PROCESS FOR CLASSROOM RESEARCH ASSIGNMENTS
WHICH QUALIFY FOR EXEMPT STATUS
Research qualifying for exemption categories are listed on page 2 of the application. Research involving minors, prisoners, pregnant women, mentally infirm or minority populations can never be exempted under categories #2 or #3, and not under category #4 if participant observation.
PROJECT TITLE:Prefix and # of class
#1To include a research project, in class curricula, in which students will collect data from humans.
#3I have reviewed the assignments and certify that they qualify for exempt status in accordance with ASU policies and procedures.
#4Sources which qualify for exempt status
#5Use of verbal script for classroom recruitment/personal contact or distribution of cover letter for questionnaires (faculty responsibility).
(Subjects may be recruited by the researcher requesting volunteers in a classroom or organizational meeting, by personal contact, or distribution of information in a group setting. Using a list of names or telephone numbers/addresses is allowed only if the information is publicly available, in order to comply with privacy laws.)
#6Verbal scripts of cover letters
(If written consent forms are required, the study does not qualify for exempt status.)
#7Verbal scripts or cover letters
#8No identifying information will appear on data collected or final report.
ATTACHMENTS:The faculty is responsible for exempt studies and applications are not submitted to the IRB unless the study exceeds exempt status.
NOTE:Interviews may be audiotaped but subjects must be advised of disposition of audiotapes. Interviews involving incriminating information or very personal/sensitive information do not qualify for exempt status.
Videotaping/photographing relinquishes confidentiality and does not qualify for exempt status.
HS LOG NO. ______
APPLICATION FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS
ARIZONA STATE UNIVERSITY
INSTITUTIONAL REVIEW BOARD (IRB)
The Arizona State University IRB reviews all requests to conduct research involving human subjects. In completing the following application, be advised that the persons reviewing it may be entirely unfamiliar with the field of study involved. Present the request in TYPEWRITTEN form and in nontechnical terms understandable to the IRB. It is the investigator's responsibility to give information about research procedures that is most likely to entail risk but not to express judgment about the risk. Please submit a copy of your complete proposal, an informed consent/assent form as subjects will view it, any other material or background information that will assist the IRB's review, and a curriculum vitae or biographical sketch.
PRINCIPAL INVESTIGATOR DEPT./CENTER DATE OF REQUEST
FACULTY NAME / (to be completed) / (to be completed)TYPE OF REVIEW:NEW ( )RENEWAL ( )FULL BOARD ( )
EXEMPT: ( )Identify by numbers that apply--see page 2 ______
EXPEDITE: ( )Identify by numbers that apply--see page 4 ______
If renewal, are there any substantive changes? Yes ( ) No ( )
PROJECT TITLE: (Prefix) * (#) of class______
AGENCY SUBMITTED TO:
N/A / SUBMISSION DATE:
N/A / LOCATION OF PROJECT:
N/A
- GENERAL PURPOSE OF THE RESEARCH:
2. DATA OBTAINED BY:Questionnaire ( )Telephone ( ) Interview( )
Observation ( )Experiment ( )Secondary Source( )
Other (explain) ______
3. PROJECT DESCRIPTION: The IRB must have sufficient information, nontechnical and detailed, about what will happen with/to subjects to evaluate/estimate the risks. Assurance from the investigator, no matter how strong, will not substitute for a description of the transactions between investigator and subject. If a questionnaire is used, attach a copy. (When visual or auditory stimuli, chemical substances, or other measures might affect the health of the subjects, a statement from a qualified person or other appropriate documentation will aid in evaluating the nature of any risk created. In questionable cases, the IRB will require such documentation.)
[Summary of Methodology]
I have reviewed the assignments and certify that they quality for exempt status in accordance with
ASU policies and procedures.
2/98(Continued)
How many subjects will participate? Male ( ) Female ( ) Age ______to ______
Will subjects be students at Arizona State University? Yes ( ) No ( )
Source: ______Sources which qualify for exempt status______
5. How will subjects be selected, enlisted or recruited?
Verbal scripts or cover letters
6. How (in writing) will subjects be informed of procedures, intent of the study, and potential risks to them?
Verbal scripts or cover letters
7. How (in writing) will subjects be informed they may withdraw at any time without prejudice?
Verbal scripts or cover letters
8. How will subjects' privacy be maintained and confidentiality guaranteed?
No identifying information will appear on data collected or final report.
ATTACHMENTS: Please indicate those items we can expect to find as attachments.
Proposal( )Informed consent form (as adult subjects view it)( )
or release form
Questionnaire/Interview Outline( )Assent form (as child subjects will view it)( )
Cover Letter( )Curriculum Vitae or Bibliographical Sketch( )
(Faculty ONLY) (Not required for exemptions)
Verbal Script( )
Other Documentation ______
In making this application, I certify that I have read and understand the Policies and Procedures for Projects that Involve Human Subjects and that I intend to comply with the letter and spirit of the University Policy. Significant changes in the protocol will be submitted to the IRB for written approval prior to these changes being put into practice. Informed consent/assent records of the subjects will be kept for at least three (3) years after the completion of the research.
