KEAN UNIVERSITY INSTITUTIONAL REVIEW BOARD
APPLICATION FORM TO REQUEST REVIEW OF A RESEARCH PROTOCOL
INVOLVING HUMAN SUBJECTS
FOR IRB USE ONLY:
IRB #: ______
Received: ______Reviewed: ______
______Approved; _____ Approved with Provisions; ______Denied.
This form should be prepared by the Principal Investigator (P.I.) and attached to any project proposal involving human experimental subjects, including all grant applications and Released Time for Research and UFRI applications.
Please send completed form as an e-mail attachment to with the subject heading "IRB" along with a signed hard copy containing any additional information that cannot be scanned and electronically attached to: “IRB”, the Office of Research and Sponsored Programs, CSE 101. Full details must be given and all necessary documentation submitted. Handwritten and/or incomplete forms will be returned to the investigator(s) without review.
IRB REVIEW TYPE REQUESTED: (specify only one of the following)_X____Full IRB panel review
______Expedited review - specify category(s): ______
______Exemption from IRB panel review - specify category(s): ______
Please refer to the categories of IRB review in the policy guidelines for an explanation of the categories.
PROJECT TITLE: The Postsecondary School Experiences of Students Diagnosed with a Mental Illness
Anticipated Start Date: 4/14/2005 Project End Date: 4/14/2006
PRINCIPAL INVESTIGATOR
Name: Lauren Mavus
Department: (DO NOT ABREVIATE): Occupational Therapy
E-mail: Home phone:
Home mailing address:
Position or Title: .___Faculty; _X_Graduate Student; ___Undergraduate Student; ___Staff.
Date of successful completion of the Human Subjects Certification Program: 1/30/2005
I will not begin this study until receipt of a Notice of Approval, or Exemption, from the IRB. Once approved or exempted, I will conduct this study according to the recommendations of the Kean University Institutional Review Board. I will report any serious adverse events or emergent problems to the IRB, will obtain IRB approval before implementing modifications of protocol, and will request continuing review/approval required beyond the study end date.
__Lauren Mavus____ Date: __3/30/2005__
(Signature of PI)
OTHER INVESTIGATOR(s)
Name: Lepore, DeMeo, Bokara
Department: Occupational Therapy
E-mail: Home phone:
Home mailing address:
Position or Title: .___Faculty; _X_Graduate Student; ___Undergraduate Student; ___Staff.
Date of successful completion of the Human Subjects Certification Program: 1/30/2005
FACULTY SPONSOR INFORMATION (if applicable)
Name: Dr. Laurie Knis-Matthews
Department: Occupational Therapy
E-mail: Office phone: 73379
Campus mailing address: T214
Indicate the date that the Faculty Advisor successfully completed the Human Subjects Certification Program:
Date: 1/20/2005
As faculty advisor/course instructor for the above named student, I have read/reviewed this application for completeness and accuracy. I certify that I am familiar with Kean University policies and federal regulations regarding the protection of human subjects in research. This study meets the guidelines and requirements of the IRB and has my endorsement.
__Laurie Knis-Matthews__ Date: _3/30/2005______
(Signature)
REQUESTS RECEIVED WITHOUT THE APPROPRIATE SIGNATURE(S) WILL NOT RECEIVE REVIEW.
For students to complete
1. Is this research/student project required to fulfill the requirements of a course?
_X_ Yes
___ No
2. If yes, please name the course ID and title OT 6522 - Research III
3. Will this research/student project be published?
_X_ Yes
___ No
APPLICATIONS FOR EXEMPTIONS
State in 100 words or less the nature of the research and referring the reason (XM1-XM8) for the exemption.
APPLICATIONS FOR EXPEDITED OR FULL REVIEW (must complete the remaining sections)
A. PROTOCOL DESCRIPTION
1. Briefly describe the context and goals of your research project: (What you hope to accomplish and why? Add additional sheets as needed).
