California State University, Long Beach

Institutional Review Board for the Protection of Human Subjects

Application Form for
Standard or Expedited Review of Protocol Applications

(Rev. 02/27/01)

This is a "format" not a "form." Print the format for your reference. Begin a new document and copy (alt- E C) this text and paste (alt- E P) it into the new document, then type your unique responses to the questions and attach requested letters. As you work, please remove these instructions (blue on beige), like this paragraph, and leave only the italicized portion of each question for your application. Do not underline or italicize your answers.

All requests for permission to use human beings as subjects of research studies are considered to be "Standard," unless the research puts human subjects at no more than minimal risk and, under unique considerations, qualifies for the more abbreviated form of review, "Expedited Review," or is judged to be "Exempt" from either Standard or Expedited review. Please review the criteria for Expedited Review and for Exempt Review in the University Policy Statement or as quoted in the CSULB IRB Instructions for Standard and Expedited applications .

1. Principal Researcher: (Name) Position: (Professor, M.A. thesis student, etc.): Faculty Department: Student Home Address: Daytime Telephone Number: Email address:

2. Student Thesis Advisor / Faculty Supervisor(if applicable):
Faculty University Telephone Number: Faculty email address:

3. Title of proposed research study:

4. Will there be contact of any kind with living human beings, including: interviews, surveys, mailed surveys and questionnaires, etc., in the course of this research?

5. Other than the information and data created and produced by this research project, will the researcher(s) have access to records or to other forms of information (including previous research data) about the human subjects of this research? Yes / No. If yes, please explain. Please provide signed consent of the agency/researchers holding and providing access to such records and information.

Human beings contacted for this research and/or the human beings whose records (information, data) you may be reviewing constitute the "sample set" of "human subjects."

6. Describe the approximate number and age of each sex of the sample set of human subjects: (e.g., 400 Male 18 to 25, 350 Female 18 to 35) a. Are any children age 0-17 involved? If yes, Standard Review may be required. (See Administrative Review Decision Program .) Describe the legal parent/guardianship status of the children. b. Is any adult subject under any form of legal guardianship? If yes, Standard Review is required. Please explain in full the special characteristics of the subjects." c. If human subjects are not under legal guardianship, is there evidence that any human subjects have developmental disabilities, mental illness, or are there any other unusual circumstances whereby individuals' ability to grant fully informed consent for themselves might be compromised? If yes, Standard Review is required. Please explain in full the special characteristics of the subjects. d. Describe any other human subject characteristics relevant to the study."

Do not attach grant applications or thesis proposals, although you should excerpt from them as necessary.

8. From what source(s), e.g., hospitals, institutions, schools, classes, shopping malls, etc. will subjects be drawn into the research?

Appendix A: Original letters of approval from all participating organizations (must be on letterhead and indicate specific classes, units, etc. affected)

You must append at the end of this application letters of approval from the faculty of any class section, or the appropriate official of any institution or building in which any part of the selection of subjects or the actual research will be carried out, typed on their official letterhead. The permission statement must contain the full and exact title of your research.

9. What process (the complete sequence of events from initial approach to the point where you have obtained Informed Consent) will you use to invite people to participate in your research?

Appendix B: Proposed consent form(s)

Append copies of all consent forms in all languages used necessary for the subject pool, and include the text of oral explanations, if applicable. Also include any additional Informed Consent forms required by the participating organizations.

10. What will you do with the human subjects once informed consent has been obtained? Describe the details of research methods and procedures that involve the subjects.

11. What risk(s) do(es) this research present to the dignity, reputation, rights, health, welfare,or well-being of the subjects?

12. Describe the measures you will take to protect against or to minimize:
(1) the risks for human subjects; and (2) the operational risks relating to security of research materials and data. Explain how information will be secured and who will have access to it. (3) If your research project includes a medical, pharmacological, or behavioral intervention or therapy, which is intended to improve the physical or mental health of the subject, then provide a complete "data and safety plan," which includes a Data and Safety Monitoring Board, "stop rules," and explicit provisions for reporting adverse events to the IRB (email to research@csulb.edu).

Note: Title 45, PUBLIC WELFARE, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks, PART 46, PROTECTION OF HUMAN SUBJECTS, §46.115 stipulates that "...(b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the Department or Agency at reasonable times and in a reasonable manner."

13.Describe any benefits to the subject(s) which may reasonably be expected from the research, including summary of research findings where appropriate (as for professionals and participating organizations.) Describe benefits, if any, to others.

14. When and where will the research activities involving human subjects take place:

Initial contact begins on:
Research study begins on:
Ends on:
Location(s):

Note: The beginning date must be after approval by the IRB. Allow a minimum of 3 instructional days for Exempt Review; 10 instructional days for Expedited Review. Refer to the schedule of monthly IRB meeting dates for Standard Review. Although a project may be planned to extend over a period of years, IRB approval always covers only a twelve-month period. If the anticipated participation will take more than twelve months, please so state. Approval will be granted for additional twelve-month periods only upon receipt and approval of a renewal application and an annual report form.

15. Appendix C: Tests and Questionnaires. Attach a copy of all tests, questionnaires, surveys, or other instruments and materials to be used.

16.If applicable, describe the nature of any debriefing of subjects:

17. Briefly describe the training and experience that qualifies you to carry out the proposed research.

18. Provide a bibliography of all sources cited or otherwise identified in the application, excluding those in Item 15.

Submit Application packet to the Office of University Research,
University Foundation Building, Suite 310.
Telephone (562) 985- 5314.

Student thesis research, independent/directed study, and independent/directed research require completion of the Faculty Supervisor Form .