irb appendix and forms 9-20-2010 - dominican.edu · web viewms. susan fielding, an undergraduate...

INSTITUTIONAL REVIEW BOARD FOR PROTECTION OF HUMAN SUBJECTS

MODIFICATION APPLICATION

APPENDICES

APPENDIX A IRBPHS INITIAL APPLICATION 3

APPENDIX B PROPOSAL CHECKLIST 7

APPENDIX C RESEARCH PARTIPANT’S BILL OF RIGHTS 8

APPENDIX D CONSENT TO BE A RESEARCH SUBJECT 9

APPENDIX E PROXY CONSENT FOR RESEARCH PARTICIPATION 11

APPENDIX F LETTER TO PARTICIPANTS IN ANONYMOUS SURVEY 13

APPENDIX G LETTER OF PERMISSION TO DOMINICAN FACULTY 14

APPENDIX H LETTER OF PERMISSION TO AGENCY DIRECTORS 15

APPENDIX I PERMISSION TO USE A PSYCHOLOGICAL TEST 16

APPENDIX J HUMAN SUBJECT INCIDENT REPORT 17

APPENDIX A MODIFICATION APPLICATION

DOMINICAN UNIVERSITY of CALIFORNIA

INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS

MODIFICATION APPLICATIONAll information must be typed. Handwritten applications will be returned to researcher.See IRB Forms for Word document.IRBPHS Number on Initial Application:

Applicant Information

Name of Applicant:

Department:

Local Address or Campus Address:

Home Address: If different from campus/local address please provide home address for contact during periods when you may not be living on campus or locally.

Local Phone:

Work Phone:

E-mail Address: Note: All communication regarding your application will be by email so be sure you include a functional email address.

Name(s) of Co-investigators:

Faculty Advisor Information:

Name of Faculty Advisor:

Campus Phone:

Email Address: Note: All communication regarding your application will be by email so be sure you include a functional email address.

Project Information:

Exact Title of Project: Duration of Project (renewal applications must be submitted each year for mult-year projects):

Briefly describe the modification for which you are seeking approval:

Research Project Information: All requested information must be typed directly on the application form. Refer to page 21 in the IRBPHS Handbook for aid in providing required information.

Background and Rationale (no more than 300 words). Describe nature of research problem and purpose of current study.

Description of Sample. Indicate by an X whether the following are involved and attach all required documents to this application.

Patients as subjects Non-patient volunteers Students as subjects Minor subjects (less than 18 years) Subjects whose major language is not English (include copies of translated

documents) Mentally disabled subjects Mentally retarded subjects Prisoners, parolees, or incarcerated subjects Other vulnerable or sensitive populations (gifted children, alcoholics,

homosexuals, etc.) Please identify _____________________________ Subjects studied at non-Dominican locations Filming, video-, or voice-recording of subjects Data banks, data archives and/or registration records There is a dual relationship between researcher and subject (explain)

Recruitment Procedure. Indicate how applicant will solicit participation (face-to-face, phone contact, mail, email, etc) along with copies of materials used to recruit subjects and permission letters if applicableSubject Consent Process. Attach Informed Consent Forms to be used. If consent forms are not used explain why and provide copy of the Consent Cover Letter.

Procedures: Describe in detail what your subjects will experience and include copies of all written materials subjects will see including surveys, questionnaires, interview questions, etc.).

Research Project Information: All requested information must be typed directly on the application form. Refer to page 20 in the IRBPHS Handbook for aid in providing required information.Subjects:

Number of subjects used last year in project _____Number of subjects who completed the study _____Number of subjects needed to complete the research study _____

Summary of Results to Date (limit to 300 words or less)

Changes in Anticipated Risks. Any changes in potential risk to human subjects due to changes in protocol.

Changes in Anticipated Benefits. Any change due to impact of changes in research protocol.

Discussion of Problems: Summarize any problems experienced or encounted by human subjects during past year.

