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HUMAN SUBJECTS PROTOCOL APPROVAL FORM GENERAL INSTRUCTIONS
A. All portions of this form must be completed before submission. Incomplete forms may result in delayed review and/or approval. Additional sheets may be attached to this form. If you have any questions, please contact the Office of Research and Sponsored Projects, (818) 677-2901, University Hall 265.
B. MEETING DATES
All materials to be reviewed by the committee are due in Research and Sponsored Projects two weeks before the next scheduled meeting. Meetings are held once a month during the academic year. For meeting schedule information, contact the Office of Research and Sponsored Projects.
C. EXPEDITED REVIEW
Requests for expedited review must be accompanied by a cover letter signed by: 1) the student's advisor; or 2) the faculty member conducting the project. The cover must include a justification for the request. Only those requests with compelling reasons (e.g., circumstances beyond the project director's control) will be considered.
D. SIGNATURES
ALL SIGNATURES MUST BE OBTAINED PRIOR TO SUBMISSION. STUDENT PROJECTS
MUST HAVE FACULTY ADVISOR'S SIGNATURE.
Faculty signature on this Protocol Approval Form indicates that:
• You are familiar with the guidelines for human subject research as defined by California State University, Northridge's Standing Advisory Committee for the Protection of Human Subjects (SACPHS).
• You have reviewed this Protocol Approval Form and accompanying documentation.
• You approve of the manner in which human subjects will be involved in this study.
E. COORDINATION OF HUMAN SUBJECTS REVIEW PROCESS
Questions regarding human subjects policies and procedures should be referred to:
Office of Research and Sponsored Projects, University Hall 265, (818) 677-2901
The chair of the Standing Advisory Committee for the Protection of Human Subjects (SACPHS) is:
Dr. Aïda Metzenberg, Dept. of Biology, (818) 677-3356
RETURN COMPLETED FORM AND NINE COPIES (including any supplementary materials) TO:OFFICE OF RESEARCH AND SPONSORED PROJECTS, University Hall 265
ITEMIZED INSTRUCTIONS FOR THE HUMAN SUBJECTS PROTOCOL APPROVAL FORM
It is important that all Human Subject Protocol Approval Forms conform to the following instructions. Forms not consistent with these instructions may be returned by the SACPHS without action. The Approval Form (items 1-17) may be neatly handwritten. All other supporting documentation must be typed or word-processed.
Item 1: Title of research — The complete title of your project.
Item 2: (a) Name of researcher(s); (b) Campus ext.; (c) Major or Department
(a)Your name(s); (b) Your campus extension, if you are a faculty member or work on campus. Otherwise leave blank; (c)Your major or department.
Item 3: (a) Address; (b) Home/message phone
(a) Provide an address where notification of your approval should be sent; (b) Phone number in case the committee has any questions regarding your protocol.
Item 4: (a) Name of Faculty Advisor; (b) Faculty Advisor ext.
(a) The name of your thesis chairperson or the Faculty Advisor working with you. (b) His/Her on-campus office extension.
Item 5: Period of Project — The anticipated start and end dates for collecting data or interacting with subjects for your project.
Item 6: (a) Check one: Faculty Research or Student Thesis; (b) Course prefix and number/ Course title
(a) If you are a faculty member performing research, check Faculty Research. If you are a student performing research for your thesis project, check Student Thesis. If you are a student performing research for some other reason, check other and provide a brief explanation in the space provided. (b) Enter the course name and number from the schedule of classes or catalog (ex. EPC 698C Thesis/Graduate Project).
Revised 2/03
Item 7: (a) Check one: Unfunded or Funded; (b) Date (to be) submitted
(a) If your project is being funded, check “funded.” Otherwise check “unfunded.” (b) If you checked funded, enter the date your project will be/was submitted to the funding agency. Also, provide the name of the funding agency.
Item 8: History of Protocol
Check “new” if this is the first time this protocol is being submitted and leave the approval date line blank. Check “annual” if this is an ongoing protocol being submitted for annual approval. Enter the date of the most recent previous approval. Check “previous” if your protocol was previously approved (more than 12 months ago) and enter the date of the prior approval.
