WCU IRB Registration Number:



Request for Review of Human Subjects Research Western Carolina UniversityPlease complete and send this form and any attachments electronically to: irb@wcu.eduINSTRUCTIONS: Prior to submitting your application to the IRB, please make sure all personnel listed on the protocol have completed human subjects training. Your application will not be reviewed until training completion has been verified.WCU’s human subjects training can be accessed at . Please note: The required course for WCU's IRB training is the Social/Behavioral Research or the Biomedical Research Course. The Responsible Conduct of Research (RCR) will not meet the requirement.Detailed instructions for registering, affiliating with WCU, and selecting the correct course can be found on the IRB website.Please contact the IRB at irb@wcu.edu if you have any issues editing this form.IRB Application Checklist – please initial each item below.PRELIMINARY STEPS FORMTEXT ?????Completion of Mandatory CITI Online Human Subjects Training by all members of the investigative team.THE PROTOCOL FORMTEXT ?????Check to ensure your application is complete and all questions have been answered and filled out appropriately. FORMTEXT ?????All protocols must have a Principal Investigator (PI), who is ultimately responsible for the project. A PI must be a member of the faculty or staff member of WCU (students cannot be listed as the PI for any study). The PI must also be listed on the consent form for the study. All members of the investigative team must review and sign the application before submitting to the IRB. RECRUITMENT FORMTEXT ?????If applicable, include a copy of your recruitment material (e.g. flyers, posters, emails).DATA INSTRUMENTS FORMTEXT ?????If applicable, have you attached to your application all data instruments and other materials to be distributed to participants (e.g. surveys, questionnaires, interview questions).INFORMED CONSENT/INFORMED ASSENT FORMTEXT ?????If applicable, have you attached to your application the appropriate consent and assent form, letter, or script containing all elements of informed consent/informed assent. AGREEMENTS FROM OUTSIDE INSTITUTIONS FORMTEXT ?????If applicable, have you obtained permission from outside institutions or agencies that either serve as a source of subjects, a source of records and information, or on whose facilities your project will be conducted. ***NOTE: If your study will include tribal members from the Eastern Band of the Cherokee Indians (EBCI) or will occur on Cherokee lands (e.g. the Qualla Boundary or Snowbird community), approval may also be required by the EBCI Cultural IRB and/or Health & Medical IRB). For more information, please contact the WCU IRB Office at irb@wcu.edu or by calling 828.227.7212.Request for Review of Human Subjects Research Western Carolina UniversityPlease complete and send the form and any attachments electronically to: irb@wcu.edu Research Personnel (PI must be member of faculty or staff)Name*DepartmentInvestigator Status:(PI, co-PI, Other investigator, Other personnel)WCU Status:**(Faculty, Staff, Undergraduate, Graduate Student, Unaffiliated)Preferred Phone Number (optional) FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????*If you have more investigators than the form will allow, please complete the Additional Investigator Form.**An Unaffiliated Investigator Form is required for all non-WCU personnel that do not have an institutional IRB.The Principal Investigator (PI) is responsible for maintaining data records. Data should be stored for a minimum of three years after a study has been closed and be available for inspection by the IRB or state/federal investigators. Project SummaryProject Title: FORMTEXT ?????Funding Source, if applicable: FORMTEXT ?????Project Description: provide a concise (3-5 sentences) summary of the purpose and rationale of the activity. (Members of the IRB may not be familiar with your field’s methods and literature. Explain your project in an accessible language for non-experts. You may include citations you may believe relevant in an additional sheet): FORMTEXT ?????Intended use(s) of data collected: check all that apply FORMCHECKBOX Thesis or Dissertation FORMCHECKBOX Grant Proposal FORMCHECKBOX Classroom Project FORMCHECKBOX Other Research FORMCHECKBOX Publication FORMCHECKBOX Off-Campus PresentationInvestigator Signatures“I/We assure the IRB that the following statements are true: All information provided in this form is correct. I have evaluated this protocol and have the resources necessary to protect participants, such as appropriately trained staff, and necessary facilities. I will not begin my research until I have received written notification of final IRB approval. Any research conducted prior to IRB approval is considered noncompliance, and no guarantee of legal protection shall be afforded to the investigator(s) for research conducted prior to the approval date. I will obtain written approval from the IRB for any modifications including changes in procedures, investigators/research