Explanation of Modification in Protocol: Summarize any modifications in reseasrch protocol made during the past year.

Recruitment Procedure. Indicate how applicant will solicit participation (face-to-face, phone contact, mail, email, etc) along with copies of materials used to recruit subjects and permission letters if applicable

Subject Consent Process. Attach Informed Consent Forms to be used. If consent forms are not to be used explain why and provide copy of the Consent Cover Letter.

Procedures: Describe in detail what your subjects will experience and include copies of all written materials subjects will see including surveys, questionnaires, interview questions, etc.).

Potential Risks to Subjects: All research projects involve some potential risks to subjects. Describe all potential risks. Applications that do not address risks will be returned.

Minimization of Potential Risk. Describe ways the potential risks will be minimized by researcher.

Potential Benefits to Subjects: Describe in detail all potential benefits to the individual (focus is individual not society). There is always some benefit – why else do the study.

Costs to the Subjects: Describe any costs to subjects (transportation, time, effort, etc.).

Reimbursement or Compensation to Subjects: Describe and provide rationale for any reimbursement or compensation in response to participation in the research.

Confidentiality of Records: Data will be anonymous

How will anonymity be ensured?

Data will not be anonymousHow will data be kept confidential? Who will see it?

How will raw data and computerized data be stored?

How will subject identity be kept separate from subject data?

(Note: all tapes and records should be destroyed after a period of one year following completion of the research project).

APPENDIX B Proposal Checklist


IRBPHS PROPOSAL CHECKLIST

This Checklist is provided to aid researchers and their advisors in preparation of the IRBPHS Application so that approval of the investigation may be accomplished as quickly as possible. Applications that are not submitted with all the necessary materials will be returned to the researcher and review will be postponed to next IRB review cycle.

1. _____The proposed methodology is appropriate to the research question and the sample.

2. _____Copies of all materials (letters of introduction, consent forms, demographic questions, surveys, and/or psychological measures) are attached to this proposal in an Appendix.

3. _____Written permission has been obtained or requested (and a copy is attached) for the use or adaptation of any published tool, test, questionnaire, inventory, or survey.

4. _____Written permission has been obtained or requested (and a copy is attached) from the appropriate institutional authority for the use of clients, students, patients, or employees of any institution as participants in the study.

5. _____If human subjects are involved in the proposed project, participants understand:(a) the purpose of the project, and how the results will be used and made available.(b) what s/he is required to do as a participant.(c) participation in the project is voluntary and that s/he may withdraw from the project at any

time.(d) that his/her identity will be revealed in any way in any subsequent written or oral reports

describing the project.(e) that participation/non-participation in the project will not affect the participant's care, grade,

or status at the institution from which he or she was recruited if the subject is a student.(f) that any risks/benefits to the participant are explained.

6. _____Human subjects (and/or their parent or legal guardian) must sign an informed consent statement if any of the following conditions apply:(a) face to face interviewing between the researcher and participant or any videotaping of the

participant.(b) the research is "moderate or high risk," involving sensitive or emotional issues or any

possible physical risk to the participant.(c) situations where the participant is potentially identifiable on the basis of demographic

information.(d) the participant is a minor, is mentally disabled, or is a prison inmate or member of any other

at risk population.

7. _____Ethical issues and values pertinent to the discipline in which the student is working have been considered in making decisions about the project's methodology and the application of results.

8. _____The plan for reporting results to subjects, institutions, and the academic department reflects concern for accuracy, honesty, timeliness, and the welfare of the human subjects

APPENDIX C RESEARCH PARTICIPANT’S BILL OF RIGHTS

DOMINICAN UNIVERSITY of CALIFORNIARESEARCH PARTICIPANT’S BILL OF RIGHTS

Every person who is asked to be in a research study has the following rights:

1. To be told what the study is trying to find out;

2. To be told what will happen in the study and whether any of the procedures, drugs or devices are different from what would be used in standard practice;

3. To be told about important risks, side effects or discomforts of the things that will happen to her/him;

4. To be told if s/he can expect any benefit from participating and, if so, what the benefits might be;

5. To be told what other choices s/he has and how they may be better or worse than being in the study;

6. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study;

7. To be told what sort of medical treatment is available if any complications arise;

8. To refuse to participate at all before or after the study is stated without any adverse effects. If such a decision is made, it will not affect h/her rights to receive the care or privileges expected if s/he were not in the study.

