Illinois State University Institutional Review Board
Research with Human Subjects
Protocol Submission Form
Federal regulations and Illinois State University policy require that all research involving humans as subjects be reviewed and approved by the University Institutional Review Board (IRB). Any person (ISU faculty member, staff member, student, or other person) wanting to engage in human subject research at or through Illinois State University must receive written approval from the IRB before conducting research. For more information, templates, and forms please go to www.rsp.ilstu.edu
Please complete and forward this form and all supporting documents to your Department/Unit IRB representative. If you have any questions, please contact your Departmental/Unit IRB representative or the Research Ethics & Compliance Office, (REC) 438-8451, Campus Box 3330
I. General Information
A. Protocol InformationProtocol Title:
Primary Research Assignments for Students in ISU Writing Program Courses
(ENG 101, 101.10, 145, 145.13, and 246)
Is this research part of a thesis or dissertation proposal? No Yes
If yes, has the thesis or dissertation proposal been approved? No Yes
B. Principal Investigator Information (PI must be an ISU faculty or staff member)
Principal Joyce R. Walker
Investigator / Department English
Telephone (309) 438-1402
Number / Email
Address
Fax (309) 438-5414
Number / Mailing Campus Box 4240
Address
Co-Principal Investigator Information
Co- Principal Instructors of ENG 101, 101.10, 145, 145.13, and 246
Investigator (Please see the attached list of instructors) / Department English
Telephone
Number / Email
Address
Faculty Staff Grad. Student Undergrad. Student / Mailing
Address
Co-Principal Investigator Information
Co- Principal All students enrolled in the courses listed above
Investigator / Department English
Telephone
Number / Email
Address
Faculty Staff Grad. Student Undergrad. Student / Mailing
Address
II. Principal Investigator Assurance
As Principal Investigator, I certify that to the best of my knowledge:
1. The information provided for this project is correct
2. No other procedures will be used in this protocol
3. I agree to conduct this research as described in the attached supporting documents
4. I will request and receive approval from the IRB for changes prior to implementing changes (including but not limited to
changes in cooperating investigators or any changes in procedures).
5. I will comply with IRB and ISU policies for conducting ethical research.
6. I will be responsible for ensuring that the work of my co-investigator(s)/student researcher(s) complies with this protocol.
7. Any unexpected or otherwise significant events in the course of this study will be promptly reported to the REC.
8. In the case of student research, I assume responsibility for ensuring that any student will comply with University and Federal regulations regarding the use of human subjects in research.
9. In the case of externally funded research, I will request a modification to my approved protocol if any relative changes to the project’s scope of work are requested by the agency.
October 15, 2009
Principal Investigator Signature Date
III. Protocol Description
A. Provide a BRIEF description, in LAYMAN'S TERMS, of the proposed research.
As part of the curriculum of courses in the ISU Writing Program (ENG 101, 101.10, 145, 145.13, and 246), students are encouraged to explore various rhetorical situations and research methods. The standardized syllabus for these courses outline the inclusion of both primary and secondary research; however, each instructor modifies the standardized syllabus to fit his/her own pedagogical approaches. Generally, instructors of these courses introduce secondary research before primary research. These units are intended to work together in order to demonstrate how different research methods can influence and shape texts. Students, within the possible manifestations of the curriculum of these courses, may choose from a variety of research topics. These topics may be assigned or may develop in response to classroom activities and feedback from the instructor. The research topics may call for study of students’ writing, observations, interviews, surveys, and/or questionnaires depending upon the research questions and the design of the project. The research tools and methods are developed under the supervision of the instructor.
B. Methodology
1. Participants (ALL protocols must have a completed Appendix A)
a. How many participants will be included in the study?
Number: Male _____ Female _____ Total _2,000___
(N/A __X___ if not targeting males/females specifically)
Age range: __18___ to __90___
b. Where will participants be recruited?
