INSTITUTIONAL REVIEW BOARD —HUMAN SUBJECTS
REQUEST FOR EXEMPTION OF A PROJECT INVOLVING HUMAN SUBJECTS
For IRB Use Only
CURRENT APPROVAL PERIOD:
FROM:
SUSUBJECTS conducting the research project. For student projects, a faculty adviser must be listed as the PI. If the PI is not a faculty member or administrator at California State University, Los Angeles (CSULA), a CSULA faculty member or administrator must serve as Campus Sponsor and take primary responsibility for the use of human subjects. The application should be completed following review of, and in consultation with, the CSULA IRB Application Guidelines, which can be found at http://www.calstatela.edu/academic/aa/orad . Sections with word limits may be expanded by double clicking on the box. For questions regarding this document, please the IRB Coordinator, Elia Amaro, at irb@calstatela.edu
or 323-343-3798.
Following completion and signatures, please submit the typed ORIGINAL HARD COPY (with signatures) and one
ELECTRONIC COPY of this form (without signatures), and all supporting documents (including, but not limited to, consent forms, questionnaires, fliers, proof of tutorial completion, and letters of permission from research sites), to the IRB
Coordinator, Golden Eagle 314, and AS ONE WORD FILE at the email address above.
Project Title:
Desired Start Date (to begin recruiting and collecting data,
following IRB approval):
Estimated Duration of Project:
Funding Source (if applicable) and Grant Number (if assigned):
Principal Investigator (Last, First, Position/Title):
Status (CSULA-Affiliated)
Faculty Administrator
Status (Non-Affiliated)
Faculty Administrator
Department/Division/School/College (and institution if nonaffiliated):
Phone:
Email:
Names of Co-Investigator(s) (Last, First, Position/Title):
Status (CSULA-Affiliated)
Faculty Administrator Staff Student
Department/Division/School/College (and Institution if nonaffiliated)
Status (Non-Affiliated)
Faculty Administrator Staff Student
Phone:
Email:
CIN:
Names of Campus Sponsor (Last, First, Position/Title) for Non-Affiliated Researcher:
Department/Division/School/College Phone:
Email:
List any other IRB approvals or permission obtained or in process from other institutions (university, school or school district, hospital, court, agency, place of worship, etc.), if required, and attach copies or indicate that copies will be forthcoming.
List Relevant Training of Researchers
CSULA or comparable IRB tutorial. ATTACH CSULA TUTORIAL QUIZ SCORE/CERTIFICATE or comparable proof of completion ( REQUIRED FOR ALL RESEARCHERS & ASSISTANTS, FACULTY ADVISERS, AND ON-SITE
TRANSLATORS ).
Other professional training and experience (e.g., phlebotomist license, student currently employed as teacher/therapist). Please describe and attach copy of any pertinent license(s).
___________________________________________ (PLEASE DESCRIBE).
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IRB Application —Page 2 IRB NO.
CATEGORIES OF EXEMPT RESEARCH
The following types of research qualify for an exempt review. Please select which category or categories apply to your proposed research. However, if you are conducting research at an institution or organization that requires IRB approval, you must use the long application form.
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(i) research on regular and special education instructional strategies, or
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2), if
(i) the human subjects are elected or appointed public officials or candidates for public office; or
(ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Note: Category #3 does not apply to minors.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Notes: 1. This form of research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens may qualify for a waiver, utilizing the waiver of review section below. In order to qualify for a waiver, the archival or reanalyzed data sources must not reveal information that may have implications for the privacy, reputation, employability, or insurability of classes or individuals. Applications qualifying for a waiver will be filed in the Office of Research Development; no formal review will be conducted. However, applications are subject to periodic IRB audit to assure compliance. Research that does not qualify for an exemption waiver may still qualify for exemption, and can be verified through an administrative review of the short form application for exemption.
2. Category #4 does not apply to minors if the investigator participates in the activities being observed.
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WAIVER OF REVIEW FOR USE OF EXISTING DATA UNDER CATEGORY #4
• Do data contain information that can identify subjects directly or through identifiers linked to the subjects?
Yes No
If yes, then the research does not qualify for a waiver, but may still qualify for an exemption.
