Consent Form - Saginaw Valley State University



Content in black is information to include in your consent form.Content in red is information to include as applicable, or elaborated description of a section.Consent FormProject Title: (The IRB project title, consent form title, etc. should match.)Principal Investigator/Faculty Advisor: (Only a single principal investigator should be listed. Co-PIs may listed below in the contact section.)Supported/Funded by: (As Applicable, List the company or agency funding this project. If there are multiple funding sources, outside sponsors should be listed first).General Notes about Consent FormWrite in language understandable to the subjects—aim for a 7th grade reading level. Minimize jargon and scientific terms/language; define or describe the meaning of terms.Spell out and define Acronyms at their first use.Refer to yourself (as the researcher) in the first person (I, we) and to the participant(s) in the second person (you, your).Purpose of the StudyParticipants should be informed in clear, concise language about the nature of the study and the purpose for the research. The total number of participants involved and a description of the participant pool (age range, health status, etc.) should be given brief.Remember to:Briefly explain what the study is about; i.e., the goals of the research.Use consistency and make sure to use research, study, and/or investigation in the consent form.Examples of statements could include:You are being asked to participate in a research study…The purpose of this study is...You are being asked to participate in this study because...Study ProceduresThe research procedures that involve the participant should be explained in sufficient detail, so the participant will be fully informed about their role, including, activities he or she will be expected to perform, for how long, number of times they are to appear and over what period of time he or she will have to appear. The participant must be told where the research will take place, instrumentation to be used, if any, or the tasks to be completed. At the end of this section, the participant must have a clear understanding of what researchers will expect of them.Clear, Concise, and complete description of what participants will do or experience.Include total time commitment, the number of contacts involved, the length of each contact.Describe all activities in chronological order.Indicate whether procedures are experimental.If there are many procedures, use a table, lists, or subheadings to organize this information.If electronic recording is optional, insert “I agree...” and “I do not agree...” options at the end of the form. If it is not, then the “I agree...” “I do not agree...” options for taping are not needed if taping is required for participation and this is clearly stated on this form.Describe the procedures for discontinuation of a participant’s participation, including the right to withdraw data already collected, if applicable.Participants are free to withdraw from a study at any time without penalty. If they choose to withdraw, they will be compensated for the portion of the time of the study (if financial compensation is involved). If they choose to withdraw, they will not be penalized by reduction in points or grade in a course (if course credit is involved).There may be circumstances under which the investigator may determine that a participant should not continue. The participant must be compensated for the portion of the project completed.Possible RisksAny risks or discomforts to the research participant must be fully disclosed. Categories of risks include physical, emotional, psychological or social harm. Safeguards employed to reduce or minimize the risks must be described. If as a result of a research project, the investigator determines the participant should seek counseling or medical treatment, a list of local services should be provided. The following statement must be included in all consents except those for anonymous surveys: “As in all research, there may be unforeseen risks to the participant. If an accidental injury occurs, appropriate emergency measures will be taken; however, no compensation or additional treatment will be made available to the subject except as otherwise stated in this consent form.”Include anticipated risks of discomfort and harm (to psyche, reputation, employability, insurability, social status, criminal or civil liability) that may occur as a result of participation.Note, risks are not always immediate; anger, emotional upset, or stress may appear later. If this is a possibility, explain and provide an appropriate person’s name and contact information.Address emotional and psychological risks, including risks of emotional discomfort from being asked about or discussing sensitive issues.Provide the following information in case of emotional distress, where available counseling services are available:For Employees and Staff, you may contact the Employee Assistance Program: Click on admin professional benefits, faculty benefits or support staff benefitsUnder Additional Employee Benefits, click on Employee Assistance ProgramFor SVSU students only, you may contact the Student Counseling Center: All persons may also wish to contact the American Psychological Association website’s Psychologist Locator: issues concerning sexual harassment/assault you may contact: a full list of community resources, go to: HYPERLINK "" \t "_blank" may use the following statements:Your participation in this study does not involve any physical or emotional risk to you beyond that of everyday life; ORYour participation does not involve any risks other than what you would encounter in daily life; ORYour participation in this