Single IRB Review for Multi-Site Research

As of January 20th, 2020, all non-exempt cooperative research that is funded by a Common Rule agency must rely on a single Institutional Review Board (sIRB). This page provides instructions for research teams considering ceding oversight to another IRB or requesting the Dana-Farber Cancer Institute (DFCI) IRB to consider serving as the IRB of record for a collaborating site or investigator.

This policy applies to Federally funded cooperative research and will be applied to studies that involve more than one institution conducting research with human subjects, regardless of whether each institution is carrying out the same human subject research activities. More information on this policy can be found on the National Institute of Health’s website.

Each request to take on or cede IRB oversight for a study is carefully considered on a case-by-case basis by a group of individuals that include the Institutional Official, Director, Associate Director, and sIRB Reliance Analyst of the Office for Human Research Studies.


The Request to Rely Process

Before submitting a New Project Application, the investigator and/or research team must submit a Request to Rely application in iRIS. This allows the DFCI IRB to determine if it is applicable to cede the research project to an external IRB or serve as the IRB of record.

The DFCI IRB is the designated single IRB for oncology trials for Dana-Farber/Harvard Cancer Center (DF/HCC) member institutions which include:

  • Beth-Israel Deaconess Medical Center (BIDMC)
  • Boston Children’s Hospital (BCH)
  • Brigham and Women’s Hospital (BWH)
  • Dana-Farber Cancer Institute (DFCI)
  • Massachusetts General Hospital (MGH)

The DF/HCC member institutions do not need to submit a Request to Rely application when relying on the DFCI IRB because of the established reciprocal reliance agreements.

If you are relying on the National Cancer Institute Central IRB (NCI IRB) or the National Marrow and Donor Program IRB (NMDP IRB), then a Request to Rely application is not required because of the established master reliance agreement that applies to all oncology-related research. The research team may proceed with submitting the New Project Application in iRIS for review.

IRB Authorization Agreement (IAA)/Reliance Agreements

An IRB Authorization Agreement (IAA), or reliance agreement, is a formal written agreement between two or more sites that are collaborating in non-exempt human subjects research. This agreement outlines each site’s responsibilities in the oversight of research and identifies which IRB will serve as the IRB of record for the proposed research project. An IAA may be used when the relying site has a Federalwide Assurance (FWA), although it may or may not have a registered IRB. If a research team is collaborating with a site that does not have a FWA or with an investigator that is not acting on behalf of a site, then an Individual Investigator Agreement (IIA) must be used instead. Federalwide Assurance (FWA): an agreement between an institution and the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) which requires IRB review of human subjects research as a condition of eligibility for federal grants.

Individual Investigator Agreement (IIA)

In some circumstances, agreements may need to be established between independent investigators or investigators at an institution that do not have a Federalwide Assurance (FWA) and therefore not have an IRB overseeing their research activities. For more information on these agreements, please review the Office for Human Research Protections (OHRP) website.

Individual Investigator Agreement (IIA)
The DFCI IRB will consider a request for an Individual Investigator Agreement when the research team member is:

  • Not otherwise an agent or employee of the Dana-Farber Harvard Cancer Center (DF/HCC);
  • Conducting collaborative human subjects research activities; and
  • Not acting as an employee or agent of any FWA-covered institution with respect to their involvement in the research being conducted at DF/HCC.

Requesting an IIA
Requests for IIAs are considered by the DFCI IRB on a case-by-case basis subject to the approval of the DFCI Institutional or Signatory Official.

To request an IIA for the DFCI IRB to assume IRB oversight of an investigator, please include the following in an email correspondence to OHRS:

  • The external investigator’s resume or curriculum vitae (CV), and
  • An explanation of the research activities that will be conducted by the external investigator.

The SMART IRB Platform

In cases where an existing reliance agreement cannot be used, DFCI can enter in to a reliance agreement via the Streamlined Multisite, Accelerated Resources for Trials IRB Reliance Platform. SMART IRB an online reliance platform that streamlines the reliance process for multi-site studies. The goal of this platform is to minimize duplicative IRB reviews by establishing a single IRB for relying sites. The SMART IRB platform may be used for a range of research from a two (2) site research project to a large clinical trial. A request to rely is still required for studies utilizing the SMART platform. 

Creating a SMART IRB Account
Research team members will need to create a personal account for studies implementing the SMART IRB Platform. A representative from the research team will be responsible for uploading pertinent study related documents to the SMART platform. When requesting an account, the following information is required:

  • First Name
  • Last Name
  • Email (user ID)
  • Home Institution
  • Password

It is important to note that the home institution refers to the primary consortium site that the investigator is affiliated with. If the Dana-Farber Cancer Institute is not the primary consortium site, then the SMART IRB account will have to be approved by the investigator’s primary affiliated site IRB personnel. 

