KUMC INSTITUTIONAL REVIEW BOARD FULL COMMITTEE PROJECT DESCRIPTION – INDUSTRY USE THIS FORM FOR STUDIES THAT ARE: - GREATER THAN MINIMAL RISK - THE PROTOCOL WAS DEVELOPED BY INDUSTRY (THE IRB HAS A SEPARATE FORM FOR IITS) THIS INFORMATION IS A SUPPLEMENT TO INFORMATION ENTERED IN THE EIRB SYSTEM DOWNLOAD, COMPLETE AND SAVE THIS FORM TO YOUR DESKTOP / FILES ACCESS THE EIRB SYSTEM AT: WWW.ECOMPLIANCE.KU.EDU UPLOAD YOUR STUDY PROTOCOL IN THE “BASIC INFORMATION” TAB OF THE ELECTRONIC APPLICATION COMPLETE THE REQUESTED INFORMATION IN THE OTHER APPLICATION TABS PLEASE UPLOAD THE FOLLOWING IN THE “LOCAL SITE DOCUMENTS” TAB A THIS COMPLETED FORM B SIGNED PRINCIPAL INVESTIGATOR SUPPLEMENTAL FORM C CONSENT FORM(S), RECRUITMENT MATERIALS, DRUG/DEVICE BROCHURES, OTHER STUDY DOCUMENTS Rev 06/2021 I STUDY INFORMATION Principal Investigator: Protocol Title: Clinical Research Start Up (UKHSRR) ID # TO OBTAIN A CLINICAL RESEARCH START UP (UKHSRR) # GO TO HTTPS://REDCAP.KUMC.EDU/SURVEYS/? S=KFJYK87MAJ IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT CRA_INFO@KUMC.EDU OR THE UKHSRR TEAM AT UKHSRR@KUMC.EDU II III Study Type (Check all that apply) Phase First in Humans Phase /2 Trial Phase Trial Open-Label Extension Expanded Access Program Pilot Study Investigational Device Humanitarian Use Device Comparative Effectiveness Trial Observational Study Single Patient IND Phase 4/ Post-marketing Other: Specify Intervention type (Check all that apply) Investigational drug or unapproved use of an approved drug FDA-approved drug and approved population Biologic product Nutritional/dietary supplement Investigational device FDA-approved or marketed device Investigational in-vitro diagnostic device Other type of intervention Specify IV Study Procedures Indicate whether this research project includes any of the following procedures (a) Yes No Use of Radiation or a Radioisotope? If the study involves any form of radiation or use of a radioisotope, then complete the Radiation Safety Form RS06, posted on the RSC website: https://kumed.sharepoint.com/sites/mykumc/ehs/forms Upload the RSC form in the “Supporting Documents” tab in the eIRB system (b) Yes No Testing for reportable diseases (HIV, Hepatitis, TB, etc.)? (c) Yes No Testing for illegal drug use? (d) Yes No Genetic Testing? (e) Yes No Human Gene Transfer (protocol terms may include e.g., genetically modified or reprogrammed immune cells, recombinant DNA, viral-based vectors, retroviral transduction, gene silencing or gene editing)? (f) Yes No Submission of genetic data to national repositories (such as dbGAP)? (g) Yes No Whole Genome Sequencing? (h) Yes No Whole Exome Sequencing? (i) Yes No Storage of Blood / Tissue for purposes not related to this project? Rev 06/2021 (j) Yes No Investigational surgical procedures? (k) Yes No Audio taping or videotaping? (Please be aware of storage requirements per the KUMC Record Retention Policy) V Specimen Testing (a) Does this study use investigational testing on specimens (such as a genetic, proteomics or other test) that is not FDA-approved? No Yes (If yes, continue) (b) Is an FDA-approved in vitro diagnostic device (IVD) being used to corroborate the results of the investigational IVD? No Yes (c) Are the results of the investigational IVD being used for enrollment in the study or assignment to a treatment arm? No Yes (d) Will the results of the IVD be used for monitoring or dose adjustment during the study? No Yes (e) If (c) or (d) is “yes,” What are the risks to subjects of a false positive test? What are the risks to subjects of a false negative test? (f) What is the status of the FDA review of this IVD? IDE has been issued (note the IDE number in the eIRB system) FDA has issued a non-significant risk (NSR) determination (upload a copy of the FDA correspondence in the Supporting Document section) The sponsor is proposing an NSR determination by the IRB (upload a copy of the sponsor’s justification in the Supporting Document section) VI (a) Locations of the Study Check all KUMC/UKHS-affiliated study locations under the KUMC principal investigator’s responsibility: Facilities owned by The University of Kansas Health System or by KUMC Wichita-based locations: Specify Community sites: Specify Midwest Cancer Alliance sites KU Lawrence campus location Other universities/Colleges: Specify Rev 06/2021 (b) In what states will the KUMC principal investigator conduct the study? (Check all that apply) Kansas Missouri Other states: Specify For all studies: what state laws are relevant to your study (such as reporting communicable diseases, use of surrogate decision-makers, or inclusion of minors, emancipated minors or wards of the state)? For pediatric studies: what is the age of majority in the other state(s)? VII (a) Subject Selection and Recruitment Number of Persons Planned to be Enrolled under the KUMC PI Age Range (b) (c) Check any vulnerable populations that are specifically being studied If selections are made in this section, complete question (c) Children/Minors (under years of age) Persons with impaired decision-making Children/Minors (7 – 17 years of age) Prisoners Pregnant women Fetuses/Neonates Economically/educationally disadvantaged KUMC Employees KUMC Students/Residents/Fellows Since the protocol is specifically studying a vulnerable population, discuss the special protections being implemented to minimize risk of coercion or