staff, questionnaires, etc. I will promptly report any unanticipated problems that may occur in the course of this study. I will report any significant findings which may affect the risks and benefits to participation. I will comply with all IRB requests to report on the status of my study. I will maintain records of this research according to Federal, State, and Institutional standards. If any of the above conditions are not met, I understand that the approval of this research may be suspended or terminated, and/or all federally funded research at WCU could be suspended by the Office of Human Research Protections (OHRP)”Investigator name and email address together constitute an electronic signature to this application. Note: all personnel must sign and date the application prior to submission.NameEmail AddressDate FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Conflict of InterestAre there any known or potential conflicts of interests related to this research?Conflict of interest relates to situations in which financial or other personal considerations may compromise or involve the potential/have the appearance for compromising an investigator’s objectivity in meeting University responsibilities including research activities. (see University Policy 54) FORMCHECKBOX No FORMCHECKBOX Yes. If yes, describe and explain how participants will be protected from the influence of competing interests. FORMTEXT Participant Population and RecruitmentEnrollment InformationExpected number of participants: FORMTEXT ?????Does the study include any of the following populations, either as the target population or incidentally? If the following populations will be excluded from your study, please select “Not applicable.”Vulnerable Populations:TargetIncidentalNot applicableMinors FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Prisoners FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Pregnant Women FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Special Populations: Non-English speaking FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Decisionally or Mentally Impaired FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX WCU Students / Employees FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Native Americans FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX What are the inclusion criteria for the study? (What characteristics of the study population make them eligible to participate?): FORMTEXT ?????What are the exclusion criteria for participation in the study? (What characteristics would make someone ineligible to participate? (e.g. age or physical restrictions; “not meeting inclusion criteria” is not sufficient): FORMTEXT ?????Explain special procedures for handling vulnerable populations (enter N/A if your study involves no vulnerable or special populations): FORMTEXT ?????Give a brief description or outline of your recruitment and inducement procedures as they relate to human subjects.Explain details of the recruitment process. (How will you find participants?) FORMTEXT ?????Does this research study include any compensation, monetary inducements, or reimbursement for participation? FORMCHECKBOX No FORMCHECKBOX Yes. If Yes, please explain: FORMTEXT ?????Please include a copy of your recruitment material (e.g., flyers, e-mails) with your rmed Consent/Assent“Consent” is obtained from adult individuals participating in a study. “Assent” is given by minors agreeing to participate in the study. Additionally, parents must give “consent” allowing their children to participate in research.Explain how informed consent and assent (if applicable) will be obtained. Include information about: the setting, whether participants will have an opportunity to ask questions, and the roles of any non-research personnel involved. FORMTEXT ?????Please include a copy of your informed consent/informed assent materials with your protocol.Standard templates for informed consent and informed assent are available on the IRB website.Are you requesting a modification to the required elements for informed consent for participants, or legally authorized representatives? (See ) FORMCHECKBOX No FORMCHECKBOX Yes. If yes, include your request here: FORMTEXT ?????Will participants or their legally authorized representative sign the consent / assent form? FORMCHECKBOX No FORMCHECKBOX YesStudy ProceduresNote: The study start date MUST be “date of IRB approval” or a date in the future, or the application will be returned for editing. Projected recruitment, data collection, and data analysis dates:From: date of IRB approval To: FORMTEXT ?????List and describe the types of data that will be collected (you may provide links to information that may be reviewed electronically): FORMTEXT ?????Please include a copy of all data collection instruments which does not have an electronic referenceDescribe the activities in which participants will engage, including length of participation, nature of intervention (if applicable), and frequency of data collection: FORMTEXT ?????Risk and Benefits SectionThe risks to participants must