IRB Proposal rough draft

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)

1.     Title of the Study: Good Samaritans in Our Times: How Tibetans and Indians have come together to help one another.
2.  Principal Investigator: Matt Merrill		3.  Contact Person: (if different from PI):
Title: : undergraduate	Dept: Media Arts	Title:	Dept:
Address (+ ZIP):		Address (+ Zip):
Phone:	Email:	Phone:	Email:
4.  Co-Investigator(s): Jeff Parkin (Mentor) (Name & Affiliation)
5.  Research Originated By:   (Check One)             Faculty               X Student                Staff
6.  Research Purpose(Check All that Apply):        X Grant           Dissertation         Thesis                 ORCA Scholarship        Honors Thesis    X  Course Project: Captsone film project
7.  Correspondence Request:          Mail            X Call for Pick-Up

Part B  Research Study Synopsis

1.  Brief Study Description (Include Purpose of the Research): I will be creating a documentary film observing the relationships between Tibetan refugees and Indians living in and around McLeod Ganj, India. The purpose of this project to create a film with the theme of service and charity, that will inspire those who see it to be more charitable and service oriented.

2.  Study Length      What is the duration of the study? 05/11 to 08/11 (in the field). 08/11 to 12/11 (out of field, editing).

3.  Location of Research    a.  Where will the research take place? Mcleod Ganj, Himachal Pradesh, India    b.  Will the PI be conducting and/or supervising research activity off-campus?                              X Yes            No         If Yes, please list sites: Mcleod Ganj and nearby towns, in people’s homes, at charitable organizations, and outdoors.

4.  Subject Information:    a.  Number of Subjects: 10 - 30 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: I am learning some Tibetan and Hindi, and the majority of the population speak English, but for those who do not speak English fluently I will find a translator to help communicate with the subjects.    c.  Into what language(s) will the consent form be translated: English, Tibetan, and Hindi

7.  Additional Subject Concerns    a.  Are there cultural attitudes/beliefs that may affect subjects in this study?       X Yes            No    b.  If yes, please describe attitudes and how they may affect subjects. Many subjects may not be used to cameras or being filmed. Also, people may express varying views or ideas about the relationship between Tibetans and Indians.

8.  Dissemination of Research Findings    a.  Will the research be published?    Yes           X No       If yes, where if known?    b.  Will the research be presented?   X Yes            No       If yes, where if known? On BYU campus or through BYU TV and in various film festivals (I do not know which ones yet).

9.  External Funding    a.   Are you seeking external funding  X Yes         No      What agency? I am still waiting to hear back about several grants I have applied for. If I do not get them, or do not get enough from them, I will need to seek further funding possibly from external sources.    b.   Have you received funding?     Yes        X No         c.   Dollar amount?

10.  Method of Recruitment:  (Check All that Apply)    Flyer      Classroom Announcement        X Letter to Subjects       X 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.    Although the focus of the film will be on the good of Tibetan/Indian relationships, some subjects when interviewed may have hard feelings toward the other race. In addition, if there are any potential conflicts that I try to observe, some people may prefer that I stay out of them.  There may also be some general discomfort from the presence of a camera.

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 finished film should promote service and charity and inspire people to be more loving of their neighbors and to seek to serve them.

15.  Study Procedures (DO NOT LEAVE ANY ITEM BLANK):    a.  What will be the duration of the subjects’ participation? Between 5 and 10 participants will be involved in multiple visits over the course of three months. Another 10 – 20 participants will be briefly interviewed in one one-hour or less visit.      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. Between 5 and 10 participants will be involved in multiple visits over the course of three months, with each visit lasting about 2 – 3 hours. Some of that visit may be interviewing, but a lot of it may simply be observing them going about their day-to-day business. Another 10 – 20 participants will be briefly interviewed in one one-hour or less visit. d.     Is the study    Therapeutic?     X Non-therapeutic? e.     List all procedures that will be performed to generate data for the research.  Informal interviews will be conducted, and subjects will be observed in some of their daily tasks or interactions with others. Observations and interviews will be recorded on video. f.      List all procedures/questionnaires done solely for the purpose of the research study. Informal, recorded interviews g.     List all procedures/questionnaires participants already do regardless of research.          Their daily activities and interactions with others.

16.  Informed Consent:    a.  Are you requesting Waiver or Alteration of Informed Consent?   X Yes     No   If yes, please fill out the waiver of informed consent and attach it. (Where can I get a model?)    b.  Briefly describe your process to obtain consent: I will obtain written consent from subjects before I begin any interviewing.

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: I’m not sure what this means. 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. Data will be video recorded on cards and then put onto a hard drive. I will be the only one to have access to the raw data and I will either keep it with me or in a locked box when not in use. 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):                                                                         

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* 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  Synopsis of the Proposal—Specific Aims

My goal with the finished film is that I will be able to show it to any audience, whether it be American or foreign, and that it will inspire people to love their neighbors, and to be more charitable and service oriented. This is a message I feel the world greatly needs and I hope that my film will be able to give that message to the people who see it. 

1.     Hypothesis or Research Question

A shared belief in charity and compassion has the power to bring different cultures and people together.

2.     Background and Significance

The significance of this project will be more in the message of the film than in any field research or factual value. Still, as far as I can tell (and I need to do more digging) there has been very little said or studied about the relationship between Tibetans and Indians, and what studies have been made seem to deal with it more from a political point of view. This of course plays a large role in the relationship, but my film will mostly be looking at individuals, not in political positions, and how and why they have found ways to help one another.