undue influence [Special protections may include parental permission and assent (for children); fulfillment of special conditions for research with pregnant women and fetuses (for pregnant women); design considerations for jail and prisons (prisoners); assessment of cognitive status, use of surrogate decision-makers and assent (for cognitively impaired persons); modified consent procedures, non-coercive recruitment and retention measures (disadvantaged); institutional permissions (KUMC personnel).] VIII Consent Process (a) How will subjects be informed about the possibility of research participation? (b) Where will the consent interview occur? (c) Do you anticipate enrolling subjects whose primary language is not English? No Yes If yes, how will you obtain informed consent in the language of those participants? Rev 06/2021 If yes, who will be present during study visits to translate instructions, assess adverse events, etc? (d) How will subjects indicate their agreement to be in the study? Signatures on paper consent forms Electronic means (e.g, iPads or websites that use a mouse or stylus to capture signatures) FOR ADULT STUDIES ONLY: (e) Will all adult subjects be able to consent for themselves? (a) Yes (b) No It is expected that all subjects will need a surrogate decision-maker No It is expected that some subjects may need a surrogate decision-maker (c) If (c), how will study personnel assess the capacity of the subject to consent and to comprehend the consent? If (c), how will you verify that the surrogate decision-maker is a valid legally authorized representative under state law? If (b) or (c), you plan to obtain written assent from the subjects? FOR PEDIATRIC STUDIES ONLY: (f) What are your plans for child assent? Subjects’ assent will be required for enrollment The study will be discussed with the child subject, but parental permission will determine enrollment, due to the therapeutic nature of the trial Subjects will not be capable of providing assent (g) At what age will you obtain assent? Not applicable - 17 12 - 17 Other: Specify (h) How you propose to document assent? Not applicable By obtaining the child’s/adolescent’s signature on an assent form By documenting verbal assent in the research or clinical record Other: Specify (i) Will any of the study subjects be foster children or wards of the State or other agency? No Rev 06/2021 Yes Contact the IRB Office for guidance if subjects will be foster children or wards and the research offers no prospect of direct benefit to the child Additional state requirements may apply IX Data Privacy/Security **Please note: Starred responses will require review by KUMC Information Security (a) How will subjects be identified? (Check all that apply) Selection during the course of usual clinical care Chart reviews by persons involved in the patients’ care Chart reviews by persons not involved in the patients’ care Self-referral in response to IRB-approved ads or Websites Referrals from outside physicians Database searches; specify the database: HERON Data Repository Pioneers Research Participant Registry Other; Specify: (b) Who holds the patient/client records you will use or disclose for the study? The University of Kansas Health system Outside clinic/collaborator, etc Specify: (c) How will electronic data be stored? High Risk Data - [Note: High risk data must be stored on any of the locations below Examples of High risk data include, PHI, financial records, sensitive information related to HIV status, sexual behaviors, etc., data sets received from government agencies (ResDAC, KDHE, and CMS), etc See the KUMC Data Classification Policy/Guidance for more information.] Server hosted by a research sponsor or data coordinating center, with which KUMC has an approved sponsored research agreement KUMC VELOS/CRIS System KUMC REDCap server KUMC P: drive (The principal investigator should request a P: drive location by emailing kumc-security@kumc.edu) KUSM-Wichita P: drive (The principal investigator should request a P: drive location by emailing itswichita@kumc.edu) Low to Moderate Risk Data - [Note: Only data categorized as low to moderate risk should be stored on department drives See the KUMC Data Classification Policy/Guidance for more information.] KUMC department network drive (e.g., G, K, R, or S drive) KUSM -Wichita department network drives Encrypted CDs/DVDs – for imaging studies only Other servers, devices or drives** Rev 06/2021 Specify: Detailed Description of the Technology that will be used During the Course of the Study to Capture, Record, or Transmit Data Please select which technology(ies) will be used in this study (check all that apply and answer the questions in the relevant required section) If all answers below are ‘no’ proceed to Section XI Technology Type Yes No Mobile technology Yes No Website survey, or similar tool Yes No Cloud based storage Yes No Wearable Technology Yes No Yes Yes Examples (Descriptions of the technology are offered in the respective sections below) For example, e-diary, iPhone, Android devices, iPods, tablets, or other wireless devices For example, REDCap survey, surveys on external websites If Yes, Answer the Required Questions Complete section (d) below Complete section (e) below Cloud storage is a cloud computing model in which data is stored on remote servers accessed from the internet, or "cloud." Examples include