ࡱ>  bjbjww 4^k^kbM88}W !"'!'!'!o"#Da#$W!W!W!W!W!W!W[b^J!WE#o"o"##!W'!'!HfW&&&#F'!'!W&#W&&MDQ'!,}t #RN& W|W0WN^$r^LQQ&^?Q##&#####!W!W%T###W####^######### s:  Institutional Review Board STANDARD (SIGNED) INFORMED CONSENT STANDARD (SIGNED) INFORMED CONSENT PROCEDURESUse of this template is optional. However, by federal regulations ( HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html" \l ":~:text=The%20HHS%20regulations%20require%20that,been%20waived%20by%20an%20IRB." 45CFR46.116), all consent documentation must address each of the required elements listed below (purpose, procedures, duration, benefits, risks, alternative procedures, confidentiality, whom to contact in case of injury, and a statement that participation is voluntary). Signed copies of the consent form should be provided to all participants. INSTRUCTIONS: Delete this section before submitting your IRB application. The language should be changed as appropriate for your study. Provide relevant information in the sections below, replacing italicized directions/guidance (anything in this font color) with information specific to your study. Delete sections that do not apply to your research. This form was adapted with permission from Cornell Universitys Research & Innovation Office ( HYPERLINK "https://researchservices.cornell.edu/forms/irb-consent-form-templates" https://researchservices.cornell.edu/forms/irb-consent-form-templates). Last Updated 07/01/2026  Todays date: FORMTEXT       FORMTEXT      Project InformationProject Title:  FORMTEXT      Protocol Number:  FORMTEXT      Principal Investigator:  FORMTEXT      Phone:  FORMTEXT      Email:  FORMTEXT      College: Choose an item. FORMTEXT      School and Program:  FORMTEXT       I am/we are asking you to participate in a research study titled  Project Title . I/We will describe this study to you and answer any questions you may have before you decide to participate. This study is being led by Name of PI, from the School/Department of at The Ƶ. (If the PI is a student) The Research Advisor for this study is Name, from the Department of at The Ƶ. This study has been approved by Ƶs Institutional Review Board (IRB protocol number). Purpose: The purpose of this research is to. Provide a clear, concise explanation in lay language of the purpose(s) of the research, including why it is being performed and what use may be made of the results. Description of Study: I/We will ask you to Explain in simple, non-scientific language what will happen to the participant or what they will be asked to do in the study. Describe the participant's time commitment for each part, as well as the total time for participation. All procedures listed in the IRB application must be described, and any experimental procedures (interventions, manipulations, treatments) should be specifically noted. Please note that information may be withheld in a deception study only if it is scientifically justified, poses no more than minimal risk, and cannot be achieved using non-deceptive methods. Researchers must actively justify the deception in their IRB submission and include a comprehensive debriefing process that informs participants of the true nature of the study. If the use of deception could cause participant distress or could affect participants' willingness to participate had they known the true nature of the study from the outset, participants should be given the choice to withdraw their data/request that their data be destroyed without penalty. If any study procedures involve the use of artificial intelligence (AI) (e.g., interacting with participants, accessing identifiable data, data analysis), explain in lay terms how the AI tool will be used in the study. Benefits: Describe any probable benefits of participation. Be sure to distinguish between a likely direct benefit (e.g., from therapeutic or intervention research) and a possible indirect benefit (e.g., reflecting on an experience may lead to a better understanding of oneself). If there are no known benefits, state: I/We do not expect any benefits from taking part in this research. Describe the expected benefits to society or scientific knowledge (e.g., information from this study may benefit other people now or in the future or we hope to learn more about). Note: Compensation, financial incentives, learning about how experiments are conducted, receiving a gift, or earning extra credit for being a research participant are not benefits and should not be listed here. Incentives for Participation: Indicate whether the participant will receive incentives, compensation, or extra credit for being in the study. If students will receive course credit for participation, describe an alternative activity that requires equivalent time and effort and will allow them to earn the same credit without taking part in the research. If participants are unwilling or unable to complete their participation, describe how their incentives will be distributed. If completing all research materials (e.g., answering all survey or interview questions; passing attention checks; meeting a minimal requirement of entries in a weekly/monthly log) is needed, you must make this condition clear to them here. State that they can choose not to participate if they are uncomfortable with these conditions. If there are no incentives, say that there are none. Risks and Discomforts: In simple, non-scientific language, describe any reasonably foreseeable risks or discomforts, with consideration given to: Legal risks (e.g., discovering activities that may require reporting to authorities, the possibility of being arrested); Physical risks (e.g., nausea, muscle aches, rashes, infection, discomfort); Social risks (e.g., loss of confidentiality, embarrassment, stigma); Economic risks (e.g., effect on financial standing, employability, or insurability); Psychological risks (e.g., feelings of sadness, stress, or anxiety); Occupational (e.g., loss of wages or future earnings); AI tools (e.g., the potential for the system to reinforce existing societal biases, which may lead to unfair treatment or representation; an unknown or unforeseeable risk of reidentifying private or sensitive information, even after the removal of identifiers) Describe