Item 9: Does this protocol contain modification(s) from a previously approved protocol?
If “annual” or “previous” were checked in item 8, please explain any changes that have been made to the protocol since the last submission. Attach additional pages if necessary.
Item 10: Special Procedures
If any of these items (radioactive materials, drugs, or unusual electrical devices) apply to your protocol, check the appropriate box and provide a detailed description on a separate sheet.
Item 11: Is a Subject Bill of Rights attached? — This form must be included with your protocol. A sample is attached for your use.
Item 12: Does the protocol concisely describe the research and how the rights of the human subjects involved are to be protected from unreasonable risk?
Self-explanatory.
Item 13: Are copies of any questionnaire(s), survey instrument(s) and/or interview(s) referred to in this protocol attached?
A copy of any questionnaire or survey being utilized in your protocol must be attached for the committee’s approval. Interview questions (if applicable) must also be submitted with your protocol.
Item 14: Is a draft Informed Consent Form(s) attached?
Written informed consent must be obtained for virtually all non-exempt research AND is highly recommended for all exempt
research in which it would aid the subject in making an informed decision whether to participate. The fundamental requirements of informed consent are that participants be made aware that they would be involved in research, what the purposes of the research are, the expected duration of the participation and the description of the procedures to be followed. Research involving minors (persons under the age of 18) requires written consent of a parent or guardian. A sample parental consent form is attached to the back of this packet. If your project does not involve minors (persons under the age of 18) change the language as necessary. The sample consent form has been provided for your use--please follow the format as closely as possible. All elements MUST BE INCLUDED except: 1) Those items marked as optional; and/or 2) Statements regarding video/audio taping if not applicable.
A Consent Form should include:
• A description of any foreseeable risks or discomforts to subjects
• A description of any benefits to the subjects or to others which may be expected as a result of the research
• A statement regarding protection of subjects' confidentiality & final disposition of data
• Contact information for questions regarding the research and subjects' rights
• A statement that participation is voluntary, that there will be no penalty due to refusal to participate, and that the subject may discontinue participation at any time without penalty
• A statement requesting permission for video/audio taping or photographing to be conducted if applicable
ALL PAGES OF CONSENT FORM MUST INCLUDE PAGE NUMBERS IN THE FOLLOWING FORMAT: PAGE X OF X
Consent forms must be translated to the primary language of the reader.
Item 15: Is a letter of permission attached? — If you are using a facility other than CSUN to conduct you r project or recruit your subjects (church, hospital, school, etc.), you must obtain a letter of permission on letterhead from that facility. The letter must be signed by someone who can authorize these activities, e.g., a principal, director, etc. See attached sample.
Item 16: Signatures
If you are a student, you must obtain the signature of your faculty advisor and you must sign the Protocol Approval Form prior to submission to this office. If you are a faculty member, please sign the line indicating the signature of Faculty Researcher or Student Advisor.
PROJECT INFORMATION FORM
Please provide all information requested and attach any necessary documentation.
Revised 2/03
HUMAN SUBJECTS PROTOCOL APPROVAL FORM
CALIFORNIA STATE UNIVERSITY, NORTHRIDGE
This Protocol Approval Form must be completed for all California State University, Northridge faculty and student research which involves human subjects. Additional material(s), as described below, must be attached to this form at the time it is submitted to the Standing Advisory Committee for the Protection of Human Subjects (SACPHS) in the Office of Research and Sponsored Projects (UH 265, ext. 2901).In ALL cases, RESEARCH MAY NOT PROCEED until authorized by the Committee. You will be notified of the action of the Committee following the receipt of an original and nine copies of this / form and all required supplementary information (see below) in the Office of Research and Sponsored Projects.
ALL SIGNATURES MUST BE OBTAINED PRIOR TO SUBMISSION.
Brief, excerpted definitions and guidelines regarding research involving human subjects appear on the attached instructions. For a copy of complete regulations, contact the Office of Research and Sponsored Projects. Read all instructions before completing the form.
