Informed Consent
Requirements
CITI
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Research News @ Tufts


How do I submit a protocol?

Once you have determined that you need IRB review or an exemption, the next step is to write a protocol and submit it to the Office of the Vice Provost for Research at 20 Professors Row. A protocol includes completed cover sheet form and protocol application signed by the PI, consent form(s), copy of survey/interview questions/other instrumentation, and proof of completion of CITI online tutorial. It is very important that your protocol form clearly explain what you intend to do and provide all requested information. Failure to provide complete or clear information may result in a delay of the approval of the protocol. If the IRB does not have sufficient information to make a decision at a meeting, they will often table the proposal to be taken up again at the next meeting, one month later.

Protocols requesting exemption will be reviewed by the IRB administrator. Investigators whose protocols qualify for exemption will be notified by email, normally within one to two weeks of having submitted the protocol. Protocols that are not eligible for exemption will be considered for expedited review. Protocols eligible for expedited review will be reviewed by a single member of the IRB outside of the regular meeting. Protocols that are not eligible for either an exemption or expedited review will be placed on the agenda for the next IRB meeting if submitted by the deadline. Continuing review protocols must also be submitted by the deadline.

The IRB meets once each month. Committee members are mailed copies of all protocols one week prior to the scheduled meeting. All protocols received in the office in time to be photocopied and included in this mailing will be considered at the meeting. Protocols not received in time will be put on the agenda for the next regular meeting.

Research may not begin until you have received a written approval and a stamped, approved consent form from the IRB. Only the approved version of the consent form may be used and it may only be used during the time period for which it has been approved. Using an outdated consent form is considered noncompliance.

 

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