study may involve the following risks; ORYou may be uncomfortable with some of the questions and topics we will ask about. If you are uncomfortable, you are free to not answer or to skip to the next question; ORYou may withdraw from the study at any timeParticipant Rights(Recommended Statement)If you choose to be in this study, you have the right to be treated with respect, including respect for your decision whether or not you wish to continue or stop being in the study. You are free to stop being in the study at any time. Choosing not to be in this study or to stop being in this study will not result in any penalty to you or loss of benefits to which you are otherwise entitled. Specifically, your choice not to be in this study will not negatively affect (insert statement about not losing any present or future medical treatment; class standing; present or future employment).The participant is free not to answer any questions or respond to experimental situations that he or she chooses without penalty.Benefits The benefits, if any, to the participant must be described (tangible and intangible). If there are no benefits to the participant, then explain (if any) the larger societal benefits of the research. An analysis of the risks to benefits must clearly be on the benefits side.Include a statement that no promise or guarantee of benefits has been made to encourage participation. Optionally, the researcher may inform the participant they may contact the researcher at a later time for a summary of the research results. If the participant is a child, the parent/guardian must make the request.State any benefits that can be reasonably expected in a way that is not potentially coercive. If this study focuses on persons with a condition (e.g., a learning disability) avoid stating the participant may benefit from closer monitoring of their condition.Do not include information on payment or reimbursement for participation. Put this information in the Financial Information section.If participation in the research project provides course credit, describe this in a separate section on Course Credit.Explain appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject; if there are none, state that that alternative is to not participate.You may use the following statements:You are not likely to have any direct benefit from being in this research study;ORThe possible benefits to you from this study include…AND/ORTaking part in this study may help scientists to better understand...ConfidentialityExplain the extent to which the participant will be identifiable. If confidentiality is promised (individuals can be identified, but the researchers promise not to divulge that information), you must explain how that will be accomplished. Social security numbers should not be used as identifiers in lieu of names. You may also include that at no time will the researchers release the results of the study to anyone other than individuals working on the project without your written consent. If taping (video, audio/digital or physical) is to occur, the participants must be informed. You must state how the recordings will be secured and stored, under whose supervision, who will score or transcribe, who will have access and when they will be destroyed. The following statement must be included. “It is possible that the Institutional Review Board (IRB) may view this study’s collected data for auditing purposes. The IRB is responsible for the oversight of the protection of human subjects involved in research.”Also, in some situations, it may be necessary for an investigator to break confidentiality. If child abuse is known or strongly suspected, investigators are required to notify the appropriate authorities. If a participant is believed to be a threat to herself/himself or others, the investigator should notify the appropriate authorities. The conditions under which the investigator may break confidentiality must be described. You must also verify in the consent form who will have access to the data and how long it will be stored. Use the clauses below as applicable:If you are giving subjects the option of being identified or associated with their work, study materials, or results, indicate this in the following paragraph and provide explicit “I agree...” “I do not agree...” options at the end of the form.Do not replace “confidential” with synonyms such as “secret.”Centralized Data Collection or Registries (e.g., Online Surveys). (if applicable)Your responses will be collected in a centralized computer or data registry at (name the facility and give the location—city and state.) (Indicate whether results will be stored by name, identifier, or other code, and describe protections in place for maintaining security of records.)Optional (recommended) information for Online Surveys: The consent must disclose that if a participant completes an anonymous survey and then submits it to the researcher, that the researcher will be unable to extract anonymous data from the database should the participant wish it withdrawn.You may state:“By completing the survey you are agreeing to participate in the research”“Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties.”Audio/Video Recordings (if applicable)At the end of this consent form, you need to ask that if “given the option of allowing researchers to take photographs and/or make audio or video recordings of participants,” they may be used in analyzing the research data or in scientific publications or presentations. With participant’s permission, researchers may publish and present photographs, audio recordings, and videos of subjects (including/not including, specify one) your face. State that no other personal information about participants will be included