• Do the data contain information that may have implications for the privacy, reputation, employability, or insurability of classes of individuals? Yes No
If yes, then the research does not qualify for a waiver, but may still qualify for an exemption
• If data are publicly available:
Source of the data: ____________________________________________________
Name of the data set: __________________________________________________
• If data are obtained from another researcher:
Name of the researcher: _________________________________________________
Data originally collected under relevant IRB approval: Yes No
Institution: _____________________________Date: _____________________
Note: If the research qualifies for a waiver, research may begin as soon as this form is submitted. You do not need to complete the remaining sections. No final exemption memo will be sent.
(5) Research and demonstration projects which are conducted by or subject to the approval of the federal department or agency heads, and which are designed to study, evaluate or otherwise examine:
(i) public benefit or service programs,
(ii) procedures for obtaining benefits or services under those programs,
(iii) possible changes in or alternatives to those programs or procedures,
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed or
(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the
Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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IRB Application —Page 4
SUBJECT CHARACTERISTICS AND RECRUITMENT
IRB NO.
1. Description of the proposed subject population. Indicate x for all that apply.
Adults (18 years >) Female Male Transgender
School-aged Children and Adolescents (< 18 years)
Senior Citizens (65+ years)
Female
Female
Male
Male
Transgender
Transgender
Fetuses
Institutionalized Persons
Parolees
Physically Disabled Persons
International Persons
Subject Pool
Pregnant Women
Prisoners
Disabled Persons
Cognitively or Developmentally
Substance Abusers
Undocumented Immigrants
Other (please describe)
Hospitalized Patients
Incarcerated Youth
Individuals with Mental or Physical Illness or Disability
Homeless Persons
Limited English-Speaking Persons
Estimated Number of Subjects Estimated Ages or Age Range Estimated Gender Distribution
Desired Racial/Ethnic Background of Sample (if applicable) Desired Physical and Mental Health Status of Sample
(if applicable)
Other (please describe):
1. Recruitment. Indicate x for all that apply.
In-person
Telephone
Email or other electronic messaging
Flyer/Posting/Advertisement (including web-based)
Other (please describe)
U.S. Mail
Network/Snowball
Describe briefly how potential subjects will be identified and recruited.
2. Identify the method you will use to document consent/assent. A consent form is not mandatory for exempt research.
I will obtain written informed consent, with signature.
I will obtain oral informed consent.
I will use an informational cover letter.
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IRB Application —Page 5 IRB NO.
3. OPTIONAL: Attach consent/assent form(s), information cover letter, or script you plan to use. For CSULA consent
form template, see IRB Application Guidelines Appendix. Substitute the following statement for the statement contained in
the consent form template: THIS PROJECT HAS BEEN DETERMINED TO BE EXEMPT FROM REVIEW AND APPROVAL
BY THE CALIFORNIA STATE UNIVERSITY, LOS ANGELES INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION
OF HUMAN SUBJECTS IN RESEARCH.
4. OPTIONAL: List and attach a copy of any planned advertisement/fliers/letters/telephone scripts/email or electronic
messaging scripts to be distributed to potential subjects. Use the statement above on any recruitment materials.
5. Setting(s) Where the Research Will Be Conducted ( Indicate x for all that apply).
CSULA Campus
Other College Campus
K-12 Schools
Business Office
Subject’s Home*
Shelter
In Class
In Class
In Class
Government Agency
Out of Class
Out of Class
Out of Class
Researcher’s Home*
Religious Setting
Park
Hospital
Conference/Professional Organization
Sports Setting
Store or Mall
Internet (e.g., web-based, social networking,
Community Organization
Subject’s Work Location
Other (please describe) and professional association sites)
Outpatient/Community Clinic
Foreign Country
*Not recommended. Include justification below. If the researcher is a student and the study is taking place in the subject’s home, attach proof of professional liability insurance and a copy of the researcher’s driver’s license.
List the specific location(s) where the study will take place (e.g., names of schools, agencies).
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IRB Application —Page 6
6. Methods ( Indicate x for all that apply) .
IRB NO.
