter of Agreement’ section of the attachments page of the HawkIRB application. Investigators may contact school administrators or school district personnel to confirm willingness to approve the research. However, NO study procedures can begin, including recruitment activities, the consent process or data collection, until the investigator has obtained formal approval for the research from the appropriate school administrator AND final approval from the IRB.

Investigators must have approval from at least one site when the New Project form is submitted. Other sites can be added via Modification forms when they obtain documentation of approval from the school administrator.

International Research

The regulations, standards and norms for human subjects research conducted in other countries may differ from those in the U.S. Investigators must design studies that comply with local requirements. See our page on International research for more information, including:

  • Determining whether an IRB Review is Required
  • Obtaining International Ethics Committee Reviews
  • Local Context Review Requirements
  • General Data Protection Regulation (GDPR) Requirements
  • Information related to U.S. Department of Defense (DoD) research
  • Completing an IRB application for International Research, including relevant documentation to provide as attachments to a New Project Form.
  • Guidelines for collaborating with researchers in another country, including the addition of these researchers as non-UI research team members (see below).

Non-UI Research Team Members

When individuals who do not have an active appointment as UI faculty, staff, or student will be involved in off-campus research on behalf of a UI investigator, a series of steps is necessary to determine whether or not IRB oversight is required.  The location of the individual, entity, or academic institution could affect how the UI IRB may proceed.  The involvement may result in the UI IRB serving as an IRB of record for another academic entity, an organization, or an individual for research related activities they are conducting on behalf of the research.  The UI IRB strongly encourages researchers to contact the UI External IRB staff to discuss how to proceed prior to the submission of the IRB application.  The next steps may involve one of the following:

  1. Setting up the study and all associated research activities to utilize a single IRB of record under an IRB Reliance Agreement OR
  2. Setting up an IRB reliance relationship using either an IRB Authorization Agreement (IAA) or the SMARTIRB Reliance platform with an entity or organization OR
  3. Complete an Individual Investigator Agreement (IIA) to describe the individual’s research-related activities.
  4. Relying on an external or commercial IRB or ethics committee for oversight of the non-UI team member’s research related activities.

This is required for any non-UI individuals working or volunteering with the project, even on a short-term basis. The IRB application will be updated accordingly based on which of the above scenarios apply to the research.  More information can be found on Single & External IRB portion of the HSO Website.