9. To receive a copy of the signed and dated consent form;

10. To be free of pressure when considering whether s/he wishes to be in the study.

If you have questions about the research you may contact me at (insert student’s Dominican e-mail address here). If you have further questions you may contact my research supervisor, (insert Faculty research supervisor’s name and phone # here) or the Dominican University of California Institutional Review Board for the Protection of Human Subjects (IRBPHS), which is concerned with protection of volunteers in research projects. You may reach the IRBPHS Office by calling (415) 257-1389 and leaving a voicemail message, or FAX at (415) 257-0165, or by writing to IRBPHS, Office of Associate Vice President for Academic Affairs, Dominican University of California, 50 Acacia Avenue, San Rafael, CA 94901

APPENDIX DSAMPLE CONSENT FORM TO BE A RESEARCH SUBJECT

DOMINICAN UNIVERSITY OF CALIFORNIA CONSENT FORM TO ACT AS A RESEARCH PARTICIPANT

1. I understand that I am being asked to participate as a subject in a research study designed to assess certain personal attitudes related to death and dying. This research is part of Sarah Student's Senior Thesis research project at Dominican University of California, California. This research project is being supervised by Afshin Gharib, Ph.D., Associate Professor of Psychology , Dominican University of California.

2. I understand that participation in this research will involve taking part in a one-hour phone interview, which will include a personal life history, as well as thoughts and feelings on the topic of death and dying.

3. I understand that my participation in this study is completely voluntary and I am free to withdraw my participation at any time.

4. I have been made aware that the interviews will be recorded. All personal references and identifying information will be eliminated when these recordings are transcribed, and all subjects will be identified by numerical code only; the master list for these codes will be kept by Sarah Student in a locked file, separate from the transcripts. Coded transcripts will be seen only by the researcher and her faculty advisors. One year after the completion of the research, all written and recorded materials will be destroyed.

5. I am aware that all study participants will be furnished with a written summary of the relevant findings and conclusions of this project. Such results will not be available until May 1, 2010.

6. I understand that I will be discussing topics of a personal nature and that I may refuse to answer any question that causes me distress or seems an invasion of my privacy. I may elect to stop the interview at any time.

7. I understand that my participation involves no physical risk, but may involve some psychological discomfort, given the nature of the topic being addressed in the interview. If I experience any problems or serious distress due to my participation, Sarah Student will provide, at no cost to me, a one-time consultation with a licensed therapist. Ms. Student may be contacted at (insert student's Dominican e-mail address here).

8. I understand that if I have any further questions about the study, I may contact Ms. Student at (insert student’s Dominican e-mail address here) or her research supervisor, Afshin Gharib,Ph.D., Associate Professor of Psychology, Dominican University of California at 415-xxx-xxx. If I have further questions or comments about participation in this study, I may contact the Dominican University of California Institutional Review Board for the Protection of Human Subjects (IRBPHS), which is concerned with the protection of volunteers in research projects. I may reach the IRBPHS Office by calling (415) 482-3547 and leaving a voicemail message, by FAX at (415) 257-0165 or by writing to the IRBPHS, Office of the Associate Vice President for Academic Affairs, Dominican University of California, 50 Acacia Avenue, San Rafael, CA 94901.

9. All procedures related to this research project have been satisfactorily explained to me prior to my voluntary election to participate. I HAVE READ AND UNDERSTAND ALL OF THE ABOVE EXPLANATION REGARDING THIS STUDY. I VOLUNTARILY GIVE MY CONSENT TO PARTICIPATE. A COPY OF THIS FORM HAS BEEN GIVEN TO ME FOR MY FUTURE REFERENCE.