Many individuals diagnosed with a psychiatric disorder who participate in treatment programs spend most of their time fulfilling the role as “patient”. However, many clients report a desire to fulfill other social roles such as workers, friends, or students. Many individuals diagnosed with a mental illness transition from the patient to student role through education programs as start of their quest to acquire more complex occupational and social roles in the future. To be successful in a school environment, students may require accommodations in the classroom. Services to help these individuals integrate into a classroom environment are not always implemented or even fully understood by educators. Limited attention has been given to understanding the experiences of students diagnosed with a mental illness who are participating in postsecondary education.
For this study, postsecondary school is defined as education beyond high school, and may include a person participating in educational experiences such as college, technical school, or supportive education. Our goal is to conduct a research study, utilizing qualitative methods, to learn more about the perceptions of students with mental illness who have pursued or are pursuing a postsecondary education. The following question will be investigated: What are the experiences of taking courses in a postsecondary institution for people who have been diagnosed with a mental illness?
2. Describe the involvement of human subjects in this project (Who are the subjects? How many subjects will be involved in the project?). Specify how subjects will be recruited (e.g. advertisements, announcements in class, e-mail, internet, etc.).
After receiving institution review board (IRB) approval from the university and research site, we intend to gain access to the students at the day program with assistance from the director of the day program. He will present us with the names of potential participants who may meet the criteria for this research study.
To be eligible for this study, potential participants must have experience attending postsecondary school and be members of a psychosocial day program. Participants must have attended classes in the past or be currently enrolled in a postsecondary educational program, and be diagnosed with a mental illness according to the Diagnostic and Statistical Manual IV-TR (DSM-IV-TR).
We will than conduct a meeting in which all interested potential participants are present, so that we may explain to them the purpose of our study, describe participant criteria, and identify confidentiality issues. Flyers announcing details as to the time, place, and purpose of the meeting will be posted ahead of time on the walls of the cafeteria, hallways, lounges, and program rooms in the facility so they are available for all staff and additional members to see. A phone number will be included on the flyer so other potential participants, who cannot attend the meeting, may call the researchers and still have an opportunity to learn more about the study. After this meeting is held, those interested in participating in our study may either approach the researchers directly or speak to their primary counselors regarding contact information and arranging specific times to meet. We will contact these four people through their primary counselor at the day program, and any remaining interested people will be placed on a waiting list and contacted as needed due to possible attrition of participants.
3. Indicate the duration of anticipated research as applicable (the length of each session and the number of sessions). Describe where the research will be conducted.
Note: If the research is to be conducted in another institution (e.g. a school, hospital, agency, etc.) a signed copy of the IRB approval or a permission letter from that institution must be attached.
The data for this research study will be gathered through a series of in-depth interviews. Participants will be asked to take part in a series of at least two in-depth interviews, lasting approximately 1-2 hours each. The interviews will take place in a private room at the psychosocial day program. The interviews will contain broad, open-ended questions that will encourage the participants to express their perceptions and experiences as a student diagnosed with a mental illness returning to school. The first interview will cover topics about the students’ past and present school experiences, perceptions about their illness while attending school and the types of support provided to them. The second interview will take place no more than two weeks later. At this time the interviewer will complete a participant check, and review and clarify areas discussed in the first interview. This second interview will give the participant the opportunity to rephrase, omit, expand upon, or add to topics that were discussed in the initial interview.
4. State in detail your plans for obtaining each subject’s informed consent to participate in this project (attach copies of any “informed consent” forms or agreements).
Once we contact our potential participants, each researcher will set up a time to discuss the goals of this study and consent form with a participant. Each of the four researchers will work exclusively with one participant throughout this research study. These meetings will be held in a room at the research site, during regular hours of the day program that are convenient for both the participant and researcher. During these meetings, each researcher will discuss the consent form in depth. Each participant will have the opportunity to ask questions, express concerns, and clarify issues regarding the study. If someone should decide not to participate, the researcher will thank that person for their time, and assure them that their refusal to take part will not affect the services they continue to receive at the day program. If someone decides to participate, he or she will be asked to review and sign a two page consent form that provides and overview of the purpose of the study, risks, benefits, and rights of voluntary participation and confidentiality (please see attached consent form). Participant rights include: the right to withdraw from the study or refuse to answer questions at any time with no penalty, the right to review written and audio-taped data and refuse its use in the study, the understanding that names, places, transcripts, and tapes of the interviews and all identifying information will be kept confidential. A copy of the consent form will be given to each participant. After this meeting, each researcher will then schedule the first interview session.
