ࡱ> 5 5bjbjr2r2 4XhXhP-0 88888LLL8,L;b&N(vvvQoaaaaaaa$adg~a8QQa88vva'''F8v8va'a''0[ _v$@k6<]6a b0;br]Rggl__&g8_'aa;bg X : Institutional Review Board Office of Research ComplianceDetermination of IRB Submission V08232022 DETERMINATION OF MU IRB SUBMISSION INSTRUCTIONS: Not all research involving humans will require MU IRB submission or approval. Only activities meeting the regulatory definitions of (a) research and (b) human subjects and where (c) MU is engaged in the conduct of human subjects research require MU IRB review and approval. Use this form as a tool to help you determine whether formal IRB submission through Kuali is needed. Project Title:Completed by: SECTION 1: DETERMINATION OF RESEARCH Research a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. RESEARCH Activities designed to develop or contribute to generalizable knowledge are those activities designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations beyond the specific study population), inform policy, or generalize findings. The project may be research if it: intends to advance general knowledge in the academic, scientific, or professional community; is conducted using a research design that will lead to scientifically valid findings; or subjects are not expected to benefit personally from the knowledge gained. is being conducted to support a dissertationNOT RESEARCH Projects may be systematic but not research. Some examples of not research include: classroom projects solely to fulfill course requirements and the intention is to not share the results beyond the University community; quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the University community. Most of the subjects who participate in the project are expected to benefit from the knowledge gained and the main goal of the project is to improve services; Oral history activities, in general, are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge. Only those oral history projects that conform to that regulatory definition of research need to submit their research protocols for IRB review. Capstone projects which demonstrate a students skill and knowledge with the intent to apply those skills towards solving a clinical problem.Use the information above to answer the following questions.Do the proposed activities involve a systematic approach? A systematic approach involves a predetermined method or a plan for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory. A systematic approach incorporates collection of data, either quantitative or qualitative, or specimens; and analysis. [__] YES [__] NO If NO, please explain why the proposed activities do not involve a systematic approach: MACROBUTTON NoMacro  Is the intent of the proposed activities to develop or contribute to generalizable (scholarly) knowledge? [__] YES [__] NO If NO, please explain the intent of proposed activities and explain how the proposed activities are not intended to contribute to generalizable knowledge: MACROBUTTON NoMacro  Will the data collected be used in a thesis or dissertation? [__] YES [__] NO  SECTION 2: DETERMINATION OF HUMAN SUBJECT Human subject - a living individual about whom* an investigator (whether faculty, student, or staff) conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information. (1) Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. (1) Interaction includes communication or interpersonal contact between researcher and subject. (2) Identifiable includes where the identity of the subject is or may be ascertained by the researcher or associated with the information (2) Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical or educational record information). Private information must be individually identifiable * The information being obtained must be about the individual/subject; their opinions, characteristics, or behavior. Solely obtaining information, for example from an employer, how many employees they have or whether a specific HR policy exists would not be about the individual and therefore not meet the criteria for human subject.Use the definitions above to answer the following questions.Are the human subjects living individuals? This applies to charts reviews and datasets. [__] YES [__] NO If NO to 1, the criteria for human subject are not met. Go to Section 4. Do the activities involve MU personnel directly obtaining information through intervention, interaction or observations about the individuals? E.g., interviews, surveys, sensors placed on the body, etc. Directly obtaining refers to first hand collection and not analysis of existing data. [__] YES [__] NO Do the activities involve MU personnel accessing individually identifiable (e.g., names, medical record numbers, social security numbers, study ID codes, etc.) and private information about living individuals? This applies to charts, records, datasets, and specimens. Even if you are not recording identifiers, if the source of the data contains identifiers, then mark this question as a yes. [__] YES [__] NO Do the activities involve MU personnel