Final Dissertation Manual 11142023

November 2023

When a doctoral student has successfully passed all requirements in GL 897 and GL 898 then the doctoral chair will lead the effort with the doctoral student through the procedures to apply to the IRB at SMWC as follows:

1. Principle Investigators are asked to send a completed Human Subjects Review Form A, an Exempt Review Form B, Expedited Review Form C, or Limited Review Form D if applicable, consent form, flyer (if applicable), and/or other forms as required, and the CITI completion report in one file to the Chair of the IRB. If the investigator is a student, the student must have his/her/hir research advisor review and approve the proposal prior to submission to the IRB. The research proposal must be approved and submitted to the IRB by the dissertation chair/advisor/faculty . The following questions must be addressed in the materials submitted for review: a. Who are the investigators, including the faculty supervisor, for student research? b. What is the research question and what is its significance/rationale? c. When and where will the research be conducted? d. Who are the subjects and how will they be recruited and assigned to experimental groups? e. What specifically will the subjects be doing in the study? Include a copy or thorough description of the instruments and/or protocol(s). f. What level of risk is involved? Use the categories: low or minimal risk, moderate risk, or high risk. If more than minimal risk is involved, a detailed explanation of the prospect of direct benefit to the individual subjects is needed. Moderate risk might include distress or significant fatigue during the task or need for extensive debriefing or explanation due to some deception involved in the research. High risk might include potential danger or more severe levels of distress due to participation in the research. g. What procedures will be used for obtaining informed consent? How will subject confidentiality be protected? Include a copy of the consent form (and assent form for subjects under the age of 18 deemed capable of providing assent). Also, if the research includes a flyer or similar communication used for the purpose of recruiting participants, this has to be included in the proposal. h. What procedures will be used to provide feedback and/or debriefing to subjects following completion of their participation in the study? 2. The Chair of the IRB will review each proposal to confirm the appropriate level of review (exempt, limited IRB review, expedited, or full board review) as determined by the principle investigator. a. Research proposals that appear to be exempt or limited will be reviewed by the Chair of the IRB or his/her/hir designee. Research proposals meeting one or more of the categories listed on the Exempt Review Form will be exempt from further review and the investigator will be notified within ten business days of receipt of the proposal if the proposal is complete or if any other action is needed. b. Research proposals not exempt from the review process but meeting limited IRB review, or one or more of the categories for expedited review will be reviewed by the Chair of the IRB or his/her/hir designee and one additional IRB member. The investigator will be notified within ten business days of receipt of the proposal with one of the following categories of response: approved, pending changes, or disapproved (resubmit). c. Research proposals requiring full board review will be reviewed by every member of IRB. Research proposals must be approved by a majority of the IRB members. The IRB will respond in writing to the investigator within two weeks of the proposal submission’s date. with one of the

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