Human Subjects Protections:
Research Collaborations

All research activities performed by or under the direction of URI faculty, staff or students in the course and scope of University duties, or which use University resources, must comply with applicable URI policies and procedures, regardless of funding and whether performed in URI facilities or at offsite locations.

For human subjects research involving URI faculty, there are two processes to obtain IRB approval that may be used when collaborating with researchers from other institutions:

  • Multiple Reviews: Researchers request approval to conduct research from their home institutions. The URI protocol will describe the role of URI faculty, staff or students and the tasks they will undertake. Researchers affiliated with other institutions will secure approval for their portions of their research from their home institution.
  • Single Review: One institution agrees to cede authority for the review of the research to another institution through a mechanism called an IRB Authorization Agreement (IAA).

The IAA designates one IRB as the IRB that will review the research conducted at both institutions. (One institution may be the responsible IRB for multiple institutions engaged in the same research.) The reviewing IRB also reviews requests to amend and renew the protocol as well as reports of unanticipated problems. Usually, the institution that agrees to be the reviewing IRB is the institution where the research will take place.

In order to enter into IRB Authorization Agreements, institutions must have Assurances with the Office of Human Research Protections that describe how research subjects will be protected. Almost all universities in the US have these assurances as do many universities and research institutions abroad.

FAQs

  • How do I request an IAA at URI?
    1. The PI or primary contact should contact the URI IRB for a preliminary conversation on using an IAA. The URI IRB will ask that you email the IAA information using either the Institutional Authorization Agreement – Rely to URI Review or the Institutional Authorization Agreement – URI Defers URI IRB staff will determine if an IAA is appropriate.
    2. If URI is to be the IRB of Record (lead IRB):
      • Submit all relevant IRB Protocol documents on IRBNet for the URI IRB to review.
    3. If URI is to rely on another institution’s IRB,
      • URI IRB staff will communicate with the other institution’s IRB staff to preliminary receive approval that an IAA is appropriate.
      • Submit the appropriate documents to the other institution’s IRB per that institution’s IRB requirements.
    4. After signatures from both institutions have been obtained, the URI IRB will ask the URI faculty to upload the signed IAA to the IRBNet package (if URI IRB is the lead) or URI IRB staff will upload to IRBNet as an administrative package (if URI is to rely on another IRB).
  • Can an IAA be obtained for student research?
    • Typically, an IAA is not an option for student research. Students conducting their thesis or independent study at a collaborating site must obtain IRB approval at both the collaborating site and the URI IRB. In these cases, obtain IRB approval from the institution where the majority of human subject research will be conducted (e.g., where participants will be recruited). Once approved, contact the URI IRB regarding procedures to obtain URI IRB approval. Work cannot commence until approval is obtained at both institutions.
    • One exception to this rule are students enrolled in the joint URI/RIC Ph.D. Program in Education. URI and RIC have established an umbrella IAA that allows for a single IRB review. In most cases, the URI of Record will be the IRB of the Ph.D. advisor’s home institution. If the RIC IRB is the reviewing IRB, students will still need to submit documents to the URI IRB to ensure the URI Graduate School has the information to approve the program of study.   
  • Who prepares IRB Authorization Agreements? IRB staff members prepare the documents with information provided by the researcher and coordinate with IRB staff at the collaborator’s institution.
  • What is the timeframe for an IAA? It varies by institution. IAAs generally take a couple of weeks for processing, but the timeframe is ultimately driven by the availability of the Institutional Officials who are responsible for signing these agreements. URI’s institutional official is the Vice President for Research and Economic Development.
  • Who decides if an IRB Authorization Agreement is appropriate? Usually the URI IRB Administrator, Director of Research Integrity, or IRB Chair in consultation with the researchers will decide if an IAA is appropriate. The funding source, potential risks of harm to research subjects and the research site where the risks are incurred are factors in making the decision. Generally, URI should be the IRB of Record if a URI investigator is the prime awardee of a grant or other funding, or if the majority of research activities will take place at URI with other institutions collaborating. Another institution may be best served as IRB of Record if all research activities are taking place there, or if the URI IRB does not have the relevant expertise to review a study (i.e. clinical trial at external medical facility).
  • What if my research qualifies for exempt review? IRB Authorization Agreements are not intended for use when collaborators are engaged in exempt research. If all research activities qualify for exemption, researchers will have to secure approval from their home institutions.
  • What is my research is part of the joint URI/Rhode Island College (RIC) Ph.D. Program in Education and involves both URI and RIC? URI and RIC have established an umbrella IAA for research involving both URI and RIC under the Ph.D. Program in Education. Generally, the Reviewing IRB will be the IRB of the Ph.D. Advisor’s home institution. If the RIC IRB is the reviewing IRB, students will still need to submit documents to the URI IRB to ensure the URI Graduate School has the information to approve the program of study. For guidance, please contact the URI IRB Administrator.
  • What if my collaborator’s institution doesn’t enter into IRB Authorization Agreements? Some institutions do not enter into IRB Authorization Agreements as a matter of institutional policy. In these cases, obtain IRB approval from the institution where the majority of human subject research will be conducted (e.g., where participants will be recruited). Once approved, contact the URI IRB regarding procedures to obtain URI IRB approval. Work cannot commence until approval is obtained at both institutions.
  • What do I do if researchers from another institution allow me to use their facilities, but they are not involved in the research in any way? Get approval from the URI IRB before beginning the research.
  • What if my role on a multi-institutional study is advisory only? If you are not interacting with human subjects or collecting or analyzing identifiable information, your role on the project does not meet the definition of research with human subjects. You likely do not need IRB approval. You should consult with the Office of Research Integrity prior to making this decision.
  • How long do IAAs last? IAAs last for the duration of the research study or for however long the collaborator remains engaged in human subjects research. They need not be updated unless an expiration date is provided or the Principal Investigator (PI) or study information changes.
  • Now that I have an IAA, what do I need to do?
    • After obtaining an IAA you will need to do the following:
      • If URI is the IRB of Record, you should continue to correspond with the URI IRB as you would normally do, such as submitting renewals, modifications, or closure requests.
    • If the other institution has been designated the IRB of Record, you should correspond with the other institution and submit renewals, modifications, and closure requests in accordance with their local procedures. You must contact the URI IRB if any of the following are true:
      • Change in risk level for the study;
      • Subject complaint;
      • Unanticipated problem involving risk to subjects or others;
      • Suspension or termination of the research by the investigator, IRB, or sponsor;
      • Change in PI;
      • Change in funding arrangements;
      • Change in URI staff roles and responsibilities; OR
      • Closure of the study.
  • Do I have to get an IRB Authorization Agreement to just share de-identified data with researchers at another institution? However, data sharing should be done in a manner consistent with your URI IRB approved study. Additionally data sharing typically requires a Data Use Agreement (DUA) signed by the URI Vice President for Research and Economic Development.  If a DUA is needed, please contact the URI Office of Research Integrity.