PLEASE TYPE OR PRINT NEATLY
1. Title of research
Campus Major or
2. Name of researcher(s) ext. Department
3. Address Home phone
Email Address
4. Name of Faculty Advisor Faculty Advisor ext.
5. Period of Project (see pg. 1-Itemized Instructions) From To
6. Check one: Faculty Research Student thesis Other (specify)
Course prefix and number Course title
7. Check one: Unfunded Funded Date (to be) submitted
8. History of Protocol: New Annual Previous Approval Date
9. Does this protocol contain modification(s) from a previously approved protocol? Yes (explain) No N/A
10. Special procedures: (give detailed description on separate sheet)
Radioactive materials Drug(s) Unusual electrical devices
11. Is a Subject Bill of Rights attached? Yes No
12. Does the protocol concisely describe the research and how the rights of the human subjects involved are to be protected from
unreasonable risk? Yes No
13. Are copies of any questionnaire(s), survey instrument(s) and/or interview schedule(s) referred to in this protocol statement attached? Yes No
14. Is draft Informed Consent Form(s) attached? Yes No 15. Is a letter of permission attached? Yes No
16. SIGNATURES: Refer to page 1, General Instructions–letter D, before signing.
Signature of Faculty Researcher or Student Advisor Date Student Investigator's Signature (specify grad. or undergrad.) Date
FOR SACPHS AND RESEARCH OFFICE USE ONLYNoted, exempt Approved, expedited review See attached memo
Noted, minimal risk Approved, reasonable risk Not approved, see attached memo
date received
Chair, SACPHS, or Director, RSCH Date
Expedited Reviewer(s): Rev. 4/01
California State University, Northridge
Standing Advisory Committee for the Protection of Human Subjects
Guidelines For Having Your Research Project Approved
This document is meant to supplement (not replace) the instructions provided on the Human Subjects Protocol form. If you have any questions regarding the Human Subjects Protocol Form, contact the Office of Research and Sponsored Projects, (818) 677-2901, University Hall 265.
The Standing Advisory Committee for the Protection of Human Subjects (SACPHS) has the responsibility of examining research proposals to determine whether they meet guidelines for the protection of the welfare of human subjects. Approval for a project conducted by a faculty member, or by a student under the guidance of a faculty member, must be obtained prior to initiation of contact with human subjects. The successful application meets the following criteria:
· The protocol form (original and nine copies) is submitted to Research and Sponsored Projects no later than two weeks in advance of the Committee's next monthly meeting.
· The face page is completely filled out, with signatures as appropriate.
· A clear and concise statement of the hypothesis to be tested is presented.
· A detailed description of the procedure methods to be used is provided. Additional sheets may be attached to the protocol form if necessary.
· The source, age(s) and number of subjects to be used in the study are clearly stated, and if the subjects will be obtained at a non-CSUN institution, a letter of permission from a representative of that institution is provided.
· The significance of the work is clearly described.
· A consent form that follows the sample format detailed in the application is provided. However, if your protocol requires additional details beyond the example, please include them.
· The risks to subjects are clearly detailed both in the application and in the consent form. "No risk" is almost never appropriate. Risks may include emotional distress, physical stress, or risk of bodily injury, as appropriate. There should be an indication on the consent form as to whether financial support for medical or counseling treatment is available to subjects in case of difficulties resulting from participation in the research.
· Clear language understandable by an educated layperson is used throughout the protocol, consent form, etc. Avoid excessive use of technical jargon.
In planning the research, investigators should think carefully about potential avoidable harm to subjects, for example keeping in mind the ethical guidelines of the American Psychological Association, and considering the need for cultural sensitivity in approaching subjects. Potential harm will be weighed against potential gain on each proposal reviewed by the Committee.
Benefits (financial or otherwise) of participation in the study should be clearly indicated in the consent form.
When personal information or videotaping or voice recording is to be obtained during the course of the research, planned disposition of that information should be clearly stated in the consent form.
Remember — The protocol form is your chance to describe your project clearly to the committee. Failure to provide sufficient detail regarding your project may result in the protocol being returned to you without action causing considerable delay in your research.
Revised 2/03
National Institutes of Health Federal Guidelines for Informed Consent
A. Basic and Additional 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
· Identification of any procedures which are experimental
· A description of any reasonably foreseeable risks or discomforts to the subject