obtaining or receiving individually identifiable (e.g., study ID codes, names, medical record numbers, social security numbers, etc.) and private information about living individuals? This applies to charts, records, datasets, and specimens. [__] YES [__] NO If yes to #4, will the data/specimens be coded such that a link exists that could allow the source of the data/specimens to be re-identified (i.e., key available to decipher the code)? [__] YES [__] NO Is there a written agreement that prohibits the MU researcher and his/her research team from having access to the link, or the likelihood for the MU researcher to have access to the identifiers is extremely unlikely? [__] YES [__] NO  SECTION 3: DETERMINATION OF ENGAGED MU Auspices: MU personnel (student, faculty, or staff) who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. Non-MU researchers wishing to conduct human subjects research using MU personnel as subjects or its facilities are not considered to be engaged. This document is for the determination of MU IRB review only and you are expected to obtain other permission as necessary. For example, the MU IRB does not have authority to grant the release or use of MU listservs, equipment, or facilities. ENGAGED MU is considered to be engaged in human subjects research if MU or MU personnel are involved in any the following activities under MU auspices: direct awardee of a federal grant, award, or contract; obtaining informed consent; performing invasive or noninvasive procedures with subjects; intervening for research purposes with any subjects by manipulating the environment; interacting for research purposes with any subject; (e.g., conducting research interviews or administering questionnaires); or obtaining private identifiable information.NOT ENGAGED MU is considered to not be engaged in human subjects research if MU or MU personnel are solely involved in the following activities: performing commercial/service where: (a) the services performed do not merit professional recognition or publication privileges; (b) the services performed are typically performed by those institutions for non-research purposes; and (c) the institutions employees or agents do not administer any study intervention being tested or evaluated under the protocol; inform (e.g., provide a copy of informed consent document, information about contacting the investigator, seek or obtain the prospective subjects permission for investigators to contact them) prospective subjects about the availability of the research but do not obtain subjects consent for the research or act as representatives of the investigators; or release of identifiable private information/specimens pertaining to the subjects of the research.Use the information above to answer the following question.Is MU engaged in human subjects research? [__] YES* [__] NO* *If YES or NO, please explain why MU IS or is NOT engaged in human subjects research: MACROBUTTON NoMacro  Is any non-MU IRB involved in reviewing this project? [__] YES* [__] NO *If YES, please explain which IRB(s) and the status of IRB approval(s): MACROBUTTON NoMacro   SECTION 4: IS YOUR PROTOCOL HUMAN SUBJECTS RESEARCH, AND MU IS ENGAGED?  If based on your responses in Section 1 the activities constitute research; and per your responses in Section 2 the activities involves human subjects; and per your responses in Section 3 MU is engaged. Please complete and submit the appropriate documents for Initial Review. All forms are available on the IRB website. If you have questions, contact the IRB office at orc@marquette.edu. If the activities appear that MU is not engaged in human subjects research, you are not required to submit an IRB application. If you would like confirmation and documentation from the IRB staff that your proposed activities do not constitute MU being engaged in human subjects research, please complete this form including Sections 5 - 6 below with the subject line reading Determination of MU IRB Submission and submit to  HYPERLINK "mailto:orc@marquette.edu" orc@marquette.edu. You will receive a completed pdf version of this form back within 2-3 working days. SECTION 5: STUDY INFORMATION  Describe the purpose of the proposed activities. State the overall objectives and specific aims. Provide a brief description of the procedures. MACROBUTTON NoMacro   Describe the subject population, or the type of data and/or specimens to be studied. MACROBUTTON NoMacro  Describe how the data and/or specimens will be obtained. If you are receiving de-identified data OR will not have access to the key which links coded data, submit supporting documentation (can be email correspondence or formal memo) from the provider of the dataset attesting to the data being de-identified or coded but you will not have access to the key. MACROBUTTON NoMacro  Describe how the results of the project will be used or disseminated. MACROBUTTON NoMacro   Do not submit this word document to the IRB.Keep for your own use. 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