INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH Consent Form Template Instructions 4/15/2016 Version The consent form should be written at no greater than an eighth grade reading level and using lay person language (i.e., no complex scientific or medical terms). Avoid dense paragraphs using long sentences and large words. Use bullets, headings, and white space wherever possible to facilitate understanding. In the following template: Headings should be kept as part of the consent form unless otherwise indicated. Instructions are in red. Remove these instructions from your final document. Suggested wording is in plain font. This information should be edited/deleted/revised to accurately represent participation in your study. Please carefully review all the language to ensure correct information specific to your study is relayed to potential participants. The consent form should be written in the second person, e.g., “You will be asked to….” If the consent form is for the involvement of children in a study, “you” should be replaced with “your child.” Pages of the consent form should be numbered. If the IRB requires the researcher to obtain signed consent forms from participants, the researcher must keep the signed consent form as part of the research files for a minimum of three years after the end of the study, and provide a copy to each participant. Staff in Research Integrity Services office can provide assistance in developing consent forms or pre-review your draft consent form at anytime. Please email Julie Simpson (or call @ 603/862-2003) if you need help with developing consent forms. CONSENT FORM FOR PARTICIPATION IN A RESEARCH STUDY RESEARCHER AND TITLE OF STUDY Identify yourself (e.g., My name is Mary Jones and I am an undergraduate at the University of New Hampshire) and the title of the study. WHAT IS THE PURPOSE OF THIS FORM? This consent form describes the research study and helps you to decide if you want to participate. It provides important information about what you will be asked to do in the study, about the risks and benefits of participating in the study, and about your rights as a research participant. You should: Read the information in this document carefully. Ask the research personnel any questions, particularly if you do not understand something. Not agree to participate until all your questions have been answered, or until you are sure that you want to. Understand that your participation in this study involves you (describe participation [e.g., taking a survey]) that will last about (explain anticipated time commitment). WHAT IS THE PURPOSE OF THIS STUDY? State the purpose of the research in as few words as necessary and in a manner that participants will be able to understand. Usually, this can be accomplished in one sentence, e.g., "The purpose of this research is....." State the anticipated number of participants who will be involved in the study. Where appropriate, state that participants must be at least 18 years old to participate in the study. WHAT DOES YOUR PARTICIPATION IN THIS STUDY INVOLVE? Describe the research in a manner that will ensure that participants understand what they are being asked to do. This will probably involve a short paragraph, depending on the complexity of the research, and should include sentences explaining: Detailed descriptions of procedures to be followed/tasks involved, and Expected length of time of a participant's involvement. WHAT ARE THE POSSIBLE RISKS OF PARTICIPATING IN THIS STUDY? Describe the risks which participants may reasonably expect from the research. The information should reflect that provided in the narrative. If the study presents only minimal risk, state this (e.g., “Participation in this study is expected to present minimal risk to you.” WHAT HAPPENS IF YOU GET SICK OR HURT FROM TAKING PART IN THIS STUDY? Include this section (including title) only if applicable. If you are injured or require medical treatment, you may seek treatment from your primary care provider or, if eligible, from University Health Services. The University of New Hampshire is not responsible for the cost of any care required as a result of your participation in this study. 1 WHAT ARE THE POSSIBLE BENEFITS OF PARTICIPATING IN THIS STUDY? Describe the potential benefits that participants may reasonably expect from participating in the research. If there are no direct benefits to participants, state this and explain the benefits of the knowledge to be gained through the study. (Money, course credit, raffle prizes, etc. are considered compensation, not benefits, and thus should not be included in this section [they should be described in Compensation section of the form].) IF YOU CHOOSE TO PARTICIPATE IN THIS STUDY, WILL IT COST YOU ANYTHING? Include this section (including title) only if applicable. Describe any costs to participants to participate in the study. WILL YOU RECEIVE ANY COMPENSATION FOR PARTICIPATING IN THIS STUDY? State whether compensation will be provided for participating in this study. If compensation will be provided, provide all the relevant details, including conditions that need to be met to receive the compensation. DO YOU HAVE TO TAKE PART IN THIS STUDY? Taking part in this study is completely voluntary. You may choose not to take part at all. If you agree to participate, you may refuse to answer any question. If you decide not to