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Ivy Tech Community College values and supports research efforts by and on behalf of our faculty, staff, and students. It is important for the College to ensure that those conducting research protect the rights and welfare of human subjects. As such, the purpose of this policy is to establish responsibility for review and approval for research involving human subjects. This policy refers to research projects sponsored by, or associated with, Ivy Tech Community College. This policy includes all proposed research projects that have one or more of the following characteristics: a) the human subjects of the project will be faculty, staff, students, Trustees (State Board or Campus Boards), or Foundation Directors of Ivy Tech Community College; b) the research project will be conducted by, or on behalf of, Ivy Tech Community College faculty, staff, students, trustees, or directors.
The purpose of the IRB is to protect the rights and welfare of human research subjects participating in research studies. The IRB reviews applications to conduct research projects with the primary aims of evaluating the risk to human subjects and appropriate protections against such risks. The Ivy Tech IRB reviews research proposal applications to ensure that rights and welfare of human subjects are protected; that PIs have considered risks to human subjects and made all efforts to minimize those risks; that the potential for benefit to human subjects has been identified and maximized; that human subjects are voluntary participants in the study and have been provided with informed consent; and that research is conducted in an ethical manner. The IRB reviews each research project proposal to see that it is compliant with ethical standards with regards to informed consent, confidentiality, and risk to human subjects.
This type of research typically is low-risk research in which no personal identifiers are collected and that meets certain Federal regulations regarding IRB review and approval. Under 45 CFR 46.101(b), certain categories of activity are considered research but may be declared exempt by the IRB. Determination still must be made by the IRB before a study may be identified as exempt (in other words, a PI may NOT simply determine that his/her research is exempt and proceed without IRB approval). If a study falls under one of the six federal categories for exempt research, the PI still has a responsibility to protect the rights of the human subjects. The six categories are as follows.
NOTE: While the vast majority of research applications submitted for IRB review at Ivy Tech Community College meet the definition of exempt, PIs should take care not to automatically assume that research that does not include the collection of personally identifiable information and that involves surveys, interviews, or observations will be exempt. The type of data collection does not assume the level of risk. For example, research involving surveys or interviews may pose more than minimal risk to participants due to sensitive questions or situations, which may lead to distress that exposes participants to greater than minimal risk. Further, loss of confidentiality may cause harm to human subjects. Research studies that involve more than minimal risk, despite the data collection procedures, may require expedited (or even full) review, both of which are described in the next sections.
Federal regulations allow certain types of research to quality for expedited review (45 CFR 46.110). This type of research typically involves no more than minimal risk. Expedited review may be conducted by a single IRB reviewer, without the involvement or approval of the full IRB. Research included under expedited review does not meet one of the categories described in exempt review. Research conducted under expedited review should present no more than minimal risk to human subjects. Research that falls under expedited review may include, but is not necessarily limited to, the following categories:
Any research that does not meet the criteria listed under exempt or expedited review is required to undergo full IRB board review. When full board review is necessary, the IRB application is presented and discussed at a meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of voting members present.
Those wishing to engage in research involving Ivy Tech faculty, staff, students, trustees, or directors may not begin the proposed research project (including subject recruitment and data collection) until IRB approval has been sought and gained, either through exempt, expedited, or full review processes. It is the responsibility of each PI to seek review by the IRB prior to beginning a research project. Note that only projects that meet the definition of research are subject to IRB review. Normal educational practices, including activities solely for instructional purposes, as well as data collection solely for use by college faculty or staff in making determinations for best practices in education and administration for the college, are typically not subject to IRB review. However, if a student, faculty, staff, trustee, or director wishes to collect or utilize data in order to present or publish the information, whether for a college or graduate school research project, thesis, or dissertation; in conjunction with other researchers wishing to present or publish; or for other reasons that will result in presentation or publication in a context beyond the class or situation in which it was gathered, the activity is considered research and must be reviewed by the IRB. Any Ivy Tech student, staff, faculty, trustee, or director who is unsure about whether an activity constitutes research should contact the IRB.
If review is required, the PI must submit an IRB application for review. The IRB application is available at https://ivytech.qualtrics.com/jfe/form/SV_8AroWGWz3pNZReB. If the research involves the approval of other colleges, universities, agencies, governmental entities, or other related organizations, the information and related approval must be attached to the application.
The application requires:
Once submitted, IRB personnel will review the application and make a determination. The determination may be one of the following:
Any modifications to approved research applications (whether approved as exempt or through expedited or full review) must be communicated to the IRB. The PI may contact the IRB reviewer by email to make notifications of modifications. Any modifications to the research, including (but not limited to) changes to the purpose or focus of the research; changes to the types of human subjects used in the research; changes to data collection or instrumentation methods; changes to recruitment procedures or methods; and changes to informed consent documentation and processes must be submitted for IRB review. It is the responsibility of the PI to submit notification of any modifications. If the PI has any questions as to whether something constitutes a modification, the PI must contact the IRB. Modification requests will be reviewed by the designated IRB reviewer. Should modifications be determined to be more than minimal, the PI may be required to submit a new application for review (if the modifications are determined to have significantly changed the research) or the existing application may be re-reviewed (expedited or full), dependent upon the determination of the IRB reviewer (and additional board members, if determined necessary).
Adverse events and incidents that occur during the course of the research must be reported immediately to the IRB representative. The incident(s) may be reported via email but should include a detailed description of the incident and an assessment of the situation, to determine whether the protocol requires modification to minimize risk, whether the informed consent must be revised, or if subjects should be contacted to re-consent to participate in the study. Incident reports should include a detailed description of the event; an explanation as to why the event was unexpected and related to the research study; a description of changes to the protocol to minimize further risk or a rationale if no changes are required; description of changes to the informed consent or a rationale if no changes are required; a description of the plan to obtain re-consent or a rationale if none is required; and an explanation of why the risks and benefits of the research are still acceptable after the incident(s).
Research projects approved under expedited or full review are approved for a specific timeframe, which is noted in the approval document. Continuing research activities beyond the approval period requires submission of a continuation request. A continuation request may be submitted via email to the IRB. A continuation request for research that was approved under expedited or full review may be reviewed through the expedited review process, if modifications are minor or nonexistent. The PI must submit a continuation request and additional documents, as requested. The IRB reviewer will verify the appropriate level of review for the continuation request and will inform the PI if full review is necessary. For continuation requests without any or with minor modifications that do not fundamentally change the project, the IRB reviewer will conduct the review and submit a determination. For continuation requests originally approved under expedited review, with modifications that are beyond minor, the expedited review process, timeline, and actions will be the same as those for a new application reviewed under the expedited procedures. For continuation requests originally approved through full review with modifications that are beyond minor, the full review process, timeline, and actions will be the same as those for a new application reviewed under the full review process.
If the PI fails to request a continuation or to submit required information along with the continuation request, IRB approval will be terminated upon the expiration date determined in the original approval. Should termination occur, all research activities must cease.
For a completed research project that was approved through expedited or full review, the PI must submit a completion of research notification on or before the IRB approval expiration date. The completion notification may be submitted by email to the IRB.
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