in the presentation.With the clause above, include check-boxes in the Consent section, stating:“I [do][do not] give permission for photographs or videotapes of me to be used (as described in this section)”Course Credit/Payment/Raffle Drawing (Select section heading as applicable)The participant does not have to be compensated, but if they are, they must be fully informed. If no compensation is to be earned, the participant must be so informed. Course credit, money or redeemable coupons or other currency may be given. The participant must be informed about how much, when it will be paid, any bonuses for completing all the tasks, etc. Awarding Course Credit? (if applicable)If research participation is a part of a course requirement, explain the amount of credit and indicate whether you will award credit if the subject shows up but decides not to participate.Include specific procedures for participant rmation regarding monetary payment (if applicable)Use following statement:Participation in this study will involve no cost to you. You will not be paid for participating in this study; ORProvide specific information about payment and reimbursement (e.g., payment for testing, evaluation, transportation).Specify when payment will be made and in what form (cash, check, gift card), including how you will prorate payment for partial participation.For lotteries/raffles, include when the drawing(s) will occur, who will conduct the drawing(s), how payment will be made, the value of the prize(s), the number of prizes, the chances of winning.Do not use the word “compensation.” Acceptable terms include “payment,” “remuneration,” “reimbursement,” “gift,” “prize,” “token of appreciation,” etc.Example:In appreciation for your participation in the study, you will be entered into a lottery drawing for a $50 gift card to . With 200 persons participating in the study, your chances of winning are 1 in 200. The drawing will be conducted by the principal investigator after all participants have finished their study participation, on or about (date). The study staff will send you an e-mail message with a link to , which will allow you to redeem the gift.NOTE: Study payments above certain amounts are considered taxable income. See IRB Administrator for Information.Alternatives Available to Participants (if applicable)Use following statement:You may choose to not participate in this research study. And, if applicable:If you do not wish to participate in this study, the following alternatives are available:List any and all currently available alternative procedure(s). (If there is no alternative to participation, the opening statement is sufficient.)For studies awarding course credit for participation, describe the IRB-approved alternative(s) to research participation, for which equal credit will be awarded.Questions or Concerns about this Research Study(Recommended Statement)If you have any questions, problems, illness, or injury during your time on this study, call us promptly. (PI’s name) is the person in charge of this research study. You can call him/her at (phone number) (insert when the person is available, for example Monday through Friday, from time available—include weekend options). You can also call (insert research personnel name, telephone number, and times available) with questions about this research. You may also contact the Chair, Human Subjects Institutional Review Board (989-964-7488; irbchair@svsu.edu) if questions or problems arise during the course of the study.Contact information for evenings and weekends is not necessary for minimal risk research.For more than minimal risk research, information for reporting injuries is required.Consent (ensure all parts are on one page) Participant’s ResponsibilitiesAs a participant, you voluntarily agree to participate in this study. As a participant, you have the following responsibilities: (List medical conditions to be reported, staying in place for a specific length of time after drawing a blood sample, consumption of alcohol, etc.)Participant’s PermissionI have read this form and the research study has been explained to me. I have been given the opportunity to ask questions and my questions have been answered. If I have additional questions, I have been told whom to contact. I agree to participate in the research study described above and will receive a copy of this consent form after I sign it.This consent document has been approved for use for one year by the Human Subjects Institutional Review Board (HSIRB) as indicated by the stamped date and reference number in the upper right corner. Subjects should not sign this document if the corner does not show a stamped date and reference number.__________________________________________________________Participants Name (printed) and SignatureDate___________________________________________________________Name (printed) and Signature of Person Obtaining ConsentDateInclude ONLY if appropriateFor participants unable to give consent, permission is given by an authorized participant representative:Authorized Representative (Print)Authorized Representative (Sign)DateInclude if appropriate:My authority to sign as the participant’s authorized representative is as the (mark one):ParentSpouseLegal GuardianAuthorized Agent (e.g., Health Care Power of Attorney)Optional Study Elements (If applicable)This section should include other explicit consents for optional elements of the research, such as audiotaping, videotaping, storing photographs for future use, or using the participant’s actual name in research publications.Initial one of the following to indicate your choice:_____ (initial) I agree to…_____ (initial) I do not agree to… ................
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