邢唷��>� ��欹�O ��膜bjbjrKrK 4�!慹!慹-:8�� 8A]� T�� "� � � "��"4�"怱扴扴扴扴扴扴�[ZJ扴E��"""�"�"扴�� H譙�$�$�$�"F�� 怱�$�"怱�$�$�bKD闚� ��`c魐嘿��=#F&|S鞸0T蘈�#�L闚闚&�Ol�"�"�$�"�"�"�"�"扴扴/$��"�"�"T�"�"�"�"���"�"�"�"�"�"�"�"�"� �: 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." 45燙FR�46.116), 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 finalizing your consent form to submit with your IRB protocol application. The language should be modified 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 University抯 Research & Innovation Office ( HYPERLINK "https://researchservices.cornell.edu/forms/irb-consent-form-templates" https://researchservices.cornell.edu/forms/irb-consent-form-templates). Last Updated 06/30/2023 Today抯 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 of your questions. This study is being led by Name of PI, from Department at 欧博娱乐城. (If the PI is a student) The Faculty Advisor for this study is Name, Department at 欧博娱乐城. This study has been approved by 欧博娱乐城抯 Institutional Review Board (IRB protocol #). Purpose: The purpose of this research is to�. Provide a clear, concise explanation in lay language of the purposes 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 time commitment for each component, as well as the total time for participation. All procedures listed in the IRB application should be described, and any experimental procedures (interventions, manipulations, treatments) specifically noted. 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 direct benefits, indicate that there are none. Describe the expected benefits to society or scientific knowledge: e.g., 搮information from this study may benefit other people now or in the future厰 or 搮we hope to learn more about _______ 厰 Note: Compensation, financial incentives, learning about how experiments are conducted, receiving a gift, or earning extra credit for being a research participant are not 揵enefits� 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, ways of earning equivalent credit without participating in the research should be described here. If participants are unwilling or unable to complete their participation, describe how their incentives will be distributed. If there are no incentives, indicate 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., the possibility of discovering activities that may require reporting to authorities, the possibility of being arrested) Physical risks (e.g., nausea, muscle aches, rashes, infection, discomfort) Social (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) 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 the potential for medical injury exists, identify treatment procedures or the absence thereof. Include the following statement, if applicable: 欧博娱乐城 has no mechanism to provide compensation for participants who may incur injuries as a result of participation in research projects. However, efforts will be made to make available the facilities and professional skills at the University. Participants may incur charges as a result of treatment related to research injuries. Information regarding treatment or the absence of treatment has been given above. If there are no known risks, state: I/We do not anticipate any risks from participating in this research. Privacy/Confidentiality/Data Security: Explain briefly, and in lay terms, how you will protect the participant抯 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, state this here; If you are not planning to collect any identifying information at all (as in anonymous surveys); Physical security of data/research files; Who will have access to identifying information; How sensitive data will be kept secure in an electronic environment; If audio and/or video recording devices will be used, explain why these are needed and what will be done with them upon completion of the research (kept indefinitely, archived after transcription, destroyed after X years). This next section is required for all federally funded research, and recommended for all other studies: We will do 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 欧博娱乐城抯 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. OR Your confidentiality will be kept to the degree permitted by the technology being used. We cannot guarantee against interception of data sent via the internet by third parties. If you will be doing interviews, provide a separate signature line for the participant to be audio/video recorded, if the recording is optional for participation. 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, other promotional purposes), include a section that: Informs the participant that you are making a [type(s) of media used] recording in which the person抯 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 rights 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. The same signature line below may be used for this performance release information. Please sign below if you are willing to have this interview (specify audio or video) recorded. You may still participate in this study if you are not willing to have the interview recorded. I do not want to have this interview recorded. I am willing to have this interview recorded. Signed: Date: If you may share data without identifiers, we strongly recommend that you include this section in your consent, to inform participants that you may share de-identified 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. 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 we share. Despite these measures, we cannot guarantee the anonymity of your personal data. Include this section if you will or might approach participants for a follow-up study: We may contact you again to request your participation in a follow-up study. As always, your participation will be voluntary and we will ask for your explicit consent to participate in any of the follow-up studies. Explicit consent may not be necessary. Here is suggested language if you choose to ask for specific consent: May we contact you again to request your participation in a follow-up study? Yes/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 obtaining 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, indicate that there are none. 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, and no effect on the compensation earned before withdrawing, or their academic standing, record, or relationship with the university or other organization or service that may be involved with the research. If completing all research materials (e.g., answering all survey or interview questions; meeting a minimal requirement of entries in a weekly/monthly log) is required for participation, you must make this condition clear to them here. State that people can choose not to participate if they are uncomfortable with these conditions. Participant抯 Assurance: Explain how the participant can contact you with questions or concerns. A standard statement follows: The main researcher conducting this study is [principal investigator抯 name], a [professor, graduate/undergraduate student, etc.] at 欧博娱乐城. Please ask any questions you have now. If you have questions later, you may contact [principal investigator抯 name] at [email address] or at [phone number]. This project and this consent form have been approved by 欧博娱乐城抯 Institutional Review Board, which ensures that research projects involving human subjects follow federal regulations. If you have any questions or concerns regarding your rights as a subject in this study, you may contact the Institutional Review Board (IRB) at 601-266-5997 or: Chair of the Institutional Review Board 欧博娱乐城 118 College Dr. #5116 Hattiesburg, MS 39406 If participants will be given a copy of this form or some other information sheet, indicate that here. Statement of Consent I have read the above information, and have received answers to any questions I asked. I consent to take part in the study. 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