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These links provide instructions for making a request to the Tufts Health Sciences IRB to consider ceding oversight to another IRB or assuming IRB oversight of a research study:

Complete FORM 10: IAA/IIA Request Form when requesting:

Activating an Individual Study Through an Existing IRB Authorization Agreement

Requests to activate individual studies through an existing agreement:

  • Central IRB networks: FORM 9: Central IRB for Network Studies Form
    • NCI CIRB [National Cancer Institute (NCI) Central IRB for Cooperative Group Studies]
    • CEGIR [Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR); Cincinnati Children’s Hospital Medical Center (CCHMC) is the coordinating center and central IRB]

IRB Reliance Options for Tufts Investigators

What is it? Which studies can use this option?
Tufts Health Sciences IRB The Tufts Health Sciences IRB is our institution’s local IRB, made up of 2 panels which each meet monthly.

 

Any study
Western IRB (WIRB) WIRB is a commercial IRB.  Refer to the IRB’s WIRB webpage for more information & instructions for obtaining authorization to submit a study to WIRB.

 

Phase II, III, and IV multi-center, industry sponsored (sponsor initiated) studies.
IRBchoice IRBchoice is a joint IRB review model for multisite studies that provides a mechanism to streamline IRB submission and the IRB review process at all phases of IRB review through the sharing of and reliance on IRB-approved documents between IRBs.

 

Any multi-center study where one IRB is willing to post their review to IRBchoice and act as a lead site and other IRBs are willing to share the lead site’s review. Tufts Health Sciences IRB would still be the IRB of record for the Tufts site. Refer to the IRB’s IRBchoice webpage for more information & instructions for initiating a study under IRBchoice.
Harvard Catalyst Reliance Agreement This is an agreement that can be used when collaborating with an institution that has signed the Harvard Catalyst Master Reciprocal Common IRB Reliance Agreement. Multi-site collaborations with institutions that have signed the Harvard Catalyst Reliance Agreement.  Refer to the IRB’s Harvard Catalyst Reliance Agreement webpage for more information & instructions for initiating a study under the Harvard Catalyst Reliance Agreement.

 

IRB Authorization Agreement (IAA) This is the generic name for an agreement where Tufts Medical Center or Tufts University would rely on another IRB or another IRB would rely on Tufts. Multi-site collaborations where the institutions have agreed to a reliance. Tufts Medical Center or Tufts University would take into consideration the level of risk associated with the research, the location, oversight, and other factors.  Refer to the IRB’s IAA webpage for more information & instructions for requesting an IAA.

 

Individual Investigator Agreement (IIA) This is the generic name for an agreement where Tufts Medical Center or Tufts University would cover research activity of an individual investigator not associated with another IRB. Studies where Tufts Medical Center or Tufts University agrees to cover the activity of a research team member whose institution does not have its own FWA or IRB.  Refer to the IRB’s IIA webpage for more information & instructions for requesting an IIA.

 

Established Network Agreements

NCI CIRB National Cancer Institute Central IRB for Cancer Cooperative Group Studies; CIRB Independent Model NCI Cancer Cooperative Group studies.  Refer to the IRB’s CIRB webpage for more information & instructions for activating a CIRB study.

 

NIH StrokeNet The Stroke Trials Network (NIH StrokeNet); University of Cincinnati is the national coordinating center and central IRB; MGH is the Regional Coordination Center (RCC)

 

Stroke Trials Network (NIH StrokeNet) studies. Contact the IRB Office (ext. 6-7512) for information about activating a new study through the StrokeNet Trials network.
PETAL cIRB Prevention and Early Treatment of Acute Lung Injury (PETAL) funded by the National Heart, Lung, and Blood Institute (NHLBI) for Acute Respiratory Distress Syndrome (ARDS); PETAL cIRB is through Vanderbilt University

 

Prevention and Early Treatment of Acute Lung Injury (PETAL) funded by the National Heart, Lung, and Blood Institute (NHLBI) for Acute Respiratory Distress Syndrome (ARDS).  Contact the IRB Office (ext. 6-7512) for information about activating a new study through the PETAL network.
 CEGIR Network Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR); Cincinnati Children’s Hospital Medical Center (CCHMC) is the coordinating center and central IRB

 

Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) studies.  Refer to the IRB’s CEGIR webpage for more information & instructions for activating a CEGIR study.