An IRB Authorization Agreement (IAA) assigns the responsibility for the review of research required under an FWA to one or more IRBs. This IRB can assume this responsibility for another institution, or can cede this responsibility to another IRB.

An IAA is put in place when the relying institution has an FWA*, although it may or may not have a registered IRB.  If you are collaborating with an institution that does not have an FWA, or with an investigator not acting on behalf of an institution, you will need an IIA instead.

Cooperative Research Provision: As of January 20th 2020, all non-exempt cooperative research that is federally funded or supported must rely upon a single reviewing IRB. Research that is not federally funded may rely on a single IRB, or each institution may use its own IRB.

Refer to our guidance on When to Use a Single IRB to determine whether you should use a single-IRB model for collaborative research.

Requests for IAAs are considered by the IRB on a case-by-case basis subject to the approval of the IRB Chair and the Institutional Official.

* A Federal Wide Assurance (FWA) is an agreement between an institution and the U. S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) which requires IRB review of human subjects research as a condition of eligibility for federal grants.

SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is a Reliance Agreement that streamlines IRB review and oversight of multi-site studies.

The goal of the SMART IRB agreement is to reduce duplicative IRB review by naming a single IRB of record for a research project and the institutions that will rely on that single IRB. The SMART IRB agreement eliminates the time and effort typically required to negotiate an IRB authorization agreement for each new study; a reviewing IRB as well as relying institutions can then be designated on a study-by-study basis via the SMART IRB Online Reliance System. The SMART IRB model can be used for a range of research, from large clinical trials to two-site collaborations. 

The SMART IRB Learning Center includes walkthrough videos, a sample reliance request form, and other helpful resources to familiarize yourself with the process for making a reliance request.

To request an account, go to https://reliance.smartirb.org/users/sign_up.

If Tufts Health Sciences IRB is being asked to serve as the single IRB of record, see the resources in the Assuming review over participating sites section below for information about when and how to submit a reliance request.

If a different institution’s IRB is the IRB of record, then the lead study team should submit the SMART IRB request. The Tufts team will not need to do anything in the Online Reliance System, but will receive notifications about the progress of the reliance agreement.

To request permission to use an external IRB (other than WCG IRB and the established networks listed below), follow the instructions on the External-IRB Guidance Checklist for Local Principal Investigator & Study Team. You must submit in eIRB for permission before proceeding with the external IRB.

• For a brief overview of key policies, see Expectations when an external IRB serves as the IRB of record for Tufts as a participating site

Use the External IRB Detailed Instructions worksheet to prepare a submission in eIRB. IRB forms can be found on our Forms webpage and on the eIRB Library. Required documents include:

• Protocol (finalized and already reviewed by the External IRB)
• ICF Template with customizable sections clearly marked, if the Tufts site will enroll participants
• Research Financial Interest Disclosure Form: The Local PI and each local research team member are to complete this form. The Local PI is to submit his/her completed COI form to the IRB. Any form(s) from research team members with “YES” responses are also to be submitted to the IRB. Completed forms for all study team members should be retained in the study files. 
• Form 10B unless you are submitting to WCG IRB
  • Form 8 for submissions to WCG IRB
• Form 12 for all research conducted at MelroseWakefield and/or Lowell General or with MelroseWakefield and/or Lowell General personnel on the study team
• Clinicaltrials.gov Checklist: Required for all studies that utilize an ICF
• Clinical Research Recruitment Website form: Required for all Tufts Medical Center studies that utilize an ICF. For Tufts University studies, MelroseWakefield Healthcare studies, and Lowell General studies, submitting this form for posting studies on this recruitment website is optional.
• If there is research-related radiation: Form 4
• If the research involves a drug or device: Investigator’s Brochures, package inserts, pharmacy manuals, material safety data sheets, Operator/User Manuals, device specifications, IND/IDE documentation, etc.
• Any local context information or forms required by the reviewing IRB (see additional requirements for network agreements below)

Ancillary reviews (Pharmacy, Radiation Safety, Institutional Biosafety Committee) can be processed through eIRB before or after submission. The PI is responsible for ensuring all Ancillary Review comments have been addressed and resolved prior to starting the study.

