ࡱ> e bjbj }(xj\xj\E<( ( $P4e0D:~+ + + ///////$242/+ @+ + + 2/W0&&&+ v /&+ /&&d+X,@~ N,.500e0,:W5!PW5,X,W5X,+ + &+ + + + + 2/2/?$z+ + + e0+ + + + W5+ + + + + + + + + ( > f: Application for Initial Review Institutional Review Board (IRB) Principal InvestigatorDepartmentDepartment AddressEmail AddressPhone Number ExtensionStudy Coordinator/Additional Contact Person:Study Coordinator/Additional Contact Phone:Is investigator a student? Yes % No % Please provide information of faculty advisor including department, email and phone number. Project Title I am requesting (please check one): Exempt Expedited Review Full Committee ReviewIf you are applying for an exemption from IRB review, please fill out Appendix 1. If requesting Expedited review, please fill out Appendix 2. Note that the IRB may adjust the review category. If your study proposes to include any of the following study subjects, indicate in the box below and include the proposed number of each:If your study proposes to include any of the following items, indicate in the box below:Minors (under age 18)Human Tissue SamplePrisonersHuman DNACognitively ImpairedOther protected populations (explain):Assurance: The undersigned assures that protocols involving human subjects described in this application are complete and accurate, and are consistent with applicable protocols submitted to any external funding agencies. All protocol activities will be performed in accordance with institutional guidelines and any applicable State and Federal regulations. Research conducted by researchers falls under the purview of the University even when conducted elsewhere. Research at international sites must receive approval by the local equivalent of the IRB. No activities involving the use of human subjects can be initiated without prior review and approval by the Institutional Review Board. Signature of Principal InvestigatorDateIf this is a Student Project, Signature of Supervising FacultyDateSignature of Department Chair(s)Date For IRB Use Only:ApprovalDateProtocol # Application for Initial Review Institutional Review Board (IRB) I.Research Plan: Provide a brief summary, in non-technical language, of the proposed research. Include the following sections: purpose, research design, anticipated products of the research (presentations, articles, organizational uses, etc.) and references cited (if references are included). (500 Words or Less) II. Performance Site and Proposed Dates: a. Provide the name and location of the site(s) where the study will take place. If the site is not public, you must attach an official letter of permission to conduct the from organization/academic department hosting the study.  Check here if you are obtaining Protected Health Information (PHI) as part of this research. Your letter of permission must give permission for use of PHI. Any investigator using Protected Health Information must complete the Responsible Conduct of Research (RCR) module on Information Privacy and Security - Health Privacy Modules. For more information, please contact the IRB. b. Duration of the Study: Indicate the beginning and end dates of the project. IIa. Personnel: List all personnel in the project. Include name, contact information (email address, telephone number) and the role of each person in the study. All personnel must have training in the protection of human subjects through CITI. The proper training is the Social and Behavioral Basic Training or the Biomedical Basic Training. See IRB website. If using social media platforms to recruit subjects, please provide the appropriate documentation of additional training or certification. Briefly describe the qualifications of the principal investigator(s) and supervising personnel (education and research experience) to conduct this research project (limit 200 words each). In addition, in the appendix provide an abbreviated CV or Resume for the PI and supervising personnel.  III. Subjects, Recruitment and Consent Process: Subjects: Provide a brief description of exactly who will be in your study? Include demographic characteristics (if known) by gender, race, etc; how they are identified and selected, and inclusion and exclusion criteria. Give the maximum number of participants. Provide information regarding the compensation, if any, that will be provided to the study. b. Recruitment: Provide information regarding which members of the research team will approach subjects, where or on what platform, and exactly what will be said or otherwise communicated to the potential subjects regarding the study? Attach a copy of your recruitment fliers and/or script. c. Consent: Clearly describe your procedure for obtaining informed consent and/or assent (for youth younger than age 18). Include information on location of consent process, and who will be obtaining consent. Anyone involved in the consent process must be key personnel on the study. Attach a copy of all consent and assent documents. Investigators should use the Consent Templates available under the Informed Consent Guidelines tab on the IRB website:  HYPERLINK "http://www.csu.edu/irb/informedconsentguidelines.htm" http://www.csu.edu/irb/informedconsentguidelines.htm d. Waiver of Documentation of Informed Consent: In certain circumstances, the requirement of documentation of informed consent may be waived. Note that in these cases informed consent will often still be required, but documentation through signing a document may not be. Please see guidelines at  HYPERLINK "http://www.csu.edu/irb/informedconsentguidelines.htm" http://www.csu.edu/irb/informedconsentguidelines.htm.  Check here if you are seeking a waiver of documentation of informed consent. Please describe below the reasons you are seeking a waiver and the methods by which you will obtained informed consent.  IV.Procedure: Describe the data collection process. Include details regarding any software or on-line program that is going to be used to collect data. V.Measures: Describe any Medical, Psychiatric, or Social and/or Behavioral surveys, devices, or instruments to be used in the study. Include a discussion of the origin of any surveys used. Attach copies of any surveys or questionnaires. VI.Risks: Describe any potential risks to the subjects. Explicit consideration must be given to all risks; for example, physical, psychological, emotional, legal, social or financial risks to the participants. Risks related to privacy and confidentiality should be considered as well. Please explain any and all procedures taken to minimize risk. VII.Benefits: Describe potential benefits to individual study participants and/or others that may result from the study. Compensation for participation is not a benefit. VIII.Confidentiality: Please describe how confidentiality of data will be protected. Include any discussions of de-identifying data, storage of data, subject lists, tapes and other electronic recordings, etc., and eventual destruction of raw data. IX.Alternatives to Participation: Describe any alternatives to participation including currently accepted practices or treatments. Non-participation is a reasonable alternative. X.Other Issues: Please describe any potential conflict of interest or financial benefit to the investigator, or any other relevant information deemed relevant to IRB consideration.Appendix 1. Request for Statement of Exemption Some research qualifies for exempt review which means that it is exempt from full review of the board and from continued