Human Subjects / IRB QuickStart

Before you are allowed to experiment with people, you need approval from the IRB. There are two steps to this:

1. Get Human Subjects Certification so you are approved to submit IRB applications and work with human subjects.
2. Get your proposal approved by the IRB.

This stuff is all covered at http://humansubjects.stanford.edu, but here is the short version:

Getting Human Subjects Certification

To get Human Subjects Certification, you need to complete the "Required Collaborative IRB Training Initiative Training." You only need to endure this once every two years. It's easy:

1. Go to https://www.citiprogram.org/default.asp
2. Register for the tutorial using the "Register for the CITI Course" link, select "Stanford University" under "All Others," and then make yourself a username and password.
3. Log yourself in and follow instructions to take the "Basic Course."
4. To get through a unit quickly:
   • Open the link to the unit (e.g., "History and Ethical Principles").
   • DO NOT READ IT YET -- skip to the bottom.
   • Hold down the shift key and click "Take the Quiz." Another browser window will open.
   • Read the questions. Answer the really obvious ones.
   • Go back to the first window with the lesson unit text and read it, keeping the questions in mind (or in view).
   • When finished reading, answer the remaining questions and close the lesson unit text window (NOT the quiz window).
   • Submit the quiz answers, and move on to the next unit.
   • Repeat for all units.
   • Is this cheating? No. It's strategic test-taking.
5. In addition to the 7 standard units and the Stanford one, you have to complete 2 optional ones. I recommend "Research with Prisoners - SBR" and "Vulnerable Subjects- Research With Prisoners" as interesting options.
6. You are now approved to work with people. Congratulations!

Getting Your IRB Proposal Approved

1. Determine the review type you need at http://humansubjects.stanford.edu/research/review_type.html.
   • Chances are, you qualify for expedited review.
   • You may qualify for exemption, if you're using data that already exists, or your study meets these criteria
2. Start a non-medical protocol at https://hatswebhs.stanford.edu/hs/ using the "Create Protocol" button.
   • Follow the directions that guide you through the protocol.
   • You'll need to fill out the "required questions" document and create a consent form (see attached example). You can check the consent form against this checklist to make sure it's complete.
   • Attach "required questions" and consent form documents to the protocol where prompted.
3. If you have any doubts or questions, DO NOT HESITATE to e-mail Lauri Kanerva (Lauri.Kanerva@stanford.edu or 650-723-2480) and ask your questions before you submit the protocol. Lauri is a nice guy, and he wants you to get your protocol approved. It is much easier to ask questions ahead of time than to wait 30 days, only to find out your protocol has been rejected!
4. Submit the protocol when you're finished.
   • The IRB meets once a month. Submission deadlines and IRB meeting dates can be found here (under "Non-Medical Human Subjects" in the middle-bottom).
   • In general, your IRB protocol is due on the first day of the month, and will be reviewed at the meeting that comes 15-30 days later.

• CALO-MASemlabconsentform.doc: Sample consent form

-- PatrickEhlen - 01 May 2008