While this topic could be studied in many other parts of the world, I feel that Dharamsala will be a prime example because of what’s going on there now. There is conflict still, but also much love and compassion. BYU’s history in Dharamsala will also make it easier for me to make this film because many students before me have already been to the area and the people living there have seen these students conducting research in their towns. So when I come into the area, I will not be a complete alien to the people living there.

Also, because of BYU’s history with this area, I will be fortunate to live with a Tibetan host family in McLeod Ganj during my time in the field. I will do some contacting work before entering the field, to get in touch with a Tibetan charitable organization set up in Dharamsala, but a lot of the work in finding people for my project will have to come once I have arrived in the field.

3.     Description of Subjects

I will be looking for subjects who are involved one way or another in helping others, whether it be Tibetans helping Indians, Indians helping Tibetans, or even just people helping others in general, regardless of their culture. I will also look for people who are being helped by others in order to see how they appreciate or value this help.

4.     Confidentiality

Data will be video recorded on cards and then put onto a hard drive. I will be the only one to have access to the raw data and I will either keep it with me or in a locked box when not in use.

5.     Method or Procedures

Before entering the field I will have a base or an outline of the story of my film and what I suspect may happen while I am there. Once in the field, I will spend at least the first week or two just getting to know the area and the people I will be working with. When I feel that I have established good relationships with these people and they have agreed to be filmed I will start to shoot footage. Filming will include sit down interviews with these individuals as well as watching them in their day-to-day lives and how they interact with others. It will also follow the events or projects conducted by the Tibetan and Indian charitable organizations. In addition, I will want to get some footage of the general area to establish to the audience where the film is taking place.

I will work closely with a few Tibetan individuals as well as a few Indian individuals, preferably people who may know or be connected to each other in some way. It will be important to see and represent the Tibetans and Indians equally, and to find common ground between them despite their different cultural backgrounds. I plan to start by getting in contact with the Indians and Tibetans who are involved in charitable organizations, and then finding Tibetans and Indians that have benefitted from the services of these organizations. On a smaller level I will also talk to others in the streets or in their homes to get a basic idea of how people feel about certain issues involving the relationship between Tibetans and Indians.

6.     Data Analysis

After filming I will review my footage and make notes of what each segment suggests and where I could possibly use it in the overall film.

7.     Risks

Although the focus of the film will be on the good of Tibetan/Indian relationships, some subjects when interviewed may have hard feelings toward the other race. In addition, if there are any potential conflicts that I try to observe, some people may prefer that I stay out of them.  There may also be some general discomfort from the presence of a camera.

8.     Benefits

The finished film should promote service and charity and inspire people to be more loving of their neighbors and to seek to serve them.

9.     Compensation

There will be no direct compensation. If subjects would like, I may send them a copy of the finished film.

10.  References

(Is this a bibliography?)

12. Qualifications

I feel that I am qualified to do this project as a filmmaker because I have been studying film for over a year now and this semester I have been specifically studying documentary film and practicing techniques. I have also been working as a documentary filmmaker for BYU’s center for service and learning for the past six months. The center for service and learning has also helped me to get more involved in and take interest in service and charity, which is the theme of my film. As for qualifications for the location, I served a full-time mission in Mexico, and learned how to adapt to another culture. I am also currently enrolled in Tibetan and Hindi language classes to learn a little of the native languages before going to the field.

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: Any consent modification including a consent script for telephone or oral consent, mail survey, online consent statements require a request for a Waiver and/or Alteration of Informed Consent. You will request to waive the participants’ signatures and you may consider an abbreviated consent statement if the research is low risk. See examples on the forms page.  Read the instructions and add it to your application for consideration.

On the Consent Form. Indicate the number of pages and an area for initials:  For example, page 1 of 2 _____ (initials).   

Ethical research practices and respect for persons as outlined in the Belmont Report require that all subjects be given adequate information to allow them to make an informed and voluntary decision whether or not to participate in the research. The following information includes all the required elements of informed consent needed and how to write an informed consent form.

All elements of informed consent should be present on surveys, interviews (both written and oral), and signed consent forms. Some survey research may not require a signed consent form, but needs to include all elements of informed consent. Informed consent must be sought from all prospective participants (or their legally authorized representative), unless waived by the IRB. Investigators should be sensitive to the possible need for an interpreter/translator for persons who do not speak English. Translated versions of the form must be submitted if research is conducted in a foreign language.

The informed consent must include the following information:

1.                        A statement that the study involves research.

2.                        A description of the procedures to be followed, the expected duration, the conditions of the subject’s participation, and an identification of the experimental procedures proposed.

3.                        The reasonably foreseeable risks and discomforts.

4.                        The expected benefits of the research.

5.                        A description of the extent to which confidentiality of information will be maintained.

6.                        An explanation as to the availability of compensation and the availability of treatment if injury occurs, except where the research involves no more than minimal risk(s).

7.                        A contact person, phone number, and email address to which inquiries about the research project can be made.

8.                        A contact person not associated with the research, phone number, and address to which other questions may be sent (IRB Administrator).

9.                        A statement that participation is voluntary.

10.                        A statement that no penalties will result from non-participation or withdrawal.

Appendix F – Questionnaires, Surveys, Instruments, Interview questions, etc.

Translated tools must be submitted if conducted in a foreign language.

Appendix G – Tutorial Certificate

All researchers must submit their tutorial certificates on each application submission regardless if it was turned in previously. Additionally, all research staff interacting with human subjects must submit an IRB certificate.

Appendix H – All other supporting documents such as letters of support from other institutions or universities, grant applications, vitae, etc.