It is college policy to ensure that the rights and welfare of human subjects are adequately protected in research conducted under its auspices. In addition, federal and state laws and regulations require these protections. In order for the college to fulfill its responsibility and to comply with the law and regulations, all human subjects research conducted under college auspices must receive appropriate review and approval.
Does my project need to be reviewed?
Before the review process, researchers must be sure that their project is, in fact, human subjects research as defined by the federal government. In order to qualify as human subjects research, the following must be true:
- The participants must be living. Thus, oral history projects fall under the guidelines, but research involving diaries kept in the 1800s does not.
- The project is a systematic investigation. That is, it is designed to be a study. For example, instances in classrooms where teachers ask students' opinions on the material to gauge progress are not research. However, if that same teacher designs a study to evaluate two different methods of teaching the material to see which is more effective, this would be research if the third criterion is met.
- The project is designed to contribute to the generalized knowledge. To qualify as research, the person conducting the project must intend it to be for dissemination at some level. On our campus, we also review student projects that may not be disseminated but that meet the first two criteria so that our students will learn the process of human subjects research and because we have contracted with the federal government to do so. At what level does my project need to be reviewed?
LEVEL 1: Department Level Review (download the form)
Certain student research projects do not have to be submitted for Institutional Review Board approval but should be reviewed at the department level. Projects that may be reviewed at the department level include laboratory projects, educational exercises and class projects, and action research within a classroom with performance or grades as the sole outcome measure. Each department is to designate one representative to the IRB to serve as the reviewer for department level protocols. In order to qualify for department level review, the research must be disseminated only within the BSC campus. For example, research presented at the Student Research and Creativity Celebration or theses bound and filed in the library may be reviewed departmentally, but any research that will be presented at regional or national conferences or published in journals should be reviewed at Levels 2, 3, or 4. All faculty research, all research that may be risky or on a sensitive topic, or that includes children, except as noted for action research, must be reviewed at Levels 2, 3, or 4.
LEVEL 2: Exempt or Limited Review (download the form)
The federal government uses the term "Exempt" to indicate that a protocol is exempt from the higher levels of review because of its low risk for harm. This does not mean that the project is exempt from oversight. Exempt projects simply require less paperwork. Projects that qualify for Exempt or Limited Review include, but are not limited to:
- Action research in the classroom with syllabus-related outcomes, including syllabus-related attitude questions. This does not include the administration of personality measures. That is, "What was your opinion of the unit on World War II?" is acceptable, but a survey on introversion/extraversion would require expedited review.
- Surveys on innocuous topics completed by adults.
- Anonymous surveys (even on more controversial topics) completed by adults.
- Research using existing data or documents if the sources are publicly available or the individual source of the data cannot be identified.
- Research on individual or group behavior of normal adults where there is no psychological intervention, physiological intervention or deception.
- Interviews and interactive surveys on non-sensitive topics.
- A Sample of an Exempt Review Protocol
Projects that are more intrusive than exempt projects or that require the participation of children (aside from action research as noted in Levels 1 and 2), may qualify for Expedited Review. In this case, the protocol is similar to that of the Full-Board Review, but the project is reviewed by one designated member of the IRB. The designee may approve the project, request additional information, or submit the proposal to the IRB for Full-Board Review and approval. Some examples of Expedited Review projects include, but are not limited to:
- Educational research that involves separating the child for individualized field testing.
- Continuations and/or modification of proposals initially approved under the Full-Board Review process, if they present no additional risks to participants.
- Interviews or surveys on sensitive topics where the subject can be identified.
- A Sample of an Expedited Review Protocol
Full-Board Review is the highest level of review for human subjects protocols and is designed for projects that are sensitive in nature. The review is conducted at the next scheduled meeting of the IRB. Some examples of Full-Board Review projects include, but are not limited to:
- Research that might put participants at risk, such as research on domestic violence or illegal drug use.
- Research involving psychological or physiological intervention.
- Non-curricular, interactive research in schools.
- Research involving deception.
- Research conducted outside of the United States.
- Unapproved protocols at the Expedited level.
Do I need ethics training?
All faculty members conducting human subjects research or supervising student research need to complete ethics training, as specified by the federal regulations. All students conducting human subjects research at Levels 2, 3, or 4 also need to complete this training. We encourage students conducting Level 1 research to complete the training as well, but this is not mandatory. Although researchers may complete other federally-approved training programs to satisfy this requirement, we encourage researchers to complete the CITI program, for which the college has a site license. To access this training, visit the CITI website http://www.citiprogram.org/.
◊ Overview of Training and Review Requirements Table (.pdf)
◊ CITI Collaborative IRB Training Initiative http://www.miami.edu/citireg/
◊ An Investigator's Guide to Research with Human Participants (.pdf)
◊ Request for Changes to a Protocol (.pdf)
◊ Collaborative Research (.pdf)
◊ Informed Consent Template (.pdf)
◊ Internet Research (.pdf)
◊ Investigator's Checklist for Human Participants Compliance (.pdf)
◊ Miscellaneous Categories of Research (.pdf)
◊ Organizational Research (.pdf)
◊ Policy Manual for Research Activities Involving Human Participants (.pdf)
◊ Research Involving Human Subjects Training Programs (.pdf)
◊ Review Board Members 2011 - 2012 (.pdf)
◊ Socially Sensitive Research (.pdf)