Once you receive the initial site-specific approval from the External IRB of record, forward the approval letter to the IRB office or attach it to the study in a Comment. You may also upload approved documents to eIRB by clicking “Edit Study.”

Modifications, Continuing Reviews, & New Information Reports for Studies under an External IRB

After initial approval, all following submissions (modifications, changes to the research team, continuing review, AEs/SAEs, unanticipated events, protocol deviations/violations, non-compliance) should be submitted to the external IRB of record.

Changes that should also be submitted to Tufts IRB include: change to the funding source and other major study elements, a change in PI or study team members, or new COIs to report.

• Click “Create Site Modification” in eIRB to update the PI and study team members, and any other responses or documents NOT shown on the Basic Study Information page.
• Click “Update Study Details” to update the Protocol or change any other responses on the Basic Study Information page. (If you use this option, there will be no Submit button. Use the “Add Comment” button to notify an IRB Coordinator of your update.)

Reportable New Information (RNI):

For NCI CIRB studies, refer to the CIRB Division of Responsibilities for information about PI responsibilities around RNI reporting. Contact the IRB staff with any questions.

For other external IRBs, all RNI should be submitted to the external IRB of record. If the external IRB makes an allegation or finding of serious non-compliance and/or continuing non-compliance, notify Tufts IRB by following the instructions for Reportable New Information. Tufts will work with the IRB of record to consider notification to the Office of Human Research Protection (OHRP), US Food and Drug Administration (FDA), and federal agencies.

WCG IRB (formerly Western Institutional Review Board / WIRB):

Follow the instructions on the WCG IRB Guidance Checklist for Local Principal Investigator & Study Team. Studies that meet the eligibility criteria below are eligible to go to WCG IRB. You must receive Tufts IRB’s sign-off in eIRB before proceeding with WCG IRB.

Use the External IRB Detailed Instructions worksheet to prepare a submission in eIRB. Tufts IRB office staff will review the submission to confirm eligibility for WCG IRB and will request any needed ancillary reviews. We will provide you with a signed list of institutional comments to be included in the submission to WCG IRB.

All Tufts MC/TUHS institutional policies pertaining to the institutional ICF format (including the template Introduction), research-related record retention, consent procedures, COI, SAE reporting, HIPAA authorization, institutional inspection/monitoring, research education, PI eligibility, etc., apply to studies submitted to WCG IRB.

WIRB was integrated with several other IRBs in January 2021 to form WCG IRB. All policies that previously applied to WIRB now apply to WCG IRB.

Studies Eligible for Submission to WCG IRB

Studies conducted at Tufts Medical Center (Tufts MC) / Tufts University Health Sciences (TUHS) that meet the following criteria are eligible for submission to WCG IRB:

1. Industry sponsored (or non-federally funded foundation sponsored)
2. Multi-Center
3. Sponsor initiated (Sponsor initiated is defined as sponsor created, designed, and developed)

If the study involves research on an FDA-regulated test article, it must also meet one of the following criteria:

• Drugs, Biologics, Substances: Study is in Phase II, III or IV (Phase I studies are NOT eligible)
• Devices: Study is in pivotal, post-marketing, or equivalent, phase (Pilot or first-in-man studies are NOT eligible)

If the study involves a test article that has been issued an investigational new drug (IND) or investigational device exemption (IDE) number, in order for the study to be eligible for submission to WCG IRB, the IND or IDE number must be issued to the sponsor of the study and not an investigator. If a determination must be made by the IRB about the need for an IND or IDE for a test article (21 CFR 312 or 21 CFR 812) the study will not be eligible for submission to WCG IRB. Arrangements for sub-sites under a Tufts MC or TUHS primary site are the responsibility of the PI to pursue separately with WCG IRB, independent of his/her relationship with Tufts MC or TUHS. Tufts MC and TUHS reserve the right to allow or deny any study submission to WCG IRB.