IRB review. Under an exempt review material is reviewed by the IRB Chair and administrator and/or a designated member of the IRB. Exempt projects may or may not have a signed consent form, but where feasible must always have a consent process with enough information to allow the research subject to make an informed decision about participation in the study (see waiver of documented consent under Informed Consent Guidelines). Exempt review requires submission of an application, IRB review and approval prior to initiation of research. Exempt categories have greatly changed with the New Common Rule effective January 21, 2019. Some exempt research may be subject to Limited Review. Please indicate the exempt categories that apply to your research in your statement below: Please indicate the exempt categories that apply to your research: Research represents negligible or no risk to subjects AND o 1) Research in Established or Commonly Accepted Educational Settings: Exempt research must be not likely to have adverse impacts on students learning required educational content or assessment of educators who provide instruction. The exemption may only be used for studies about normal educational practices. o 2) Research involving the use of educational tests, survey procedures, interview procedures or observation of public behaviors: Such research must meet at least ONE of the following conditions: (1) Information obtained is not identifiable (2) Disclosure outside of the research would not put subjects at risk of harm (3) Information obtained can be identifiable but the IRB has completed a limited IRB review, which relates to there being adequate provisions for protecting privacy and maintaining confidentiality o 3) Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects: Benign behavioral interventions are defined as  brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. This exemption is permitted only if the data are recorded in such a way that the identities of the subjects cannot be readily ascertained either directly or indirectly or if the identities can be ascertained, a disclosure of the subjects responses outside the research setting would not reasonably place the subjects at risk of harm or if the IRB conducts a limited review and determines that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. o 4) Secondary Research for which Consent is not Required: Research involving the collection or study of data, documents, records, pathological specimens, or diagnostic specimens. The study material may be existing or prospective (to be collected in the future). There are four available options for use of the exemption: 1. Use of publicly available identifiable private information or identifiable biospecimens. 2. Information recorded by the investigator in such a way that the identity of the subjects cannot be readily ascertained, and the investigator will neither contact the subjects nor re-identify subjects. 3. Research use of identifiable health information when that use is regulated by HIPAA as health care operations, research, or public health activities and purposes as those terms are defined in HIPAA. 4. Analysis of data on behalf of a federal agency or department as opposed to an investigator-initiated analysis of federally supplied data if the requirements of certain federal laws are met. o 5) Research and demonstration projects which are conducted by, supported by, or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. o 6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or APA or the Food Safety and Inspection Service of the USDA. The federal government has also created two new Exempt categories involving broad consent, or a subject giving consent for future uses of information that are not known when the subject gives the consent. These include Category 7: Storage or Maintenance for Secondary Use for Which Broad Consent is Required and Category 8: Secondary Research for Which Broad Consent is Required. The allowance of broad consent is optional for IRBs. At this time, is not allowing broad consent. PLEASE EXPLAIN WHY YOUR PROJECT SHOULD BE EXEMPT AND HOW IT FITS INTO THE INDICATED CATEGORY. Appendix 2. Request for Expedited Review (Optional) Some research activities may be eligible for expedited review procedures. Under expedited review, the review is carried out by the IRB chairperson and/or co-chairperson or by other reviewers designated by the chairperson rather than the full committee. In general, all rules of full review apply including the need for consent documents (unless waived). Under the New Common Rule (effective January 21, 2019), low risk studies (that are often classified as expedited) that do not involve children or prisoners, DO NOT have to do a continuing review report on an annual basis following approval. However, you do still have to file amendments to your IRB application to report any changes and you need also to file a termination report to the IRB on your project at its end (see forms section on IRB webpage). Expedited reviews may be requested for research that involves no more than minimal risk and fits in one or more of the specified categories indicated on the IRB website under Submission Requirements at  HYPERLINK "http://www.csu.edu/irb/submission.htm" http://www.csu.edu/irb/submission.htm. If you believe that your study qualifies as expedited, Please indicate the expedited categories that apply to your research in your statement below: o Research involves no more than minimal risk (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). 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Application for Initial Review Institutional Review Board (IRB) Investigator Agreement Please read and initial each of the following items in the space provided: I agree to conduct the study in accordance with the relevant, current protocol and will only make changes in a protocol after notifying the sponsor and the IRB, except when necessary to protect the safety, rights, or welfare of the research participants. I agree to personally conduct or supervise the described investigation. I agree to ensure that all of the requirements relating to the recruitment and consent process are met. I agree to report to the sponsor and the IRB any adverse experiences and/or events that occur during the course of the experiment. I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations consistent with and in meeting the above commitments. I agree to maintain adequate and accurate records in accordance with IRB regulations and to make those records available for inspection in accordance with those regulations.I agree to ensure that I will submit a request for initial and continuing review and approval to the IRB within the appropriate period of review.I agree to report promptly to the IRB any and all changes in the research activity and all unanticipated problems involving risk to the participants and/or others. I agree to submit a copy of the final report of the results and a summary of those results upon completion of the study. I have completed applicable training in Human Participant Protection and agree to follow the ethical and legal obligations outlined in this training.  IRB reserves the right to audit any/all IRB approved protocols to inquire about the progress of the study, inspect consent documents, inspect data, and/or observe the consent and recruitment process utilized. 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