It is hard to believe that the IRB application is already here! The IRB is a review board on campus that ensures that all human subjects research is ethical. I have a lot of work to do. I know that somewhere on this thing I am supposed to write my methods and literature review, but I am not quite sure where? Anyone have any ideas? It is easier to fill out this time though, so that is really nice.
Application for the Use of Human Subjects
Part A Application Information (Only typed applications will be reviewed; submit 2, unstapled copies to ORCA in A-285 ASB) Fill in every item For help completing this application, click here
1. Title of the Study: A Portrait of Dharamsala: A Collection of Short Stories
2. Principal Investigator: Rachel Rueckert 3. Contact Person:
(if different from PI):
Title: Student Dept: English Title: Dept:
Address (+ ZIP): 489 Sandy Oaks Drive
Sandy, Utah, 84070 Address (+ Zip):
Phone:801-916-5211 Email: racheladventure@gmail.com Phone: Email:
4. Co-Investigator(s): Gideon Burton, English Professor
(Name & Affiliation)
5. Research Originated By: (Check One) ~ Faculty X~Student ~ Staff
6. Research Purpose(Check All that Apply): ~ Grant ~ Dissertation ~ Thesis
~ ORCA Scholarship ~ Honors Thesis ~ Course Project: Which Course?
7. Correspondence Request: ~ Mail X~ Call for Pick-Up
Part B Research Study Synopsis
1. Brief Study Description (Include Purpose of the Research):
Because stories are such an important part of the human experience, I am going to gather stories about the population that makes up Dharamsala, India. As part of that, I also want to better understand the nature of storytelling and the authenticity of our experiences abroad.
2. Study Length
What is the duration of the study? (mm/yr to mm/yr format)01/2011-04/2011 for prep class, 05/2011-09/2011 for work in the field, and 09-12/2011 for post field write ups.
3. Location of Research
a. Where will the research take place? Dharamsala, India
b. Will the PI be conducting and/or supervising research activity off-campus?
X~ Yes ~ No If Yes, please list sites:
4. Subject Information:
a. Number of Subjects: 5-20 b. Gender of Subjects: Male and Female
c. Ages of Subjects: 18 and older
5. Potentially Vulnerable Populations: (Check All that Apply)
~ Children ~ Pregnant Women ~ Cognitively Impaired ~ Prisoners ~ Institutionalized
~ Faculty’s Own Students ~ Other. Please describe:
6. Non-English Speaking Subjects
a. Will subjects who do not understand English participate in the research: X ~ Yes ~ No
b. If yes, describe your resources to communicate with the subjects: A translator
c. Into what language(s) will the consent form be translated: Tibetan
7. Additional Subject Concerns
a. Are there cultural attitudes/beliefs that may affect subjects in this study? ~ Yes X ~ No
b. If yes, please describe attitudes and how they may affect subjects.
8. Dissemination of Research Findings
a. Will the research be published? X~ Yes ~ No If yes, where if known? The BYU Inquiry Journal
b. Will the research be presented? X ~ Yes ~ No If yes, where if known? The BYU Inquiry Conference
9. External Funding
a. Are you seeking external funding? ~ Yes X~ No What agency?
b. Have you received funding? ~ Yes X~ No c. Dollar amount?
10. Method of Recruitment: (Check All that Apply)
~ Flyer ~ Classroom Announcement ~ Letter to Subjects ~ Third Party ~ Random
X~ Other: Convenience Sampling
11. Payment to Subjects
a. Will subjects be compensated for participation? ~ Yes X~ No If yes, please indicate amount:
b. Form of Payment: ~ Cash ~ Check ~ Gift Certificate ~ Voucher ~ 1099 ~ Other
c. Will Payment be prorated? ~ Yes ~ No If yes, please explain:
d. When will the subject be paid? ~ Each Visit ~ Study Completion ~ Other
12. Extra Credit
a. Will subjects be offered extra credit? ~ Yes X~ No
b. If yes, describe the alternative:
13. Risks: Identify all potential risks/discomforts to subjects.
The risks of this study are minimal. There is the risk of causing discomfort to subjects when they tell their stories and remember certain difficulties, but they will not be pressured to tell me anything that would in any way put them in an uncomfortable position.
14. Benefits:
a. Are there direct benefits to participants? ~ Yes X~ No If yes, please list.
b. Are there potential benefits to society? X~ Yes ~ No If yes, please list. The Dalai Lama himself has encouraged the people to share their stories with the world. By gathering this narratives, I can help generate awareness for these people and also contribute to an academic discussion.