Navigating the SMART IRB Platform
The SMART IRB Learning Center includes walkthrough videos and companion resources designed to assist investigators and research teams in establishing a reliance request for their research. The investigator must work with the sponsor when determining a single IRB that will assume IRB oversight for relying sites through SMART IRB. Please review the following steps in detail.

  • Submit a Request to Rely in iRIS to obtain institutional approval for a proposal to use SMART IRB. If there are other DF/HCC consortium sites, besides DFCI, that are engaged in the research, OHRS will communicate with those IRB personnel to ensure that they agree to cede IRB oversight.
  • Confirm that the collaborating sites have agreed to rely on a single IRB.
  • Confirm that the single IRB and the relying sites are  listed in the SMART IRB participating institutions
  • Submit a SMART IRB reliance request that records the:
    • Reviewing IRB – the institution whose IRB will be conducting the review
    • Relying Sites – include all institutions involved in the collaborative research
    • Protocol Document
    • Consent Form(s), if applicable.

To finalize the SMART IRB online reliance agreement, all collaborating sites will submit their reliance decisions through SMART IRB. Once all decisions have been entered the SMART IRB will send the reviewing and relying sites an email notification with a determination letter. This letter does not replace the IRB review and approval processes that are required by the reviewing IRB.

NCI CIRB

The National Cancer Institute Central Institutional Review Board (NCI CIRB) serves as the single IRB for cancer cooperative group research. Phase I through IV trials may be ceded to the NCI CIRB without the submission of Request to Rely application.

When you are ready, please submit a New Protocol Application submission  through iRIS.

You can also view a comprehensive training on using the NCI CIRB which includes the submission process and other requirements for study teams.

Advarra

What is Advarra?

Advarra Institutional Review Board (IRB) was formed after the merger of  Chesapeake, Quorum, and Schulman IRBs. Advarra is an AAHRPP accredited business providing services for academic and non-academic institutions.

Creating a CIRBI Account

The review process for Advarra is conducted through CIRBI, it's online system. Prior to submission, a log in must be created by providing individual and institutional information including:

  • First Name
  • Last Name
  • Email 
  • Institutional Address
  • Questions regarding the type of research PI conducts

Advarra Review process

  1. The DF/HCC research teams submit a Request to Rely in iRIS. If the study is eligible, the research team will receive a Request to Rely approval memo from iRIS indicating that the study is eligible to rely on an external IRB. 
  2. The DF/HCC research teams submit a New Protocol Application in iRIS indicating Advarra as the IRB of record. 
  3. Various DF/HCC committees, including ancillary, feasibility, and SRC reviews will begin.
  4. Once SRC approval is granted, the research team may submit their protocol in CIRBI.  
  5. After Advarra approval is granted, all approved study documents, as well as Advarra approval are uploaded in iRIS to prepare for study activation.

WIRB Copernicus Group (WCG)

What is WCG IRB?

WCG IRB is an independent IRB which conducts reviews for both academic and non-academic institutions. WCG IRB is AAHRPP accredited and may be utilized for all Phase II and III trials. Additional information can be found in the  WCG FAQs below.

Creating a Connexus Account

WCG utilizes an online protocol management system named Connexus. Research team members will need to create an account for studies that rely on the WCG IRB. A representative from the research team may be responsible for submitting any local submissions  and uploading any study related documents in the Connexus portal. When requesting an account, the following information is required: 

  • First Name
  • Last Name
  • Email (user ID)
  • Password

Note: Once you have created a Connexus account, you may request to obtain different access privileges. OHRS recommends that at least one research team member should have managerial access to the study in the  portal. 

WCG Review process

  1. The DF/HCC research teams submit a Request to Rely in iRIS. If the study is eligible, the research team will receive a Request to Rely approval memo from iRIS indicating that the study is eligible to rely on an external IRB. 
  2. The DF/HCC research teams submit a New Protocol Application in iRIS indicating WCG as the IRB of record. 
  3. Various DF/HCC committees, including ancillary, feasibility, and SRC reviews will begin.
  4. Once SRC approval is granted, the research team may submit their protocol in Connexus. Please Note: Each DF/HCC site must submit to WCG IRB separately. 
  5. After WCG approval is granted, all approved study documents, as well as WCG approval are uploaded in iRIS to prepare for study activation.

National Marrow Donor Program

What is National Marrow Donor Program (NMDP) IRB?

The NMDP/Be The Match IRB protects the rights and welfare of individuals who participate in research, including unrelated volunteer donors listed on the Be the Match Registry and donors and recipients participating in research sponsored by the Center for International Blood and Marrow Transplant Research or the Blood and Marrow Transplant Clinical Trials Network BMT CTN.

OHRS works annually with NMDP to provide local signatory context information and an approved consent form template. Protocol specific local context issues are conveyed to NMDP by the PI through completion of the NMDP sIRB Study-Specific Local Context Worksheet in IRBManager.