the methods that will be taken to minimize any risks, inconveniences, or discomforts. If your study may involve psychological risk, you must include relevant mental health resources in your informed consent document. If there is potential for bias when working with AI tools, describe the strategies that will be used to check for bias and ensure fair outcomes, such as including a mechanism for human oversight and intervention to address unexpected harm during research procedures. If the potential for medical injury exists, identify treatment procedures or the absence thereof. Include the following statement, if applicable: The Ƶ has no mechanism to provide compensation for participants who may incur injuries because of participation in research projects. However, efforts will be made to make the facilities and professional skills at the University available. Discuss any qualifications or training to manage medical injuries or emergencies that the researcher has, as well as access to devices such as an AED within the facility and any other relevant emergency procedures that will be followed. Participants may incur charges because of treatment related to research injuries. Information about treatment or the absence of treatment has been given above. If there are no known risks, state: I/We do not expect any risks from taking part in this research. Privacy/Confidentiality/Data Security: Explain briefly, and in lay terms, how you will protect the participants privacy and/or confidentiality. Consider the following: If you will completely de-identify data, or keep identifying information separate from research data (e.g., signed consent forms kept separate from the survey data and the two will not be connected); If you plan to keep identifying information with the data; If you are not planning to collect any identifying information at all (as in anonymous surveys with IP address tracking disabled); Physical security of data/research documents and devices; Who will have access to identifiable information; How sensitive data will be kept secure in an electronic environment; If audio and/or video recording devices are used, explain why these are needed and what will be done with them upon completion of the research (e.g., kept indefinitely, archived after transcription, destroyed after X years); Plans for data retention and disposal, with consideration given to the 3-year minimum retention period required by federal regulations; Additional considerations when working with AI: The risk of re-identification using current and anticipated AI capabilities and implementing safeguards (e.g., encryption, access controls); When using cloud-based AI services, confirm that data storage and processing comply with institutional and federal data protection standards If you are doing interviews, provide a separate signature line for the participant to agree to be audio/video recorded. Likewise, if you will take photographs or make audio, video, or other recordings that you want to use for activities beyond research analysis (publications, presentations, or other promotional purposes), include a section that: Informs the participant that you are making a [type(s) of media used] recording in which the persons name, likeness, image, and/or voice will be included; Asks the participant to grant you the right to make, use, and publish recordings in whole or in part in media forms now known (such as film, slides, and digital audio) or developed in the future. This includes the right to edit or duplicate any images/recordings; Explains the limitations on reproduction, distribution, performance, or display of images/recordings; Explains that the participant does not have the right to inspect or approve the finished product or printed/published matter that uses the images/recordings or versions of the images/recordings; and Explains that the participant will not receive any financial compensation for commercial and/or non-commercial (as appropriate) uses of the images/recordings. Please sign below if you are willing to have this interview (specify audio or video) recorded. You may/may not participate in this study if you are not willing to have the interview recorded. I do not want to have this interview recorded, but I will allow the researchers to take notes. I am willing to have this interview recorded. Signed: Date: Per Ƶs Information Security Policy, the use of external information systems could pose an unacceptable risk to the confidentiality of research data, as well as a potential for non-compliance with applicable laws, regulations, or policies. ITech is working to address these issues, but in the interim, we are requesting that PIs do the following: 1) if you will record and transcribe your interviews, you must use your Ƶ Teams or Zoom account that requires your single-sign-on (SSO) credentials; 2) thoroughly review your transcript to make sure any identifying information is removed or masked; once this is done, you may use your preferred external information system for your analysis; 3) in the informed consent document, you must specify the external information system(s) you will use and provide a link to their website(s) so that they have the option to seek additional information. If you will use an AI transcription service, describe what the AI will do with the data, what limitations, if any, will be placed on it, whether data can be removed from the platform, and how data will be shared and analyzed, as applicable. Also, address the potential unknown or unforeseen risk for AI to reconnect de-identified data back to the participant. Include the following statement, as applicable: If you agree, I/we will use an AI service to transcribe the recorded data you provide. The AI service I/we will use is _______, which has a data governance statement that can be found here ________. Provide information on your procedures for reviewing transcripts and consider using the following statements, as appropriate: Since AI-generated transcription may add text, misattribute text to a speaker, and/or incorrectly transcribe phrases or sentences, I/We will also review and verify the AI-generated transcripts. You will also have an opportunity to review and make corrections to