Cover Sheet Clinicaltrials.gov ID NCT03459794 Protocol Ivermectin and human immunity ID#STUDY00005069 Adrian Adrian PI: Primary Contact: Wolstenholme Wolstenholme Submission Initial Study Type: IRB Brooke Harwell Parent Protocol: Coordinator: Review Category: Approved 9/27/2017 Date: Expiration 7/11/2018 Date: Print: STUDY00005069 - Ivermectin and human immunity https://ovpr-click-prod.ovpr.uga.edu/uga-ovpr/ResourceAdministration/P... Date: Monday, November 26, 2018 12:06:50 PM View: SF: Basic Information UGA v2 Section 1 - Basic Information 1. * Title of Study: If the study is/will be funded, the IRB recommends The effects of ivermectin on the normal human matching the title in the funding proposal. immune system 2. * Short Title: This can match the long title or be shortened if your Ivermectin and human immunity project uses an acronym or nickname; however, all system generated lists, searches, and documents (including approval letters) will show the short title. 3. Only UGA faculty and selected staff members (senior Principal Investigator (faculty or senior staff) are eligible to serve as PI. See the policy for staff only - see help): more information: http://research.uga.edu/documents Adrian Wolstenholme /eligibility 4. * Does the Principal Investigator have a See the policy for more information: https://research.uga.edu/docs/policies financial interest related to this /compliance research? Yes No /hso/PP_Financial%20Conflicts%20of%20Interests.pdf 5. If you are not sure if your project needs IRB * Are you requesting determination if review, choose "Yes" in the first question. A form will your project meets the definition of open and provide prompts to guide you through an initial assessment to see if your project needs IRB Yes No human subjects research? review. If you are seeking external funding and the sponsor or Are you requesting determination if the Office for Sponsored Programs requests for IRB your project meets the criteria for approval but you are not ready to create materials for developmental review? the human subject research activities, choose "Yes" in Yes No the second question. A form will open and provide prompts to guide you through an initial assessment to Will an external IRB act as the IRB of see if you can receive a letter from the IRB without record for this study? completing a full submission for review. Yes No If you are collaborating with other institutions and the collaboration model involves review by a central IRB, and UGA is not the lead institution, choose "Yes" on the third question. Be prepared to submit information that the other IRB will review. 1 of 24 26-Nov-18, 12:07 Print: STUDY00005069 - Ivermectin and human immunity https://ovpr-click-prod.ovpr.uga.edu/uga-ovpr/ResourceAdministration/P... View: UGA SF: Project Funding Details Project Funding Details 1.0 Mark all that apply: Identify below if the study is/will be supported in Internal sources whole or in part. If the funding has not been awarded yet, mark pending. include UGA Check all that apply. If you have not applied for funding or have no plan to departments or institutes. External at the time of initial submission, mark “No Funding” and continue to the sources may be next page. If you will or have applied for funding, choose Externally federal agencies Funded or Internally Funded depending on the source (see Help on right.) (e.g., NIH, NSF), If the funding has not been awarded yet, mark “Pending.” Finally, indicate industry sponsors whether UGA is/will be the prime awardee or a sub-award/contract. (e.g., Novartis), or Funding Status: private sponsors (e.g., Bill and No Funding Melinda Gates Externally Funded Foundation.) Internally Funded Pending Primary Awardee is UGA Sub-Award or Sub-Contract to UGA 2.0 Identify each funding source. If you have more than one, add each The IRB must separately. If the sponsor agency is not in the selection list, choose TBD review any funding and identify the source in Q5. The Grants Office ID number is required: proposal, contract, or sub-contract for this is the Grants Portal Project ID (FP000XXXX) or Award ID congruence with the (AWD000XXXX.) description of Sponsor's Grants Funding Source Attachments human subjects Funding ID Office ID activities described Clinical & Translational CTRU Seed Grant RFP in this submission. Research Unit FY18.docx The funding proposal or draft contract must be provided. 3.0 Name of Project and/or Project PI if different from this IRB submission. 4.0 Describe the scope of this IRB submission compared to the grant proposal (sub-award or statement of work) related to this project. Scope of Application: All human subjects activities in the grant proposal are covered in this IRB Application. Not all human subjects activities in the grant proposal are covered in this IRB Application; however, these activities will be covered in future UGA IRB Application(s). Not all human subjects activities in the grant proposal are covered in this IRB Application; however, these activities have been covered in another UGA IRB Application. Identify the UGA PI (if different from PI of this IRB Application) and the IRB Project Number below. Not all human subjects activities in the grant proposal are covered in this IRB Application; however, these activities have been or will be reviewed by another institution’s IRB. Identify the PI and name of the other institution below. Other, please explain. 