____________________________________________________________ _____________ Signature Date

APPENDIX E PROXY CONSENT FOR RESEARCH PARTICIPATION

SAMPLE


Purpose and BackgroundMs. Susan Fielding, an undergraduate student, and Dr. Samuel Togood, Professor, Department of Nursing at Dominican University of California, are doing a study on the social skills of children who have chronic ear infections. Because children with chronic ear infections miss many days of school and sometimes have difficulty hearing, the researchers are interested in learning whether these children are slower to develop social skills as compared with children who do not suffer from chronic ear infections.

My child is being asked to participate because s/he suffers from chronic ear infections.

ProceduresIf I agree to allow my child to be in this study, the following will happen:

1. I will complete a questionnaire about my child’s health, development, and friendship relationships.

2. My child will be observed through a one-way mirror while she plays with three other children she does not know but who are similar in age. The play period will be for 30 minutes.

3. The researchers will review my child’s medical records to obtain information about the nature and extent of my child’s ear infections.

4. I will complete the questionnaire and my child will participate in the 30-minute free play period at my pediatrician’s office.

Risks and/or discomforts1. My child may become uncomfortable or upset during the 30-minute free-play

period. If this happens, the researchers will attempt to comfort my child. If my child continues to be upset, the researches will return my child to me in the waiting room.

2. Study records will be kept as confidential as is possible. No individual identities will be used in any reports or publications resulting from the study. All personal references and identifying information will be eliminated when the data are transcribed, and all subjects will be identified by numerical code only, thereby assuring confidentiality regarding the subject’s responses. The master list for these codes will be kept by Ms. Fielding in a locked file, separate from the transcripts. Only the researcher and her faculty advisors will see coded transcripts. One year after the completion of the research, all written and recorded materials will be destroyed.

BenefitsThere will be no direct benefit to me or to my child from participating in this study. The anticipated benefit of this study is a better understanding of the effect of the chronic ear infections on the development of children’s social skills.

Costs/Financial ConsiderationsThere will be no costs to me or to my child as a result of taking part in this study.

Payment/ReimbursementNeither my child nor I will be reimbursed for participation in this study.

QuestionsI have talked to Ms. Fielding about this study and have had my questions answered. If I have further questions about the study, I may call her (510) 444-4444 or Dr. Togood (415) 778-9999. If I have any questions or comments about participation in this study, I should first talk with the researchers. If for some reason I do not wish to do this, I may contact the Dominican University of California Institutional Review Board for the Protection of Human Subjects (IRBPHS), which is concerned with protection of volunteers in research projects. I may reach the IRBPHS Office by calling (415) 485-3278 and leaving a voicemail message, or FAX at (415) 257-0165, or by writing to IRBPHS, Office of Associate Vice President for Academic Affairs, Dominican University of California, 50 Acacia Avenue, San Rafael, CA 94901.

ConsentI have been given a copy of this consent form, signed and dated, to keep.

PARTICIPATION IN RESEARCH IS VOLUNTARY. I am free to decline to have my child be in this study, or to withdraw my child from it at any point. My decision as to whether or not to have my child participate in this study will have no influence on my child’s present or future status as a patient in my pediatrician’s office.

My signature below indicates that I agree to allow my child to participate in this study.

Signature of Subject’s Parent/Guardian Date

Signature of Person Obtaining Consent Date

(Model letter adapted from USF IRPHS Handbook)

APPENDIX F SAMPLE LETTER OF INTRODUCTION TO PARTICIPANTS IN

ANONYMOUS SURVEY RESEARCHDear Study Participant,

My name is Steve Student and I am an undergraduate Psychology major at Dominican University of California. I am conducting a research project as part of my senior thesis requirements, and this work is being supervised by Matthew S. Davis, Ph.D., Professor of Psychology at Dominican University of California. I am requesting your voluntary participation in my study, which concerns people’s television viewing habits and their attitudes regarding the content of popular TV programs.