15. Study Procedures (DO NOT LEAVE ANY ITEM BLANK):
a. What will be the duration of the subjects’ participation? 90 days
b. Will the subjects be followed after their participation ends? ~ Yes X ~ No If yes, please describe:
c. Describe the number, duration and nature of visits/encounters. I will hold somewhere between 3-10 informal interviews for an hour during each interview. They will be informal interviews, and will only be conducted when convenient for the subject. If the subject does not want to continue, they can quit at any given time.
d. Is the study ~ Therapeutic? X ~ Non-therapeutic?
e. List all procedures that will be performed to generate data for the research. I will be using a jotting notebook, a field journal, and photography to gather my material.
f. List all procedures/questionnaires done solely for the purpose of the research study. Informal interviews
g. List all procedures/questionnaires participants already do regardless of research.
Activities such as attending to spiritual duties or walking around town. These I would observe through participant observation.
16. Informed Consent:
a. Are you requesting Waiver or Alteration of Informed Consent? ~ Yes X~ No If yes, please fill out the waiver of informed consent and attach it.
b. Briefly describe your process to obtain consent: If needed, I will obtain written consent and a photo release form. I will also be respectful of the people I talk to and make sure I have their verbal approval as well.
17. Confidentiality:
a. Are the subject’s social security number, BYU ID number or any identifier (other than study number and initials) being sent off site? ~ Yes X~ No If yes, describe and explain reasons:
b. Will any entity other than the investigative staff have access to medical, health or psychological information about the subject? ~ Yes X ~ No If yes, please indicate who:
c. Briefly describe provisions made to maintain confidentiality of data, including who will have access to raw data, what will be done with the tapes, where data will be stored, how long data will be stored, etc. In order to maintain confidentiality of data I plan to keep all notebooks and writings in a briefcase with a lock. I will keep my memory cards to my camera in there as well. The door of my bedroom will be locked at all times, and I will never tell anyone where I store my information. No one will have access to the raw data other than me and my field mentor, and the material will be stored under the protection of a lock upon returning.
d. Will raw data be made available to anyone other than the PI and immediate study personnel?
~ Yes X ~ No
If yes, describe the procedure for sharing data. Include with whom it will be shared, how and why.
Part C
The attached investigation involves the use of human subjects. I understand the university’s policy concerning research involving human subjects and I agree:
1. X~ Yes ~ No To obtain voluntary and informed consent of subjects who are to participate in this project.
2. X~ Yes ~ No To report to the IRB any unanticipated effects on subjects which become apparent during the course of, or as a result of, the experimentation and the actions taken.
3. X~ Yes ~ No To cooperate with members of the committee charged with continuing review of this project.
4. X~ Yes ~ No To obtain prior approval from the committee before amending or altering the scope of the project or implementing changes in the approved consent document.
5. X~ Yes ~ No To maintain the documentation of consent forms and progress reports as required by institutional policy.
6. X~ Yes ~ No To safeguard the confidentiality of research subjects and the data collected when the approved level of research requires it.
Signature* of the Principal Investigator: Date:
*Faculty Sponsor Signature Required for All Student Submissions (will not be processed without this)
“I have read and reviewed this proposal and certify that it is ready for review by the IRB. I have worked with the student to prepare this research protocol. I agree to mentor the student during the research project.”
Faculty Sponsor (Please sign and print):
Required: Thesis/Dissertation – Date of Approval by the Proposal Review Committee:
Required: Committee Chair/Faculty Sponsor (Please sign and print):
_______________________________________________________
* If you are faculty submitting by email, please check this box to verify that you are the PI listed on this application and agree to follow the items listed above. ~ I agree
Only professors can submit applications electronically via email.
Part D Summary of Research Proposal
Part D, 1-9, should only be 5 pages or less (not including instruments, consent forms, etc.). Please use 12pt font, page numbers and the headings noted below.
Use everyday language.
This will allow the widest audience, including the IRB members, to understand the purpose of your research, and the procedures you have planned, and any risks or benefits involved.
Protocol Guidelines
IRB committee members, from a wide variety of disciplines, must be able to understand the language used in protocols. Please do not use discipline-specific jargon or acronyms. If you must, please define them. Be clear and concise, and limit the scope of the document to the purpose and background of your research, the procedures you will use to elicit data from your human subjects, risk and benefits, and how you intend to analyze the data to answer your research question. If you are conducting a qualitative research project, please define your methodology clearly.
1. Specific Aims
2. Hypothesis
3. Background and Significance
4. Description of Subjects
5. Confidentiality
6. Method or Procedures
7. Data Analysis
8. Risks
9. Benefits
10. Compensation
11. References
12. Qualifications
Include the following information as necessary in the appropriate appendix.
Appendix E – Consent Document or Request for a Waiver and/or Alteration of Informed Consent
Appendix F – Questionnaires, Surveys, Instruments, Interview questions, etc.
