FAQ (Frequently Asked Questions)

Does the IRB review requirement vary by funding source?
Tufts University is allowed to participate in human subject research under an agreement with the federal government called a Federal Wide Assurance (FWA). Like most universities, Tufts does not distinguish between funding sources in its requirement for IRB review. Any human subject research, whether funded or not, is subject to the same requirements.

Does student research require IRB review?
Students who conduct research involving human subjects must abide by the same standards for the protection of those subjects as the faculty. Students are required to have a faculty advisor's approval to conduct research.

What is the responsiblity of the researcher?
Researchers are responsible not only for obtaining the required approval from the IRB but also for doing their best to protect the rights and welfare of human subjects. This includes complying with all provisions of the Tufts FWA and the Code of Federal Regulations, following the prescribed protocol, requesting IRB approval for any changes to the approved protocol using the modification form, using only the approved version of a consent form, keeping accurate and complete records (including a complete, original, signed consent form for every subject), protecting subject privacy, making a good faith effort to present the consent form in a manner and setting that is conducive to the subject's understanding of it, reporting at least annually to the IRB on the progress of the research using the continuing review form, and informing the IRB in a timely manner of any adverse or unexpected events using the adverse report form that occur in the course of the research. Proposed changes to an approved protocol can not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.

What if the research happens off campus?
Tufts University researchers who are conducting research entirely at another institution where the research will be reviewed and approved by a duly constituted, registered IRB with an active FWA may request that Tufts defer to that IRB for the particular protocol in order to avoid having two IRB's independently reviewing the same protocol. Deferral to another IRB will be at the sole discretion of the Vice Provost and will only be done in circumstances where the protocol is one that could reasonably have been approved by our own IRB, where there is no reason to expect that the other IRB will perform the review with any lower standard than would have been applied by our own IRB, and where an adequate program for the protection of human subjects appears to be in place. Requests for deferral to another IRB should be initiated with IRB Administrator.

When should I submit my protocol?
At least three weeks prior to the committee meeting.

How will I find out about the status of my protocol?
Contact the IRB Administrator, Yvonne Wakeford.

What can happen if I do not have my research reviewed by the IRB?
Failure to obtain IRB approval or an exemption prior to beginning human subject research is considered noncompliance. The University is required to report serious or continuing non-compliance or the suspension of human subject research to the Office of Human Research Protections at the Department of Health and Human Services and to any funding agencies that may be involved. For the researcher, noncompliance can result in suspension of research, inability to publish, destruction of data, and other sanctions. For the institution, it could mean the suspension of our FWA, which would cause all human subject research at Tufts to stop until we could get the FWA reinstated. Often, reinstatement requires that all studies be reviewed again before they resume. This is a serious matter for both individuals and for the community and it is critically important that everyone follow the appropriate procedures for human subject research.