5. What expected benefits will accrue to each human subject or to humankind in general, as a result of this project? (Add additional sheets as needed).
The results of this study may add to the current body of knowledge about the postsecondary school experiences of students diagnosed with a mental illness. With this information, mental health and education programs may provide improved supports and resources needed to better serve other students with a mental illness who are interested in attending school. This study will gather information surrounding such topics as: the importance of postsecondary education, supportive education, barriers to serving students with mental illness, the role of the student, and accommodations for students with psychiatric disabilities.
6. What do you believe are all the possible risks (physical, psychological, sociological, or other) to humans that can result from participation in or assistance to this project? Describe in detail procedures to protect the human participants involved from each of the risks (Add additional sheets as needed).
H = High Risk M = Moderate Risk L = Low Risk
Nature of Risk: Potential of revealing sensitive information about past personal experiences
Risk Level
___H
___M
_X_L
Steps taken to minimize risk: Inform participants of this risk during initial meeting. Remind participants that they have the right to omit ant questions they do not feel comfortable answering.
Nature of Risk: The participants will be required to set aside approximately 2-3 total hours of time spent at the day program.
Risk Level
___H
___M
_X_L
Steps taken to minimize risk: Principal investigators will be accommodating to participant’s schedule when arranging interview times, and make schedule changes or adjustments to fit the participant’s need. Principal investigators will come prepared and ready to interview at the scheduled times. This includes setting up audio taping equipment and preparing interview topics to be discussed before the scheduled interview times.
Nature of Risk:
Risk Level
___H
___M
___L
Steps taken to minimize risk:
Nature of Risk:
Risk Level
___H
___M
___L
Steps taken to minimize risk:
7. In the utilization of the results of your project, are humans protected from possible risks, such as embarrassment or invasion of privacy? (Add additional sheets as needed).
Indicate whether possible breach of confidentiality is High = H ; Moderate = M ;Low = L
Nature of possible breach: Identity of participants, family, friends, or school being revealed.
___H
___M
_X_L
Steps taken to minimize risk: All identifying information will be kept in a locked cabinet in a designated researcher’s house for five years. All transcripts, consent forms, and logs will be shredded five years after the study is completed. Only the principal investigators will have access to it. All participants’ identifying information such as signed consent forms will be kept in a separate locked cabinet from the interview data, in a designated researcher’s house. Only the principal investigators will have access to it. Names of participants, places, and identifying information on transcribed data will be omitted or changed. All of the audio taped interviews will be transcribed by the principal investigators only.
Nature of possible breach: Protecting privacy during interviews conducted at the participants’ day program.
___H
___M
_X_L
Steps taken to minimize risk: All interviews will be conducted in a pre-arranged private room with the door closed. Only one principal investigator and one participant will be present during the interview. No one will be allowed entry into the room during the interview, and the tape will be stopped if the interview is interrupted. Topics discussed during the interview will not be discussed outside of the designated room and scheduled interview sessions, except among the principal investigators and their research advisor.
Nature of possible breach:
___H
___M
___L
Steps taken to minimize risk:
8. Specify how you will keep your data secure, and maintain confidentiality during the research.
All identifying information will be kept in a locked cabinet in the research advisor’s office for five years. Only the principal investigators and thesis advisor will have access to it. All participants’ identifying information such as signed consent forms will be kept in a separate locked cabinet from the interview data, in the thesis advisor’s office. Only the principal investigators and thesis advisor will have access to it. Names of participants, places, and identifying information on transcribed data will be omitted or changed. All of the audio taped interviews will be transcribed by the principal investigators only.