ࡱ> ilh !.bjbj 4dgg&* * 8ltl0&Hdy4C0E0E0E0E0E0E0$25\i0i0~0jC0C0+|-`5F,/00001,5]@5$--5.,i0i0F05* X : Department/Division-Specific Guidelines for eIRB Submission Pre-Review Requirements Prior to an IRB review, there are required pre-reviews which may identify revisions to ensure your application is complete and clearly written prior to being reviewed by the IRB. The pre-review is not considered part of the IRB review, but it can be a helpful step to speed up the IRB review process and to help prevent your application from having to be reviewed numerous times (which is more time consuming than revisions during the pre-review process). The following have unit-specific scientific review requirements:  HYPERLINK \l "cphsj" College for Public Health and Social Justice  HYPERLINK \l "communication" Department of Communication  HYPERLINK \l "family_community_medicine" Department of Family and Community Medicine  HYPERLINK \l "internal_medicine" Department of Internal Medicine  HYPERLINK \l "nutrition_dietetics" Department of Nutrition and Dietetics  HYPERLINK \l "pediatrics" Department of Pediatrics  HYPERLINK \l "psychology" Department of Psychology  HYPERLINK \l "radiology" Department of Radiology  HYPERLINK \l "business" Richard A. Chaifetz (formerly John Cook) School of Business  HYPERLINK \l "nursing" School of Nursing If you would like the 91Ů IRB to enforce unit-specific pre-review requirements, please send an email to  HYPERLINK "mailto:irb@slu.edu" irb@slu.edu detailing your units pre-review process with confirmation of your units department/division head approval. College for Public Health and Social Justice To satisfy scientific pre-review requirements, PIs are asked to identify a colleague to conduct the pre-review. The reviewer can't be on the study team and should be able to objectively assess the scientific merit of the research in accordance with the 91Ů IRB Guidelines for Scientific Pre-Review. This person should be searched for and selected in the scientific pre-review section of eIRB during submission. All studies must get a department chair pre-review. Department of Communication Dr. April Trees should be listed as the Department Chair on the first page of the electronic submission for all protocols. Pick Dr. April Trees as the Department Chair for pre-review for all protocols. If the study is investigator initiated, pick an appropriate scientific reviewer at the same time as choosing Dr. April Trees. Department of Family and Community Medicine While Dr. Christine Jacobs should be listed on actual protocols as Department Chair, researchers in Family and Community Medicine should select Dr. Jeffrey Scherrer or Dr. Dixie Meyer to conduct the Department Chair pre-review in the eIRB system. Both have been designated to perform this role for Dr. Jacobs. On the IRB pre-review assignment page, please search for and select Dr. Jeffrey Scherrer or Dr. Dixie Meyer to do the pre-review. Department of Internal Medicine While Dr. Ravi Nayak should be listed on protocol personnel page as Department Chair, researchers in Internal Medicine should select Stephen Schmidt (stephen.schmidt@health.slu.edu) to conduct the Department Chair pre-review in the eIRB system. He has been designated to perform this role for Dr. Nayak. On the eIRB pre-review assignment page, please search for and select Stephen Schmidt to do the pre-review. If he is not going to be available, Sue Stevens (sue.stevens@health.slu.edu) should be selected on the pre-review assignment page. Department of Nutrition and Dietetics Dr. Anthony Breitbach should be listed as the Department Chair on the first page of the electronic submission for all protocols (Personnel Information page) and selected to complete the Department Chair pre-review. If the PI is a student, please add the PIs Committee Chair as an Administrative Contact on the Personnel Information page; the student's Committee Chair should be selected to complete the Department Chair pre-review. If the study is requires scientific pre-review, pick an appropriate scientific reviewer at the same time as choosing Dr. Anthony Breitbach (or the PI's Committee Chair if the PI is a student); scientific reviewers for student protocols are selected within the department. Department of Pediatrics Dr. Jeffrey Teckman should be listed as the Department Chair on the first page of the electronic submission for all protocols. Dr. Teckman requires departmental pre-review of all IRB submissions prior to signing off. DO NOT SUBMIT the protocol in eIRB until the pediatric pre-review process is complete. All pediatric pre-reviews must be coordinated through Vikki Kociela. In eIRB, list Vikki as an Administrative Contact. When the protocol is complete (including consents, attachments, etc.), send an e-mail to