SIGNATURES: Principal Investigator (faculty)Department Chair Date
This application has been reviewed by the Arizona State University IRB:
FULL REVIEW BOARD ( )EXEMPT ( ) EXPEDITE ( ) CATEGORIES: ______
APPROVED ( ) DEFERRED ( )DISAPPROVED ( )
Project requires review more often than annual ( ) Every ______months
Comments or modifications/conditions for approval, or reason for disapproval:
SIGNATURE Date
Chair of University IRB -3-
HS LOG NO. ______
APPLICATION FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS
ARIZONA STATE UNIVERSITY
INSTITUTIONAL REVIEW BOARD (IRB)
The Arizona State University IRB reviews all requests to conduct research involving human subjects. In completing the following application, be advised that the persons reviewing it may be entirely unfamiliar with the field of study involved. Present the request in TYPEWRITTEN form and in nontechnical terms understandable to the IRB. It is the investigator's responsibility to give information about research procedures that is most likely to entail risk but not to express judgment about the risk. Please submit a copy of your complete proposal, an informed consent/assent form as subjects will view it, any other material or background information that will assist the IRB's review, and a curriculum vitae or biographical sketch.
PRINCIPAL INVESTIGATOR DEPT./CENTER DATE OF REQUEST
TYPE OF REVIEW:NEW ( )RENEWAL ( )FULL BOARD ( )EXEMPT: ( )Identify by numbers that apply--see page 2 ______
EXPEDITE: ( )Identify by numbers that apply--see page 4 ______
If renewal, are there any substantive changes? Yes ( ) No ( )
PROJECT TITLE: ______
AGENCY SUBMITTED TO: / SUBMISSION DATE: / LOCATION OF PROJECT:
1. GENERAL PURPOSE OF THE RESEARCH:
2. DATA OBTAINED BY:Questionnaire ( )Telephone ( ) Interview( )
Observation ( )Experiment ( )Secondary Source( )
Other (explain) ______
3. PROJECT DESCRIPTION: The IRB must have sufficient information, nontechnical and detailed, about what will happen with/to subjects to evaluate/estimate the risks. Assurance from the investigator, no matter how strong, will not substitute for a description of the transactions between investigator and subject. If a questionnaire is used, attach a copy. (When visual or auditory stimuli, chemical substances, or other measures might affect the health of the subjects, a statement from a qualified person or other appropriate documentation will aid in evaluating the nature of any risk created. In questionable cases, the IRB will require such documentation.)
[Summary of Methodology]
2/98(Continued)
How many subjects will participate? Male ( ) Female ( ) Age ______to ______
Will subjects be students at Arizona State University? Yes ( ) No ( )
Source: ______
5. How will subjects be selected, enlisted or recruited?
6. How (in writing) will subjects be informed of procedures, intent of the study, and potential risks to them?
7. How (in writing) will subjects be informed they may withdraw at any time without prejudice?
8. How will subjects' privacy be maintained and confidentiality guaranteed?
ATTACHMENTS: Please indicate those items we can expect to find as attachments.
Proposal( )Informed consent form (as adult subjects view it)( )
or release form
Questionnaire/Interview Outline( )Assent form (as child subjects will view it)( )
Cover Letter( )Curriculum Vitae or Bibliographical Sketch( )
(Faculty ONLY) (Not required for exemptions)
Verbal Script( )
Other Documentation ______
In making this application, I certify that I have read and understand the Policies and Procedures for Projects that Involve Human Subjects and that I intend to comply with the letter and spirit of the University Policy. Significant changes in the protocol will be submitted to the IRB for written approval prior to these changes being put into practice. Informed consent/assent records of the subjects will be kept for at least three (3) years after the completion of the research.
SIGNATURES: Principal Investigator (faculty)Department Chair Date
This application has been reviewed by the Arizona State University IRB:
FULL REVIEW BOARD ( )EXEMPT ( ) EXPEDITE ( ) CATEGORIES: ______
APPROVED ( ) DEFERRED ( )DISAPPROVED ( )
Project requires review more often than annual ( ) Every ______months
Comments or modifications/conditions for approval, or reason for disapproval:
SIGNATURE Date
Chair of University IRB -3-
MODEL FORM
SAMPLE VERBAL SCRIPT
(Recruitment of subjects from classrooms, telephone surveys,
and recruitment by personal contact)
I am a professor [a graduate student under the direction of Professor ______in the Department/Division/College of ______at Arizona State University. I am conducting a research study to (state purpose of study) .
I am recruiting subjects to ______which will take approximately ______.
Your participation in this study is voluntary. If you choose not to participate or to withdraw from the study at any time, there will be no penalty, (it will not affect your grade, treatment/care, whichever applies - select only one). The results of the research may be published, but your name will not be used.
If you have any questions concerning the research study, please call me at (602) ___- ____.
NOTE:If data collection involves audiotape/videotape of activities, any verbal script, consent letter/form, assent or information letter must advise subjects that the activities will be audiotaped/videotaped and the disposition of the tapes.
MODEL FORM
COVER LETTER
(Typically accompanies a questionnaire)
Dear ______:
I am a professor [a graduate student under the direction of Professor ______] in the Department/Division/ College of ______at Arizona State University. I am conducting a research study to (state purpose of study) ).
I am requesting your participation, which will involve ______. (Include the expected duration of the subject's participation). Your participation in this study is voluntary. If you choose not to participate or to withdraw from the study at any time, there will be no penalty, (it will not affect your grade, treatment/care, whichever
applies - select only one). The results of the research study may be published, but your name will not be used. [If anonymous questionnaire is completed, include statement that "The questionnaire is anonymous. The results of the study may be published but your name will not be known].
If you have any questions concerning the research study, please call me [or Dr. _____] at (602) ___-___.
Return of the questionnaire will be considered your consent to participate.
Sincerely,
(researcher's name)