IRB Decision Testing Q1: Does the research involve collecting or looking at data from people?*YesNoHelp: If you will be interacting, observing, or looking at information from people in order to gather information in support of a research question, then the answer is probably YES. For example, you plan to interview individuals about their experiences to answer a research question, or you plan to include them in an experiment of some kind. If you are looking at data or specimens already collected from people then the answer is STILL YES. Even indirect interaction with participants (e.g., general requests to complete questionnaires) counts as a YES. Studies that would typically NOT require IRB would include studies on mathematical theories, inanimate objects, nature, literature or media studies. QA: Is this a “real study” or a classroom/student demonstration project?*Real studyDemo onlyHelp: A real study is one that may result in data that can be used to answer a research question and is useful to a field of study or to meet a particular research need. A demonstration research project is one that is being conducted for a class to demonstrate research techniques or improve curriculum. For example, a teacher may want to give a survey so students have real data to analyze or to learn interview techniques. In some cases a demo project may turn into a real project. If there is a chance that a demo project could lead to real data that you may want to present or make public in some way then you should opt to call this a “real study” just in case. QB: Is your study for institutional use only?*YesNoHelp: Institutional research, such as program evaluations, opinion polls and needs assessments are generally exempt from review by the IRB. This would include surveys to evaluate institutional effectiveness, satisfaction surveys related to goods or services provided by the college or its affiliates, and needs assessments conducted by the college or its affiliates. One more thing: Most institutional research meets a very specific need and is not conducted to test theories. If your use of an opinion survey or needs assessment is to answer a broader question about human nature or to test a theory, then you should answer NO. If you are only conducting the study so you can fill out a report, make a change to programs or services, or establish a need for programs and services, then you should select YES. If you are still unsure please contact the chair of the IRB. QC: Is this a pilot project?YesNoHelp: A pilot project is one in which the primary purpose is to test procedures, logistics, or other aspects of the research protocol prior to implementing a fully developed protocol. The resulting “data” will not be published or presented anywhere and is not intended to answer a research question. QCa: Could any aspect of this pilot project pose physical, psychological, emotional, or legal risk to participants?*YesNo QD: Is your study entirely archival in nature?*YesNoHelp: Archival means the data has already been collected by you or someone else. This could include databases, collections of letters, diary entries, photographs or videos of individuals, etc. Presumably the data were collected in an ethical manner and all applicable polices and procedures were followed at the time of its original collection. If you are using only existing data to answer a new question and will NOT be collecting additional information from people, then the answer is YES. If you are collecting all new data or you plan to include new participants, ask more questions of participants, or add anything new to an existing data set that might change the level of risk to participants (such as matching their data to other data that might identify them) then you should select NO. QDa: Is there any way for anyone on your research team to know or to figure out the identity of any of the individuals who provided the archival data?*YesNoHelp: If the archival data set is set up in such a way that the people are anonymous or their names can not be matched up to any other information then the answer is NO. QDb: Is all the information available through public or open sources?*YesNoHelp: Examples of public or open sources would include any information that is available to anyone and which does not require prior authorization, password protections , or other permission to obtain. If you can collect this data through a library search or web search, then it is probably not private data and is therefore exempt from review by the IRB. If there is an expectation that at least some of the information being used for your study is private or available to only certain organizations or people then you must select “No”. QE: Is this an entirely educational study?*YesNoHelp: To count, a study must be conducted entirely in an educational setting (schools, colleges, preschools, after-school programs, and other sites where educational activities regularly occur) and involve only normal education practices. Typical studies would include comparison among instructional techniques, curricula, or classroom management strategies for use by a teacher or teachers within a specific school or school system. Studies done by someone other than a student-teacher or teacher probably do not count. Studies that serve additional purposes, such as contributing to generalizable knowledge by testing educational or psychological theories about learning would also NOT count. Additionally, surveys or testing that is done with students on subjects unrelated to curricular subjects would not count (e.g., collecting family, social, or health surveys). Q4: Are you targeting or including only healthy adults with no known risk factors?*YesNoHelp: If your study could include anyone under the age of 18, please select No. Please select No, if any adults in your study could be considered “at risk”. This includes those who may not be in a position to give complete informed consent, such as prisoners or adults who have known health risks that may be aggravated by participation in your study. When in doubt about whether your participant(s) is at risk, consult the chair of the IRB. Q5: Are you doing anything to your participants that might pose any risk of physical injury or psychological/social harm?