Appendix G – Tutorial Certificate
Appendix H – All other supporting documents such as letters of support from other institutions or universities, grant applications, vitae, etc.
Part A Application Information (Only typed applications will be reviewed; submit 2, unstapled copies to ORCA in A-285 ASB) Fill in every item For help completing this application, click here
1. Title of the Study: A Portrait of Dharamsala: A Collection of Short Stories
2. Principal Investigator: Rachel Rueckert 3. Contact Person:
(if different from PI):
Title: Student Dept: English Title: Dept:
Address (+ ZIP): 489 Sandy Oaks Drive
Sandy, Utah, 84070 Address (+ Zip):
Phone:801-916-5211 Email: racheladventure@gmail.com Phone: Email:
4. Co-Investigator(s): Gideon Burton, English Professor
(Name & Affiliation)
5. Research Originated By: (Check One) ~ Faculty X~Student ~ Staff
6. Research Purpose(Check All that Apply): ~ Grant ~ Dissertation ~ Thesis
~ ORCA Scholarship ~ Honors Thesis ~ Course Project: Which Course?
7. Correspondence Request: ~ Mail X~ Call for Pick-Up
Part B Research Study Synopsis
1. Brief Study Description (Include Purpose of the Research):
Because stories are such an important part of the human experience, I am going to gather stories about the population that makes up Dharamsala, India. As part of that, I also want to better understand the nature of storytelling and the authenticity of our experiences abroad.
2. Study Length
What is the duration of the study? (mm/yr to mm/yr format)01/2011-04/2011 for prep class, 05/2011-09/2011 for work in the field, and 09-12/2011 for post field write ups.
3. Location of Research
a. Where will the research take place? Dharamsala, India
b. Will the PI be conducting and/or supervising research activity off-campus?
X~ Yes ~ No If Yes, please list sites:
4. Subject Information:
a. Number of Subjects: 5-20 b. Gender of Subjects: Male and Female
c. Ages of Subjects: 18 and older
5. Potentially Vulnerable Populations: (Check All that Apply)
~ Children ~ Pregnant Women ~ Cognitively Impaired ~ Prisoners ~ Institutionalized
~ Faculty’s Own Students ~ Other. Please describe:
6. Non-English Speaking Subjects
a. Will subjects who do not understand English participate in the research: X ~ Yes ~ No
b. If yes, describe your resources to communicate with the subjects: A translator
c. Into what language(s) will the consent form be translated: Tibetan
7. Additional Subject Concerns
a. Are there cultural attitudes/beliefs that may affect subjects in this study? ~ Yes X ~ No
b. If yes, please describe attitudes and how they may affect subjects.
8. Dissemination of Research Findings
a. Will the research be published? X~ Yes ~ No If yes, where if known? The BYU Inquiry Journal
b. Will the research be presented? X ~ Yes ~ No If yes, where if known? The BYU Inquiry Conference
9. External Funding
a. Are you seeking external funding? ~ Yes X~ No What agency?
b. Have you received funding? ~ Yes X~ No c. Dollar amount?
10. Method of Recruitment: (Check All that Apply)
~ Flyer ~ Classroom Announcement ~ Letter to Subjects ~ Third Party ~ Random
X~ Other: Convenience Sampling
11. Payment to Subjects
a. Will subjects be compensated for participation? ~ Yes X~ No If yes, please indicate amount:
b. Form of Payment: ~ Cash ~ Check ~ Gift Certificate ~ Voucher ~ 1099 ~ Other
c. Will Payment be prorated? ~ Yes ~ No If yes, please explain:
d. When will the subject be paid? ~ Each Visit ~ Study Completion ~ Other
12. Extra Credit
a. Will subjects be offered extra credit? ~ Yes X~ No
b. If yes, describe the alternative:
13. Risks: Identify all potential risks/discomforts to subjects.
The risks of this study are minimal. There is the risk of causing discomfort to subjects when they tell their stories and remember certain difficulties, but they will not be pressured to tell me anything that would in any way put them in an uncomfortable position.
14. Benefits:
a. Are there direct benefits to participants? ~ Yes X~ No If yes, please list.
b. Are there potential benefits to society? X~ Yes ~ No If yes, please list. The Dalai Lama himself has encouraged the people to share their stories with the world. By gathering this narratives, I can help generate awareness for these people and also contribute to an academic discussion.
