To be completed by IRB:
PROTOCOL #_______
Minimum Risk_______
Expedited Review______

PROTOCOL APPROVAL APPLICATION

(view-only form)

INSTITUTIONAL REVIEW BOARD
CALIFORNIA STATE POLYTECHNIC UNIVERSITY, POMONA

All relevant sections of this application must be completed and submitted electronically to the Office of Research and Sponsored Programs. Email to kagruber@csupomona.edu
All applicants need to provide evidence of passing the NIH tutorial on Human Participant Protections for Research Teams before a protocol can be activated. The tutorial can be accessed at http://cme.nci.nih.gov/intro.htm. The Certificate of Completion should be printed and a copy faxed to the Research Office (869-2993).
If you have questions concerning the completion of this form, please read the sheet "Directions for Completion of Human Subjects Protocol Approval Application" or contact Dr. Kenneth Gruber, Director, Research and Sponsored Programs (909-869-2954). In all cases, no research may proceed on or off campus until authorized by the Institutional Review Board.

DATE SUBMITTED: ____________________

NEW ____________ or RENEWAL of Protocol #____________________

TITLE OF PROJECT / PROTOCOL:


RESPONSIBLE FACULTY MEMBER:

Name: _________________________________________________________________
College and Department: __________________________________________________
Campus Phone Number: __________________________________________________

DECLARATION BY RESPONSIBLE FACULTY MEMBER:
This research is guided by the ethical principles regarding research involving human subjects set forth in the Belmont Report.

Signature of Responsible Faculty Member: ____________________________________


This protocol has been reviewed and approved by the Institutional Review Board, California State Polytechnic University, Pomona

________________________________
David Adams, Ph.D., Chair, IRB / Date

I. SUBJECTS

A. What is the number of Human Subjects to be used in your research?

B. Briefly describe the subject population.

C. Will the subjects be compensated? If yes, how?

D. Describe the control group(s), if any.

II. RESEARCH

A. Purpose (State the relationship of the proposed research to previous scientific investigations in the field.)

B. Methods (Describe in detail all procedures to be performed on human subjects.)

III. POTENTIAL RISKS

A. Discuss the risks, if any, to the subjects.

B. Discuss procedures for protecting against or minimizing potential risks.

C. Are the risks reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to risk confidentiality?

D. Describe in detail all procedures to assure confidentiality of the subjects.

IV. Describe procedures for recruitment of a racially and ethnically representative population. If this will not be the case, discuss the reasons for not having such a balanced population.

V. Will children be recruited for this research? If children will be recruited, justify this.

VI. How will informed consent be documented?

VII. Will there be recruitment of subjects who cannot themselves provide informed consent? If so, how will informed consent be documented for this population?

VIII. Does the research plan have provision for the ongoing monitoring of data collection to ensure safety of subjects? Describe the plan.

IX. Attach a copy of the Informed Consent Form to be used. The IRB would like the following header on all Cal Poly Pomona approved protocols:

California State Polytechnic University, Pomona
Informed Consent for Research Involving Human Subjects

You are being invited to participate in a research study. This form is designed to provide you with information about this study. The Principal Investigator or representative will describe this study to you and answer any of your questions (include a telephone number for a study point of contact). If you have any questions or complaints about the informed consent process of this research study, please contact the Office of Research & Sponsored Programs (909) 869-3406.

A properly written Informed Consent Form will include the following elements:

A statement that the study involves research

An explanation of the purposes of the research

The expected duration of the subject's participation

A description of the procedures to be followed in lay terms (5th grade reading level)

Identification of any procedures which are experimental

A description of any reasonable foreseeable risks or discomforts to the subject

A description of any benefits to the subject or others which may reasonably be expected from the research

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments arc available, if injury occurs and, if so, what they consist of, or where further information may be obtained

An explanation of whom to contact for answers to pertinent questions about the research and research subject's right, and whom to contact in the case of a research-related injury to the subject

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled