ࡱ>   bjbjcTcT ݿ>>9H 4   844 &9(aaaannn%%%%%%%'*`%n|nnn%aa%n^laa%n%:$,Y,7%a) $ %%0 &$R**7%*7%dnnnnnnn%%nnn &nnnn*nnnnnnnnn :  INFORMED CONSENT Title of the Study: Principal Investigator(s): 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. DESCRIPTION OF THE RESEARCH The purpose of the research is ______________________________________. You have been invited to participate because_________________________________. This study will include [males and females] between the ages of ___ and ___. The research will take place in/at [ɬ﷬, 3307 3rd Ave West, ɬ﷬ WA] and at __________________________. WHAT WILL MY PARTICIPATION INVOLVE? If you decide to participate in this research you will be asked to_____. [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.] If applicable to your study, please include a statement regarding information concerning taping or filming (will the participant be recognizable on film?). Your participation will last for ___________________. You may withdraw from the study at any time. ARE THERE ANY RISKS TO ME? 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. Please include: ɬ﷬ and associated researchers do 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, (Name and #). ARE THERE ANY BENEFITS TO ME? 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).  HOW WILL MY CONFIDENTIALITY BE PROTECTED? While there will probably be publications as a result of this study, your name will not be used nor will you be identified in any way. [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.] WHOM SHOULD I CONTACT IF I HAVE QUESTIONS? You may ask any questions about the research at any time. If you have questions about the research after you leave today you should contact the Principal Investigator, (Name and #). If you have questions about your rights as a research subject you should contact the ɬ﷬ Institutional Review Board Chair at 206.281.2201 or HYPERLINK "mailto:IRB@spu.edu"IRB@spu.edu. Your participation is completely voluntary. If you begin participation and change your mind you may end your participation at any time without penalty. Your signature indicates that you have read this consent form, had an opportunity to ask any questions about your participation in this research and voluntarily consent to participate. In no way does this waive your legal rights nor release the investigators, sponsors, or involved institutions from their legal and professional responsibilities. You will receive a copy of this form for your records. Participants Name (please print):______________________________ Participants Signature:_______________________________________Date:______________ PIs Name (please print):__________________________________________ PIs Signature:_______________________________________ 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.  Where the Federal government requires informed consent for research.     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