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Here is the sample of the consent form i need. University of North Florida Office of Research and Sponsored Programs GUIDELINES FOR CREATING INFORMED CONSENT

Here is the sample of the consent form i need.

University of North Florida Office of Research and Sponsored Programs GUIDELINES FOR CREATING INFORMED CONSENT FORM The Principal Investigator must prepare, in language appropriate to the level of understanding of the subject, a narrative description of the planned procedure or treatment. This must be submitted as part of the protocol. For student projects, the Informed Consent form must contain the name and telephone number of the responsible faculty member. In all cases, the principal investigator's name and telephone number must appear on the form. Additional information about the informed consent document can be found in the Federal Regulations, the UNF Standard Operating Procedures, and the Informed Consent Checklist. I. UNF informed consent documents shall include the following elements of information: 1. Clearly identify UNF as the source of the research 2. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 4. If applicable, for research involving more than minimal risk, an explanation of whether any compensation and any medical treatments are available if an injury occurs, and, if so, what they consist of, or where further information may be obtained. 5. An explanation of who to contact for answers to pertinent questions about the research and, if applicable, who to contact if a subject suffers research-related injury. Include the name and telephone number of the Chair of the UNF Institutional Review Board, (904) 620-2498, for questions regarding the rights of research subjects. The following email address can also s..5@yahoo.com. 6. A statement that the study involves research, an explanation of the purposes for the research, the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental. 7. A description of any reasonably foreseeable risks or discomforts to the subject. 8. If applicable, a description of any benefits to the subject or to others that may reasonably be expected from the research. 9. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 10. A statement of whether monetary or other compensation or inducement will be awarded or not, and if so, the amount or nature. 11. If the subject pool could contain minors but they will not be included, attestation that participating subject is 18 years old or older. 12. If applicable, assent of a minor subject in addition to the consent of parents. Assent may need to be on a separate form designed to communicate with children. If you plan to involve minors, see additional section in this document about including minors as participants.

Rev. December 2012 13. Include the following signatures block (below is a sample only): Subject Name Date Principal Investigator Date Additional elements of informed consent may be required by the IRB on a case-by-case basis. A copy of the Informed Consent, signed by the subject is to be retained by the experimenter and a duplicate copy is to be given to the subject. II. Waivers 1. Waiver of documentation of informed consent (aka. Waiver of signed informed consent): If in the judgment of the IRB the participants are not at risk, informed consent may be delivered orally and signatures may not be required. Please note, that the criteria for receiving a waiver of signed informed consent are the following: The only record linking the subjects and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. OR The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. 2. Waiver of informed consent: In special cases that are clearly justified, the informed consent procedure may be waived by the IRB. Additionally, the IRB may approve a justified consent procedure which does not include, or which alters, some or all of the elements of informed consent. Please note, that the criteria for receiving a waiver or alteration of informed consent are the following: a) Option 1 The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: i. Public benefit or service programs; ii. Procedures for obtaining benefits or services under those programs; iii. Possible changes in or alternatives to those programs or procedures; or iv. Possible changes in methods or levels of payment for benefits or services under those programs AND The research could not practicably be carried out without the waiver or alteration. b) Option 2 The research involves no more than minimal risk to the subjects; The waiver or alteration will not adversely affect the rights and welfare of the subjects; The research could not practicably be carried out without the waiver or alteration; AND Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Rev. December 2012 III. Including minors as participants a) Child Assent: Definition of Assent: "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (45 CFR 46.402(b)). By definition, children are unable to provide informed consent to participate in research, although they might be able to give their assent. The IRB should determine that unless parental permission can be waived if adequate provisions are made for soliciting the permission of the parent(s) or legal guardian(s). While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research. Where appropriate, the IRB may choose to review on a case-by-case basis whether assent should be sought from given individuals. The federal regulations do not require that assent be sought from children starting at any specific age, but their assent should be sought when, in the judgment of the IRB, the children are capable of providing their assent, taking into account the ages, maturity, and psychological state of the children involved. For research activities involving adolescents whose capacity to understand resembles that of adults, the assent procedure should likewise include information similar to what would be provided for informed consent by adults or for parental permission. For children whose age and maturity level limits their ability to fully comprehend the nature of the research activity but who are still capable of being consulted about participation in research, it may be appropriate to focus on conveying an accurate picture of what the actual experience of participation in research is likely to be. If a child is capable of assent and the Institutional Review Board (IRB) requires that assent be sought, it must be obtained before the child can participate in the research activity. Thus, if the child dissents from participating in research, even if his or her parents or guardian have granted permission, the child's decision prevails. b) Parent/Guardian Permission Regardless of whether assent is obtained, it will be necessary to obtain permission from each child's parent/guardian before the child can be approached. The regulations define "permission" at 46.402 (c) as the "agreement of parent(s) or guardian to the participation of their child or ward in research." The term "parent" means a "child's biological or adoptive parent." The term "guardian" means "an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care." An Institutional Review Board (IRB) may waive the requirements for obtaining parental or guardian permission if it makes and documents the findings under either45 CFR 46.116(c) or (d). In addition to the provisions for waiver contained in 46.116(c) and (d), if the IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the parental permission requirements provided that an appropriate mechanism is in place to protect the children, and provided that the waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)). The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child's age, maturity, status, and condition (45 CFR 46.408(c)). Permission by parents or guardians shall be documented in accordance with and to the extent required by 46.117 in the federal regulations. Essentially, parental permission should be documented in a manner similar to that used to document informed consent.