Dropbox, Google Drive and other Google services, iCloud, Amazon Web Services, Microsoft Azure, etc (This category does not apply to servers hosted by pharmaceutical sponsors or data coordinating centers.) Examples of wearable biosensors include accelerometers, activity trackers, wireless heart rate monitors, pulse oximetry sensors, and glucose sensors Complete section (f) below Phone, Video or Web Conferencing Examples include Zoom, Adobe Connect, Skype for Business, Facetime, Acano, etc Complete section (h) below No Text messaging/secure messaging Examples include MyChart, Outlook, text, etc Complete section (i) below No Mobile Applications Examples include electronic patientreported outcomes (ePRO), Apple health, Garmin connect, Fitbit, etc Complete section (j) below Complete section (g) below (d) MOBILE TECHNOLOGY Electronic devices that allow for offsite or remote data capture directly from study participants For example, e-diary, iPhone, Android devices, iPods, tablets, or other wireless devices Also complete the mobile app section below if a mobile app will be used with the mobile technology Yes; who does the mobile technology belong to? Study participant owned device Sponsor-provided device Rev 06/2021 Is the mobile technology password protected? No Yes, password protected (e) WEBSITE SURVEY, OR SIMILAR TOOL Name of the website survey, or similar tool you are using: Who developed the site, survey, or tool? Commercially available Study sponsor Other (specify): Is the data encrypted at rest? No** Yes Data at rest is data that is sitting on a file server, data stored in a spreadsheet on a desktop or laptop, ultrasound images on the hard drive of the ultrasound machine, files or images on an iPad, tablet or smartphone Is the data encrypted in transit? No** Yes Data that is being transmitted includes uploading or downloading to a website, sending data via email, using protocols such as FTP to transmit data, etc (f) CLOUD BASED STORAGE** Name of the cloud based solution: Examples include Dropbox, Google Drive and other Google services, iCloud, Amazon Web Services, Microsoft Azure, etc (This category does not apply to servers hosted by pharmaceutical sponsors or data coordinating centers.) (g) WEARABLE TECHNOLOGY Wearable technology is simply anything that is worn (on the wrist, clipped to a belt, even imbedded in clothing) that contains sensors that pair with a web connection or Bluetooth to connect wirelessly with a mobile technology Examples of wearable biosensors include accelerometers, activity trackers, wireless heart rate monitors, pulse oximetry sensors, and glucose sensors Also complete the mobile app section below if a mobile app will be used with the wearable device Name of the device What information must the participant provide when the wearable is registered to them? What type of data will be collected and provided to the KUMC researcher? What type of data will be collected and provided to external parties? Is the data encrypted at rest? No** Yes Is the data encrypted in transit? No** Yes When and how will the wearable be de-activated from the user? The study team has reviewed the terms of agreement and/or privacy policy and will inform participants on how their data will be collected via the wearable Yes No (h) PHONE, VIDEO OR WEB CONFERENCING Examples include Zoom, Adobe Connect, Skype for Business, Facetime, Acano, etc Name of the conferencing system: The recordings capture: images video audio Will recordings be transmitted over the Internet? Yes No How will recordings be secured to protect against unauthorized viewing or recording: (i) TEXT MESSAGING/SECURE MESSAGING Examples include MyChart, Outlook, text, etc Rev 06/2021 What type of messaging will be used: Text Email Other How will the messaging be delivered: Standard text messaging on a mobile device Separate application; name of the application Secure email Unsecure email Other** What is the purpose of the messaging: (j) MOBILE APPLICATIONS Software applications that can be run on a mobile device (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity) or a web-based software application that is tailored to a mobile platform but is executed on a server Examples include electronic patient-reported outcomes (ePRO), Apple health, Garmin connect, Fitbit, etc Name of the application: Who developed the mobile application? Commercially available Sponsor Other (specify): Explain how the app will be used in the study: What type of data will be collected within the app and provided to the KUMC team? If applicable, what type of data will be collected and provided to external parties? Is the data encrypted at rest? No** Yes Is the data encrypted in transit? No** Yes When and how will the data be securely wiped from the device The study team has reviewed the app terms of agreement and privacy policy and will inform participants on how their data will be collected via the mobile app No Yes X (a) Funded Studies Only Has the contract been submitted to the Research Institute? Yes No (b) Does the consent discussion about payment for injury match the contract provisions? Yes No; Explain: Pending Thank you for your submission Please ensure this application form is accompanied with the signed Principal Investigator Supplement and the IRB Checklist For questions, contact the KUMC IRB office at (913) 588-1240 or IRBhelp@kumc.edu Rev 06/2021 Rev 06/2021 10