Participation in this study involves keeping a record of the television shows you watch in the course of a one week period, and then filling out a five page questionnaire containing items on your opinions of television programming today, as well as some demographic questions to be used for statistical purposes. Please note that your participation is completely voluntary and you are free to withdraw your participation at any time. Likewise, your participation or non-participation will not affect your class grade. In addition your survey responses will be completely anonymous. Aside from keeping the television viewing record, filling out the survey is likely to take approximately 15 minutes of your time.

If you choose to participate in this study, please fill out the attached materials as honestly and completely as possible. You may then return them to me at your earliest convenience in the envelope provided via the Psychology Student research drop-box, located in the basement of Bertrand Hall. Remember, this survey is completely anonymous; do not put your name or any other identifying information on your survey form. If you choose not to participate, please return your unused survey materials to me in the envelope provided.

If you have questions about the research you may contact me at (student inserts Dominican e-mail address here). If you have further questions you may contact my research supervisor, (insert Faculty research supervisor’s name and phone # here) or the Dominican University of California Institutional Review Board for the Protection of Human Subjects (IRBPHS), which is concerned with protection of volunteers in research projects. You may reach the IRBPHS Office by calling (415) 482-3547 and leaving a voicemail message, or FAX at (415) 257-0165, or by writing to IRBPHS, Office of Associate Vice President for Academic Affairs, Dominican University of California, 50 Acacia Avenue, San Rafael, CA 95901.

If you would like to know the results of this study once it has been completed, a summary of the results will be presented at Dominican University of California's Academic Showcase in April, 2010.

Thank you in advance for your participation.

Sincerely,

Steve S. Student Psychology Student Research Box Dominican University of California 50 Acacia Avenue San Rafael, CA 94901

APPENDIX G LETTER OF PERMISSION TO DOMINICAN FACULTY

SAMPLE


LETTER OF PERMISSION TO DOMINICAN FACULTY

Joseph Professor, Ph.D.Psychology DepartmentDominican University of California

RE: PRESENTATION OF RESEARCH PROJECT

Dear Dr. Professor:

This letter confirms that you have read a brief description of my research project that examines student attitudes about the food served at the Student Cafeteria and that I have your permission to recruit participants for this project from your Research Methods class at a date and time convenient for you. I would only need 5-7 minutes of class time to summarize my project, ask for volunteers, and leave my materials.

This project is an important part of my undergraduate research requirements as a Biology major at Dominican. Dr. Richardson, Ph.D., Professor of Biology, is supervising my research. If you have questions about the project you may contact me at 555-5555. If you have further questions you may contact Dr. Richardson, at 666-6666, or the Institutional Review Board for the Protection of Human Subjects at (415) 485-3278.

Shortly after completion of my study, I will send you a brief summary of relevant findings and conclusions.

If my request to contact the students in your class meets with your approval, please sign this letter on the line provided below, date, and return this letter to me as soon as possible. I have enclosed a stamped self-addressed envelope for your convenience. I will then contact you to arrange a convenient time for visiting your class.

Thanks for your assistance.

Sincerely,

Sharon A. Senior50 Acacia AvenuePsychology Student Research BoxDominican University of CaliforniaSan Rafael, CA 94901

(415) 457-5533 x669

I agree with the above request Signature Date

APPENDIX H LETTER OF PERMISSION TO AGENCY DIRECTORS

SAMPLE


LETTER OF PERMISSION TO AGENCY DIRECTORS

Mr. StanhopeManager, Vanna White Health & Fitness Center123 Playa Del Sol, Suite CMarina Del Ray, CA 90111

Dear Mr. Stanhope:

This letter confirms that you have been provided with a brief description of my senior thesis research project, which concerns factors related to successful weight loss, and that you give your consent for me to visit your facility to interview a random sample of your clients. This project is an important part of my undergraduate requirements as a Nursing major, and is being supervised by Dr. Fred Montaque, Professor of Nursing at Dominican University of California.

