ARCHIVE -- Duke IRB

Start early!

It takes a long long long time to get new protocols approved, and you don't want your funding to be sitting there rotting while you're waiting for the IRB.

Get the New Protocol Form

On the campus IRB website, click on "Amendment Forms" then "Forms for new submissions"). Typically the one we want to use is "request for Protocol Approval," but this may not be the case for truly independent undergraduate work, or if we are doing something that may be exempt from full review-- see here for guidelines.

Make a new folder in psych/BergelsonLab/Lab_Documentation/Protocols/ and title it with the proposed title of your protocol. You don't have an IRB number yet-- the IRB will assign that upon review. Copy the structure of the other protocol files. Note: the title of your protocol must be unique, and if your research will be federally funded, it must share the same name as the primary federal grant supporting the research.

Download your form to psych/BergelsonLab/Lab_Documentation/Protocols/[protocol_name]/in_progress and rename it to "ProtocolName_Bergelson.docx"

Fill out the form, being as descriptive as possible.

However, don't reinvent the wheel. It's absolutely fine to reference other existing protocols and do some copying/pasting for things that will be standard in the lab; e.g. data storage, confidentiality, consent form language, etc.

Once you have described your process in each of the segments on the form, make sure to attach surveys, consent forms, sample recruiting materials, and example stimuli to the end of the document in the appendices. Make sure to make an index with links to each bookmarked appendix.

Add the signature and title of all labe members who will work on the research.

The form will be quite long and that's okay.

Run it past Elika for approval and to make sure we were as thorough and descriptive as possible.

Email to Campus IRB with a nice helpful explanation of why we're opening a new protocol

campusirb@duke.edu. Make sure to attach the form! Check in with the IRB in a few weeks if you haven't heard anything about your protocol.

Once they submit the new protocol to review, you will receive a notification with a newly-assigned protocol number. Rename your files on psych/BergelsonLab/Lab_Documentation/Protocols/ to include this number.

Once approved

Save the copy of the protocol that the IRB sends you into the"current protocol" folder.

Add a section to psych/BergelsonLab/Lab_Documentation/Protocols/IRB_protocols_current.xlsx listing the protocol name, number, in-lab description of the studies covered by that protocol, researchers on the protocol, and the next check in date (provided to you by the IRB-- typically one year from the approval date).

Get to work on your research activities!

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