Submit and renew an IRB protocol

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This page contains information about: (1) submitting an IRB protocol for review before starting human subjects research at Brown, and (2) renewing an IRB protocol that is ongoing (e.g., annual report). This page is written to someone who is preparing the documentation needed to submit or renew a proposal. Documentation about IRB proposals run by the VRL is kept the filesystem at: /pro/graphics/proposals/brown/.

Submit New Protocols

This section is under construction.

Renew an Ongoing IRB-Approved Protocol

This section is written based on our renewal process for the protocol "Quantifying the Benefits of Scientific Visualization", but these steps could apply to other ongoing protocols.

In general, the IRB contacts PIs annually who have ongoing approved protocols (ones that have not been officially "exempt"). The point of the contact is to either renew the protocol if the experiment(s) it covers are ongoing, or officially close the book on the protocol. In either case, the PI has to submit some paperwork to the IRB, usually a month before the official expiration date of the protocol, or the protocol renewal will lapse and cannot be used.

To begin work on this paperwork, the PI should receive a half-filled in page from the IRB with some of the metadata (PI name, protocol name, expiration date, continuing review number...). In my experience, the best way to finish the report is to run through the following steps.

  1. Before the deadline (hopefully a few weeks), contact all students/researchers who potentially ran a study using this protocol in the last calendar year. Emailing dhlgroup is a good start, but also check with David if he has other students who ran experiments using this protocol who might not be on that list.
    • Ask them to email you a title for their experiment, the number of participants they ran (all of whom should have signed a consent form), a summary of activities and findings, and a summary of any unexpected side effects (e.g., people getting dizzy looking at VR). When you can confirm that you've accounted for all experiments using this protocol, move to the next step.
  2. Double-check that the form has correct info for this year's renewal.
    • You can compare it to a review report from last year, e.g., for 2016 last year's report is at /pro/graphics/proposals/brown/review_01_15/full_2015-01-12.pdf.
    • Make sure the appropriate fields have been copied over and incremented where necessary (i.e., review number)
  3. Question 1 asks about the Protocol Status.
    • For a renewal, check the NO box that asks whether this "project has been completed since the last IRB approval".
    • In the Protocol status YES/NO questions, these will most likely all be NO, but ask David if you have questions.
  4. Question 2 asks about the number of participants who have been run using this protocol. There are two numbers to provide here.
    • The first is "since last approval", and this is the sum of participants who signed a consent form under the protocol in the last year (2015).
    • It is critical to ping everyone in the group to get an update about whether they performed experiments in the last year, and how many participants they ran under this protocol. Participants who were run under a different IRB protocol will be accounted for elsewhere and should not be double-counted here.
    • The second number is "since initial approval", and you can get this by summing the "since last approval" number you included above with the "since initial approval" number last year's form,
  5. Question 3 asks about whether participants were withdrawn in the past year. This is uncommon but it happens. Experimenters should notify you about this when they send you a summary of their experiments/participants.
  6. Question 4 asks you to attach more detailed descriptions of what has been done since the last approval, experiment-wise. Check out the previous year's report for a good example of how to prepare this.
    • Make a copy of last year's report to use as a template, and update the info in the header for the current year (expiration date, and continuing review number).
    • The Brief Lay Summary is a very broad overview of the protocol in a couple paragraphs. It is safe to assume that you can start will last year's summary and take a pass to update any minor changes you see fit.
    • The Progress of the research section includes a numbered list of the specific experiments that were run in the last year.
      • Before filling this out, make sure you've received info about all experiments done under the protocol in the last year.
      • Each experiment needs a Title (if it resulted in a paper, use that paper title), an Experimenter (name of grad student or researcher leading the project), Number of Subjects, a paragraph describing briefly the Methods and Findings, and at the end a summary of Side effects, which will typically say "No adverse events occurred during the execution of the study described above".
    • Finally, attach the Consent Forms that were used in any experiments during the last year. In the 2015 renewal, we have two approved consent from that were used. As a sanity check, these should all already be approved through previous dealing with the IRB. Talk to David ASAP if you discover that an unapproved form was used.

Finally, you can drop off the report at the IRB office in a manila envelope when it is finished unless otherwise instructed to send it electronically.

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