Institutional Research Board

The Institutional Review Board can grant approval at three levels

• Exempt

  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.

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. This may include research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management techniques.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement); survey procedures (paper-based or online); interview procedures (in person or via technology); or observation of public behavior, UNLESS i) information obtained will be recorded in a manner that may allow human subjects to be identified, directly or through identifiers linked to them, except under explicitly agreed-upon conditions delineated in a data sharing agreement (DSA) with the college or ii) disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement); survey procedures (paper-based or online); interview procedures (in person or via technology); or observation of public behavior not exempt under (b) but involving public officials or candidates for public office, or where federal statutes require without exception that confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information will be recorded by the investigator in such a way that subjects cannot be identified, directly or through identifiers linked to the subjects.
  5. Research or demonstration projects conducted by or subject to the approval of Department or Agency heads that are designed to study, evaluate, or examine public benefit or service programs; procedures for obtaining benefits or services; possible changes in or alternatives to programs or procedures; or possible changes in methods or levels of payment.
  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 a level and for a use found to be safe, or agricultural chemical and environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

  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. 

• Expedited review

  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:

  1. Clinical studies of drugs or medical devices one of the following conditions are met: i) research on drugs for which an investigational new drug application (21 CFR 312) is not required (although research on marketed drugs that significantly increase the risks or decreases the acceptability of risks associated with the use of the product are not eligible for expedited review); or ii) research on medical devices for which an investigational medical device application (21 CFR 812) is not required, or the medical device is cleared/approved for marketing and the device will be used in accordance with its cleared/approved labeling.
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: i) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than two times per week; or ii) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than two times per week.
  3. Prospective collection of biological specimens for research purposes by noninvasive means.
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving xrays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis). Some research in this category may be exempt from federal regulations for the protection of human subjects.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Some research in this category may be exempt from federal regulations for the protection of human subjects.
  8. Continuing review of research originally approved through full review process where the research is permanently closed to the enrollment of new subjects; all subjects have completed research-related interventions; and the research remains active only for longterm follow-up of subjects, or where the remaining research activities are limited to data analysis; or where no subjects have been enrolled and no additional risks have been identified. 
• Full review

  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.

• Modification Requests (All Research)

  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).

• Reporting of Incidents

  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). 

• Continuation Requests (Expedited or Full Review)

  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.

• Completion Notification (Expedited or Full Review)

  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.