1) What needs to be reviewed by the IRB?

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

In addition, any human research that is conducted at another institution/location or in foreign countries by Tufts Medicine or TUHS faculty, staff, or students must be reviewed by the IRB. See IRB Jurisdiction for more details.

2) How do I know whether my study will go to the convened IRB?

Research that presents greater than minimal risk to subjects and/or that does not fall under the categories for expedited review must be reviewed by a convened IRB. This determination is made by the IRB. Please contact the IRB office with any questions about whether your study requires review at a convened IRB meeting.

3) How do I know whether my project qualifies for expedited review, exemption, or if it is Not Human Subjects Research?

The IRB makes the determination as to whether a study qualifies for expedited review, exemption, or a determination of Not Human Subject Research. Minimal-risk projects that fall into one of these three categories are reviewed in the IRB office. These studies are not reviewed at a convened meeting of the IRB; therefore, there are no submission deadlines for these types of studies.

In order to know which documents to submit for your study, carefully review the information about the three categories listed on our website. Please also feel free to call the IRB office at (617) 636-7512 with any questions.

4) Does my study need to be reviewed by the Scientific Review Committee (SRC)?

The SRC routinely reviews greater than minimal risk protocols submitted for review by the convened IRB. The basic requisite for requiring SRC review is that a protocol has not previously undergone an independent, scientific peer review process. You do not need to do anything to send your study to the SRC, but make sure to factor it into the timeline for your study.

The SRC will routinely review new intervention protocols submitted for full committee or convened IRB review except the following:

• Research approved for federal funding* (DoD, DoE, DoJ, EPA, HHS, AHRQ, CDC, FDA, NIH, etc.)
• Research approved for corporation/foundation/organization/association funding utilizing an adequate peer review mechanism
• Research that qualifies for expedited IRB review
• Research that qualifies for exemption from IRB review

*This applies to secured federal funding only (documentation of scientific peer review will be requested at the time of pre-review)

Please note: The IRB and/or the Institutional Officials may, at their discretion, forward any protocol to the SRC at any point during the review process.

Please refer to the SRC webpage for more information.

You can call or email the IRB office at (617) 636-7512 or at IRBOffice@tuftsmedicine.org, and the SRC Coordinator or a member of the IRB office staff will help you.

5) What do I need to submit for a new study?

Submit your study electronically through the eIRB system. Refer to Documents to Upload with eIRB for detailed information on what to include with your new study submission. More instructions for eIRB, including step-by-step guides, can be found on eIRB Tips for HS IRB Studies.

6) Do students’ academic human subjects research projects require IRB approval?

Yes. All student projects must be submitted to the IRB prior to initiation. Student research that involves human subjects, whether biomedical or social/behavioral, requires approval or an exemption determination by the IRB. Please note: student researchers are not eligible to serve as the principal investigator and must list an eligible principal investigator.

7) What do I need to keep for my research records?

The PI is responsible retaining all documents related to a research study. The PI is to retain all original correspondence from the IRB and a copy of all correspondence submitted to the IRB. Refer to the File Review Checklist, Participant File Checklist, and Regulatory Binder Tabs to ensure your study files are complete.

8) I’m working on a project with collaborators from another institution. If my co-investigators receive IRB approval from their institution, do I still need approval from Tufts IRB?

Yes, if Tufts Medicine/TUHS is engaged in research then you will either need IRB approval from Tufts HS IRB or a reliance agreement between Tufts and the other institution. (If you believe that your involvement does not engage Tufts in the research, a submission to Tufts HS IRB is still required so that the IRB may make this determination – see Tufts Not Engaged in Research for submission instructions.)

Each institution develops its own policies and procedures, and our institution’s policies and procedures may differ from other institutions. You will need to submit the forms required by our institutions. See the appropriate submission instructions and contact the IRB office with any questions.

9) I have an appointment at another institution that has an IRB. Do I have to submit research I do at that institution to this IRB?

Yes. Researchers affiliated with Tufts Medicine and/or TUHS must submit for IRB review any project they will be involved in if it is conducted at Tufts and/or conducted on behalf of Tufts. As above, you may either need IRB approval from Tufts HS IRB, a reliance agreement, or a determination that Tufts is not engaged in the research. If you think the project does not fall under the IRB Jurisdiction at all, contact the IRB office.

10) What if I only have a draft of my questionnaire, instrument, etc., or a portion of it (i.e., the consent form or a survey)?

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 the final version receives IRB approval.

11) The study Sponsor has requested an IRB roster. Is this information available?

No, we do not release the IRB rosters. However, in lieu of a roster, you can print the Tufts Health Sciences IRB Statement of Compliance and provide this to your study Sponsor. See IRB Membership Roster for a copy of the statement and for more information.

12) I plan to collaborate with another institution and send them Tufts data for research analysis. Can I submit an initial proposal to the IRB if the data use agreement is still pending?

Investigators can submit their initial IRB applications without a fully executed (signed) data use agreement (DUA), material transfer agreement (MTA) or collaboration agreement. If an agreement has not been established, confirm in a comment in the eIRB that no data and/or specimens will be transferred to another person or entity until an agreement is executed by Tufts MC Grants & Contracts or Tufts University Technology Transfer.