participate, you will not be penalized or lose any benefits for which you would otherwise qualify (modify this sentence if there are conditions to receive compensation/incentive). CAN YOU WITHDRAW FROM THIS STUDY? If you agree to participate in this study and you then change your mind, you may stop participating at any time. Any data collected as part of your participation will remain part of the study records (modify this sentence where applicable). If you decide to stop participating at any time, you will not be penalized or lose any benefits for which you would otherwise qualify (modify this sentence if there are conditions to receive compensation/incentive). WHAT ALTERNATIVES ARE AVAILABLE IF YOU DO NOT WANT TO PARTICIPATE IN THIS STUDY? Include this section (including title) only if the study takes place in a classroom setting and extra credit is awarded. Revise as necessary to fit the specifics of the study. Participation in this study is not part of your required coursework. If you want to earn the extra credit offered for participating in the study but you do not want to participate in the study, the alternative assignment for this study is (describe the alternative assignment). HOW WILL THE CONFIDENTIALITY OF YOUR RECORDS BE PROTECTED? I plan to maintain the confidentiality of all data and records associated with your participation in this research. If your study involves personally-identifiable information, include the following sentence and bullets. There are, however, rare instances when I may be required to share personally-identifiable information with the following: Officials at the University of New Hampshire, The sponsor(s), or 2 Regulatory and oversight government agencies. If your study may lead to disclosure of information covered by New Hampshire mandatory reporting laws, such as suspected child abuse and/or neglect, or Federal laws relating to sexual harassment and violence include the following sentence and applicable bulleted language. [See the document, Information Individuals in New Hampshire are Legally Required to Report at http://unh.edu/research/irb-application-resources for more information.] I am also required by law to report certain information: To government and/or law enforcement officials (e.g., child abuse, threatened violence against self or others, communicable diseases), or To appropriate UNH authorities (e.g., disclosures involving Sexual Violence - which includes sexual harassment, sexual assault, unwanted sexual contact, sexual misconduct, domestic violence, relationship abuse, stalking [including cyberstalking] and dating violence - must be reported to the UNH Title IX Coordinator or UNH Police). If your study involves transmitting data via email or the web [e.g., web-based survey], include the following sentence. Further, any communication via the internet poses minimal risk of a breach of confidentiality. If your study involves focus groups, include the following sentence. While I plan to maintain confidentiality of your responses, other focus group participants may repeat responses outside the focus group setting. To help protect the confidentiality of your information, (address the following: (1) explain procedures in place to protect confidentiality of study data; (2) identify everyone named in the application with access to the data; if applicant is a student, the faculty advisor must have access to data; (3) explain if de-identified data may be shared with other researchers; (4) if audio and/or videorecording, explain how and where recordings will be stored, and what will happen to them during and after the study [e.g., transcribed and then destroyed].) I will report the data (explain how data will be reported [e.g., in aggregate, using pseudonyms]). The results may be used in reports, presentations, and publications (modify this sentence to reflect how the results may be used). WHOM TO CONTACT IF YOU HAVE QUESTIONS ABOUT THIS STUDY If you have any questions pertaining to the research you can contact (insert researcher's name and contact information and/or advisor's name and contact information) to discuss them. If you have questions about your rights as a research subject you can contact Dr. Julie Simpson in UNH Research Integrity Services, 603/862-2003 or Julie.simpson@unh.edu to discuss them. If the consent document will be mailed and returned, include the sentences in this paragraph. I have enclosed two copies of this letter. Please sign one indicating your choice and return in the enclosed envelope. The other copy is for your records. 3 If the consent document is for participation only in a non-web-based survey (see below the format for web-based surveys), remove the participant signature block below (the IRB generally does not require signed consent forms for surveys). Yes, I, __________________________consent/agree to participate in this research project. No, I, __________________________do not consent/agree to participate in this research project. ___________________________ Signature __________________ Date If the consent information is for participation only in a web-based survey, (e.g., using Qualtrics), replace the participant signature block above with the following format for participants to give consent or decline participation. o o Click here if you consent to participate in the research study. Click here if you decline to participate in the research study. 4