Rev. December 2012 IV. Obtaining and documenting informed consent of subjects who do not speak English Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR 46.116 and 46.117). Where informed consent is documented in accordance with 46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them. When documentation of informed consent is waived, the information orally presented to participants should also be understandable to the participant. Additionally, participants should be able to ask questions and have those questions answered to their satisfaction. The IRB must receive, review, and approve all foreign language versions of the short form document as a condition of approval under the provisions of 46.117(b)(2). V. Obtaining Electronic Informed Consent In some cases, a secure digital signature can be used for electronic informed consent (e.g., online informed consent and data collection). However, in many cases it will be a better option to request a waiver of signed informed consent if your study meets the criteria for such a waiver. For information about the criteria required for a waiver of signed informed consent, please see section II above. The UNF IRB generally requires that participants be informed about how they can print a copy of the electronic informed consent document to keep for their records. Suggested language: Please note that you have the option to save or print a copy of this informed consent document for your records. To print this informed consent page from a PC, look for a Print icon at the top of the web browser. If you do not see a Print icon, right click anywhere on the informed consent text and select "Print" from the menu that appears. If you are using a Mac computer you can print the screen by pressing the Command, Shift and 3 buttons simultaneously. Screenshots are automatically placed on your desktop by default. VI. Sources Lin, M. (1995). Obtaining and documenting informed consent of subjects who do not speak English. Department of Health and Human Services. Retrieved from http://www.hhs.gov/ohrp/policy/ic-non-e.html. Protection of Human Subjects, Title 45 C.F.R. Part 46. (2009). Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. United States Department of Health and Human Services. (2011). Informed consent - FAQs.

Please create a consent form for The Impact of Fruit and Vegetable Consumption on High School Students' Participation in Physical Activity:

Word document that includes the following items, and type your responses next to each item. Please check theUNF ORSP Guidelines for Informed Consent

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for more details about what information to include.Sometimes some of the requirements are not applicable to the research being conducted. That is particularly true for 1e, 4 and 6.

  1. Research Statement (10 points)
    1. A statement that the study involves research (2 points)
    2. An explanation of the purposes of the research (2 points)
    3. An explanation of the expected duration of participation (2 points)
    4. A description of what procedures will be followed (2 points)
    5. Identification of any procedures that are experimental (2 points)
  2. Reasonably foreseeable risks or discomforts (5 points)
  3. Reasonably expected benefits to participants or others (5 points)
  4. Appropriate alternatives
  5. Extent of confidentiality (5 points)
  6. Compensation or treatment for injury (5 points)
  7. Contact information (5 points)
  8. Voluntary participation statement (5 points)

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