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 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. If an SJSU investigator wishes to have SJSU rely on an external IRB review, the SJSU investigator is responsible for conducting the preliminary step of compiling the required documents outlined below and submitting the documents to the SJSU IRB. The IRB office is unable to gather documents on behalf of the SJSU invstigator. You may need to contact the PI at the reviewing institution to obtain some of the required documents. If we receive communication from an external IRB, it is still the SJSU investigator's responsibility to provide the information outlined below -- all documents should be submitted together in one email.
SJSU Investigators with External IRB Approval
The SJSU IRB accepts IRB approvals from outside institutions that have an active federalwide assurance (FWA). As an SJSU investigator, your name and role must be outlined in the IRB application of the reviewing institution in order for it to be accepted. If the external IRB is not willing to approve a protocol until a reliance agreement is established, the SJSU investigator is responsible for submitting all documents noted below except for the approval notification.
SJSU Investigator External IRB Approval Registration Form [docx]
Register external IRB approvals by emailing the above form, along with the documents outlined below to firstname.lastname@example.org.
You will need to provide the following information and documents in order to complete the submission:
- The name and contact details of the reviewing IRB.
- The FWA number of the reviewing IRB.
- A study approval letter from the reviewing IRB.
- The approved application, which lists you as part of the study personnel.
- Consent documents, if applicable.
- Data instruments, if applicable.
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 submit an SJSU IRB application.
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.
Non-Collaborative, External Research
Non-SJSU investigators who wish to conduct human subjects research at San Jose State University should first seek IRB approval from their home institution.
Once IRB approval is obtained from your home institution, follow the steps outlined below for registration:
- Fill out the External Investigator IRB Approval Registration Form [docx]
The form describes the documents that must be submitted. You do not need to submit any other SJSU-specific forms or documents. Be prepared to provide the FWA number of the reviewing IRB. You can obtain this number by contacting your IRB. Please do not rely on SJSU IRB staff to determine this for you. Registration forms that do not provide the FWA number or provide a number that is invalid will not be accepted, and you will be directed the reviewing IRB to resolve this.
- Email the form and accompanying documents to email@example.com.
- Await an email confirmation of your registration from the IRB Analyst (7-10 business
- Contact us to report any campus-specific problems that may place subjects at risk of harm or to report a research-related injury affecting SJSU subjects or the SJSU campus.
NOTE: SJSU IRB registration does not obligate campus departments and staff 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.
External Investigators from Institutions Lacking IRBs
SJSU policy does not require its IRB to review research projects by external investigators who either come from an institution lacking an IRB or who are conducting research independent of any institutional support. SJSU will not take responsibility for or provide institutional support for external investigators’ research activities.