Studies conducted at Tufts Medical Center (Tufts MC) / Tufts University Health Sciences (TUHS) that meet the following criteria are eligible for submission to WIRB:
Industry sponsored (or non-federally funded foundation sponsored)
Sponsor initiated (Sponsor initiated is defined as sponsor created, designed, and developed)
If the study involves research on an FDA regulated test article, it meets 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)
A Principal Investigator (PI) may choose to submit a study that meets these criteria to either the Tufts Health Sciences IRB or WIRB, but not both. If the study has previously been reviewed by the Tufts Health Sciences IRB, then it is not eligible for submission to WIRB. Tufts MC and Tufts University cannot approve any research study that has been disapproved by WIRB. WIRB review would be performed in place of the Tufts Health Sciences IRB review. There is no obligation to use WIRB.
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 WIRB, 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 WIRB. Arrangements for sub-sites under a Tufts MC or TUHS primary site are the responsibility of the PI to pursue separately with WIRB, 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 WIRB.
Please contact WIRB for fee schedule information. There is a Tufts MC/TUHS fee of $1000 for studies reviewed by WIRB in addition to WIRB’s fee schedule.
Studies that will be reviewed through the WIRB-Copernicus Single Review Solution (SRS) are eligible for submission to WIRB if they meet the above criteria. If a study is submitted as part of the WIRB-Copernicus SRS, a WIRB application must be completed and submitted directly to WIRB (www.WIRB.com). WIRB will provide an approval letter – Do NOT submit the application to the Copernicus Group IRB or the WIRB-Copernicus Group.
Call the IRB Office (ext. 6-7512) if you have any questions about this before you begin your application
Paper documents will not be accepted. All documents with original signatures must be submitted as scanned PDFs. The PI must retain the original documents. Other components of the submission may be in WORD or PDF format. Each document should be saved separately. If documents are password protected, please provide the passwords.
Submit the following documents to the Tufts Health Sciences IRB:
A completed Form 8 signed by the Investigator and Department Chair/Division Chief. Every field in Form 8 must be completed; incomplete forms might result in delays.
A copy of the study protocol, including any appendices and supplemental documents provided by the sponsor.
If the study includes a drug/biologic/substance (including placebo), submit:
Test article Operator/User Manual, device specifications, etc.,
A signed institutional Conflict of Interest (COI) form for the PI. Each research team member must complete a research COI form. Submit the PI’s signed COI form along with the COI form of any research team member with a “YES” response in any field.
Documentation of approval from each institutional committee (as required based on the study) or confirmation from the institutional committee (e.g. Radiation Safety) that review is not required.
A copy of the sponsor’s template informed consent form (ICF) with proposed final language for the Costs, Payment, and Research-Related Injury sections (including any language required by the Radiation Safety Officer) included, as these sections will be reviewed before the study is submitted to WIRB.
Note: WIRB will modify the sponsor’s ICF template to include Tufts ICF template language; however WIRB requires Tufts IRB approval of changes to our template language. To avoid delay, when submitting a WIRB 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 Form 8.
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 form, institutional inspection/monitoring, research education, etc., apply to studies submitted to WIRB.
Tufts Health Sciences IRB office staff will review the submitted documents to confirm eligibility for submission to WIRB and will verify Institutional Committee Reviews:
Radiation Safety Committee (RSC)
Institutional Biosafety Committee (IBC)
Investigational Drug Service (IDS) pharmacy review
Proposed changes to Tufts ICF template language
Tufts Health Sciences IRB staff will facilitate additional Institutional Committee Reviews:
Tufts MC and/or Tufts University Research Administration will review the Costs, Payment, and Research-Related Injury language in the informed consent form.
IRB staff will include any Tufts MC / TUHS institutional committee review comments on the signed Form 8 to notify WIRB of any comments
Once the institutional Committee Reviews are complete, the IRB staff person will print and sign the Form 8 and e-mail the signed Form 8 to the PI. The original Form 8, signed by the IRB office staff person, will be retained in the IRB office.