be reasonable in relation to the anticipated benefits, if any, to the participants and the importance of the knowledge that may be reasonably expected to result. Select all applicable: FORMCHECKBOX Participants of the study may directly benefit (describe): (note that compensation for participation is not considered to be a benefit): FORMTEXT ????? FORMCHECKBOX Society may benefit from the study (describe): FORMTEXT ?????Give a full description of potential risks to study participants.Minimal Risk:Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [45 CFR 46.102]Minimal Risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons [45 CFR 46.303] (This definition only applies to research involving prisoners.)Select the appropriate level of risk for each category below. *Options are: no foreseeable risk, no more than minimal risk, or more than minimal riskLegal FORMTEXT ?????Psychological FORMTEXT ?????Social FORMTEXT ?????Economic FORMTEXT ?????Physical FORMTEXT ?????If you answered anything other than “no foreseeable risks,” explain the nature of the risk, its likelihood of occurring, and its potential impact on participants: FORMTEXT ?????Explain what steps have been taken to minimize these risks: FORMTEXT ?????What provisions have been made to insure that appropriate facilities and professional attention necessary for the health and safety of the subjects are available and will be utilized? FORMTEXT ?????Confidentiality, Anonymity and SafeguardsConfidentiality and AnonymityWill the data from your study be (check one) FORMCHECKBOX Anonymous (Not even the researcher can match the data to the participant.) FORMCHECKBOX Confidential (The researcher can match the data to the participant but participant identity is not disclosed.) FORMCHECKBOX Neither (The researcher can match the data to the participant and participant identity will be disclosed.)If the data will be confidential, explain the steps you will take to maintain confidentiality: FORMTEXT ?????Do the data to be collected relate to illegal activities? FORMCHECKBOX No FORMCHECKBOX Yes. If yes, explain: FORMTEXT ?????Is deception involved? FORMCHECKBOX No FORMCHECKBOX Yes. If yes, explain: FORMTEXT ?????SafeguardsHow will data be monitored to ensure the safety of subjects (e.g., if during a trial it is found that an intervention has increased risk/benefit not in the consent, how will you ensure that this is monitored and conveyed to the IRB and participants)? FORMTEXT ?????Describe what will be done with the data and resulting analysis: FORMTEXT ????? (Note: data should be stored by the PI for a minimum of three years after a study has been closed such that they are accessible for inspection by the IRB, federal, and state agencies. Describe measures you are taking to safeguard study data: FORMCHECKBOX Data is not linked to identifying information FORMCHECKBOX Maintain consent forms in a separate location from data. List location: FORMTEXT ????? FORMCHECKBOX Using subject codes on all data collected and maintaining the key linking subject codes with identifiable information in a separate location from data. List location: FORMTEXT ????? FORMCHECKBOX Locking cabinets/doors. List locations: FORMTEXT ????? FORMCHECKBOX Data kept in area with limited public access. List locations: FORMTEXT ????? FORMCHECKBOX Password protected computers. List locations: FORMTEXT ????? FORMCHECKBOX Encryption FORMCHECKBOX iPads, tablets, digital storage devices and removable media will be kept in a secure location. List locations: FORMTEXT ????? FORMCHECKBOX Other, describe: FORMTEXT ?????Data Sharing. What type of data will be shared? (Note, sharing includes releasing, transmitting, and providing access outside of the research team). Check all that apply: FORMCHECKBOX Data collected anonymously FORMCHECKBOX De-identified or de-linked data FORMCHECKBOX Identifiable data; Indicate which secure methods of transmission will be used: FORMCHECKBOX Secured website, or FTP client; Provide name of website: FORMTEXT ????? FORMCHECKBOX Encrypted email FORMCHECKBOX US Postal Service or other traceable courier FORMCHECKBOX Fax in a secured area FORMCHECKBOX Shared drive with password protection FORMCHECKBOX Personal delivery by member of research team FORMCHECKBOX Private telephone conversation FORMCHECKBOX Other, please describe: FORMTEXT ?????FOR RESEARCH INVOLVING Qualtrics SURVEYS, the PI must initial this statement: FORMTEXT ????? I understand that approval of the use of WCU’s online survey software (Qualtrics) is limited to the survey(s) specifically described in this IRB proposal. Any further use of Qualtrics for research purposes will require me to submit and receive approval for an amendment to this proposal or a new IRB proposal before I can proceed. Use of Qualtrics is governed by WCU Policies on Conducting Surveys (#51) and Ethics in Research (#56), and to IRB policies. My initials indicate adherence to these policies.Please send this application form with any accompanying attachments to irb@wcu.edu ................
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