ࡱ> pso $bjbjބބ .d% IIIII]]]8$L]}"''',u+ "I"II''7XI'I':T,uDZF M0}  IL""}  + :   ҹ Committee for the Ethical Treatment of Human Subjects (IRB) Human Subjects Research Proposal Principal Investigator: Name: Degree: Title/Rank: Department: Campus Mailbox: Phone Number or extension: Email Address: Faculty supervisor (if researcher is a student): Name: Campus Mailbox: Phone Number or extension: Email Address Funding Agency or Source (if applicable): Level of Project: ____ Faculty Research ____ Student Research: ___ Thesis ___ Honors Project ___ Class Project ___ Other (specify) _____________________________ Descriptive Title of your Proposed Project: Type of Application Requested ____ New : ___ Exempt ___ Expedited ___ Regular ____ Previously approved: ___ Change in Title or Funding Agency IRB Number:____ ___ Modification /Addendum ___ Annual review Please answer the following questions: Ethical Issues Information Does your research involve any of the following: YesNoQuestionDeception?Shock or other forms of punishment?Sexually explicit materials?Sexually explicit questions?Sexual experience?Sexual orientation?Sexual abuse?Handling of money?Extraction of blood?Extraction of other bodily fluids (if yes, please specify)?Questions about drug use?Purposeful creation of anxiety?Invasion of privacy?Physical exercise or stress?Administration of substances (food, drugs, etc.please specify)?Any other procedure that might place participants at risk? If you answered Yes to any of these, please provide an explanation and ethical justification for the procedure and describe how you would adequately protect participants. Erase this line and insert answer here. Does your research collect data from any of the following sensitive populations: YesNoQuestionUnder 18?Over 65?Physically disabled?Mentally disabled?Economically disadvantaged?Educationally disadvantaged?Unable to provide informed legal consent?Pregnant female as target population?Victim?Subject in an institution (prison, hospital, halfway homeplease specify)? If you answered Yes to any of these, please provide an explanation and ethical justification for the procedure and describe how you would adequately protect participants. Erase this line and insert answer here. YesNoQuestionIn your opinion, does the research involve more than minimal risk to participants?  If you answered Yes, provide an explanation of the benefits of the research to the participants and to the discipline or profession. Erase this line and insert answer here. YesNoQuestionDo you have a plan for responding to any emergencies or other problems arising from the research (such as dealing with upset or emotionally distraught subjects)?Are any emergencies or adverse reactions (physical, psychological, social, legal, or emotional) probable as a result of the research?  If you answered Yes to any of these, please provide an explanation of your plan on how you would adequately protect deal with any problems arising from your research. Erase this line and insert answer here. YesNoQuestionDo subjects leave the study or experiment in approximately the same emotional state as they began? If no, then explain how distress will be handled (usually this involves more detailed informed consent and debriefing).Do you preserve the anonymity of participants? If no, explain why and describe how you will protect the identity of participants. If you answered No to any of these, please provide an explanation. Erase this line and insert answer here. Research Project Description Erase this paragraph and replace with a description of your research project here (250 words or less). Include enough detail so that reviewers can understand the purpose of the study, any relevant variables, and how participants will be selected and treated. Assume an intelligent audience, but not one from your discipline, so please avoid jargon and overly technical descriptions. Erase this paragraph and replace with a copy the informed consent form that you will be using and/or other procedures to be used to assure informed consent. The basic elements of informed consent include: a statement about the purposes of the research, a description of the procedures to be followed, the expected duration of the subjects participation, a description of any reasonably foreseeable risks or discomforts, a description of any reasonably expected benefits to the participant and/or others, a statement describing the extent to which confidentiality of records will be maintained, a description of any compensation to the participant, contact information for researcher, supervisor, or IRB in case of questions, and a statement that participation is voluntary, that participants may choose to not participate or discontinue their participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. These elements should be included as part of the consent form or as part of the instructions prior to consent. If participants are unable to provide their own consent, please provide copies of the assent form (in simplified language) and the consent form to be signed by a parent/guardian. A written consent is not required for exempt level submissions unless participants will be audio- or video-taped or unless participants are minors, but is required for all expedited and regular level submissions. Erase this paragraph and replace with a copy your research instructions and debriefing that will be given to the participants (orally or written). If participants are not debriefed, explain why. Debriefing generally involves an educational process whereby the participant learns about the hypotheses and theories involved (including disclosure of any deception) and is given the opportunity to provide feedback about the research process. Every attempt should be made to undo any ill effects so that participants leave in as good as, if not better, a state than they were when they began. Erase this paragraph and copy any questionnaires or stimulus materials that will be given or presented to the participants. For All Researchers: I hereby certify that I have completed training on and am aware of all KWU policies regarding the ethical treatment of human subjects in research. Signature: ________________________________________ Date: ________________ For Student Researchers: I hereby certify that I have reviewed this project with the student and have approved their submission to the IRB Council. 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