A Principal Investigator (PI) may choose to submit a study that meets these criteria to either the Tufts Health Sciences IRB or WCG IRB, but not both. If the study has previously been reviewed by the Tufts Health Sciences IRB, then it is not eligible for submission to WCG IRB. Tufts HS IRB cannot approve any research study that has been disapproved by WCG IRB. WCG IRB review would be performed in place of the Tufts Health Sciences IRB review. There is no obligation to use WCG IRB.

WCG IRB Informed Consent Forms

See our Templates page for:

• WIRB Consent Form Template
• WIRB Minor Assent Form
• ICF Template Key

Note: WCG IRB will modify the sponsor’s ICF template to include Tufts ICF template language; however, WCG IRB requires Tufts IRB approval of changes to our template language. To avoid delays, when submitting a WCG IRB study to the Tufts Health Sciences IRB for sign-off, specify any proposed changes to the ICF template language (for example, changes to template HIPAA or confidentiality language). Approval of these changes will be included with the signed institutional comments.

Tufts MC and/or Tufts University Research Administration will review the Costs, Payment, and Research-Related Injury language in the ICF.

NCI CIRB

NCI CIRB: National Cancer Institute Central IRB for Cancer Cooperative Group Studies

Tufts Medical Center and Lowell General Hospital participate in the National Cancer Institute (NCI) Central Institutional Review Board (CIRB). The NCI CIRB supports NCI funded studies and NCI Networks, and serves as the IRB of record for these studies.

Any NCI Cancer Cooperative Group studies can use the NCI CIRB. Follow the submission instructions above.

The Tufts Health Sciences IRB Office will provide notification through eIRB once you are approved to activate the study. Once you receive this approval to proceed, you may submit the Study-Specific Worksheet about Local Context to the CIRB using IRB Manager. Once CIRB approves this worksheet, CIRB is the IRB of record for the study, responsible for study review and local context considerations for the Tufts site.

When to correspond with the Tufts Health Sciences IRB once an NCI CIRB study is active at Tufts MC or Lowell General:

Make the following updates / upload documents in eIRB:

• Changes to the Local PI or Research Team
• New or changed financial Conflicts of Interest
• Regulatory deficiencies cited during audits
• RNI when required per the CIRB Division of Responsibilities

Site-Specific Appendix
The Tufts Health Sciences IRB Site-Specific Appendix is not needed, because the information in this document is included in the CIRB Study-Specific Worksheet about Local Context.

Locally-Developed Material
Any local recruitment tools and locally-developed materials should be submitted to CIRB for review and approval via the Locally-Developed Material Submission Form.

Short Forms
Per Tufts’ Annual Signatory Institution Worksheet about Local Context, Tufts Health Sciences IRB approved short forms may be used per the Tufts Health Sciences IRB short form policy.

CIRB Division of Responsibilities (as described in the IRB Authorization Agreement)

TIN

Trial Innovation Network (TIN)

TIN studies use the SMART IRB agreement, but have already identified an IRB of record, so would not require use of the SMART IRB Online Reliance System. Johns Hopkins University, University of Utah, and Vanderbilt University Medical Center serve as single IRBs for TIN studies.

TIN studies use IRB Reliance Exchange (IREx) to support single IRB review (to facilitate central IRB (CIRB) documentation, communication, and the exchange of information for all TIN studies). IRBs, coordinating centers, and study teams use IREx for the life of a TIN study. The IRB will help you complete the local context information to be entered into IREx.

Follow the instructions above for Ceding Review to an External IRB.

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).

Any StrokeNet studies can use the StrokeNet central IRB. Follow the submission instructions above, and include the StrokeNet Local Site Context Form.

NMDP

National Marrow Donor Program (NMDP)

Any minimal-risk NMDP network studies can use the NMDP IRB. Follow the submission instructions above.

PETAL cIRB

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.

Any PETAL network studies can use the PETAL cIRB. Follow the submission instructions above, and include any required local context forms.

Click here to request permission to identify Tufts Health Sciences IRB as the Single IRB on a grant application.

