For this assignment, you will complete an informed consent document. Use this for this assignment. You will edit the Informed Consent template to make it about your proposed research project. The language you use to complete the template should be professional, objective, and clear. It should be grammatically correct and free of spelling and punctuation errors. For the purposes of this assignment, you are the Primary Investigator (PI) in the study. Informed Consent Template This informed consent template has been adopted by the Regis IRB to assist researchers in developing easy-to-read consent documents. The format may be expanded, but the consent form must contain all the elements below. The brackets [ ] contain additional instructions and areas for customizing the form according to the purpose and procedure of your study. For studies involving (ages 18 and older), you must obtain . If your study involves , you must obtain . For participants ages , you must obtain and . Consent cannot truly be called informed unless the participant understands the terms of his or her participation in the study. It is the researchers responsibility to ensure that the consent documents are comprehensible to the participants. which is calculated based on the average sentence length and the average number of syllables per word. A grade of 7.0 would indicate that a seventh grader would likely understand the document. To test your documents grade level score in Microsoft Word: · Click the File tab, and then click Options. · Click Proofing. · Under When correcting spelling and grammar in Word make sure the Check grammar with spelling box is selected. · Select Show readability statistics. After you enable this feature, check the documents spelling (Click the Review tab; click Spelling & Grammar). When Word finishes checking the spelling and grammar, it displays information about the reading level of the document. If the score is too high, try the following: · Minimize the use of colons, semicolons, and punctuation other than standard periods and question marks. · Use short, concise sentences. Long, complex sentences can often be divided into shorter ones to reduce the readability level. · Use a thesaurus to find synonyms that are more comprehensible to the participants. · People are often unfamiliar with terms commonly used in academic fields. Use lay terms, and avoid academic jargon. · Write as if you are speaking directly with a person. Sometimes, this process can be a bit frustrating. Try to remember that appropriate readability is at the core of fully informing research participants about their rights and what they will experience. In other words, informed consent is a vital element in conducting ethical research. Please read this form carefully. You are being asked to be in a research study of [Insert a general statement about the study.]. You were selected to be in this study because [List inclusion criteria.]. You are not eligible to participate if [List exclusion criteria.]. Please ask any questions you may have before you agree to be in the study. You will receive copy of this consent form. The purpose of this study is [Explain the research question and purpose in lay language.]. If you agree to be in this study, we would ask you to [Explain procedures and tasks. Identify any procedures that are experimental. Describe the length of time for participation, frequency, and duration of procedures, etc. For example, if participants will be interviewed during the study you would describe: how many interviews, the length of each interview, and/or where the interview will take place.]. The benefits of being in this study are [State the anticipated benefits the research will produce for society and/or the participants. If there are no expected benefits, state as such.]. The study has the following risks. First [Explain the first risk, its likelihood, and how it will be minimized.]. Second, [Explain the second risk, its likelihood, and how it will be minimized.]. Third, . . . [If there are no foreseeable risks, state there are no expected risks.]. You will receive the following payment for being in the study: [Explain the amount of payment or other reimbursement information (e.g., class points, tokens, donations, etc.), as well as when payment and/or reimbursement will occur and in what cas
es payment will not occur, if any]. [If there is no payment, state: There is no payment for being in this study.] There is no cost to you for being in this research study. It is your choice to be in this study. If you choose not to be in this study, it will not affect your current or future relations with Regis. You are free to decline to answer questions or quit at any time, for any reason. There is no penalty for not taking part or for quitting. [If you are using students, you must include a statement that participating or not participating in the study will have no impact on their academic status. If you are using employees, you must state that participating or not participating in the study will have no impact on their employment status. Explain consequences (e.g., adjusted monetary benefits) of early withdrawal, if any.] The researcher may dismiss you from the study at any time for the following reasons: [Include the reasons, for example, (1) it is in your best interests (e.g., side effects or distress), (2) you have not followed the study rules, or (3) the study sponsor decided to end the study.]. The records of this study will be kept private. [Explain how information about the participants will be protected, for example, Research records will be kept in a locked file or All electronic information will be coded and secured using a password-protected file. Explain who will have access to the study records, and when and how they will be destroyed. Responses are anonymous when the researcher does not know the identity or any identifying information about who wrote them. If you are keeping a list connecting participants names to ID numbers, explain how you will keep that information protected and separate from your data analysis. If applicable, state that the responses are meant to be combined with other participants data and are not meant to gather information about specific individuals.] No published reports will include any information that will make it possible to identify you. The researcher conducting this study is: [PIs name]. The researcher will be available to answer any questions about the study at: [phone number and email address]. If you have questions or concerns about your rights, you may contact the Regis Institutional Review Board Chair: Statement of Consent [Choose only one statement according to the type of consent form.] [Adult Participant Informed Consent] I have read this form (or have had it read to me). I have been encouraged to ask questions. I have received answers to my questions. I give my consent to be in this study. I have received (or will receive) a copy of this form. I understand the risks and discomforts associated with the above study and understand that I may quit the study at any time without penalty. [Parent/Guardian Informed Consent for Participants Ages 17 and Younger] I have read this form (or have had it read to me). I have been encouraged to ask questions. I have received answers to my questions. I give my consent for my child to be in this study. I have received (or will receive) a copy of this form. I understand the risks and discomforts associated with the above study and understand that my child may quit the study at any time without penalty. Signature(s)/Date [Delete any that do not apply to your protocol.] [Adult Participant Informed Consent] Participant Printed Name: ___________________________________ Participant Signature: ___________________________________ Date: __________ [Parent/Guardian Informed Consent for Participants Ages 17 and Younger] Study Participant Printed Name: ___________________________________ Parent/Guardian Printed Name: ___________________________________ Parent/Guardian Signature: ___________________________________ Date: __________ [Interpreter for Non-English-Speaking Participants] Interpreter Printed Name: ___________________________________ Interpreter Signature: ___________________________________ Date: __________ [Participants Legal Representative] Participant Printed Name: ___________________________________ Legal Representative Printed Name: ___________________________________ Legal Representative Signature: ________________________________ Date: __________ Witness Printed Name: ___________________________________ Witness Signature: ___________________________________ Date: __________ Purchase the answer to view it