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IRB

Overview

Plan well, plan ahead! Your protocol must be submitted, reviewed and approved in writing by the IRB via UMass e-Protocol before you can start a study. IRB approval can take 4-6 weeks and is valid for a maximum period of one year (unless the study was found to be exempt, in which case it’s three years).

Protocol examples

Protocol for acceptability judgments

Important deadlines

Applications not requiring full board review are reviewed on a rolling basis upon submission of all necessary materials. The studies we do typically qualify for Expedited Review. Be strategic about IRB submission deadlines and meeting dates. You may also find the Human Subjects FAQ helpful.

Making changes

All modifications to a project previously approved must be received and approved by the IRB before they are initiated, except where necessary to eliminate apparent immediate hazard to the subject. This includes:

  • adding RAs
  • changing language used in advertising blurbs on flyers or in SONA
  • editing consent/demographics forms

...

In SONA as well, you'll need to confirm with an administrator that you’ve gotten any modifications to a study description approved by the IRB in order to make any changes in the system. Only administrators may make changes to a study in SONA after it has been marked as Approved.

Submit your protocol for review

You must complete CITI training for human subjects (take the Group 2 course) before contacting the Human Research Protection Office (HRPO) to receive login information for e-Protocol (see the e-Protocol User Guide for detailed help, complete with helpful screencaps).

Studies undertaken by students must be sponsored by a faculty advisor. Postdocs may submit independently if they have written approval from the Department and Dean -- otherwise they should submit listing the faculty mentor as Co-Investigator.

Address any reviewer comments

Part of your protocol should include a blurb or blurbs for advertising as part of your description of how you'll be recruiting subjects, and it's those approved blurbs you must use. You may find these IRB guidelines for advertising and recruitment helpful.

Compensate your subjects

Cash or credit

To pay subjects in cash, the PI will have to submit a form, with the IRB approval attached. There's a $100/subject and a $600 total non-payroll compensation/subject/year limit to human subject cash advances. Participants will have to sign a release form for their payment. For more details and other options, see the Human Subject Compensation guidelines.

You may give participants the option to earn either cash or credit for their participation, but in that case you should set it up in SONA as a for-credit study and note in the description that participants may choose to receive cash compensation instead. If a participant chooses to receive monetary compensation, you should grant credit, but mark the credit as 0 credits, and then note in the comments for the timeslot that payment was received.

See the SONA guide on for-credit studies.

Multi-part studies

Participants must be compensated for each day that they participate (so you can't leave payment until the last day). You may adjust the times and compensation per day, however (e.g., $5 the first day, $10 + $5 dollar bonus on the last day if they complete the study within a week).