*NoYesHelp: Consideration of risk should be taken very seriously and the researcher should consider all components of the study and anticipate all possible risks. Examples of studies that would NOT normally constitute any risk include: Surveys or interviews on innocuous topics. Anonymous, non-interactive observation of public behavior. Research on PK-12 educational curriculum or teaching methods. Use of common tests and measures under anonymous conditions. Examples of studies that WOULD constitute risk include: Surveys or experiments involving embarrassing, shameful, guilt-inducing, scary or other uncomfortable topics or activities. Physically demanding activities or exertion that may put some individuals at greater risk for injury. Cognitive or psychological testing that is likely to leave participants feeling bad about themselves or others. Q6: Are you doing an intervention or treatment of some kind? (help)*NoYesHelp: An intervention would include some kind of psychological or physiological therapy to correct or treat a problem or condition. Most experiments DO NOT involve an actual intervention or treatment of any kind. Rather, the experimenter is looking at differences in variables assigned to participants who are healthy and not in need of treatment for any problems or conditions. In cases, where an experiment or study is needed to determine the effectiveness of a specific type of intervention or treatment then the answer is YES. In addition, most educational studies would also NOT be considered interventions. When in doubt please contact the chair of the IRB. Q7: Are you going to be lying to participants or temporarily deceiving them? (help)*NoYesHelp: In many experiments you may decide to withhold some information, such as your expected findings (hypothesis) or which condition/ group they are in relative to other participants (placebo vs. experimental). These kinds of omissions ARE NOT the same as lying or intentionally deceiving participants. Most studies do not require any overt deception. If that is the case for your study you may select NO. Some studies may require deception, however, in order to mask the true purpose of the study or to prevent participants from acting a certain way. If you will be lying to participants about any part of the study purpose, methods or results you must select YES. Q8: Does the research involve only the use of educational tests, surveys, or conventional interview procedures and no manipulations of any kind?*YesNoHelp: Select NO if the only way to know for certain who participated in your study is for the volunteers to offer that information themselves . Select YES if there is a possibility of identifying participants based on their responses or by their presence at a study where the survey is administered (e.g., classroom setting). Even if you do not ask for names, if the researcher can tell who took the survey or test by their presence or responses then it is not anonymous. Q8a: Is there any way in which your participants can be identified by you or anyone on your research team?*YesNo Q8B: Could any disclosure of the responses outside the research reasonably place a participant at risk?*YesNoHelp: Risks might include criminal or civil liability or damage to one’s reputation, financial stability, employability, or social status within their community or network. At this point, you have said that you are giving an anonymous survey but even if it is anonymous you must consider the possible risks to the participants. If there is any risk at all to participants you must select YES no matter how unlikely the risk. Q9: Does this study only involve the observation of public behavior and no interaction with participants?*YesNoHelp: Answer yes if you are simply observing the behavior of people in public settings or venues (social network sites) where they would not have any expectation that their behavior is private. Answer no if the participants have a reasonable expectation that what they say and do will not be seen or heard by anyone or by only certain people. Answer no if you plan to interact with the participants at all (stop to interview them, manipulate their behavior through your presence or interactions). Typical studies involving observation without interaction would include observing the flow of traffic around an intersection or the reaction of audience members to a show. Exempt A Only research studies involving human subjects requires approval by the IRB. If you will not be using information from people as sources of data to help answer your research question then you do NOT need approval from the IRB. Refer to 45 CFR 46.102(f) Exempt B It looks like your study is exempt because it does not meet the definition of a research activity. Therefore, it does not require approval by the IRB. However, you should follow ethical practices even when just practicing or demonstrating research. Refer to 45 CFR 46.102(d) Student researchers may benefit from going through the IRB process even if they are only collecting data to learn techniques. Exempt C It looks like your study is exempt from IRB approval. You should have your study approved by the highest person in the department or area overseeing the targeted participants. For example, a campus-wide survey should be approved by the President, a student or faculty survey should be approved by the Academic Dean, and a survey specific to a certain major should be approved by the Area Chair. Refer to 45 CFR 46.101(b)(5) However, you should carefully review all procedures and questions to ensure that anonymity is protected especially in the case of institutional surveys where questions such as age, race and gender could be used to identify participants even if they are not asked for their names. Exempt D This project appears to be minimal risk and exempt from review. Only human-subjects research for which there is intent to develop or to contribute to “generalized knowledge” must be submitted for approval by the IRB. Refer to 45 CFR 46.102(d) Once the project is finalized, revisit the Decision Tree and go through the questions again. Another words, the actual project should be subjected to these questions after you have finalized your research protocol. Exempt E Your project appears to be exempt from review by the IRB because it meets one or more of the qualifications as indicated by CFR 46.101(b)(4). “Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.” Refer to 45 CFR 46.101(b)(4) Exempt F It looks like your research is exempt because it is educational research. Refer to 45 CFR 46.101(b)(1) Exempt G It looks like your study is exempt because your participants will be adults taking conventional tests or surveys under anonymous conditions and that there is no risk to them even if their responses were to become known. Refer to 45 CFR 46.101(b)(2) Exempt H It looks like your study is exempt from review because you will only be observing public behavior and you will not be interacting with them or posing any risk of harm to them. Refer to 45 CFR 46.101(b)(2) Non-Exempt E (Expedited) Based on your responses it looks like your study will require only an expedited review. Please visit the website to complete the online application form. Non-Exempt: F (Full) Based on your responses it looks like your study may require a full review by the IRB. Please visit the website to complete the online application form.