As we discussed in our phone conversation, I will make every effort to ensure that my data collection does not interfere with your regularly scheduled classes and workshops, and that your clients are treated with the utmost discretion and sensitivity. If you have questions about the research you may contact me at 555-5555. If you have further concerns you may contact my research supervisor, Dr. Montague, at 666-6666 or the Institutional Review Board for the Protection of Human Subjects at Dominican University of California by calling (415) 485-3278.

After my research project has been completed in May 2004, I will be glad to send you a summary of my research results.

If my request to visit your establishment and to interview your clients meets with your approval, please sign and date this letter below and return it to me in the enclosed self-addressed, stamped envelope as soon as possible. Please feel free to contact me if you have any questions about this project.

Thank you very much for your time and cooperation.

Sincerely,

Bruce T. Rockford43 Thesis TerraceSan Rafael, CA 94903

I agree with the above request

Signature Date

APPENDIX I PERMISSION TO USE A PSYCHOLOGICAL TEST

SAMPLE


LETTER REQUESTING PERMISSION TO USE A PSYCHOLOGICAL TEST

September 1, 2003

Princeton University Press41 Williams StreetPrinceton, NJ 08540

RE: Couch Potato Inventory

Dear Madame or Sir:

I am writing to request written permission to use the Couch Potato Inventory (Remote, 1993) in my undergraduate research project relating stress levels to the amount of time adolescents spend watching television. This project is part of an undergraduate senior thesis research requirement in psychology at Dominican University of California.

I would also appreciate receiving copies of the test/questionnaire, the standard instructions for administering the test, and scoring procedures.

My research is being supervised by my advisor, Dr. Robert Knodoz, Psychology Department, Dominican University of California, San Rafael, CA, 94901, (415-889-9000).

If this request meets with your approval, please sign, date, and return this letter to me in the enclosed self-addressed, stamped envelope. I am also enclosing an additional copy of this letter for your records.

If you have any questions, please do not hesitate to contact me or, if you prefer, Dr. Knodoz.

Thank you for your help.

Sincerely,

Samantha J. Student2001 Graduation GardensSan Rafael, CA 94903510-667-8888

I agree to the above request.

_____________________________________ _______________(Addressee's name) Date

APPENDIX J HUMAN SUBJECT INCIDENT REPORT


HUMAN SUBJECT INCIDENT REPORT

All incidents of injury or other adverse effects experienced by human subjects must be reported to the IRBPHS, Office of Associate Vice President for Academic Affairs, Dominican University of California, 50 Acacia Avenue, San Rafael, CA. 94901 (415-485-3278).

A written report, along with a copy of the original signed consent form, should be submitted as soon as possible, but NO LATER THAN 10 WORKING DAYS after first awareness of the problem.

Name of Researcher: University Title: Department: Home and/or Campus Address (s): Home and/or Work Phone (s): E-mail address:

Name(s) and University Title(s) of Other Investigators:

Name of Faculty Advisor: University Title: Campus Address: Campus Phone: E-mail Address:

Project Title:

IRBPHS #

Name of Human Subjects(s)

Respond to the items 1-4 on separate sheets of white paper, single-sided, typed in black ink using standard 12-point font. Responses to #1-4 should be stapled to this Human Subject Incident Report form.

1. Nature of Injury/Adverse Effect2. Treatment(s)/Response Provided to Human Subject3. Reporting (to whom has this already been reported?)4. Additional Comments

Signature of Person Reporting Incident DateName of Person Reporting Incident: Home and/or Campus Address(s): Home and/or Work Phones(s): E-Mail Address(s):

irb appendix and forms 9-20-2010 - dominican.edu · web viewms. susan fielding, an undergraduate...

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