Participants will be recruited by students in ENG 101, 101.10, 145, 145.13, and/or 246 . Generally, students design research projects that engage campus issues or topics within their own majors or areas of interest.
c. How will they be recruited? (Attach all recruitment documentation, i.e.
letters, flyers, etc.)
Participants will be invited to participate by the Writing Program student-researchers.
d. What procedures will be used (and in what order) to secure informed
consent/assent?
Informed consent documents will be distributed with any questionnaires and prior to an interview, observation, or study of documents. The attached sample informed consent forms will be provided as templates for students to use in their research.
e. Where will the research take place?
A majority of the research will take place at Illinois State. It is possible that students might design projects that require research at home or at local businesses.
If consent (and assent) forms are being used, attach copies. If presented verbally, a copy of any presentation text must be submitted. Templates for informed consent, parent consent /permission, and minor assent can be found at www.rsp.ilstu.edu
2. Procedure
a. What are you asking the participants to do? In what order?
Participants will be asked to complete questionnaires or will consent to be interviewed. The order depends entirely upon the individual student’s project and her/his research questions.
b. Will you involve them in a psychological intervention, deception, or
biomedical procedure?
No.
c. Will you audio _(No)_ , or videotape __(No)____, or digitally record _(No)__ , participant responses? Please check.
3. Instruments/Apparatus
What forms, surveys, equipment, etc. will you use? (Attach copies of all forms,
surveys and instruments to be used.)
Students in ENG 101/101.10 will design questionnaires and/or interview questions as part of the course.
4. Data
a. How/where will the data be stored and kept secure?
Once the students have designed the questionnaires and/or interview questions and have collected the data, they will compose their research projects. After the projects have been completed, the students will submit the surveys and/or notes along with their unit for an advisory grade. The instructor will then store the data in his/her locked office.
b. Who will have access?
Only the instructor will have access to the data after the unit is submitted.
c. How will the data be used (during and after the research)?
Students enrolled in Writing Program courses will use the data to write up their primary research project. Students may choose to revise the initial project as part of their semester portfolio working from the same data set. Some of these papers may appear in next year’s issue of the Redbird Reader, an annual publication of students’ writing published by the Writing Program and assigned as a required text in ENG 101 and 101.10.
d. How will the data be disposed of?
The instructor will shred any paper documents after one semester and delete all related electronic files.
C. RISKS
1. What are the physical, psychological, or social (loss of reputation, privacy, or
employability) risks?
The risks to participants in these research projects should be minimal. All participants’ identities will be kept confidential, and the instructors of these Writing Program courses will work with the students in order to revise their questionnaires prior to any data collection. The drafting and revising of their questionnaires and other research instruments will provide the student-researchers with an opportunity to think through their projects, understand the risks in researching with human participants, and revise accordingly. Similarly, interview questions and interviews will be designed and implemented under the supervision of the instructors.
Instructors will be provided with:
[1] published materials which outline the important ethical considerations in primary research,
[2] training sessions to review these published materials,
[3] Program Assistants (administrative staff) to oversee the instructors and to provide any extra
assistance.
These materials, training sessions, and administrative support are intended to minimize any risks and to ensure that the primary research assignments are in accordance with the Institutional Review Board’s guidelines.
2. Will the data be anonymous ______or confidential____X_____? (Please check one)
D. BENEFITS
1. What do you hope to learn?
This assignment is attended to introduce first-year students to primary research. It is our hope that students will learn about the various kinds of research and how to ethically perform and incorporate this research into their projects.
2. Who might find these results useful?
This research will primarily benefit students in the Writing Program classrooms listed. Student-researchers will gain experience designing and carrying out primary research projects in a responsible and professional manner. Future readers of the Redbird Reader will benefit from seeing examples of the results of primary research carried out by Writing Program students who preceded them.