15. Study Procedures (DO NOT LEAVE ANY ITEM BLANK):
a. What will be the duration of the subjects’ participation? 90 days
b. Will the subjects be followed after their participation ends? ~ Yes X ~ No If yes, please describe:
c. Describe the number, duration and nature of visits/encounters. I will hold somewhere between 3-10 informal interviews for an hour during each interview. They will be informal interviews, and will only be conducted when convenient for the subject. If the subject does not want to continue, they can quit at any given time.
d. Is the study ~ Therapeutic? X ~ Non-therapeutic?
e. List all procedures that will be performed to generate data for the research. I will be using a jotting notebook, a field journal, and photography to gather my material.
f. List all procedures/questionnaires done solely for the purpose of the research study. Informal interviews
g. List all procedures/questionnaires participants already do regardless of research.
Activities such as attending to spiritual duties or walking around town. These I would observe through participant observation.
16. Informed Consent:
a. Are you requesting Waiver or Alteration of Informed Consent? ~ Yes X~ No If yes, please fill out the waiver of informed consent and attach it.
b. Briefly describe your process to obtain consent: If needed, I will obtain written consent and a photo release form. I will also be respectful of the people I talk to and make sure I have their verbal approval as well.
17. Confidentiality:
a. Are the subject’s social security number, BYU ID number or any identifier (other than study number and initials) being sent off site? ~ Yes X~ No If yes, describe and explain reasons:
b. Will any entity other than the investigative staff have access to medical, health or psychological information about the subject? ~ Yes X ~ No If yes, please indicate who:
c. Briefly describe provisions made to maintain confidentiality of data, including who will have access to raw data, what will be done with the tapes, where data will be stored, how long data will be stored, etc. In order to maintain confidentiality of data I plan to keep all notebooks and writings in a briefcase with a lock. I will keep my memory cards to my camera in there as well. The door of my bedroom will be locked at all times, and I will never tell anyone where I store my information. No one will have access to the raw data other than me and my field mentor, and the material will be stored under the protection of a lock upon returning.
d. Will raw data be made available to anyone other than the PI and immediate study personnel?
~ Yes X ~ No
If yes, describe the procedure for sharing data. Include with whom it will be shared, how and why.
Part C
The attached investigation involves the use of human subjects. I understand the university’s policy concerning research involving human subjects and I agree:
1. X~ Yes ~ No To obtain voluntary and informed consent of subjects who are to participate in this project.
2. X~ Yes ~ No To report to the IRB any unanticipated effects on subjects which become apparent during the course of, or as a result of, the experimentation and the actions taken.
3. X~ Yes ~ No To cooperate with members of the committee charged with continuing review of this project.
4. X~ Yes ~ No To obtain prior approval from the committee before amending or altering the scope of the project or implementing changes in the approved consent document.
5. X~ Yes ~ No To maintain the documentation of consent forms and progress reports as required by institutional policy.
6. X~ Yes ~ No To safeguard the confidentiality of research subjects and the data collected when the approved level of research requires it.
Signature* of the Principal Investigator: Date:
*Faculty Sponsor Signature Required for All Student Submissions (will not be processed without this)
“I have read and reviewed this proposal and certify that it is ready for review by the IRB. I have worked with the student to prepare this research protocol. I agree to mentor the student during the research project.”
Faculty Sponsor (Please sign and print):
Required: Thesis/Dissertation – Date of Approval by the Proposal Review Committee:
Required: Committee Chair/Faculty Sponsor (Please sign and print):
_______________________________________________________
* If you are faculty submitting by email, please check this box to verify that you are the PI listed on this application and agree to follow the items listed above. ~ I agree
Only professors can submit applications electronically via email.
Part D Summary of Research Proposal
Part D, 1-9, should only be 5 pages or less (not including instruments, consent forms, etc.). Please use 12pt font, page numbers and the headings noted below.
Use everyday language.
This will allow the widest audience, including the IRB members, to understand the purpose of your research, and the procedures you have planned, and any risks or benefits involved.
Protocol Guidelines
IRB committee members, from a wide variety of disciplines, must be able to understand the language used in protocols. Please do not use discipline-specific jargon or acronyms. If you must, please define them. Be clear and concise, and limit the scope of the document to the purpose and background of your research, the procedures you will use to elicit data from your human subjects, risk and benefits, and how you intend to analyze the data to answer your research question. If you are conducting a qualitative research project, please define your methodology clearly.
1. Specific Aims
2. Hypothesis
3. Background and Significance
4. Description of Subjects
5. Confidentiality
6. Method or Procedures
7. Data Analysis
8. Risks
9. Benefits
10. Compensation
11. References
12. Qualifications
Include the following information as necessary in the appropriate appendix.
Appendix E – Consent Document or Request for a Waiver and/or Alteration of Informed Consent
Appendix F – Questionnaires, Surveys, Instruments, Interview questions, etc.
Appendix G – Tutorial Certificate
Appendix H – All other supporting documents such as letters of support from other institutions or universities, grant applications, vitae, etc.
No comments:
Post a Comment