ࡱ> beaO .bjbjUU D`7׎e7׎e% %%%9998qL|9)h9(aaaa!!!((((((($y+/.(%!!!"!!(aap( $ $ $!Ra8a( $!( $ $& &a?UE"j&|((0)&,.".&.%&!! $!!!!!((=#!!!)!!!!.!!!!!!!!! : EXAMPLES OF WORDING FOR PARENTAL PERMISSION FORM Parental Permission forms need to be written in a manner so that they can be easily understood by the targeted readers. Each form should be modeled on the following examples; use wording that is appropriate for your project. The IRB stamp has been inserted into the footer; this will be dated and signed upon approval of your project. Typically, written parental permission is required with any research involving minors [45 CFR 46.408(d)]. All categories below are required [45 CFR 46.408], unless if applicable is noted. Do not include any of these instructions in the final version, and remove the text in brackets. PARENTAL PERMISSION FORM Research Title: Sponsor: [For grants or funded studies, if applicable] Investigator(s): [Name, University address and telephone, or other contact numbers. If investigator is a student, identify and include University information for faculty supervisor.] Special instructions: [If applicable] [Example:] This permission form may contain words that are new to you. If you read any words that are not clear to you, please ask the person who gave you this form to explain them to you or contact the project director. Inclusion Criteria: [Only use if there are specific criteria for this subject population; if not, delete this section.] In bullet format, clearly list the inclusion criteria to participate in this research. Keep the wording brief and succinct. Exclusion Criteria: [Only use if there are specific criteria for this subject population; if not, delete this section.] In bullet format, clearly list the exclusion criteria to participate in this research (do not repeat the opposite of the inclusion criteria). Keep the wording brief and succinct. Purpose: [Examples:] You are being asked to give permission for your child to take part in a research study comparing... Your child has been chosen because he/she The purpose of this research study is to learn how to... Procedures: [Examples:] If you agree, your child will be given ... Your child will be asked... A ... will be done. Your child may also... Your child will be required to ... The study will take place at the ... The session will last for ... minutes. It will take about minutes to complete the survey. Payment for Participation: [If applicable] [Example:] Your child will receive ... for each visit to help cover your travel expenses. Risks/Discomforts: [Describe the risks/discomforts and how they will be minimized. Typically, one cannot guarantee there are no risks/discomforts, so minimal is preferable.] [Examples:] Mild discomfort may result from... Muscle soreness may occur as a result of... Answering the questions may cause your child to think about feelings that make him/her sad or upset. You will be informed of any new findings that may affect your decision to allow your child to remain in the study. There is no anticipated discomfort for those contributing to this study, so risk to your child is minimal. Benefits: [If there are none for the subject, say so.] [Examples:] Your childs help with this study may help... There is no promise that you or your child will receive any benefit from taking part in this study. Although your child may not benefit from taking part in this study, ... Alternative Therapy: [If applicable] [Example:] If you choose not to permit your child to take part in this study, other treatments can be used. These would include... Confidentiality: [Required:] All records will be kept confidential and will not be released without your consent except as required by law. [Examples:] Only the researcher and his/her faculty supervisor will have access to the files. Both your and your childs identity will be kept private. If the results of this study are written in a scientific journal or presented at a scientific meeting, neither your nor your childs name will be used. The data will be stored in a locked file cabinet. Your childs signed assent form, as well as this parental permission form, will be stored in a locked cabinet separate from the data. The audiotape will be transcribed without any information that could identify your child. The tape will then be erased. Voluntary Participation/Withdrawal: [Examples:] Your decision to allow your child to take part in this research study is entirely voluntary. You may refuse to allow your child to take part in or you may withdraw your child from the study at any time without penalty or loss of benefits to which you or your child are normally entitled. If you decide to withdraw your child, ... Your child may leave the study for any reason. Your child may be asked to leave the study for any of the following reasons: 1. Failure to follow the Project Directors instructions; 2. A serious adverse reaction which may require evaluation; 3. The Project Director thinks it is in the best interest of your childs health and welfare; or 4. The study is terminated. Future research: [Required. For any research that involves the collection of identifiable private information or identifiable biospecimens, the Parental Permission Form must now include a notice about whether information and/or biospecimens collected as part of the current research might be stripped of identifiers and used for future research. Include one of the following statements as appropriate (adjust wording):] Identifiers might be removed from the identifiable private information or identifiable biospecimens and could then be used for future research studies or distributed to another investigator for future research studies without additional parental permission from you or the childs legal guardian. OR Your childs information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. [We suggest using caution when implementing the second statement in your form, as it can be very challenging to keep subjects information or biospecimens from being used for future research. This is not to say the second statement should not be used; researchers will just need to be extra vigilant to make sure the information/biospecimens are used or not used in accordance with the Parental Permission form.] Questions: [Optional:] You may wish to discuss this with others before you agree to allow your child to take part in this study. [Required:] If you have any questions about the research now or during the study contact: [Study director name and telephone number]. If you have any questions regarding your childs rights as a research subject, you may contact the UM Institutional Review Board (IRB) at (406) 243-6672. Parents Statement of Permission: I have read the above description of this research study. I have been informed of the risks and benefits involved, and all my questions have been answered to my satisfaction. Furthermore, I have been assured that any future questions I may have will also be answered by a member of the research team. I voluntarily agree to have my child take part in this study. I understand that I will receive a copy of this permission form. Printed Name of Subject (Minor) Printed Name of Parent or Legally Authorized Representative ______________________ Signature of Parent or Legally Authorized Representative Date Statement of Permission to be Photographed, Audiotaped, Videotaped, etc. [If applicable] [Examples:] I understand that photographs (audio/video recordings) may be taken during the study. I give permission for my childs photograph to be taken. (or to be audio/video recorded) I give permission for the use of my childs photograph (audio/video) in presentations related to this study. I understand that if photographs (audio/video recordings) are used for presentations of any kind, names or other identifying information will not be associated with them. I understand that audio recordings will be destroyed following transcription, and that no identifying information will be included in the transcription. ________________________ Signature of Parent or Legally Authorized Representative Date Compensation for Injury: [Only if appropriate: For research involving more than minimal risk, the following statement is required in the consent form. Generally speaking, this will apply to any project requiring full IRB committee review; however, the IRB may require it for some expedited projects. If in doubt, please consult with the IRB office.] In the event that your child is injured as a result of this research you should individually seek appropriate medical treatment. If the injury is caused by the negligence of the ؿ or any of its employees, you may be entitled to reimbursement or compensation pursuant to the Comprehensive State Insurance Plan established by the Department of Administration under the authority of M.C.A., Title 2, Chapter 9. In the event of a claim for such injury, further information may be obtained from the Universitys Risk Manager (406-243-2700; HYPERLINK "mailto:jason.sloat@mso.umt.edu"jason.sloat@mso.umt.edu) or the Office of Legal Counsel (406-243-4742;  HYPERLINK "mailto:legalcounsel@umontana.edu" legalcounsel@umontana.edu). (Reviewed by University Legal Counsel, May 9, 2013)      The ؿ IRB Expiration Date_________________________ Date Approved _________________________ Chair/Admin ___________________________ 012T    ! 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