Frequently Asked Questions (FAQ's)

It depends on whether or not the Research has previously undergone peer review. Please click here to see if your study requires SRC review.

You can contact Elizabeth Grimm, the SRC Coordinator, at (617) 636-1344, or the main IRB office at (617)636-7512.

The PI, all co-investigators, and any person who is involved in the conduct of a research study must complete one of the two recognized education modules.

If any specimen (blood, tissue, sera, urine, stool, saliva, etc.) will be stored for future use, Form VI and the corresponding optional tissue banking informed consent form are to be submitted to the IRB for review. Please consult the Institutional tissue banking guidelines for guidance.

All submissions are reviewed in the order of receipt unless a patient is identified for a treatment intervention study and is eligible and interested in participating in the study. Responses are sent via interdepartmental mail to the PI. If the submission was to be reviewed by expedited review procedures please allow at least 10 business days before contacting the IRB office regarding the status.

If a study requires SRC review, that must happen first. Once a study is approved by the SRC to proceed to the IRB, or if SRC review is not required, it will be prereviewed by the IRB Office. If the submission is complete (all necessary documents present and complete, including required signatures and supporting documents) it is forwarded to the next possible meeting agenda. After the convened IRB meeting, letters of of review comments are sent to the Principal Investigator within 2 weeks of IRB review.

Provided the submission is complete, a new exempt study is generally reviewed in 10 business days.

Provided the submission is complete, a new expedited study is generally reviewed in 10 business days.

If the amendment requires full IRB review, it will be placed on the next available IRB agenda. If the amendment may be reviewed by expedited review procedures, it will be reviewed in the order of receipt. Depending on the number of submissions received, documentation is generally reviewed within 10 business days of receipt.

Generally an advertisement is reviewed within 5 business days, depending on the number of submissions received in the IRB office.

Provided the documentation is complete and addresses all questions, revisions, etc., posed by the IRB, the submission is generally reviewed within 10 business days. Items are reviewed in the order of receipt. In order to decrease the amount of time it takes to receive your final approval, please respond to all comments point by point and provide a rationale or justification for any recommended or requested revisions that were not made.

Yes, any material given to subjects or used in recruitment of study subjects must be reviewed and approved by the IRB office prior to use.

A protocol is a document that details the conduct of a research study and includes the operational details of the study. Please click here for the protocol template.

A new research study submitted for full IRB review is to include the necessary forms (Form I, II, III, IV, VI, as appropriate) with original signatures and 1 copy of each original signature forms, 2 copies of the protocol, and 2 copies of the informed consent form.

2 copies of any supporting documentation is also to be included, for example, Investigator's Brochure, package insert information, device manual, etc.

2 copies of proposed advertisements, questionnaires, etc., are also to be included.

If the study is supported by a grant, 2 copies of the grant are also required.

The original signature Form V and 1 copy, 2 copies of the protocol, 2 copies of the informed consent form, 2 copies of any supporting documentation (i.e., Investigator's Brochure, device user's manual). 2 copies of any questionnaires, advertisements, pamphlets, etc., are to be submitted.

If the study is supported by a grant, 2 copies of the grant are also required.

If there are revisions to the protocol and/or informed consent form, 2 tracked copies and 2 untracked copies of the document(s) are to be included.

If an amendment or revisions are included, a cover letter detailing the changes signed by the PI is to be included. One set of copies must be single sided.

Any research conducted on or by faculty, staff, or students at Tufts Medical Center or Tufts University Health Sciences (TUHS), or their affiliates that involves human subjects, or human subjects records, requires IRB review. This is true regardless of the funding source or area of research.

Any human research that is conducted at another institution or in foreign countries by Tufts Medical Center or TUHS faculty, staff, or students must be reviewed by the IRB.

The PI is responsible for safe maintenance of all documents related to a given research study. The PI is to retain all original correspondence from the IRB and a copy of all correspondence submitted to the IRB.

No. All serious adverse events/IND safety reports must be submitted with a single, PI-signed AE cover sheet.

No. The IRB roster is confidential. In lieu of a roster, you can print a memorandum of FWA verification which will provide the sponsor with an assurance that this IRB complies with all federal standard governing the conduct of an IRB.

No. Once a research study is terminated, your regulatory requirement has been fulfilled and the IRB will no longer accept submissions for the study. It is strongly suggested that you consult the sponsor before terminating a research study with a sponsor.

An IAA must be submitted to the IRB office, attention David Chelmow, MD, IRB Chair. Each IAA must be accompanied by a detailed cover letter, which identifies the research study the IAA pertains to, and the exact duties this IRB, or another IRB, will be required to fulfill. The IRB Executive Committee will consider the IAA. If the IAA is approved by the IRB Executive Committee, it will by signed by the IRB Institutional Official of your institution.

WIRB is an option at Tufts Medical Center and TUHS for select studies. Only Phase III, industry (for-profit) sponsored, multi-centered, sponsor initiated (defined as sponsor created, designed, and developed) studies are eligible for WIRB review. A Principal Investigator (PI) may choose to submit such a study to either the Tufts MC/TUHS IRB or WIRB. An eligible research study may only be submitted to and reviewed by the Tufts MC/TUHS IRB or WIRB, not both. For more information, please see the WIRB page on the IRB website.

Yes. Researchers affiliated with Tufts Medical Center and/or Tufts University Health Sciences must submit for IRB review any human research project they will be involved in if it is conducted at Tufts Medical Center and/or TUHS.

If human subjects are involved, then yes. Student research that involves human subjects, whether of a biomedical or social-scientific nature, requires approval or granting of exemption by the IRB prior to initiation. Please note: student researchers are required to have a faculty sponsor for each research project.

You will place the Institutions out of compliance with Federal requirements that regulate human subjects research. This can result in Federal or IRB actions that will prevent you, your Department/Division, or the Institution from conducting human subjects research. It will also jeopardize the Institution's human research certification with the Office for Human Research Protections (the FWA).

No. Each AE report form must contain an original ink signature of the Principal Investigator. If the event must be reported to the IRB immediately call the IRB office at (617) 636-7512 and make an initial verbal report. A verbal report is not a substitute for a written report. Please do not submit routine AE reports via email.

No. At this time, the IRB only accepts hard copies of documents with a cover letter/form signed by the Principal Investigator, or, under special circumstances, a Co-Investigator.

Yes. Each institution develops its own policies and procedures regarding the use of human subjects in research. As a result, our institution's policies and procedures may differ from the other institution. You need to submit the required forms for our institutions and should include a copy of the other institution's IRB approval, including their approved protocol, and informed consent form (ICF), if applicable.

Submit your draft as a "DRAFT" instrument. This will allow the IRB to review what you are proposing to do. Be certain to provide information regarding your plans to finalize the instrument and a timeline for completion. The instrument may only be used after it receives IRB approval.

Risk is defined by the federal regulation to the probability of harm or inquiry (harm can be physical, psychological, social, or financial) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

Yes. The IRB office is exploring options to facilitate electronic submissions.

Yes.

No, federal guidance states that current IRB approval is needed.