Human subjects

So, you want to work with human subjects.

The #1 thing to remember is to leave lots of time. Start working on your protocol 3-4 months before you want to begin your experiment.

• It generally takes 4-6 weeks to get your stimuli and protocol together, and another 8-10 weeks to get your protocol approved.

• It is illegal to collect any data before your protocol is approved.

At Berkeley, the IRB (Institutional Review Board) is housed at CPHS (the Center for the Protection of Human Subjects). Anyone who does any work with human subjects, whether in the form of surveys, recording, or perception experiments, must get their experiment approved by CPHS.

Protocols need to be renewed every year.

The CPHS website is pretty navigable these days, and you can probably get your questions answered there. The website is also good if you need any paper forms.

How to submit to CPHS

1. Find yourself a faculty advisor. You can collect data yourself, but anyone below the rank of faculty needs a faculty advisor.
2. Make sure you (and any research assistants) have taken the CITI IRB training course. Save an e-copy of the certificate!
3. Your faculty advisor can help you come up with a good experimental design. You can submit to the IRB before you are completely finished, as long as you know (a) what sort of data (survey, audio, video) you’ll be getting from subjects, (b) how long your experiment will take, and (c) how you’ll collect your data (roughly).
4. Create a file on eProtocol as soon as possible. That will give you a good idea of what you need to do to submit.
5. Only your faculty advisor can submit your proposal. Make sure you ask her/him to do so!

Your protocol will get processed faster if it is either exempt or expedited because fewer people need to review your protocol.

Exempt is the fastest and is reviewed by the fewest people. Your experiment might be exempt if it’s an anonymous survey, interview, or cognitive test. See the CPHS exemptiions document for other ways your research might be exempt.

Expedited is the second fastest sort of review. Many experiments done in the lab are expedited. Your experiment might be expeditable if it (a) involves minimal risk, and (b) collects data through voice or video recordings, or through noninvasive procedures. See the CPHS document on expedited review for more details.

Parts of an eProtocol

1. Personnel. Here, you should list your faculty advisor as the PI (principal investigator), and yourself as the Student or Postdoctoral Investigator. Your administrative contact is Paula Floro. Any research assistants that will be helping you should be listed under Other Personnel.
2. Vulnerable Subject Checklist. Here, you’ll indicate whether you are working with children or other vulnerable populations. If you are, you will need extra consent forms: one set for the parents/consenters and a set of assent forms for the kids.
3. General questions about your funding and where you’ll be doing your experiment.
4. Request for Expedited Review. Check the boxes that apply to you. Boxes #6 and #7 are common.
5. Protocol. Lots of stuff that CPHS wants to know about your application, including: purpose, hypothesis, your qualifications, sample size, recruitment procedures, compensation procedures, study procedures, consent procedures, risks to subjects, data confidentiality. Feel free to work from the examples posted on this website.
6. Attachments. You’ll need to submit consent forms, flyers, and surveys / background questionnaires, along with CITI certificates for everyone administering the experiment.

Examples

Please help by adding a link to your approved eProtocol!

Here are some protocols and consent forms that were approved before the move to eProtocol.

http://linguistics.berkeley.edu/~shira/katseff_protocol_renewal.doc

http://linguistics.berkeley.edu/~shira/katseff_consent_and_flyer.pdf

http://linguistics.berkeley.edu/~shira/katseff_childconsent.pdf