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Sample Informed Consent Documents

ICF Sample 1: Most appropriate for Adult Consent

Informed Consent

Protocol Title

The effects of cryotherapy on Gator ankle strength

Please read this consent document carefully before you decide to participate in this study.

Purpose of the research study

The purpose of this study is to examine the effects of cold therapy on Gator ankle strength.

What you will be asked to do in the study

Following a brief 5 minute warm-up on a stationary bicycle, you will be asked to volunteer to perform several stretching exercises. You will then be asked to sit on the Gatorkinetic testing device with your dominant ankle and lower leg securely fastened to the footplate attachment. You will be given a series of warm-up repetitions to familiarize yourself with the appropriate ankle motion to be tested. Following the warm-up you will be asked to perform 3 maximal test bouts with the dominant ankle only. A total of 4 ankle motions will be tested at two different test speeds (slow and fast). The speed is controlled by the computer in the Gatorkinetic testing device. Following the test you will be asked to place your dominant ankle in a whirlpool tub filled with ice and cold water maintained at a temperature of 400 F for 10 minutes. At the conclusion of the procedure you will again be tested for ankle strength using the identical procedure described above. At the conclusion of the test session, you will be asked to perform a series of stretches.

Time required

1 hour

Risks and Benefits

You may experience some mild muscle soreness in your calf muscles at a period of 24-48 hours after the test. If you have any cold allergies, you will be excluded from the study. We do not anticipate that you will benefit directly by participating in this experiment.

Compensation

You will be paid $6.00 compensation for participating in this research.

Confidentiality

Your identity will be kept confidential to the extent provided by law. Your information will be assigned a code number. The list connecting your name to this number will be kept in a locked file in my faculty supervisor’s office. When the study is completed and the data have been analyzed, the list will be destroyed. Your name will not be used in any report.

Voluntary participation

Your participation in this study is completely voluntary. There is no penalty for not participating.

Right to withdraw from the study

You have the right to withdraw from the study at anytime without consequence.

Who to contact if you have questions about the study

Ima Gator, Graduate Student, Department of Exercise and Gator Sciences, 000 Lake Alice, phone 392-0000.

Nat N. L. Champ, PhD, College of Health and Gator Performance, 999 STA, 846-0000.

Who to contact about your rights as a research participant in the study

IRB02 Office

Box 112250

University of Florida

Gainesville, FL 32611-2250

phone 392-0433.

Agreement

I have read the procedure described above. I voluntarily agree to participate in the procedure and I have received a copy of this description.

Participant: ___________________________________________ Date: _________________

Principal Investigator: ___________________________________ Date: _________________

ICF Sample 2: Parental Informed Consent in Letter Format

Department of Gator Instruction

PO Box 12345

University of Florida

Gainesville, FL 32600-0000

Sample Parental Consent

Dear Parent/Guardian,

I am a graduate student in the Department of Gator Instruction at the University of Florida, conducting research on language comprehension skills of adolescent alligators under the supervision of Dr. Nat N. L. Champ. The purpose of this study is to compare the student’s comprehension of oral vs written text under two different conditions, under and above water. The results of the study may help Gator teachers better understand the amount of knowledge gained and allow them to design instructional practices accordingly. These results may not directly help your child today, but may benefit future students. With your permission, I would like to ask your child to volunteer for this research.

Half of the participating children will either read or listen to a fish story under water, while the other children read or listen to the same story above water. The story will be selected from the school library. Children will then be asked to answer ten questions related to the story; but, they will not have to answer any question they do not wish to answer. The procedure will be presented by your child’s teacher during the English class period. The 30-minute procedure will take place twice during the month of April. With your permission, your child will be videotaped during the instructional period. The video will be accessible only to the research team for verification purposes. At the end of the study, the tape will be erased. Although the children will be asked to write their names on the questionnaires for matching purposes, their identity will be kept confidential to the extent provided by law . We will replace their names with code numbers. Results will only be reported in the form of group data. Participation or non- participation in this study will not affect the children’s grades or placement in any programs.

