IRB Manual

rev. (see Change Page )

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 University Research, Foundation Building 310, 562-985-5314.

CONTENTS

Preface

Policy Documents

A. 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)

B. The Code of Federal Regulations, All Human Subjects Titles

C. American Psychological Association, "Ethical Principles of Psychologists and Code of Conduct," 2002

D. CSU Long Beach Policy Statement 00-03 "Protection of Human Subjects," 1/28/00

E. Membership of the IRB

F. Office for Human Research Protections (OHRP, formerly OPRR) website

and
OHRP IRB Guidebook

G. CSULB's Federal-wide Assurance

H. (not assigned)

The written procedures and resources developed by the IRB:

I. Dear Colleague Letter re: Disclosure of Information Obtained in Research of 11/12/98

Dear Colleague Letter re: Faculty Sponsor Statements of 3/11/99

Dear Colleague Letter re: Broad Change to Policy (00-03);
    Assessment of Risks; Faculty Sponsor Statement Clarification
of 3/10/00

Dear Colleague Letter re: Faculty Sponsorship of Student Research Involving Human Subjects of 1/22/01

Dear Colleague Letter re: New IRB Application Forms and IRB Training Requirement of 9/06

J. Administrative Review Decision Program

K. Informed Consent Instructions and Template

L. IRB Procedures

M. CSULB Responsible Conduct of Research Orientation Program

N. Research Use of Existing Data Involving Human Beings

The application forms and guidelines developed by the IRB:

O. Instructions for Completing the IRB Application Forms

P. IRB Application Form for Standard, Expedited, or Administrative Review

Q. IRB Application Form for Use of Existing Human Data

R. (not assigned)

S. Faculty Supervisor's Statement

T. Check-Off List for Application Submissions

U. Annual Renewal

V. Modifications

W. Federal Certificate of Responsibility "Kiosk"

X. (not assigned)

Y. (not assigned)

Z. Changes to this Manual