The IRB reviews all projects that meet two criteria: (1) The project must be “research,” and (2) the project must include “human subjects.” The federal regulations provide definitions for each of these terms, which are the definitions that we use.
Research is defined as “. . . a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102d). For example, a case report on a single individual may not meet this definition because it is unlikely that one could generalize from that single case. On the other hand, an open-ended interview that includes a number of probing questions to ensure that all interviewees address the same topics would be considered to be systematic and would meet the definition of research—so long as several individuals were interviewed so that the resulting information was generalizable.
A Human Subject is defined as “. . . a living individual about whom an investigator conducting research obtains (1) data through intervention of interaction with the individual, or (2) identifiable private information (45 CFR 46.102.f). Thus, individuals are considered a human subject if the researcher interviews them, surveys them, formally observes and takes notes on their behavior, or asks them to complete an experiment, or if the researcher obtains private information about them (e.g., medical or educational information obtained from reviewing their confidential records).
IRB oversight is required when a project meets the criteria for both research and human subject participation. A project that only analyzes data from publicly available databases would not require IRB oversight because there is no interaction with the individuals whose data are being studied and the information being studied is not private (it is publicly available).
Unless they are part of a project described below that is considered research by the IRB, the following activities are not considered research by the IRB and therefore are not subject to IRB oversight:
· Scholarly and journalistic activities (e.g., oral histories, journalism, biography, literary criticism, legal research, and historical scholarship) designed to provide an accurate and evidence-based portrayal of individuals and not to protect them from public attention
· Surveillance of public health activities, including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health
· Collection and analysis of information, biospecimens, and records for a criminal justice agency or criminal investigation
· Operational activities in support of intelligence, national security, defense, or homeland security
Many classroom or course projects that are designed solely to instruct students about research methods and data collection procedures would not require IRB oversight because they would not result in generalizable knowledge. Nonetheless, these projects should be supervised by a faculty member to ensure that they do not intrude on human rights. If a course related project involves more than routine pedagogical procedures employed on a regular basis, involves more than minimal risk to participants, and/or involves participants outside the college and formal permission is required from the research site, the project may need to be submitted to the IRB for review.
A faculty member or student who is writing an article for a campus newspaper would not be considered to be engaged in research but instead would be subject to the ethics of journalism since journalistic activity is not intended to contribute to generalizable knowledge. If the article is intended to publish findings from a project designed to contribute to generalizable knowledge, however, then the activity constitutes research and should be reviewed by the IRB prior to beginning the project.
Projects that involve data gathering that is only to be used for internal purposes by an instructor, department, organization, or institution (e.g. for quality control, routine course or program development, or student or employee evaluations) do not need to be submitted to the IRB for review.
The following activities, if they involve human subjects and meet the definition of research, would require IRB review:
· A project to be used as a thesis or other form of capstone project;
· A project intended for publication or presentation, if the college is to be listed as the researcher’s affiliated institution;
· Pilot testing of materials to be used for a formal research project.
Special considerations: There are circumstances where IRB oversight may be required, even if these projects do not neatly fit the specific definition of “research.”
If the findings of a project are to be disseminated in any public forum (either a public presentation that is not part of a course or required program evaluation or a publication that is not part of a course or required program evaluation), the research proposal must be submitted to the IRB for review before the study may be conducted. This means that if a researcher thinks there is any possibility of sharing her/his findings beyond a course or program requirement, the researcher must submit a proposal to the IRB for approval. If a researcher engages in a project that initially did not involve an intent to publish or present finding but at a later date, decides to pursue formal publication or presentation of the work, the project should be submitted to the IRB for review when such a decision is made. In this case, the IRB will determine whether the project data may be used for publication/presentation purposes or if it may only be used for its originally intended purpose.
If the research is to be conducted with human subjects who are members of a protected population, the project must be submitted to the IRB for full board review. Under federal regulations, Protected populations include children, minors under 18 years of age, and prisoners. Others who may be considered protected are cognitively impaired persons; traumatized persons; comatose persons; terminally or seriously ill persons; elderly/aged persons; minorities; and students or employees who may potentially feel coerced into participation in a study.