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Institutional Review Board Manual


  • As of July 2, 2012 all IRB applications must be submitted electronically through IRBNet.It is no longer necessary to submit hard paper copies of your IRB application.

  • Training Resources are available at:

  • When you have finished training, visit www.IRBNet.org to register.


    Be sure that the "irbnet.org" domain is identified as a "Safe Sender" in your email program. Otherwise important communications could get caught in your Junk Mail filter

    If you are looking for the Human Subjects Training Certification see Item M. Below


  • For Questions, contact Mary Walker (Mary.Walker@csulb.edu) X5-5314

This is a manual for students, faculty, staff, and external researchers employing human subjects in research conducted under the aegis of (or on the premises of) the University, including both on- and off-campus research by and with University personnel as researchers or research subjects.

This Web site is the principal and authoritative expression of the manual. The manual is produced by the Office of Research & Sponsored Programs, FO5-111, 562-985-8147, e-mail Mary.Walker@csulb.edu

(See revisions to the manual)

Contents

Policy Documents

  1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (1979; updated 1998)
  2. The Code of Federal Regulations, All Human Subjects Titles
  3. American Psychological Association, "Ethical Principles of Psychologists and Code of Conduct," 2002
  4. CSU Long Beach Policy Statement 00-03 "Protection of Human Subjects," 1/28/00
  5. Membership of the IRB
  6. Office for Human Research Protections (OHRP, formerly OPRR) website and OHRP IRB Guidebook
  7. CSULB's Federal-wide Assurance Adobe PDF Format
  8. Federal Certificate of Confidentiality "Kiosk"

The written procedures and resources developed by the IRB:

  1. Dear Colleague Letter re: Disclosure of Information Obtained in Research of 11/12/98
  2. Administrative Review Decision Program
  3. Informed Consent Instructions and Template
  4. IRB Procedures
  5. Collaborative Institutional Training Initiative
    • As of September 1, 2013 IRB Training Certification must be done by Completing the " Social & Behavioral Research - Basic/Refresher " Course offered by CITI (Collaborative Institutional Training Initiative ).
    • If you were IRB Certified using the CSULB Training Modules before September 1, 2013, that Certification remains valid until further notice. You do not have to complete the CITI course.
  6. Research Use of Existing Data Involving Human Beings

The application forms and guidelines developed by the IRB:


NOTE: Standard Reviews (Full Committe Reviews) must be submitted no later than the last Friday of the month prior to the month of the meeting. For example, to be considered at the October IRB meeting an application must be received not later than the last Friday in September.
  1. Instructions for Completing the IRB Application Forms
  2. IRB Application Form [Also available from the Documents Library on IRBNet)
  3. IRB Application Form (Existing Human Data Study)   [Also available from the Documents Library on IRBNet)
  4. Sample Informed Consent Form [Also available from the Documents Library on IRBNet)
  5. Faculty Supervisor's Statement Template   [Also available from the Documents Library on IRBNet)
  6. IRB Application Check List [Also available from the Documents Library on IRBNet)
  7. Annual Report  and Renewal Application   [ Also available from the Documents Library on IRBNet)
  8. Protocol Modifications [Also available from the Documents Library on IRBNet)
  9. Closure of an IRB -Approved Study---Final Progress Report
  10. FAQ: Submitting Subsequent Packages
  11. FAQ: Qualtrics "unanswer" method
  12. Changes to this Manual

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