To request that Tufts Health Sciences IRB assume IRB oversight of other participating sites for a new or existing research study, follow the instructions on the Single-IRB Guidance Checklist for Lead Principal Investigator & Study Team.

• For a more detailed view of which steps can be done at different points in the process, see the Single-IRB Process Flowchart. (If you would rather follow a simpler, linear order of steps, stick with the Checklist above.)
• For a brief overview of key policies, see Expectations when Tufts Health Sciences IRB serves as the IRB of record for a non-Tufts site.
• For a list of each team’s responsibilities, see Communication and Responsibilities - Tufts HSIRB as Single IRB of Record. This will help you develop a communication plan with your collaborators.

Modifications, Reportable New Information, & Continuing Reviews for Relying Sites

Modifications and Reportable New Information can be submitted for individual Sites after initial approval, just as they can be submitted for entire studies. See the Step-by-Step Guide to Modifying a Participating Site for Modification instructions. (Note: You can have a Site Modification open at the same time as another Modification to the main study page!)

Annual continuing review submissions must include updates for each relying site. The Tufts PI should report summaries of the relying sites’ enrollment and research activities by clicking “Report Continuing Review Data” on the left menu of the site workspace. (This button will only show up for the Tufts PI, not for PI Proxies.)

Individual Investigator Agreements (IIAs) bind independent investigators or investigators at institutions that do not already have agreements with the federal government through a Federal Wide Assurance (FWA) to have their human subjects research reviewed by an IRB.  Most investigators working at academic institutions in the United States will already be bound by these agreements and an IRB Authorization Agreement (IAA) will be required instead.  Please refer to the OHRP website for more information on IIAs.

Independent Investigator Agreement

Tufts will consider a request for an Independent Investigator Agreement when the research team member is:

• Not otherwise an employee or agent of Tufts Medical Center / Tufts University / MelroseWakefield Healthcare / Lowell General Hospital;
• Conducting collaborative research activities outside the facilities of Tufts Medical Center / Tufts University / MelroseWakefield Healthcare / Lowell General Hospital; and
• Not acting as an employee of any institution with respect to his or her involvement in the research being conducted by Tufts Medical Center / Tufts University / MelroseWakefield Healthcare / Lowell General Hospital.
• Any payment will be made directly to the collaborating independent investigator, if applicable.

Note: If 2 or more independent investigator agreements are required for investigators at a single institution, institutional investigator agreements (IIAs) may be required.

Institutional Investigator Agreement

Tufts will consider a request for an Institutional Investigator Agreement when the research team member is:

• Not otherwise an employee or agent of Tufts Medical Center / Tufts University / MelroseWakefield Healthcare / Lowell General Hospital;
• Conducting collaborative research activities outside the facilities of Tufts Medical Center / Tufts University / MelroseWakefield Healthcare / Lowell General Hospital;
• Acting as an employee or agent of an institution that does not have an FWA (with respect to his or her involvement in the research being conducted by Tufts Medical Center / Tufts University / MelroseWakefield Healthcare / Lowell General Hospital); and
• Employed by, or acting as an agent of, an institution that does not routinely conduct human subjects research.
• Any payment will be made to the collaborating institution, if applicable.

Note: If the institution routinely conducts human subjects research, then an IIA is not appropriate and the institution must obtain an FWA and execute an IAA for the study.

Requesting an IIA

Requests for IIAs are considered by the IRB on a case-by-case basis subject to the approval of the IRB Chair and the Institutional Official.

To request an IIA for Tufts Health Sciences IRB to assume IRB oversight of an investigator, please include the following with your New Study submission or Modification submission:

• Form 10C – Request for Independent/Institutional Agreement
• Documentation that the external investigator completed their home institution’s education requirements or Tufts’ CITI requirements 
• The external investigator’s curriculum vitae (CV) or resume (unless their qualifications are adequately described in the Protocol or Site-Specific Appendix)
• The Protocol or Site-Specific Appendix should specify the research activity that will be done by the external investigator