IRB: Collaborative and External Studies

Collaborative studies are those in which each of the institutions involved are significantly engaged in the research, usually by means of local investigators carrying out research activities at each study site. If the study does not entail employees of external institutions collecting data from participants, obtaining informed consent, or being involved as members of the research team, then the work is probably not a collaborative study. Likewise, if SJSU study personnel will be asking employees at other institutions to pass along recruitment information to prospective participants this, alone, does not constitute a collaborative study.

For collaborations that involve both SJSU investigators and external investigators, different approaches may be used to obtain approval depending on how the research will be conducted. Either each investigator can independently obtain approval from their respective IRBs or one institution can agree to be the reviewing IRB; a reliance agreement is established in the latter case.

In addition to the expectations outlined below for various circumstances, you may also need to obtain ancillary agreements depending on the type of data or materials shared between institutions. Agreements such as Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs) are handled by the SJSU Research Foundation. The IRB office may direct you to the Research Foundation when applicable, though an IRB reliance agreement process between intuitions can be pursued separately from any additional agreements that may be required.

SJSU Investigators with External IRB Approval

The SJSU IRB accepts IRB approvals from outside institutions that have an active federalwide assurance (FWA) so long as the reviewing IRB is willing to engage in a reliance agreement. We engage in reliance agreements for all review types, including administrative reviews of exempt research.

IRB Mentor User Guide for SJSU Investigators Relying on an External IRB Approval (required reading) [pdf]
Follow the instructions and steps outlined in this document for registering your external IRB approval within our online submission system (IRB Mentor) to allow the SJSU IRB Office to initiate a reliance agreement with the reviewing IRB. For a link to the IRB Mentor website, visit our submission page.

Required Documents

Most of these elements will be required within the IRB Mentor system and you will not be able to submit your request until you provide the required information. If we receive initial communication from an external IRB, it is still your responsibility to provide the information outlined below via the IRB Mentor system.

The name, title, and contact details of the reviewing IRB.
The name, title, contact details of the signatory official for the reviewing institution.
The FWA number of the reviewing IRB.
The tracking number assigned to the protocol by the reviewing IRB.
A study approval letter from the reviewing IRB. If the external IRB is not willing to approve a protocol until a reliance agreement is established, you are responsible for submitting all other documents except for the approval notification.
The IRB application, outlining the methods and procedures of the study, which lists you as part of the study personnel.
Consent documents, if applicable.
Data instruments, if applicable.
Any site-specific forms required by the reviewing IRB and/or the reliance agreement form that the external IRB wishes to use. The reliance agreement form is typically referred to as an Institutional Authorization Agreement (IAA). If the reviewing IRB does not supply a form, we will provide our own.
Be prepared to explain how SJSU is involved in the study, whether subjects will be recruited on campus (if so, provide the recruitment materials), whether data will be collected on campus, and what kind of information will be shared with external team members.

Confirmation Notification

The SJSU IRB Office will contact the reviewing IRB to establish a reliance agreement once we receive your submission. You will receive an email that you may begin the study only after a reliance agreement is established. The timeframe for the confirmation will depend on whether the external IRB is willing to serve as the IRB of record and how quickly they can provide the signed agreement. We recommend that you contact the reviewing IRB ahead of time to confirm their cooperation and to determine a timeline for the signing of the reliance agreement. If we are unable to establish a reliance agreement, the SJSU IRB will conduct its own review and you will be asked to provide a complete SJSU application via the IRB Mentor system.

SJSU IRB Approved Studies with External Personnel

SJSU investigators may list external personnel in their applications. However, the SJSU IRB does not assume responsibility for the compliance of external personnel. Instead, external personnel should contact their IRB, either to coordinate a reliance agreement with the SJSU IRB as the IRB of record or to have their IRB conduct a separate review for their activities. External personnel who do not have the support of an external IRB and have not established a contract with SJSU should not receive access to individually identifying information about subjects. SJSU investigators are encouraged to be judicious about who they add as part of the study personnel, as responsibility for compliance rests with the SJSU PI in the event that external personal do not have the support of an outside IRB.

International Research Involving Human Subjects

The SJSU IRB does not recognize informal agreements between SJSU investigators and international collaborators. The IRB does not have the authority to grant permission to conduct research that relies on the support of non-US institutions or personnel to access human subjects or their identifying information unless a formal arrangement is in place. SJSU investigators may either elect to only receive de-identified data from international collaborators (thus eliminating the involvement of human subjects in the activities of SJSU affiliates) or they must pursue a formal agreement via the CSU Chancellor's Office if they wish to rely on international institutional support for access to subjects or their identifying information. Contact the Compliance Office for information on pursuing a CSU-level agreement.

For international research where local institutional support is not needed, SJSU investigators are responsible for determining what kinds of permissions are needed from the country where the human subjects research will be conducted and for providing documentation to the IRB that the local requirements have been fulfilled. Permissions may include (but are not limited to) formal applications via the country’s embassy or regulatory authority, a local ethics review, as well as the fulfillment of all applicable local privacy laws.

In addition, investigators traveling abroad should review the information and expectations regarding international travel provided on the Compliance Office website.

External Investigators Conducting Non-Collaborative Studies at SJSU

Non-SJSU investigators who wish to conduct human subjects research at San Jose State University should seek IRB approval from their home institution, and be prepared to provide evidence of IRB approval to anyone who requests it. The SJSU IRB does not provide review services or evaluate research projects conducted by external investigators. The SJSU IRB will not provide you with an acknowledgment regarding your study, and we will not take responsibility for or provide institutional support for your research activities.

Campus departments and staff are not obligated to assist you with your research activities, including the recruitment of subjects or the release of student directory information. Cooperation by the campus community is strictly voluntary. The IRB office will not assist you with recruitment, the acquisition of secondary data, or referrals to SJSU personnel or offices. Voluntary cooperation by SJSU personnel does not mean that SJSU endorses your study.