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Human Subjects Procedures

The Brandeis Committee for Protection of Human Subjects (BCPHS) will review the research that you have designed to assure that the research meets with federal and institutional regulations. Potential subjects may not be recruited until the BCPHS has reviewed and approved your study.

Please note this change in the submission procedures and use this procedure in place of the instructions on the IRB forms:
Send one (1) copy of the protocol and associated forms
via email to: irb@brandeis.edu
Mail or deliver hard copy originals of signed documents only to:
IRB Coordinator
Office of Research Administration, Bernstein-Marcus 117
Brandeis University, MS 116
Note that a submission will not be deemed ready for review until both the emailed and hard copy materials have been received by the IRB Coordinator

IRB Meeting Dates and Submission Deadlines

Human Subjects Decision Tools will help you determine whether or not you need to apply for IRB review, whether or not HIPAA applies to your work, etc.

There are three different procedures that we use to review an application: Exempt, Expedited and Full Committee Review. The review procedure selected depends on how human subjects are involved in your research.

The most notable difference between the three types of review is how informed consent is obtained and documented. For exempt research, a signed written informed consent may not be required whereas in either expedited or full committee reviews, an informed consent document following the informed consent guidelines provided by the Office for Human Research Protections is required.

Each review procedure is listed in this document along with the application materials that you will need to submit. Included with each review category are a few examples of studies that may qualify.

Please note that BCPHS approvals are valid for one year, unless otherwise noted in your approval notice. A new approval must be obtained by the anniversary of your approval date (see instructions for Continuing Review.

If you wish to make revisions to your approved protocol, you must submit these revisions to the Committee for review and approval (see instructions for Modification Request).

HIPAA
If your study involves the use of protected health information (PHI) that is maintained by a covered entity, you must insure that it is being used in accordance with the Privacy Act under the Health Information Portability and Accountability Act (HIPAA). See HIPAA Decision Tool

This page was last modified on March 12, 2008