ࡱ>  $bjbjcTcT >>f eeeyyy8L4y&'t1(Y(&&&&&&&(<+&e|&&v v v Re&v &v v :%,C" & !yn% &&0&'%R+n+ &+e &v &&F0&'+ :  INFORMED CONSENT  [List title of project here] Include or exclude following information as applicable. Investigators: List Principal Investigator first followed by all others who will collect data from participants give title, phone and e-mail for PI and others. If the PI is a student, the faculty / staff sponsor must be listed as a Co-investigator with contact information.  PURPOSE You are invited to take part in a research study. The purpose of this study is to ___________. You have been invited to take part in this study because ______________. The number of people that will be part of this research is ____. PROCEDURES List all procedures, preferably in chronological order, which will be employed in the study. Point out any that are considered experimental and explain technical and medical terminology. State where the study will take place and the amount of time required of the participant per session and for the total duration of study. If applicable to your study, list: Information concerning taping or filming. Indicate which procedures are experimental RISKS and DISCOMFORTS List the foreseeable risks or discomforts, if any, of each of the procedures to be used in the study, and any attempts that will be used to minimize the risks. Order multiple risks by magnitude and time duration. BENEFITS List the direct benefits to participants. If there are no direct benefits (e.g. cure of the participants disease), you must state: We do not anticipate direct benefits; however, following this statement, you may also include benefits to others, or the body of knowledge, or indirect benefits to the participant (e.g. satisfaction). PARTICIPATION AND ALTERNATIVES TO PARTICIPATION Your participation in this study is voluntary; you may decline to participate without penalty. If you decide to participate, you may withdraw from the study at anytime without penalty and without loss of benefits to which you are otherwise entitled. If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed. Likewise, the Researcher may terminate your participation in the study at any time. Alternatives to participation in this study include . . . . . . If the research includes medical treatment disclose appropriate alternative procedures or courses of treatment that might be advantageous to the participant. EMERGENCY MEDICAL / PSYCHOLOGICAL TREATMENT (For research involving more than minimal risk add here) «Ƶ does not offer to reimburse participants for medical claims or other compensation. If physical injury is suffered in the course of research, or for more information, please notify the investigator in charge, (list PI name and phone number). List referral number for medical or mental health counseling if there is any risk of impact from research CONFIDENTIALITY The information in the study records will be kept confidential. Data will be stored securely and will be made available only to persons conducting the study unless you specifically give permission in writing to do otherwise. No reference will be made in oral or written reports that could link you to the study. Your de-identified data may be used in future research, presentations or for teaching purposes by the Principal Investigator listed above. COMPENSATION (if applicable add here) For participating in this study you will receive ______________. Other ways to earn the same amount of credit or compensation are ________________. If you withdraw from the study prior to its completion, you will receive _________. SUBJECT RIGHTS If you have questions at any time about the study or the procedures, (or you experience adverse effects as a result of participating in this study,) you may contact the Principal Investigator, [Name], at [Office Address], and [Office Phone Number]. If you have questions about your rights as a participant, contact the SPU Institutional Review Board Chair at 206-281-2201 or  HYPERLINK "mailto:IRB@SPU.edu" IRB@SPU.edu . CONSENT Your signature on this form indicates that you have understood to your satisfaction the information regarding participation in this research project and agree to participate in this study. In no way does this waive your legal rights nor release the investigators, sponsors, or involved institutions from their legal and professional responsibilities. I have read the above information and agree to participate in this study. I have received a copy of this form. Participant's name (print) __________________________________ Researchers name (print) ___________________________________ Participant's signature ___________________________________ Researchers signature ___________________________________ Date ______________ Date ______________  Copies to: Participant Principal Investigator INSTRUCTIONS TO INVESTIGATORS: Preparing the Informed Consent Form Use the format and headings given in the template. These headings are required by the Federal Office of Human Research Protections. The SPU logo must be present. After your IRB application is approved you will receive an IRB number and valid through date. These must be added to your informed consent. Use language that is appropriate for an eighth grade reading level. You can test the reading level of your document in MS Word. See  HYPERLINK "http://www.ohsu.edu/research/rda/irb/docs/policies/readtips.pdf" http://www.ohsu.edu/research/rda/irb/docs/policies/readtips.pdf for more suggestions for simplified writing. Remember, you are speaking TO the participant. Make the language as clear and consistent as possible. Do not use the word I except at the very end, since it can be interpreted as being coercive. Reviewing the Informed Consent Form with Participants Prepare a copy for both the participant and the PI. Read through the Informed Consent with the participant. Make sure the participant initials any page besides the signature page Give participants time to ask any questions before they sign the informed consent form. Make sure that the participant as well as the researchers signature is on both forms. Give the Participant his or her form before you begin the study. Informed Consent with minor A parent or guardian must sign the informed consent for research with Children For Children over 7 to the age of 18 you need to prepare an informed assent form for their signature in addition to the adult informed consent. For Children under 14 consider a simplified version of your document. Children 14 & over can read and sign an assent document that is the same as their parents consent. You can receive verbal assent for children under 7. Provide a script for the verbal assent and a signature line for the researcher to acknowledge that they verbally reviewed the study and attained verbal assent from the minor.  See instructions at end of this document. ___________________________  Note that electronically collected data through Survey Monkey is automatically destroyed if participants do not complete the entire survey  Where the Federal government requires informed consent for research.     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