Sample Proxy Consent Form

SAMPLE PROXY CONSENT FOR RESEARCH PARTICIPATION

DOMINICAN UNIVERSITY of CALIFORNIA

Purpose and Background

Ms. 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.

Procedures

If 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 discomforts

1. 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 researchers will return my child to me in the waiting room.

2. Study records will be kept as confidential as 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 Participants will be identified by numerical code only, thereby ensuring confidentiality regarding the Participant’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.

Benefits

There 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 Considerations

There will be no costs to me or to my child as a result of taking part in this study.

Payment/Reimbursement

Neither my child nor I will be reimbursed for participation in this study.

Questions

I 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 Participants (IRBPHP), which is concerned with protection of volunteers in research projects. I may reach the IRBPHP Office by calling (415) 482-3547 and leaving a voicemail message, or FAX at (415) 257-0165, or by writing to IRBPHP, Office of Associate Vice President for Academic Affairs, Dominican University of California, 50 Acacia Avenue, San Rafael, CA 94901.

Consent

I 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.