your transcript. A copy of your transcript will be shared with you within ____ days/weeks of participating in the study, and you will have ____ days/weeks to notify us of any corrections before I/we proceed with using the transcript as is. If you are uncomfortable with us using an AI service to create a transcript, please let us know before you participate by making the appropriate selection below. I am willing to allow an AI service to generate a transcript of my information. I am not willing to allow an AI service to generate a transcript of my information; I will allow the use of ________ to generate a transcript of my information. Signed: Date: This next section is required for all federally funded research, and recommended for all other studies: I/We will do my/our best to keep your participation in this research study confidential to the extent permitted by law; however, it is possible that other people may need to review the research records and may find out about your participation in this study. For example, the following people/groups may check and copy records about this research: The Office for Human Research Protections in the U. S. Department of Health and Human Services (For sponsored studies, add:) The research study sponsor, Name of Sponsor The Ƶs Institutional Review Board (a committee that reviews and approves research studies) and the Office for Research Integrity When the research involves e-mail communication, include the following statement: Please note that email communication is neither private nor secure. Though I am/we are taking precautions to protect your privacy, you should be aware that information sent through e-mail could be read by a third party. For sensitive research data with identifiers, stored in the cloud or on servers, or transmitted via the internet, consider including the following statement: Data may exist on backups and server logs beyond the timeframe of this research project. Data will be stored on ________________. This data will only be uploaded to platforms that are approved by Ƶ. OR Your confidentiality will be kept to the degree permitted by the technology being used. I/We cannot guarantee against the interception of data sent via the internet by third parties. If you may share data without identifiers, we strongly recommend that you include this section with your consent to inform participants that you may share the data you collect from them. Certain sponsors now require researchers to make available their de-identified data to the research community, as do a growing number of journals. If you choose not to include the following language and later wish to share de-identified data, you may not be able to do so without re-contacting participants to obtain consent. De-identified data from this study may be shared with the research community at large to advance science and health. I/We will remove or code any personal information that could identify you before files are shared with other researchers to ensure that, by current scientific standards and known methods, no one will be able to identify you from the information I/we share. Despite these measures, I/we cannot guarantee the anonymity of your personal data. Include this section if you will or might approach participants for a follow-up study: I/we may contact you again to request your participation in a follow-up study. As always, your participation will be voluntary, and I/we will ask for your explicit consent to participate in any follow-up studies. Explicit consent may not be necessary. Here is suggested language if you choose to ask for specific consent: May I/we contact you again to request your participation in a follow-up study?  FORMCHECKBOX  Yes  FORMCHECKBOX  No In addition to the recommended data-sharing language above, if you are collecting identifiable data or identifiable biospecimens, you must include one of the following: Identifiers might be removed, and the de-identified information or biospecimens used for future research without additional consent. OR Identifiable information might be used for future research with your consent. OR Your information or biospecimens will not be used or distributed for future research studies. If you are collecting biospecimens, you must include the following: Specimens collected from you for this study and/or information derived from your specimens will/may/will not be used to generate commercial profit. You will/will not share in any commercial value or other compensation from products developed using these specimens. If clinically relevant research results may be generated, you must include this statement: You will/will not receive any clinically relevant results discovered about you and/or the general subject population. If your study may involve whole genome sequencing, include this statement: This research may/will include whole genome sequencing. Alternative Procedures: Describe alternatives to participation that will be presented to participants in the study (generally another accepted course of therapy or diagnostic procedure, etc.). If there are no alternative procedures, state: There are no alternative procedures. Taking part is voluntary: Explain that the participant's involvement is voluntary; the participant may refuse to participate before the study begins, discontinue at any time, or skip any questions/procedures that may make them feel uncomfortable, with no penalty to them, or their academic standing, record, or relationship with the university or other organization or service that may be involved with the research. Participants Assurance: Explain how the participant can contact you with questions or concerns. A standard statement follows: The main researcher conducting this study is [principal investigators name], a [professor, graduate/undergraduate student, etc.] at The Ƶ. Please ask any questions you have now, or if you have questions later, you may contact [principal investigators name] at [Ƶ email address] or at [phone number]. This project and this consent form have been approved by The Ƶs Institutional Review Board, which ensures that research projects involving human subjects follow federal regulations. 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