3. How will the participants directly benefit?
Because there will be a variety of projects and a great number of participants, it is difficult to specifically outline exactly how the participants will benefit. Participants may have their thoughts and reflections stimulated, may become more aware of their writing processes and strategies, and may learn new techniques for writing and research.
IV. Checklist
This checklist must be completed and attached to all protocols or Department Representatives will return them to the PI. Please note that for any items checked “yes” you must attach the designated, completed appendices.
__X___ Yes _____ No Informed consent procedures/ documentation have been clearly explained.
(All protocols must have a completed Appendix A.)
_____ Yes __X___ No Is your research being funded? (If yes, complete Appendix B.)
_____ Yes __X__ No Are you recruiting and enrolling subjects 0-7 years old? (If yes, complete
and attach Appendix C.)
_____ Yes __X___ No Are you recruiting and enrolling subjects 8-17 years old? (If yes, complete
and attach Appendix C.)
_____ Yes ___X__ No Are you recruiting and enrolling prisoners as subjects? (If yes, complete and
attach Appendix D.)
_____ Yes __X___ No Are you recruiting and enrolling pregnant women as subjects? (If yes, complete
and attach Appendix E.)
_____ Yes __X___ No Are you recruiting and enrolling mentally incapacitated individuals as subjects? (If
yes, complete and attach Appendix F.)
_____ Yes __X___ No Will the subjects of this study be exposed to the possibility of harm, including
physiological, psychological, or social (e.g., loss of reputation, privacy, or
employability). (If yes, complete and attach Appendix G.)
_____ Yes __X___ No Will the subjects of this study be exposed to any psychological interventions such
as contrived social situations, manipulation of the subject's attitudes, opinions or
self-esteem, psychotherapeutic procedures, or other psychological influences. (If
yes, complete and attach Appendix H.)
_____ Yes __X___ No Will this study involve any elements of deception? (If yes, complete and attach
Appendix I.)
_____ Yes __X___ No Will the proposed research involve any biomedical procedures (e.g., the taking or
withholding of medication, ingestion of any food or other substances, injections,
blood drawing, or any other procedure which would normally be done under
medical supervision). (If yes, complete and attach Appendix J.)
_____ Yes __X___ No Will all or some of the subject(s) of the proposed research be audio or
videotaped or recorded in any other manner? (If yes, complete and attach
Appendix K.)
__X___ Yes _____ No Will this proposed research involve any elements of technology? (i.e. web-based
subject recruitment, email recruitment, web survey, etc.)
Attachment One:
Participant Information Sheet
(for the participants’ personal records)
Primary Research Assignments
For courses in the ISU Writing Program
(ENG 101, 101.10, 145, 145.13, and 246)
You are being invited to participate in a primary research project for one of the courses in the Illinois State University Writing Program: English 101, 101.10, 145, 145.13, and 246. The educational purpose of this research project is to provide an opportunity for students in the Writing Program to design and perform primary research. Because students will develop these materials themselves, the topics and themes of the projects will be varied. Ultimately, the students will write a course paper analyzing the data they collect and presenting interpretations and conclusions. As part of the study, you may be asked to allow the student researchers to study some of your writing, to complete an anonymous survey or questionnaire, or to participate in a confidential interview or a focus group.
Because we will never disclose any personal information or names that may identify you, the risks to you are minimal. Your participation in this study is completely voluntary and confidential. You do not have to participate and you will not be penalized in any way for choosing not to participate in the study. Also, you may choose to stop your involvement in this research at any time.
Attachment Two:
Informed Consent
(one copy for the participants’ records, another copy for the researcher)
1. I have read the Participant Information Sheet of the research project “Primary Research Assignments for Courses in the ISU Writing Program,” and I understand what will happen in the research project.
2. I understand that I may direct any questions about the research project and the role of participants to:
Bob Broad, Director of the Writing Program [here list name and contact info of Co-Principle Investigator]
Department of English
Campus Box 4240
Illinois State University
Normal, Illinois 61790-4240