5.0 Provide any additional information as requested above. This submission is associated with an application to the CTRU Seed Funding Program. 2 of 24 26-Nov-18, 12:07 Print: STUDY00005069 - Ivermectin and human immunity https://ovpr-click-prod.ovpr.uga.edu/uga-ovpr/ResourceAdministration/P... View: UGA SF: Study Team Members Study Team Members 1.0 Identify each UGA faculty, staff, or student who will be engaged in the conduct of human research. Do not select the PI again. Involved Financial Name Roles in E-mail Phone IsStudentProject Interest Consent View Maisie RESEARCH no yes [email protected] 706-713-2722 Anderson- COORDINATOR Frost View ROBERT RESEARCH no yes [email protected] 706-713-2722 no CAPITANO COORDINATOR View KRISTIN RESEARCH no yes [email protected] 706-713-2722 no Capitano COORDINATOR View STEPHANIE RESEARCH no yes [email protected] 706-713-2732 no CROYLE COORDINATOR View Jennifer RESEARCH no no [email protected] 706-713-2722 Dunlop COORDINATOR View TEJAL HILL RESEARCH no yes [email protected] 706-713-2722 COORDINATOR View Jonathan CO- no yes [email protected] 706-542-4378 no Murrow INVESTIGATOR View Barbara CO- no no [email protected] 706-542-6516 no Reaves INVESTIGATOR View ANGELIA RESEARCH no yes [email protected] ROGERS COORDINATOR View Kimberly RESEARCH no yes [email protected] 706-713-2722 no Schmitz COORDINATOR 2.0 If the collaborator Identify non-UGA collaborators* who will be engaged in the conduct of human research. has not Name Email Organization completed There are no items to display human subjects research training, *Submit an Individual Investigator Agreement for all study personnel with an institution that does not have an assurance with the contact your Office for Human Research Protections or OHRP (typically, local schools, private doctors, clinics). business department to *For study personnel who are affiliated with an institution that has an assurance (has its own IRB), do not submit an Individual get a UGA Investigator Agreement. Instead indicate that you have an External Site on the Study Scope page. MyID for them. Note: The Individual Investigator Agreement is not required for projects that will be submitted for Exempt determination (see Study Scope page). 3 of 24 26-Nov-18, 12:07 Print: STUDY00005069 - Ivermectin and human immunity https://ovpr-click-prod.ovpr.uga.edu/uga-ovpr/ResourceAdministration/P... View: UGA SF: CITI Training Records Study Team Members CITI Training Records 1.0 If a record does not Principal Investigator (PI):Adrian Wolstenholme display for someone that has completed Job Title: PROFESSOR training, try Please note: The training records update three times daily. Depending on when the course is removing/deleting completed or updated, the record may not be uploaded until 24 hours later. that person and adding them again PI CITI Courses: on the Basic Info page (PI) or Study Stage Group Date Taken Expiration Date Team Member page. 1 - Basic Course Bio-Medical Research 6/7/2012 6/7/2017 2 - Refresher Course Bio-Medical Research 7/3/2017 7/3/2022 2.0 If any study team Study Team Members: member including the PI has either not Expiration Person Group Stage completed training Date or has not linked 1 - previously- Bio-Medical Maisie Anderson-Frost Basic 10/19/2022 completed training Research Course to a valid UGAID, the record will show Expiration Person Group Stage "There are no items Date to display". Social & 1 - The application will ROBERT CAPITANO Behavioral Basic 3/1/2022 not successfully Research Course submit to the IRB if the training 1 - Bio-Medical requirement is not Basic 5/12/2021 Research met. Likewise, if Course training has expired Expiration and a refresher Person Group Stage Date course has not been completed or the 1 - Bio-Medical training will expire in KRISTIN Capitano Basic 2/18/2021 Research less than 90 days, Course the application will not sucessfully Expiration Person Group Stage submit to the IRB. Date 1 - Bio-Medical STEPHANIE CROYLE Basic 6/21/2021 Research Course Expiration Person Group Stage Date 1 - Bio-Medical Jennifer Dunlop Basic 12/14/2021 Research Course Expiration Person Group Stage Date Social & 1 - TEJAL HILL Behavioral Basic 5/28/2020 Research Course Social & 1 - Behavioral Basic 5/28/2020 Research - Course Prisoners 1 - Bio-Medical Basic 10/24/2022 Research Course Expiration Person Group Stage Date 1 - Bio-Medical Jonathan Murrow Basic 4/15/2019 Research Course 1 - IRB Members Basic 3/5/2023 Course 4 of 24 26-Nov-18, 12:07 Print: STUDY00005069 - Ivermectin and human immunity https://ovpr-click-prod.ovpr.uga.edu/uga-ovpr/ResourceAdministration/P..