After the PI receives the signed Form 8 for the study, the PI may submit the study directly to WIRB.
The PI and research team members are to communicate directly with WIRB and submit all future study-related documents directly to WIRB without submitting copies to Tufts Health Sciences IRB office.
For example, changes to the research team, advertisements, amendments/revisions, continuing review, AEs/SAEs, unanticipated events, protocol deviations/violations, non-compliance must be submitted to WIRB.
Tufts Health Sciences IRB Office Staff will e-mail the signed Form 8 to the PI.
Contact the Tufts MC / TUHS IRB office at (617) 636-7512 with questions about this WIRB process.
As with all studies submitted to the Tufts Health Sciences IRB, the PI is to obtain review and approval from applicable institutional committees before submitting Form 8 to the Tufts Health Sciences IRB office.
Institutional committees include:
Radiation Safety Committee (RSC): Approval is required if the study includes research-related ionizing radiation. If subjects will be exposed to ionizing radiation as a result of study participation, a Form 4 is to be submitted to the RSC. The Radiation Safety Officer (RSO) will provide a signed Form 4 to the PI to submit to the Tufts Health Sciences IRB along with Form 8.
If the study involves exposure to ionizing radiation, but the exposure is standard care (i.e., the subject would receive regardless of participation in the research study) the PI is to send a copy of the protocol and template ICF to the RSO, who will confirm the PI’s assessment or will request a Form 4. Provide RSO confirmation to the Tufts Health Sciences IRB along with Form 8.
Institutional Biosafety Committee (IBC): Required if the study involves biohazardous materials that include pathogenic microorganisms, infectious materials, biological toxins, recombinant DNA, and select agents. The IBC will provide a letter to the PI after IBC review. Submit a scanned copy of this letter to the Tufts Health Science IRB along with Form 8.
Investigational Drug Service (IDS): If the study includes a drug/biologic/substance (including placebo), the PI is to request IDS review. Provide the Pharmacy Review along with the Form 8.
The PI is to retain all correspondence, including any signed originals, in the study files.
(After the Tufts Health Sciences IRB has Signed-off on Form 8)
WIRB requires Tufts Health Sciences IRB sign off (Form 8)
The WIRB application asks, “Does this site have an obligation to use another IRB?” This refers to the Tufts site having an obligation to any IRB other than the Tufts Health Sciences IRB.
Studies that will be reviewed through the WIRB-Copernicus Single Review Solution (SRS) mechanism are eligible for submission to WIRB, if they meet all eligibility criteria. If a study is submitted as part of the WIRB-Copernicus SRS, a WIRB application must be completed and submitted directly to WIRB (www.WIRB.com). WIRB will provide an approval letter. Do NOTsubmit the application to the Copernicus Group IRB or the WIRB-Copernicus Group.
WIRB has a shorter submission form for those studies that have previously been reviewed by WIRB for other sites. The PI or a research team member is to contact WIRB directly to determine whether the short form is allowable: (800) 562-4789 or email@example.com. Please be sure to submit the correct form, as submitting the short form when the study has not been previously reviewed will lead to delay and extra effort.
Contact WIRB directly with any questions about submitting a study to WIRB.
The PI and research team are to communicate directly with WIRB about the study and are to submit all future documents directly to WIRB for review/approval without submitting copies to the Tufts Health Sciences IRB office.
WIRB will notify the Tufts IRB office staff of non-compliance findings. Non-compliance is subject to review by the Tufts Health Sciences IRB. Notification to the Office of Human Research Protection (OHRP), US Food and Drug Administration (FDA), and federal agencies will be addressed by Tufts Health Sciences IRB.
WIRB will send an invoice for services rendered directly to the study sponsor. If information is needed regarding the appropriate sponsor contact for the invoice, please contact your research administrator.
Tufts Medical Center will not accept any WIRB invoices. All invoices from WIRB must be paid directly by the study funding source. At no time will Tufts Medical Center pay WIRB and invoice the sponsor on a pass-through basis.
Refer to the WIRB website for detailed instructions for submitting a study directly to WIRB.