Vikki ( HYPERLINK "mailto:vikki.kociela@health.slu.edu" vikki.kociela@health.slu.edu) that includes the IRB # and a request for pre-review. There is no need to attach documents as all materials should be available in eIRB. Feedback (via e-mail) will be provided. Once you have been given approval (via e-mail) to submit the protocol, you may submit the protocol for pre-review in eIRB. Search and select Dr. Teckman to complete the Department Chair Review and Vikki Kociela to complete the Scientific Review (unless Vikki instructs you to list another person for the Scientific Review). Department of Psychology Although discouraged, it was determined that the departmental scientific pre-review could be done on paper outside of the system if documentation is uploaded in the attachments page of the protocol in eIRB. Department Chair/Advisor pre-approval still must be obtained using the eIRB system. When doing departmental scientific pre-review in the eIRB system, this will be the process: Once the protocol is ready to proceed to pre-review (which for students includes acceptance from Advisor to proceed), the investigator should email Destiny Brooks ( HYPERLINK "mailto:destiny.brooks@slu.edu" destiny.brooks@slu.edu) with the IRB Protocol Pre-Review Request Form. Click HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/psychology_prereview_request_form.doc"here for the form. Destiny will email the PI with the name of the person conducting the departmental scientific pre-review and additional instructions of how to proceed. The PI will submit the protocol for pre-review in the eIRB system, which involves selecting one departmental scientific pre-reviewer (name provided by Destiny) and selecting the Department Chair/Advisor wholl need to pre-approve. Make sure that the Department Chair/Advisor listed on the Personnel page of the IRB application matches the person selected to do Department Chair/Advisor pre-review; otherwise, the protocol could be returned by the IRB. Department of Radiology Anna Hardy should be listed as the Administrative Contact on the Personnel Information Page. When your protocol is ready for scientific review, please notify her by email. In the email include the following: (1) IRB protocol #; (2) Study focus (e.g., device, drug, chart review, etc.); (3) How quickly does this need to be reviewed? Please justify your timeframe. If the Study Feasibility Assessment Form ( HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/radiology_study_feasibility_assessment.docx" click here) has been completed, Anna will select a scientific reviewer appropriate for the study. The PI should select Dr. Brown as the Department Chair. Once both reviews are complete, the PI may submit the protocol to the IRB. Richard A. Chaifetz (formerly John Cook) School of Business Select Brad Carlson, PhD as the Scientific Pre-Reviewer. If Dr. Carlson is on the research team of your study, contact him to identify an alternative Scientific Pre-Reviewer. School of Nursing Personnel Information PagePre-Review Assignment(s)Administrative ContactDepartment Chair/AdvisorDepartment Chair/AdvisorScientific/PPC ReviewFaculty Proposalsleave blankDr. Joanne ThanavaroDr. Joanne ThanavaroDr. Helen LachPhD Student Dissertation Proposalsleave blankDissertation ChairDissertation ChairCommittee member not on research teamDNP Student Project Proposalsleave blankDr. Joanne Thanavaro See below*Project Chair*Dr. Joanne Schneider See below** * Personnel Information Page for DNP Projects: Enter Dr. Thanavaro as Department Chair on the personnel page and the DNP Project Chair as Department Chair/Advisor when you assign pre-reviewers. ** Pre-Review Assignments for DNP Projects: Select the DNP Project Chair as Department Chair/Advisor and Dr. Schneider as the Scientific/PPC Reviewer on the pre-review assignment page. Once the entire protocol has been entered into the system, click on Print View to generate a PDF. Email the PDF to the person indicated for PPC/Scientific Review in the table above. After you have received the final approval from the PPC/Scientific Reviewer by email, go into the protocol in the eIRB system, complete the obligations page and select Submit. NOTE: PI (student) must be the one who checks the responsibilities/signature box on the PI Obligations page. Then search for and select the appropriate people for the Department Chair/Advisor pre-review and the Scientific/PPC pre-review (see table above). Finally, at graduation, student PIs must CLOSE their IRB protocols. If in the rare case the student PI wishes to transfer the study to a new PI (such as their committee chair) for additional work after graduation, the student should contact the IRB for instructions on how to do so.     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