You and your child have the right to withdraw consent for your child’s participation at any time without consequence. There are no known risks or immediate benefits to the participants. No compensation is offered for participation. Group results of this study will be available in December upon request. If you have any questions about this research protocol, please contact me at 392-0000 or my faculty supervisor, Dr. Champ, at 846-0000. Questions or concerns about your child’s rights as research participant may be directed to the IRB02 office, University of Florida, Box 112250, Gainesville, FL 32611, (352) 392-0433.

Ima Gator

I have read the procedure described above. I voluntarily give my consent for my child, _________________, to participate in Ima Gator’s study of adolescent alligator’s language comprehension skills. I have received a copy of this description.

____________________________          ___________

Parent/Guardian                                       Date

____________________________          ___________

2nd Parent/Witness                                 Date

ICF Sample 3: Adult Informed Consent in Letter Format

Department of Gator Instruction

PO Box 12345

University of Florida

Gainesville, FL 32600-0000

Sample Consent

Dear Educator:

I am an undergraduate student at the University of Florida. As part of my coursework I am conducting an interview, the purpose of which is to learn about how educators use the specialized knowledge of curriculum. I am asking you to participate in this interview because you have been identified as a highly successful educator. Interviewees will be asked to participate in an interview lasting no longer than 45 minutes. The schedule of questions is enclosed with this letter. You will not have to answer any question you do not wish to answer. Your interview will be conducted by phone or at your office after I have received a copy of this signed consent from you in the mail. With your permission I would like to audiotape this interview. Only I will have access to the tape which I will personally transcribe, removing any identifiers during transcription. The tape will then be erased. Your identity will be kept confidential to the extent provided by law and your identity will not be revealed in the final manuscript.

There are no anticipated risks, compensation or other direct benefits to you as a participant in this interview. You are free to withdraw your consent to participate and may discontinue your participation in the interview at any time without consequence.

If you have any questions about this research protocol, please contact me at 392-0000 or my faculty supervisor, Dr. Nat N. L. Champ, at 846-0000. Questions or concerns about your rights as a research participant rights may be directed to the IRB02 office, University of Florida, Box 112250, Gainesville, FL 32611; (352) 392-0433.

Please sign and return this copy of the letter in the enclosed envelope. A second copy is provided for your records. By signing this letter, you give me permission to report your responses anonymously in the final manuscript to be submitted to my faculty supervisor as part of my course work.

Ima Gator

I have read the procedure described above for the School Curriculum Interview assignment. I voluntarily agree to participate in the interview and I have received a copy of this description.

____________________________          ___________

Signature of participant                          Date

I would like to receive a copy of the final “interview” manuscript submitted to the instructor. YES/ NO

Assent Sample Script 1: Older Children

Hello [child’s name]. My name is [examiner’s name] and I am a student at the University of Florida. I am trying to learn about how students think, learn, and behave in school. I will be working with several students at [name of school or after-school program]. If you decide to participate, you will be asked to do a series of activities, including some reading, writing, and math activities, and answering some questions about your feelings and emotions. We will spend about an hour and a half working in a group with other students and we will spend another hour and a half working on tasks individually. There are no known risks to participation, and most students actually enjoy the tests. You do not have to be in this study if you don’t want to and you can quit the study at any time. Other than the researchers, no one will know your answers, including your teachers or your classmates. If you don’t like a question, you don’t have to answer it and, if you ask, your answers will not be used in the study. I also want you to know that whatever you decide, this will not affect your grades in class. Your [parent / guardian] said it would be OK for you to participate. Would you be willing to participate in this study?

Assent Sample Script 2: Younger Children

Hi, my name is [examiner’s name], and I’m from the University. I’d like to tell you a few little stories and ask you some questions about them. Your [teacher / mom] said it was OK. We’ll do it in the conference room, and it takes about 15 minutes. Would you like to come do this?

Additional Consent options

Back Translations

Back-translation: “A document is translated into a target language by the researcher or colleagues; then that translation is given to a third party who is fluent in both languages, and they translate it back (hence, back-translation) into the original language, not having seen the original (or ideally, knowing much about the research).” 

In our case, for example, English to Spanish, then back to English. The rationale for this is that, while for many documents, it’s enough to (a) see that the translation into the target language has been done, and (b) the translator is qualified to do so, in some cases, you want to be sure that key ideas or phrases are getting communicated clearly – language differences can be subtle, and translations can differ in small but potentially important ways. The back translation can insure that the initial translation was as intended.

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