Enhance Your Research with Consent: A Comprehensive Guide

Abstract

THIS IS A TEMPLATE. PLEASE REVISE ACCORDINGLY. Consent to Participate in a Research Study [University] Title of Study: Investigators: Name: Dept: Phone: Name: Dept: Phone: Name: Dept: Phone: Introduction You are being asked to be in a research study of/about [insert general statement about study]. You were selected as a possible participant because [explain how subject was identified, include any exclusionary criteria]. Please read this form. You may also request that the form be read to you. The purpose of this form is to give you information about this research study, and if you choose to participate, document that choice. You are encouraged to ask any questions that you may have about this study now, during or after the project is complete. You can take as much time as you need to decide whether or not you want to participate. Your participation is voluntary; however, you may withdraw at any time. Why is this study being done? What is the purpose of this study? The purpose of the study is [explain research question and purpose in lay language]. Ultimately, this research may be [published as part of a book on…, presented as a paper, etc.]. What will I be asked to do? If you agree to be in this study, you will be asked to do the following things: [explain procedures and tasks; identify any procedures that are experimental; describe length of time for participation, frequency and duration of procedures; etc. If applicable, explain any alternative procedures or courses of treatment available to the subject.] What are the risks and/or discomforts of being in this study? [If there are no foreseeable risks, state as such] There are no reasonable foreseeable (or expected) risks. The study has the following risks. First, [explain first risk, including the likelihood of the risk]. Second, [explain second risk, including the likelihood of the risk]. Third, … What are the benefits of being in this study? The benefits of participation are [explain direct benefits of participation that will be gained by the participants. If a benefit is not likely to occur to each participant, do not include. If there are no expected benefits, state as such.] [Alternatively:] Although there may be no direct benefits to you as a result of taking part in this study, the results may indirectly benefit you [explain possible indirect benefits of participation] Will I be compensated for participating in this study? You will receive the following payment/reimbursement: [explain 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 cases payment will not occur if any. If there will be no payment, state this.] How will my privacy be protected? How will my data be kept confidential? This study is anonymous. We will not be collecting or retaining any information about your identity. The records of this study will be kept strictly confidential. Research records will be kept in a locked file, and all electronic information will be coded and secured using a password-protected file. [If audio or video tape recordings are made, explain specifically who will have access to them, if they will be used for educational purposes, and when they will be erased/destroyed and indicate how they will be destroyed or erased. See below for more information about audio and video recordings.] We will not include any information in any report we may publish that would make it possible to identify you unless you provide additional consent. May I refuse to participate in the study? Yes. The decision to participate in this study is entirely up to you. You may refuse to take part in the study at any time without affecting your relationship with the investigators of this study or Johnson & Wales University. You have the right not to answer any single question, and you have the right to request that the researcher not use any of your data. Your participation is voluntary. Your decision to participate will have no impact on your current or future relations with the university. You may skip or refuse to answer any question for any reason. If you choose not to participate there is no penalty to you, and you will not lose any benefits that you are otherwise entitled to receive. What if I decide I no longer want to participate in the study? May I withdraw? You are free to withdraw from this research study at any time, for any reason. If you choose to withdraw from the research study there will be no penalty to you, and you will not lose any benefits that you are otherwise entitled to receive. If you are not satisfied with the way in which this study was conducted, you may convey your concerns to the chair of the JWU IRB at [email] or [phone] and/or [insert contact information here]. What are my rights as a research participant? You will be informed of any significant findings developed during the course of the research that may affect your willingness to participate in the research. If you sustain an injury while participating in this study, your participation may be ended. If you have any other concerns about your rights as a research participant that have not been answered by the investigator(s), you may contact the chair of...