Review of Medical Records
Review of Public Records
Review of Educational Records
Evaluative Tests
Review of Case Files
Observations (e.g., ethnographic, clinical, classroom)
Surveys/Questionnaires
Paper-and-pencil
Telephone
Interview
Face-to-Face
Webcam
In-person
Review of Work Samples
Physical Exercise
Computer- or web-based
Individual
Telephone
Email or other electronic messaging
Audio Recording
External Sensors
Inhalation, Injection, or Ingestion of ANY SUBSTANCE (please describe):
Blood Draws Other Specimen Collection
Other Experiment or Intervention (please describe):
U.S. Mail/Fax
Focus Group
Email or other electronic messaging
U.S. Mail
Video Recording
Internal Sensors
Secondary Data Analysis (previously collected data or records). Note: You may qualify for a waiver (see previous section). For more information, see IRB Application Guidelines sec. 2.6
.
Other (please describe)
7. Identify the instrumentation used in obtaining data (e.g., questionnaire, interview, electrocardiograph, blood pressure monitor, syringes). If questionnaires are used, attach copies.
8. Describe in detail the procedures for the activity, intervention, or experiment in which subjects will participate (i.e. describe data collection procedures that illustrate how the study will unfold). If any activity, intervention, or experiment will be added to the subjects’ regular routine or curriculum, differentiate between what is routine and what is not routine (limit 500 words) .
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9. Include the duration of each interaction, the time intervals, and numbers of interactions, and the overall length
of interaction with research subjects .
10. Briefly explain and justify if there less than full disclosure of the study’s purpose to subjects (For more
information, see IRB Application Guidelines sec.3.4.3.) However, projects involving deception as to the purpose
of the study do not meet the criteria for exempt review.
11. Please describe how data will be recorded and stored (e.g., audio, video, field notes, database). Indicate if the
procedure will be anonymous (there will be no association between responses and respondents) OR confidential
(data are associated with personal identifiers or coded to protect personal privacy). (For description of anonymity
and confidentiality, see IRB Application Guidelines sec.3.4.8.1.) (Limit 250 words)
Yes Will audio or video recordings be used for educational purposes or be included for publication with
No reports, articles, or thesis (please describe) ?
12. Describe any risks associated with the study, and how you will minimize those risks. Note that projects
involving only minimal risk qualify for exempt review . There is never “no risk,” as, minimally, the risk
of a breach of anonymity or confidentiality always exists. For more information about risk level,
see IRB Application Guidelines, sec. 3.4.7.
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IMPORTANT NOTES
The use of human subjects may commence only after you have received a final exemption memo from the IRB, unless the research has qualified for a waiver.
IF ANY CHANGES ARE MADE TO THE METHODS AND PROCEDURES DESCRIBED IN THIS PROTOCOL, YOU
MUST SUBMIT ANOTHER APPLICATION SO THAT THE PROJECT MAY BE RE-EVALUATED FOR EXEMPTION
FROM IRB REVIEW.
By signing below, the Principal Investigator (PI), who is responsible for the safe conduct of this project, is assuring the
Institutional Review Board —Human Subjects that all procedures performed under the protocol will be conducted by individuals legally and responsibly entitled to do so.
If the PI is a faculty adviser on a student project, the PI is assuring that the student researcher is competent to conduct the activity described in this form and that the design meets the ethical and scientific standards of the field and the University.
The PI will provide appropriate direction and supervision to ensure the safety of the research subjects. If the PI is a campus sponsor for an unaffiliated researcher, the PI will likewise provide appropriate oversight to ensure the safety of the research subjects.
The study must be conducted in the manner described in this form. The PI will notify the Institutional Review Board –-
Human Subjects immediately, in writing, to request approval to change any procedures, prior to implementation, or to report any problems that may put subjects at risk. This includes any adverse reaction or risk associated with the study.
I understand that if the information in this application is unclear or incomplete, the application will be returned without review.
Signature of Principal Investigator Date
Name of Principal Investigator (please print)
Signature of Co-Investigator(s)
Name of Co-Investigator(s) (please print)
Signature of Campus Sponsor (for non-CSULA researcher)
Name of Campus Sponsor (please print)
Date
Date
By signing below, the Department/Division Chair/School Director and Dean are assuring that this project has scientific merit and the liability assumed by its conduct is acceptable to California State University, Los Angeles.
Signature of CSULA Department/Division Chair, School Director or College Dean Date
Name of CSULA Department/Division Chair, School Director or College Dean
(please print)
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IRB Application —Page 9
FOR OFFICE USE ONLY:
Date Received
Exempt Category Number
IRB NO.
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