Multi-site or Collaborative Studies

What is a Multi-site or Collaborative Research?

• A multi-site study uses the same research procedures (i.e., protocol) outlined in a single site protocol but is carried out at multiple institutions (i.e., each institution enrolling its own subjects and carrying out the protocol at its own site).
• Cooperative or collaborative research occurs when two or more institutions coordinate to complete a portion/specific aspect of the research outlined in a protocol at their respective locations (e.g., consenting subjects, data analysis only).

Multi-site Study/Collaborative Research – Who is the IRB of Record?

When a study involves the institution and one or more other DOE sites, the study will typically be sent to the Central DOE IRB for review, unless the Oak Ridge Sitewide Institutional Review Board (ORSIRB) or other IRB internal or external to DOE is determined to be the preferred IRB of record and this alternate approach is authorized by the Institutional Official and the DOE Human Subjects Protection program manager (as is required by DOE Order 443.1C).

When a study involves the institution and one or more non-DOE site(s), contact the ORSIRB Administrator to determine the path forward. The ORSIRB Administrator can help determine whether the ORSIRB or an external IRB is the appropriate IRB of record.

Common Rule Single Mandate

Section 45 CFR 46.114(b) of the revised Common Rule (i.e., the 2018 requirements) requires that all institutions located in the United States and engaged in cooperative research conducted or supported by a federal department or agency rely upon determination by a single IRB for the portion of the research that is conducted in the United States.

Reliance on a single IRB of record in cooperative research was required beginning January 20, 2020, unless the study meets the criteria for an exception described in §46.114(b)(2) of the 2018 requirements.

Reliance Agreements

When research involves more than one institution a Reliance Agreement (i.e., Institutional Authorization Agreement) is needed. Investigators must still obtain IRB determination from the IRB of record before beginning any study activities. See Reliance Agreements for more information.

How to Submit a Multi-Site or Collaborative Study

Once you are in the electronic IRB system, begin the submission by clicking the “Create New Study” button. On the Basic Information page, the question “What kind of study is this?” select Multi-site or Collaborative study. Follow the SmartForm and attach all requested documents. To submit the study, click the “Submit” activity on the study workspace. Maintain electronic copies of all information submitted to the IRB in case revisions are required. If revisions are needed to documents already in the electronic system, submit a clean version document by using “Update” button next to the document. Do not upload a track-changed document.