Human Subjects

All lab members should be familiar with Human Subjects Protections. A good resource is the UCSD IRB web pages, which are here.

Anyone involved with experiments in the lab has to complete online training in Human Subjects Research as of Oct 2009. Information is provided here and here.

This is very important and is not optionalThe training, and compliance with everything that you will learn, is required by UCSD’s Institutional Review Board, which oversees all research on campus, following federal regulations on the protection of human subjects.

Every member of the lab needs to take the Social-Behavioral Protection of Human Research Subjects module. In addition, some members may need to also take the Biomedical module (before you can be involved with imaging or patient research). Anyone working with patient populations will also need to complete the HIPAA tutorial.

Once you take the tutorial(s), please email me a (pdf) copy of your completion certificate. After this, we will also go over our lab’s IRB approval, consent forms, and procedures.

Behavioral experiments have to be approved by Social Sciences IRB and imaging experiments by School of Medicine IRB. We have different protocols for fMRI and EEG studies. You may not collect data in the lab without first checking with the PI about whether your project and all personnel involved are already approved under the current IRB approval. If not, you will need to submit and get approval for the project separately.

You should become familiar with SONA, the online scheduling tool that is provided by the Psychology department. Be sure to understand participants’ rights before you begin testing. We also use calendars to schedule time in experiment rooms in the lab (beatles and stones have google calendars). After testing, you must enter each subject’s information in the lab database right away, and file away the consent and information questionnaires. For more, see Data Collection.

You must have a copy of the documents listed below prior to testing subjects. Keep the documents organized and ready before the subject’s arrival.
– Copy of the current and stamped Human Subjects Consent Form. Consent forms are renewed annually and cannot be used past the date of expiration. Make sure you are using the correct consent.
– Subject information questionnaire that is relevant for the study (behavioral, fMRI, EEG studies may have different forms).
– Copy of current UCSD IRB approved protocol.
– Copy of the UCSD’s IRB department letter of approval for your protocol.
– For MRI experiments, all required safety screening forms.
– Please check with your PI or your supervisor to find out if there are any other forms that are needed for your experiment.

Note: You must store signed consents securely and enter the subject’s information in the subject database the same day you collect the data. Be sure to use the correct database (different ones for behavioral, EEG and MRI studies). Failure to keep these records up to date is a violation of IRB regulations. If you don’t know the URL for the database entry form, ask your colleagues or see the lab wiki.

See also: Data Collection, Research Integrity and Ethics, Lab Policies, EEG, fMRI.