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CSUDH Institutional Review Board (IRB)
for the Protection of Human Subjects

Subject recruitment and data collection may not be initiated prior to formal written approval
from the CSUDH Institutional Review Board for the Protection of Human Subjects.



  Where do I start?
  1. Read the following-
  Tips for filing a proposal
  Frequently Asked  Questions
    Print out the following-
  Proposal Filing Checklist
     
  2. Complete the online training course in Human Subject Protections. Print or save to your
computer a copy of the completion certificate after you finish this course.
    The link to the course is:
  NIH Online Tutorial, Course Registration and Certificate
     
  3. Determine when you plan to submit your proposal. It is best to submit at least two weeks
before you plan to begin recruiting subjects
to allow time for any required revisions. In some
cases, the protocol must be reviewed and approved by the full board. The meeting schedule is shown below. Your proposal should be in the IRB office two weeks before the board
meeting to be placed on the agenda.
  IRB Meeting Schedule
     
  4. Fill out the forms - follow instructions below for all forms that need to be filled out. Please
edit all forms carefully and only turn in final copies (no rough drafts). When all are completed, submit electronically by attaching to an email sent to irb@csudh.edu.

Check your submission against the checklist in step one to ensure that all necessary
elements are included. As noted below, one hard copy of the cover form (Form A) needs to be delivered to the IRB office in Welch Hall D445. IMPORTANT NOTE: Your protocol will not be logged in or reviewed until the signed copy of the cover sheet is received in the IRB Office.

     
  Cover form - required on all protocols. Preferred method, open-fillable Word document and enter all information. Send one copy electronically with your submission packet. Print out one copy, obtain all signatures and deliver to the IRB office in Welch Hall D445.
  Form A - Fillable Word document
  Form A - to be completed by hand
     
  Proposal Narrative - required on all protocols. Open the Word document and follow all instructions.
  Form B
     

*Special Note about data securityIn order to ensure confidentiality, all computer files containing
data about human subjects must be password protected.  This applies to the file, not just the computer. 
For information concerning ways to password-protect Microsoft Word and Microsoft Excel files, open the
link below-

 

Password Protected Files
 
  Consent Form - open appropriate form for your protocol. Most of the research performed at CSUDH is within Social and Behavioral Science so that would be the form you use.
  Form D - Social and Behavioral Science
  Form D - Biomedical Research
     
  Other possible forms needed - (check with IRB office or faculty advisor to determine need)
  Form E - Parental Consent Form (if minors are involved)
  Form F - Assent from Child (if minors are involved)
     
  Additional Form:
  Form G - Continuing Review Form (only for use if project lasts more than 12 months)
     
  For Biomedical Research Protocols:
  California Experimental Subject's Bill of Rights (English)
  California Experimental Subject's Bill of Rights (Spanish)
     
  Other documents you may want to examine:
  IRB Policy
  IRB Guidebook
  CSUDH Policy on Oral History and IRB Reviews
     
  Other documents you may want to examine:
  Office for Human Research Protections
  Public Responsibility in Medicine and Research (PRIMR)
  California Health and Human Services Agency (CHHSA)
     
  For more information, contact the IRB Coordinator:
  Telephone: (310) 243-3756
  Email: irb@csudh.edu
 
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The statements found on the (departments /college / auxiliary) Web page are for informational purposes only. While every effort is made to ensure that this information is up to date and accurate, official information can be found in the University Catalog and Class Schedule.
Last updated Wednesday, January 23, 2008, 10:25 am, by cg (mailto:cgeber@csudh.edu)